Needle assembly and blade assembly for biopsy device

Needle assembly and blade assembly for biopsy device

[0001] Background of the Invention

[0002] Various devices have been used to obtain biopsy samples in various medical operations in various ways. The biopsy device can be used under stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other guidance. For example, some biopsy devices can be operated entirely by the user with one hand and perform a single insertion to intercept one or more biopsy samples from the patient. In addition, some biopsy devices can be connected to the vacuum module and/or control module, such as for fluid (for example, pressurized air, saline, atmospheric air, vacuum, etc.) communication, for electrical connection and/or for Command connectivity and similar uses. Other biopsy devices may be fully or at least partially operable without being docked or otherwise connected to another device.

[0003] Only an exemplary biopsy device is disclosed in US Patent No. 5,526,822 entitled Method and Apparatus for Automated Biopsy and Collection of Soft Tissue issued on June 18, 1996; U.S. Patent No. 6,086,544 entitled an Automated Surgical Biopsy Device; U.S. Patent No. 2003/0109803 issued on June 12, 2003 under the title "MRI Compatible Surgical Biopsy Device; U.S. Patent No. 2003/0109803 issued on April 6, 2006 under the title " US Publication No. 2006/0074345 titled Biopsy Apparatus and Method; US Publication No. 2007/0118048 titled Remote Thumbwheel for a Surgical Biopsy Device published on May 24, 2007; published on September 4, 2008 Take Presentation of Biopsy Sample by Biopsy U.S. Publication No. 2008/0214955 titled "Device"; U.S. Publication No. 2009/0171242 titled "Clutch and Valving System for Tetherless Biopsy Device" published on July 2, 2009; U.S. Publication No. 2009/0171242 published on June 17, 2010 Hand Actuated Tetherless Biopsy Device with Pistol Grip titled US Publication No. 2010/0152610; US Publication No. 2010/0160819 titled "Biopsy Device with Central Thumbwheel published on June 24, 2010; December 16, 2010 U.S. Publication No. 2010/0317997, titled "Tetherless Biopsy Device with Reusable Portion" published on November 24, 2010; and U.S. Patent Application No. 12/953,715, filed on November 24, 2010, titled Handheld Biopsy Device with Needle Firing Each of the U.S. patents, U.S. patent application publications and U.S. non-provisional patent applications cited above The public content requested is incorporated into this article by reference.

[0004] In some cases, the user of the biopsy device may prefer to insert a needle with a generally flat blade into the patient. When a flat blade is used, it may be preferable to properly fix the blade to the needle part and seal the end of the needle part. When a flattening blade is combined into a very small needle part, it becomes particularly difficult to achieve these preferences at the same time.

[0005] In addition, some biopsy devices may have a needle portion that exhibits a substantially circular cross-section, a substantially oval cross-section, a substantially elliptical cross-section, or some other cross-section. In some designs, a shelf or tray has been inserted into the oval needle portion to form a "figure eight" cross section. However, when a rack or tray is installed in an oval cross-sectional needle portion, the attachment of the tray is limited by the number of ports available for welding the rack or tray in the needle portion. In addition, when inserted or welded in place, the shelf or tray may be deformed. This can result in interference with internal knives during use of the biopsy device.

[0006] Although several systems and methods for obtaining biopsy samples have been manufactured and used, it is believed that no one has manufactured or used the invention described in the appended claims before the inventor.

[0007] Brief description of the drawings

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[0008] Although this conclusion is specifically pointing out and clearly claiming the claims of the present invention, it is believed that the present invention will be better understood from the following description of certain examples in conjunction with the accompanying drawings. In the accompanying drawings, similar reference numerals denote the same elements. In the figure, some components or parts of components are shown in phantom as depicted by dashed lines.

[0009] FIG. 1 depicts a perspective view of an exemplary biopsy device showing various components of the exemplary biopsy device;

[0010] FIG. 2 depicts a perspective view of an exemplary biopsy device showing the housing detached from the probe;

[0011] FIG. 3 depicts a schematic diagram of an exemplary cabinet showing various electrical and/or motor components contained in the cabinet;

[0012] FIG. 4 depicts a side view of an exemplary needle assembly for a biopsy device, the exemplary needle having a blade assembly, a needle portion, a needle coupling member, and a vent sleeve;

[0013] FIG. 5 depicts a cross-sectional side view of the tip of the exemplary needle assembly of FIG. 4 showing the blade assembly, the needle portion, and the tubular cutter in the closest position;

[0014] FIG. 6 depicts a cross-sectional front view along line 6-6 of the needle portion of FIG. 5 with a needle and a knife receiving tube.

[0015] FIG. 7 depicts an exploded isometric view of the blade assembly of FIG. 5 with a first coupling member, a second coupling member, and a blade;

[0016] FIG. 8 depicts another exploded isometric view of the blade assembly of FIG. 7;

[0017] FIG. 9 depicts a rear perspective view of the needle coupling member and vent sleeve of the needle of FIG. 4;

[0018] FIG. 10 depicts a cross-sectional side perspective view of an exemplary needle tip protector;

[0019] FIG. 11 depicts a graphical representation of an exemplary output signal from a vacuum sensor; and

[0020] FIG. 12 depicts a top view of an exemplary muffler assembly having a muffler, a first outlet tube, and a second outlet tube.

[0021] The figures are not intended to be limited in any way, and it is anticipated that various embodiments of the present invention may be implemented in various other ways, including those that are not necessarily depicted in the figures. The drawings incorporated and formed as part of the drawings illustrate several aspects of the present invention and are combined with the description to explain the principles of the present invention; however, it should be understood that the present invention is not limited to the explicit layout shown.

Detailed ways

[0022] The following description of certain examples of the invention should not be used to limit the scope of the invention. Those skilled in the art will understand other examples, characteristics, aspects, embodiments, and advantages of the present invention from the following description, which is one of the best modes expected to implement the present invention by way of illustration. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Therefore, the diagrams and descriptions should be regarded as descriptions of attributes and not restrictive.

[0023] I. Overview of Exemplary Biopsy Devices

[0024] FIG. 1 shows an exemplary biopsy device (10). The biopsy device (10) includes a probe (20) and a housing (30). The probe (20) includes a needle assembly (100) extending at least partly from the housing of the probe (20) to the distal end, and the needle assembly (100) can be inserted into the patient's tissue as described below to obtain a tissue sample. The biopsy device (10) also includes a tissue sample holder (40) for storing tissue samples. For example only, as shown in Figure 2, the probe (20) may be a disposable component and the housing (30) may be a reusable component that can be coupled to the probe (20). The use of the term "chassis" in this context should not be interpreted as requiring the insertion of any part of the probe (20) into any part of the chassis (30). In fact, in one configuration of the biopsy device (10), the probe (20) can simply be placed on the top of the housing (30). Alternatively, a part of the probe (20) can be inserted into the casing (30) to fix the probe (20) to the casing (30). In yet another configuration, a part of the housing (30) can be inserted into the probe (20). In addition, the probe (20) and the housing (30) can be integrated to form a single unit. The probe (20) and housing (30) are available

In the construction of the separation member, a port and/or seal may be provided in the housing (30)± to be coupled with the second port and/or second seal on the probe (20) so as to pass through the housing (30) The vacuum generated by the vacuum pump (50) inside) can be fluidly connected to the probe (20). In fact, in a merely exemplary configuration, the vacuum pump (50) generates a vacuum in the needle assembly (100) as will be described in more detail below. Alternatively, the vacuum pump (50) can be independent of the housing (30) and the probe (20) and can be simply coupled to a suitable port on the biopsy device (10) through a vacuum tube. The biopsy device (10) can also be constructed in accordance with at least some of the teachings of U.S. Patent Application No. 12/953,715 filed on November 24, 2010 with the title Handheld Biopsy Device with Needle Firing, the disclosure of which is based on reference The way is incorporated into this article. A person of ordinary skill in the art will understand other suitable structure and function combinations of the probe (20) and the housing (30) from the teachings herein. [0025] II. Exemplary housing

[0026] The housing (30) schematically shown in FIG. 3 includes a vacuum pump (50), a motor (70), a control module (1000), a vacuum sensor (52) and any other suitable electrical and/or motor components. The vacuum pump (50) of this example includes a conventional diaphragm pump that is mechanically coupled to a motor (70). The vacuum sensor (52) is coupled to the vacuum pump (50) or along any vacuum path extending therefrom so that the vacuum sensor (52) can measure the vacuum level formed by the vacuum pump (50). The vacuum sensor is electrically coupled to the control module (1000) so that the vacuum sensor (52) can output a signal indicating the vacuum level to the control module (1000)_oIn the configuration shown, as will be described below, the motor (70) is operable to translate and/or rotate the tubular cutter (60), and to activate the vacuum pump, but this is only an optional solution and a second motor (not shown) Out) to operate the vacuum pump (50). As those of ordinary skill in the art will understand from the teachings herein, various other configurations regarding the casing (30) can be provided. In fact, the casing (30) can be constructed in accordance with at least some of the teachings of US Patent Application No. 12/953,715, entitled Handheld Biopsy Device with Needle Firing, filed on November 24, 2010. The publication of said patent application The content is incorporated into this article by reference.

[0027] III. Exemplary Needle Assembly

[0028] FIG. 4 depicts an exemplary needle assembly (100) for the probe (20)_oThe needle assembly (100) includes a needle part (110), a blade assembly (200), a needle coupling member (150) and a ventilation sleeve (180). It can be seen from Fig. 3 that the needle part (110) includes a needle (120) and a knife receiving tube (130). The needle (120) of this example is a tube with an oval cross-section and a proximal end and a distal end, and a lumen is formed between the two ends. However, it should be understood that the needle (120) may have other configurations, such as a circular tube, a square tube, or any other suitable cross-sectional shape for the needle (120) as those of ordinary skill in the art will understand from the teachings herein. The needle (120) has a cut-out portion (122) that extends longitudinally from the distal end of the needle (120) and terminates at a position close to the distal end. For example, the cut-out portion (122) may extend longitudinally along the entire length of the needle (120) or the cut-out portion (122) may terminate at a certain longitudinal position away from the proximal end of the needle (120). For example only, the longitudinal length of the cut-out portion (122) may be in the range of 0.8 to 4.0 inches. In particular, for the exemplary 13 gauge needle only, the cut-out portion (122) extends longitudinally from the distal end of the needle (120) to near and approximately 1.088 inches from the distal end of the needle (120).

[0029] The cut-out portion (122) also extends downward from the top of the needle (120) and terminates at a certain plane below the top of the needle (120). In one exemplary configuration only, the cut-out portion (122) may extend below the midpoint of the needle (120). Alternatively, the cut-out portion (122) may terminate above the midpoint of the needle (120), the midpoint of the needle (120), or any suitable point as those of ordinary skill in the art will appreciate from the teachings herein. In the example of a 13-gauge needle, the cut-out portion (122) terminates in a plane about 0.08124 inches down from the top of the needle (120) so that when the knife receiving tube (130) is placed in the cut-out portion (122) As will be described in more detail below, the vertex of the cutter receiving tube (130) is tangentially aligned with the vertex of the needle (120). Once the cut portion (122) of the needle (120) is removed, the local needle portion (124) remains and extends distally from the remaining uncut needle (120). As will be described in more detail below, the partial needle portion (124) is coupled to the tool receiving

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Tube (130). Those of ordinary skill in the art will understand from the teachings herein that the cutting portion (122) and the needle (120) are of other equally suitable sizes and configurations.

[0030] Α. Exemplary tool receiving tube

[0031] In some cases, it may be preferable to have two sections in the needle portion of the needle assembly. This can be used to provide a lateral vacuum to assist tissue prolapse through a lateral opening and/or to provide a vacuum differential on the opposite side of the cut tissue sample to help transport the tissue sample through the biopsy device. Previously, a prefabricated tray or shelf was inserted and welded into the needle to form two sections. However, due to space constraints, the tray may not be completely welded in the needle or the tray may be deformed during insertion. Therefore, the use of tubes can eliminate these problems by providing a welding surface on the outside of the needle and limiting the potential for deformation.

[0032] The cutter receiving tube (130) can be sized to be substantially the same as the length of the cut-out portion (122) (for example, for the 13 gauge needle described above, the cutter receiving tube (130) is also about 1.088 inches long). The cutter receiving tube (130) is placed at the position of the cut-out part (122) and is firmly fixed to the needle (120) and the partial needle part (124). Therefore, the cutter receiving tube (130), the partial needle part (124) and the needle (120) are combined to form the needle part (110)_οIn this configuration, the distal end of the cutter receiving tube (130) and the partial needle portion (124) are substantially coplanar and form an attachment end (126) that can be coupled to the blade assembly (200), as will be described in more detail below Describe like that. In this example, when the cutter receiving tube (130) is aligned in the cutout portion (122), the cutter receiving tube (130) is welded to the needle (120) and the partial needle part (124), but those skilled in the art will Learn about other suitable attachment methods from the teachings of this article. These methods may include mechanical attachment (such as by set screws or bolts), adhesive attachment, or any other suitable attachment.

[0033] The exemplary tool receiving tube (130) is shown as a tube having a circular cross-section, best as shown in FIG. 6. When the cutter receiving tube (130) is fixed to the partial needle part (124), the combination of the cutter receiving tube (130) and the partial needle part (124) forms a first cavity part (140) and a second cavity part (142) ). The second inner cavity portion (142) has a circular cross-section with an inner diameter (144) that is sized so that a tubular cutter (60) with a sharp distal edge can rotate and translate therein. For example only, for a 13-gauge needle as described above, the inner diameter (144) may be about 0.086 inches. The first inner cavity portion (140) of this example has a semicircular cross-section defined by the lower portion of the cutter receiving tube (130) and the partial needle portion (124).

[0034] Referring again to FIG. 5, the tool receiving tube (130) further includes a lateral opening (132) and a plurality of openings (134). The lateral opening (132) is sized to receive prolapsed tissue during operation of the biopsy device (10). The plurality of openings (134) in the cutter receiving tube (130) are formed in the side wall opposite to the lateral opening (132) so that the plurality of openings (134) provide the first inner cavity portion (140) and the Fluid communication between the two inner cavity parts (142). For example, the first inner cavity portion (140) may selectively provide atmospheric air to ventilate the second inner cavity portion (142), and the first inner cavity portion (140) may selectively provide vacuum to the second inner cavity portion (142) In order to make the tissue prolapse into the lateral opening (134), and/or the first lumen portion (140) may provide saline to flush the first lumen portion (140), the second lumen portion (140) during the operation of the biopsy device (10) The inner cavity portion (142) and/or the tubular cutter (60), as will be described in more detail below.

[0035] As shown in FIG. 5, the plurality of openings (134) include circular openings, but it should be understood that the plurality of openings (134) may have any other configuration, including oval openings, slits, dimples, triangular openings, nets Grid or any other suitable configuration. The cutter receiving tube (130) also has a foremost opening (136) formed away from the plurality of openings (134) and close to the distal end of the cutter receiving tube (130). The foremost opening (136) is also aligned away from the distal edge of the lateral opening (132) so that when vacuum is applied, the distal end of the prolapsed tissue is also drawn toward the foremost opening (136). In addition, the second lumen portion (142) can maintain fluid communication with the first lumen portion (140) via the foremost opening (136), even if the tubular cutter (60) is advanced to the point when the sharp distal edge is located away from the lateral direction.

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A certain position of the longitudinal position of the distal edge of the opening (132).

[0036] The tool receiving tube (130) of this example also includes a tubular tool docking portion (138). The docking portion (138) is located near the proximal edge of the lateral opening (132) so that the tubular cutter (60) can be retracted to the docking portion between the incisions of the prolapsed tissue during operation of the biopsy device (10) (138) In. In the case of only an exemplary 13 gauge needle, the docking portion (138) extends longitudinally from the proximal edge of the lateral opening (132) about 0.273 inches. A guide portion (not shown) extending from the docking portion (138) of the cutter receiving tube (130) to the proximal end may also be provided. The guide portion may be configured as a simple buckle extending from the proximal end of the cutter receiving tube (130) on the side wall opposite to the lateral opening (132). The guide part can also be bent downwards toward the side wall of the needle (120) opposite to the lateral opening (132) so that when the tubular cutter (60) is inserted into the proximal end of the needle (120), the guide part provides a funnel-like function To guide the tubular cutter (60) into the cutter receiving tube (130). The guide portion may also include a plurality of openings to allow fluid communication via the guide portion and into the first lumen portion (140) as described above. Of course, as with any other components described herein, any other suitable configuration of the cutter receiving tube (130) may be used.

[0037] Β. Exemplary blade assembly

[0038] In some cases, it may be preferable to use a substantially flat blade to reduce the impact of the biopsy needle being inserted into the patient. However, for extremely small needles, it is difficult to properly couple the small flat blade to the needle. In some cases, plastic molding may be formed around the blade, through a hole in the blade, and coupled to the needle. However, the attachment to the needle may be restricted due to the coupling of the plastic to the metal needle. The metal-to-metal contact area provided between the blade assembly and the needle may allow the blade assembly to be welded to the needle, thereby providing a stronger bond between the blade assembly and the needle.

1. Exemplary blade

[0040] It can be seen from FIGS. 5 and 7 to 8 that the needle assembly (100) further includes a blade assembly (200) located at the distal end of the needle assembly (100) and coupled to the distal end of the needle part (110). The blade assembly (200) includes a blade (210) and a multi-component coupling assembly (300). The blade (210) is shown in FIGS. 7-8 as a substantially flat blade having a first side (212) (shown in FIG. 7) and a second side (214) (shown in FIG. 8). The first side (212) includes a flat portion (220) and a pair of sharp leading edges (216) that intersect at the tip (218) at the distal end of the blade (210). The leading edge (216) and the tip (218) are coplanar in a plane parallel to the flat portion (220). A pair of polished surfaces (222) extend from the front edge (216) to the flat portion (220), as shown in Figures 7 to 8. The structure of the second side (214) is substantially the same as that of the first side (212), but it should be understood that the blade (210) may also be asymmetric, so that the second side (214) only includes a flat portion or is configured to be different from the first side (212). One side (212). The blade (210) can also be constructed in accordance with at least some of the teachings of US Patent Publication No. 2008/0281224 entitled "Biopsy Device Needle Tip" published on November 13, 2008, the disclosure of which is based on reference The way is incorporated into this article.

[0041] At the proximal end of the blade (210), a pair of tangs (224) extend proximally from the substantially flat proximal surface (226) of the blade (210). A pair of recesses (228) are sized and configured to correspond to the thickness of the sidewall of the knife receiving tube (130) and the partial needle portion (124) to allow the blade (210) portion to be inserted into the attachment end using the recess (228) (126), as shown in Figure 5. The inner notch (230) is located just above the lower tang (224) and is sized and configured to correspond to the thickness of the side wall of the portion of the tool receiving tube (130) with multiple openings (134), but it should be understood The inner notch (230) is only optional. It can be seen from Fig. 5 that the tang (224) of this example is asymmetric due to the asymmetry of the inner notch (230) and the needle part (110). In an alternative configuration, the tangs (224) may be symmetrical. In this example, the combination of the tang (224), the outer recess (228), and the inner recess (230) cooperates to be coupled to the attachment end (126) of the needle portion (110) at the blade (210) When restricting its vertical movement.

[0042] As shown in FIGS. 7 to 8, a retention channel (240) is formed in the blade (210). Just for example, the retention channel

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(240) is a sagittal cut with a first area (242) and a second area (244). The first area (242) is a generally triangular area (e.g., the head of the arrow) and the second area (244) is a generally rectangular area (e.g., the main body of the arrow). In this configuration, the second area (244) is sized to be narrower than the proximal end of the first area (242), but this is only optional. In an alternative, the first area (242) and/or the second area (244) may be a circular area, a rectangular area, or any other suitable shaped area. In addition, the retention channel (240) may not be a single continuous cut portion, but may instead include a plurality of openings formed through the blade (210). For example, the retention channel (240) may include two independent circular through holes formed through the blade (210). The circular through holes can be aligned longitudinally, vertically or in any other suitable layout. It should be understood that the retention channel (240) can be constructed in various other suitable ways as those of ordinary skill in the art will appreciate from the teachings herein.

[0043] 2. Exemplary multi-member coupling assembly

[0044] In the exemplary blade assembly (200) shown in FIGS. 7 to 8, the blade (210) is held in place by a multi-member coupling assembly (300). The exemplary multi-member coupling assembly (300) is shown as a two-piece assembly including a first coupling member (350) and a second coupling member (400), but it should be understood that the multi-member coupling assembly (300) is not Limited to two components. In fact, the multi-component coupling assembly (300) can have any number of components, including one-piece, three-piece, four-piece, or five-piece components, or any other components as those of ordinary skill in the art will understand from the teachings herein. In this example, when the first coupling member (350) and the second coupling member (400) are coupled, the blade (210) is substantially constrained by the resulting multi-member coupling assembly (300). As shown in Figures 7 to 8, the combination of the first coupling member (350) and the second coupling member (400) forms a generally conical member with a second area (244) corresponding to the retention channel (240) The bridge member (410) of) passes therethrough to connect the first coupling member (350) to the gap of the second coupling member (400). Therefore, when the first coupling member (350) and the second coupling member (400) are coupled together in such a way that the blade (210) is located between the two coupling members, the blade (210) is obtained and retained. (240) The interlocking multi-member coupling assembly (300) is generally constrained.

[0045] The receiving tube base (460) extends longitudinally from the proximal surface of the multi-component coupling assembly (300) so that the receiving tube base (460) can be inserted into a portion of the cutter receiving tube (130). In this example, the receiving tube base (460) is sized to substantially conform to the inner diameter (144) of the cutter receiving tube (130). Therefore, when the receiving tube base (460) is inserted into the cutter receiving tube (130), the receiving tube base (460) is substantially restrained therein. The receiving tube base (460) of this example is a cylindrical protrusion extending from the multi-component coupling assembly (300) and insertable into the circular cutter receiving tube (130). In this example, the receiving tube base (460) is divided into two sections (462, 464), each section corresponds to the first coupling member (350) or the second coupling member (400), but it should be understood that this Only optional. In fact, the receiving tube base (460) can be entirely formed on either the first coupling member (350) or the second coupling member (400) in a similar manner as the tissue plug (470), as will be described in more detail below Describe like that. Alternatively, in other multi-component coupling assemblies, the receiving tube base may be divided into more than two sections on multiple members of the alternative multi-component coupling assembly.

[0046] In this example, the tissue plug (470) extends proximally from the receiving tube base (460), but it should be understood that if the receiving tube base (460) is not provided, the tissue plug (470) can be simply removed from the multi-member The proximal surface of the coupling component (300) extends proximally. The tissue plug is configured so that when the tubular knife (60) is advanced to cut prolapsed tissue, the tubular knife (60) can be advanced beyond the tissue plug (470) at or near the end of the cutting stroke. Therefore, when the tubular knife (60) is advanced to cut the prolapsed tissue, the tissue plug (470) abuts the distal end of the prolapsed tissue to provide a surface for the tissue to be held in place against. As shown in Figures 7 to 8, the tissue plug (470) is a cylindrical member sized to fit within the inner diameter of the tubular cutter (60), but it should be understood that the tissue plug (470) can have other geometric shapes, including A cube, a rectangular parallelepiped, a half egg-shaped member, a hemispherical member, a half-oval member, or any other suitable configuration as those of ordinary skill in the art will appreciate from the teachings herein. When the tubular knife (60) is advanced by the prolapsed tissue, the tissue plug (470) of this example prevents the tissue from being only pushed by the tubular knife (60) but assists

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Cut off the organization. The tubular cutter (60) can be advanced beyond the proximal end of the tissue plug (470) to generally ensure that the prolapsed tissue is cut off.

[0047] As described above, the multi-member coupling assembly (300) of this example includes a first coupling member (350) and a second coupling member (400), and the combination is a combination between the two coupling members. The pontic member (410) is a generally conical member. As shown in FIGS. 7 to 8, the first coupling member (350) is a semi-conical member having a first part (360) and a second part (370). The first part (360) is sized and configured to be inserted through the first area (242) in the blade (210). For example only, the first portion (360) is a conical portion sized to have a cross-sectional portion substantially corresponding to the shape of the first region (242). Alternatively, if the first area (242) is designed to have other shapes, such as a circle, a rectangle or any other shape, then the cross-sectional portion of the first portion (360) will also have a similar shape. When the first portion (360) is inserted into the first region (242) of the retention channel (240), the proximal end of the first portion (360) generally restrains the blade (210) in the longitudinal direction. In this configuration, the first portion (360) is a three-dimensional conical member having a width (362) wider than the blade width (250) of the blade (210). The first part (360) also includes a head groove (362) into which a part of the second coupling member (400) can be inserted, as will be described below.

[0048] The second portion (370) of the first coupling member (350) is shown as the lower half of the conical member. The second part (370) of this example has a corresponding half part formed by the second coupling member (400) so that the combination forms a substantially conical part, but it should be understood that this configuration is only optional. As shown in Figures 7 to 8, the second part (370) has a flat inner surface and a rounded outer surface. In this example, the second part (370) also has a pontic groove (372) formed in the flat inner surface, which can be inserted into a part of the pontic member (410) of the second coupling member (400).

[0049] The first coupling member (350) further includes a section (462) that receives the tube base (460) extending longitudinally from the second portion (370), as shown in FIGS. 7 to 8. The first coupling member (350) also has a tail alignment groove (380) formed at least partially in the section (462). The tail alignment groove (380) is configured to receive the tail alignment member (420) of the second coupling member (400) to better ensure the alignment and proper assembly of the multi-member coupling assembly (300), but should Understand that this is optional. Of course, as with any other components described herein, any other suitable configuration of the first coupling member (350) may be used.

[0050] The second coupling member (400) is configured to be coupled with the first coupling member (350) to jointly form a multi-member coupling assembly (300). In this example, the second coupling member (400) is a semi-conical member complementary to the second portion (370) of the first coupling member (350). The second coupling member (400) also includes a pontic member (410) and a distal protrusion (412). The distal protrusion (412) is sized to be inserted into the head groove (362), and the pontic member (410) is sized to be at least partially inserted into the pontic groove (372) of the first coupling member (350) ), as shown in Figure 7 to Figure 8. Therefore, when the second coupling member (400) is coupled to the first coupling member (350), a substantially conical member having a bridge portion connecting two lower portions is formed. The second coupling member (400) also has a complementary section (464) of the receiving tube base (460) extending from the proximal end to the proximal end of the second coupling member (400). When the second coupling member (400) and the first coupling member (350) are coupled, the two sections (462, 464) are aligned to form a receiving tube base (460). As described above, the second coupling member may further include a tail alignment member (420), which is sized and configured to be inserted into the tail alignment groove (380) to better ensure the second coupling member (400). ) And the first coupling Alignment of component (350). In this example, the tissue plug (470) extends from the proximal surface of the section (464), but as described above, the tissue plug (470) can be divided into sections for use in the multi-component coupling assembly (300). Each component. Of course, as with any other components described herein, any other suitable configuration of the second coupling member (400) may be used.

[0051] In order to assemble the blade assembly (200) of this example, first the first portion (360) of the first coupling member (350) is inserted through the first region (242) of the retention channel (240). The first coupling member (350) of this example is aligned so that the flat inner surface of the second part (370) is parallel and abuts the flat part (220) of the second side (214) of the blade (210). In this way,

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The pontic groove (372) is substantially aligned with the second area (244) of the retention channel (240). Then the distal protrusion (412) of the second coupling member (400) is inserted into the head groove (362) of the first part (360) of the first coupling member (350) and the second coupling member (400) The pontic member (410) of the first coupling member (350) is inserted into the pontic groove (372) of the second part (370) of the first coupling member (350). Therefore, when the second coupling member (400) and the first coupling member (350) are assembled around the blade (210), the retention channel (240), the distal protrusion (412), the head groove (362), the bridge The combination of the body member (410) and the pontic groove (372) cooperatively constrain the blade (210) between the first coupling member (350) and the second coupling member (400). In this example, this cooperative coupling is achieved by "sandwiching" the blade (210) between the first coupling member (350) and the second coupling member (400), but it should be understood that the coupling can be As those of ordinary skill in the art will understand from the teachings herein, various alternatives will be realized.

[0052] For example, the first coupling member (350) may only penetrate the first region (242) and extend outward from the first side (212) and the second side (214) of the blade (210) at the same time. The first coupling member (350) may include a restriction feature, such as a head groove (362), into which a part of the second coupling member (400) can be coupled. The second coupling member (400) may only penetrate the second region (244) and extend outward from the first side (212) and the second side (214) of the blade (210) at the same time. Therefore, when the second coupling member (400) and the first coupling member (350) are longitudinally coupled together according to this configuration, the blade (210) does not have to be "sandwiched" between the first coupling member (350) and the first coupling member (350). Between the second coupling member (400); instead, the first coupling member (350) and the second coupling member (400) restrict the blade (210) only by their positioning in the retention channel (240). As with other components, those of ordinary skill in the art will understand various other combinations of the first coupling member (350) and the second coupling member (400) from the teachings herein. In addition, the multi-member coupling assembly (300) is not limited to two coupling members; instead, the multi-member coupling assembly (300) may include more than two coupling members, or the multi-member coupling assembly (300) Can include a single component.

[0053] In this example, the multi-component coupling assembly (300) is assembled in such a way that the blade (210) is located in the assembly, and the resulting combination has a distally extending blade (210) and a proximally extending receiving tube base (460) and tissue plug (470). With the receiving tube base (460) extending proximally from the multi-component coupling assembly (300), the blade assembly (200) can be coupled to the needle portion (110). In this configuration, the receiving tube base (460) is sized to be inserted into the cutter receiving tube (130), as best shown in FIG. 5. In one configuration, the receiving tube base (460) can be sized so that a friction fit attachment occurs when the receiving tube base (460) is inserted into the cutter receiving tube (130). Alternatively, the receiving tube base (460) may be slightly smaller than the inner diameter (144) of the knife receiving tube (130) so that the receiving tube base (460) can be more easily inserted into the knife receiving tube when the blade (210) is present. The blade assembly (200) can also be fixed to the needle part by welding, adhesive attachment, mechanical attachment (such as set screws or bolts), or any other suitable method as those of ordinary skill in the art will understand from the teachings herein ( 110) ο

[0054] C. Exemplary needle coupling member

[0055] Referring again to FIG. 4, the needle coupling member (150) is coupled to the proximal end of the needle portion (110) and the distal end of the ventilation sleeve (180). In this example, the needle coupling member (150) is a plastic member configured to couple the needle portion (110) to the vent sleeve (180), but it should be understood that the needle coupling member (150) can be made of any suitable material , Including metal, rubber, synthetic materials or any other suitable materials. The needle coupling member (150) includes a needle groove (152) formed at the distal end and a vent sleeve groove (154) formed at the proximal end. As shown in Figure 9, the vent sleeve groove (154) is sized to receive a portion of the distal end of the vent sleeve (180), as will be described in more detail below. In this example, the vent sleeve groove (154) is a cylindrical groove corresponding to the cross-sectional shape of the vent sleeve (180). The vent sleeve groove (154) can be sized so that a friction fit attachment occurs when the vent sleeve (180) is inserted into it. A plurality of adhesive holes (156) are formed in the needle coupling member (150) and arranged radially around the vent sleeve groove (154). The adhesive hole (156) of this example extends from the proximal surface of the needle coupling member (150) to the distal end of the vent sleeve groove (154), but it should be understood that the adhesive hole (156) may

CN 103561663 Β

It extends from the proximal surface of the needle coupling member (150) to the distal end so that the adhesive hole (156) does not terminate at the distal end of the vent sleeve groove (154). Therefore, when the vent sleeve (180) is inserted into the vent sleeve groove (154), an adhesive, such as epoxy, can be injected into the adhesive hole (156) to further connect the vent sleeve (180) ) Is fixed to the needle coupling member (150). [0056] The needle groove (152) is generally similar to the vent sleeve groove (154), except that the needle groove (152) is formed in the distal end of the needle coupling member (150) and is sized to receive the needle portion ( 110) the proximal part. In the present configuration regarding the needle part (110) with an oval needle (120), the needle groove (152) is an oval groove. A plurality of adhesive holes (156) are formed in the needle coupling member (150), which radially surround the needle groove (152) in a similar manner as the adhesive hole (156) surrounds the vent sleeve groove (154). Layout. Therefore, when the needle part (110) is inserted into the needle groove (152), an adhesive, such as epoxy, can be injected into the adhesive hole (156) to further fix the needle part (110) to the needle Coupling member (150). Those of ordinary skill in the art will understand other suitable configurations of the needle coupling member (150) from the teachings herein.

[0057] D. Exemplary ventilation sleeve

[0058] As described above, the vent sleeve (180) is coupled to the proximal end of the needle coupling member (150) and extends from the proximal end to the proximal end. A reversing valve slide can be arranged in the breather sleeve (180), such as the reversing described in US Patent Application No. 12/953,715 filed on November 24, 2010 under the title Handheld Biopsy Device with Needle Firing' Valve slide, the disclosure of the patent application is incorporated herein by reference. The distal end portion of the ventilation sleeve (180) can be inserted into the proximal end of the needle coupling member (150). As described above, in this example, the outer diameter of the ventilation sleeve (180) and the ventilation sleeve groove (154) of the needle coupling member (150) are fixed together to couple the ventilation sleeve (180) and the needle The connecting member (150) rotates and/or translates unitarily. It should also be understood that, like the tubular cutter (60) arranged through the vent sleeve (180) and the needle coupling member (150), the inside of the vent sleeve (180) is passed through the needle coupling member (150). The oval opening of) is in fluid communication with the second inner cavity portion (142) of the needle portion (110). The vent sleeve (180) includes a plurality of transverse openings that are co-located longitudinally with each other and are equidistantly spaced from each other around the outer periphery of the vent sleeve (180) at their common longitudinal positions (182). The lateral opening (182) provides communication between the atmospheric air and the inside of the vent sleeve (180) so that when the reversing valve slide is in a predetermined position, the atmospheric air can be fluidly connected to the second inner cavity portion (142) on demand.

[0059] Therefore, when the blade assembly (200) is coupled to the needle part (110), the needle part (110) is coupled to the needle coupling member (150) and the needle coupling member (150) is coupled to the ventilation When the cannula (180) is used, the needle assembly (100) is thus formed and can be incorporated into the probe (20) for the biopsy device (10). As those of ordinary skill in the art will understand from the teachings herein, the vent sleeve (180) and/or the needle coupling member (150) can be replaced with replacement components or even omitted from the needle assembly (100) altogether.

[0060] III. Exemplary tip protector

[0061] FIG. 10 shows an exemplary needle tip protector (500) for the exemplary needle assembly (100). In this example, the needle tip protector (500) includes a main body (510) and a seal (550). In some cases, the main body (510) is mainly composed of polycarbonate; however, those of ordinary skill in the art will understand other suitable materials from the teachings herein. The main body (510) includes a distal portion with a closed distal end (512) and a proximal portion with an open proximal end (514). The proximal end (514) includes an outwardly extending annular flange (516). In some cases, the main body (510) is configured just enough to cover the needle assembly (100) so that the lateral opening (132) is contained in the main body (510). Of course, the main body (510) can be configured to cover the needle assembly (100) more or less, as those of ordinary skill in the art will understand from the teachings herein. In this example, the polycarbonate of the main body (510) is translucent (eg, in a colored polycarbonate main body) so that the user can observe through the main body (510) to inspect the blade assembly (200) before use. However, it should be understood that the main body (510) may be transparent or opaque and/or have any suitable combination of these properties.

CN 103561663 Β

[0062] In this example, the main body (510) includes a blade groove (520), a side hole groove (530), and a funnel (540). As shown in Figure 10, the funnel (540) extends from the proximal end (514) of the main body (510) to the distal end and the funnel (540) is configured to help the needle part (110) and the blade assembly (200) be inserted into the main body (510) However, it should be understood that the funnel (540) is only optional. The lateral opening groove (530) of this example extends distally from the funnel (540) and is sized to receive a part of the needle portion (110) therebetween. In this configuration, the lateral aperture groove (530) has an oval cross-section corresponding to the needle portion (110), but it should be understood that the lateral aperture groove (530) can have any other suitable cross-sectional geometry. In addition, the lateral opening groove (530) may have a larger cross-section than the needle portion (110) so that fluid, such as saline or atmospheric air, may be contained therein. The blade groove (520) extends from the proximal end to the distal end of the lateral opening groove (530) and is sized to receive the blade, such as the above-mentioned blade assembly (200). The present blade groove (520) is shown as a rectangular groove narrower than the lateral opening groove (530), but, alternatively, the blade groove (520) may be a truncated cone that generally conforms to the blade assembly (200) Conical groove of the blade. In addition, the blade The groove (520) may not be narrower than the lateral hole groove (530); instead, the blade groove (520) may be the same size as the lateral hole groove (530) or may be even larger than the lateral hole groove (530). Slot (530). In short, the blade groove (520) and the lateral opening groove (530) have a certain longitudinal depth so that when the needle part (110) of the blade assembly (200) and the needle assembly (100) is inserted into the lateral opening When in the middle, the lateral opening (132) of the needle part (110) is located away from the proximal end (514).

[0063] The seal (550) is coupled to the proximal end (514) of the main body (510). The seal (550) may comprise a variety of different materials, including rubber, butadiene rubber, polychloroprene, silicone rubber, or any other suitable elastomer or resilient material. The seal (550) includes an attachment part (552) and a sealing part (570). The attachment portion (552) is sized and configured to fit on the proximal end (514) of the main body (510) to form a seal between the attachment portion (552) and the exterior of the main body (510). In this example, since the main body (510) has a circular cross-sectional shape at the proximal end (514), the attachment portion (552) will also have a circular cross-section. The attachment portion (552) of the present structure is a hollow cylindrical member extending from the micro-inch portion (570) to the distal end. In one exemplary configuration only, the attachment portion (552) has an outer diameter slightly smaller than the diameter of the main body (510) so that when the attachment portion (552) is coupled to the main body (510), the attachment portion (552) ) Is compressed by the elastic material to fit tightly around the outer periphery of the main body (510), thereby forming an airtight seal. Alternatively, the attachment portion (552) may be sized so that the inner diameter of the attachment portion (552) is equal to the diameter of the main body (510). In addition, if the main body (510) has an alternate cross-sectional shape, the attachment portion (552) can be sized accordingly to provide a seal when coupled to the proximal end (514) of the main body (510). In this example, the attachment portion (552) also includes a flange groove (556). The flange groove (556) is configured to receive the annular flange (516) when the body (510) is coupled to the seal (550). In another configuration, the attachment part (552) may also include an outer member, such as an aluminum or stainless steel cylindrical member, to restrain the elastic body or the elastic part therein. A person of ordinary skill in the art will understand other other configurations regarding the attachment portion (552) from the teachings herein.

[0064] The sealing portion (570) is located near the attachment portion (552) and is configured to allow the needle portion (110) and the blade assembly (200) to pass into the main body (510). In one exemplary configuration only, the sealing portion (570) is formed integrally with the attachment portion (552), but it should be understood that the sealing portion (570) may or be a separate component. In fact, if the attachment portion (552) includes an outer member, the sealing portion (570) may be a separate component coupled to the attachment portion (570) and constrained by the outer member. In this configuration, the sealing portion (570) is a simple flat member having an opening (572) through which the needle portion (110) and the blade assembly (200) can be inserted. In this configuration, the opening (572) is sized and configured to fit around the needle part (110) so that the seal is generally formed by the sealing part (570) around the needle part (110). The opening (572) of this example is an oval opening adjusted to be smaller than the cross section of the needle part (110). Alternatively, the sealing portion (570) may be a simple flat member having a slit or a pair of orthogonal slits. In yet another configuration, the sealing portion (570) may include a duckbill-shaped dense size such that the duckbill portion extends proximally from the attachment portion (552). Like the other components described in this article, the secret part

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(570) It can have other configurations as those of ordinary skill in the art will understand from the teachings herein.

[0065] When the needle portion (110) and blade assembly (200) are inserted into the needle tip protector (500), the lateral opening (132) is located in the main body (510) and is sealed (550) generally sealed therein. Therefore, the user of the biopsy device (10) can activate the vacuum pump (50) in the casing (30) to test the vacuum generated by the vacuum pump (50). In one exemplary configuration only, the probe (20) may be pre-assembled with a needle tip protector (500) coupled to the distal end of the needle assembly (100) when it is provided to the user. The tubular cutter (60) of this configuration can initially be in the most proximal position, as shown in the previous figure 5, so that the fluid in the lateral opening groove (530) passes through the lateral opening (132) and the second cavity Portion (142) is in fluid communication. Alternatively, the tubular cutter (60) can be retracted as part of the diagnostic procedure, as will be described below.

[0066] In the case of the detachable probe (20) initially coupled with the needle tip protector (500), when the user couples the probe (20) to the housing (30), the housing (30) A diagnostic program that starts the vacuum pump (50) and uses the vacuum sensor (52) can be run to determine whether an appropriate amount of vacuum is generated when the needle tip protector (500) is attached. If the tubular cutter (60) is not retracted, the diagnostic program can retract the tubular cutter (60) before starting the vacuum pump (50). The diagnostic program can be automatically activated by the attachment of the probe (20) to the casing (30) (for example, by detecting the coupling of the probe (20) to the casing (30) or a switch activated by the coupling), Or the diagnostic program can be manually started by the user (such as using buttons or other input methods). If the vacuum pump (50) cannot form a sufficient vacuum, the casing (30) may display a symbol indicating that the diagnostic test has failed and/or the sounding device may emit an audible sound to indicate that the diagnostic test has failed. Alternatively, if the vacuum pump (50) has formed a sufficient vacuum, the casing (30) can remain silent or the casing (30) can display a symbol indicating the success of the diagnostic test and/or the sound device can emit an audible sound to indicate the diagnostic test success. If the initial diagnostic test is successful, the user can remove the needle tip protector (500) from the needle assembly (100) to use the biopsy device (10). Although the needle tip protector (500) has been described It is an exemplary use for testing the vacuum generated by the vacuum pump (50) in the casing (30), but those skilled in the art will understand other suitable uses and configurations of the needle tip protector (500) from the teachings herein. In addition, the needle tip protector (500) can be constructed in accordance with at least some of the teachings of the U.S. Patent Application No. 12/843,088 filed on July 26, 2010 under the title of Biopsy Device with Detachab 1 e Needle Tip Protector. The disclosure is incorporated herein by reference.

[0067] IV. Exemplary Vacuum Sensor and Control Module Configuration for Increased Sampling Rate

[0068] In some cases, it is desirable to reduce the time spent between tissue samples. This can shorten the total time that the biopsy device needs to be inserted into the patient, thereby reducing the discomfort of the patient, and it can also increase the number of patients that the physician can visit in a day. Therefore, one method of achieving this goal includes determining whether the tissue sample has reached the tissue sample holder. Once the tissue sample has been stored in the tissue sample holder, the biopsy device can be reset to the initial position to collect another sample.

[0069] Referring again to FIGS. 1 to 3, the biopsy device (10) of this example includes a motor (70), a plurality of gears (72), a vacuum pump (50), a vacuum sensor (52), and a control module (1000)_οIn one exemplary configuration only, the motor (50) of the biopsy device (10) is mechanically coupled to actuate the tubular cutter (60) from the most distal position to the most proximal position. In this configuration, the motor (70) contained in the casing (30) is mechanically connected to the tubular cutter (60) through a plurality of gears (72) and/or other components, but it should be understood that these are only optional. In the configuration of the detachable probe (20) and the housing (30) shown in FIG. 2, a complementary gear (72) is provided to transmit the rotation provided by the motor (70) in the housing (30) to The tubular cutter (60) in the probe (20). In addition, the motor (70) can also be operated to activate the vacuum pump (50). In an alternative, a second motor (not shown) may be provided instead of using the motor (70) to activate the vacuum pump (50). Various other configurations of the biopsy device (10) can be provided as those of ordinary skill in the art will understand from the teachings herein. In fact, the biopsy device (10) can be submitted on November 24, 2010

CN 103561663 Β

At least some doctrinal constructions of U.S. Patent Application No. 12/953,715, entitled Handheld Biopsy Device with Needle Firing, the disclosure of which is incorporated herein by reference.

[0070] When the biopsy device (10) is ready to collect a tissue sample, the tubular cutter (60) is initially located at the most distal position to "close" the lateral opening (132), as shown in FIG. 4. Therefore, when the blade assembly (200) and the needle part (110) are inserted into the tissue of the patient, the tubular cutter (60) at the most distal position can substantially prevent the tissue from hooking on the lateral opening (132). Once the lateral opening (132) is aligned with the tissue area that the user wants to sample, the tubular cutter (60) can be retracted to the most proximal position by the motor (50). Once the tubular cutter (60) is in the most proximal position, the lateral opening (132) is "opened", as shown in Figure 5, so that the tissue can prolapse into the lateral opening (132). In the present configuration shown, the most proximal position of the tubular cutter (60) is located in the area defined by the docking portion (138), but it should be understood that the proximal position of the tubular cutter (60) can be located close to the lateral opening ( 132) at any point on the proximal edge.

[0071] When the tubular cutter (60) is retracted, vacuum can be communicated from the vacuum pump (50) to the first lumen portion (140) and/or the second lumen portion (142) to help tissue prolapse to the side To the opening (132). Alternatively, the vacuum pump (50) may apply vacuum only when the tubular cutter (60) is in the most proximal position. In yet another alternative, the vacuum can be selectively applied at any point during the retraction of the tubular cutter (60), such as when the tubular cutter (60) is retracted 20% to 30% of the entire retraction distance. The entire retracted distance can be calculated as the longitudinal displacement between the most distal position and the most proximal position. In this example, the vacuum is connected to the first inner cavity portion (140) by the vacuum pump (50) and enters the second inner cavity portion (142) via the opening (134) and the foremost opening (136), as described above and As shown in Figure 5, a lateral vacuum is provided. Therefore, when the tubular cutter (60) is in the process of retracting, the tissue may be compressed by the applied vacuum to prolapse into the second lumen portion (142) via the lateral opening (132).

[0072] Once the tissue prolapses into the lateral opening (132), the tubular cutter (60) is actuated distally. When the tubular cutter (60) moves to the farthest position, the tubular cutter (60) can simply translate longitudinally or the tubular cutter (60) can translate and rotate at the same time. Therefore, when the tubular cutter (60) is advanced, the prolapsed tissue is cut off by the tubular cutter (60). The reversing valve slide may be coupled to the tubular cutter (60) to selectively communicate vacuum and/or atmosphere to the first inner cavity portion (160) and/or the second inner cavity portion (162). Specifically, when the tubular cutter (60) is advanced, the reversing valve slide can switch the vacuum provided by the vacuum pump (50) from the first inner cavity portion (160) to the second inner cavity portion (162) and/or Inside the tubular cutter (60). After the tubular cutter (60) reaches the most distal position, the tubular cutter (60) can be configured to rotate in a proper position without advancing to the distal end. This approach can be implemented so that the motor (70) continues to operate the vacuum pump (50) to provide a vacuum in the tubular cutter (60) and the second inner cavity portion (162) to remove tissue from the second vacuum portion (142) via The tubular cutter (60) is then transferred to the tissue sample holder (40). The reversing valve slide as described above can also be actuated to allow the atmosphere to pass through the breather sleeve (180) through A lateral opening (182) is provided into the first lumen portion (140) and passes through the foremost opening (136) and/or opening (134) to facilitate the transfer of the tissue sample through the tubular cutter (60). Once the tissue is stored in the tissue sample holder (40) and/or a predetermined period of time has elapsed, as will be described below, the biopsy device (10) can be reset to the initial state for collecting another tissue sample.

[0073] As described above, the vacuum sensor (52) is configured to sense the vacuum generated by the vacuum pump (50). The vacuum sensor (52) is electrically coupled to the control module (1000), and the control module can be configured to receive the output signal from the vacuum sensor (52) and output the control signal to other components of the biopsy device (10). The control module (1000) can be constructed in accordance with at least some of the teachings of US Patent Application No. 12/953,715 filed on November 24, 2010 with the title Handheld Biopsy Device with Needle Firing, the disclosure of which is incorporated by reference The method is incorporated into this article. The control module (1000) may include hardware and/or software configured to control various components of the biopsy device (10). Just cite

CN 103561663 Β

For example, the control module (1000) may include RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, ASICs, programmable processors and/or any other as those of ordinary skill in the art will understand from the teachings herein Suitable control module (1000)_o

[0074] In this configuration, the control module (1000) is partially configured to determine whether the tissue cut by the tubular cutter (60) has been successfully transferred to the tissue sample holder (40) and/or whether a predetermined period of time has passed. time. Initially, the control module (1000) activates the motor (70) coupled to the vacuum pump (50) and maintains it for a predetermined period of time (for example, a time between 0 and 1 second). If the vacuum pump (50) generates sufficient vacuum, the time taken for the tissue sample to move to the tissue sample holder can be shortened to zero seconds or close to zero seconds. This allows more samples to be collected in a certain period of time.

[0075] The control module (1000) also receives signal data (1100) from the vacuum sensor (52), as shown in FIG. 11. The control module (1000) of this example may be configured to detect a predetermined vacuum pressure (shown as a point (1110) in FIG. 11) after the tubular knife (60) is commanded to advance and cut the tissue sample. For example, the predetermined vacuum pressure (1110) may be a value in the range of 4 to 10 inHg, but it should be understood that as those skilled in the art will understand from the teachings herein, a value outside this exemplary range may be selected based on the configuration of the device Other values. The predetermined vacuum pressure (1110) may be a static value or the predetermined vacuum pressure may vary according to the speed of the motor (70). The predetermined vacuum pressure (1110) can also be a preset factory value or the predetermined vacuum pressure (1110) can be tested through various configurations of the biopsy device (10) (these variables can include different needle sizes, lengths, sample size options, and other various Variable factors). When the control module (1000) detects a predetermined vacuum pressure (1110) after the tubular knife (60) is advanced, the control module (1000) is configured to reset the biopsy device (10) to the initial state to collect another tissue sample . If the control module (1000) cannot detect the predetermined vacuum pressure (1110) and And a predetermined period of time has passed, then the control module (1000) is configured to still reset the biopsy device (10) to the initial state or indicate an error. Therefore, if the tissue sample is quickly transported through the second lumen portion (142), through the tubular cutter (60), and into the tissue sample holder (40), the control module (1000) can be configured to pass through the aforementioned section The biopsy device (10) is reset before a predetermined time. Therefore, it is possible to collect more tissue samples in the same period of time than a biopsy device that only waits for a predetermined period of time, thereby increasing the sampling rate.

[0076] The control module (1000) may alternatively be configured to detect a predetermined rate of change of the signal data (1100), which is represented graphically by the tilt signal data (1120). The tilt signal data (1120) of this example corresponds to a part of the signal data (1100) output by the vacuum sensor (52) when the cut tissue sample is being transported into the tissue sample holder (40). The tilt signal data (1120) can be a preset slope value or can be determined by testing various configurations of the biopsy device (10) in advance. A mere exemplary value of the tilt signal data (1120) can be -10inHg/s_oTherefore, when the control module (1000) detects the tilt signal data (1120) equal to the set slope value or a negative slope greater than that, the control module (1000) is configured to reset the biopsy device (10) to Initial state to collect another tissue sample. If the control module (1000) cannot detect the tilt signal data (1120) and a predetermined period of time has passed, the control module (1000) may be configured to still reset the biopsy device (10) to the initial state or indicate an error. Therefore, in this alternative structure, the number of tissue sampling can still be increased within an equal period of time.

[0077] In another alternative, a minimum slope value can be set, such as -2inHg/s_oThe control module (1000) may also be configured to adjust a predetermined period of time to adapt to the value of the tilt signal data (1120) between the preset value and the minimum slope value. For example, if the tilt signal data (1120) is -8inHg/s, the preset value is -10inHg/s and the minimum value is -2inHg/s, then the control module (1000) can be configured to adjust a predetermined period of time to be longer This allows the motor (70) to operate the vacuum pump (50) for a longer time so that the tissue sample can still be transported into the tissue sample holder (40). If a new predetermined period of time has passed, the control module (1000) can be configured to reset the biopsy device (10) to the initial state or

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Indicates an error.

[0078] Although some mere exemplary methods of adjusting the sampling rate of the biopsy device (10) using the vacuum sensor (52) and the control module (1000) have been described, those of ordinary skill in the art will understand equally suitable alternative configurations from the teachings herein. .

[0079] V. Exemplary Vacuum Pump Silencer

[0080] In other cases, it may be preferable to keep the noise emitted from the biopsy device (10) to a minimum. Providing a quiet or substantially quiet biopsy device (10) can make the patient calmer during the operation than a noisy device. Therefore, reducing the noise output of certain components in the biopsy device (10) can achieve this goal. One such component that can generate noise when the biopsy device (10) is in use is the vacuum pump (50) in use. Therefore, the vacuum pump (50) can be provided with a silencer to reduce the noise generated by the vacuum pump (50).

[0081] An exemplary configuration is the vacuum pump (50) shown in FIG. 12 coupled to the muffler assembly (600). The exemplary muffler assembly (600) includes a first outlet tube (610) and a second outlet tube (620) that are both coupled to the muffler (650). The first outlet pipe (610) is coupled to the vacuum pump (50) at the first end and to the muffler (650) at the second end to provide a connection between the vacuum pump (50) and the muffler (650) Fluid communication. The first outlet pipe (610) may be coupled to the muffler (650) using adhesive, a mechanical connection (such as a barb connection on the muffler (650)), integrally formed or by any other suitable means. The second outlet pipe (620) is coupled to the muffler (620) at the first end and can be coupled to the port on the casing (30) at the second end, but it should be understood that the second outlet pipe (620) The second end of) may be substantially free.

[0082] The muffler (650) of this example includes a generally flexible bladder that is inflatable when a fluid (such as air) is pumped to the muffler (650). In other configurations, the muffler (650) can be replaced with a rigid structure, such as plastic or metal, and can be a square box, an L-shaped box, an S-shaped box, or any other suitable shape. The muffler (650) may also include an acoustic panel, such as a rigid plastic sheet in the rigid muffler (650) or a flexible panel if the muffler (650) is a flexible bladder. The baffles may also include a plurality of holes that allow a portion of the fluid to flow through each baffle. As shown in FIG. 12, the first outlet pipe (610) and the second outlet pipe (620) are coupled on opposite sides of the muffler (650) and are offset at the opposite corners of the muffler (650). In an alternative configuration, the two tubes (610, 620) may be coupled to the muffler (650) on the same side of the muffler (650) but diagonally. In another configuration, the two tubes (610, 620) may be aligned collinearly on opposite sides when coupled to the muffler (650). The two tubes (610, 620) can also be angularly offset from each other. Those of ordinary skill in the art will understand other equally suitable configurations of the first outlet pipe (610), the second outlet pipe (620) and the silencer (650) from the teachings herein.

[0083] In the configuration shown in FIG. 12, when the muffler assembly (600) is coupled to the vacuum pump (50), the muffler assembly (600) can use the offset of the pipe (610, 620) and use the muffler The (650) flexible bladder attenuates the vibration emitted by the vacuum pump (50) to reduce the audible noise emitted by the vacuum pump (50). In addition, the use of flexible tubes (610, 620) and flexible silencers (650) can allow the silencer assembly (600) to be inserted into a biopsy device with a close fit, because the silencer assembly (600) can be dispatched into the device Any suitable location. Therefore, the silencer assembly (600) can be provided in a variety of different biopsy devices, including the biopsy device (10), to potentially reduce the noise emitted when the device is in use. As those of ordinary skill in the art will appreciate from the teachings herein, other suitable structures and configurations of the muffler assembly (600) can be provided.

[0084] It should be understood that the full or part of any patent, publication, or other published material that is alleged to be incorporated herein by reference is only provided that the incorporated material does not correspond to the existing definitions, statements or other disclosures described in the present disclosure. The material is incorporated into this article within the degree of contradiction. Therefore, and to the extent necessary, the disclosure as expressly described herein shall supersede any contradictory material incorporated herein by reference. Allegedly incorporated by reference into this article but with the existing definitions and declarations described in this article

CN 103561663 Β

Any material or part thereof that is inconsistent with other disclosed materials will only be incorporated to the extent that the incorporated material does not conflict with the existing published materials.

[0085] Embodiments of the present invention have applications in conventional endoscopic and open surgical instrument operations as well as applications in machine-assisted surgery.

[0086] Embodiments of the devices disclosed herein can be designed to be discarded after a single use, or can be designed to be used multiple times. In either or both cases, the embodiment can be trimmed to be reused after at least one use. Refurbishment can include any combination of disassembly of the device, followed by cleaning or replacement of specific components, and subsequent reassembly steps. In particular, embodiments of the device can be disassembled, and any number of specific device components or parts can be selectively replaced or removed in any combination. After the cleaning and/or replacement of specific parts, the device embodiment can be reassembled for subsequent use at the trim facility or by the surgical team shortly before the surgery. Those skilled in the art will understand that various different disassembly, cleaning/replacement and reassembly techniques can be used for the refurbishment of the device. The use of these technologies and the resulting dressing devices are within the scope of this application.

[0087] By way of example only, the embodiments described herein can be processed prior to surgery. First, obtain new or used instruments and, if necessary, clean them. The instrument can then be disinfected. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument can then be placed in a field of radiation 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 sterilized instrument can then be stored in a sterile container. Before being opened in a medical facility, the sealed container can keep the instrument sterile. Any other technique known in the art, including but not limited to B or Y radiation, ethylene oxide, or steam, can also be used to sterilize the device.

[0088] Various embodiments of the present invention have been shown and described, and those of ordinary skill in the art can implement further adaptations to the methods and systems described herein through appropriate modifications without departing from the scope of the present invention. Several of these potential modifications have been mentioned, and others will be obvious to those skilled in the art. For example, the above-mentioned examples, embodiments, geometric forms, materials, dimensions, ratios, steps, and the like are illustrative and not essential. Therefore, the scope of the present invention should be considered with reference to the appended claims and should be understood not to be limited to the details of the structure and operation shown and described in the drawings.

CN 103561663 Β