Circular stapler with selectable motorized and manual control, including a control ring.

(54) Title: CIRCULAR STAPLER WITH MOTORIZED CONTROL AND SELECTABLE MANUAL, INCLUDING A CONTROL RING.

(54) Title: CIRCULAR STAPLER WITH SELECTABLE MOTORIZED AND MANUAL CONTROL, INCLUDING A CONTROL RING.

(57) Summary

A tissue stapling apparatus (210) comprising a stapling head unit (220), a rotary drive stem (264) and a mode selector; the stapling head unit comprises a closing unit and a trip unit; the closure unit can be used to hold tissue against an anvil; the trigger unit can be used to propel at least one staple through the tissue towards the anvil; the mode selector can be used to select between a tissue holding mode and a shooting mode; the rotary drive stem can be used to drive the closure unit in response to the selection of the tissue holding mode; the rotary drive stem can be used to drive the trigger unit in response to selection of the trigger mode; the mode selector can be used to move the rotary actuation stem between a first longitudinal position and a second longitudinal position to select between the tissue holding mode and the firing mode; the mode selector may comprise a slip ring (252).

(57) Abstract

An apparatus for stapling tissue (210) comprises a stapling head assembly (220), a rotary drive shaft (264), and a mode selector. The stapling head assembly comprises a closure assembly and a firing assembly. The closure assembly is operable to clamp tissue against an anvil. The firing assembly is operable to drive at least one staple through tissue toward the anvil. The mode selector is operable to select between a tissue clamping mode and a firing mode. The rotary drive shaft is operable to actuate the closure assembly in response to selection of the tissue clamping mode. The rotary drive shaft is operable to actute the firing assembly in response to selection of the firing mode. The mode selector may transíate the rotary drive shaft between a first longitudinal position and a second longitudinal position to select between the tissue clamping mode and the firing mode. The mode selector may comprise a sliding ring (252).

PATENT TITLE No. 360428

Headlines):

Home:

Denomination:

Classification:

ETHICON ENDO-SURGERY, INC.

4545 Creek IRoad, Cincinnati, Ohio, 45242, USA

CIRCULAR STAPLER WITH SELECTABLE MOTORIZED CONTROL, INCLUDING A CONTROL RING.

AND MANUAL

CIP:

CPC:

A61B17 / 115 A61B17 / 115

Inventors): JEFFREY S. SWAYZE; CHE

GREGORYW. JOHNSON

Number

MX / a / 2015/007739

XTER, III: FREDERICK E. SHELTON, IV;

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Ub

Validity: V Date of

Exp Date

The patent of reference!

Pursuant to the starting date

Who subscribes to the present title Is (Official Gazette of the Federation

01/25/2006, 05/06/2009, 01/06/20110, and 12 * fractions I and 111 of the! Regias 07/28/2004 and 09/07/2007); articles 1 ', 3,

Industrial Property (DOF 12/27/1999, n powers in the Deputy General Directors'

Departmental Coordinators and other subordinates' 07/29/2004, 08/04/2004 and 09/13/2007).

International:

e2013 lustrial.

'extended extensions, cut to hos.

the Industrial Property Law

999, 01/26/2004, 06/16/2005, 1 », 3 · fraction V Clause a), 4^toon 07/01/2002, 07/15/2004, Organic Statute of the Mexican Institute of the, 3 and 5 'subsection a) of the Agreement that delegates Regáñales Offices, Divisional Su-Directors,' (DOF 45/12/1999, amended on 04 / 02/2000,

This letter is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 fraction Iii, 2 traction V, 26 BIS and 26 TER of the Agreement establishing the Guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in The procedures indicated.

THE DIVISIONAL DIRECTOR OF PATENTS

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NAHANNY CANAL REYES

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Arenal No: 550, Floor 1, Pueblo Santa Marta Tepepan, Xochírnílco, 16020, (55) 53340700 www.góD.rnwifnpi

<img file="MX360428B_D0003.tif" />

CIRCULAR STAPLER WITH MOTORIZED CONTROL AND MANUA

INCLUDES A CONTROL RING

BACKGROUND OF THE INVENTION

In some cases, a surgeon may wish to place a surgical instrument through a hole in the patient's body and use the Instrument to adjust, position, adhere, and / or in any other way interact with the patient's Internal tissue. For example, in some surgical procedures, portions of the gastrointestinal tract may be cut and removed to remove undesirable tissue or for other reasons. Once the desired tissue has been removed, the remaining portions should be joined together again. One such useful tool for these anastomotic procedures is a circular stapler that is inserted through a hole in the patient's body.

Examples of circular surgical staplers are described in US Pat. USA no. 5,205,459, entitled Surgical Anastomosis Stapling Instrument, issued April 27, 1993; US patent USA no. 5,271,544, entitled Surgical Anastomosis Stapling Instrument, issued December 21, 1993; US patent USA no. 5,275,322, entitled Surgical Anastomosis Stapling Instrument, issued January 4, 1994; US patent USA no. 5,285,945, entitled Surgical Anastomosis Stapling Instrument, issued February 15, 1994; US patent USA no. 5,292,053, entitled Surgical Anastomosis Stapling Instrument, issued March 8, 1994; US patent USA no. 5,333,773, entitled Surgical Anastomosis Stapling Instrument, issued August 2, 1994; US patent USA no. 5,350,104, entitled Surgical Anastomosis Stapling Instrument, issued September 27, 1994; and US patent. USA no. 5,533,661, entitled Surgical Anastomosis Stapling Instrument, issued July 9, 1996. The description of each of the US patents. USA cited above is incorporated herein by reference. Some of these staplers are used to hold the tissue layers securely, cut through the attached tissue layers, and drive the staples through the tissue layers to substantially seal the cut tissue layers together of the cut ends of the tissue layers and thus join two cut ends of an anatomical lumen.

Other illustrative surgical staplers are described in US Pat. USA no. 4,805,823, entitled Pocket Configuration for Internal Organ Staplers, issued February 21, 1989; US patent USA no. 5,415,334, entitled Surgical Stapler and Staple Cartridge, issued May 16, 1995; US patent USA no. 5,465,895, entitled Surgical Stapler Instrument, issued November 14, 1995; US patent USA no. 5,597,107, titled Surgical Stapler

<img file="MX360428B_D0004.tif" />

IMPI

Instrument, issued January 28, 1997, US patent. UU

Surgical Instrument, granted on May 27, 1997; US patent USA num. 5,673,840, entitled Surgical Instrument, issued on October 7, 1997; US patent USA no. 5,704,534, entitled '' Articulation Assembly for Surgical Instruments, issued January 6, 1998; US patent USA no. 5,814,055, entitled Surgical Clamping Mechanism, issued September 29, 1998; US patent USA no. 6,978,921, entitled Surgical Stapling Instrument Incorporating an EBeam Flrlng Mechanism, issued December 27, 2005, US Patent No. USA no. 7,000,818, entitled Surgical Stapling Instrument Having Separate Dlstinct Closing and Flrlng Systems, issued on February 21, 2006; US patent USA no. 7,143,923, entitled Surgical Stapling Instrument Having a Flrlng Lockout for an Undosed Anvil, issued December 5, 2006; US patent USA no. 7,303,108, titled Surgical Stapling Instrument Incorporating a Multl-Stroke Flrlng Mechanism with a Flexible Rack, issued December 4, 2007 and US Patent No. USA no. 7,367,485, entitled Surgical Stapling Instrument Incorporating a Multlstroke Firing Mechanism Having a Rotary Transmission, issued May 6, 2008; US patent USA no. 7,380,695, entitled Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing, issued June 3, 2008; US patent USA no. 7,380,696, entitled Articulatlng Surgical Stapling Instrument Incorporating a Two-Plece E-Beam Firing Mechanism, issued June 3, 2008; US patent USA no. 7,404,508, entitled Surgical Stapling and Cutting Device, issued July 29, 2008; US patent USA no. 7,434,715, entitled Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout, granted on October 14, 2008; and US patent. USA no. 7,721,930, entitled Disposable Cartridge with Adhesive for Use with a Stapling Device, issued May 25, 2010. The description of each of the US patents. USA cited above is incorporated herein by reference. Although the aforementioned surgical staplers are described as being used in endoscopic procedures, it should be understood that such surgical staplers can be used, in addition, in open procedures and / or other non-endoscopic procedures.

While various types of Surgical Stapling Instruments and associated components have been made and used, it is believed that no one prior to the inventor (s) has made or used the present invention as described in the appended claims.

BRIEF DESCRIPTION OF THE FIGURES

Although the description concludes with claims that particularly point to and clearly claim this technology, it is believed that this technology will be better understood from the following description of certain examples taken in conjunction with the attached figures, in which similar reference numbers identify elements in which:

Figure 1 illustrates a side elevation view of an illustrative circular surgical stapling instrument;

Figure 2A illustrates an enlarged longitudinal cross-sectional view of an illustrative stapling head unit of the instrument of Figure 1 showing an illustrative anvil in an open position;

Figure 2B illustrates an enlarged longitudinal cross-sectional view of the stapling head unit of Figure 2A showing the anvil in a closed position;

Figure 2C illustrates an enlarged longitudinal cross-sectional view of the stapling head unit of Figure 2A showing an illustrative staple driver and a blade in a triggered position;

Figure 3 illustrates an enlarged partial cross-sectional view of an illustrative clip formed against the anvil;

Figure 4A illustrates an enlarged side elevation view of an illustrative actuator handle unit of the surgical instrument of Figure 1 with a portion of the body removed, showing a trigger in a non-triggered position and a locking feature in a locked position. ;

Figure 4B illustrates an enlarged side elevation view of the actuator handle unit of Figure 4A, showing the trigger in a triggered position and the locking feature in an unlocked position;

Figure 5 illustrates an enlarged partial perspective view of an Illustrative Indicator unit of the surgical instrument of Figure 1 showing an indicator window and an Indicator lever;

Figure 6 illustrates a diagrammatic view of the indicator window of Figure 5 showing representations of an illustrative indicator bar and a corresponding illustrative clip;

Figure 7 illustrates a perspective view of another illustrative circular surgical stapling instrument;

Figure 8 illustrates an exploded view of the handle and stem units of the instrument of Figure 7;

Figure 9 illustrates a cross-sectional view of the handle unit of the instrument of Figure 7;

Figure 10 illustrates an enlarged brown cross-sectional view of the motor and battery units of Figure 7;

Figure 11A illustrates a side elevation view of an operating mode selection unit of the instrument of Figure 7, with a first and a second gear;

Figure 11B illustrates a side elevation view of the operating mode selection unit of Figure HA, with the first gear coupled to the second gear;

Figure 12 illustrates a front elevation view of the first gear of the operating mode selection unit of Figure 11A;

Figure 13 illustrates a perspective view of the second gear of the operating mode selection unit of Figure 11A;

Figure 14 illustrates an enlarged partial perspective view of the handle unit of the Instrument of Figure 7;

Figure 15A illustrates a cross-sectional view of the Instrument of Figure 7, with a selected motorized mode of operation, showing an anvil coupled to a trocar;

Figure 15B illustrates a cross-sectional view of the Instrument of Figure 7, with a selected motorized mode of operation, in a tissue holding position;

Figure 15C illustrates a cross-sectional view of the Instrument of Figure 7, with a selected motorized mode of operation, in a triggered position;

Figure 16 illustrates a cross-sectional view of the handle unit of the Instrument of Figure 7 showing the selected manual mode of operation;

Figure 17A illustrates a cross-sectional view of the instrument of Figure 7, with a selected manual mode of operation, showing an anvil coupled to a trocar;

Figure 17B illustrates a cross-sectional view of the instrument of Figure 7, with a selected manual mode of operation, in a tissue holding position;

Figure 17C illustrates a cross-sectional view of the Instrument of Figure 7, with a selected manual mode of operation, in a triggered position;

Figure 18 illustrates a schematic of an illustrative control unit for use with the instrument of Figure 7;

Figure 19 illustrates a partial perspective view of another illustrative operating mode selection unit; and Figure 20 illustrates a front view of the operating mode selection unit of Figure 19.

The figures are not intended to be limiting in any way and it is considered that various modalities of the technology can be carried out in various other ways, including those not necessarily described in the figures. The accompanying figures which are incorporated in and are part of the description illustrate various aspects of the present technology and together with the description serve to explain the principles of the technology; it is understood, however, that this technology is not limited to

DETAILED DESCRIPTION OF THE INVENTION precise provisions shown.

The following description of certain examples of technology should not be used to limit its scope. Other examples, characteristics, aspects, modalities and advantages of the technology will be evident to those with experience in the matter from the following description, which is, by way of illustration, one of the best ways contemplated to carry out the technology. As will be seen, the technology described in the present description is capable of presenting other obvious and different aspects, all without departing from the technology. Accordingly, the figures and descriptions should be considered as illustrative and not restrictive in nature.

I. Overview of the Illustrative Circular Surgical Stapling Instrument

Figures 1 to 6 show an illustrative circular surgical stapling instrument (10) having a stapling head unit (20), a stem unit (60) and an actuator handle unit (70), each of the which will be described in more detail below. The stem unit (60) extends distally from the actuator handle unit (70), and the stapling head unit (20) is coupled to a distal end of the stem unit (60). In summary, the actuator handle unit (70) can drive a staple driver (24) of the staple head unit (20) to drive a plurality of staples (66) out of the staple head unit (20) . The staples (66) are bent to form complete staples by the action of an anvil (40) attached at the distal end of the instrument (10). Consequently, the tissue (2) shown in Figures 2A to 2C can be stapled with the use of the instrument (10).

In the present example, the instrument (10) comprises a closure system and a trigger system. The closure system comprises a trocar (38), a trocar actuator (39), and a rotary boss (98). An anvil (40) can be attached to a distal end of trocar (38). The rotary boss (98) can be useful to make the trocar (38) move, longitudinally, with respect to the stapling head unit (20) and, thus, make the anvil (40) move when the anvil (40) engages the trocar (38) to hold the tissue between the anvil (40) and the staple head unit (20). The trigger system comprises a trigger (74), a trigger actuator unit (84), a driver actuator (64) and a staple driver (24). The staple driver (24) includes a blade (36) configured to cut tissue when the staple driver (24) is actuated longitudinally. In addition, the staples (66) are positioned distal to a plurality of staple driver members (30) of the staple driver (24) such that the staple driver (24) further drives the staples ( 66) distally when it is actuated longitudinally. Therefore, when the trigger (74) is actuated and the trigger activation (84) activates the Staple Driver (24) by means of the Driver Driver (64), the blade (36) and the members (30 ) cut the tissue (2) and drive the staples (66) distally with respect to the stapling head unit (20) to the tissue at substantially the same time. The components and functionalities of the locking system and trigger system will now be described in more detail.

A. Illustrative anvil

As shown in Figures 1 to 2C, the anvil (40) can be selectively coupled to the instrument (10) to provide a surface against which the staples (66) can be bent to staple material contained between the feed head unit stapled (20) and anvil (40). The anvil (40) of the present example can be selectively coupled to a trocar or rod with a tip (38) that extends, distally, with respect to the stapling head unit (20). Referring to Figures 2A-2C, the anvil (40) can be selectively coupled by coupling a proximal stem (42) to the anvil (40) to a dlstal tip of the trocar (38). The anvil (40) comprises a generally circular anvil head (48) and a proximal stem (42) extending proximally from the anvil head (48). In the example shown, the proximal stem (42) comprises a tubular member (44) having flexibly offset retaining clips (46) to selectively engage the anvil (40) to the trocar (38), although this is simply optional, and It should be understood that other retention features can also be used to engage the anvil (40) with the trocar (38). For example, C-shaped fasteners, jaws, threads, pins, adhesives, etc. can be used to attach the anvil (40) to the trocar (38). Furthermore, while it is disclosed that the anvil (40) can be selectively coupled to the trocar (38), in some versions, the proximal stem (42) may include a one-way coupling feature such that the anvil (40) cannot be removed of the trocar (38) after the anvil (40) was attached. Simply illustrative one-way features include burrs, snaps, metal plates, collars, tabs, bands, etc. Other useful configurations for coupling the anvil 40 to the trocar 38 will become apparent to one skilled in the art in light of the teachings of the present disclosure. For example, the trocar (38) may be a hollow shank and the proximal shank (42) may comprise a tapered rod that can be inserted into the hollow shank.

The anvil head (48) of the present example comprises a plurality of staple forming pockets (52) formed on a proximal face (50) of the anvil head (48). Accordingly, when the anvil (40) is in the closed position and the staples (66) are driven out of the staple head unit (20) into the staple forming pockets (52), as shown in Figure 2C , the legs (68) of the staples ((complete staples.

It should be understood that the anvil (40), as a separate component, can be inserted and secured to a tissue portion (2) prior to engagement with the staple head unit (20). As an example, the anvil (40) can be inserted inside and secured to a first tubular tissue portion (2) while the instrument (10) is inserted inside and secured to a second tubular tissue portion (2). For example, the first tubular tissue portion (2) may be sutured to or around an anvil portion (40) and the second tubular tissue portion (2) may be sutured to or around the trocar (38).

As shown in Figure 2A, the anvil (40) then engages the trocar (38). The trocar (38) of the present example is shown in the most activated distal position. Said extended position for the trocar (38) can provide a larger area to which the tissue (2) can be attached prior to the attachment of the anvil (40). Furthermore, the extended position of the trocar (38) can facilitate the attachment of the anvil (40) to the trocar (38). The trocar (38) further includes a conical distal tip. Although the use of a conical distal tip is simply optional, such a tip may have the ability to pierce tissue and / or facilitate insertion of the anvil (40) into the trocar (38). For example, in other versions, the trocar 38 may have a blunt tip. Additionally or alternatively, the trocar (38) may include a magnetic portion (not shown) that can attract the anvil (40) toward the trocar (38). Obviously, other configurations and arrangements for anvil 40 and trocar 38 will be apparent to one skilled in the art in light of the teachings of the present invention.

When the anvil 40 engages the trocar 38, the distance between a proximal face of the anvil 40 and a distal face of the staple head unit 20 defines a separation distance d. The trocar (38) of the present example can be moved longitudinally with respect to the stapling head unit (20) by means of an adjusting boss (98) placed at a proximal end of the actuating handle unit (70), as will be described in more detail below. Consequently, when the anvil (40) engages the trocar (38), the rotation of the adjusting boss (98) increases or decreases the separation distance d by activating the anvil (40) with respect to the unit. stapling head (20). For example, as shown in sequence in Figures 2A to 2B, the anvil (40) is actuated proximally with respect to the actuator handle unit (70) from an open initial position to a closed position and, thereby, reduces the separation distance d and the distance between the two tissue portions (2) to be joined. Once the separation distance d reaches a predetermined range, the stapling head unit (20) can be fired, as shown in Figure 2C, to staple and cut tissue (2) between the anvil (40) and the stapling head unit (20). The staple head unit (20) can be useful for cutting tissue (2) when a trigger (74) of the actuator handle unit (/ Dj) rotates, as will be described in more detail below.

As indicated above, the separation distance dcorresponds to the distance between the anvil (40) and the stapling head unit (20). When the instrument 10 is inserted into the body of a patient, this separation distance d may not be easily visible. Accordingly, a movable indicator bar (110) is provided, shown in Figures 5 through 6, which can be seen through an indicator window (120) opposite the trigger (74). The indicator bar (110) can move in response to the rotation of the adjusting boss (98), such that the position of the indicator bar (110) is representative of the separation distance d. As shown in Figure 6, the indicator window (120) further comprises a scale (130) indicating that the anvil gap is within a desired operating range (eg, a green colored region or green area ) and a representation of the compression of the corresponding clip at each end of the scale (130). As an example, as shown in Figure 6, a first image of a staple (132) illustrates the height of a large staple while a second image of a staple (134) illustrates a height of a small staple. Consequently, a user can view the position of the attached anvil (40) relative to the staple head unit (20) through the indicator bar (110) and scale (130). Thereafter, the user can correspondingly adjust the position of the anvil (40) by means of the adjustment boss (98).

Again referring to Figures 2A-2C, a user sutures a portion of tissue (2) around tubular member (44) such that anvil head (48) is positioned within a portion of tissue (2) that is to be stapled. When the tissue (2) is attached to the anvil (40), the retaining clips (46) and a portion of the tubular member (44) project from the tissue (2) so that the user can attach the anvil (40) to the trocar (38). With tissue (2) coupled to trocar (38) and / or to another portion of stapling head unit (20), the user attaches anvil (40) to trocar (38) and drives anvil (40) proximally toward the staple head unit (20) to reduce the separation distance d. Once the instrument (10) is within the operating range, the user staples the ends of the tissue (2) together and thereby forms a substantially continuous tubular tissue portion (2).

The anvil 40 can be further constructed in accordance with at least some of the teachings of US Pat. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945; US patent USA no. 5,292,053; US patent USA no. 5,333,773; US patent USA no. 5,350,104; and US patent. USA no. 5,533,661, the descriptions of which are incorporated by reference in the present description; and / or according to other configurations that will be apparent to a person skilled in the art in view of the teachings of the f

B. Illustrative Staple Head Unit

The staple head unit (20) of the present example is coupled to a distal end of the stem unit (60) and comprises a tubular liner (22) that houses a sliding staple driver (24) and a plurality of staples ( 66) contained within staple pockets (32). Staples (66) and staple pockets (32) are placed in a circular arrangement around the tubular liner (22). In the present example, the staples (66) and the staple pockets (32) are arranged in a pair of concentric annular rows of staples (66) and staple pockets (32). The staple driver (24) can be actuated longitudinally within the tubular liner (22) in response to rotation of the trigger (74) of the actuator handle unit (70). As shown in Figures 2A to 2C, the staple driver (24) comprises a flared cylindrical element having a trocar opening (26), a central slit (28), and a plurality of members (30) arranged circumferentially around the central groove (28) and which extend distally with respect to the stem unit (60). Each member (30) is configured to contact and engage a corresponding staple (66) of the plurality of staples (66) within the staple pockets (32). Accordingly, when the Staple Driver (24) is actuated distal to the actuator handle unit (70), each member (30) drives a corresponding staple (66) out of its staple pocket (32) through a staple opening (34) formed at a distal end of the tubular liner (22). Since each member (30) extends from the staple driver (24), the plurality of staples (66) are driven out of the staple head unit (20) at virtually the same time. When the anvil (40) is in the closed position, the staples (66) are urged into the staple forming pockets (52) to fold the legs (68) of the staples (66) and thereby staple the material placed between the anvil (40) and the staple head unit (20). Figure 3 illustrates a merely illustrative staple (66) driven by a member (30) into a staple forming pocket (32) of the anvil (40) to fold the legs (68).

The staple driver (24) further includes a cylindrical blade (36) coaxial with respect to the trocar opening (26) and which is inserted from the staple pockets (32). In the present example, the cylindrical blade (36) is arranged within the central slit (28) to move distally with the Staple Driver (24). When the anvil (40) is secured to the trocar (38), as previously described, the anvil head (48) provides a surface against which the cylindrical blade (36) cuts the material contained between the anvil (40) and the staple head unit (20). In some versions, the anvil head (48) may include a slit (not shown) for the cylindrical blade (36) to cut through the material (for example, a rim is provided &lt;

In addition or as an alternative, the anvil head 48 may include one or more opposing cylindrical blades (not shown) spaced from the cylindrical blade 36 so that a scissor-like cutting action can be provided. Other configurations will be apparent to one skilled in the art in light of the teachings of the present invention. Therefore, the stapling head unit (20) can staple and cut tissue (2) substantially simultaneously in response to activation by means of the actuator handle unit (70).

Obviously, the stapling head unit 20 can be further constructed in accordance with at least some of the teachings of US Pat. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945; US patent USA no. 5,292,053; US patent USA no. 5,333,773; US patent USA no. 5,350,104; and US patent. USA no. 5,533,661, the descriptions of which are incorporated by reference in the present description; and / or in accordance with other configurations that will be apparent to one skilled in the art in view of the teachings of the present invention.

As indicated above, the staple driver (24) includes a trocar opening (26). The trocar opening (26) is configured to allow the trocar (38) to slide longitudinally with respect to the stapling head unit (20) and / or the stem unit (60). As shown in Figures 2A to 2C, the trocar (38) is coupled to a trocar actuator (39) so that the trocar (38) can be actuated longitudinally by rotation of the rotary boss (98) , as will be described in more detail below with reference to the actuator handle unit (70). In the present example, the trocar actuator (39) comprises a relatively rigid elongated stem coupled to the trocar (38), although this is simply optional. In some versions, the actuator (39) can comprise a longitudinally rigid material and, at the same time, allow lateral flexion so that portions of the instrument (10) can be selectively bent or curved during use; or the instrument (10) may include a preconfigured bent stem unit (60). A merely illustrative material is nitinol. When the anvil (40) is coupled to the trocar (38), the trocar (38) and the anvil (40) can be moved by means of the actuator (39) to adjust the separation distance d between the anvil (40) and the unit stapling head (20). Other configurations for actuator 39 to longitudinally activate trocar 38 will become apparent to one skilled in the art in light of the teachings of the present invention.

C. Illustrative stem unit

The stapling head unit (20) and the trocar (38) are placed at a distal end of the stem unit (60), as shown in Figur;

The stem (60) of the present example comprises an outer tubular member (62) and an impeller actuator (64). The outer tubular member (62) engages the tubular liner (22) of the staple head unit (20) and a body (72) of the actuator handle unit (70), and thereby, provides a mechanical basis for actuation of the components therein. The proximal end of the Impeller actuator (64) couples to a trigger actuator unit (84) of the actuator handle unit (70) described below. The distal end of the impeller driver (64) engages the staple driver (24) such that rotation of the trigger (74) longitudinally drives the staple driver (24). As shown in Figures 2A to 2C, the actuator of the Impeller (64) comprises a tubular member having an open longitudinal axis so that the actuator (39) coupled to the trocar (38) can be actuated longitudinally within and with respect to the impeller actuator (64). Obviously, it should be understood that other components may be disposed within the Impeller actuator (64) as will be apparent to one skilled in the art in light of the teachings of the present invention.

The stem unit 60 can be further constructed in accordance with at least some of the teachings of US Pat. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945; US patent USA no. 5,292,053; US patent USA no. 5,333,773; US patent USA no. 5,350,104; and US patent. USA no. 5,533,661, the disclosures of which are incorporated by reference in the present description; and / or in accordance with other configurations that will be apparent to one skilled in the art in view of the teachings of the present invention.

D. Illustrative Actuator Handle Unit

Referring to Figures 4A through 5, the actuator handle unit (70) comprises a body (72), a trigger (74), a locking feature (82), a trigger activation unit (84), and a unit trocar activation (90). The trigger (74) of the present example is positioned on the body (72) so that it can pivot and engages the trigger activating unit (84) such that the rotation of the trigger (74) from an untriggered position ( shown in Figure 4A) to a tripped position (shown in Figure 4B) activates the impeller actuator (64) described above. A spring (78) engages the body (72) and the trigger (74) to divert the trigger (74) to the non-triggered position. The locking feature (82) is a pivotable member that engages the body (72). In a first locked position, the locking feature (82) pivots up and away from the body (72) so that the locking feature (82) engages the trigger (74) and mechanically prevents a user from activating the trigger (74). ). In a second non-locked position, such as that shown in the figures, the lock (82) pivots down in such a way that the trigger (74) can be operated by the user. Consequently, with the locking feature (82) in the second position, the trigger (74) can engage a trigger activation unit (84) to trigger the instrument (10).

As shown in Figures 4A to 4B, the trigger actuation unit (84) of the present example comprises a slideable trigger carriage (86) coupled with a proximal end of the impeller actuator (64). Carriage (86) includes a set of tabs (88) at a proximal end of carriage (86) to retain and engage a pair of trigger arms (76) extending from trigger (74). Accordingly, when the trigger (74) is pivoted, the carriage (86) is actuated longitudinally and transfers the longitudinal movement to the impeller actuator (64). In the example shown, the carriage (86) is fixedly coupled to the proximal end of the impeller actuator (64), although this is simply optional. Clearly, in a merely illustrative alternative, carriage 86 may simply abut the impeller actuator 64 while a distal spring (not shown) deflects impeller actuator 64 proximally from the unit. with actuator handle (70).

Trigger activating unit 84 can be further constructed in accordance with at least some of the teachings of US Pat. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945; US patent USA no. 5,292,053; US patent USA no. 5,333,773; ios us patent USA no. 5,350,104; and US patent. USA no. 5,533,661, the disclosures of which are incorporated by reference in the present description; and / or in accordance with other configurations that will be apparent to one skilled in the art in view of the teachings of the present invention.

The body (72) further houses a trocar activation unit (90) configured to actuate the trocar (38) longitudinally in response to the rotation of the adjustment boss (98). As shown in Figures 4A to 5, the trocar activation unit (90) of the present example comprises the adjusting boss (98), a slotted pin (94) and a sleeve (92). The slotted pin (94) of the present example is placed at a distal end of the trocar actuator (39), although it should be understood that the slotted pin (94) and the trocar actuator (39), alternatively, may be separate components that couple to transmit longitudinal movement. The adjusting boss (98) is supported, so that it can rotate, by the proximal end of the body (72) and can make the sleeve (92) coupled with the slotted pin (94) by means of an internal tongue (not shown) rotate. The slotted pin (94) of the present example comprises a continuous slot (96) formed on the outer surface of the slotted pin (94). Accordingly, when the adjusting boss (98) rotates, the inner tab is displaced within the slot (96) and the slotted pin (94) is actuated longitudinally with respect to the sleeve (92). Since the grooved pin (94) is placed in the end-trocar (39), the rotation of the adjustment protrusion (98) in a first direction results in the trocar actuator (39) advancing distally with respect to the drive unit. actuator handle (70). Consequently, the separation distance d increases between the anvil (40) and the stapling head unit (20). Rotation of the adjustment boss (98) in the opposite direction causes the trocar actuator (39) to act proximally with respect to the actuator handle unit (70) to reduce the separation distance d between the anvil (40) and the stapling head unit (20). Therefore, the trocar activating unit (90) can actuate the trocar (38) in response to rotation of the adjustment boss (98). Obviously, other configurations for the trocar activation unit (90) will become apparent to one skilled in the art in light of the teachings of the present invention.

The groove (96) of the present example comprises a plurality of different portions (96A, 96B, 96C) having a variable pitch or number of grooves per axial distance. This slot 96 is divided into a distal portion 96A, a medial portion 96B, and a proximal portion 96C. As shown in Figure 5, the distal portion (96A) comprises a fine pitch or a large number of grooves over a short axial distance from the grooved pin (94), such that a large number of rotations are required. adjusting boss (98) to traverse the short axial distance. The middle portion 96B comprises a section with a comparatively thicker pitch or a smaller number of grooves per axial distance, such that a relatively low number of rotations are required to traverse a long axial distance. Consequently, the separation distance d can be rapidly reduced through a relatively low number of rotations of the adjusting boss (98). The proximal portion (96C) of the present example is substantially similar to the distal portion (96A) and comprises a fine pitch or a large number of grooves in a short axial distance from the grooved stem (94) such that a large number of rotations to traverse the short axial distance. The proximal portion (96C) of the present example is disposed within the sleeve (92) when the anvil (40) is substantially close to the stapling head unit (20) so that the Indicator bar (110) moves within the indicator window (120) along scale (130) to indicate that the anvil gap is within a desired operating range, as will be described in more detail below. Accordingly, when the tab is within the proximal portion 96C of the slot 96, each rotation of the adjustment boss 98 can reduce the gap distance c / by a small amount to provide a fine adjustment.

The trocar activation unit (90) can further be constructed in accordance with at least some of the teachings of US Pat. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945;

US patent USA no. 5,292,053; US patent USA no. 5,333, no. 5,350,104; and US patent. USA no. 5,533,661, the descriptions of which are incorporated by reference in the present description; and / or in accordance with other configurations that will be apparent to one skilled in the art in view of the teachings of the present invention.

In the example shown in Figures 4A to 4B, a U-shaped fastener (100) is attached to an intermediate portion of the trocar actuator (39) located distal of the slotted stem (94). In the present example, an extension of! Trocar actuator (39) engages a slot in the handle unit housing (70) to prevent the trocar actuator (39) from rotating about its axis when the adjusting boss (98) is rotated. In some other versions, the U-shaped fastener (100) engages with a portion of the body (72) to substantially prevent the trocar actuator (39) from rotating around its axis when the adjustment boss (98) broken. The U-shaped fastener (100) of the present example further includes an elongated groove (102) on each of the opposite sides to receive a joint member, such as a thread, bolt, pin, fastener, etc. , to selectively adjust the longitudinal position of the elongated slot (102) of the U-shaped fastener (100) relative to the trocar actuator (39) for the purpose of calibrating the indicator bar (110) relative to the scale (130 ).

As shown in Figure 5, the actuator handle unit (70) further includes an Indicator bracket (140) configured to couple and pivot an indicator (104). The indicator bracket (140) of the present example is slidable with respect to the body (72) along a pair of grooves formed in the body (72). The indicator support (140) comprises a rectangular plate (144), an indicator arm (146) and an angled projection (142). The angled protrusion (142) is formed at the proximal end of the rectangular plate (144) and includes an opening (not shown) to position it so that it can slide over the trocar actuator (39) and / or slotted pin (94 ). A coil spring (150) is interposed between the projection (142) and a protrusion (152) to deflect the projection (142) against the U-shaped fastener (100). Consequently, when the U-shaped fastener (100) is actuated distally with the trocar actuator (39) and / or slotted pin (94), the coil spring (150) acts on the indicator holder (140) to move distally with the U-shaped clamp (100). Furthermore, the U-shaped clamp (100) acts on the indicator support (140) proximally with respect to the boss (152) when the trocar actuator (39) and / or slotted pin (94) are proximally translated and, in this way, they compress the spiral spring (150). Obviously, it should be understood that in some versions the indicator support (140) can be fixedly attached to the trocar actuator (39) and / or slotted pin (94).

In the present example, a portion of the locking feature (82) abuts a surface (141) of the indicator bracket (140) when the indicator bracket (140) is in a longitudinal position that does not correspond to the position exist, the anvil is within an operating range (for example, an ae coior verae region or green zone). When the anvil gap is within an operating range (for example, a green region or green area), the gauge bracket (140) tapers to provide a pair of gaps (145) on either side of a gauge arm (146) allowing the locking feature (82) to pivot and thereby release the trigger (74). Consequently, the locking feature 82 and indicator bracket 140 can substantially prevent a user from releasing and operating the trigger 74 until the anvil 40 is in a predetermined operating range. Obviously, it should be understood that the locking feature (82) can be completely omitted in some versions.

This operating interval can be visually communicated to the user through an indicator bar (110) of an indicator (104) shown against a scale (130), briefly described above. At the distal end of the indicator holder (140) there is a distally projecting indicator arm (146) ending in a laterally projecting finger (148) to control the movement of the indicator (104). The indicator arm (146) and the finger (148), better illustrated in Figure 5, are configured to engage a tab (106) of the indicator (104) such that the indicator (104) pivots when the indicator (140) is actuated longitudinally. In the present example, indicator (104) is pivotably coupled to body (72) at a first end of indicator (104), although this is simply optional, and other pivot points for indicator (104) will become apparent. for a person skilled in the art in view of the teachings of the present invention. An indicator bar (110) is positioned at the second end of indicator (104) such that indicator bar (110) moves in response to activation of indicator support (140). Consequently, as described above, the indicator bar 110 can be viewed through an indicator window 120 against a scale 130 (shown in Figure 6) to show the relative separation distance between anvil (40) and stapling head unit (20).

Obviously, the indicator holder (140), the indicator (104) and / or the actuator handle unit (70) can be further constructed in accordance with at least some of the teachings of the US patent. USA no. 5,205,459; US patent USA no. 5,271,544; US patent USA no. 5,275,322; US patent USA no. 5,285,945; US patent USA no. 5,292,053; US patent USA no. 5,333,773; US patent USA no. 5,350,104; and US patent. USA no. 5,533,661, the descriptions of which are incorporated by reference in the present description; and / or in accordance with other configurations that will be apparent to one skilled in the art in view of the teachings of the present invention.

II. Mcto-¡circular surgical stapling instrument;

selectable

In some cases, it may be desirable to provide motorized control of the instrument (10). It may further be desirable to allow a user to select between manual control or motorized control of a motorized version of a circular surgical stapling instrument (10). For example, instrument 10 may include an operating mode selection unit that allows the user to decouple an automated motorized rotary drive system and provide manual drive of that system. It may further be desirable to provide a switching unit for changing the mode of a single rotary actuator between a tissue holding mode and a tissue cutting / stapling mode. In other words, such a switching unit can allow a single rotary actuator to drive the clamping features of the anvil (40) or to drive the staple and knife driving features (36) of the instrument (10). The following examples include merely illustrative versions of the instrument (10) where a single motor can be used to control both the clamping and the cutting / stapling of tissues by means of a single rotary actuator; where the operator can select between motorized operation and manual operation; and a staple head cartridge unit responsive to a single rotary actuator in motorized and manual operation.

A. Illustrative operating mode selection unit

Figure 7 shows another illustrative circular stapling instrument (210), which is a selectively motorized variation of the instrument (10). The Instrument (210) in this example comprises a stapling head unit (220), an anvil (240), a stem unit (260) and a handle unit (270). The staple head unit (220) is similar to the staple head unit (20) in that the staple head unit (220) selectively engages with the anvil (240). The staple head unit (220) can be used to hold tissue between the staple pockets (32) and the staple forming pockets (52) of the anvil (240). The staple head unit (220) comprises a cylindrical blade (36) that can be used to section captured tissue between the staple head unit (220) and the anvil (240). The staple head unit (220) drives the staples (66) through the captured tissue between the staple head unit (220) and the anvil (240). The Stapler Tool 210 can be used to create a safe anastomosis (eg, end-to-end anastomosis) within a patient's gastrointestinal tract or elsewhere.

The staple head unit (220) differs from the staple head unit (20) in that the staple head unit (220) can be used to hold tissue, cut tissue, and staple tissue, all in response to a single input. rotat of the stem unit (260). Consequently, activation inputs are not required to translate linearly through the stem unit (260) for the staple head unit (220), although the staple head unit (220) may comprise a travel clutch feature. Illustratively only, at least part of the stapling head unit 220 can be configured in accordance with at least some of the teachings of the US patent application. USA no. [PROXY FILE NO. END7161USNP.0597922], entitled Motor Driven Rotary Input Circular Stapler with Modular End Effector, filed on the same date with the present invention, the disclosure of which is incorporated herein by reference. Other suitable configurations for the staple head unit 220 will be apparent to one skilled in the art in view of the teachings of the present invention.

The stem unit (260) is similar to the stem unit (60) in that the stem unit (260) couples the handle unit (270) with the stapling head unit (220). The stem unit (260) differs from the stem unit (60) in that the stem unit (260) comprises a single actuating feature, the rotary drive actuator (264) shown in Figure 8. The driver actuator (264) can be used to drive the staple head unit (220) to hold tissue, cut tissue, and staple tissue. Consequently, linear actuation through the stem unit (260) is not required, although the rotary impeller actuator (264) can be translated, longitudinally, to switch between a tissue holding mode and a staple cut / staple mode. tissue. For example, the impeller actuator (264) can be translated from a first longitudinal position, where rotation of the impeller actuator (264) provides the tissue clamping in the staple head unit (220), to a second position. longitudinal, where rotation of the Impeller actuator (264) provides for cutting and stapling tissue in the staple head unit (220). Some versions of the stem unit (260) may include one or more flexible sections. An example of a stem unit that is configured with flexible sections and that can be incorporated into a stem unit (260) is described in US Patent Application. USA no. [PROXY FILE NO. END7163USNP.0597933], entitled Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft, filed on the same date herewith, the disclosure of which is incorporated herein by reference. Alternatively, the stem unit (260) may be rigid along the length of the stem unit (260) or have one or more flexible sections configured in some other way.

The handle unit (270) is shown in Figures 8 to 10. The handle unit (270) comprises a handle housing (272), a housing of the mo or a battery (281), a rotary boss (298), a Selection unit is soooo operational (shown in Figures 11A to 11B) and a trigger ring (252). The motor housing (274) is placed inside the handle housing (272). The handle housing (272) comprises ribs (255, 256, 257) that extend inwardly into the handle housing (272) to support the motor housing (274), as shown in Figure 9. The battery ( 281) is placed proximal to the motor (280) within the motor housing (274). The battery (281) can be removed from the motor housing (274) to be replaced, discarded, or recharged. As best seen in Figure 10, the battery (281) comprises electrical contacts (231, 232) that extend distally from the battery (281). The motor (280) comprises electrical contacts (233, 234) that extend proximally from the motor (280). The battery electrical contact (232) and the motor electrical contact (234) are coupled by means of a conductive metal band (242). A thread (243) couples the band (242) to the motor housing (274) to fix the position of the band (242) in relation to the motor housing (274). Consequently, the band (242) is configured to constantly couple the battery electrical contact (232) and the motor electrical contact (234).

As shown in Figure 10, the battery electrical contact (231) is coupled to a conductive metal band (245). The metal band (245) is secured to the motor housing (274) by means of a conductive thread (247). The electrical contact of the motor (233) is coupled to a band of conductive metal (244). The metal band (244) is secured to the motor housing (274) by means of a conductive thread (246). The motor housing (274) is formed from an electrically insulating material (eg, plastic) and comprises annular contacts (284, 286) wrapped around the motor housing (274). Each of the threads (246, 247) mates with a respective annular contact (284, 286) to electrically couple the battery electrical contact (231) and the motor electrical contact (233) to the annular contacts (284, 286 ), respectively.

Another conductive metal band (282) is secured to the handle housing (272). Each end of the metal band (282) forms a respective spring contact (283, 285). The motor housing (274) moves proximally and / or distally relative to the handle housing (272) to selectively engage and / or disengage the spring contacts (283, 285) with the annular contacts (284, 286 ). Particularly, when the motor housing (274) is in a distal position (Figure 15A), the spring contact (283) couples the ring contact (284) and the spring contact (285) couples the ring contact (286) to coupling the battery (281) with the motor (280) and supplying power to the motor (280). It will be understood that since the spring contacts (283, 285) are part of the same conductive metal band (282), and since the contacts (232,

234) are already coupled by means of the band (242), the coupling at (283, 285) and the annular contacts (284, 286) complete a circuit between the Battery (281) and the motor (280). This placement is used to provide motorized actuation of the staple head unit 220 as will be described in greater detail below. When the motor housing (274) is in a proximal position (Figure 17A), the spring contacts (283, 285) disengage from the annular contacts (284, 286), such that the battery (281) decouples motor 280 and motor 280 receive no power. This placement is used to provide manual actuation of the staple head unit 220 as will be described in greater detail below. The annular shape of the annular contacts (284, 286) allows proper contact between the spring contacts (283, 285) and the annular contacts (284, 286) regardless of the angular position of the motor housing (274) within the housing mango (272). In some versions, the band (282) may include an interrupt that engages with an external switch, such that a user can operate the external switch in order to complete the coupling between the battery (281) and the motor (280 ) after the motor housing (274) is in the distal position.

A proximal end of the motor housing (274) is securely secured to the rotating boss (298), as shown in Figure 8. The rotating boss (298) projects proximally from the handle housing (272) and comprises ribs ( 296) extending distally from the rotary boss (298). The handle housing (272) comprises corresponding teeth (251) to selectively engage the splines (296). The rotary boss (298) is pulled and / or pushed to move the motor housing (274) into the handle housing (272). When the rotating boss (298) is in the proximal position (Figure 17A), the splines (296) are disengaged from the handle housing (272) such that the rotating boss (298) and the motor housing (274) remain free to rotate relative to the handle housing (272). This placement is used to provide manual actuation of the staple head unit 220 as will be described in greater detail below. When the rotary boss (298) is in a distal position (Figure 15A), the splines (296) engage the corresponding teeth (251) in the handle housing (272) to block the rotation of the rotary boss (298) and the motor housing (274) in relation to the handle housing (272). The splines (296) and the teeth (251) thus provide a mechanical base for the motor housing (274) relative to the handle housing (272). This placement is used to provide motorized actuation of the staple head unit 220 as will be described in greater detail below. The rotary boss (298) is deflected into the distal position by means of a flexible member (279) in the handle housing (272). Particularly, the flexible member (279) extends distantly from the rib (255) of the handle housing (272) to a first gear (278), the cycic to the distal end of the motor housing (274). When the rotary boss (298) is in the proximal position, the flexible member (279) is compressed between the first gear (278) and the rib (255) to flexibly deflect the handle housing (272) to the distal position.

An operating mode selection unit is positioned distal to the motor housing (274) within! handle housing (272). As shown in Figures HA through 13, the operating mode selection unit comprises a first gear (278) and a second gear (276), with the first gear (278) coaxially and slidably arranged around the second gear (276). The first gear (278) comprises square teeth (277) aligned around an Inner opening of the first gear (278), as shown in Figure 12. The teeth (277) define an arrangement of clcunferentially spaced grooves. The second gear (276) comprises a stem (273), splines (275) and annular projections (258), as shown in Figure 13. The stem (273) has a distally presented opening (259). The distally presented opening (259) is hexagonal to receive the proximal end (263) of the impeller actuator (264), which is also hexagonal (Figure 8). The stem (273) further has a proximally presented opening (not shown) that is semicircular to complement and receive the drive stem (287) that extends distally from the motor (280). Other suitable shapes and configurations of pins (263, 287) can be used to couple the second gear (276) with the pins (263, 287).

The splines (275) of the second gear (276) are placed at a proximal end of the stem (273) and extend distally. The splines (275) correspond to the teeth (277) of the first gear (278), such that the splines (275) are configured to fit within the indentations defined between the teeth (277). A pair of annular projections (258) are placed at a distal end of the stem (273) and extend outwardly to engage an inwardly extending annular rib (253) of the handle housing (272) and thus secure , the longitudinal position of the second gear (276) within the handle housing (272). While the annular rib (253) fixes the longitudinal position of the second gear (276) within the handle housing (272), the annular rib (253) nonetheless allows the second gear (276) to rotate relative to the handle housing (272). Other suitable coupling characteristics for longitudinally fixing the second gear (276) will become apparent to one skilled in the art from the teachings of the present invention.

The first gear (278) is placed around the second gear (276), as shown in Figures HA through 11B. The first gear (278) is fixedly coupled to a distal end of the motor housing (274) such that the first gear (278) moves and rotates unitarily with the motor housing (274). When the motor housing (274) is in a proximal position, as shown in Figures 1 IB and 17A, the motor (280) is also in a proximal position. In this position, the neriLo [¿/ j uei iiioloi (280) drive rod disengages from the second gear (276), and the teeth (277) of the first gear (278) engage the splines (275) of the second gear ( 276). Thus, when the rotating boss (298) rotates, the motor housing (274) and the first gear (278) also rotate. This placement thus provides manual actuation of the staple head unit 220, as will be described in detail below. With the teeth (277) of the first gear (278) coupled with the splines (275), the rotating boss (298) thus rotates the second gear (276) relative to the motor housing (274). When the motor housing (274) is in a distal position, as shown in Figures 11A and 15B, the motor (280) and the first gear (278) are, in addition, in a distal position. The motor (280) is coupled with the second gear (276) by means of rods (287, 273). The first gear (278) slides on the stem (273) of the second gear (276) to disengage the splines (275). Thus, the rotation of the drive rod (287) of the motor (280) thus rotates the second gear (276). This placement thus provides motorized actuation of the staple head unit 220, as will be described in detail below. In other words, when the boss (298) and the motor housing (274) are in a distal position as shown in Figures 11A and 15B, the motor (280) rotates the second gear (276). When the boss (298) and the motor housing (274) are in a proximal position as shown in Figures 11B and 17A, the boss (298) rotates the second gear (276).

Referring again to Figures 8 through 9, a distal end of the second gear (276) engages the impeller driver (264), such that rotation of the second gear (276) rotates the impeller driver (264). Impeller actuator (264) is similar to impeller actuator (64). Consequently, when the second gear (276) rotates, the impeller actuator (264) rotates to adjust the separation distance ¿/ between the anvil (240) and the staple head unit (220). The handle housing (272) further comprises a trigger ring (252) and a coupling member (268). The coupling member (268) is secured around the slit (261) of the impeller actuator (264), as shown in Figure 8. Consequently, the coupling member (268) translates with the impeller actuator (264), but the impeller actuator (264) is free to rotate within the coupling member (268). The coupling member (268) comprises outwardly extending projections connecting the coupling member (268) to the trigger ring (252). The projections of the coupling member (268) extend through the grooves (265, 266, 267) of the housing unit (272), as shown in Figure 14. The groove (265) extends circumferentially around part of the handle unit (272). The slot (266) extends proximally from the slot (265). The groove (267) extends transversely from the groove (266) and is substantially parallel with the groove (265). It wraps around the handle housing (272) and can rotate and translate relative to the handle housing (272) to manually drive the projections of the coupling member (268) through the grooves (265, 266, 267) .

When the trigger ring (252) is in a distal position, the projections of the coupling member (268) are placed within the slot (265) of the handle housing (272). When the coupling member (268) is placed into the slot (265), the coupling member (268) couples the Impeller actuator (264) with the features in the staple head unit (220) that can be used to adjust the separation distance ¿/ between the anvil (240) and the staple head unit (220). For example, if the coupling member (268) rotates clockwise within the slot (265), the separation distance ¿/ decreases to close the anvil (240) relative to the staple head unit (220). If the coupling member (268) rotates counterclockwise within the slot (265), the separation distance ¿/ increases to open the anvil (240) relative to the stapling head unit (220). A flexible member (269) is positioned proximal to the coupling member (268) to deflect the coupling member (268) distally (Figure 8). Thereafter, the coupling member (268) of the trigger ring (252) can be proximally translated through the slot (266) to the slot (267). When the trigger ring (252) is in the proximal position, the projections of the coupling member (268) are placed within the slot (267). When the coupling member (268) is placed into the slot (267), the coupling member (268) couples the Impeller actuator (264) with the features in the staple head unit (220) that drive the blade (36) and clamps (66) in response to rotation of the Impeller actuator (264). For example, if the coupling member (268) rotates clockwise within the slot (267), the staple head unit (220) drives the knife (36) and the staples (66). The configuration of the groove (367) prevents the coupling member (268) from rotating counterclockwise. Other suitable rotation configurations for the coupling member (268) will be apparent to one skilled in the art in view of the teachings of the present invention.

As shown in Figure 9, a Switch (248) is placed in the handle housing (272) to align with the coupling member (268). When the motorized operating mode is selected, the Switch (248) is configured to electrically couple the motor (280) and the battery (281) when the switch (248) is pressed, and the Switch (248) is configured to electrically disengage motor (280) and battery (281) when switch (248) is not pressed. The coupling member (268) is configured to engage and press the Switch (248) when the coupling member (268) rotates. For example, when the coupling member (268) is in a neutral position (eg, when the coupling members (268) are aligned with the respective slots (266)), the switch (248) is not depressed and the motor (280) (281). When the coupling member (268) rotates away from the neutral position, the coupling member (268) couples the switch (248) to press the switch (248) and couple the motor (280) with the battery (281) to operate the instrument (210). It will be understood that the housing (272) can include three switches (248). For example, a switch (248) can be placed for activation when the trigger ring (252) rotates clockwise while in the proximal position (eg. eg, with the coupling member (268) in the slot (267)); with another switch (248) positioned for activation when the trigger ring (252) rotates clockwise while in the distal position (eg, with the coupling member (268) in the slot (265)); with yet another switch (248) positioned for activation when the trigger ring (252) rotates counterclockwise while in the distal position. A control logic may be in communication with the switches (248) that are activated when the trigger ring (252) rotates while in the distal position. Such control logic can be used to selectively reverse the direction of rotation of the motor 280 and thus provide selective advance or retraction of the trocar 238 and anvil 240 to adjust the distance. spacing d, depending on the direction in which the trigger ring (252) is rotated.

It will be understood that the trigger ring (252) and the coupling member (268) act as a clutch control to change the impeller actuator (264) from an anvil clamping mode (when the coupling member (268) is in the distal position) to a cut / staple mode (when the coupling member (268) is in the proximal position). An example of a staple head unit (220) responsive to these changes in the position of the impeller actuator (264) is described in US Patent Application. USA no. [PROXY FILE NO. END7161USNP.0597922], entitled Motor Driven Rotary Input Circular Stapler with Modular End Effector, filed on the same date with the present invention, the disclosure of which is incorporated herein by reference. Other suitable shapes for the staple head unit 220 will be apparent to one skilled in the art in view of the teachings of the present invention. The outer tubular member (262) is coupled to the actuator handle unit (270). The outer tubular member (262) is similar to the outer tubular member (62) to provide a mechanical base between the staple head unit (220) and the handle unit (270).

one. Motorized operation

Figures 15A to 15C show Instrument (210) during motorized operation. Figure 15A shows the anvil (240) coupled to the trocar (238). The anvil (240) engages the trocar (238) in a manner similar to that described above with respect to the anvil (40) and trocar (38). When motorized operation is selected, the rotary boss (298) is in

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a distal position. In the distal position, the splines (296) of the corresponding protuberances (251) in the handle housing (272) to position the rotation of the rotary boss (298) relative to the handle housing (272). When the rotary boss 298 is in the distal position, the motor housing 274 is furthermore in a distal position. When the motor housing (274) is in the distal position, the spring contacts (283, 285) align with the annular contacts (284, 286) to couple the electrical contact (231) of the battery (281) with the electrical contact (233) of the motor (280). Power is supplied from the battery (281) to the motor (280) when the coupling member (268) is rotated to press the switch (248). The motor (280) is coupled with the second gear (276) by means of rods (287, 273) and the first gear (278) is decoupled from the splines (275) and thus allows the second gear ( 276) rotate relative to the first gear (278), the motor housing (274) and the handle housing (272). The projections of the coupling member (268) are positioned distally within the slot (265) of the handle housing (272) to lock the longitudinal position of the trigger ring (252) and the impeller actuator (264).

As shown in Figure 15B, the trigger ring (252) rotates clockwise to translate the coupling member (268) into the slot (267). When the coupling member (268) rotates, the switch (248) is depressed to couple the motor (280) and the battery (281) and supply power to the motor (280). Thus, the motor (280) is activated to rotate the stem (287). The stem (287) thus rotates the second gear (276). Since the second gear (276) is coupled to the impeller actuator (264), the rotation of the second gear (276) further rotates the impeller actuator (264). This rotation of the impeller driver (264) drives the features in the staple head unit (220) to adjust the gap distance / between the anvil (240) and the staple head unit (220). Once the anvil (240) is in a desired position relative to the stapling head unit (220), the trigger ring (252) rotates counterclockwise to a neutral position to release the switch (248), from such that the motor (280) is decoupled from the battery (281). The Instrument 210 can then be triggered, as shown in Figure 15C. The trigger ring (252) is translated to position the coupling member (268) out of the slot (265) to the proximal position in the slot (267). When the coupling member (268) is moved proximally to the groove (267), the coupling member (268) further transports the Impeller actuator (264) proximally to engage the impeller actuator (264) with the features in the staple head unit (220) operable to drive the blade (36) distally and drive the staples (66) into the anvil (240) to staple the attached tissue (2, 4) and create an anastomosis. Trigger ring (252) rotates clockwise within slot (267) to press Switch (248) and re-couple battery (281) with motor (280) to supply power to motor (280). The motor (280) rotates again with the coupling member (268) and the Impeller actuator (264) in the proximal position. This rotation is communicated to the impeller actuator ('drive (287) and the second gear (276) and, thus, is communicated to the actuator and the impeller (264) to cut and staple the tissue (2, 4). , the trigger ring (252) can be rotated counterclockwise within the slot (267) to the neutral position to release the Switch (248) and uncouple the motor (280) from the battery (281).

2. Selecting the operating mode

As shown in Figure 16, the instrument 210 is switched from the «

motorized operation to manual operation. A user can take the rotary protrusion (298) to move it from the distal position to the proximal position. In the proximal position, the splines (296) of the rotary protrusion (298) disengage from the corresponding teeth (251) in the handle housing (272) to allow the rotary protrusion (298) to rotate relative to the mango (272). This further allows the motor housing (274) and the first gear (278) to rotate relative to the handle housing (272). When the rotary boss (298) is in the proximal position, the motor housing (274) is also in a proximal position. When the motor housing (274) is in the proximal position, the spring contacts (283, 285) deviate from the annular contacts (284, 286) to decouple the battery (281) from the motor (280) such that no power is supplied to the motor (280). The first gear (278) is translated proximally to engage the splines (275) of the second gear (276). In this way, the rotation of the rotary boss (298) rotates the motor housing (274), the first gear (278), second gear (276) and the impeller actuator (264). Additionally, a user can push the rotary boss distally again to re-select motorized operation. By using the rotary knob (298) as an actuator to select between motorized and manual operation, the need for locks or switches to simultaneously disconnect power from the motor (289) is eliminated. The rotary protrusion 298 thus provides a rescue system for motorized operation, while allowing the instrument 210 to be fully operational in the manual mode of operation. Therefore, it will be understood that even when an operator initially uses the Instrument (210) in a motorized mode, the operator will be able to quickly and easily convert the instrument (210) to manual mode by simply pulling on the rotary protrusion (298). ) without sacrificing the essential functionality of the instrument (210),

3. Manual operation

Figures 17A to 17C show the instrument 210 during manual operation. Figure 17A shows the anvil (240) coupled to the trocar (238). The rotary boss (298) is in the proximal position, as described above. With

17B, ​​the rotary boss (298) is rotated to rotate the motor housing aei (¿/ t) relative to the handle housing (272). The motor housing (274) thus rotates the first gear (278). The first gear (278) engages with the splines (275) to rotate the second gear (276). Since the second gear (276) is coupled to the impeller actuator (264), the rotation of the second gear (276) further rotates the impeller actuator (264). This rotation of the impeller actuator (264) rotates the features on the staple head unit (220) to adjust the gap distance / between the anvil (240) and the staple head unit (220). When the anvil (240) is in a desired position relative to the staple head unit (220), the Instrument (210) can be triggered, as shown in Figure 17C. The trigger ring (252) is translated from the distal position and out of the slot (265) to the proximal position with the slot (267). When the coupling member (268) is moved proximally to the slot (267), the coupling member (268) further translates the impeller driver (264) proximally to engage the impeller driver (264) with the features in the stapling head unit (220) operable to drive the blade (36) distally and drive the staples (66) into the anvil (240) to staple the attached tissue (2, 4) and create an anastomosis. The rotating boss (298) is rotated again with the coupling member (268) and the impeller actuator (264) in the proximal position. This rotation is communicated to the impeller actuator (264) by means of the first gear (278) and the second gear (276) and, in this way, is communicated to the Impeller actuator (264) to cut and staple the tissue (2, 4).

Four. Control unit

Figure 18 shows an illustrative control unit (228) for use with instrument (210). The control unit (228) comprises a sensor (222), a control module (224) and a feedback feature (226). The feedback feature (226) can be used to give visual, auditory and / or haptic feedback (LED lights, LED display, speakers, vibration generator, etc.). Sensor (222) is coupled to instrument (210) and configured to detect movement within the drive train of Instrument (210). For example, sensor (222) may comprise an encoder positioned to detect rotation of drive actuator (264) or some other drive train rotation component (eg, a component that rotates but also does not is transferred). Sensor (222) couples with control module (224) to provide the detected signal to control module (224). The control module (224) is configured to process the detected signal and can determine the selected operating mode for the instrument (210), the separation distance d between the anvil (240) and the staple head unit (220) and / or the firing of the knife (36) and the staples (66). In the present example, the control module (224) is coupled with the instrument (210) and with the feedback feature (226).

The control (224) can be coupled with the instrument (210) or with the feedback characteristic. In addition, the control module (224) can be coupled with the Switch (248) to drive the motor (280) when the switch (248) is pressed. . Each of the sensor (222), control module (224), and feedback feature (226) can be positioned within the instrument (210) or remotely with respect to the instrument (210).

Depending on the detected signal, the control module (224) can be operated to drive the instrument (210) and / or the feedback feature (226). For example, the control module (224) can operate the feedback characteristic (226) to indicate the selected operating mode of the instrument (210). In some versions, the feedback feature (226) may have a first LED that corresponds to the motorized mode of operation and a second LED that corresponds to the manual mode of operation. Sensor (222) can detect the proximal and / or distal position of rotary boss (298) and / or motor housing (274) and provide the information to control module (224). Thereafter, the control module (224) can illuminate the first LED if the sensor (222) detects the proximal position to indicate that the motorized operating mode is selected. The control module (224) can illuminate the second LED if the sensor (222) detects the distal position to indicate that the manual operating mode is selected. Alternatively, the feedback feature (226) may have only one LED that is illuminated or not to indicate the operating mode, or the feedback feature (226) may have a speaker to provide a sound when the operating mode is changed.

In some versions, the control module (224) can operate the feedback feature (226) to indicate the selected mode of the staple unit (220). The feedback feature (226) can have a first LED that corresponds to the tissue holding mode and a second LED that corresponds to the firing mode. Sensor (222) can detect the proximal and / or distal position of trigger ring (252), coupling member (268) and / or impeller actuator (264) and provide the information to control module (224). Thereafter, the control module (224) can illuminate the first LED if the sensor (222) detects the distal position to indicate that the tissue clamp mode is selected. The control module (224) can illuminate the second LED if the sensor (222) detects the proximal position to indicate that the trigger mode is selected. Alternatively, the feedback feature (226) may have a single LED that is illuminated or not to indicate the mode of the staple head unit (220), or the feedback feature (226) may have a speaker to provide sound when the mode of the staple head unit (220) is changed.

Additionally or alternatively, the control module (224) can operate the feedback feature (226) to indicate the sep distance (240) and the stapling head unit (220). Sensor (222) can detect the number of rotations of impeller actuator (264). Then, the control module (224) will be able to determine the separation distance d based on the detected signal and activate the feedback characteristic (226). The feedback feature (226) may comprise a plurality of LEDs that are individually illuminated to indicate the separation distance d. When the separation distance ¿/ increases, the LEDs can Light up to correspond to the separation distance d. When the separation distance d decreases, the LEDs can be turned off to correspond to the separation distance d. To give another simply illustrative example, the feedback feature 226 may comprise an LED display that provides a real-time indication of the separation distance d. The feedback feature 226 may further have a loudspeaker that emits a sound that changes the pitch or volume to indicate the corresponding separation distance d. Alternatively, an LED can be used to indicate when a particular / separation distance is reached, or a sound can be provided when the particular / separation distance is reached.

In versions where the feedback feature (226) includes the ability to provide haptic feedback to the operator, it should be understood that various conventional components may be incorporated into the handle unit (270) to provide such haptic feedback. It will be understood that haptic feedback may further be provided through the motor (280). Just as an example, the feedback feature (226) can be configured to provide a sine wave signal to the motor (280) to essentially rotate the drive stem (287) slightly clockwise and then immediately rotate it slightly in the direction counterclockwise the exact same amount. The net result would be zero rotational displacement of the drive stem (287). When this sequence is repeated (p. (in rapid succession), movement of the drive stem (287) may cause the handle unit (270) to vibrate or be agitated in any other way for the operator to perceive through the hand holding the handle unit (270). With net zero movement of the drive stem (287) through this feedback algorithm, the haptic feedback cannot cause any activation in the head unit (220), regardless of whether the Driver actuator (264) is in the distal or proximal position. This haptic feedback can be provided to indicate the end of the staple stroke, to indicate a blocking condition and / or to indicate some other condition. Various other suitable ways in which auditory, visual and / or haptic feedback may be provided will become apparent to one skilled in the art in light of the teachings of the present invention.

In some versions, the control module (224) can ac &lt;

The sensor (222) can be configured to detect when the knife and staples (66) have tripped. Thus, the control module (224) can automatically reverse the motor (280) once the knife (36) and the staples (66) have been triggered. The control module (224) can also activate the feedback characteristic. (226) to indicate to a user that the instrument (210) has been triggered. Other suitable ways in which the sensors (222), the control module (224) and the feedback feature (226) can be used will be apparent to one skilled in the art in view of the teachings of the present invention. It will be further understood that these characteristics can simply be omitted if desired.

B. Illustrative Switching Unit

As previously described, the surgical stapling instrument (10, 210) has two subsystems, a closure subsystem (for holding tissue between the anvil (40, 240) and the stapling head unit (20, 220)) and a firing subsystem (to drive the blade (36) and staples (66) distally towards the anvil (40, 240)), in order to create an anastomosis. It may be desirable to electrically drive both subsystems with a single rotary motor to eliminate the cost and packaging of an additional motor and transmission. Figures 19 to 20 show an illustrative drive unit (371) configured to electrically drive two subsystems with a single rotary motor (380). While the instrument 210 provided for closing and tripping with a single rotary drive stem, the drive unit 371 in this example provides for closure and tripping through two separate rotary drive rods actuated by a single engine (380). The drive unit (371) comprises a motor (380), a transmission stem (392), a solenoid (390), a lock rod (364) and a trip rod (362). The motor (380) comprises a stem (368) that extends from the motor (380) and a gear (370) coupled to the stem (368). The transmission stem (392) comprises a gear (372) coupled with the gear (370) of the motor (380). A gear (377) is placed on the opposite end of the transmission stem (392).

A pivoting swing arm (391) is wrapped around the drive stem (392) such that the drive stem (392) can rotate freely relative to the swing arm (391), as shown in Figure 18 The swing arm (391) extends from the transmission stem (392) and comprises a gear (376). The gear (376) is fixedly secured to the swing arm (391). A pin (394) extends from the swing arm (391) and is coaxial with the gear (376). The pin (394) is pivotally supported with a bracket (393) such that the swing arm (391) can pivot around a pin (394) relative to the bracket (393) in response to rotation of the gear (376).

The solenoid (390) comprises a gear (374) coupled to a frame, furthermore engages a gear (375), which couples the gear (376) of the swing arm (391). Alternatively, the gear (374) of the solenoid (390) can be directly coupled to the gear (376) of the swing arm (391). The closing rod (364) comprises a gear (378). The trigger rod (362) is positioned adjacent to and substantially parallel to the closure rod (364). The trigger rod (362) comprises a gear (379). The transmission stem gear (377) (392) oscillates selectively to engage the lock rod gear (378) (364) or the trip rod gear (379) (362).

As shown in Figures 19-20, the transmission stem (392) is positioned to engage the locking rod (364). Consequently, when the motor (380) is activated, the stem (368) rotates the gear (370). In this way, the gear (370) rotates the gear (372) and the transmission stem (392) rotates the gear (377). Since gear (377) engages gear (378), drive rod (392) thus rotates lock rod (364). Locking rod (364) can be used to adjust the gap distance entre between anvil (40, 240) and staple head unit (20, 220). If a user wishes to switch to the trip subsystem, the solenoid (390) can be actuated. When solenoid (390) is actuated, solenoid (390) rotates gear (374) to move frame (371). Then, the frame (371) rotates the gear (375) and the gear (376) of the swing arm (391). The gear (376) thus pivots the oscillating arm (391). When the oscillating arm (391) pivots, the oscillating arm (391) moves the transmission rod (392) in such a way that the transmission rod (392) disengages the closing rod (364) and engages the trigger rod (362 ). Consequently, when the motor (380) is activated, the stem (368) rotates the gear (370). In this way, the gear (370) rotates the gear (372) and the transmission stem (392) rotates the gear (377). Since gear (377) now engages gear (379), drive rod (392) thus rotates trigger rod (362). Trigger rod (364) can be used to drive blade (36) and staples (66) distally to anvil (40, 240). Thereafter, the solenoid (390) can be actuated again such that the switching unit (371) switches to the closing subsystem by means of the swing arm (391).

The solenoid (390) can be activated with a button or manually activated in any other way. Alternatively, the switch unit 371 may incorporate logic such that solenoid 390 is automatically activated. For example, a user can drive the drive unit (371) by inputting a user input (310) into a control module (312), as shown in Figure 19. The control module (312) is coupled to the motor (380) and the solenoid (390) to selectively drive the motor (380) and / or the solenoid (390) based on user input (310). The control module (312) can be integral with the instrument (10, 210), or the control module (312) can be a separate unit. Suitable configurations of the control module (312) one skilled in the art in view of the teachings of the present invention,

III. Various

It should be understood that any or other of the teachings, expressions, modalities, examples, etc. which are described in the present description can be combined with any or other teachings, expressions, modalities, examples, etc. which are described in the present description. The teachings, expressions, modalities, examples, etc. described above should not be separated from each other. Various suitable ways in which the teachings of the present invention can be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. Such modifications and variations are intended to be included within the scope of the claims.

At least some of the teachings of the present invention can easily be combined with one or more teachings of US Pat. USA no. 7,794,475, entitled Surgical Staples Having Compressible or Crushable Members for Securlng Tlssue Thereln and Stapling Instruments for Deploylng the Same, issued September 14, 2010, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. 13 / 693,430, entitled Trans-Oral Circular Anvil Introduction System with Dilation Feature, filed on December 4, 2012, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. 13 / 688,951, entitled Surgical Staple with Integral Pledget for Tip Deflection, filed on November 29, 2012, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. 13 / 706,827, entitled Surgical Stapler with Varying Staple Widths Along Different Clrcumferences, filed on December 6, 2012, the disclosure of which is incorporated herein by reference. Various suitable ways in which &lt;

teachings will be evident to those experienced in the field.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. 13 / 688,992, entitled Plvoting Anvil for Surgical Circular Stapler, filed on November 29, 2012, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. 13 / 693,455, entitled Circular Anvil Introduction System with Alignment Feature, filed on December 4, 2012, the description of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. [PROXY FILE NO. END7159USNP.0597920], entitled Circular Stapler with Selectable Motorized and Manual Control, filed on the same date with the present invention, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. [PROXY FILE NO. END7161USNP.0597922], entitled Motor Driven Rotary Input Circular Stapler with Modular End Effector, filed on the same date with the present invention, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

Similarly, at least some of the teachings of the present invention can be easily combined with one or more teachings of the US patent application. USA no. [PROXY FILE NO. END7163USNP.0597933], entitled Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft, filed on the same date with the present Invention, the disclosure of which is incorporated herein by reference. Various suitable ways in which the teachings can be combined will be apparent to those skilled in the art.

It will be appreciated that any patent, publication or other described material, in whole or in part, which is incorporated by reference in the present disclosure ¹ description only insofar as the incorporated material is not in accordance with the aermitions, statements or other described material set forth in this description. As such, and to the extent necessary, the disclosure as explicitly set forth in the present invention supersedes any conflicting material incorporated by reference herein. Any material, or portion thereof, that is incorporated by reference in this description, but is in conflict with the definitions, statements, or other described incorporated material set forth in this description, will only be incorporated to the extent that no conflict arises between that stuff! incorporated and the existing described material.

The versions of the devices described above may have application in conventional treatments and medical procedures performed by a medical professional, as well as in the application of medical treatments and procedures that are assisted by robotics. By way of example only, various teachings of the present invention can be easily Incorporated into a robotic surgical system, such as the DAVINCI ™ system from Intuitive Surgical, Inc. of Sunnyvale, California. Likewise, those skilled in the art will recognize that various teachings of the present invention can be easily combined with various teachings of the US patent. USA no. 6,783,524, entitled Robotic Surgical Tool with Ultrasound Cauterizlng and Cutting Instrument, published August 31, 2004, the disclosure of which is incorporated herein by reference.

The devices described in the present description can be designed to be discarded after a single use, or they can be designed to be used multiple times. Versions may, in one or both cases, be reconditioned for use, again, after at least one use. Repair may include any combination of device disassembly stages, followed by cleaning or replacement of particular parts, and subsequent assembly . Particularly, some versions of the device can be disassembled, and any number of particular parts or pieces of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing particular parts, some versions of the device can be reassembled for later use, either in a reconditioning facility, or by a user, immediately prior to a procedure. Those of skill in the art will appreciate that a variety of techniques for disassembling, cleaning / replacing, and reassembling can be used to recondition a device. Both the use of such techniques and the cloning device are within the scope of the present application.

As an example only, the versions described in the present description can be sterilized before and / or after a procedure. In a sterilization technique, the device is placed in a closed, sealed container, such as a bag pl;

and the device 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 in the device and in the container. The sterilized device can then be stored in the sterile container for later use. A device can also be sterilized by using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

By showing and describing various modalities of the present invention, other adaptations of the methods and systems described herein may be carried out by appropriate modifications by a person experienced in the field without departing from the scope of the present invention. Several of these potential modifications are mentioned, and others will be apparent to those skilled in the art. For example, examples, modalities, geometries, materials, dimensions, proportions, measures, etc. Described above are illustrative and not required. Accordingly, the scope of this

Invention should be considered in terms of the following claims and it is understood that it is not limited to the details of the structure and operation shown and described in the description and figures,