BRPI0806150A2

Engagement interface for biopsy system vacuum module

Abstract

COUPLING NTERFACE FOR VACUUM MODULE OF BIOPSY SYSTEM. The present invention relates to a biopsy system that includes a biopsy device, a vacuum vessel, a vacuum control module, and a plurality of tubes. A first tube is configured to provide axial vacuum to the biopsy device, while the second tube is configured to provide lateral vacuum. A third tube is configured to communicate atmospheric air to the second tube. A fourth tube is configured to communicate saline to the second tube. The vacuum container is configured to collect fluids that are absorbed through the first tube and the second tube. The container has a lid with channels formed in it to hold the first, second, third and fourth tubes. The cap is also provided with coupling regions to selectively clamp each tube against itself to prevent fluid communication through the selected tubes. The container can be removably inserted into the vacuum control module, which includes components to selectively pinch the tubes against the coupling regions

BRPI0806150A2, drawing sheet 1 — Sheet 1 of 70

Term

2.2 yearsleft in the term

Expires 21 November 2028.

1 claim: 1 independent, 0 dependent

1
REIVINDICAÇÃO 1. Sistema de biópsia, onde o sistema de biópsia compreende:(a) um dispositivo de biópsia configurado para obter amostras de tecido a partir de um paciente onde o dispositivo de biópsia compreende: (i) uma cânula dotada de uma ponta de perfuração de tecido, onde a cânula inclui uma abertura transversa formada proximal à ponta, onde a cânula inclui uma parede que separa a primeira porção de luz a partir da segunda porção de luz, onde a parede é dotada de uma pluralidade de aberturas formadas através da mesma, e (ii) um cortador disposto dentro da primeira porção de luz da cânula, onde a cânula é transladável dentro da cânula para seccionar uma porção de tecido que se salienta através da abertura, onde o cortador é giratório dentro da cânula, onde o cortador define uma luz de corte;(b) um primeiro tubo em comunicação de fluido com a luz de corte, onde o primeiro tubo está adicionalmente em comunicação de fluido com uma fonte de vácuo;(c) um segundo tubo em comunicação de fluido com a segunda porção de luz por meio de uma tubulação de agulha, onde o segundo tubo está adicionalmente em comunicação de fluido com a fonte de vácuo;(d) um terceiro tubo em comunicação de fluido com o segundo tubo, onde o terceiro tubo está adicionalmente em comunicação de fluido com o ar atmosférico;(e) um quarto tubo em comunicação de fluido com o segundo tubo, onde o terceiro tubo está adicionalmente em comunicação de fluido com uma fonte de solução salina;(f) um recipiente de vácuo, onde o recipiente de vácuo é configurado para coletar fluidos sorvidos através do primeiro tubo e do segundo tubo, onde o recipiente de vácuo inclui uma tampa dotada de canaletas formadas na mesma, onde o primeiro tubo, o segundo tubo, o terceiro tubo e o quarto tubo são parcialmente dispostos dentro das canaletas, onde a tampa adicionalmente compreende uma pluralidade de regiões de engate para apertar o primeiro tubo, o segundo tubo, o terceiro tubo e o quarto tubo contra para seletivamente evitar a comunicação de fluido através do primeiro tubo, do segundo tubo, do terceiro tubo e do quarto tubo;e (g) um módulo de controle de vácuo, onde o módulo de controle de vácuo compreende: (i) uma fonte de vácuo, (ii) um compartimento para receber por inserção o recipiente de vácuo, (iii) uma pluralidade de solenóides, onde cada solenóide está associado com um correspondente do primeiro tubo, do segundo tubo, do terceiro tubo e do quarto tubo, onde cada solenóide é configurado para acionar uma haste correspondente, e (iv) uma pluralidade de pontas, onde cada uma das pontas é fixada a uma correspondente das hastes, onde cada uma das pontas é configurada para apertar um correspondente de primeiro tubo, segundo tubo, terceiro tubo e quarto tubo contra uma região de engate associada para evitar a comunicação de fluido através do tubo correspondente;onde um ou mais de primeiro tubo, segundo tubo, terceiro tubo e quarto tubo inclui uma pluralidade de fendas externas formadas através de uma porção do tubo. 1/69

347 paragraphs, as filed

(54) Title: ENGINE INTERFACE FOR VACUUM MODULE OF THE BIOPSY SYSTEM (30) Unionist Priority: 11/20/2007 us 11 / 942,951 (73) Holder (s): Ethicon Endo-Surgery, INC.

(72) Inventor (s): David A. Deupree, John A. Hibner, Michael J. Àndreyko, Paul G. Ritchie, Trevor WV Speeg, Wells D. Haberstich, William D. Dannaher (57) Summary: coupling interface for VACUUM SYSTEM OF BIOPSY SYSTEM. The present invention relates to a biopsy system that includes a biopsy device, a vacuum vessel, a vacuum control module, and a plurality of tubes. A first tube is configured to provide axial vacuum to the biopsy device, while the second tube is configured to provide lateral vacuum. A third tube is configured to communicate atmospheric air to the second tube. A fourth tube is configured to communicate saline to the second tube. The vacuum container is configured to collect fluids that are absorbed through the first tube and the second tube. The container has a lid with channels formed in it to hold the first, second, third and fourth tubes. The cap is also provided with coupling regions to selectively clamp each tube against itself to prevent fluid communication through the selected tubes. The container can be removably inserted into the vacuum control module, which includes components to selectively pinch the tubes against the coupling regions

ΡΙ0806150 -5

Descriptive Report of the Invention Patent for COUPLING INTERFACE FOR VACUUM MODULE OF BIOPSY SYSTEM. Background of the Invention

The present invention relates to biopsy samples that have been obtained in a variety of ways in a variety of medical procedures using a variety of devices. Biopsy devices can be used under stereotactic guidance, ultrasound guidance, MRI guidance, or other. Merely exemplary biopsy devices are described in US Patent No. 5,526,822, entitled Method and Apparatus for Automated Biopsy and Collection of Soft Tissue, filed on June 18, 1996; US Patent No. 6,086,544, entitled Control Apparatus for an Automated Surgical Biopsy Device, filed July 11, 2000; US Publication No. 2003/0109803, entitled MRI Compatible Surgical Biopsy Device, published on June 12, 2003; US Publication No. 2007/0118048, entitled Remote Thumbwheel for a Surgical Biopsy Device, published on May 24, 2007; US provisional patent application serial number 60 / 869,736, entitled Biopsy System, filed on December 13, 2006; and US provisional patent application serial number 60 / 874,792, entitled Biopsy

Sample Storage, filed on December 13, 2006. The description of each of the US patents, Publication of patent application and publication of provisional patent application mentioned above is incorporated herein by reference. Although several systems and methods have been produced and used to obtain a biopsy sample, it is believed that no one before the inventors has produced or used the invention described in the attached claims.

Brief Description of Drawings

Although the specification concludes with the claims that particularly point and distinctly claim the invention, it is believed that the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which similar reference numbers identify the same elements and in which:

Figure 1 illustrates a schematic view of an exemplary biopsy system.

Figure 2 illustrates a perspective view of an exemplary assembled biopsy device, for use in a stereotactic set.

Figure 3 shows an exploded view of the biopsy device of Figure 2, with the probe detached from the case.

Figure 4 illustrates a perspective view of an exemplary assembled biopsy device, for use in an ultrasound installation.

Figure 5 shows an exploded view of the biopsy device of Figure 4, with the probe detached from the case.

Figure 6 illustrates a top perspective view of the probe portion of the biopsy device of Figure 3.

Figure 7 shows a bottom perspective view of the probe portion of Figure 6.

Figure 8 shows a top perspective view of the probe portion of Figure 6, with the top cover removed.

Figure 9 shows a bottom perspective view of the probe portion of Figure 6, with the base removed.

Figure 10 shows a side cross-sectional view of the probe portion of Figure 6, taken along a longitudinal plane.

Figure 11 illustrates a perspective view of the needle component of the probe portion of Figure 6.

Figure 12 illustrates a partial perspective view of the probe portion of Figure 6, showing a needle hub assembly.

Figure 13 illustrates a partial perspective view of the probe portion of Figure 6, showing a needle hub assembly with the needle tap removed.

Figure 14 illustrates a partial cross-sectional view of the rotation and translation cutter mechanism of the probe portion of Figure 6, taken along a longitudinal plane.

Figure 15 illustrates a front perspective view of an exemplary tissue sample holder.

Figure 16 illustrates the tissue sample holder of Figure 15, with the cup and other components removed.

Figure 17 illustrates the tissue sample holder of Figure 15, with a tissue sample tray removed.

Figure 18 illustrates a rear view of the tissue sample holder of Figure 15.

Figure 19 illustrates a rear view of the tissue sample holder of Figure 15, with the cup and other components removed.

Figure 20 illustrates a perspective view of an engaging member.

Figure 21 illustrates an exploded view of an applicator and the tissue sample holder of Figure 15.

Figure 22 illustrates a perspective view of the applicator of figure 21 inserted in the tissue sample holder of figure 15.

Figure 23 illustrates a perspective view of the case of the biopsy device of Figure 2.

Figure 24 shows a top view of the case of Figure 23, with the top cover removed.

Figure 25 illustrates a side view of the case of Figure 23, with the side panels removed.

Figure 26 illustrates another side view of the case of figure 23, with the side panels removed.

Figure 27 illustrates a partial view of the case of Figure 23, showing an exemplary needle rotation mechanism.

Figure 28 illustrates a partial view of the case of Figure 23, showing an exemplary needle drive mechanism.

Figure 29 illustrates a partial view of the case of Figure 23, showing an exemplary needle drive mechanism in a raised configuration.

Figure 30 illustrates a partial view of the case of Figure 23, showing an exemplary cutter drive mechanism.

Figure 31 illustrates a partial view of the case of Figure 23, showing an exemplary tissue support rotation mechanism.

Figure 32 illustrates another partial view of the case of Figure 23, showing an exemplary tissue support rotation mechanism.

Figure 33 illustrates a bottom perspective view of the probe portion of the biopsy device of Figure 4.

Figure 34 illustrates a top perspective view of the probe portion of Figure 33, with the top cover removed.

Figure 35 illustrates a bottom perspective view of the probe portion of Figure 33, with the base removed.

Fig. 36 illustrates a partial perspective view of the probe portion of Fig. 33, showing a needle hub assembly.

Figure 37 illustrates a partial perspective view of the probe portion of Figure 33, showing a needle hub assembly with the needle tap removed.

Figure 38 illustrates a front perspective view of an exemplary tissue sample holder, with the cup and other components removed.

Figure 39 illustrates the tissue sample holder of Figure 38, with the tissue sample tray removed.

Figure 40 illustrates a rear view of the tissue sample holder of Figure 38, with the cup and other components removed.

Figure 41 illustrates a front perspective view of the case of the biopsy device of Figure 4.

Fig. 42 shows a rear perspective view of the case of Fig. 41.

Fig. 43 shows a top view of the case of Fig. 41, with the top cover removed.

Figure 44 illustrates a partial view of the case of Figure 41, showing an exemplary cutter drive mechanism.

Figure 45 illustrates a partial view of the case of Figure 41, showing an exemplary tissue support rotation mechanism.

Fig. 46 illustrates a perspective view of an exemplary vacuum control module and an exemplary vacuum container.

Fig. 47 illustrates a vacuum control module of Fig. 46 with the vacuum container of Fig. 46 separated from it.

Fig. 48 illustrates a perspective view of the vacuum container of Fig. 46.

Fig. 49 shows a top view of the vacuum container of Fig. 46.

Fig. 50 shows a top view of the vacuum container of Fig. 46, with tubes engaged with a top portion of the can.

Fig. 51 illustrates a cross-sectional view of the can of Fig. 46, taken along a longitudinal plane.

Figure 52 illustrates a rear perspective view of the vacuum control module of figure 46.

Figure 53 illustrates the vacuum control module in figure 46, with an outer wrapper removed.

Fig. 54 illustrates a perspective view of the vacuum container orifice assembly of the vacuum control module of Fig. 46.

Figure 55 shows a front view of the vacuum container orifice assembly of Figure 54.

Fig. 56 illustrates a rear view of the vacuum container orifice assembly of Fig. 54.

Fig. 57 illustrates a cross-sectional view of the vacuum container orifice assembly of Fig. 54.

Figure 58 illustrates a cross-sectional view of the vacuum container orifice assembly of Figure 54 with the vacuum container of Figure 46 inserted therein.

Fig. 59 illustrates a perspective cross-sectional view of an exemplary tube.

Figure 60 illustrates a schematic flow diagram showing an exemplary rotation sequence of the tissue sample holder:

Figure 61 illustrates an exemplary sequence of the cutter's position within a cannula, with respect to fluid communication being provided through lateral and axial vacuum tubes, in an exemplary sample cycle.

Figure 62 illustrates an exemplary sequence of the cutter's position within a cannula, with respect to fluid communication being provided through lateral and axial vacuum tubes, in an exemplary probe clean cycle.

Fig. 63 illustrates an exemplary sequence of the cutter's position within a cannula, with respect to fluid communication being provided through lateral and axial vacuum tubes, in an exemplary position cycle.

Figure 64 illustrates an exemplary sequence of the position of the cutter inside a cannula, with respect to fluid communication being provided through lateral and axial vacuum tubes, in an exemplary vacuuming cycle.

Figure 65 illustrates an exemplary sequence of the cutter's position within a cannula, with respect to fluid communication being provided through lateral and axial vacuum tubes, in an exemplary smart vac cycle.

Figure 66 illustrates an exemplary status page for an exemplary user interface for a biopsy system.

Figure 67 illustrates an example probe page of an exemplary user interface for a biopsy system.

Figure 68 illustrates a page of an example system of an exemplary user interface for a biopsy system.

Fig. 69 illustrates an exemplary user interface that can be applied to a portion of the biopsy device.

Detailed Description

The following description of certain examples of the present invention should not be used to limit the scope of the present invention.

Other examples, characteristics, aspects, modalities, and advantages of the invention will become apparent to those skilled in the art from the following description, which is for illustration only, of one of the best methods contemplated for implementing the present invention. As will be realized, the invention is capable of other obvious and different aspects, all without deviating from the present invention. Thus, drawings and descriptions must be observed as illustrative and not restrictive in nature.

As shown in figure 1, an exemplary biopsy system (2) includes a biopsy device (100, 101) and a vacuum control module (400). As shown in figures 2 - 3, the biopsy device (100) comprises a probe (102) and a case (202). Similarly, as shown in figures 4 - 5, the biopsy device (100) comprises a probe (103) and a case (302). As will be described in more detail below, each probe (102, 103) is capable of being separated from its corresponding case (202, 302). The use of the term kit here should not be read as requiring any probe portion (102, 103) to be inserted into any portion of the kit (202, 302). In fact, in some variations of the biopsy devices (100, 101), the probe (102, 103) may simply be in the case (202, 302). In some other variations, a portion of the kit (202, 302) can be inserted into the probe (102, 103). In addition, in some biopsy devices (Ί00, 101), the probe (102, 103) and the case (202, 302) can be of unitary and integral construction, so that two components cannot be separated. Still other structural and functional relationships between the probe (102, 103) and the case (202, 302), will be apparent to those versed in the technique in view of the teachings here.

Some variations of the biopsy devices (100, 101) may include one or more sensors (not shown), on the probe (102, 103) and / or on the case (202, 302), which is / are configured to detect when the probe (102, 103) is coupled to the case (202, 302). Said sensors or other characteristics can be additionally configured to allow only certain types of probe (102, 103) and cases (202, 302) to be coupled together. In addition or alternatively, said sensors can be configured to disable one or more functions of the probes (102, 103) and / or cases (202, 302) until a suitable probe (102, 103) and case (202, 302) are coupled together. Of course, said sensors and features can be varied or omitted, as desired.

Just as an example, the probe (102, 103) can be provided as a disposable component, while the kit (202, 302) can be provided as a reusable component. The vacuum control module (400) is provided on a cart (not shown) in the present example, although other similar components described herein, a cart is purely optional. Among other components described here, a foot switch (not shown) and / or other devices can be used to provide at least some degree of control over at least a portion of the biopsy system (2). Ducts (200) provide communication of energy (eg electrical, pneumatic, etc.), control signals, saline, vacuum, and ventilation from the vacuum control module (400) to the biopsy device (100, 101 ). Each of these components will be described in more detail below.

I. Exemplary Probe for Stereotactic Use

As shown in figures 6 - 14, the probe (102) comprises a needle portion (10) and a body portion (112). The body portion (112) comprises a cover member (114) and a base member (116). A tissue sample holder (140) is removably attached to the base member (116), although the tissue sample holder (140) can alternatively be attached to the cover member (114) or some other component. As will be described in more detail below, a pair of tubes (402, 404) is coupled with the probe (102).

A. Exemplary Needle

In the present example, the needle portion (10) comprises an outer cannula (12) provided with a tissue piercing tip (14) and a transverse tissue receiving opening (16) located proximally from the tissue piercing tip (14). The tissue perforation tip (14) is configured to penetrate tissue without requiring a large amount of force, and without requiring an opening to be made in the tissue prior to insertion of the tip (14). Suitable settings for the tissue drilling tip (14) will be apparent to those skilled in the art in view of the teachings here. For example, as shown in figure 11, the tip (14) of the present example is part of a needle piece (18), which is formed from a stamped metal piece. In particular, the needle piece (18) is stamped to form the tip (14) and the wall (30), which will be described in greater detail below. A plurality of openings (32), including ventilation openings (34) are formed through the wall. Several ways in which the fluid can be communicated through the openings (32, 34) will be described in greater detail below, with reference to figures 61 - 65. The needle piece (18) is then twisted so that the tip (14) and the wall (30) are substantially perpendicular to each other. The needle piece (18) is then inserted into the cannula (12), with the tip (14) protruding through a slot formed at the distal end of the cannula (12). A fabric stop (26) is provided immediately near the tip (14). Yet other ways in which the tip (14) can be formed, including alternative techniques, materials, and configurations, will be apparent from those skilled in the art in view of the teachings here.

The inside of the outer cannula (12) of the present example defines a cannula light (20) and a vacuum light (40), with a wall (30) separating the cannula light (20) from the vacuum light (40 ). A plurality of external openings (22) are formed in the outer cannula (12), and are in fluid communication with the vacuum light (40). Examples of openings that are similar to external openings (22) are described in US Publication No. 2007/0032742, entitled Biopsy Device with Vacuum Assisted Bleeding Control, published on February 8, 2007, the description of which is incorporated herein. by reference. Of course, as with other components described here, the external openings (22) are merely optional.

In some embodiments, the wall (30) extends a substantial amount of the length of the needle portion (10). In other ways, the wall (30) proximally extends just ahead of the region where the distal end of a cutter (50), which will be described below, ends at a needle portion (10). For example, the cannula light (20) can be dimensioned and configured so that, with the cutter (50) arranged there, there is a space between the outside of the cutter (50) and at least a portion of the inside of the cannula ( 12). Said space can provide a vacuum light (40) along the length of the cannula (12) proximal to the proximal end of the wall (30). Yet other ways in which vacuum light (40) can be provided will be apparent to those skilled in the art from the teachings here.

In the present example, a plurality of transverse openings (32, 34) are formed through the wall (30) to provide fluid communication between the cannula light (20) and the vacuum light (40). As will be described in greater detail below, vacuum, saline, and / or pressurized air can be communicated from the vacuum light (40) to the cannula light (20) through transverse openings (32, 34).

B. Exemplary Cutter

A hollow cutter (50) is arranged inside the cannula light (20).

The interior of the cutter (50) defines a cut light (52), so that fluid and fabric can be communicated through the cutter (50) by means of the cut light (52). As will be described in more detail below, the cutter (50) is configured to rotate within the cannula light (20) and is axially transferred into the cannula light (20). In particular, the cutter (50) is configured to section a biopsy sample from the tissue that protrudes through the transverse opening (16) of the outer cannula (12). As will also be described in greater detail below, the cutter (50) is additionally configured to allow several tissue samples (4) to be proximally communicated through the cutter's light (52). Merely illustrative examples of said cut and proximal communication are described in US Patent No. 5,526,822, the description of which is incorporated herein by reference, although any other structures or techniques can be used to section and / or communicate tissue samples (4) within the biopsy system (2).

The cutter (50) can be subjected to various treatments or configurations in order to facilitate the proximal communication of tissue samples (4) through the cutter's light (52). For example, the surface finish inside the cutter (50), which defines the cutter's light (52), can be subjected to hammer strikes (for example, with glass beads, sodium bicarbonate, etc.) to reduce the adhesion between the fabric and the cutter (50). Additionally, or as an alternative, the interior of the cutter (50), which defines the cutter's light (52), can be subjected to acid etching and / or plasma etching to reduce the adhesion between the fabric and the cutter (50 ). Additionally, or as an alternative, a hydrolubricating material or other non-adherent coating can be applied to the interior of the cutter (50), which defines the cutter's light (52), to reduce friction between fabric and cutter (50). Additionally, or as an alternative, the interior of the cutter (50), which defines the light of the cutter (52), can be subjected to cooling of the surface by means of cuts. Other suitable treatments for the interior of the cutter (50) will be apparent to those skilled in the art in view of the teachings here15. Alternatively, the interior of the cutter (50) may not be subjected to any treatment in some embodiments.

In an alternative form of the cutter (50), a distal portion of the cutter (50) is provided with an inner diameter and an outer diameter that are smaller than the inner diameter and outer diameter of a proximal portion of the cutter (50). For example, the 25.4 mm (inch) furthest from the cutter (50) can provide a narrowing region (not shown), which provides a transition to a region with a larger diameter along the remaining proximal length of the cutter (50). Said narrowing configuration can reduce tissue compression as the tissue sample (4) moves proximally through the cutter's light (52). The distal end of the outer cannula (12) can also be provided with a complementary narrowing region which is either the same length, shorter or longer than a cutter narrowing region (50). Other lengths suitable for a cutter narrowing region (50) and / or external cannula (12) will be apparent to those skilled in the art in view of the teachings here.

In another alternative form of the cutter (50), a plurality of raised surfaces is provided, extending internally into the interior of the cutter (50), running the length of the cutter (50). The raised surfaces can be configured to reduce the contact of the fabric surface with the interior of the cutter (50).

In yet another alternative cutter embodiment (50), an inner sleeve (not shown) can be provided within the inner distal end of the cutter (50). For example, said inner sleeve can be provided with a length of approximately 3.81 mm (0.15 inches) or any other suitable length. The distal end of the cutter (50) can be chamfered after said inner sleeve is inserted, so that the chamfered end of the cutter (50) and the chamfered end of the collectively provide a sharp edge for sectioning fabric. As the sectioned tissue sample (4) runs proximally through the cutter's light (52), it will encounter a larger internal diameter of the cutter's light (52) as soon as the tissue sample (4) passes the end proximal to the inner sleeve. This increase in effective diameter can reduce the compression of the tissue sample (4), thereby improving the transport reliability of the tissue sample (4). Still other suitable variations of the cutter (50) will be apparent to those skilled in the art in view of the teachings here.

C. Exemplary Needle Cube

As shown in figures 12 - 13, a needle hub (60) is attached to the outer cannula (12), and comprises a hand-operated wheel (62) and a sleeve portion (64) extending proximally from the wheel manually operated (62). The needle hub (60) of the present example is molded on the proximal portion of the outer cannula (12), although the needle hub (60) can be formed and / or fixed with respect to the outer cannula (12) using any other techniques (for example, adjusting screws, adhesives, etc.). In addition, although the needle hub (60) of the present example is formed of a plastic material, any other suitable material or combination of materials can be used.

The sleeve portion (64) of the present example comprises an annular projection (66), a longitudinal slot (68), and a transverse opening (70), which is formed near the proximal end of the sleeve portion (64). One or more additional transverse openings (70) (e.g., diametrically opposed transverse openings (70)) can also be provided in the sleeve portion (64). A pair of O-rings (72) is positioned so that an O-ring (72) is proximal to the transverse opening (70) and the other O-ring (72) is distal to the transverse opening (70). As will be described in more detail below, the transverse opening (70) is in fluid communication with the interior defined by the needle hub (60), which is also in fluid communication with the vacuum light (40) of the outer cannula. (12). Other configurations suitable for the sleeve portion (64) will be apparent to those skilled in the art in view of the teachings here.

The hand-operated wheel (62) is operable to rotate the outer cannula (12) about its longitudinal axis, with respect to the cover member (114) and the base member (116). For example, the hand-operated wheel (62) can be used to orient the aperture (16) to a number of desired orientations on the longitudinal axis defined by the outer cannula (12). Said multiple orientations may be desirable, just as an example, to obtain a plurality of tissue samples (4) from a biopsy field, without requiring the needle portion (10) to be removed from the patient during acquisition of the said plurality of tissue samples (4). An illustrative example of said rotation and acquisition of multiple tissue samples (4) is described in US Patent No. 5,526,822, the description of which is incorporated herein by reference. Other ways in which multiple tissue samples (4) can be obtained at various locations will be apparent to those skilled in the art in view of the teachings here. For example, the rotation of the outer cannula (12) can be motorized or automated, such as by using any of the components described in greater detail below, or using any other suitable components or techniques. As another non-exhaustive example, the entire biopsy device (101) can be rotated during the acquisition of tissue samples (4), without necessarily removing the biopsy device (101) from the patient during said rotation and sample acquisition tissue (4), to obtain tissue samples (4) from various orientations on the longitudinal axis defined by the external cannula (12).

It will also be appreciated that other structures can be used to perform manual rotation of the external cannula (12). In particular, and as shown in figures 12-13, an exposed gear (74) can be engaged with an external cannula (12). In this example, the gear (74) is slid over the proximal end of the sleeve portion (64). A projection extending radially inward (not shown) of the gear (74) is configured to correspond with the slot (68) of the sleeve portion (64), so that the gear (74) rotates unitarily with the sleeve portion (64) while moving longitudinally along the sleeve portion (64). With the sleeve portion (64) being unitarily engaged with the outer cannula (12), rotation of the gear (74) will additionally cause the rotation of the cannula (12) to reorient the opening (16). The gear (74) is additionally configured to engage with an exposed complementary gear (206) of the case (202), as will be described in greater detail below. In particular, the gear (74) is configured to interlock with the gear (206) so that the gear (206) can provide rotation for the gear (74), thereby rotating the outer cannula (12). Some exemplary structures and techniques for selectively making the gear (206) turn will be discussed in greater detail below, while others will be apparent to those skilled in the art in view of the teachings here.

It will also be noted in view of the teachings here that the orientation of the opening (16) can be indicated in a graphical user interface. For example, one or more sensors may be operable to detect the orientation of the opening (16), and communicate indicative data to the processor. The processor may be in communication with a screen (e.g., display screen (702), described below, etc.) to provide vi15 Suai indication of the orientation of the aperture (16). Other ways in which the opening orientation (16) can be indicated to a user will be apparent to those skilled in the art in view of the teachings here. Alternatively, the orientation of the opening (16) may not be indicated to a user.

D. Exemplary Needle Derivation

As shown in figure 12, a needle shunt (80) is provided over the sleeve portion (64). The needle tap (80) is fixed with respect to the base member (116) in this example. The needle bypass (80) is in fluid communication with the tube (402), so that the tube (402) can communicate saline, a vacuum, atmospheric air, and / or pressurized air, etc., for the derivation of needle (80), as will be described in more detail below. The needle tap (80) is additionally in fluid communication with the interior of the sleeve portion (64), through a transverse opening (70). O-rings (64) are configured to maintain a fluid seal between the needle tap (80) and the sleeve portion (64), even as the sleeve portion (64) travels longitudinally with respect to the needle (80), such as during triggering the needle (10) as will be described in more detail below; and even during the rotation of the sleeve portion (64) about its longitudinal axis. A seal (not shown) is also provided at the proximal end of the sleeve portion (64), at the interface between the sleeve portion (64) and the cutter (50). The needle shunt (80), the sleeve portion (64), and the outer cannula (12) are thus configured and arranged so that saline, vacuum, atmospheric air, and / or pressurized air, etc. , which is communicated via the tube (402) to the needle shunt (80) will be communicated to the vacuum light (40) via a transverse opening (70). Of course, any other suitable structures or arrangements can be used to communicate saline, vacuum, atmospheric air, and / or pressurized air, etc. from the tube (402) to the vacuum light (40).

E. Exemplary Rotation and Translation Cutter Mechanism

In the present example, and as shown in figure 14, the body portion (112) of the probe (102) comprises a rotating and translating cutter mechanism (120), which is operable to rotate and translate the cutter (50) in the inside the outer cannula (12). The rotating and translating cutter mechanism (120) comprises a sleeve (122) unitarily attached to the cutter (50), a nut member (124), and the gear (138). In the present example, the sleeve (122) is formed of molded plastic over a cutter (50), although any other suitable material can be used, and the sleeve (122) can be fixed with respect to the cutter (50) using any other structures or techniques (eg adjusting screws, etc.). The nut member (124) is fixed with respect to the base member (116), and is provided with internal threads (126). A portion of the sleeve (122) is provided with external threads (128) which are configured to engage with threads (126) of the nut member (124). The threads (126, 128) are configured so that, as the sleeve (122) rotates with respect to the nut member (124), the sleeve (122) will longitudinally translate with respect to the nut member (124) , depending on the direction of the relative rotation. Just as an example, the threads (126, 128) can be configured to have a pitch that provides approximately 40-50 threads per 25.4 mm (inch). Said thread pitch can provide a cutter rotation ratio (50) for translation of the cutter (50) that is ideal for sectioning fabric. Alternatively, any other thread pitch can be used. With the sleeve (122) being unitarily fixed to the cutter (50) in the present example, the longitudinal translation of the sleeve (122) with respect to the nut member (124) will result in the same translation as the cutter (50).

Another portion of the sleeve (122) is provided with a plurality of external planes (130), which are configured to engage with a complementary plurality of internal planes (132) of the gear (138). The gear (138) is positioned coaxially over the sleeve (122) and the cutter (50). The planes (130, 132) are configured so that the rotation of the gear (138) promotes the rotation of the sleeve (122). With the sleeve (122) being unitarily fixed to the cutter (50) in the present example, the rotation of the gear (138) and the sleeve (122) will result in the same rotation of the cutter (50). The planes (130, 132) are additionally configured so that the sleeve (122) can translate longitudinally with respect to the gear (138) (for example, the fit between the sleeve (122) and the gear (138) is not so tight in order to avoid such transfer). It will therefore be observed that, the gears (138) rotate, considering the relative configurations of the threads (126, 128) and the planes (130, 132), the said rotation of the gear (138) simultaneously will result in the rotation and longitudinal translation of the sleeve (122), which in turn will result in the simultaneous rotation and longitudinal translation of the cutter (50).

In the present example, the gear (138) is partially exposed through the base member (116), and is configured to correspond with a complementary exposed gear (208) of the case (202), as will be described in more detail below. In particular, the gear (138) is configured to interlock with the gear (208) so that the gear (208) can provide rotation for the gear (138), thereby activating the rotation and translation cutter mechanism (120). As will be described in more detail below, the gear (208) is in communication with a motor (272) which is located inside the case (202). In the present example, gears (138, 208) and threads (126, 128) are configured so that each revolution of the motor (272) results in approximately 3 micrometers (0.00012 inches) of translation of the cutter (50). Of course, any of the said components can be provided with other configurations that result in any other suitable proportion of the translation of the cutter (50) to the rotation of the motor (272).

It will be seen in view of the teachings here that the rotation and translation cutter mechanism (120) described above is merely exemplary, and that translation and / or rotation of the cutter (50) may alternatively be provided in several other ways. For example, the biopsy probe (102) may include a motor (not shown) or other positive device, so that the biopsy probe (102) is devoid of the exposed gear (138). Alternatively, any other suitable structure of the exposed gear (138) (for example, a frame, etc.) can be used18 to receive communication of movement or energy from some other component, in order to rotate and / or move the cutter (15). In addition, the rotating and translating cutter mechanism (120) can be configured so that more than one exposed gear (138) is present (for example, one gear (138) to receive the translation movement, and another gear (138) to receive the rotation movement, etc.). In other merely illustrative embodiments, the translation and / or rotation of the cutter (50) can be carried out at least in part by pneumatic actuators (not shown), pneumatic motors (not shown), or a variety of other components. Additionally, it will be noted that pneumatic components can be combined with other mechanical components and / or electro-mechanical components in order to translate and / or rotate the cutter (50).

The base member (116) additionally comprises a cutter passage (54), through which the proximal end of the cutter (50) is arranged. A seal (56) is provided at the cutter's distal interface (50) and cutter's passage (54), to prevent vacuum or fluid leakage between the cutter's outer surface (50) and the inner surface of the cutter's passage's distal end (54). The cutter passage (54) is dimensioned so that, as the cutter (50) moves during the use of the biopsy device (100), the distal end of the cutter (50) remains inside the cutter passage (54 ). Of course, any other suitable structures or configurations can be used.

F. Exemplary Tip Reduction Variation

In the present example, the needle portion (10) and the cutter (50) are configured to be removed from the biopsy probe (102), such as after a session of using the biopsy device (100). In particular, the base member (116) of the body portion (112) of the biopsy probe (102) comprises a release tab (118), which is flexibly movable with respect to the base member (116) by means of a arm (119). The release tab (118) is configured to restrict the axial movement of the needle portion (10) by restricting the axial movement of the gear (74), which is engaged with the sleeve portion (64) of the hub (60) as observed above, when the release tab (118) is in a default position. Of course, the engagement between and the settings of the gear (74) and the sleeve portion (64) will allow some degree of axial movement of the needle portion (10), such as by actuation of the needle portion (10), even while the release tab (118) is in a default position. However, when the release tab (118) is sufficiently pressed, such as by a user, the release tab will provide space for the gear (74) to be moved distally from the base member (116). In other words, with the release tab (118) sufficiently pressed, the entire needle portion (10), including the entire needle hub (60) and gear (74), can be pulled axially distally from the portion body (112) of the biopsy probe (102); so that the entire needle portion (10), including the entire needle hub (60) and gear (74), can be completely separated from the body portion (112).

It will be appreciated in view of the description here that, with the entire needle portion (10), including the entire needle hub (60) and gear (74), completely separated from the body portion (112), the cutter (50) will still extend from the body portion (112). To remove the cutter (50) from the body portion, a user can simply unscrew the cutter (50) from the body portion (112). In particular, the user can take the needle portion (50) that protrudes from the body portion (112) and rotate the needle (50) with respect to the body portion (112) while pulling distally on the cutter (50) . Said rotation and the pull of the cutter (50) can cause the threads (126, 128) to interact, which in the end results in the threads (128) passing completely distally ahead of the threads (126). With threads (128) passing completely distally ahead of threads (126), no other component of the body portion (112) will substantially restrict the cutter (50) in the axial direction, so that the cutter (50) can be pulled away completely from the body portion (112) without further rotation. In other words, after sufficient rotation of the cutter (50) with respect to the body portion (112), the cutter (50) can be completely separated from the body portion (112). It will be seen in view of the teachings here that the sleeve (122) and the needle tap (80) can be configured so that the sleeve (122) can be axially passed completely through the needle tap (80). The gear (138) can remain essentially in place as the sleeve (122) and the rest of the cutter (50) are pulled axially with respect to it. Other suitable relationships between the components to provide, allow, or facilitate the ability to remove the needle portion (10) and the cutter (50) from the body portion (112) will be apparent to those skilled in the art in view of the teachings on here.

While a release tab (118) and other components have been described as providing and / or allowing complete removal of the needle portion (10) and cutter (50) from the body portion (112), it will be seen in view from the teachings here that said removal capability can be provided using a variety of other structures and techniques. For example, in some embodiments, the flap (118) or some other feature is configured to be detached from the base member (116) when engaged with sufficient force, allowing removal of the entire needle portion (10), including the entire needle hub (60) and the gear (74). In yet another alternative embodiment, the probe (102) is configured so that when the needle portion (10) and the needle hub (60) are manually angled with respect to the rest of the body portion (112), a retaining feature located on the base member (116) is disengaged, allowing the entire needle portion (10), including the entire needle hub (60) and the gear (74), to be removed axially from the portion body (112). Still other components, features, and techniques for providing, enabling, or facilitating the ability to remove the needle portion (10) and cutter (50) from the body portion (112) will be apparent to those skilled in the art in view of the teachings here.

It will also be appreciated that said removal capability can reduce the amount of tips provided by the biopsy device (100). In particular, to the extent that sharp device components that have been exposed to body fluids need to be disposed of differently than the disposal of other refuse (for example, disposed in a special container for sharp elements other than a regular waste container), the complete ability to remove the needle portion (10) and cutter (50) from the body portion (112) can allow the needle portion (10) and cutter (50) to be handled according to the procedure tip disposal without requiring the rest of the body portion (112) to undergo the same disposal procedure. In other words, and just as an example, after using the biopsy device (100), the needle portion (10) and cutter (50) can be removed from the body portion (112) and arranged in a tip container, while the remainder of the body portion (112) can be disposed of in a regular trash container.

G. Derivation of Exemplary Tissue Sample Support

As shown in figures 15 - 19, the tissue sample holder (140) is provided at the end of the body portion (112) of the probe (102). The tissue sample holder (140) comprises a cup (142), a branch (144), and a plurality of trays (160). The branch (144) includes a central recess (146), a plurality of longitudinal passages (148), a plurality of chambers (150) defined by radially extending walls (152), and a plurality of radial passages (154). Each longitudinal passage (148) is substantially in fluid isolation from each other longitudinal passage (148). However, each radial passage (154) is substantially in fluid communication with each other radial passage (154) by means of an annular passage (not shown) located inside the rear of the branch (144). Alternatively, each radial passage (154) can be substantially in fluid isolation from each other radial passage (154). In the present example, each longitudinal passage (148) is in fluid communication with a correspondent of each radial passage (154). In particular, each longitudinal passage (148) ends proximally in a corresponding radial passage (154).

In addition, each radial passage (154) is in fluid communication with a corresponding one in each chamber (150), through a respective pair of openings (156). In this way, it will be observed that each longitudinal passage (148) is in fluid communication with a corresponding chamber (150), by means of a corresponding radial passage (154) and a pair of openings (156). In particular, the radial position of each longitudinal passage (148) with respect to the central recess (146) corresponds to the radial position of the associated radial passage (154), a pair of openings (156), and a chamber (150). Of course, any other suitable structures or configurations for the bypass (144) can be used.

In some variations, a fabric, mesh, or other component is provided at or at the branch (144), or anywhere else within the tissue sample holder (140), to prevent the passage of tissue into or through certain openings or spaces. In other variations, said components are omitted.

H. Exemplary Tissue Sample Trays

The trays (160) of the present example are configured to be arranged in branch (144), and to receive tissue samples (4) as will be described in more detail below. Each tray (160) can be rigid, and can be pre-formed to be provided with a generally arcuate configuration. Alternatively, the trays (160) can be formed from a flexible material, so that the trays (160) can be bent to conform to the curvature of the bypass (144). Alternatively, the trays (160) can comprise one or more joints, so that portions of trays (160) can be folded or flexed in said joints. Still other suitable configurations can be used.

Each tray (160) of the present example has a base portion (162) and a plurality of hollow wall portions (164). The hollow wall portions (164) define chambers (166). Just as an example, each chamber (166) can be configured to receive a single tissue sample (4) captured by the cutter (50). Alternatively, chambers (166) can be configured so that each chamber (166) can support more than one tissue sample (4). The bypass (144) and chambers (166) of the present example are additionally configured so that blood, saline, and / or other fluids can pass through the chamber (166) and out through the tube (404), even if the tissue sample (4) is located inside said chamber (166). In other words, the chamber (166) will allow fluids to pass around the tissue sample (4).

As shown, the underside of each hollow wall portion (164) is configured to receive the branch wall (152) (144). The wall portions (164) and walls (152) are configured so that a space is provided between each base portion (162) and the bypass (144) when trays (160) are arranged in the bypass (144). As is also shown, each hollow wall portion (164) is provided with a generally tapered configuration, although any other suitable configuration can be used. Additionally, the trays (160) are provided with a plurality of openings (168) which are formed, in sets, through the base portion (162) inside each chamber (164). In this way, each tray chamber (166) is in fluid communication with an associated chamber (150) of the bypass (144) through openings (168). Each longitudinal passage (148) of the bypass (144) is therefore in fluid communication with a corresponding chamber (166) of the trays (160). It will therefore be noted that when the tube (404) is arranged in fluid communication with a given longitudinal passage (148), the tube (404) will be in fluid communication with the chamber (166) which is associated with that longitudinal passage ( 148).

In the present example, bypass (144) and trays (160) provide eighteen chambers (150, 166). Alternatively, any other number of chambers (150, 166) (i.e., more or less than eighteen) can be provided. For example, in a variation, bypass (144) provides three chambers (150), and three trays (160) are used and each of which has only one chamber (166). In yet another variation, a single tray (160) is used. For example, a single tray (160) can provide a single large chamber (166) or any suitable number of chambers (166). Other suitable numbers of chambers (150, 166) and the means by which said chambers (150,166) can be provided will be apparent to those skilled in the art in view of the teachings here. In addition, the bypass (144) and trays (160) can be provided in any suitable format.

Each tray (160) may additionally comprise one or more types of markings or other indication to distinguish one chamber (166) from the other chamber (166). For example, a number or other mark of distinction can be provided in or near each chamber (166), such as in relief, in slotted form, or otherwise. In another embodiment, a radiopaque marker is provided in or near each chamber (166). For example, the entire tray (160) carrying one or more tissue samples (4) can be placed under X-ray for evaluation, and the radiopaque marker associated with each chamber (166) (and consequently, associated with each tissue sample (4)), can be visible in the image obtained using X-ray. In other words, the tissue samples (4) do not necessarily need to be removed from the trays (160) in order to obtain an X-ray or a radiographic image of the tissue samples (4). Additionally, the trays (160) can be placed directly in formalin or any other liquid with tissue samples (4) still in the trays (160). In addition, trays (160) can be arranged in a sleeve or container, etc., individually or in groups, to protect fabric samples (4) and / or to ensure that fabric samples (4) remain in trays ( 160) or for other purposes. Said sleeve or container may be flexible, rigid, or have other properties. Just as an example, a sleeve or other container can be flat, and can be configured to flatten a flexible tray (160) which is inserted into it. Other structures and techniques that can be used with trays (160), such as after tissue samples (4) are communicated with the trays (160) will be apparent to those skilled in the art in view of the teachings here.

The cup (142) is configured to engage bayonets (134) of the base member (116), so that the cup (142) can be removed from or attached to the base member (116) with sufficient rotation of the cup (142) with respect to the base member (116). In addition, a 0 ring (136) is provided on the base member (116) to provide a seal between the base member (116) and the cup (142). Of course, any other suitable structures can be used to provide engagement of the cup (142) with the base member (116) and / or to provide a seal between the base member (116) and the cup (142). The cup (142) is also formed from a transparent material in the present example, allowing the user to visually inspect the tissue samples (4) on the tissue sample holder (140) while the tissue sample holder (140) it is further coupled with the base member (116). For example, a user can inspect the tissue samples (4) for color, size and density (for example, as the chamber (166) is filled with saline, etc.).

It will also be noted in view of the teachings here that the removal capacity of the cup (142) and the trays (160) can allow a user to collect a relatively large number of tissue samples in a relatively short period of time. In addition, the removal capacity of the cup (142) and trays (160) may allow a user to remove unsatisfactory tissue samples (4) from the tissue sample holder (140) (for example, using tweezers, etc.). ) and then re-couple the trays (160) and the cup (142) for further sampling. Other ways in which the removal ability and other properties of the tissue sample holder (140) of the present example can be used will be apparent to those skilled in the art in view of the teachings here.

I. Exemplary Rotation and Alignment of the Derivation

The branch (144) of the present example is configured to rotate with respect to the base member (116), as will be described in greater detail below. The bypass (144) of the present example is further configured so that each longitudinal passage (148) can be selectively aligned with an orifice (406) which is in fluid communication with the tube (404). Said alignment of the longitudinal passage (148) and the orifice (406) will arrange the aligned longitudinal passage (148) in fluid communication with the tube (404), so that the vacuum induction inside the tube (404) it will effect the vacuum induction inside the longitudinal passage (148), as well as inside the chamber (166) associated with that longitudinal passage (148). In addition, the bypass (144) and trays (160) of the present example are configured so that each chamber (166) can be selectively arranged in fluid communication with the cutter light (52). It will therefore be noted that the vacuum in the tube (404) can induce a vacuum in light from the cutter (52), with the vacuum being communicated through an orifice (406), an associated longitudinal passage (148), an associated radial passage ( 154), a pair of associated openings (156), an associated chamber (150), a set of associated openings (168), and an associated chamber (166). Of course, there are a variety of other ways in which a vacuum can be induced within the light of the cutter (52), and any other structures or techniques can be used. In addition, pressurized air, a liquid (e.g., saline), or any other fluid can be communicated in any direction via the above-mentioned components instead of or in addition to a vacuum being induced therein.

The gear (170) is engaged with the tap (144) of the present example. In particular, the gear (170) is provided with an axis (172) which is inserted into the central recess (146) of the branch (144).

The axis (172) is provided with a plane (174) which is configured to engage a complementary plane (147) of the central recess (146). The coupling of the planes (174, 147) is such that the gear (170), the shaft (172), and the derivation (144) rotate unitarily. Alternatively, the gear (170) and the tap (144) can be provided with any other suitable configurations or ratios. However, the gear (170) of the present example can be used to rotate the tap (144), which in turn will allow the selective alignment of the longitudinal passages (148) with the orifice (406), additionally to allow the selective alignment of the chambers (166) with the cutter light (52). In particular, and as will be described in more detail below, the gear (170) is configured to interlock with a complementary gear (210) of the case (202), so that the gear (210) can be used to provide rotation for the gear (170). Said rotation can be used to selectively (for example, consecutively) align the chambers (166) with the cutter light (52), to successively collect a distinct tissue sample (4) in each chamber (166) during the use of the biopsy device (100). Additionally, said tissue sample collection (4) can be performed without having to remove and reinsert the needle portion (10) with respect to the patient during said process.

J. Exemplary Positioning Pledge

The body portion (112) of the present example additionally comprises an engaging member (180), which is attached to the base member (116). As shown in figure 20, the engagement member (180) comprises a tongue portion (182) provided with teeth (184). The tongue portion (182) is flexibly released by the teeth (184) to engage with the gear (170). In particular, engaging the teeth (184) of the tongue portion (182) with gear (170) prevents rotation of the gear (170) (and consequently prevents rotation of the tap (144)). In this way, the tongue portion (182) is configured to prevent rotation of the tap (144) when the tongue portion (182) is in a default position. In the present example, the tongue portion (182) is in the default position when the biopsy probe (102) is not coupled with a case (202). However, when the biopsy probe (102) is coupled with a case (202), a projection (212) on the case (202) is configured to engage the tongue portion (182). In particular, the projection (212) in the case (202) is configured to disengage the tongue portion (182) from the gear (170) when the biopsy probe (102) is coupled with a case (202), so that the tongue portion (182) will no longer prevent rotation of the gear (170) or tapping (144) when the biopsy probe (102) is coupled with a case (202). When the biopsy probe (102) is removed from the case (202), the flexibility of the engagement member (180) throws the tongue portion (182) back to the default position, so that the tongue portion (182) will again prevent rotation of the gear (170) and the tap (144).

When the biopsy probe (102) is packaged for transportation from the factory, or in other situations, the tissue sample holder (140) can be configured so that a predetermined chamber (166) is aligned with the light from the cutter (52). With the tongue portion (182) maintaining said alignment until the moment when the biopsy probe (102) is coupled with a case (202) for a first use, the program or the logic control that is used to control the device biopsy device (100) can safely assume that the predetermined chamber (166) is aligned with the cutter light (52), and can control the biopsy device (100) in this way. Additionally, if the biopsy probe (102) is removed from the case (202) during the tissue sample acquisition procedure (4), the program or logic control that is used to control the biopsy device (100) can remember which chamber (166) was last aligned with the cutter light (52), as the program tracks which chamber (166) is being or was used during a procedure. If the biopsy probe (102) is re-coupled with a case (202) to continue the procedure, the program or logic control can continue to control the biopsy device (100) based on the chamber (166) that the program recalled. Alternatively, a user can specify that a new biopsy probe (102) has been attached to the case (202), which may result in the program or logic control once again assuming that the predetermined chamber (166) is one that is aligned with the cutter light (52).

While a tongue portion (182) has been described as a structure that selectively prevents gear rotation (170) and tapping (144), it will be seen that any other alternative structures can be used for said purpose. Just as an example, a Geneva wheel mechanism (not shown) can be used as an alternative mechanism to rotate the tap (144) and maintain the rotational position of the tap (144) between intentional rotations. For example, gear (170) can be replaced with a Geneva driven wheel (not shown), while gear (210) can be replaced with a Geneva drive wheel (not shown). Other suitable alternatives for rotating the tap (144) and / or maintaining the rotational position of the tap (144) will be apparent to those skilled in the art in view of the teachings here. Additionally, it will be appreciated that a biopsy device (100) can be devoid of a tongue portion (182) or other rotation prevention feature, so that a bypass (144) can freely rotate when the biopsy probe (102) it is not coupled with a case (202).

K. Exemplary Dedicated Passage

As shown in figures 16 - 17, 19, and 21, the tissue sample holder (140) of the present example is provided with a passage (158) formed through the bypass (144). The passage (158) extends longitudinally, completely through the branch (144), and is displaced from but parallel to the central axis defined by the branch (144). In similar chambers (166), the passage (158) is configured to be selectively aligned with the cutter light (52). However, in non-similar chambers (166), the passage (158) is not in fluid communication with any of the longitudinal passages (148) or radial passages (154). In other versions, the passage (158) can be provided in fluid communication with one or more longitudinal passages (148) and / or radial passages (154).

The passage (158) of the present example is configured to allow instruments and / or liquids, other materials, etc., to be passed through the bypass (144) and through the cutter light (52). For example, the passage (158) can be used to insert an instrument to distribute one or more markers in a biopsy field, through the cutter light (52) and through the outer cannula (12), out through opening (16). A purely exemplary marker applicator that can be inserted through the passage (158) may include the MAMMOMARK biopsy field marker applicator, offered by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Other suitable marker applicator devices that can be inserted through the passage (158) can include any of those described in US Patent No. 7,047,063; US Patent No. 6,996,433; US Patent No. 6,993,375; or at the Pub. US No. 2005/0228311, a description of which is incorporated herein by reference. Any of the said applicators, including variations thereof, can be introduced through the passage (158) to distribute one or more markers in a biopsy field, through the opening (16), while the needle portion (10) remains inserted on a patient (for example, right after biopsy samples are taken from the patient, etc.). Said marker distribution can be carried out even while the tissue samples (4) reside inside the tissue sample holder (140), attached to the biopsy probe (102). Alternatively, said marker applicators can be inserted directly into the cutter light (52) with the tissue sample holder (140) being removed from the biopsy probe (102).

As noted above, the biopsy probe (102) can initially be provided with a predetermined chamber (166) being aligned with the cutter light (52) by default. However, in other versions, the biopsy probe (102) is initially provided with the passage (158) being aligned with the cutter light (52) by default. Additionally, to the extent that a user wishes to have the passage (158) aligned with the cutter light (52) during the use of the biopsy device (100), after the bypass (144) is rotated during said use, Controls can be used to command tap (144) to rotate to align the passage (158) with the cutter light (52).

The cup (142) additionally comprises an opening (176) and a fenestra (178). The opening (176) is configured to be aligned with the passage (158) when the cup (142) is attached to the base member (116), such as by turning the tap (144) to align the passage (158) with the opening (176). The fenestra (178) is configured to selectively cover the opening (176). For example, the fenestra (178) can be configured to seal the opening (176) when the fenestra (178) covers the opening (176). The fenestra (178) can additionally be configured to allow a user to peel the fenestra (178) and / or pivot the fenestra (178) in order to gain access to the opening (176) and the passage (158). It will be appreciated in view of the description here that fenestra (178) can be replaced or supplemented with a variety of alternative structures, including but not limited to a removable stop or other structure.

L. Exemplary Medication Applicator

As shown in figures 21 - 22, an applicator (90) can be coupled with the biopsy probe (102) through the opening (176) in the cup (142) and the passage (158) in the bypass (144). In this example, the applicator (90) comprises a hollow shaft portion (92) and a Luer lock portion (94). The shaft portion (92) is dimensioned and configured so that when the applicator (90) is inserted through the opening (176) and through the passage (158), the shaft portion (92) creates a seal with light of the cutter (52) (for example, by engaging with the inner surface of the cutter light (52)). The shaft portion (92) and the Luer lock portion (94) can thus be arranged in fluid communication with the cutter light (52). Just as an example, a syringe (not shown) or other device can be coupled with the Luer lock portion (94). A therapeutic agent can thus be injected from said syringe, through the applicator (90), through the cutter light (52), through the outer cannula (12), and out through the opening (16) to reach a field biopsy. Said injections can be produced before or after the tissue samples (4) are acquired using the biopsy device (100), and can be produced while the needle portion (10) remains inserted in the patient.

Other suitable ways in which an applicator (90) can be used, as well as alternative ways in which an applicator (90) can be configured, will be apparent to those skilled in the art in view of the teachings here. Just as an example, the applicator (90) can alternatively be inserted directly into the light of the cutter (52) with the tissue sample holder (140) being removed from the biopsy probe (102).

II. Exemplary Case for Stereotactic Use

As shown in figures 23 - 32, a case (202) comprises a top cover (204), through which the portion of each of the gears (206, 208, 210) is exposed, side panels (214, 216), and a base member (218). As described above, a projection (212) is provided on the top cover (204), and is configured to disengage the tongue portion (182) from the gear (170) when the biopsy probe (102) is coupled with the case (202). The case (202) of the present example further comprises a needle rotation mechanism (220), a needle drive mechanism (240), a cutter trigger mechanism (270), and a tissue support rotation mechanism (280 ). In addition, a user interface (800) is provided on each side panel (214, 216). Each of these merely illustrative components will be described in more detail below.

As noted above, the kit (202) of the present example is configured to be coupled with a biopsy probe (102), such as the biopsy probe (102) described above, to provide a biopsy device (100). Additionally, the case (202) is configured to be mounted to a table, fixture, or other device, such as for use in a stereotactic or X-ray installation. However, it will be appreciated in view of the description here that the case (202) can be used in a variety of other installations and combinations.

A. Exemplary Needle Rotation Mechanism

In the present example, and as shown in figure 27, the needle rotation mechanism (220) comprises a pair of buttons (222), each of which is provided with respective gears (224) in chamfered engagement with the gear (226) in the proximal end of an elongated axis (228). Another gear (not shown), which is provided at the distal end of the shaft (228), is engaged with the gear (230). The gear (230) is engaged with yet another gear (232) at the proximal end of yet another axis (234). The distal end of the shaft (234) is provided with another gear (236), which is engaged with the gear (206) described above. Therefore it will be observed in view of the teachings here that the rotation of one or both buttons (222) will result in the rotation of the gear (206), with said rotation being communicated by means of gears (224, 226, 230, 236) and axes (228, 234). In addition, also as noted above, when the biopsy probe (102) is coupled with the case (202), the gear (206) will correspond with the gear (74). Thus, when the biopsy probe (102) is coupled with the probe (202), rotation of one or both buttons (222) will cause the needle portion (10) of the biopsy probe (102) to rotate. Of course, a variety of alternative mechanisms, structures, or configurations can be used as a substitute or supplement for a needle rotation mechanism (220). Just as an example, a motor (not shown) can be used to rotate the needle portion (10). In other versions, a needle rotation mechanism (220) can simply be omitted.

B. Exemplary Needle Drive Mechanism

As shown in figures 28 - 29, a needle drive mechanism (240) of the present example comprises a pair of triggers (242), buttons (244), a motor (246), a drive rod (248), and a fork (250). The fork (250) is configured to engage the sleeve portion (64) of the needle hub (60) when the biopsy probe (102) is coupled with the case (202). For example, the fork (250) can engage the sleeve portion (64) between the hand-operated wheel (62) and the annular projection (66). In the present example, the engagement between the fork (250) and the sleeve portion (64) is such that the sleeve portion (64) (and therefore the needle portion (10)) will translate longitudinally with the fork ( 250). The fork (250) is coupled with the driving rod (248), so that the fork (250) will travel longitudinally with the driving rod (248).

A damper (252) with a stop (253) is provided on the drive rod (248). A spiral spring (254) is also provided on the drive rod (248). In particular, the spiral spring (254) is engaged with both the washer (253) and the base member portion (218). The spiral spring (254) is oriented to release the damper (252), the washer (253), and the drive rod (248) distally. It will be appreciated, however, that as with other components described herein, the spiral spring (254) is merely exemplary, and a variety of alternative components (flexible or otherwise) can be used in addition to or instead of the spiral spring (254).

A trolley (256) and a screw gear (258) are also coupled with the drive rod (248). In particular, the carriage (256) is coupled with the proximal end of the drive rod (248), and is configured to translate longitudinally

with the actuation rod (248). Similarly, the screw gear (258) is configured to translate longitudinally with the actuation rod (248) (through at least some movement range), en20 when avoiding turning on the actuation rod (248). An external gear (260) is engaged with the screw gear (258). In particular, the interior (not shown) of the external gear (260) is engaged with the threads of the screw gear (258); so that when the external gear (260) rotates with respect to the screw gear (258), said rotation causes the screw gear (258) to translate longitudinally with respect to the external gear (260). The external gear (260) is in communication with another gear (262), which itself is in communication with the gear (264) which is coupled with the motor (246). Thus, when the motor (246) is activated to rotate, said rotation will cause the screw gear (258), the drive rod (248), and the cart (256) to translate longitudinally. In other words, the rotation of the motor (246) will be communicated to the external gear (260) through the gears (262, 264), and said rotation will be converted into a longitudinal movement due to the configuration and engagement of the external gear ( 260) and the screw gear (258). Of course, all of the said components are merely illustrative, and any other components, configurations, or suitable techniques can be used to cause the longitudinal translation of the drive rod (248).

The triggers (242) of the present example are each configured to partially rotate back and forth, while the buttons (244) are configured to be pressed inward. Additionally, a plurality of keys (not shown) can be coupled in communication with the triggers (242) and / or buttons (244), so that the keys are selectively activated by a user when the triggers (242) are moved forward or back and / or when the buttons (244) are pressed. One or more flexible members (e.g., a spring, etc.) can be included to orient each trigger (242) to a substantially vertical or centered orientation. One or more flexible members (for example, a spring, etc.) can also be included to orient each button (244) to an outward position. The triggers (242) and buttons (244) are also sealed in the present example to prevent fluid from entering the case (202), although like other features, the present is merely optional.

In the present example, the triggers (242) are additionally configured so that when one or both triggers (242) are moved backwards, said movement triggers a switch that is in communication with the motor (246). Said activation causes the motor (246) to rotate, which in turn causes the drive rod (248) to translate longitudinally proximally as described above. As will be described in greater detail below, said backward movement of the trigger (242) can thus cause the motor (246) to arm or raise the needle drive mechanism (240).

A needle drive mechanism (240) of the present example additionally comprises the lock (266), which is configured to selectively engage the cart (256). In particular, as the drive rod (248) and the cart (256) are longitudinally translated proximally (for example, by rotation of the motor (246)), the cart (256) approaches the lock (266). When the lock (266) and the cart (256) engage, the lock (266) is configured to hold the cart (256) (and therefore the drive rod (248)) in place. The lock (266) can maintain the said position of the trolley (256) even after the engine (246) has a turning field, and even with the spring (254) releasing the trolley (256) and the actuating rod (248) towards the distal position. When said components are in said positions and proximal configurations, it can be said that a needle drive mechanism (240) is in an elevated configuration. An exemplary elevated needle drive mechanism configuration (240) is shown in figure 29.

It will be seen in view of the teachings here that, with a needle drive mechanism (240) in said raised configuration, the fork (250) and the needle portion (10) will be in a proximal position, ready to act. One or more components of the biopsy device (100) can be configured to provide an audio and / or visual indication that a needle drive mechanism (240) is completely raised. For example, the biopsy device (100) may produce a distinct click, beep, or other audible signal; and / or the graphical user interface can provide some visual indication that a needle drive mechanism (240) is elevated.

In addition, the case (202) may additionally include one or more sensors (not shown) or other feature (s) configured to read or detect when a needle drive mechanism (240) has been raised and / or when a needle drive mechanism (240) was activated. For example, the biopsy system (2) can be configured so that one or more functions of the biopsy system (2) are essentially disabled while. a needle actuation mechanism (240) is raised, until a needle actuation mechanism (240) is actuated. Just as an example, the biopsy system (2) can prevent the initiation of the sample cycle (described below), initiation of the probe cleaning cycle (described below), or other functions while a needle drive mechanism (240) is elevated . Said functions can again be enabled after a needle drive mechanism (240) is activated and after the needle (10) has reached a fully activated position. Alternatively, the elevation of a needle drive mechanism (240) may not have any influence or other influences on one or more functions of the biopsy system (2).

In a variation, after the cart (256) is moved in engagement with the lock (266) to raise a needle drive mechanism (240), the motor (246) can reverse its rotation. In said variation, the proximal portion of the driving rod (248) can be provided with a longitudinal slot or recess (not shown) formed transversely through or in the driving rod (248). The screw gear (258) can be provided with an internal pin or other feature (not shown) that is configured to engage said slot or other feature of the drive rod (248), so that the pin or other characteristic of the screw gear (258) is additionally configured both to prevent the screw gear (258) from rotating on the drive rod (248) and to allow the screw gear (258) to translate through some range of motion with respect to the drive rod (248). For example, before a needle drive mechanism (240) is raised, said pin or other characteristic of the screw gear (258) can be positioned at or near the proximal end of a longitudinal slot or recess in the drive rod ( 248); so that as the motor (246) is activated to move the screw gear (258) proximally to raise a needle drive mechanism (240), the pin or other feature engages the drive rod (248) to launch the drive rod (248) proximally with the screw gear (258). Then, after the trolley (256) is moved proximally in engagement with the lock (266), the motor (246) can reverse its rotation. Said reversing of the rotation of the motor (246) can translate the screw gear (258) distally. The slot configuration or other characteristic of the drive rod (248) and the configuration of the pin or other characteristic of the screw gear (258) can allow said distal translation of the screw gear (258) with respect to the drive rod (248) ), leaving the drive rod in an elevated proximal position. In addition, when the needle portion (10) is actuated as described below, the slot configuration or other characteristic of the drive rod (248) and the configuration of the pin or other characteristic of the screw gear (258) may allow the rod drive (248) translates distally with respect to the screw gear (258) with relative ease during said drive. Other suitable relationships between the drive rod (248) and the screw gear (258) can be used, including but not limited to the variation described below.

When a user is ready to trigger the needle portion (10), the user can push and hold one or both triggers (242) forward, and can push one or both buttons (244) while one or both triggers ( 242) are held forward. Said actuation of the trigger (s) (242) and button (s) (244) can cause the lock (266) to release the cart (256). Adequate structures and configurations that can be used to cause the trigger (s) (242) and button (s) (244) to act on the lock (266) releasing the cart (256) will be apparent to those versed in technique in view of the teachings here. With the carriage 25 (256) thus released, the spring flexibility (254) can launch the damper (252) and washer (253) (and therefore the drive rod (248), the fork (250), and the needle portion (10)) distally, thereby driving the needle portion (10). Said distal movement of the needle portion (10) can be relatively sudden, and can be carried out with sufficient force to penetrate the tissue with the tip (14) of the needle portion (10).

In another variation, the motor (246) does not reverse its rotation to advance the screw gear (258) back to the distal position before the needle portion (10) is driven. For example, the screw gear (258) may be unitarily attached to a drive rod (248), and may be unable to travel longitudinally in any direction through any range of motion with respect to the drive rod (248). In said variation, the needle portion (10) is driven, the gears (260, 262, 264) can be configured to rotate freely, thereby providing insignificant resistance to the distal movement of the drive rod (248). Alternatively, a clutch mechanism (not shown) can be provided to disengage one or more of the gears (260, 262, 264) during actuation of the needle portion (10). Other ways in which a needle drive mechanism (240) can be configured or operated will be apparent to those skilled in the art in view of the teachings here.

In the present example, the triggers (242) and the buttons (244) are configured so that the pushing or pressing of the buttons (244) will have no triggering effect unless the triggers (242) are held forward. Similarly, holding the triggers (242) will not trigger the needle portion (10) until the buttons (244) are also pressed while the triggers (242) are held forward. Suitable structures and configurations for the said interdependence of the triggers (242) and buttons (244) will be apparent to those skilled in the art. For example, the buttons (244) can rotate with the triggers (242), so that the buttons (244) rotate forward with the triggers (242).

In said versions, the buttons (244) and the lock (266) can be configured so that pressing the buttons (244) will not cause the lock (266) to release the cart (256) unless the buttons ( 244) are turned forward. In addition or as an alternative to the buttons (244) rotating with the triggers (242), the triggers (242) can be configured to lock the lock (266) in place (for example, even with the buttons (244) being operated) until the triggers (242) are rotated forward, so that forward rotation of the triggers (242) will allow the lock (266) to be released when the buttons (244) are operated. Other ways in which triggers (242) and buttons (244) can be provided, interdependent with the triggering objectives (or for other purposes) will be apparent to those skilled in the art in view of the teachings here.

C. Cutter Orientation Mechanism

As shown in figure 30, the cutter guiding mechanism (270) of the present example comprises a motor (272) with an axis (274) extending therefrom. The gear (208) is mounted to an axis (274), and is configured to rotate unitarily with it. As noted above, the gear portion (208) is exposed through the top cover (204), so that the gear (208) engages with the gear (138) of the rotation and translation cutter mechanism (120) when the biopsy probe (102) is coupled with the case (202). In this way, when the motor (272) is activated to rotate, said rotation can be communicated by means of axis (274) and gears (208, 138), to effect the simultaneous rotation and translation of the cutter (50) as described above. Other ways in which a cutter drive mechanism (270) can be configured or operated will be apparent to those skilled in the art in view of the teachings here.

D. Exemplary Tissue Holder Rotation Mechanism

As shown in figures 31 - 32, the fabric support rotation mechanism (280) of the present example comprises a motor (282) provided with an axis (284) with a gear (286) mounted on it, so that the gear (286) rotates unitarily with the axis (284). The gear (286) is configured to interlock with the gear (288), which is mounted to the shaft (290). The gear (210), which was observed above, is also mounted to the shaft (290), at the proximal end of the shaft (290). In particular, the gear (210) is configured to interlock with the gear (170) of the tissue sample holder (140) when the biopsy probe (102) is coupled with the case (202). In this way, when the motor (282) is activated to turn, said rotation can be communicated by means of axes (284, 290) and gears (286, 288, 210, 170), to effect the rotation of the branch (144) , as described above.

In addition, a coding wheel (292) is coupled with the shaft (290), and is configured to rotate unitarily with it. The coding wheel (292) is provided with a plurality of slots (294) formed through it. The slots (294) open radially outward, and are angularly spaced with respect to each other. Of course, the slots (294) can be provided with any other suitable configuration. A sensor (296) is positioned adjacent to the coding wheel (292). In particular, the sensor (296) is positioned so that slots (294) pass successively before the sensor (296) as the coding wheel (292) pivots (290). The sensor (296) can therefore be used to count the passage of the slits (294), which can be translated into data indicative of the rotational position of the branch (144). In other words, since the coding wheel (292) and the bypass (144) rotate concomitantly when the biopsy probe (102) is coupled with the case (202) in the present example, the passage of the slits (294) ahead of the sensor (296) during the rotation of the axis (290) can be indicative of the rotation of the branch (144), and therefore of the position of the branch (144). It will be appreciated that the information indicating the bypass position (144) can be additionally indicative of which particular chamber (166) is aligned with the cutter light (52). Suitable uses for said information will be apparent to those skilled in the art in view of the teachings here.

Suitable devices that can be used for the sensor (296) will also be apparent to those skilled in the art in view of the teachings here. Similarly, suitable substitutes for the coding wheel (292) and sensor (296) will be apparent to those skilled in the art, including but not limited to combinations of hall effect magnets and sensors, light sources and photosensors, etc. In addition, other ways in which a tissue support rotation mechanism (280) can be configured or operated will be apparent to those skilled in the art in view of the teachings here.

III. Exemplary Probe for Use in Ultrasound

As shown in figures 33 - 37, an alternative to a biopsy probe (103) comprises a needle portion (350) and a body portion (352). The body portion (352) comprises a cover member (354) and a base member (356). The tissue sample holder (368) is removably attached to the base member (356), although the tissue sample holder (368) may alternatively be attached to the cover member (354) or some other component. As will be described in more detail below, a pair of tubes (402, 404) is coupled with the probe (103). As will also be described in greater detail below, and as noted above, the biopsy probe (103) is configured to be coupled with a case (302) to provide a biopsy device (101).

A. Exemplary Needle

In the present example, the needle portion (350) comprises an outer cannula (12) provided with a tissue piercing tip (14) and a transverse tissue receiving opening (16) located proximally from the tissue piercing tip (14). In this example, the said components are essentially the same as the components that carry the same names and item numbers described above, so they will not be described in more detail here. In other words, the characteristics, properties, and components of the outer cannula (12), tip (14), and the opening (16) as described above (including the cannula light (20), the vacuum light (40), the wall (30), transverse openings (32), etc.) can be the same for the needle portion (350) as described above with respect to the needle portion (10). Of course, they can alternatively be varied in any suitable way, as desired.

Similarly, the cutter (50) on the probe (103) can be provided with the same relationship with the needle portion (350) as the relationship described above between the cutter (50) and the needle portion (10); as well as all the same characteristics, properties, and components as the cutter (50) described above in the context of the probe (102). The said aspects of the cutter (50) will therefore not be repeated here.

B. Exemplary Needle Cube

As shown in figures 36 - 37, a needle hub (358) is attached to the outer cannula (12) of the probe (103), and comprises a hand-operated wheel (62) and a sleeve portion (360) that extends proximally from the hand-operated wheel (62). The needle hub (358) of the present example is molded on the proximal portion of the outer cannula (12), although the needle hub (358) can be formed and / or fixed with respect to the outer cannula (12) using any other techniques (for example, adjusting screws, etc.). In addition, although the needle hub (358) of the present example is formed of a plastic material, any other suitable material or combination of materials can be used.

The sleeve portion (360) of the present example comprises an annular projection (66), a plurality of planes (362), and a transverse opening (70), which is formed near the proximal end of the sleeve portion (360). A pair of O-rings (72) is positioned so that an O-ring (72) is proximal to the transverse opening (70) and the other O-ring (72) is distal to the transverse opening (70). As will be described in greater detail below, the transverse opening (70) is in fluid communication with the interior defined by the needle hub (60), as well as with the vacuum light (40) of the outer cannula (12). In the present example, another transverse opening (70) is formed through the sleeve portion (360), also between the O-rings (72), and in opposition to the other transverse opening (70). Other configurations suitable for the sleeve portion (360) will be apparent to those skilled in the art in view of the teachings here.

The hand-operated wheel (62) of the sleeve portion (360) is essentially the same as, and can be operated in a similar way to the hand-operated wheel (62) of the sleeve portion (64) of the probe (102) described above . The hand-operated wheel (62) will therefore not be discussed in any detail here. Of course, the hand-operated wheel (62) can alternatively be varied in any suitable form, as desired, if not omitted, in the case of any of the probes (102, 103).

In the present example, an exposed gear (364) is slid over the sleeve portion (360). In particular, the interior of the gear (364) is configured to correspond with the planes (362) of the sleeve portion (360), so that the gear (364) rotates unitarily with the sleeve portion (360). With the sleeve portion (360) being unitarily engaged with the outer cannula (12), the rotation of the gear (364) will further promote the rotation of the cannula (12) to reorient the opening (16). The gear (364) is exposed through the base member (356), and is further configured to engage with an exposed complementary gear (not shown) of the case (not shown). In particular, the gear (364) is configured to interlock with an exposed complementary gear so that the complementary gear can provide rotation for the gear (364), thereby rotating the outer cannula (12). However, in the present example, the gear (364) is not engaged with a complementary gear when the probe (103) is coupled with a case (302). It will therefore be noted that, as with other components and features described here, the gear (364) and the planes (362) can simply be omitted if desired.

C. Exemplary Needle Derivation

As shown in figures 34 - 36, a needle tap (366) is provided over the sleeve portion (360). The needle tap (366) is fixed with respect to the base member (356) in this example. The needle tap (366) is in fluid communication with the tube (402), so that the tube (402) can communicate saline, vacuum, and / or pressurized air, etc., to the needle tap (366) as will be described in more detail below. The needle tap (366) is additionally in fluid communication with the interior of the sleeve portion (360), through transverse openings (70), one of which is shown in figure 37. O-rings (64) are configured to maintain a fluid seal between the needle tap (366) and the sleeve portion (360), even when the sleeve portion (360) rotates with respect to the needle tap (366). A seal (not shown) can also be provided at the proximal end of the sleeve portion (360), at the interface between the sleeve portion (360) and the cutter (50). The needle shunt (366), the sleeve portion (360), and the outer cannula (12) are thus configured and arranged so that saline, vacuum, and / or pressurized air, etc. which are communicated via the tube (402) to the needle bypass (366) will be communicated to the vacuum light (40) via transverse openings (70). Of course, any other suitable structures or arrangements can be used to communicate saline, vacuum, and / or pressurized air, etc., from the tube (402) to the vacuum light (40).

D. Exemplary Rotation and Translation Cutter Mechanism

In the present example, and as shown in figures 34 - 35, the body portion (350) of the probe (103) comprises a rotating and translating cutter mechanism 15 (120), which is operable to rotate and translate the cutter (50) inside the outer cannula (12). The rotation and translation cutter mechanism (120) in this example has essentially the same components, characteristics, and operability as the rotation and translation cutter mechanism (120) described above with respect to the probe (102). The rotation and translation cutter mechanism (120) therefore will not be discussed in great detail here. Of course, the rotation and translation cutter mechanism (120) can alternatively be varied in any suitable form, as desired, in the case of any of the probes (102, 103).

E. Exemplary variation in tip reduction

In addition, the needle portion (350) and the cutter (50) of the biopsy probe (103) can be configured to be removed from the biopsy probe (103) in essentially the same manner as described above with respect to the removal capacity of the needle portion (10) from the biopsy probe (102). For example, the body portion (352) may include the feature similar to the release tab (118), or any other suitable feature, to provide, allow, or facilitate the ability to remove the needle portion (350) and cutter (50) from the body portion (352).

F. Derivation of tissue sample holder

As shown in figures 38 - 40, the tissue sample holder (368) is provided at the end of the body portion (352) of the probe (103). The tissue sample holder (368) comprises a cup (142), a branch (370), and a plurality of trays (372). The branch (370) includes a central recess (146), a plurality of openings (374), and a longitudinally extending side wall (382). The side wall (382) extends only a portion of the length of the branch (370) in this example, although the side wall (382) may alternatively extend to any other degree as desired. The branch (370) also includes a plurality of radially extending walls (380). The walls (380) and the inner surface of the side wall (382) define a plurality of longitudinal passages (376). Each longitudinal passage (376) is in fluid communication with a corresponding opening (374).

In addition, the walls (380) and the outer surface of the side wall (382) define a plurality of chambers (378). With the side wall (382) providing space (for example, by not extending the total length of the branch (370)), each chamber (378) is in fluid communication with a corresponding longitudinal passage (376). The bypass (370) is thus configured so that each opening (374) is in fluid communication with a corresponding chamber (378). Of course, any other suitable structures or configurations for the bypass (370) can be used. For example, the lead (144) described above with respect to the biopsy probe (102) can be used with the biopsy probe (103) in place of the lead (370) being used with the biopsy probe (103). Likewise, the lead (370) can be used with the biopsy probe (102) instead of the lead (144) being used with the biopsy probe (102).

G. Exemplary Tissue Sample Trays

The trays (372) of the present example are configured to be arranged in branch (370), and to receive tissue samples (4) as will be described in greater detail below. Each tray (372) is provided with a plurality of base portions (382), a plurality of hollow wall portions (384), and a plurality of screens (386). Base portions (392), hollow wall portions (384), and screens (386) define chambers (388). Just as an example, each chamber (388) can be configured to receive a single tissue sample (4) captured by cutter (50). Alternatively, the chambers (388) can be configured so that each chamber (388) can contain more than one tissue sample (4). As shown, the underside of each hollow wall portion (384) is configured to receive a wall (380) from the branch (370). As is also shown, each hollow wall portion (384) is provided with a generally tapered configuration, although any other suitable configuration can be used.

Additionally, trays (372) are provided with a plurality of openings (390), which extends longitudinally, formed through the base portion (392) inside each chamber (388). The openings (390) continue, extending radially outward, through the portion of each screen (386). Thus, with the side wall (382) not extending the entire length of the bypass (370), the openings (390) allow fluid communication between each longitudinal passage (376) and each corresponding chamber (388). In other words, each opening (374) is in fluid communication with a corresponding chamber (388).

Each tray (372) may additionally comprise one or more types of markings or other indication for distinguishing one chamber (388) from the other chamber (388). Said markings or indications may be similar to those described above with respect to the chambers (166) of the trays (160). Thus, a discussion of the mentioned markings or indications will not be repeated here. Similarly, the cup (142) of the tissue sample holder (368) is essentially the same as the cup (142) of the tissue sample holder (140) described above. A discussion of the cup (142) will therefore not be repeated here.

H. Rotation and Alignment of Exemplary Derivation

The branch (370) of the present example is configured to rotate with respect to the base member (356), as will be described in greater detail below. The bypass (370) of the present example is further configured so that each opening (374) can be selectively aligned with an orifice (not shown) which is in fluid communication with the tube (404). Said alignment of an opening (374) and said orifice will arrange the aligned opening (374) in fluid communication with the tube (404), so that the vacuum induction inside the tube (404) will effect the vacuum induction through the opening (374), as well as inside the chamber (388) associated with that opening (374). In addition, the bypass (370) and the trays (372) of the present example are configured so that each chamber (388) can be selectively arranged in fluid communication with the cutter light (52). It will therefore be noted that a vacuum in the tube (406) can induce a vacuum in the light of the cutter (52), with the vacuum being communicated through the above observed door, an associated opening (374), an associated longitudinal passage (376), and an associated chamber (388). Of course, there are a variety of other ways in which vacuum can be induced within the light of the cutter (52), and any other structures or techniques can be used. In addition, pressurized air, a liquid (e.g., saline), or any other fluid can be communicated through the above-mentioned components instead of or in addition to the vacuum being induced therein.

A gear (170) is engaged with the derivation (370) of the present example. In particular, the gear (170) is inserted into the central recess (146) of the branch (370). The gear (170) and the central recess (146) of the tap (370) are essentially the same in configuration and operation as the gear (170) and the central recess (146) described above with respect to the tap (144). For example, gear (170) is configured to interlock with a complementary gear (210) from the case (302), so that gear (210) can be used to provide rotation for gear (170). Said rotation can be used to selectively (for example, consecutively) align the chambers (388) with the cutter's light (52), to successively collect a distinct tissue sample (4) in each chamber (388) while using the biopsy device (101). Additionally, said tissue sample collection (4) can be performed without having to remove and reinsert the needle portion (350) with respect to the patient during said process.

I. Exemplary placement tag

The body portion (352) of the present example additionally comprises a tongue portion (182) provided with teeth (not shown). The tongue portion (182) is flexibly released to the teeth to engage with the gear (170). The tongue portion (182) in the present context is thus essentially the same in configuration and operational capability as the tongue portion (182) discussed above in the context of the engagement member (180) of the probe (102). Thus, the similar details of configuration, function, operational capacity, etc. will not be repeated here. However, it should be noted that in the present example, the tongue portion (182) is integral with the rest of the base member (356), rather than being provided as a separate part of the engagement member (180). Of course, the body portion (352) can be modified so that the tongue portion (182) is provided as a separate part piece that is fixed with respect to the base member (356). Similarly, the base member (116) of the probe (102) can be modified so that the tongue portion (182) is formed as an integral part of the base member (116), instead of being a separate part the coupling member (180) which is fixed with respect to the base member (116). Still other variations will be apparent to those skilled in the art in view of the teachings here. In addition, it will be noted that a biopsy device (101) can be devoid of a tongue portion (182) in general, so that a bypass (370) can freely rotate when the biopsy probe (103) is not coupled with a case (302).

J. Exemplary Dedicated Chamber

As shown in figures 38 - 40, the tissue sample holder (368) of the present example is provided with a passage (158) formed through the bypass (370). The passage (158) of the bypass (370) is essentially the same in configuration, function, operational capacity, etc. than the passage (158) of the derivation (144) described above. Passage details (158) will therefore not be repeated here. However, it will be noted that, as in lead (158) of lead (144), lead (158) of lead (370) can be used to pass instruments such as biopsy field marker implantation devices, an applicator (90 ), and / or other devices or liquids, etc., into and / or through the cutter light (52). Similarly, the biopsy probe (103) can be initially provided with the passage (158) being aligned with the cutter light (52) by default.

The cup (142) of the tissue sample holder (368) additionally comprises an opening (176) and a fenestra (178). The cup (142), the opening (176), and the fenestra (178) of the tissue sample holder (368) are essentially the same in configuration, function, operational capacity, etc. than the cup (142), the opening (176), and the fenestra (178) of the tissue sample holder (140). Thus, details of the cup (142), the opening (176), and the fenestra (178) will not be repeated here.

IV. Exemplary Case for Use in Ultrasound

As shown in figures 41 - 45, an alternative case (302) comprises a top housing member (304), through which a portion of each of the gears (208, 210) is exposed, and a bottom housing member (306). A protrusion (212) is provided on the top housing member (304), and is configured to disengage the tongue portion (182) from the gear (170) when the biopsy probe (103) is coupled with a case (302 ). A plurality of hook members (305) extends from the top housing member (304) to selectively attach the probe (103) to the case (302), although other structures or techniques can be used. The case (302) of the present example additionally comprises a cutter drive mechanism (310) and a fabric support rotation mechanism (320). Each of these merely illustrative components will be described in more detail below. The kit (302) of the present example is configured to be coupled with a biopsy probe (103), such as the biopsy probe (103) described above, to provide a biopsy device (101). Additionally, the case (302) is configured to be manipulated, so that the biopsy device (101) can be manipulated and operated by a single user hand (for example, using an ultrasound guide, etc.). However, it will be appreciated in view of the description here that the case (302) can be used in a variety of other settings and combinations. Just as an example, the kit (302) can alternatively be coupled with the biopsy probe (102) instead of the biopsy probe (103). As another illustrative example, the case (302) can be coupled with the variation of the biopsy probe (102) which is equipped with the modified needle hub (60) (for example, a shorter needle hub (60) , not configured to activate the needle portion (10), etc.)

A. Exemplary Cutter Guidance Mechanism

As shown in figure 44, the cutter guiding mechanism (310) of the present example comprises a motor (312) with an axis (314) extending therefrom. The gear (208) is mounted to the shaft (314), and is configured to rotate unitarily with it. As noted above, a portion of the gear (208) is exposed through the top housing member (304), so that gear (208) interacts with the gear (138) of the rotating and translating cutter mechanism (120) when the biopsy probe (103) is coupled with the case (302). In this way, when the motor (312) is activated to rotate, said rotation can be communicated by means of axis (314) and gears (208, 138), to effect the simultaneous rotation and translation of the cutter (50) as described above . Other ways in which a cutter drive mechanism (310) can be configured or operated will be apparent to those skilled in the art in view of the teachings here.

B. Exemplary Tissue Support Rotation Mechanism

As shown in figure 45, the fabric support rotation mechanism (320) of the present example comprises a motor (322) provided with an axis (324) with a gear (326) mounted to it, so that the gear (326 ) rotates unitarily with the axis (324). The gear (326) is configured to interlock with the gear (328), which is mounted to the shaft (330). The gear (210), which was observed above, is also mounted to the shaft (330), at the proximal end of the shaft (330). In particular, the gear (210) is configured to interlock with the gear (170) of the tissue sample holder (368) when the biopsy probe (103) is coupled with the case (302). In this way, when the motor (322) is activated to rotate, said rotation can be communicated by means of axes (324, 330) and gears (326, 328, 210, 170), to effect the rotation of the branch (370) as described above.

In addition, a coding wheel (292) is coupled with the shaft (330), and is configured to rotate unitarily with it. The coding wheel (292) is provided with a plurality of slots (294) formed through it, similar to the slots (294) seen above. A sensor (296) is positioned adjacent to the coding wheel (292). In particular, the sensor (296) is positioned so that the slots (294) successively pass before the sensor (296) as the coding wheel (292) rotates with the axis (290). The sensor (296) can therefore be used to count the passage of the slits (294), which can be translated into the rotational position of the bypass (366). In other words, since the coding wheel (292) and the bypass (366) rotate concomitantly when the biopsy probe (103) is coupled with the case (302) in the present example, the passage of the slits (294) in front of the sensor (296) during the rotation of the axis (330) can be indicative of the rotation of the branch (366), and therefore of the position of the branch (366). It will be appreciated that said information can be additionally indicative of which particular chamber (388) is aligned with the cutter light (52). Suitable uses for said information will be apparent to those skilled in the art in view of the teachings here. Suitable devices that can be used for the sensor (296) will also be apparent to those skilled in the art in view of the teachings here. In addition, other ways in which a tissue support rotation mechanism (320) can be configured or operated will be apparent to those skilled in the art in view of the teachings here.

C. Exemplary Lighting Features

As shown in figures 41 - 43, the case (302) of the present example still includes a plurality of LEDs (308, 316, 318). In particular, a pair of LEDs (308) is provided on a distal end of the case (302). The light emitted by the LEDs (308) is visible through openings formed at the distal end of the upper housing element (304). The LEDs (308) are positioned and configured to act as beacons for the biopsy device (101), such as by lighting a patient's location where a needle portion (350) has to be inserted. The LEDs (308) can be continuously activated, just as they are activated while the biopsy device (110) is activated. Alternatively, the LEDs (308) can be selectively activated, such as by a switch (not shown) on the case (302), on a probe (103), on a vacuum control module (400) or others. Other ways in which the LEDs (308) can be activated, positioned or otherwise operated or configured will be evident to those skilled in the art in view of the teachings here.

The LEDs (316, 318) are provided on the distal end of the case (302). The light emitted by the LEDs (316, 318) is visible through the openings formed at the distal end of the lower housing element (306). As shown, the LEDs (316) are each positioned on either side of the LED (318), which is positioned between the gear (210) and the protrusion (212). The LEDs (316) are confined to provide illumination for the tissue sample holder (368).

In particular, branch (370) and the other components are configured to allow illumination of the tissue sample holder (368) by the LEDs (316, 318) in this example. For example, branch (370), gear (170), shaft (172) and / or other components can be formed from a substantially transparent or substantially translucent material, including combinations of materials that provide a combination of transparent and / or properties or translucent. The cup (142) can also be substantially transparent or substantially translucent to allow a user to see at least some amount of light emitted by the LEDs (316, 318). Adequate selections and arrangements of materials and components to allow illumination of the tissue sample holder (368) by the LEDs (316, 318) will be evident to those skilled in the art in view of the teachings here.

It will also be appreciated that one or more of the LEDs (316, 318) can be positioned to illuminate a particular chamber (388) within the tissue sample holder (368) instead of illuminating the entire tissue sample holder (368) . For example, the LEDs (316, 318) can be configured to illuminate an active chamber (388), such as the chamber (388) located at the nine o'clock, twelve o'clock and / or three o'clock position. In addition, one or more of the LEDs (308, 316, 318) can be configured to light or change color to indicate an error condition (for example, cutter light blocked (52), probe (103) insufficiently attached to the case (302), leak in a tube (402, 404, 408, 410), etc.). Other ways in which the LEDs (316, 318) can be activated, positioned or otherwise operated or configured will be evident to those skilled in the art in view of the teachings here.

Also, it will be appreciated that the case (202) can be modified to include any of the LEDs (308, 316, 318). Similarly, the branch (144) and / or other components of the probe (102) can be configured to allow the branch (144) to be illuminated by the LEDs (316, 318); and the cup (142) can be configured to allow an observer to observe the illumination of the lead (144) in the biopsy device (100). Alternatively, any or all of the LEDs (308, 310, 318) can simply be omitted from the biopsy device (100, 101) in general.

Although LEDs (308, 316, 318) have been described in the preceding example 55 as providing lighting, any other suitable source of light can be used including, but not limited to, an incandescent bulb. Alternatively, a biopsy device (100, 101) can be devoid of a light source in general.

V. Exemplary Vacuum Control Module and Can

Figures 46 - 47 show an exemplary vacuum control module (400) and an exemplary vacuum container (500). As shown, the vacuum container (500) is configured to be inserted into a vacuum control module (400). As will be described in more detail below, the vacuum control module (400) is operable to induce a vacuum through the vacuum container (500) and said vacuum can be communicated to the biopsy probe (102, 103) as described above. In addition, the vacuum container (500) is operable to collect fluids that are communicated from the biopsy probe (102, 103) during use of the biopsy probe (102, 103). The vacuum container (500) can thus be considered to provide a fluid interface between the biopsy probe (102, 103) and the vacuum control module (400).

A. Exemplary Vacuum Can

As shown in figures 48 - 51, the vacuum container (500) comprises a base portion (502), a cap portion (506) and a handle (508). The cable (508) is configured to be held by a user when the user inserts the vacuum container (500) into a vacuum control module (400) or removes the vacuum container (500) from the vacuum control module ( 400), as will be described in greater detail below. The base portion (502) is substantially hollow and is configured to provide a reservoir (504) for collecting fluids (e.g., saline, blood, etc.) communicated from the biopsy probe (102, 103).

The lid portion (506) of the present example is provided with tracks (530) formed on its sides. The tracks (530) are configured to fit with rails (460) in the can compartment (458) of the vacuum control module (400), as will be described in more detail below. The tracks (530) are each provided with an enlarged portion (532) to provide guidance so that the tracks (530) fit into the tracks (460) to thereby facilitate the insertion of the vacuum container (500) in the can compartment (458) of the vacuum control module (400). In other embodiments, the tracks (530) are provided on a base portion (502). Alternatively, trails (530) can be replaced or supplemented with other suitable structures at any other suitable location (s) or can simply be omitted in general.

In the present example, the lid portion (506) is provided with a plurality of trenches (510) formed therein. As will be described below, the trenches (510) are configured to receive tubes (402, 404, 408, 410). A plurality of upper orifices (512) are formed over the cap portion (506) and each upper port (512) is configured to have a path for fluid communication from a connecting tube (402, 404) to the reservoir (504 ) defined by the base portion (502). The cap portion (506) further comprises a vacuum port (514), which is configured to be placed in fluid communication with a vacuum source (412) on the vacuum control module (400), as will be described in further details below. The vacuum port (514) included a pair of O-rings (534) configured to provide a seal when fitted with a complementary vacuum port (462), as will be described in greater detail below. It will be appreciated in view of the teachings here that when the vacuum source (412) is used to generate a vacuum, such a vacuum can be communicated to the tubes (402, 404) via the vacuum port (514), reservoir (504) and upper holes (512). The vacuum can also be communicated to the biopsy probe (102, 103) through the tubes (402, 404). The lid portion (506) also includes a vent (544), configured to vent the open end of a vent tube (410) therein. Such ventilation will be described in greater detail below.

The lid portion (506) is also provided with a lid (526) which is removably attached to an access door (528) while using the biopsy system (2). After the biopsy system (2) has been used and liquid is present in the reservoir (504), the cap (526) can be removed to gain access to the reservoir (504). Of course, as with other similar components mentioned here, the cover (526) and the access door (528) are merely optional and can be varied, replaced, implemented or simply omitted in general, as desired.

As best seen in figure 51, a float (516) is provided in a cage (518), which extends from the bottom of the cap portion (506) in the reservoir (504). Although the float (516) is shown as a spherical shape, any other suitable shape can be used. An elastomeric funnel member (520) is partially arranged in and engaged with the cage (518). In addition, a hydrophobic filter (522) is provided between the bottom of the cap portion (506) and the funnel member (520). A conduit (524) is formed in the cap portion (506), providing fluid communication from the vacuum port (514) to the filter (522) and the funnel member (520) and therefore to the reservoir (504) . The filter (522) is configured to prevent communication of liquids (for example, saline, blood, etc.) from the reservoir (504) through the conduit (524) and the vacuum port (514); while allowing a vacuum to be communicated or induced through them.

The float (516) has properties (for example, density) so that it will float in a liquid, but will not be pulled when a vacuum is induced inside the reservoir (504). In other words, when the vacuum source (412) is activated to induce a vacuum through the vacuum port (514), the float (516) will not necessarily be pulled against the funnel member (520). The vacuum, therefore, can be communicated around the float (516) and through the funnel member (520). However, as the reservoir (504) fills with liquid, the float (516) will begin to float through the funnel member (520). Eventually, the liquid extracted in the reservoir (504) through the tubes (402, 404) and upper orifices (512) can reach a level inside the reservoir (504) to indicate where the float (516) fits with the funnel member (520) in a manner sufficient to prevent fluid from passing between the float (516) and the funnel member (520). In addition, said fitting between the float (516) and the funnel member (520) can prevent the vacuum from being communicated from the reservoir (504) through the vacuum port (514). Such a vacuum communication block can be captured within the biopsy system (2) and can trigger some type of notification that the vacuum container (500) is substantially filled with liquid. For example, a vacuum lock can automatically stop the vacuum source (412). A vacuum lock can also trigger a visual indication on a graphical user interface and / or an audible signal.

Those skilled in the art will appreciate, in view of the teachings here, that the filter (522), the float (516), the cage (518) and the funnel member (520) are all exemplary. In fact, any other suitable devices or structures can be used in addition to or in place of said components. Alternatively, the components can simply be omitted in general. In other words, the inventors consider that a variety of other configurations for the vacuum container (500) can be used and that, like every other component of the biopsy system (2) described here, the vacuum container (500) does not. it needs to be limited to the particular construction that is explicitly described here.

B. Exemplary Tube Connection and Configuration

Fig. 50 shows an example of tubes (402, 404, 408, 410) being provided in trenches (510). The trenches (510) can include one or more features configured to retain the tubes (402, 404, 408, 410) within the trenches (510). For example, upright flaps or protrusions can be provided close to the upper parts of the trenches (510). Alternatively, the side walls of the trenches (510) provide an interference fit; or they can be angled, so that the upper parts of the side walls of the trenches (510) provide less clearance than the lower parts of the side walls. Alternatively, an adhesive can be used to secure the tubes (402, 404, 408, 410) within the trenches (510). In yet another variation, one or more caps, closures or other elements can be attached over portions of the tubes (402, 404, 408, 410) to secure the tubes (402, 404, 408, 410) within the trenches (510). Other ways in which the tubes (402, 404, 408, 410) can be attached or retained within the trenches (510) will be apparent to those skilled in the art.

A plurality of upper orifices (512) are formed on the lid portion (506) and each upper port (512 ) is configured to have one of the tubes (402, 404) coupled thereto. In particular, each upper port (512) is configured to provide a path for liquid communication from a connected tube (402, 404) to the reservoir (504) defined by the base portion (502). In one embodiment, the can (500) is prepacked with tubes (402, 404, 408, 410) already positioned in the trenches (510), in addition to having tubes (402, 404) coupled with the probe (102, 103) before packaging the product. In other embodiments, the can (500) and / or the probe (102, 103) can be packaged without some or all of the tubes (402, 404, 408, 410) already connected. However, in some modalities where the can (500) and the probe (102, 103) come with pre-connected tubes (402, 404, 408, 410), to the can insertion part (500) in the can compartment (458 ) as described below, a user can have pipe connection (408) with a saline bag (444) as the only fluid connection the user needs to make. Of course, in modalities where saline is not used, the fluid communication to the biopsy system (2) can be ready for use as soon as the user inserts the can (500) into the can compartment (458).

As shown in figure 1, the tube (408) is fed into the tube (402). As shown in figures 1 and 50, the tube (410) is also fed into the tube (402). In particular, a connector (446) connects the ventilation tube (410) with the tube (402); and a connector (448) connects the saline tube (408) with the tube (402). As shown, the connector (446) is provided adjacent to the can (500), while the connector (448) is provided close to the biopsy probe (102, 103). In the present example, the connectors (446, 448) simply provide a constantly open conduit between the tubes (410, 402) and the tubes (408, 402), respectively. In other embodiments, the connectors (446, 448) can have any other suitable components (for example, valve, etc.). It will be appreciated in view of the description here, that the configuration of the tubes (402, 408, 410) and connectors (446, 448) allows any of a vacuum, ventilation or saline to be communicated through the tube (402). An exemplary determination of how they will be communicated through the tube (402) will be described in more detail below.

C. Exemplary Vacuum Control Module

As shown in figures 46 - 47 and 52 - 58, the vacuum control module (400) of the present example comprises an outer shell (414), a slot for the vacuum container (416), a portion of cable (418) and a user interface (700). The outer housing (414) includes a face portion (420), behind which resides a display screen (702), capacitive keys (704) and a speaker (706). The face portion (420) is configured so that the viewing screen (702) can be seen through it; so that the capacitive switches (704) can be activated through it; and so that sounds that come from the speaker (706) can be heard through it. As will be described in more detail below, the display screen (702), keys (704) and loudspeaker (706) can be considered to collectively form the user interface (700). The outer shell (414) further comprises a top cover (422), a cover cover (424) and trimmed parts (426).

The outer shell (414) is configured so that the outer shell (414) is relatively easy to clean. For example, surface transitions (for example, between the face portion, the top cover, a coating cover (424) and trimmed parts (426, etc.) are reduced. In addition, with capacitive keys (704) being provided behind the face portion (420) in place of conventional pressing buttons or other mechanical production components, the areas of fluid ingress and dirt capture are reduced if not eliminated.

As shown in figure 53, the vacuum control module (400) of the present example still comprises a base portion (428), which is provided with a pair of upright members (420) extending above it and internally in towards each other, meeting in the cable portion (418). Consequently, the base portion (428), upright members (430) and cable portion (418) are configured so that when a user transports the vacuum control module (400) through the cable portion (418), the The weight of the vacuum control module (400) is supported by the base portion (428) and upright members (430). In one embodiment, the upright members (430) and the cable portion (418) are collectively formed by a unitary metal member fixedly attached to the base member (428), such as by means of screws, clamps, welds or using others components or techniques. The cable portion (418) may further comprise an external plastic mold formed around said unitary metal member. Of course, as with other components described here, the upright members (430) and the cable portion (418) can be formed in a variety of alternative shapes using a variety of alternative structures and techniques.

With the cable portion (418), the vacuum control module (400) can be provided as a substantially portable unit. For example, the vacuum control module (400) can be of a size and weight (for example, less than 10 kg) so that a single user can hold and transport the control module (400) over the cable portion (418 ) or otherwise, with relative ease. The vacuum control module (400) can also be used with or without a cart. For example, the portability of the vacuum control module (400) may allow it to be simple to adjust on a bench or other location. Such portability may be desirable in environments for MRI and other environments.

The vacuum control module (400) of the present example also includes fans (432) and a ventilation (433) through said components can be varied or omitted. The vacuum control module (400) also includes a grounding cable (434), a USB port (436) and an Ethernet port (438). In addition, the vacuum control module (400) involves a clamp socket (435) for connecting the vacuum control module (400) to an AC outlet using a conventional cable and power switch (439). It will be noted by those skilled in the art, in view of the teachings here, that the USB port (436) and / or the Ethernet port (438) can be used to couple the vacuum control module (400) with a variety of others devices including, but not limited to, a local desktop or laptop computer, the internet, a local area network, any other network, a storage device or device associated with one or more particular imaging modalities (for example, a pod or a graphics device associated with Magnetic Resonance Imaging, etc.). Said ports (436, 438) can allow data and / or commands to be communicated from the vacuum control module (400) to an external device. In addition to or alternatively, the ports (436, 438) can allow data and / or commands to be communicated from an external device to the vacuum control module (400). Other ways in which the doors (436, 438) can be used will be evident to those skilled in the art in view of the teachings here. Similarly, it will be appreciated that the doors (436, 438) can be replaced, supplemented, varied or omitted as desired.

Also as shown in figure 53, a vacuum pump (440) is provided in the vacuum control module (400). A damper assembly (442) is connected to the vacuum pump (440) to reduce the noise generated by the vacuum pump (440). The vacuum pump (440) and the damper assembly (442) thus collectively provide a vacuum source (412) in the present example, although any other suitable components can be used. For example, the damper assembly (442) is purely optional. The vacuum pump (440) and the damper assembly (442) are fixedly attached with respect to the base portion (428), such as via screws, clamps, welds or using other components or techniques. One or more rubber feet (not shown) or similar components can be positioned between the vacuum pump (440) and the base portion (428) to absorb the vibration generated by the vacuum pump, in order to further reduce noise. Other ways in which the noise of the vacuum pump (440) can be reduced will be evident to those skilled in the art in view of the teachings here.

In the present example, saline is supplied to the biopsy system (2) via a conventional saline bag (444), which is separated from the vacuum control module (400). For example, the saline bag (444) can be attached to the tube (408) using any suitable conventional fitting. In other modalities, saline solution is supplied from inside the vacuum control module (400). For example, the vacuum control module (400) may include a feature (not shown) that is operable to receive a conventional saline bag (444), with a port (not shown) for placing the tube (408) in fluid communication with the saline bag (444). The vacuum control module (400) may alternatively include some other type of reservoir within the housing (414) for supplying saline solution. In other modalities, saline solution is not used in general with the biopsy system (2). It will also be appreciated that the vacuum control module (400) may also include a source of pressurized air, such as a loaded pump or can, etc. Said pressurized air can be communicated to a biopsy device (100, 101) for any suitable purpose including, but not limited to, pressurized air communication through one or more lights (20, 40, 52), activation of a component (for example, a motor or pneumatic actuator, etc.) within the biopsy device (100, 101) or for any other purpose. Still other components that can be incorporated into or otherwise associated with the vacuum control module (400) will be evident to those skilled in the art in view of the teachings here.

D. Vacuum can door on the Exemplary Control Module

As shown in figures 53 - 58, the vacuum control module (400) of the present example still comprises a vacuum container port assembly (450). The vacuum container port assembly (450) comprises a clamp (452), an inner casing (454) and a plurality of solenoids (456). The clamp (452) is configured to be fixedly attached to the base portion (428), such as via screws, clamps, welds or using other components or techniques. Heat sinks (459) are attached to the clamp (452), as well as solenoids (456) and the inner shell (454).

The inner shell (454) defines a can compartment (458), which is configured to receive the vacuum container (500) as mentioned above. In particular, rails (460) extend internally from the inside of the clamp (452), through the side walls of the inner casing (454) and into the can compartment (458). As described above, the rails (460) are configured to fit with tracks (530) over the vacuum container (500), to guide the vacuum container (500) as the vacuum container (500) is inserted in the can compartment (458). Each track (460) is provided with a tapered portion (460) to facilitate fitting with the tracks (530) in the present example, although the tapered portions (460) are merely optional. It will be appreciated in view of the description here, that the rails (460) may alternatively extend internally only from the side walls of the inner shell (454) instead of the clamp (452). Alternatively, the tracks (460) can be otherwise configured or positioned or can be omitted in general.

E. Quick connection of the Exemplary Vacuum Can

The inner shell (454) of the present example also includes a vacuum port (462). A port coupler (464) is provided on the outside of the inner shell (454), opposite the vacuum port (462) and is in fluid communication with the vacuum port (462). The door coupler (464) is configured to be connected with a tube, hose or other structure for fluid coupling of the door coupler (464) with the vacuum pump (440). In other words, the vacuum pump (440) can be placed in fluid communication with the vacuum port (462) via a tube (not shown) connected to the port coupler (464), so that the vacuum pump vacuum (440) can extract a vacuum through the vacuum port (462). The vacuum port (462) is configured to fit with the vacuum port (514) of the vacuum container (500) when the vacuum container (500) is inserted into the can compartment (458). In particular, the vacuum port (462) provides a female-shaped complement to the male-vacuum port (514). O-rings (534) over the vacuum port (514) are configured to provide a sealed fit between the vacuum port (462) and the vacuum port (514). Naturally, the male-female arrangement between the vacuum ports (462, 514) can be reversed or some other relationship between the vacuum ports (462, 514) can be provided. In addition, other variations can be used where O-rings (534) are replaced, supplemented or omitted in general '

F. Exemplary Manqote Valve System

Solenoids (456) each include a respective rod (470). Each rod (470) is provided with a corresponding fitting tip (472, 474, 476, 478) attached to it. Each solenoid (456) is operable to selectively move its rod (470) with the tip (472, 474, 476, 478) up or down when the solenoid (456) is activated, the up or down movement being dependent of the signal communicated to each solenoid (456). The rods (470) are positioned so that when the vacuum container (500) is inserted into the can compartment (458), the tips (472, 474, 476, 478) can be selectively fitted with the tubes (402, 404, 408, 410) through selective activation of the solenoids (456). In particular, when the vacuum container (500) is inserted into the can compartment (458) of the vacuum control module (400), the tip (472) is positioned to selectively fit into the saline tube (408), the tip (474) is positioned to selectively engage the vent tube (410), the tip (476) is positioned to selectively engage with the axial vacuum tube (404) and the tip (478) is positioned to selectively engage with the side vacuum tube (402).

Recesses (536, 538, 540, 542) are formed in the lid portion (506) of the vacuum container (500) and are configured to provide sufficient clearance for the tips (472, 474, 476, 478) to fully fit into the tubes (402, 404, 408, 410). Said fitting may include the ends (472, 474, 476, 478) in hose with the tubes (402, 404, 408, 410) against the cap portion (506) (for example, using the cap portion (506) as an interlocking surface) to thereby prevent fluid communication between the tubes (402, 404, 408, 410).

In the present example, the recess (536) is configured to allow the tip (472) to fully fit with the saline tube (408), the recess (538) is configured to allow the tip (474) to fully fit with the vent tube (410), the recess (540) is configured to allow the tip (476) to fully engage with the axial vacuum tube (404) and the recess (542) is configured to allow the tip ( 478) fits with the side vacuum tube (402). Such total engagement of the tips (472, 474, 476, 478) with the tubes (402, 404, 408, 410) will serve to prevent fluid from being communicated through the tubes (402, 404, 408, 410) fully fitted in this example. In other words, solenoids (456), rods (470) and tips (472, 474, 476, 478) can be used to serve as a valve function with respect to tubes (402, 404, 408, 410) , so that the selective activation of the solenoids (456) can allow or prevent the communication of fluid through the tubes (402, 404, 408, 410). Suitable combinations to allow / prevent fluid communication through the tubes (402, 404, 408, 410) while using the biopsy system (2) will be described in more detail below.

In some variations, each solenoid (456) is fitted with one or more flexible members (for example, springs, etc.). For example, said flexible members can be located at the bottom of the solenoids (456) and can be used to control the tolerance stack and combine the strength profile of the solenoids (456) with the strength profile of the tubes (402, 404, 408, 410). Naturally, said flexible members can be located anywhere and can perform functions other than or in place of those mentioned above. Similarly, other components can be used to control the tolerance stack and combine the strength profiles. Alternatively, said flexible members or other components can simply be omitted in general.

Although fluid control is provided by solenoids (456), rods (470) and tips (472, 474, 476, 478) in the present example, it will be appreciated that fluid control can be provided in a variety of alternative ways . For example, alternative valve devices or systems can be provided within the vacuum control module (400). Alternatively, all or some of the valve functions can be performed within the biopsy device (101, 102). For example, a constant vacuum can be communicated to the biopsy device (101, 102) and a valve element within the biopsy device (101, 102) can be operable to selectively communicate said vacuum to the vacuum light (40) and / or cutter light (52). In other embodiments, one or more of the motors within the biopsy device (100, 101) can be used to control a vacuum pump that is located within the biopsy device (100, 101) to provide a vacuum. Said vacuum motor can be dedicated to the control of said pump or a pre-existing motor (246, 272, 282, 312, 322) can be used to control said pump. Yet other ways in which fluid communication (eg, saline, vacuum, ventilation, etc.) through the tubes (402, 404, 408, 410) or otherwise within the biopsy system (2) can be selectively controlled or supplied will be evident to those skilled in the art in view of the teachings here.

G. Exemplary Crushing Piping

In some embodiments and as shown in figure 59, the tubes (402, 404, 408, 410) are formed with a plurality of longitudinal grooves (490). In the present example, grooves (490) extend along the entire length of each of the tubes (402, 404, 408, 410). In other embodiments, the grooves (490) are provided only along the length portions of the tubes (402, 404, 408, 410) where the tubes (402, 404, 408, 410) will be selectively fitted with the points (472 , 474, 476, 478). With the tubes (402, 404, 408, 410) being formed of a low hardness polymer with the grooves (490), the tubes (402, 404, 408, 410) have a relatively low resistance when being crushed by the tips ( 472, 474, 476, 478) in a manner sufficient for fluid communication to cease in a tube (402, 404, 408, 410) being crushed by a tip (472, 474, 476, 478). However, the tubes (402, 404, 408, 410) will still have enough stiffness to stop collapsing when a vacuum is induced inside the tubes (402, 404, 408, 410), despite having grooves (490 ). The tubes (402, 404,

408, 410) may also be provided with sufficient thickness to provide resistance when bent.

It will be appreciated in view of the teachings here, that grooves (490) can be formed in the tubes (402, 404, 408, 410) using a variety of techniques. For example, when tubes (402, 404, 408, 410) are formed using a thermoplastic extrusion process, cold knives can be provided at the outlet of an extrusion die to cut the material while it is still hot. Alternatively, when tubes (402, 404, 408, 410) are formed using a thermosetting extrusion process, hot knives can be provided at the outlet of an extrusion guide to cut the material while it is still green. Alternatively, grooves (490) can be formed by cutting downstream from a curing oven or cooling bath. Other ways in which the grooves (490) can be formed will be evident to those skilled in the art in view of the teachings here. It will also be appreciated that the grooves (490) can be provided with any other suitable configuration (for example, number of grooves (490), depth of the grooves (490), length of the grooves (490), selection of which tubes (402, 404 , 408, 410) will have grooves (490), etc.). Of course, the grooves (490) can simply be omitted in general.

In addition, one or more of the tubes (402, 404, 408, 410) can be colored or translucent, in order to hide the blood that can be communicated through them.

H. Exemplary Engine Control

The vacuum control module (400) of the present example also includes a controller (480) operable to control motors (246, 272, 282, 312, 322) in the cases (202, 302). For example, a single controller (480) can coordinate between motor functions on different motors (246, 272, 282, 312, 322) that are within the same biopsy system (2). The vacuum control module (400) includes a port (482) to provide communication of the motor and power control signals to the motors (246, 272, 282, 312, 322) via a cable (484). In other embodiments, motor control signals are provided wirelessly. Although the case (202) of the present example has three motors (246, 272, 282) and the case (302) of the present example has two motors (312, 322), the same controller (480) and port (482) can be used to control each case (202, 302). Alternatively, each case (202, 302) can have a dedicated port on the vacuum control module (400).

The motors (246, 272, 282, 312, 322) can include any suitable combination of brush or brushless technology. For example, one or more of the motors (246, 272, 282, 312, 322) can be a brushless motor that uses optical switching. In some embodiments, the use of optical switching can provide a degree of immunity to the environment with high magnetic fields, such as those that can be found in an MRI environment. A merely illustrative example of an engine using optical switching is disclosed in US Patent No. 5,424,625, entitled Repulsion Motor, issued on June 13, 1995, the disclosure of which is incorporated by reference here. Another illustrative example of a motor using optical switching is described in US Patent No. 7,053,586, entitled Brushless Repulsion Motor Speed Control System, issued on May 30, 2006, the description of which is incorporated herein by reference.

Just as an example, one or more of the motors (246, 272, 282, 312, 322) may include a pair of detector sensor / optical source mounted on the miniature reflective surface OPTEK OPR5005. In addition, the light that is used can be coherent (for example, LASER) or non-coherent (for example, generated by an LED). Visible or invisible light spectra can be used. In the present example, a reflective infrared (IR) sensor comprising an IR photodiode and an IR phototransistor is used. The optosensors are arranged around the motor axis in 120 ° increments in a circular arrangement on a printed circuit panel and in angular alignment with the motor phase spirals. An indicator or optical switch that is aligned with magnets on the rotor is attached to the motor shaft which is transmissive / non-reflective for half of its perimeter and reflective / non-transmissive on the other half. When the phase turns are properly aligned with the optical sensors and the optical indicator is properly aligned with the magnetic poles on the rotor, a 60 ° position capture of the rotor is possible, exactly in line with Hall effect sensors. In addition, the logic level product of the optical sensors can be made identical to that of the Hall effect sensors, allowing exchange of the types of capture with the control hardware, such as the controller (480). Other constructions suitable for engines (246, 272, 282, 312, 322), including those using optical switching or others, will be evident to those skilled in the art in view of the teachings here.

The controller (480) of the present example comprises a group of 4-axis Magellan integrated circuits from Performance Motion Devices, Inc. of Lincoln, Massachusetts. In one embodiment, the controller (480) is configured to use Hall effect signals for control based on the position of any of the motors (246, 272, 282, 312, 322). For example, as mentioned above, the motors (282, 322) of the present example are operationally coupled with coding wheels (292) and sensors (296). Said configuration can provide a quadrature encoder with three channels (A, B and index pulse) which, in combination with the controller (480), allows repeatability of the positioning tap (144, 366) within approximately 0 ,1 degree.

In some embodiments, Hall effect sensors are used to provide switching and position control for at least one of the motors (246, 272, 282, 312, 322). The controller (480) is configured to provide a multiplexing scheme with signals provided by said Hall effect sensors and those provided by the sensor (296), whereby sixteen differential signals are multiplexed over four or six differential pipes that are coupled to the port (482) and effectively continued through the cable (484). Of course, any other multiplexing scheme can be used, to the extent that either is used in general. Still other configurations suitable for and methods of operation via the controller (480) will be evident to those skilled in the art in view of the teachings here.

SAW. Exemplary Modes of Operation

It will be appreciated in view of the description here, that there are a variety of methods by which the biopsy system (2) can be operated. For example, regardless of the structures or techniques that are used to selectively control fluid communication (eg, saline, vacuum, ventilation, etc.) through the tubes (402, 404, 408, 410) or otherwise within of the biopsy system (2), there are a variety of synchronization algorithms that can be used. These synchronization algorithms can vary based on an operating mode selected by a user. In addition, there may be an overlap between the operating modes (for example, the biopsy system (2) may be in more than one operating mode at any given time, etc.). In addition to fluid communication synchronization algorithms being varied based on a selected operating mode, other operational aspects of the biopsy system (2) may vary based on a selected operating mode. For example, the operation of the tissue sample holder (140, 368) can vary based on a selective operating mode, as can the cutter operator (50) and other components of the biopsy system (2). Several purely exemplary operating modes will be described in greater detail below, while others will be evident to those skilled in the art in view of the teachings here.

A. Presentation of Exemplified Captured Tissue Samples

A purely exemplary operating mode may include a way of viewing the sample. In this mode, the tap (144, 366) can be configured to rotate after a tissue sample (4) is acquired, to present the tissue sample (4) to the operator for viewing before the user acquires the next tissue sample. In particular and as shown in figure 60, a tissue sample (4) is extracted in the chamber (166, 388) which is at the twelve o'clock position when the tissue sample (4) is initially acquired. The tap (144, 366) is then rotated until the tissue sample (4) is in the three o'clock position, thereby allowing a user to easily see the tissue sample (4) on the side of the biopsy device (100 , 101). Said rotation can occur immediately after substantially the tissue sample (4) is extracted in the chamber (166, 388). Alternatively, the biopsy system (2) can wait to see if any user input occurs within a certain period of time (for example, 2 seconds) after the tissue sample (4) has been acquired, then rotate the sample fabric (4) to the three o'clock position only if no user input has occurred within that time period.

The rotational position of the tap (144, 366) can be maintained so that the tissue sample (4) is held in the three o'clock position until some other user input is provided. For example, if a user provides input indicating a desire to obtain another tissue sample (4), the biopsy system (2) can rotate the lead (144, 366) to align the next available chamber (166, 388) available (for example, example, a chamber (166, 388) which is immediately adjacent to the chamber (166, 388) in which the most recently acquired tissue sample (4) resides) with the cutter's light (52). After the next available chamber (166, 388) has been aligned with the cutter light (52), the cutter (52) can be activated to obtain another tissue sample (4) and an axial vacuum can be used to extract that next one tissue sample (4) in the next chamber (166, 388) available. If a user input to clean probe or aspirate is provided, the bypass (144, 366) can be rotated to realign the chamber (166, 388) in which the tissue sample (4) resides with the cutter light (52) and , then the probe clean or vacuum control can be performed as described below. Similarly, if a smart vac cycle is initiated, which will be described in greater detail below, then the bypass (144, 366) can be rotated to realign the chamber (166, 388) in which the tissue sample (4) resides with the cutter light (52), so that the smart vac cycle can be performed.

An illustration of the rotation sequence of the present example is provided in figure 60. As shown in block (600), the tissue sample holder (140, 368) is initially configured so that a first chamber (166, 388) is in twelve o'clock position. Then, as shown in block (602), a tissue sample (4) is communicated to the first chamber (166, 388). With the sample view mode activated, the lead (144, 366) then rotates so that the first chamber (166, 388) is in the three o'clock position, as shown in block (604). As shown in block (606), when receiving user input to start another sampling cycle, the branch (144, 366) is rotated to place a second chamber (166, 388) at the twelve o'clock position, so that a The tissue sample (4) is then communicated via the cutter light (52) in the second chamber (166, 388). As shown in block (608), the tap (144, 366) then rotates so that the second chamber (166, 388) is in the three o'clock position to present the second tissue sample (4) to the user. As shown in block (610), the process of the present example is repeated for the acquisition of tissue sample (4) in a third chamber (166, 388). This process can be repeated until all chambers (166, 388) within the tissue sample holder (140, 368) are full.

As an alternative to waiting for user input, the tissue sample (4) can be held in the three o'clock position for a certain period of time (for example, 5 seconds) with the lead (144, 366) being automatically rotated to align the next chamber (166, 388) available with the cutter light (52), regardless of whether a user has provided an input. As another non-limiting variation, the biopsy system (2) can hold the tissue sample (4) at just three o'clock during that period, unless the user has provided some type of input before expiration of that time period, which will cause the lead (144, 366) to be rotated, as mentioned above. Yet other ways in which synchronization and / or user input can be used to determine the period of time for which a tissue sample (4) is held at the three o'clock position will be evident to those skilled in the art in view of the teachings on here. Also, it will be appreciated that said rotational control of the tap (144, 366) can be performed, at least in part, by the controller (480) in combination with feedback from the coding wheel (292) and the sensor (296) or using any other suitable components.

The biopsy system (2) can also be configured to allow a user to select the nine o'clock position (or any other position) for presenting the tissue sample (4) instead of the three o'clock position mentioned above. The biopsy system (2) can also allow a user to disable the sample view mode, so that the rotation of the lead (144, 366) between the acquisition of tissue samples (4) is just to align a next chamber (166 , 388) available with the cutter light. Other variations of the biopsy system (2) may be devoid of a sample view or similar mode, as well as components that could be used for such a mode, in general.

B. Exemplary sample cycle

Another exemplary operating mode, which can overlap with the sample view mode discussed above, is a sampling mode, during which a sample cycle can be started. An exemplary sequence of the position of the cutter (50) within the outer cannula (12) with respect to the fluid communication provided through the tubes (402, 404) in a sample cycle is shown in figure 61. The said cycle is initiated after the portion needle (10) has been inserted into a patient's chest. With the needle portion (10) inserted, lateral and axial vacuum are applied. In particular, the solenoids (456) are activated so that the tips (476, 478) are moved upward to substantially disengage from the tubes (402, 404), allowing a vacuum to be communicated through the tubes (402, 404). Given the fluid connection of the tube (402) with the needle tap (80, 366), as well as the transverse openings (32) formed through the wall (30), communication of a vacuum through the tube (402) will extract a vacuum lateral with respect to the cannula light (20). Communication of a vacuum through the tube (404) will extract an axial vacuum through the light of the cutter (52), given the fluid connection of the tube (404) to the light of the cutter (52) via the tissue sample holder (140 , 368) in this example.

With the axial and lateral vacuum applied as described above, the cutter (50) is retracted axially. Said axial retraction is performed using the motor (272, 312) and the cutter rotation and translation mechanism (120), as described above. The axial retraction of the cutter (50) will serve to open the opening (16), which results in tissue prolapse in the opening (16) under the influence of the voids described above. The cutter (50) can remain in a retracted position for a period of time to ensure sufficient tissue prolapse.

Then, the cutter (50) is advanced distally to separate the prolapsed tissue through the opening (16). This advance can be made simply by causing the motor (272, 312) to rotate in the opposite direction to the direction in which the motor (272, 312) rotated during retraction of the cutter (50). In some embodiments, the vacuum light (40) is switched from vacuum to saline as the cutter (50) advances. For example, solenoids (456) can move the tip (478) down to tighten the tube (402), thereby preventing further vacuum communication through the tube (402); and it can move the tip (472) upward to substantially disengage the tube (408), thereby allowing communication of saline through the tubes (408, 402). In some other embodiments, the vacuum light (40) is switched from vacuum to ventilation as the cutter (50) advances. For example, solenoids (456) can move the tip (478) down to tighten the tube (402), thereby preventing further vacuum communication through the tube (402); and they can move the tip (474) upward to substantially disengage from the tube (410), thereby allowing ventilation (e.g., in the atmosphere) through the tubes (408, 402). In still other modalities, the vacuum light (40) alternates between saline and ventilation. An axial vacuum continues to be communicated through the cutter light (52) as the cutter (50) is advanced.

Once the distal end of the cutter (50) passes the distal edge of the opening (16), so that the cutter (50) closes the opening (16), the prolapsed tissue will be separated and at least initially contained within the light of the cutter (52). Transverse openings (32) will be configured so that at least one or more of the transverse openings (32) are not covered by the cutter (50) when the cutter (50) has reached a position to close the opening (16). With the opening (16) closed and ventilation provided by the transverse openings (32) through the tube (402), an axial vacuum being communicated through the cutter light (52) by the tube (404) will extract the tissue sample (4 ) separated proximally by the cutter light (52) and in a chamber (166, 388) of a tissue sample holder (140, 368). The rotating and translating mechanism (120) can also be controlled to cause the cutter (50) to alternate one or more times through a slight range of motion in a distal position to separate any remaining portions that may not have been completely separated at the first cutter pass (50).

Before the tissue sample (4) is communicated proximally through the cutter light (52), with the opening (16) being closed by the cutter (50), the vacuum light (40) being ventilated by the tubes (402, 410 ) and an axial vacuum being provided by the tube (404) by means of the cutter light (52), the cutter (50) is slightly retracted to expose a portion of the opening (16) for a short period of time. During this time, saline solution can be supplied, at atmospheric pressure, under vacuum light (40) through the tubes (402, 508). Additional retraction of the cutter (50) exposes more transverse openings (32), thereby increasing fluid communication between the vacuum light (40) and the cannula light (20). Retraction of the cutter (50) also exposes the pressure from the tissue cavity (from which the tissue sample (4) was obtained) to the distal surface of the tissue sample (4). As a result of the slight retraction of the cutter (50) in this particular example, the probability of atmospheric pressure being applied to the distal face of the tissue sample (4) can be increased to help ensure that the separate tissue sample (4) does not remain the needle portion (10) (also known as a dry tap). The cutter (50) is then fully advanced distally, closing the opening (16) and all transverse openings (32). Said closing of the transverse openings (32) can ensure that, if medication is applied in that time (between samples) to reduce pain, it will reach the chest cavity through the external openings (22) instead of being aspirated through the openings transverse (32) and through the cutter light (52) and the tissue sample holder (140, 368).

With the cutter (50) fully advanced (for example, so that all the transverse openings (32) and the opening (16) are closed) and the separate tissue sample (4) is communicated proximally through the cutter's light ( 52) and to a chamber (166, 388) through an axial vacuum extracted by the tube (404), the biopsy device (100, 101) will be in a ready state. In this ready state, the vacuum light (40) is vented into the atmosphere and the axial vacuum tube (404) is sealed (also known as a zero head). In other words, the tip (472) is squeezing the saline tube (408) to prevent fluid communication through it, the tip (474) is substantially detached from the vent tube (410) to allow ventilation to the atmosphere through the tip (476) is tightening the axial vacuum tube (404) to prevent fluid communication through it and the tip (478) is tightening the side vacuum tube (402) to prevent fluid communication through it . In that ready state, the biopsy device (100, 101) is ready to take another tissue sample (4), such as starting another sampling sequence, as described above.

It will be appreciated that a sample cycle can be performed in a variety of alternative ways. For example, movement of the cutter (50) may vary during the process of acquiring a tissue sample. In addition, the synchronization, the sequence of and the interrelationships between the lateral vacuum, the axial vacuum, the ventilation and the saline solution can be varied in a number of ways. Consequently, the inventors consider a series of other permutations of said variables and do not consider the invention to be limited, in any case, to the merely illustrative permutations explicitly discussed in detail above.

C. Exemplary Probe Clean Cycle

It will be appreciated that, at some point during the use of the biopsy device (100, 101), the biopsy device (100, 101) may show signs of being obstructed with tissue or other debris. These signs will be evident to those skilled in the art in view of the teachings here. During such times, or otherwise, it may be desirable to start a sequence that can clean said tissue or debris in order to improve the performance of the biopsy device (100, 101). For this purpose, the biopsy system (2) can allow a probe clean cycle to be initiated. A purely probe clean cycle will be described in detail below, although other variations of a clean probe cycle are evident to those skilled in the art in view of the teachings here. Fig. 62 represents an exemplary sequence of the position of the cutter (50) within the needle portion (10) with respect to the fluid communication being supplied through the tubes (402, 404) in an exemplary probe clean cycle.

If the probe clean cycle of the present example is started while the biopsy system (2) is in a sample view mode as described above, the lead (144, 366) will be rotated to move the chamber (166, 388) from the three o'clock position (or nine o'clock) back to the twelve o'clock position. If the biopsy system (2) is not in a sample view mode when the probe clean cycle of the present example is started, then the lead (144, 366) is not rotated. Then, the cutter (50) retracts slightly to expose a portion of the opening (16) for a short time. During this exposure period, air and / or saline solution (at atmospheric pressure) is communicated through the tube (402). Also during this time, a vacuum is provided through the tube (404). The cutter (50) then proceeds to close the opening (16) without covering all the transverse openings (32). This same cycle is repeated additional times (for example, one to four additional times, etc.) to complete the probe clean cycle. After the probe cleaning cycle has ended, the biopsy system (2) enters a ready state. To the extent that a next sample cycle is not started within a certain period of time (for example, a few seconds, etc.), the sample view mode can be reactivated until the next sample cycle is started.

It will be appreciated that a probe clean cycle can be performed in a variety of alternative ways. For example, the movement of the cutter (50) can vary during the process of cleaning a probe (102, 103). In addition, the synchronization, the sequence of and the interrelationships between the lateral vacuum, the axial vacuum, the ventilation and the saline solution can be varied in a number of ways. Consequently, the inventors consider a series of other permutations of said variables and do not consider the invention to be limited in any way to the merely exemplary permutations explicitly discussed in detail above.

D. Exemplary Position Cycle

Fig. 63 represents an exemplary sequence of the position of the cutter (50) within the needle portion (10) with respect to the fluid communication being supplied through the tubes (402, 404), in an exemplary position cycle. If a position cycle is initiated when the opening (16) is closed (for example, when the cutter (50) is advanced to a distal position) and when the biopsy device (100, 101) is in a ready state, then the cutter (50) is retracted proximally. During that time, the tube (402) continues to be vented to the atmosphere and the tube (404) is sealed (also known as a zero head) being tightened by the tip (476).

A position cycle can be used in a variety of contexts. For example, during an ultrasound-guided procedure or another procedure, a needle (10) can be inserted into the tissue with the opening (16) closed. To confirm the location of the opening (16) within the fabric, a position cycle can be initiated to open the opening (16) to assist in viewing the opening (16). Once the location of the opening (16) is confirmed, a position cycle can be started to close the opening (16). Another application of a position cycle can be when a marker has to be revealed on the fabric through the cutter's light (52) and on the fabric through the opening (16). In this context, a position cycle can be initiated to open the opening (16) to allow the tissue marker to be revealed in the tissue by opening the opening (16). Other suitable uses for a position cycle will be evident to those skilled in the art in view of the teachings here.

If a position cycle is initiated when the opening (16) is open (for example, when the cutter (50) is retracted to a proximal position) and when the biopsy device (100, 101) is in a ready state, then the cutter (50) is advanced distally to close the opening (16). During said time, the tube (402) continues to be vented to the atmosphere and the tube (404) is sealed (also known as a null head) being tightened by the tip (476).

A variation of the position cycle can be used to vary the size of the opening (16) with the cutter (50) in such a way that the opening (16) does not open more than a pre-selected size during a sample cycle. For example, it may be desirable to shorten the length of the opening (16) in order to acquire tissue samples (4) of a relatively shorter length than to acquire tissue samples (4) that are relatively close to a patient's skin surface. or for other purposes. Exemplary uses for the position of the cutter (50) to vary the size of an opening (16) when acquiring tissue samples (4) are disclosed in US Publication No. 2006/0200040, which is incorporated herein by reference. As will be described in more detail below, the user interfaces (700, 800) can be used to selectively vary the degree to which the opening (16) can be opened during a sample cycle.

It will be appreciated that a position cycle can be performed in a variety of alternative ways. For example, movement of the cutter (50) may vary during the process of positioning a cutter (50). In addition, the synchronization, the sequence and the interrelationships between lateral vacuum, axial vacuum, ventilation and saline can be varied in a number of ways. Consequently, the inventors consider a series of other permutations of said variables and do not consider the invention to be limited in any way to the merely exemplary permutations explicitly discussed in detail above.

E. Exemplary Aspiration Cycle

It may be desirable to remove fluids from a biopsy site during a biopsy procedure. Consequently, the biopsy system (2) of the present example includes an aspiration cycle, which can be used to remove such fluids or for other purposes. Fig. 64 represents an exemplary sequence of the position of the cutter (50) within the needle portion (10) with respect to the fluid communication being provided through the tubes (402, 404) in an exemplary aspiration cycle.

If the aspirate cycle of the present example is started while the biopsy system (2) is in a sample view mode as described above, the lead (144, 366) will be rotated, moving the chamber (166, 388) from the three o'clock position ( or nine o'clock) back to the twelve o'clock position. If the biopsy system (2) is not in a sample view mode when the aspirate cycle of the present example is started, then the bypass (144, 366) is not rotated. Then, as a vacuum button (not shown) is triggered or some other user input is being provided, the cutter (50) retracts until that trigger or input ceases. Thus, the longer the button is pressed or another input is provided, the more the opening (15) is exposed by the cutter (50). In addition, as long as the suction button is pressed or some other input is provided, vacuum is provided through both tubes (402, 404). Said vacuum is thus communicated axially through the light of the cutter (52) and laterally (in relation to the light from the cannula (20)) through the transverse openings (32). It will be appreciated that, with the opening (16) being at least partially open, the vacuum supplied through the tubes (402, 404) can serve to extract fluids from the biopsy site. Said fluids will be deposited in the vacuum container (500) in the present example.

When the suction button is released or similar user input ceases or changes, the tube (402) can be changed to provide a side vacuum to provide ventilation. In other words, the solenoids (456) can be activated so that the tip (478) substantially engages the tube (402) to prevent further communication of a vacuum through the tube (402) and so that the tip (474) substantially detaches from the tube (410) to allow ventilation through the tubes (410, 402). In addition, the tube (404) is sealed (also known as a zero head) at that time, so that the tip (476) substantially engages the tube (404) to prevent further communication of a vacuum through the tube (402). After a brief pause (for example, a few seconds), the cutter (50) is completely advanced distally, closing the opening (16) and covering the transverse openings (32). The biopsy device (100, 101) is then again in a ready state.

If the opening (16) was open (for example, the cutter (50) at least partially retracted) when the vacuuming cycle was started, then the opening (16) will remain open during the vacuuming cycle and a vacuum is supplied through the tubes ( 402, 404) during the period when the vacuum button is being pressed (or during the period when some other user input is being provided). Once the aspirate button is released (or the other user input stops or changes), then the opening (16) remains open and the biopsy device (100, 101) is again in a ready state. Consequently, the cutter (50) does not need to move during a vacuuming cycle.

It will be appreciated that an aspiration cycle can be performed in a variety of alternative ways. For example, the movement of the cutter (50) can vary during the suction process through a probe (102, 103). In addition, the synchronization, the sequence and the interrelationships between lateral vacuum, axial vacuum, ventilation and saline can be varied in a number of ways. Consequently, the inventors consider a series of other permutations of said variables and do not consider the invention to be limited in any way to the merely exemplary permutations explicitly discussed in detail above.

F. Exemplary Amart Vac cycle

There may be situations that arise during the use of the biopsy system (2) when the needle portion (10) remains inserted in a patient's chest without tissue samples (4) being taken for a certain period of time. It may be desirable to remove fluids from a biopsy site during said periods. Consequently, the biopsy system (2) of the present example includes a smart vac cycle, which can be used to periodically remove said fluids during such periods or for other purposes. Fig. 65 represents an exemplary sequence of the position of the cutter (50) within the needle portion (10) with respect to the fluid communication being supplied through the tubes (402, 404) in an exemplary smart vac cycle.

A smart vac cycle of the present example can be started when the biopsy system (2) has been in a ready state for an extended period of time (for example, one minute, thirty seconds, other periods of time, etc.) without any user input has been provided during such time. Such a dormant period can cause a smart vac cycle to start automatically, whereby the cutter (50) retracts slightly to expose a portion of the opening (16) for a short period of time (for example, a few seconds). With the cutter (50) slightly retracted, vacuum is applied through the tubes (402, 404) to remove fluids from the biopsy site. The cutter (50) then automatically advances to close the opening (16) and the biopsy system (2) returns to a ready state. The smart vac cycle repeats itself automatically if no other user input is provided within a certain period of time after the first smart vac cycle has ended. This process can be repeated indefinitely.

In an alternative embodiment, the vacuum level may be lower during a smart vac cycle than during other operating cycles. Said lower level of vacuum can be provided in a variety of ways. For example, the tips (476, 478) can partially tighten the tubes (402, 404) to restrict, but not cut, fluid communication through the tubes (402, 404). Alternatively, operation of the vacuum pump (440) can be modified to adjust the vacuum levels induced by the vacuum pump (440). Other ways in which a vacuum level can be adjusted will be evident to those skilled in the art in view of the teachings here.

It will be appreciated that a smart vac cycle can be carried out in a variety of alternative ways. For example, the movement of the cutter (50) may vary during the process of removing fluids from a biopsy site. In addition, synchronization, sequence and interrelationships between lateral vacuum, axial vacuum, ventilation and saline can be varied in a number of ways. Consequently, the inventors consider a series of other permutations of said variables and do not consider the invention to be limited in any way to the merely exemplary permutations explicitly discussed in detail above.

VII. User Interface About the Exemplary Vacuum Control Module

As discussed above, the display screen (702), the keys (704) and the speaker (706) can be considered to collectively form the user interface (700). Furthermore, as also discussed above, the face portion (420) is configured so that the viewing screen (702) can be viewed through it; so that the capacitive switches (704) can be activated through it; and so that sounds that come from the speaker (706) can be heard through it. Capacitive keys (704) are configured so that the keys (704) are activated when a user's finger comes in close enough proximity to the keys (704). In particular, a capacitive switch (704) can generate an electric field, so that the finger of an approaching user can cause a disturbance in the electric field that can be detected by the switch (704) when the finger approaches. Capacitive switches (704) can be of sufficient sensitivity so that a user does not even need to touch the face portion (420) in order to activate the capacitive switch (704). In other words, the capacitive keys (704) can be configured so that a user's finger only needs to reach a certain distance from the face portion (420) on the capacitive keys (704) in order to activate the keys (704) . Of course, any other suitable touch-free technology (for example, an ultra-wide-band radar, etc.) can be used in place of or in addition to capacitive switches (704). Alternatively, other input devices (for example, buttons, keys, indicators, conventional dials, etc.) can be used.

The capacitive switches (704) of the present example are supplemented with LEDs (not shown). In particular, an LED is positioned with respect to each capacitive switch (704) to provide visual feedback when the associated capacitive switch (704) is sufficiently activated by a user. For example, an LED associated with each capacitive switch (704) can remain on by default and can switch to off when its associated capacitive switch (704) has been sufficiently activated. Alternatively, an LED associated with a capacitive switch (704) can remain off by default and can switch to lit when its capacitive switch (704) has been sufficiently activated. An LED can also be used to provide visual feedback on the status of the vacuum control module (400). For example, a status LED can remain constantly lit as long as the vacuum control module (400) is operating and can pulse (for example, lower and step up) when the vacuum control module (400) is in a standby mode (for example, powered, but not actively used). Other ways in which LEDs or other light sources or visual indicators can be incorporated into the vacuum control module, either in conjunction with capacitive switches (704) or otherwise, will be evident to those skilled in the art in view of the teachings here.

In addition, the loudspeaker (706) can emit audible tones to reinforce the feedback associated with the use of the vacuum control module (400). For example, the speaker (706) may emit a tone when a capacitive switch (704) has been activated. In addition, certain keys (704) may have certain tones or auditory patterns associated with them. Similarly, certain selections can be made by a user by activating the keys (704), so that the selections and operations described in greater detail below can each have a distinct tone or auditory pattern associated with them. Of course, tones or auditory patterns or other uses for the speaker (706) can be incorporated into the vacuum control module (400) and use them in a variety of alternative ways.

Other aspects of the user interface (700) are shown in figures 66 - 68. In particular, figures 66 - 68 show a variety of example screens (720, 740, 760) that can be viewed on the viewing screen (702 ). Each of these exemplary screens (720, 740, 760) will be described in greater detail below. In one embodiment, the face portion (420) and the display screen (702) are configured so that the perimeter of the display screen (702) cannot be seen through the face portion (420). Furthermore, the face portion (420) does not provide any definition for a perimeter associated with the viewing screen (702). Thus, text, icons and other visual cues seen on the display screen (702) appear to float on the face of the vacuum control module (400). Of course, such a configuration is merely optional.

As also shown in figures 66 - 68, the capacitive switches (704) are visually presented as buttons (708, 710) which are vertically aligned adjacent to the screens (720, 740, 760). The buttons (708, 710) include an upper button (708) which is used to switch between the various screens (720, 740, 760); and lower buttons (710) which are used to provide input selections with respect to an active screen (720, 740, 760). In particular, each time a lower button (708) is activated, such activation causes the display screen (702) to change from one screen (720, 740, 760) being active to the next screen (720, 740, 760 ) being active.

Each screen (720, 740, 760) has a corresponding tab (722, 740, 762) associated with it. In particular, a Status tab (722) is associated with a status screen (720), a Probe tab (742) is associated with a probe screen (740) and a System tab (762) is associated with a system screen (760). The tabs (722, 740, 762) are arranged at the top of each corresponding screen (720, 740, 760) and the tabs (722, 740, 762) of the screens (720, 740, 760) can still be seen when a certain screen (720, 740, 760) is active. For example, in figure 66, the status screen (720) is active, yet the Sonda tab (742) and the System tab (762) can be seen. However, the State tab (722) is brighter than the Probe tab (742) and the System tab ”(761) in figure 66. In figure 67, the probe screen (740) is active; while, in figure 68, the system tab (762) is active. It will be noted by those skilled in the art in view of the teachings here that the tabs (722, 740, 762) are merely exemplary and that the tabs (722, 740, 762) can be incorporated into a user interface (700) in a variety of alternative forms. In addition, there are a variety of alternative features that can be used in addition to or in place of the tabs (722, 740, 762).

A. Exemplary State screen

Referring again to figure 66, a merely exemplary status screen (720) includes several visual indicators (724, 726, 728, 730). For example, a sample view indicator (724) indicates whether the biopsy system (2) is in sample view mode, examples of which are described in greater detail below. As shown, the sample view indicator (724) in this example includes an icon shown as a circle with a slanted bar to indicate that sample view mode is off. A tick or other indication can be used to indicate when the sample view mode is on. A user can turn the sample view mode on or off when the probe screen (740) is active, as will be described in more detail below. Naturally, other suitable visual indicators can be used in addition to or in place of the circle with a slanted bar and / or marking to indicate the status of the sample view mode.

A vacuum level indicator (726) is also provided on the status screen (720). As shown, the vacuum level indicator (726) in this example includes an icon shown as a series of rising bars, to indicate the vacuum level of the biopsy system (2). A user can adjust the vacuum level of the biopsy system (2) when the system screen (760) is active, as will be described in more detail below. Increases in increments in the vacuum level are indicated in this example by illuminating an additional bar in the rising bar series of the vacuum level indicator (726). In other words, the number of bars that are illuminated on the vacuum level indicator (726) will be indicative of the vacuum level of the biopsy system (2). Of course, any other visual indicators (for example, a simulated needle gauge, a number, etc.) can be used in addition to or in place of the rising bars to indicate the vacuum level within the biopsy system (2).

A needle opening indicator (728) is also provided on the status screen (720). As shown, the needle opening indicator (726) in this example includes an icon shown as a needle end with a brightly lit cutter. This needle opening indicator (726) can be used to indicate the maximum distance at which the cutter (50) will be retracted within the needle portion (10) when using the biopsy system (2). For example, as mentioned above in the context of a position cycle, a user may want to restrict the proximal movement of the cutter (50) to restrict the degree to which the opening (16) will be opened within the chest. Said use of a cutter (50) to vary the opening (16) that opens for a biopsy procedure is described in US Publication No. 2006/0200040, entitled Biopsy Device with Variable Side Aperture, published on September 7, 2006 , the description of which is incorporated herein by reference. A user can adjust this effective needle opening (16) when the probe screen (740) is active, as will be described in more detail below. The position of the cutter portion of the icon on the needle opening indicator (726) in relation to the needle portion of the icon on the needle opening indicator (726) may be indicative of the effective needle opening (16) set by a user. Of course, any other suitable visual indicators can be used in addition to or in place of using a needle and cutting edge to indicate the effective needle opening set by a user.

A smart vac pulse indicator (730) is also provided on the status screen (720) to indicate whether the biopsy system (2) is in smart vac mode, as described in more detail below. As shown, the smart vac pulse indicator (730) in this example includes an icon shown as a tick to indicate that the smart vac pulse mode is on. A circle with a slanted bar or other indication can be used to indicate when the smart vac pulse mode is off. A user can switch on smart vac mode or switch off when the probe screen (740) is active, as will be described in more detail below. Of course, other visual indicators can be used in addition to or in place of the circle with a slanted bar and / or marking to indicate the status of the smart vac mode.

In view of the foregoing, the status screen (720) of the present example is used merely to indicate the status of several variables within the biopsy system (2). The status screen (720) of this particular example is not configured to accept user input to change any of these variables or otherwise change the operation of the biopsy system (2). The buttons (710) are not active when the status screen (720) is active. In order to change any of the variables, a user must activate the upper button (708) on the status screen (720) in order to switch the active screens from the status screen (720) to the probe screen (740) or the system screen (760), where the user can then provide inputs to change the variables. In other modalities, however, a status screen (720) can allow a user to change some or all of the variables whose status is indicated on the status screen (720). Other ways in which a status screen (720) or another screen can be provided will be evident to those skilled in the art in view of the teachings here. In addition, in some embodiments, a status screen (720) is simply omitted in general (for example, so that only a probe screen (740) and a system screen (760) and / or other screens are used, etc.).

B. Exemplary probe screen

Referring again to figure 67, a sonar screen (740), merely exemplary, includes several visual indicators (744,

746, 748, 750). For example, an aperture indicator (742) indicates the maximum distance to which the cutter (50) will be retracted within the needle portion (10). during the use of the biopsy system (2). For example, as mentioned above, a user may want to restrict the proximal movement of the cutter (50) to restrict the degree to which the opening (16) will be opened within the chest. A user can adjust this effective needle opening (16) by activating the button (710) which is close to the opening indicator (742). Each time the user activates this button (710), the biopsy system (2) will make a corresponding adjustment to the effective needle opening (16), such as through the controller (480). Said adjustments can be made in increments, in order to provide an opening (16) that is 50%, 75% or 100% open, although other increments can be used. In addition, each time the user activates this button (710), the cutter portion of the icon in the opening indicator (742) moves with respect to the needle portion of the icon in the opening indicator (742). Arrows are also shown above the needle portion of the icon to emphasize the maximum proximal position of the needle selected by the user. In addition, a text representation (for example, Sm for small aperture (16), Lg for large aperture, etc.) can be included to further indicate the effective size of aperture (16) selected by the user.

It will be appreciated in view of the teachings here, that the aperture indicator (742) on the probe screen (740) is similar to the needle opening indicator (728) on the status screen (720), except that the indicator opening (742) on the probe screen (740) provides additional information on the effective opening extension (16) selected by the user. In addition, unlike the status screen (720) in the present example, the probe screen (740) allows the user to adjust the effective length of the opening (16) by activating the button (710) that is close to the opening indicator ( 742). Each activation of the button (710) by the user can result in an effective extension of the opening (16) decreased in increments, until the extension reaches zero, at which time a subsequent activation of the button (710) can result in the extension of the inversion for the full length of the opening (16). As an alternative to allow changes in increments in the effective aperture extension (16), the user interface (700) can allow a user to gradually change the effective aperture extension (16), such as using an indicator, dial, button , etc., including through the use of virtual touch-sensitive representations (for example, on a touchscreen) of such input devices. Other ways in which a user may be allowed to adjust the effective length of the opening (16) will be evident to those skilled in the art in view of the teachings here. In addition, any other visual indicators can be used in addition to or in place of a needle tip and cutter to indicate the effective needle opening set by a user.

The probe screen (740) of the present example also includes a sample view indicator (746), which indicates whether the biopsy system (2) is in sample view mode, as described above. As shown, the sample view indicator (746) in this example includes an icon shown as a circle with a slanted bar to indicate that the sample view mode is off. To switch on the sample view mode, the user can activate the button (710) next to the sample view indicator (746). A mark or other icon or indicator can replace the circle with a slanted bar to indicate that the sample view mode has been turned on. To turn off the preview sample mode again, the user can activate the button (710) next to the preview sample indicator (746) again.

It will be appreciated in view of the teachings here, that the display sample (746) indicator on the probe screen (740) is similar to the display sample (724) indicator on the status screen (720), except that the probe screen ( 740) allows the user to turn the sample view mode on and off by activating the button (710) which is close to the sample view indicator (746). Of course, other suitable visual indicators can be used in addition to or in place of the circle with a slanted bar and / or marking to indicate the state of the sample view mode.

The probe screen (740) of the present example also includes a reset revolver indicator (748) which indicates that the button (710) that is next to the reset revolver indicator (748) can be activated to reset the tap position (144, 366). In particular, as mentioned above, the coding wheel (292) and the sensor (296) are used, in some embodiments, to track the rotational position of the lead (144, 366) during use of the biopsy device (100, 101). When a user replaced the lead (144, 366), so that the last chamber (166, 388) that the biopsy system (2) thinks is aligned with the cutter's light (52) is no longer aligned with the light of the cutter (52), the user can activate the button (710) that is next to the reset indicator (748) to indicate to the biopsy system (2) that a new lead (144, 366) has been coupled with the probe (102 , 103). The biopsy system (2) then admits that the predefined chamber (166, 388) or passageway (158) is aligned with the cutter light (52). The button (710) that is next to the reset revolver indicator (748) can also be activated under other conditions, such as when a user manually turned the tap (144, 366) to align the camera (166, 388) preset with the cutter (52).

The probe screen (740) of the present example also includes a smart vac pulse indicator (750), which indicates whether the biopsy system (2) is in smart vac mode, as described in greater detail above. As shown, the smart vac pulse indicator (750) in this example includes an icon shown as a tick to indicate that the smart vac pulse mode is on. A circle with a slanted bar or other indication can be used to indicate when the smart vac pulse mode is off. To turn off the smart vac mode, the user can activate the button (710) next to the smart vac pulse indicator (750). A circle with a slanted bar or another icon or indicator can replace the mark to indicate that the smart vac mode has been turned off. To switch the smart vac mode back on, the user can activate the button (710) next to the smart vac pulse indicator (750) again.

It will be appreciated in view of the teachings here, that the smart vac pulse indicator (750) on the probe screen (740) is similar to the smart vac pulse indicator (730) on the status screen (720), except that the probe screen (740) allows the user to switch the smart vac mode on and off by activating the button (710) that is close to the smart vac pulse indicator (750). Of course, other visual indicators can be used in addition to or in place of a circle with a slanted bar and / or marking to indicate the status of the smart vac mode.

C. Exemplary System Screen

Referring again to figure 68, a purely exemplary system screen (760) includes several visual indicators (764, 766, 768, 770). For example, a vacuum level indicator (764) is provided on the system screen (760). As shown, the vacuum level indicator (764) in this example includes an icon shown as a set of rising bars, to indicate the vacuum level of the biopsy system (2). To adjust the vacuum level of the biopsy system (2), the user can activate the button (710) next to the vacuum level indicator (764). Each time the user activates this button (710), the vacuum level of the biopsy system (2) may increase in increments. Said increase in increments can be indicated by lighting an additional bar in the set of rising bars of the vacuum level indicator (764). In other words, the number of bars that are illuminated on the vacuum level indicator (764) will be indicative of the vacuum level of the biopsy system (2).

If the user activates the associated button (710) when all the bars are illuminated (for example, which may indicate that the vacuum level is at maximum), the vacuum level can be significantly decreased to the lowest level, so that only the first bar in the set of bars is illuminated. Thus, a user can switch between various vacuum levels in increments by repeatedly activating the button (710) that is next to the vacuum level indicator (764) and these changes in increments in the vacuum level can be indicated in the set of upward bars of the indicator vacuum level (764).

It will be appreciated that the control of the vacuum level, as selected by a user through the system screen (760), can be performed in a variety of ways. For example, the selected vacuum level can be obtained by changing the operation of the vacuum pump (440). Alternatively, the selected vacuum level can be obtained by changing the degree to which the tips (476, 478) disengage from the tubes (402, 404) when a vacuum has to be applied through the tubes (402, 404). For example, solenoids (456) can be activated to release the tips (476, 478) of the tubes only slightly, so that the tips (476, 478) create a restriction in the tubes (402, 404) without preventing a vacuum from being created. communicated through the tubes (402, 404). In another variation, an additional valve (not shown) or another component in any suitable location is used to vary the vacuum level according to a user's selection.

It will be appreciated in view of the teachings here, that the vacuum level indicator (764) on the system display (760) is similar to the vacuum level indicator (764) on the status display (720), except that the system display ( 760) allows the user to change the vacuum level of the biopsy system (2) by activating the button (710) which is close to the vacuum level indicator (764). Of course, any other suitable visual indicators (eg, a simulated needle calibrator, etc.) can be used in addition to or in place of rising bars to indicate the vacuum level within the biopsy system (2).

The system screen (760) of the present example also includes a volume indicator (766). As shown, the volume indicator (766) of the present example includes an icon shown as a speaker and a con95 next to bars that increase in size, to indicate the volume level of the tones that will be emitted by the speaker (706) . To adjust the volume, the user can activate the button (710) which is close to the volume indicator (706). Each time the user activates this button (710), the volume may increase in increments. Said increase in increments can be indicated by illuminating an additional bar in the set of rising bars of the volume indicator (766). In other words, the number of bars that are lit on the volume indicator (766) will be indicative of the volume of the tones or other sounds that will be emitted from the speaker (706). The volume indicator (766) and its associated button (710) are thus similar to the vacuum level indicator (764) and its associated button (710) as described above, except that the former are associated with volume levels, whereas the latter are associated with vacuum levels. Of course, any other visual indicators (for example, a simulated disc, a number, etc.) can be used in addition to or in place of a speaker and bars that increase in size to indicate the volume level.

The system screen (760) of the present example also includes a hibernate indicator (768). As shown, the hibernate indicator (768) in this example includes an icon shown as a star and a moon. To place the biopsy system (2) in a hibernate mode, the user can activate the button (710) which is close to the hibernate indicator (768). In a version of hibernate mode, the vacuum pump (440) is turned off and at least some user input devices are disabled (for example, the user interface (800) on the case (202, 302), a foot switch, etc.). Other variations of the hibernate mode will be evident to those skilled in the art in view of the teachings here. In order to take the biopsy system (2) to sleep, a user can simply activate any capacitive switch (704) on the user interface (700), activate any key or button on the case (202, 302) or take action.

The system screen (760) of the present example also includes an off indicator (770). As shown, the shutdown indicator (770) for this example includes an icon representing the power button. To turn off the biopsy system (2), the user can activate the button (710) that is close to the off indicator (770). Of course, there are a variety of other ways in which a user may be allowed to turn off the biopsy system (2).

Although not shown in the accompanying drawings, it will be appreciated that the display screen (702) can show a variety of other displays not explicitly described above. Just as an example, when the cable (484) is not connected to the port (482), the display screen (702) may show a message instructing the user to connect the cable (484). Similarly, when the vacuum container (500) is not inserted in the can compartment (458) or if a satisfactory seal is not obtained between the vacuum ports (462, 514), the display screen (702) may show a message instructing the user to properly insert the vacuum container (500) into the can compartment (458).

VIII. User Interface About the Exemplary Case

In addition to or in place of a user interface (700) being provided by a vacuum control module (400), a user interface (800) can be provided on the biopsy device (100, 101). For example, said user interface (800) can be provided with a probe (102, 103) and / or on a case (202, 302). In the present example, a merely exemplary user interface (800) is provided on the case (202). Also, in the present example, controls provided through the user interface (700) of the vacuum control module (400) refer more to the biopsy system settings (2), while the controls provided over the user interface (800) of the case (202) refer more to the operation of activating the biopsy device (100). It will be appreciated, however, that such roles can be inverted or mixed. For example, the user interface (800) can be configured to allow a user to adjust at least some biopsy system settings (2) and / or the user interface (700) can be configured to allow a user operate the biopsy device (100).

Referring to figure 69, the user interface (800) of the present example is provided as a membrane that is attached to one or both side panels (214, 216). The user interface (800) can also be provided, at least in part, as an in-mold decoration (IMD). Such an IMD configuration can provide a case seal (202), so that the presence of the user interface (800) does not create undesirable leakage points. An IMD configuration, however, can provide flexible areas for user input, such as buttons (802, 803, 804, 806, 808) described below. In other embodiments, the user interface (800) is provided, at least in part, through a double point molding process. Other ways in which the user interface (800) can be provided will be evident to those skilled in the art in view of the teachings here.

The user interface (800) of the present example comprises five buttons (802, 803, 804, 806, 808), each of which will be described in greater detail below, although any other suitable number of buttons can be used. In some embodiments, the buttons (802, 803, 804, 806, 808) are provided as thin film keys as part of the membrane. In other embodiments, the buttons (802, 803, 804, 806, 808) are formed on the side panel (214, 216) to which the membrane is attached. In still other modalities, the buttons (802, 803, 804, 806, 808) comprise capacitive keys. In the present example, the buttons (802, 803, 804, 806, 808) (or at least one perimeter of the buttons (802, 803, 804, 806, 808)) are lit by LEDs or other light sources behind the membrane . Other ways in which the buttons (802, 803, 804, 806, 808) can be provided will be evident to those skilled in the art in view of the teachings here.

The buttons (802, 803) of the present example can be operated to advance or retract the cutter (50), respectively. Said advance or retraction can be used to selectively reduce the effect size of the aperture (16), as mentioned above, during the sampling cycle.

Alternatively, a user may want to vary the size of the opening (16) while vacuuming. Other situations in which a user may want to advance or retract the cutter (50) by activating the buttons (802, 803) will be evident to those versed in the technique in view of the teachings here. As will be described in more detail below, the position of the cutter (50) obtained when a user activates the buttons (802, 803) can be indicated through the illuminated sections (812) distinct from a cutter position indicator (810) on the user interface (800).

The button (804) of the present example is operable to start a sampling cycle. Exemplary sampling cycles are discussed in detail above and therefore will not be described in greater detail here. Suitable ways in which a button (804) can be made operable to initiate a sampling cycle will be evident to those skilled in the art in view of the teachings here. In addition, in some variations, the button (804) also performs the same function as the button (802) described above, so that the button (802) can be omitted. Similarly, in other variations, the button (802) performs the same function as the button (804) as described above, so that the button (804) can be omitted.

The button (806) of the present example is operable to initiate a lateral vacuum inside the probe (102). For example, pressing the button (806) can result in a vacuum being communicated through the tube (402) which can, in turn, be communicated through the transverse openings (32). Suitable ways in which a button (806) can be made operable to initiate a side vacuum will be evident to those skilled in the art in view of the teachings here.

The button (808) of the present example is operable to initiate a probe cleaning cycle. Exemplary probe cleaning cycles are discussed in detail above and therefore will not be described in greater detail here. Suitable ways in which a button (808) can be made operable to initiate a probe cleaning cycle will be evident to those skilled in the art in view of the teachings here.

The user interface (800) also includes a cutter position indicator (810), which includes a representation of the distal end of the outer cannula (12) and a plurality of distinct illuminated sections (812). Just as an example, one or more LEDs or other light sources can be used to illuminate different sections (812). The lighting of the different sections (812) can serve to indicate the position of the cutter (50) with respect to the opening (16). For example, the last separate lit section (812) can indicate the distal end of the cutter (50). In some embodiments, only those distinct sections (812) corresponding to the position of the cutter (50) are lit, while the remaining distinct sections (812) are unlit. In other embodiments, those distinct sections (812) that correspond to the position of the cutter (50) are lit with one color (for example, red), while the remaining distinct sections (812) are lit with another color (for example, yellow) . Yet other ways in which a cutter position indicator (810) can be used to indicate the position of the cutter (50) will be evident to those skilled in the art in view of the teachings here. In addition, there are a variety of ways in which the cutter position data (50) can be effectively communicated to the cutter position indicator (810). Just as an example, one or more sensors can be coupled, in communication, with the cutter (50), the cutter rotation and translation mechanism (120) and / or the cutter drive mechanism (270).

The user interface (800) also includes an icon (814) indicating the direction of the trigger needle angle (242), as well as an icon (816) indicating an unlocked direction for the trigger (242). Ways in which the trigger (242) can be used to angle the needle and fire (for example, in conjunction with pressing the button (244)) the needle portion (10) are described in greater detail above. The icons (814, 816) can simply provide visual indications of the directions for turning the trigger (242) to perform such actions.

In addition, the user interface (800) includes an error light (820). The error light (820) can be selectively on under a variety of conditions. For example, the error light (820) can be on when a tissue is caught in the cutter light (52) or anywhere within the biopsy system (2). The error light (820) can also provide trouble codes flashing in a particular pattern or sequence that is associated with a particular condition. For example, the number of times the error light (820) flashes before repeating a flashing sequence can be varied based on the error conditions. It will also be appreciated that other components of the user interface (800) can be used to report one or more error conditions, instead of or in addition to the error light (820). For example, the distinct sections (812) of the cutter position indicator (810) may flash or be selectively lit in certain patterns or sequences to indicate certain error conditions. Other ways in which error conditions can be communicated to a user, by means of lights or otherwise, will be evident to those skilled in the art in view of the teachings here. Similarly, ways in which error conditions can be detected will be evident to those skilled in the art in view of the teachings here.

In versions where both sides of a case (202, 302) are provided with buttons (802, 803, 804, 806, 808), the biopsy system (2) can be configured to assign the first side on which a button (802, 803, 804, 806, 808), is activated as the active side of the case (202, 302). Similarly, the biopsy system (2) can assign the first side on which a trigger (242) or button (244) is activated as the active side of the gorse (202, 302). Just as an example, in versions that provide a sample display mode as described above, said assignment of an active side can guide whether the newly acquired tissue samples (4) are presented at the three o'clock or the nine o'clock position. In other words, if a user first activates a button (244,

802, 803, 804, 806, 808) or the trigger (242) on the side corresponding to the three o'clock position of the tissue sample holder (140, 368), the tap (144, 366) can rotate to display a sample of fabric (4) recently acquired from the user at the three o'clock position. Alternatively, the biopsy system (2) can be configured to vary other functions in response to an assignment of an active side or it may not assign an active side in general.

It will be appreciated that a variety of components can be used to carry out the buttons (802, 803, 804, 806, 808), illuminated sections (812) and error light (820). For example, one or more printed circuit boards (not shown) can be provided inside the case (202). In addition, the user interface (800) may be, at least partially, in communication with the vacuum control module (400), such as via a cable (484) or otherwise. Other ways in which the user interface (800) can be incorporated into the biopsy system (2), as well as other variations of the user interface (800), will be evident to those versed in the technique in view of the teachings here.

Modalities of the present invention have application in conventional open and endoscopic surgical instrumentation, as well as application in robotic-assisted surgery.

Modalities of the devices disclosed here can be designed to be discarded after a single use or they can be designed to be used multiple times. Modalities can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps to disassemble the device, followed by cleaning or replacing particular parts and subsequently reassembling. In particular, arrangements of the device can be disassembled and any number of particular parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing particular parts, the device's modalities can be reassembled for subsequent use in a reconditioning unit or by a surgical team immediately before a surgical procedure. Those skilled in the art will appreciate that reconditioning a device can use a variety of techniques for disassembly, cleaning / replacement and reassembly. Use of such techniques and the resulting reconditioned device are all within the scope of this application.

Just as an example, the modalities described here can be processed before surgery. First, a new or used instrument can be obtained and, if necessary, cleaned. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a sealed container, such as a plastic bag or TYVEK. The container and the instrument can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays or high-energy electrons. Radiation can kill bacteria on the instrument and in the container. The sterile instrument can then be stored in the sterile container. The sealed container can hold the sterile instrument until it is opened in the medical unit. A device can also be sterilized using another method known in the art including, but not limited to, beta or gamma radiation, ethylene oxide or steam.

Having described and shown various embodiments of the present invention, further adaptations of the methods and systems described herein can be made through appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several of the potential modifications' references have been mentioned and others will be evident to those skilled in the art. For example, the examples, modalities, geometry, materials, dimensions, proportions, steps and the like discussed above are illustrative and are not required. Consequently, the scope of the present invention should be considered in terms of the following claims and should be understood as not being limited to the details of structure and operation shown and described in the specification and drawings.

380 members in 14 offices

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Priority claims4

Priority claims
Document	Office	Kind	Date
11942951	United States of America	–	2007-11-20
94295107	United States of America	A	2007-11-20
11942951	–	–	–
US20070942951	–	–	–

Members380

Family members, oldest first
Document	Office	Kind
US890862A	United States of America	A	1908-06-16
US2007032741A1	United States of America	A1	2007-02-08
US2007032742A1	United States of America	A1	2007-02-08
US2007032743A1	United States of America	A1	2007-02-08
AU2006278678A1	Australia	A1	2007-02-15
CA2617904A1	Canada	A1	2007-02-15
WO2007019152A2	World Intellectual Property Organization (WIPO)	A2	2007-02-15
CA2576477A1	Canada	A1	2007-08-01
US2007179401A1	United States of America	A1	2007-08-02
CN101011270A	China	A	2007-08-08
EP1815798A2	European Patent Office (EPO)	A2	2007-08-08
AU2007200142A1	Australia	A1	2007-08-16
JP2007203071A	Japan	A	2007-08-16
US2007239067A1	United States of America	A1	2007-10-11
EP1815798A3	European Patent Office (EPO)	A3	2007-10-31
BRPI0700171A	Brazil	A	2007-11-06
US2008004545A1	United States of America	A1	2008-01-03
WO2007019152A3	World Intellectual Property Organization (WIPO)	A3	2008-01-03
CA2597847A1	Canada	A1	2008-02-17
CN101125093A	China	A	2008-02-20
EP1889573A1	European Patent Office (EPO)	A1	2008-02-20
AU2007203248A1	Australia	A1	2008-03-06
EP1921997A2	European Patent Office (EPO)	A2	2008-05-21
CA2614235A1	Canada	A1	2008-06-13
CA2614259A1	Canada	A1	2008-06-13
CA3011068A1	Canada	A1	2008-06-13
EP1932481A1	European Patent Office (EPO)	A1	2008-06-18
EP1932482A1	European Patent Office (EPO)	A1	2008-06-18
US2008146962A1	United States of America	A1	2008-06-19
CA2672664A1	Canada	A1	2008-06-26
CA2969611A1	Canada	A1	2008-06-26
WO2008076712A2	World Intellectual Property Organization (WIPO)	A2	2008-06-26
AU2007242953A1	Australia	A1	2008-07-03
AU2007242954A1	Australia	A1	2008-07-03
CN101237822A	China	A	2008-08-06
US2008195066A1	United States of America	A1	2008-08-14
US2008200836A1	United States of America	A1	2008-08-21
JP2008194451A	Japan	A	2008-08-28
JP2008200481A	Japan	A	2008-09-04
US2008214955A1	United States of America	A1	2008-09-04
US2008221480A1	United States of America	A1	2008-09-11
US2008228103A1	United States of America	A1	2008-09-18
CN101297764A	China	A	2008-11-05
CN101301213A	China	A	2008-11-12
US2008312554A1	United States of America	A1	2008-12-18
WO2008076712A3	World Intellectual Property Organization (WIPO)	A3	2008-12-31
CA2638237A1	Canada	A1	2009-01-25
CA2638243A1	Canada	A1	2009-01-25
CN101352356A	China	A	2009-01-28
CN101352357A	China	A	2009-01-28
JP2009502434A	Japan	A	2009-01-29
EP2022406A2	European Patent Office (EPO)	A2	2009-02-11
EP2022407A2	European Patent Office (EPO)	A2	2009-02-11
AU2008203258A1	Australia	A1	2009-02-12
AU2008203259A1	Australia	A1	2009-02-12
JP2009028538A	Japan	A	2009-02-12
MX2007001316A	Mexico	A	2009-02-12
JP2009078130A	Japan	A	2009-04-16
EP2022406A3	European Patent Office (EPO)	A3	2009-05-06
EP2022407A3	European Patent Office (EPO)	A3	2009-05-06
CA2644133A1	Canada	A1	2009-05-20
CA2644357A1	Canada	A1	2009-05-20
CA2644364A1	Canada	A1	2009-05-20
US2009131816A1	United States of America	A1	2009-05-21
CN101438969A	China	A	2009-05-27
EP2062535A1	European Patent Office (EPO)	A1	2009-05-27
EP2062538A1	European Patent Office (EPO)	A1	2009-05-27
EP2062539A1	European Patent Office (EPO)	A1	2009-05-27
AU2008246292A1	Australia	A1	2009-06-04
AU2008246293A1	Australia	A1	2009-06-04
AU2008249141A1	Australia	A1	2009-06-04
JP2009125587A	Japan	A	2009-06-11
JP2009125589A	Japan	A	2009-06-11
EP1889573B1	European Patent Office (EPO)	B1	2009-06-17
DE602007001313D1	Germany	D1	2009-07-30
JP2009172362A	Japan	A	2009-08-06
ES2326138T3	Spain	T3	2009-10-01
CN101548898A	China	A	2009-10-07
BRPI0806161A2	Brazil	A2	2009-11-17
BRPI0806162A2	Brazil	A2	2009-11-17
EP2120724A2	European Patent Office (EPO)	A2	2009-11-25
CN101596117A	China	A	2009-12-09
BRPI0806150A2This record	Brazil	A2	2010-01-19
EP1921997A4	European Patent Office (EPO)	A4	2010-01-27
CN101641052A	China	A	2010-02-03
US7662109B2	United States of America	B2	2010-02-16
EP1932482B1	European Patent Office (EPO)	B1	2010-04-28
JP2010512848A	Japan	A	2010-04-30
US2010113971A1	United States of America	A1	2010-05-06
US2010113973A1	United States of America	A1	2010-05-06
DE602007006137D1	Germany	D1	2010-06-10
US2010160824A1	United States of America	A1	2010-06-24
EP1932481B1	European Patent Office (EPO)	B1	2010-06-30
CN101237822B	China	B	2010-07-07
ES2342621T3	Spain	T3	2010-07-09
CA2745885A1	Canada	A1	2010-07-15
WO2010080298A1	World Intellectual Property Organization (WIPO)	A1	2010-07-15
DE602007007426D1	Germany	D1	2010-08-12
CN101011270B	China	B	2010-09-29
ES2345681T3	Spain	T3	2010-09-29

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	Event	Code
2014-09-02	Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]LapsedREFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2260 DE 29/04/2014.B08K	B08K
2014-04-29	Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]REFERENTE A 5A ANUIDADE.B08F	B08F
2010-01-19	Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]B03A	B03A