Clam shell surgical stapling loading unit

A clamshell stapling end effector includes first and second jaws and defines an end effector axis. The first jaw has proximal, central, and distal portions. The central portion includes a first tissue contacting surface and defines a cavity. The second jaw includes a second tissue contacting surface and is rotatably secured to the first jaw about a rotation axis. The rotation axis is parallel to the end effector axis. The second jaw has a folded position such that the second jaw is positioned within the cavity of the first jaw with the first and second tissue contacting surfaces parallel to one another and facing in the same direction and a clamped position such that the first and second tissue contacting surfaces oppose one another.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments and, more specifically, to instruments for closing the open end of a hollow organ.

2. Discussion of Related Art

During hysterectomy procedures, such as total laparoscopic hysterectomy (TLH) procedures, the uterus and cervix are removed, creating an approximately circular structure at end of the vaginal canal called the vaginal cuff. The closure of the remaining vaginal cuff can be one of the most challenging aspects of the procedure. It is also considered to be one of the barriers to adoption of laparoscopic surgery to those trained in open procedures.

After the uterus is removed it is necessary to close the vaginal cuff while avoiding dehiscence, which is when a wound ruptures along a surgical suture. Currently the vaginal cuff closure is done manually by suturing the cuff with needle and suture or with a stitching surgical instrument. Both methods require a good deal of surgical skill and time.

There is a need for an instrument that can close a vaginal cuff that requires less skill, saves time, and provides strong, consistent anastomosis.

SUMMARY

In an aspect of the present disclosure, an end effector includes first and second jaws. The first jaw has proximal, central, and distal portions and defines an end effector axis. The central portion has a first tissue contacting surface and defines a cavity. The second jaw has a second tissue contacting surface and is rotatably secured to the first jaw about a rotation axis which is parallel to the end effector axis. The second jaw has a folded position such that the second jaw is positioned within the cavity of the first jaw with the second tissue contacting surface of the second jaw facing in the same direction as the first tissue contacting surface of the first jaw. The second jaw is rotatable to a clamped position such that the second jaw is rotated about the rotation axis with the second tissue contacting surface of the second jaw in opposition to the first tissue contacting surface of the first jaw.

In aspects, the first jaw includes a fastener cartridge that has a plurality of fasteners. The first jaw may include a sled that is translatable through the fastener cartridge to eject the plurality of fasteners from the first jaw towards the second jaw when the second jaw is in the clamped position.

In some aspects, the second jaw includes a proximal flange, a distal flange, and a central portion that connects the proximal and distal flanges. The proximal and distal portions of the first jaw may each define a folded stop recess adjacent the cavity. Each of the proximal and distal flanges of the second jaw may include a stop pin that extends away from the central portion of the second jaw. The stop pins may be received within the folded stop recesses when the second jaw is in the folded position.

In another aspect of the present disclosure, a loading unit includes a housing, an end effector, a clamping mechanism, and a firing mechanism. The housing defines a longitudinal axis and includes a connector positioned at a proximal end of the housing. The connector is configured to couple the loading unit to a surgical instrument. The end effector is supported at a distal end of the housing and includes first and second jaws. The first jaw has proximal, central, and distal portions and defines and end effector axis. The central portion has a first tissue contacting surface and defines a cavity. The central portion includes a plurality of fasteners. The second jaw has a second tissue contacting surface and is rotatably secured to the first jaw about a rotation axis which is parallel to the end effector axis. The second jaw has a folded position such that the second jaw is positioned within the cavity of the first jaw with the second tissue contacting surface of the second jaw facing the same direction as the first tissue contacting surface of the first jaw. The second jaw is rotatable to a clamped position such that the second jaw is rotated about the rotation axis with the second tissue contacting surface of the second jaw in opposition to the first tissue contacting surface of the first jaw. The clamping mechanism is disposed within the housing and is operatively associated with the second jaw to rotate the second jaw between the folded and clamped positions. The clamping mechanism includes a clamping rod, a clamping shaft, and a pivot arm positioned between the clamping rod and the clamping shaft to longitudinally translate the clamping rod in response to longitudinal translation of the clamping shaft. The firing mechanism is disposed within the housing and is operatively associated with the first jaw to eject the plurality of fasteners from the first jaw towards the second jaw when the second jaw is in the clamped position. The firing mechanism includes a fire rod that is longitudinally translatable within the housing.

In aspects, the distal end of the clamping shaft includes a clamping hook and the pivot arm includes a first end that is rotatably coupled to the housing and a second end that is coupled to a proximal end of the clamping rod. The pivot arm may include a cam follower positioned between its first and second ends. The clamping hook may engage the cam follower of the pivot arm to rotate the pivot arm between folded and clamped positions. Rotation of the pivot arm between the folded and clamped positions effects translation of the clamping rod.

In some aspects, the clamping rod is coupled to a clamping cable which is also coupled to the second jaw. The clamping cable rotates the second jaw between the folded and clamped positions. Distal translation of the clamping rod may tension the clamping cable to rotate the second jaw towards the clamped position and proximal translation of the clamping rod may tension the clamping cable to rotate the second jaw towards the folded position.

In certain aspects, the clamping mechanism includes a cable tensioner. A first portion of the clamping cable may pass form the clamping rod, through the cable tensioner, and into the end effector. The cable tensioner may be biased proximally to apply tension to the first portion of the clamping cable.

In particular aspects, the end effector includes idler, proximal, and distal pulleys rotatably attached to a lower surface of the end effector. The idler pulley may be positioned adjacent a proximal end of the end effector. The distal pulley may be positioned adjacent a distal end of the end effector. The proximal pulley is positioned between the idler and distal pulleys. Each of the proximal and distal portions of the first jaw of the end effector defines a groove adjacent a central portion. A second portion of the clamping cable may pass around the idler pulley, the proximal pulley, the distal pulley, and into the groove defined in the distal portion of the first jaw. The second portion of the clamping cable is coupled to the second jaw.

In aspects, a distal end of the fire rod is coupled to a firing cable which is coupled to a sled disposed within the first jaw. The sled may be slidable through the first jaw to eject the plurality of fasteners from the first jaw. The sled may be proximally slidable parallel to the end effector axis to eject the plurality of fasteners from the first jaw. Distal translation of the fire rod may slide the sled proximally.

In some aspects, the loading unit includes an articulation mechanism. The articulation mechanism may include an articulation rod that is disposed within the housing and extends from an articulation flag positioned within the connector of the housing to a distal end that is coupled to the end effector. The articulation flag may be longitudinally translatable to articulate the end effector relative to the housing. The end effector may be articulable between straight and articulated configurations. In the straight configuration the end effector axis is articulated a first angle relative to the longitudinal axis of the housing. In the articulated configuration the end effector axis may be articulated a second angle relative to the longitudinal axis of the housing. The first angle may be different from the second angle. The second angle may be in the range of about −4° to about 100°.

In another aspect of the present disclosure, a method for closing a vaginal cuff includes inserting a loading unit through an opening in a straight configuration, articulating an end effector of the loading unit such that an end effector axis of the end effector is perpendicular to a vaginal cuff of a patient, rotating a second jaw of the end effector for a folded position to a clamped position, and ejecting a plurality of fasteners from a first jaw of the end effector towards the second jaw to close the vaginal cuff. In the straight configuration of the loading unit, the end effector axis of the end effector is aligned with a longitudinal axis defined by a housing of the loading unit. The end effector is supported on a distal end of the housing. During insertion of the loading unit, the second jaw is in a folded position relative to the first jaw. When the second jaw is rotated to the clamped position, the vaginal cuff is positioned between tissue contacting surfaces of the first and second jaws.

Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel. Throughout this description, the term “proximal” refers to the portion of the device or component thereof that is closest to the clinician and the term “distal” refers to the portion of the device or component thereof that is farthest from the clinician.

This disclosure relates to a loading unit for a powered or manual surgical handle for including an end effector for joining tissue. The end effector has jaws that rotate to a closed position and can be in the form of a clam shell. The end effector includes a retainer jaw that is pivotally received in a recess defined by a fastener jaw. The retainer jaw is pivoted from the recess to a clamped position and then fasteners are ejected from the fastening cartridge towards the retainer cartridge to secure tissue captured between the fastener and retainer jaws. As detailed below, the loading unit may be used to during a total laparoscopic hysterectomy to close a vaginal cuff.

Referring now toFIG. 1, the loading unit10is provided in accordance with the present disclosure and includes an elongated body12extending from a connector23to an end effector30. As shown inFIG. 1and discussed in greater detail below, the loading unit10is in a shipping configuration with a shipping wedge40secured about a proximal tube14of the elongated body12. The connector23is configured to couple the loading unit10to a surgical instrument (not shown) including a drive rod which actuates the loading unit10to articulate the end effector30relative to the elongated body12, to clamp tissue within the end effector30, and to form fasteners through the clamped tissue.

The connector23of the loading unit10may be configured for selective connection to a powered hand held electromechanical instrument (not shown), may be configured for selective connection to an adapter for a powered or manual instrument, or may be configured for selective connection to a manually actuated handle assembly. For a detailed description of the structure and function of an exemplary manually actuated handle assembly, please refer to commonly owned U.S. Pat. No. 8,789,737. For a detailed description of the structure and function of an exemplary electromechanical instrument and adapter, please refer to commonly owned U.S. patent application Ser. No. 13/484,975, filed on May 31, 2012, now published as U.S. Patent Publication No. 2012/0253329. Each of these disclosures is incorporated herein by reference in its entirety.

Any of the embodiments disclosed herein can include microchips or other devices for identification purposes, for measuring certain parameters, etc. The entire disclosures of the following application are hereby incorporated by reference herein: U.S. provisional No. 62/017,626, filed Jun. 26, 2014, and U.S. application Ser. No. 14/172,109, filed Feb. 4, 2014.

With additional reference toFIG. 2, the elongated body12includes an inner housing20formed from a lower housing portion21and an upper housing portion22. The inner housing20includes the connector23, a proximal cylinder24, a distal cylinder26, and a distal extension27. The proximal cylinder24extends from the connector23and the distal cylinder26extends from the proximal cylinder24. The distal cylinder26has a diameter that is larger than a diameter of the proximal cylinder24. The distal extension27extends from the distal cylinder26and pivotally secures the end effector30to the inner housing20. The lower housing portion21and the upper housing portion22are secured together by a proximal tube14disposed over the proximal cylinder24and a distal tube16disposed over the distal cylinder26. The proximal tube14having a first diameter and the distal tube16having a second diameter greater than the first diameter. The first diameter may be in a range of about 5 mm to about 15 mm (e.g., 12 mm) and the second diameter may be in a range of about 12 mm to about 20 mm (e.g., 15 mm). The proximal tube14and the distal tube16may be joined by a housing ring15disposed over the proximal tube14and within the distal tube16. The housing ring15may seal a gap defined between the proximal and distal tubes14,16. As shown inFIG. 1, the connector23extends proximally from proximal tube14.

The housing20houses an articulation rod52, a clamping mechanism60, and a firing mechanism80that manipulate the end effector30as detailed below. The articulation rod52includes a proximal flag53and a body54extending from the proximal flag52to a distal end56. The distal end56of the articulation rod52passes through an articulation slot58defined in the end effector30and is pivotally coupled to the end effector30by an articulation pin59. The proximal flag53is longitudinally translatable in an articulation channel57defined in the connector23to articulate the end effector30relative to the elongated body12between a straight position (FIG. 38) and an articulated position (FIG. 39). In the straight position, the end effector30is substantially aligned with the elongated body12such that an angle defined between a longitudinal axis of the end effector30and a longitudinal axis of the elongated body12is in a range of about 175° to about 185° (e.g., 0° or 180°). In other words, the longitudinal axis of the end effector30may be articulated in a range of about 5° to about −5° (e.g., 0°) from the longitudinal axis of the elongated body12in the straight position. In a fully articulated position (not explicitly shown), the angle defined between the longitudinal axis of the end effector30and a longitudinal axis of the elongated body12is in a range of about 75° to about 105° (e.g., 90°). In other words, the longitudinal axis of the end effector30may be articulated in a range of about 75° to about 105° (e.g., 90°) from the longitudinal axis of the elongated body12in the fully articulated position. It will be appreciated that the end effector30may be articulated at any angle between the straight position and the fully articulated position. As detailed in greater detail below, the body54defines an articulation locking notch55that is engaged by the shipping wedge40to lock the end effector30in a shipping position (FIG. 1) between the straight position and the fully articulated position.

Referring toFIGS. 3-7, the end effector30includes a fastener jaw32and a retainer jaw34that is rotatably coupled to the fastener jaw32by pins36. With particular reference toFIGS. 5 and 6, the fastener jaw32includes a proximal portion32a, a central portion32b, and a distal portion32c. The central portion32bis disposed between the proximal and distal portions32a,32cand is configured to releasably couple a fastener cartridge130to the fastener jaw32. The fastener cartridge130includes a plurality of pushers132and a plurality of fasteners134. The central portion32bdefines a cavity33for rotatably receiving the retainer jaw34. The retainer jaw has a distal end and a proximal end that are each pivotally connected to the fastener jaw so that the retainer jaw is pivotable about a longitudinal axis of the end effector. The walls of the proximal and distal portions32a,32cdefine annular grooves79adjacent the central portion32band define folded stop recesses39in the annular grooves79adjacent the cavity33. In addition, the fastener cartridge130defines clamp stop recesses138(FIG. 6) adjacent the walls of the proximal and distal portions32a,32c. The fastener jaw32includes an end cap38having a sled retainer38athat releasably retains a sled94. The sled94is slidable through a sled channel136(FIG. 6) defined through the cartridge130to eject the plurality of fasteners134from the fastener cartridge130as detailed below. Further, as detailed below, idler pulleys76, proximal pulleys77, and distal pulleys78are rotatably coupled to a lower surface of the fastener jaw32.

With particular reference toFIG. 7, the retainer jaw34includes proximal and distal flanges34a,34c, at the proximal and distal ends, and a central portion34bextending between the proximal and distal flanges34a,34c. Each of the proximal and distal flanges34a,34cincludes a cable pin35extending away from the central portion34b. Each cable pin35includes a cable passage35athat couples to a clamping cable75(FIG. 20) as detailed below. The central portion34bis configured to releasably couple a retainer cartridge140to the retainer jaw34. The retainer cartridge140includes a body142that releasably retains a plurality of retainers144. Referring back toFIG. 4, the proximal and distal flanges34a,34care rotatably coupled to the fastener jaw32by pins36.

With reference toFIGS. 8A-10B, the end effector30has a folded position (FIGS. 8A and 8B), an open position (FIGS. 9A and 9B), and a clamped position (FIGS. 10A and 10B). In the folded position, the retainer jaw34is completely disposed within the cavity33defined in the central portion32bof the fastener jaw32such that the end effector30is substantially cylindrical and has a substantially uniform outer diameter from the proximal portion32aof the fastener jaw32to the distal portion32cof the fastener jaw32. When the end effector30is in the folded position, tissue contacting surfaces130a,140aof the fastener and retainer cartridges130,140, respectively, face in the same direction (e.g., up as shown inFIG. 8A). In the folded position, the cable pins35of the retainer jaw32are received within the folded stop recesses39defined in the annular grooves79.

In the open position of the end effector30, the fastener and retainer jaws32,34are open relative to one another (i.e., between the folded and clamped positions). In a shipping configuration of the loading unit10(FIG. 1), the end effector30is in a particular open position, as shown inFIGS. 9A and 9B, with the tissue contacting surface140aof the retainer cartridge140substantially perpendicular to the tissue contacting surface130aof the fastener cartridge130. As detailed below, the end effector30may be secured in the shipping configuration by the shipping wedge40(FIG. 1) such that the fastener cartridge130and the retainer cartridge140may be coupled to or decoupled from the fastener jaw32and the retainer jaw34, respectively.

In the clamped position of the end effector30, the tissue contacting surfaces130a,140aof the fastener and retainer cartridges130,140, respectively, oppose one another. In the clamped position, each fastener134of the fastener cartridge130is aligned with a respective retainer144of the retainer cartridge140such that when the fasteners134are ejected from the fastener cartridge130, the fasteners134form two-part fasteners with the retainers144through tissue between the tissue contacting surfaces130a,140aof the fastener and retainer jaws130,140, respectively. In the clamped position, the proximal and distal flanges34a,34cof the retainer jaw34are received within the clamp stop recesses138(FIG. 10A) of the fastener cartridge130to prevent over rotation of the retainer jaw34.

With reference toFIGS. 11-22, the clamping mechanism60converts translation of a clamping shaft62to rotation of the end effector30between the folded and clamped positions. With particular reference toFIG. 11, the clamping mechanism60includes a clamping shaft62, a pivot arm68, a clamping rod71, and a clamping pulley74disposed within the housing20(FIG. 1) of the elongated body12. The clamping mechanism60also includes idler pulleys76, proximal pulleys77, and distal pulleys78disposed on a lower surface of the fastener jaw32as shown inFIG. 12.

Referring briefly back toFIG. 2, the clamping shaft62includes a proximal portion64that defines a carriage notch65that receives a carriage18which is disposed within a carriage channel29defined in the connector23. The carriage18is configured to translate in response to a drive rod (not shown) of a surgical instrument coupled to the connector23.

Now with reference toFIGS. 13-17, the clamping shaft62includes a distal portion which defines a cam or clamping hook67. The clamping hook67slidingly engages the pivot arm68to pivot the pivot arm68between a folded position (FIG. 14) corresponding to the folded configuration of the end effector30(FIG. 8A), an open position (FIG. 15) corresponding to an open position of the end effector30(FIG. 9A), and a clamped position (FIG. 16) corresponding to the clamped position of the end effector30(FIG. 10A). The pivot arm68includes a first end68a, a second end68b, and a cam follower or engagement portion69. The pivot arm68is rotatable about a first end68athat is rotatably secured within the lower housing portion21of the inner housing20(FIG. 1). The first end68aof the pivot arm68may also be rotatably secured by the upper housing portion22(FIG. 2) of the inner housing20. The second end68bis rotatably coupled to a proximal end71aof the clamping rod71. The engagement portion69is engaged by the clamping hook67of the clamping shaft62to rotate the pivot arm68about its first end68a. As the pivot arm68pivots about its first end68a, the pivot arm68translates the clamping rod71. As the clamping shaft62is advanced as indicated by arrow “P”, the clamping hook67cams the engagement portion69of the pivot arm68to rotate the pivot arm68towards the clamped position (FIG. 16). As the clamping shaft62is retracted opposite arrow P, the clamping hook67cams the engagement portion69of the pivot arm68to rotate the pivot arm68towards the folded position (FIG. 14). The clamping hook67of the clamping shaft62may be advanced past the pivot arm68such that the pivot arm68remains in the clamped position (FIG. 16) until the clamping shaft62is retracted to reengage the engagement portion69of the pivot arm68with the clamping hook67. The clamping shaft62defines a clamping lock notch66(FIG. 2) that is engagable by the shipping wedge40(FIG. 1) to secure the clamping mechanism60in a shipping position, which is a particular open position corresponding to the shipping position of the end effector30and the shipping configuration of the loading unit10.

Referring now toFIGS. 18 and 19, the distal end71bof the clamping rod71is crimped or coupled to the clamping cable75. The distal end71bof the clamping rod71may include a pin that is crimped or coupled to the clamping cable75. The clamping cable75is a continuous cable passing from the inner housing20, through the end effector30, and back into the inner housing20. The clamping cable75extends proximally from the distal end71bof the clamping rod71and around the clamping pulleys74. The clamping pulleys74are mounted to a cable tensioner72that is attached to a biasing member73. The biasing member73(FIG. 11) is secured to the lower housing portion21to pretension the clamping cable75. From the cable pulleys74, the clamping cable75exits through the proximal end of the inner housing20and into the end effector30. The clamping cable75passes around the idler pulleys76and around the proximal pulleys77of the end effector30. The pretension applied by the cable tensioner72prevents the retainer jaw34from rotating as the end effector30is articulated relative to the housing20.

The clamping cable75extends from the proximal pulleys77and around the distal pulleys78. From the distal pulleys78, the clamping cable75passes through the fastener jaw32and into the annular groove79. The clamping cable75extends from the annular groove79and through the cable pin35coupled to the distal flange34cof the retainer jaw34. The clamping cable75is coupled or crimped within the cable passage35aof the cable pin35such that the clamping cable75is fixed relative to the cable pin35. From the cable pin35, the clamping cable35returns to the annular groove79and back around the distal pulleys78. From the distal pulleys78, the clamping cable35passes by the proximal pulleys77and around the idler pulleys76. From the idler pulleys76, the clamping cable75reenters the inner housing20and is coupled to the distal end71bof the clamping rod71.

Another portion of the clamping cable75extends proximally from the distal end71bof the clamping rod71and around the clamping pulley74. From the cable pulley74, the clamping cable75exits through the proximal end of the inner housing20and into the end effector30. The clamping cable75passes around the idler pulleys76and around the proximal pulleys77of the end effector30. The clamping cable75extends from the proximal pulleys77into the annular groove79defined in the proximal portion32aof the fastener jaw32. The clamping cable75extends from the annular groove79and through the cable pin35coupled the proximal flange34aof the retainer jaw34. The cable pin35is coupled or crimped to the clamping cable75such that the clamping cable is fixed relative to the cable pin35. From the cable pin35, the clamping cable35returns to the annular groove79and back around the proximal pulleys77. From the proximal pulleys77, the clamping cable35passes around the idler pulleys76and reenters the inner housing20and is coupled to the distal end71bof the clamping rod71.

Referring back toFIGS. 14-16and with reference toFIGS. 20-22, as pivot arm68is pivoted from the folded position towards the clamped position, the clamping cable75rotates the retainer jaw34from the folded position (FIG. 20), through an open position (FIG. 21), and to the clamped position (FIG. 22). Specifically, as the pivot arm68is pivoted to distally extend the clamping rod71, the distal end71bof the clamping rod71tensions the portion of the clamping cable75that passes around the cable tensioner72such that the clamping cable75pulls the cable pins35in a counter-clockwise direction when viewed from the distal end of the end effector30as indicated by the arrows A inFIGS. 20-22to rotate the retainer jaw towards the clamped position (FIG. 22). When the pivot arm68is pivoted towards the folded position, the distal end71bof the clamping rod71tensions the clamping cable75entering the inner housing portion20directly from the distal end71bof the clamping rod71to pull the cable pins35in a clockwise direction (i.e., opposite the direction indicated by arrows A inFIGS. 20-22) to rotate the retainer jaw34towards the folded position (FIG. 20).

Referring now toFIGS. 23-27, the firing mechanism80includes a fire rod82and a fire pulley91rotatably supported in the lower housing portion21(FIG. 13), a sled94slidingly disposed within the end effector30(FIG. 1), and a fire cable81extending from the fire rod82to the sled94. The fire rod82includes a proximal fire flag83aand a distal fire flag83bpositioned in a proximal portion of the fire rod82. The proximal and distal fire flags83a,83bdefine a fire gap84between the proximal and distal fire flags83a,83b. The carriage18is received within the fire gap84between the proximal and distal fire flags83,83b. The fire rod82includes a distal portion85having a cable retainer86and a distal finger87. The fire cable81passes through the cable retainer86, around the distal finger87, and is secured to the distal finger87by a cable retainer clip88secured or crimped over the distal finger87and the fire cable81.

The fire cable81extends proximally from the distal finger87of the fire rod82and over the fire pulley91that is rotatably supported within a fire pulley opening92(FIGS. 2 and 13) defined in the lower housing portion21. The fire cable81extends distally from the fire pulley91and around the idler pulley76of the end effector30. From the idler pulley76, the fire cable81extends through the end effector30and is attached to the sled94.

As the carriage18is advanced through the connector23(FIG. 2), the carriage18moves within the fire gap84of the fire rod82until a firing surface18a(FIG. 27) of the carriage18engages the distal fire flag83bof the fire rod82. The distance between the firing surface18aof the carriage18and the distal flag83b, indicated by dimension D, defines a clamping dwell or delay for advancing the firing rod82in response to advancement of the carriage18. The clamping dwell is at least equal to the distance required to advance the clamping shaft62to a position where the clamping hook67is past the pivot arm68as shown inFIG. 16, such that the pivot arm68is in the clamped position, as detailed above. In other words, the clamping dwell prevents the firing rod82from being advanced before the end effector30is in the clamped position. When the loading unit10is attached to a manually actuated handle, the clamping dwell is equal to a first pull of a trigger or moveable handle such that a subsequent pull of the trigger or moveable handle ejects fasteners134from the fastener cartridge130.

With the end effector30in the clamped position (FIG. 10A), the carriage18is advanced such that the firing surface18aengages the distal flag83bof the firing rod82to advance the fire rod82as indicated by the arrow B (FIG. 26). As the fire rod82is advanced, the fire rod82tensions the fire cable81, which is secured to the distal finger87of the fire rod82, about the fire pulley91to pull the fire cable81in the direction indicated by arrow C. As the fire cable81is tensioned about the fire pulley91, the fire cable81pulls the sled94proximally through the channel136of the fastener cartridge130to eject the fasteners134from the fastener cartridge130as detailed below.

With reference toFIGS. 28A-29B, in an initial position (FIGS. 28A and 28B), the sled94is retained in the distal portion32cof the fastener jaw32by a sled retainer38aof the cap38and each of the fasteners134is positioned within the fastener cartridge130. As the sled94is pulled proximally through the channel136as indicated by arrow F (FIG. 29A), an angled surface95of the sled94engages a camming surface133of the pushers132to move the pushers132towards the retainer jaw34. Each pusher132is engaged with one or more fasteners134to eject the fastener134from the fastener cartridge130towards the retainer cartridge140. As shown inFIGS. 30 and 31, each fastener130engages one or more of the retainers140to form a two-part fastener through tissue clamped between the fastener and retainer cartridges130,140.

In embodiments, the fasteners134may be unformed staples and the retainer jaw32may include an anvil (not shown). In such embodiments, the fasteners134are ejected from the fastener cartridge130such that the fasteners134interact with the anvil to form staples through tissue clamped between the fastener cartridge130and the anvil (i.e., deform legs of the unformed staples).

In some embodiments, the sled94is positioned in the proximal portion32aof the fastener jaw32and is pulled distally by the fire cable81as the fire cable81is tensioned. In such embodiments, the fire cable81passes around the distal pulley78after passing around the idler pulley76. It will be appreciated that in such embodiments the angled surface95of the sled94faces distally and the camming surface133of the pushers132face proximally.

In certain embodiments, the sled94includes a knife (not shown), that extends through a knife slot (not shown) to sever tissue between the fastener and retainer jaws32,34as the sled94is pulled through the end effector30. In particular embodiments, the knife (not shown) is separate from the sled94and is attached to the fire cable81independent of the sled94.

Referring back toFIG. 27, when a desired number of fasteners134are ejected from the fastener cartridge130, the carriage18is retracted such that the carriage18engages the proximal flag83aof the fire rod82to retract the fire rod82. As the fire rod82is retracted, the tension in the fire cable81is released such that the fire cable81is slack within the inner housing20. As the tension is released from the fire cable81, the sled94remains in position within the fastener cartridge130.

Referring now toFIGS. 32-35, the loading unit10is provided with a shipping wedge40to secure the end effector30in a shipping configuration. In the shipping configuration, the end effector30is articulated relative to the elongated body12and the retainer jaw34is in an open position with respect to the fastener jaw32. As shown inFIG. 1, in the shipping configuration, the end effector30is articulated about 45° with respect to the elongated body12; however, it is contemplated that in the shipping configuration the end effector30may be articulated in a range of about 15° to about 60° with respect to the elongated body12. Further, as shownFIGS. 9A and 9B, in the shipping configuration, the retainer jaw34is positioned such that when a retainer cartridge140is attached to the retainer jaw34, the tissue contacting surface140aof the retainer cartridge140is substantially perpendicular to the tissue contacting surface130aof the fastener cartridge130attached to the fastener jaw32. It is contemplated that in the shipping configuration, the retainer jaw34may be in any open position (i.e., between the folded position and the clamped position) that allows for the retainer cartridge140and the fastener cartridge130to be coupled and decoupled from the retainer jaw34and the fastener jaw32, respectively.

With particular reference toFIGS. 33-35, the articulation rod52defines the articulation locking notch55and the clamping shaft62defines the clamping locking notch66. In the shipping configuration, each of the locking notches55,66is engaged by a respective locking finger45,46of the shipping wedge40. Specifically, an articulation locking finger45of the shipping wedge engages the articulation locking notch55of the articulation rod52and a clamping locking finger46of the shipping wedge40engages the clamping locking notch46of the clamping shaft62. The engagement of the locking fingers45,46with the locking notches45,46fixes the articulation of the end effector30with respect to the elongated body12and the position of the retainer jaw34with respect to the fastener jaw32. By fixing the articulation of the end effector30and the position of the retainer jaw34, the fastener cartridge130and the retainer cartridge140can be coupled and decoupled from the fastener jaw32and the retainer jaw34, respectively, without moving the articulation assembly50, the clamping mechanism60, and the firing mechanism80. Further, fixing the articulation of the end effector30and the position of the retainer jaw34, the loading unit10may be attached and detached from a surgical instrument without unintentional movement of the end effector30or retainer jaw34. It is contemplated that the shipping wedge40may also include support fingers47to support the shipping wedge40on the proximal tube14of the elongated body12.

With reference toFIGS. 1, 36, and 37, the shipping wedge40is secured to the loading unit10by a locking ring42engaged with a hook41of the shipping wedge40. The locking ring42includes a locking shelf43and proximal fingers44. The locking ring42is rotatably positioned over the connector23of the inner housing20. In a locked position of the locking ring42(FIGS. 1 and 36), the locking shelf43of the locking ring42engages the hook41of the shipping wedge40to secure the shipping wedge40to the loading unit10. When the loading unit10is coupled to an adapter (not shown) or a surgical instrument (not shown), the connector23is secured to the adapter or surgical instrument by a bayonet type connection such that the adapter or surgical instrument engages the proximal fingers44of the locking ring42to rotate the locking ring42to an unlocked position (FIG. 37) such that the locking shelf43is rotated out of engagement with the hook41. With the locking ring42in the unlocked position, a release tab48of the shipping wedge40is engaged to remove the shipping wedge40from the loading unit10.

Referring now toFIGS. 38-41, the loading unit10is used during a Total Laparoscopic Hysterectomy (TLH) procedure to close the vaginal cuff VC. To begin the loading unit10is loaded by coupling a fastener cartridge130and a retainer cartridge140to the fastener jaw32and the retainer jaw34, respectively. The loading unit10may be supplied in a preloaded condition or may be supplied in a kit with one or more pairs of fastener and retainer cartridges with varying lengths and types of fasteners (e.g., 2 mm, 3 or 3.5 mm, 4 or 4.8 mm, or 5 mm two-part fasteners or deformable staples). With the fastener cartridge130and the retainer cartridge140coupled to the end effector30, the loading unit10is attached to a surgical instrument (not explicitly shown). When the loading unit10is attached to the surgical instrument, the locking ring42is rotated from a locked position to an unlocked position. With the locking ring42is in the unlocked position, the release tab48is engaged to remove the shipping wedge40from the loading unit10. It is contemplated that the loading unit10may be attached to the surgical instrument before the fastener and retainer cartridges130,140are coupled to the end effector30.

With the shipping wedge40removed from the loading unit10, the end effector30is articulated to a straight position relative to the elongated body12such that the end effector30is substantially aligned with the elongated body12. In addition, the retainer jaw32is rotated into the folded position such that the end effector30is substantially cylindrical along its length and has a substantially uniform outer diameter.

With particular reference toFIG. 38, with the end effector30in the straight position and the retainer jaw32in the folded position, the loading unit10is inserted through a surgical site S of a patient P to access a vaginal cuff VC. As shown, the loading unit10is inserted through a cannula CN positioned through an opening (e.g., a naturally occurring opening or an incision I) to access a surgical site within the body cavity of the patient P.

Referring now toFIGS. 39 and 40, the end effector30is positioned adjacent an open end of the vaginal cuff VC and is articulated such that the end effector30is substantially perpendicular to the vaginal cuff VC. The retainer jaw34is positioned closer to the open end of the vaginal cuff VC with respect to the fastener cartridge130with the vaginal cuff VC positioned between the proximal and distal flanges34a,34cof the retainer jaw34. The loading unit10is then manipulated to advance the carriage18to engage the clamping mechanism60to rotate the retainer jaw34from the folded position to the clamped position as shown inFIG. 41. As the retainer jaw34is rotated, the vaginal cuff VC is positioned between the fastener jaw32and the retainer jaw34. As the vaginal cuff VC is positioned between the jaws32,34, the vaginal cuff VC may be flattened between the tissue contacting surfaces130a,140aof the fastener and retainer cartridges130,140.

With the vaginal cuff VC positioned between the jaws32,34, a clinician verifies that the open end of the vaginal cuff VC is beyond the fastener jaw32. The loading unit10is then manipulated to further advance the carriage18to engage the firing mechanism80to pull the sled94through the fastener cartridge130to drive the fasteners134towards the retainers144to form two-part fasteners to close the vaginal cuff VC as detailed above. As detailed above, the fasteners134may also be deformable staples that are deformed to form staples to close the vaginal cuff VC. The fasteners134and the retainers144may be bioabsorbable such that the fasteners134and retainers144are absorbed as the anastomosis of the vaginal cuff VC is completed. It is contemplated that the fasteners134or the retainers144may be coated with a substance that aids in the anastomosis of the vaginal cuff VC.

Referring toFIG. 42, after the fasteners134are ejected through the vaginal cuff VC, the retainer jaw34is rotated back to the folded position. As the retainer jaw34is returns to the folded position, the vaginal cuff VC is released from between the fastener jaw32and the retainer jaw34. The end effector30is then articulated to the straight position such that the end effector30is aligned with the elongated body12. With the end effector30in the straight position and the retainer jaw34in the folded position, the loading unit10is withdrawn from the surgical site S.

After the loading unit10is withdrawn from the surgical site S, the loading unit10may be detached from the surgical instrument. With the loading unit10separated from surgical instrument, the loading unit10may be sterilized for reuse in another surgical procedure.

Alternatively, the loading unit10may be reloaded by positioning loading unit10in the shipping configuration (i.e., articulating the end effector30to the shipping position and rotating the retainer jaw34to the shipping position). With the loading unit10in the shipping configuration the shipping wedge40may be coupled about the proximal tube14to fix the loading unit10in the shipping configuration. With the loading unit10in the shipping configuration, the fastener cartridge130and the retainer cartridge140may be decoupled from the fastener jaw32and the retainer jaw34, respectively. Then, a new fastener cartridge and retainer cartridge may be coupled to the fastener jaw32and retainer jaw34, respectively, such that the loading unit10may be reused during the same surgical procedure.

While the loading unit10is detailed above for performing a TLH, it is contemplated that the loading unit10may be used for closing a variety of tubular structures including, but not limited to, veins, arteries, and bowels.

In any of the embodiments disclosed herein an end effector can have a first jaw and a second jaw having a distal end and a proximal end, the distal end and the proximal end each being pivotally connected to the first jaw, the second jaw being pivotable about a longitudinal axis of the end effector. The first jaw can hold a plurality of fasteners, and the second jaw can have a plurality of retainers. In other embodiments, the end effector has a staple cartridge jaw and an anvil with staple forming recesses on the other jaw.

The end effector has a folded position, an open position, and a clamped position. In the folded position, the tissue contacting surfaces face in the same direction and the end effector has a circular envelope/profile. The end effector jaw can rotate or slide between its various positions.

The end effector can have a tetainer jaw with a cable pin with a hole for allowing the passage of a clamping cable. The end effector can have a cable for moving the position of the jaws, for firing, and/or for articulation. In certain embodiments, other means of actuating functions are used, such as threaded rotatable members, pushing rods, electronics, etc.

A method of clamping the jaws of a surgical fastening instrument, can include retracting a clamping shaft, a clamping hook of the clamping shaft camming an engagement portion of a pivot arm to rotate the pivot arm toward a folded position, the folded position of the pivot arm corresponding to a folded position of an end effector of the instrument. In certain embodiments, advancing the clamping hook past the pivot arm so that the claming hook disengages the pivot arm and keeps the end effector in the clamped position.

In certain embodiments, a combination of cables and push rods are used. A clamping cable can be connected to the clamping rod, for moving the jaws of the instrument. The clamping cable extends around pulleys and the pulleys have a tensioning device to pre-tension the clamping cable. The clamping cable has an end that extends through one jaw of the instrument, and an end that extends through the other jaw. A cam mechanism may be used to disconnect the clamping cable and push rod.

One end of the cable extends around one or more pulleys and is fixed to a cable pin of the second jaw or retainer jaw. The other end of the cable extends through fastener jaw and is fixed to the other cable pin of the second jaw or retainer jaw.

An end effector can have a firing rod defining a clamping delay. The clamping hook is disengaged from the clamping rod, maintaining the jaws in the clamped position, before the firing begins. In certain embodiments, a firing cable extends from a firing rod to a sled. A carriage moves within a fire gap in the fire rod to define a clamping delay before firing. After the clamping delay, the carriage engages the firing rod, which tensions the cable and pulls a sled proximally. A clamping mechanism with a delay may be used in any of the embodiments disclosed herein. The delay may be effected by a clamping shaft that engages and disengages a camming member (such as the pivot arm) so that further movement of the clamping shaft does not move the clamping rod and clamping cable while the end effector remains in the clamped position

The device has two or three rows of fasteners and may have no knife. The device can deploy absorbable fasteners having one or two parts, surgical staples, clips or other fasteners. The sled can be parked in a distal portion of the end effector and moved proximally, or the sled can move distally starting from the proximal end. The pushers are desirably double or triple pushers; that is, the pushers desirably support two or three fasteners that are driven at the same time.

A shipping wedge can be included in any of the embodiments disclosed herein. The shipping wedge can prevent the movement of the articulation rod, and/or protect the sled from moving or may have other functions.

In certain embodiments, the end effector is part of a loading unit that is attachable to an adapter or handle, whether manual or powered. The articulation rod has flag or other engagement feature at a proximal end thereof. In certain embodiments, the flag must be in an intermediate position in order to attach the loading unit to the adapter, handle, or other actuator. A shipping wedge or shipping appliance is attached to the loading unit and has a member that engages the articulation rod, to maintain the intermediate position of the articulation rod. The shipping appliance may also maintain the position of the clamping shaft and/or firing rod.

Any of the embodiments disclosed herein can be used to close the vaginal cuff after a hysterectomy, or used to close some other hollow organ.