Surgical stapling device

1. Technical field The present disclosure relates generally to surgical staples, especially to surgical staples having a single trigger for approaching anvils and cartridge assemblies and for ejecting staple rows from the cartridge assemblies. ..

2. Background of related technology Surgical staple clasps used in the art to apply parallel staple rows through compressed tissue are well known, for example to close tissue before excision, before amputation, or at dissection. , As well as commonly used to occlude tissue in chest and abdominal surgery.

Typically, such surgical staple fasteners are anvil assemblies, cartridge assemblies for supporting arrays of surgical staples, access mechanisms for bringing anvils and cartridge assemblies closer together, cartridges and anvil assemblies. Alignment pin assembly to capture tissue between and to maintain alignment between the cartridge and anvil assembly during approach and launch, and to eject surgical staples from the cartridge assembly. Includes launch mechanism. The approach and launch mechanisms generally include different actuators for approaching and firing the staples. The alignment pin assembly can be manually manipulated to advance the alignment pin from the cartridge assembly and engage the anvil, or the pin assembly can be driven automatically when the approach mechanism operates. For instruments with a manually operated alignment pin assembly, the actuator for the alignment pin assembly is located away from the handle of the instrument.

U.S. Pat. No. 4,930,503 granted to Pruitt discloses such surgical staple fasteners. Pruitt's instruments include a manually operated alignment pin assembly, an approach mechanism including a rotatable knob actuator, and a launch mechanism including a swivel trigger. In use, the surgeon must first bring the anvil and cartridge members closer together by rotating the knob actuator. The surgeon can then advance the alignment pin assembly by advancing the knob supported by the central body portion of the instrument. The device can then be fired by turning the trigger towards the stationary handle of the device.

U.S. Pat. No. 5,697,543 granted to Burdorff also discloses a surgical staple fastening device with an approach mechanism, a launch mechanism and an alignment pin mechanism. The approach and launch mechanisms each include a different swivel trigger actuator. The alignment pin mechanism is operationally related to the approach mechanism so that when the approach mechanism is driven, the alignment pin assembly automatically advances.

<p> Known prior art staple surgical devices have some drawbacks. First, the use of multiple actuators to approach and launch the instrument complicates the manufacture and operation of the instrument, and in most cases the surgeon uses both hands to hold and operate the instrument. Need to do. Second, although surgeons prefer to advance the alignment pin assembly before approaching, for instruments in which the alignment pin assembly is operationally related to the approach mechanism, the alignment pin assembly is advanced. Therefore, it is necessary to bring the device close to each other. In contrast, instruments in which the alignment pin assembly is manually advanced typically require the surgeon to use a second hand to drive the alignment pin assembly. Therefore, there is an ongoing need for surgical staple fasteners that include an alignment pin assembly that can be operated by the surgeon with one hand and can be advanced automatically or manually.</p>

<p> According to the present disclosure, a surgical staple fastening device including a frame having a proximal end and a distal end is provided. A body defining a stationary handle is fixed to the proximal end of the frame. Anvil and cartridge assemblies are supported at the distal ends of the frame. The anvil assembly and the cartridge assembly are movable between the separated and close positions. The approach mechanism includes a clamp sliding assembly with distal and proximal ends configured to support the cartridge assembly. The firing mechanism includes a thrust bar with a distal end that is slidably housed within the cartridge assembly. A swivel trigger is supported by the body and is operatively coupled to the approach mechanism and the launch mechanism so that the trigger swivels through an approach stroke to bring the anvil assembly and the cartridge assembly closer together. It is possible and then swivel through the firing stroke to eject an array of staples from the cartridge assembly.</p><p> The surgical staple fastening device disclosed here also has an alignment pin assembly that includes an alignment pin, a pin extruder and a bell-shaped crank. The alignment pin extruder is slidably supported by the frame between the forward and backward positions. The alignment pin extruder includes a distal contact member for engaging and advancing the alignment pin from a retracted position located within the cartridge assembly to a forward position that engages the anvil assembly. There is. The bell-shaped crank is operably coupled to the clamp sliding assembly and is removably coupled to the pin extruder. When the clamp sliding assembly is advanced, the bell-shaped crank is swiveled to simultaneously advance the alignment pin extruder. The alignment pin extruder includes a pair of posts extending through a slot in the body. A thumb button is supported on each post. Prior to approaching the device, the thumb button can be pressed to manually advance the alignment pin assembly and engage it with the anvil assembly.</p><p> A claw mechanism is supported by the body, which includes a clamp claw and a firing claw. The clamp claw functions to prevent the approach mechanism from returning after the trigger has already moved approximately 3/4 of the approach stroke. The clamp claws also provide an audible and tactile indicator that the device has moved to approximately 3/4 of the approach position. The launch claws provide an indicator that the device is in a launch ready position. The firing claw also functions to lock the trigger to the compressed position after the device has been fired, providing a visual indicator of what has happened. A release button is provided to return the approach mechanism to the retracted position at any operating point of the device. The swivel trigger, release button and thumb button are all located adjacent to the handle of the device and are operated by the surgeon with one hand.</p><p> The anvil assembly of the surgical staple fastening device is provided with a stiffener plate to give the assembly increased strength. By using this reinforcing material plate, the size of the profile of the head portion can be reduced. The present invention provides:<u style="single">(1) In surgical staple fastening device:</u><u style="single">With a frame with first and second ends;</u><u style="single">The body part that defines the stationary handle, and the body part that is fixed to the first end of the frame;</u><u style="single">With a trigger that is rotatably fixed to the body;</u><u style="single">A head portion that includes an anvil assembly and a cartridge assembly, wherein the anvil assembly is fixed to a second end of the frame, and the cartridge assembly and the anvil assembly are distant and close to each other. It is equipped with a head portion that can move with respect to each other.</u><u style="single">The above-mentioned anvil assembly includes an anvil having a plurality of staple molding pockets and one reinforcing material plate, the anvil is configured to be fixed around the reinforcing material plate, and the reinforcing material plate is said to be said. A surgical staple fastening device that provides additional strength to the anvil assembly and allows the size of the head portion to be reduced.</u><u style="single">(2) In the surgical staple fastening device according to item 1, a device in which the reinforcing material plate and the anvil are made of stainless steel.</u><u style="single">(3) In the surgical staple fastening device according to item 1, the frame includes left and right frame members, and the anvil assembly is fixed between the second ends of the left and right frame members.</u><u style="single">(4) In the surgical staple fastening device according to item 4, the anvil assembly further includes a spacer plate, and the spacer plate is configured to be arranged around the reinforcing material plate.</u><u style="single">(5) In surgical staple fastening device:</u><u style="single">With the body with a stationary handle part;</u><u style="single">With a trigger fixed to the body so that it can be swiveled;</u><u style="single">A head portion that includes an anvil assembly and a cartridge assembly, wherein the anvil assembly and the cartridge assembly are movable relative to each other between a separated position and an approached position;</u><u style="single">An approach mechanism operably coupled to the head portion that allows the anvil assembly and the cartridge assembly to be movably driven relative to each other between the separated and close positions. With mechanism;</u><u style="single">An alignment pin assembly that includes an alignment pin with a tip that can be driven to advance the alignment pin from a retracted position to a forward position where the tip of the alignment pin engages the anvil assembly. Being equipped with Lee</u><u style="single">The alignment pin assembly can be released to the approach mechanism so that the alignment pin assembly can be manually driven independently of the approach mechanism or automatically driven in response to the drive of the approach mechanism. Surgical staple fastening device combined with.</u><u style="single">(6) In the surgical staple fastening device of item 5, the alignment pin assembly includes an alignment pin extruder and a bell-shaped crank, the bell-shaped crank being detachably coupled to the alignment pin extruder. A device operably coupled to the approach mechanism.</u><u style="single">(7) In the surgical staple fastening device according to item 6, the bell-shaped crank is rotatably mounted in the main body and housed in a C-shaped clip formed in the alignment pin extruder. A device that includes a post as measured, the post being removable from the C-clip to facilitate manual drive of the alignment pin assembly.</u><u style="single">(8) In the surgical staple fastening device of item 7, the approach mechanism is operably coupled to a first end configured to support the cartridge assembly and the swivel trigger. Including at least one clamp sliding member having two ends, the drive of the trigger moves the at least one clamp sliding member to bring the cartridge assembly and the anvil assembly into the separated position and the approach. A device that moves to and from a stapled position.</u><u style="single">(9) In the surgical staple fastening device according to item 8, the at least one clamp sliding member includes a cam slot, and the bell-shaped crank is at least one measured so as to be accommodated in the cam slot. A device comprising one cam member, wherein the cam slot is configured to swivel the bell-shaped crank as the at least one clamp sliding member moves.</u><u style="single">(10) In the surgical staple fastening device of item 9, the alignment pin extruder comprises at least one post measured to extend through a slot formed in the body, wherein the alignment pin. A device that is slidable within the slot to manually drive the assembly.</u><u style="single">(11) In the surgical staple fastening device of item 10, said at least one post includes first and second posts, the first post extending through a slot formed on one side of the body. The second post is a device that extends through a slot formed on the opposite side of the main body.</u><u style="single">(12) The surgical staple fastening device according to item 11, further comprising a thumb button fixed to each of the first and second posts.</u><u style="single">(13) In the surgical staple fastening device according to item 5, the approach mechanism includes a clamp sliding assembly and a bilink assembly, the bilink assembly includes an anterior link and a posterior link, the posterior link. The clamp sliding assembly was configured to support the cartridge assembly, having one end rotatably fixed to the body and a rotatably fixed front end to the rear end of the anterior link. The bilink assembly has a rotatably fixed proximal end at the distal end and the anterior end of the anterior link, from a position where the longitudinal axes of the anterior and posterior links are not aligned, the anterior link. A device capable of moving the clamp sliding assembly from a retracted position to a forward position by moving the longitudinal axes of the rear link to a substantially aligned position.</u><u style="single">(14) In the surgical staple fastening device according to item 13, the trigger includes an extension located adjacent to the bilink assembly, which extends the bilink assembly to the non-alignment. A device that is movable so as to urge it from a position to the aligned position.</u><u style="single">(15) In the surgical staple fastening device of item 14, further comprising a firing mechanism, the firing mechanism being operably coupled to a distal end located within the cartridge assembly and the trigger. A device that includes a thrust bar with an end.</u><u style="single">(16) In the surgical staple fastening device of item 15, the trigger further comprises a firing link rotatably coupled to the trigger, the thrust bar having a notch formed at its proximal end, the trigger. As it moves through the firing stroke, the firing link goes into the notch of the thrust bar after the anvil assembly and the cartridge assembly have moved to the close position to eject staples from the cartridge assembly. A device that can be moved.</u><u style="single">(17) In the surgical staple fastening device according to item 5, the trigger is a device including a grip member provided with a cushion.</u><u style="single">(18) In the surgical staple fastening device according to item 5, the stationary handle portion is a device including a grip member provided with a cushion.</u></p>

<figref num="1">FIG. 1 is a perspective view showing an embodiment of the surgical staple fastening device disclosed this time.</figref><figref num="2">FIG. 2 is a side view of the surgical staple fastening device shown in FIG.</figref><figref num="3">FIG. 3 is a top view of the surgical staple fastening device shown in FIG.</figref><figref num="4">FIG. 4 is a perspective view showing the parts of the surgical staple fastening device shown in FIG. 1 in an exploded manner.</figref><figref num="5">FIG. 5 is a perspective view showing the surgical staple fastening device shown in FIG. 1 by removing the left half of the main body from the handle portion of the device.</figref><figref num="6">FIG. 6 is a perspective view showing the handle portion of the surgical staple fastening device shown in FIG. 7 by removing half of the main body and cutting out a part of the frame.</figref><figref num="7">FIG. 7 is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="8">FIG. 8 is a rear perspective view showing the staple assembly of the surgical staple fastening device shown in FIG.</figref><figref num="8A">FIG. 8A is a rear perspective view showing the staple extruder assembly shown in FIG. 8 with separated parts.</figref><figref num="8B">FIG. 8B is a perspective view showing another embodiment of the staple extruder assembly shown in FIG. 8 with separated parts.</figref><figref num="8C">FIG. 8C is a perspective view showing the staple extruder assembly shown in FIG. 8B in an assembled state.</figref><figref num="9">FIG. 9 is an enlarged perspective view showing the distal end of the surgical staple fastening device shown in FIG.</figref><figref num="9A">FIG. 9A is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="9B">FIG. 9B is a cross-sectional view taken along the cutting line 9B-9B of FIG. 9A.</figref><figref num="10">FIG. 10 is a perspective view of the firing claw of the surgical staple fastening device shown in FIG. 1 as viewed from one side.</figref><figref num="10A">FIG. 10A is a perspective view of the firing claw of the surgical staple fastening device shown in FIG. 10 as viewed from the other side.</figref><figref num="11">FIG. 11 is a perspective view of the clamp claw of the surgical staple fastening device shown in FIG. 1 as viewed from one side.</figref><figref num="11A">FIG. 11A is a perspective view of the clamp claw of the surgical staple fastening device shown in FIG. 11 as viewed from the other side.</figref><figref num="12">FIG. 12 is a perspective view showing the trigger and launch link of the surgical staple fastening device shown in FIG. 1 in a separated state.</figref><figref num="13">FIG. 13 is a perspective view showing the release button assembly and the bilink assembly of the surgical staple fastening device shown in FIG. 1 with the parts separated.</figref><figref num="14">FIG. 14 is a perspective view showing the pin extruder and bell-shaped crank of the surgical staple fastening device shown in FIG. 1 with the parts separated.</figref><figref num="15">FIG. 15 is a side sectional view of the surgical staple fastening device along the cutting line XX-XX of FIG.</figref><figref num="15A">FIG. 15A is a partially cutaway side view showing the handle portion of the surgical staple fastening device shown in FIG. 1 with half of the main body removed.</figref><figref num="15B">FIG. 15B is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="15C">FIG. 15C is an enlarged view showing the details of the indicated region shown in FIG. 15A.</figref><figref num="16">FIG. 16 is a side sectional view of the surgical staple fastening device shown in FIG. 1 when the anvil assembly and the cartridge assembly are brought close to each other.</figref><figref num="16A">FIG. 16A shows a part of the handle portion of the surgical staple fastening device shown in FIG. 1 when the anvil assembly and the cartridge assembly are brought close to each other, with the left half of the main body removed from the handle portion of the device. It is a notch side view.</figref><figref num="16B">FIG. 16B is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="16C">FIG. 16C is an enlarged view showing the details of the instruction region shown in FIG. 16A.</figref><figref num="17">FIG. 17 is a side sectional view showing the surgical staple fastening device shown in FIG. 1 in a close position where the trigger is in the compression position.</figref><figref num="17A">FIG. 17A is a partially cutaway side view showing the surgical staple fastening device shown in FIG. 1 with the left half of the body removed from the handle portion of the device and the trigger in the compressed position.</figref><figref num="17B">FIG. 17B is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="17C">FIG. 17C is an enlarged view showing the details of the instruction region shown in FIG. 17A.</figref><figref num="18">FIG. 18 is a side sectional view showing the surgical staple fastening device shown in FIG. 1 in a close position where the trigger is in the firing ready position.</figref><figref num="18A">FIG. 18A shows a partially notched side surface showing the handle portion of the surgical staple fastening device shown in FIG. 1 with the left half of the body removed from the handle portion of the device and the trigger in the compressed position. It is a figure.</figref><figref num="18B">FIG. 18B is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="18C">FIG. 18C is an enlarged view showing the details of the indicated region shown in FIG. 18A.</figref><figref num="19">FIG. 19 is a side sectional view showing the surgical staple fastening device shown in FIG. 1 in a state where the trigger is in the compressed position after the device is fired.</figref><figref num="19A">FIG. 19A shows the handle portion of the surgical staple fastening device shown in FIG. 1 in the fired position, with the left portion of the body removed from the handle portion of the device and the trigger in the compressed position. It is a partial notch side view.</figref><figref num="19B">FIG. 19A is an enlarged view showing the details of the instruction region shown in FIG.</figref><figref num="19C">FIG. 19C is an enlarged view showing the details of the instruction region shown in FIG. 19A.</figref><figref num="20">FIG. 20 is a side sectional view showing the surgical staple fastening device shown in FIG. 1 after the staples have been fired from the staple cartridge and the cartridge assembly has been moved to the retracted position.</figref><figref num="20A">FIG. 20A is an enlarged view showing the details of the instruction region shown in FIG. 20.</figref><figref num="21">FIG. 21 is a top view of the tissue showing the staple arrangement applied to the tissue by the surgical staple fastening device shown in FIG.</figref><figref num="22">FIG. 22 is a top view of the tissue shown in FIG. 16 showing the staple arrangement after the tissue has been cut.</figref>

Preferred embodiments of the surgical staple fastening device disclosed this time will be described with reference to the accompanying drawings. The preferred embodiments of the surgical staple fastening device disclosed herein will then be described in detail with reference to the drawings, in which the same reference numbers indicate corresponding elements in each of several figures. ..

The surgical staple fasteners disclosed here, commonly shown in FIGS. 1 to 3, include a body 12 defining a stationary handle 14, a swivel trigger 16, an elongated central body portion 18, a cartridge assembly 20 and an anvil. Includes assembly 22. The thumb button 24 is slidably arranged on each side of the main body 12. The thumb button 24 is movable to manually advance the alignment pin assembly in a manner detailed below. The release button 26 is located at the proximal end of the body 12, and by pressing it, the cartridge assembly 20 is moved from an approach position adjacent to the anvil assembly 22 to the anvil assembly 22. It is possible to return to a separated position (not shown).

Referring to FIG. 4, the body 12 is formed from a pair of molded halves 12a and 12b. Preferably, the halves 12a and 12b are made of plastic, but other materials, including metals, may be used to form these halves. The cushioned grip member 14a is secured to the stationary handles 14 of the semi-shaped 12a and 12b, respectively. Grip member 14a is Versaflex^TMAlternatively, a thermoplastic resin such as Santaprene may be formed by injection molding onto the stationary handle 14. Alternatively, the cushioned grip member 14 can be formed on or secured to the stationary handle 14 using any known fixing technique, including adhesives, screws, welds, overmolds, etc. it can. A pair of spaced frame members 28a and 28b extend between the housing halves 12a and 12b and the anvil assembly 22. The central portion of the frame members 28a and 28b forms an elongated central body portion 18. Preferably, the frame members 28a and 28b are made of surgical grade metal such as stainless steel. Alternatively, other suitable materials that meet the required strength requirements may be used.

Also referring to FIGS. 9-9B, the anvil assembly 22 includes a stiffener plate 30, a spacer plate 32, a T-track 34, and an anvil 36. An opening 67 is formed in the anvil 36 to allow the alignment pin 38 to pass through. The stiffener plate 30 includes a vertical portion 30a and a horizontal portion 30b. A notch 30c is formed at the distal end of the vertical portion 30a. The notch 30c is configured to accommodate the tip of the cartridge alignment pin 38. The horizontal portion of the plate 30 includes a notch 40 sized to accommodate the interlock member 42, described in more detail below. In the assembled state, the distal vertical portions 30a of the frame members 28a and 28b are arranged on both side facing surfaces of the vertical portion 30a in the vertical portion 30a of the reinforcing plate 30. Spacer The rate 32 includes a pair of legs, which are arranged on both sides of the stiffener plate between the stiffener plate 30 and the anvil 36. The anvil 36 defines the channel 36a and is also located around the spacer plate 32. A cap 39 is placed over the assembly to provide a smooth surface that is less likely to damage tissue during use. The cap 39 includes a groove 39a, which defines one end of a cutting guide slot 41 formed between the anvil 36 and the frame member 28b. The groove 39a and the cutting guide slot 41 facilitate cutting the tissue with a scalpel after the device 10 has been fired. The T-track 34 defines a through slot 44. The slot 44 is arranged between the frame members 28a and 28b so as to cover the horizontal portion 30b of the reinforcing plate 30. The T-track 34 is placed around the notch 40 to define the cavity in which the interlock 42 is placed. Preferably, the anvil assembly parts and The frame members 28a and 28b are fixed together using rivets 44. Alternatively, other fixing members, including screws, pins, welds, etc., may be used to secure the anvil assembly parts and frame members together. Preferably, the parts of the anvil assembly 22 are made of stainless steel. Alternatively, other materials, including metals with the required strength requirements, can be used to form some or all of the anvil parts.

Referring to FIG. 9, the anvil 36 contains a plurality of staple pockets 37 formed on the surface of the anvil. Each staple pocket 37 includes first and second staple-molded cups 37a and 37b, as well as channeling surfaces 37c arranged around each of these staple-molded cups. Anvils containing such staple molded pockets are disclosed in US Pat. No. 5,480,089, filed August 19, 1994, the entire patent of which is incorporated herein by reference.

With reference to FIGS. 4 and 7-8A, the cartridge assembly 20 includes a cartridge 50 with a row of staple containment slots 52. The staple extruder assembly 54 includes a plurality of extruder members 58. Each extruded member 58 includes a plurality of fingers 58a configured to be slidably accommodated within their respective staple accommodating slots 52. The finger 58a is placed after the staple 56 in the slot 52 so that the staple 56 is ejected from the slot 52 as the finger 58a advances. The guide channel 60 (FIG. 15) formed in the cartridge 50 is configured to slidably accommodate the alignment pin 38. A spring 64 is placed around the pin 38 to urge the alignment pin 38 to a retracted position in the guide channel 60. The opening 65 formed in the cartridge 50 allows the alignment pin 38 to extend from the guide channel 60 through the anvil opening 67 (FIG. 9A) into the notch 30c formed in the anvil assembly 22. The operation of the alignment pin mechanism for advancing the alignment pin 38 will be described in detail below.

With reference to FIGS. 8B and 8C, the staple extruder assembly 54 includes a plurality of extruder members 58, which are combined with each other to form the extruder assembly 54. The extruder assembly 54 may be modified to accommodate cartridges of various sizes by increasing or decreasing the extrusion member 58. For example, as shown in FIGS. 8B and 8C, the extruder member 58 may be removed to accommodate a smaller cartridge assembly.

With reference to FIGS. 4 and 5, the surgical staple fastening device 10 includes a pair of clamp sliding members 66a, 66b, a rowing pin extruder 68, and a thrust bar 70. The clamp sliding members 66a, 66b, the alignment pin extruder 68, and the thrust bar 70 respond to the retracting position and the forward position when the trigger 16 moves through the entire approaching stroke and / or firing stroke. It is slidably supported between the frame members 28a and 28b for movement between. The operation of each of the above members will be described in detail below.

The clamp sliding members 66a and 66b form part of the approach mechanism in the surgical staple fastening device. Each clamp sliding member has a distal end 72, a proximal end 74 and an elongated body 76. The elongated body 76 includes a pair of elongated guide slots 78a and 78b. The guide slots 78a and 78b are sized to slidably accommodate the pins 80a and 80b (FIG. 15) extending between the frame members 28a and 28b, respectively. Placing the pins 80a and 80b in the guide slots 78a and 78b allows the clamp sliding members 66a, 66b and the frame members 28a, 28b to move between the forward and backward positions. It functions to maintain alignment and also to limit the longitudinal range of movement of the clamp sliding members 66a, 66b. That is, the fully advanced position of the clamp sliding member is reached when the proximal end of slot 78a engages the pin 80a, and the fully retracted position of the clamp sliding member is far from slot 78a. The end is a pin Reached when engaging 80a. The distal ends 72 of each clamp sliding member 66a and 66b include a head portion 82. Each head portion 82 has a plurality of openings 84 such that these openings accommodate a fixing member 86 (FIG. 5) for anchoring the clamp sliding members 66a and 66b together in a spaced relationship. It is configured in. In the assembled state, the clamp sliding members 66a and 66b are separated from each other, defining an elongated channel in which the pin extruder 68 and thrust bar 70 are slidably arranged. The distal ends of the clamp sliding members 66a and 66b define a cartridge support receptacle for accommodating the cartridge assembly 20. A series of dimples 85 of each clamp sliding member functions to frictionally hold the cartridge assembly 20 within the cartridge support. The proximal ends 74 of the clamp sliding members 66a and 66b each include a hole for accommodating a pin 88 of the drive assembly described in detail below.

Also referring to FIG. 14, the alignment pin extruder 68 defines a channel along its length, which is sized to slidably accommodate the thrust bar 70. The alignment pin extruder 68 includes a vertical portion having a contact member 91 configured to engage the proximal end 38b of the alignment pin 38, with the alignment pin 68 advancing (as described below). When moving to position, the alignment pin 38 advances from within the cartridge 50 through the opening 65 of the cartridge 50 and the opening 67 of the anvil 36 into the notch 30c of the anvil assembly 22. There is. The alignment pin extruder 68 includes a pair of elongated slots 92a and 92b. Pins 80a and 80b (FIG. 15) extend through slots 92a and 92b, respectively, and pin extruders as they move between the forward and backward positions. Guide 58. The proximal end of the alignment pin extruder 68 includes a pair of separated legs 68a and 68b. Each leg 68a and 68b contains a post 120 that extends radially, which is measured to extend through an elongated slot 122 (Fig. 4) formed within the half-shapes 12a and 12b of the body. There is. A thumb button 24 is secured to the post 120 to facilitate manual drive of the alignment pin extruder 68. A C-shaped clip receptacle 126 is formed on the alignment pin extruder 68 and is measured to accommodate the link 94 of the bell-shaped crank 96 in a releasable manner. The operation of the bell crank 96 and the handle drive assembly is described in detail below.

Referring to FIG. 4, the thrust bar 70 is slidably arranged in a channel 69 formed in the alignment pin extruder 68. The distal end of the thrust bar 70 includes an engagement head 100 configured to engage the staple extruder assembly 54. The thrust bar 70 also includes a pair of elongated slots 102a and 102b, which are measured to accommodate pins 80a and 80b (FIG. 15) slidably. As mentioned above for the clamp sliding members 66a and 66b, the pins 80a and 80b not only guide the movement of the thrust bar 70 between the retracted position and the whole body position, but also fully advance the thrust bar 70. It serves to define the position and the fully retracted position. As shown in FIG. 15, the slots 102a and 102b of the slot bar 70 are longer than the slots 78a and 78b formed in the clamp sliding members 66a and 66b, respectively. The increased length of slots 102a and 102b allows the thrust bar 70 to assemble the cartridge independently of the clamp sliding members 66a and 66b. Advances distally from the approach position through Lee 20 to allow the staples to be ejected from the cartridge assembly 20. The proximal end of the thrust bar 70 is fitted to engage the bias member 71, which is tensioned between the body 12 and the thrust bar 70 to place the thrust bar 70 in the retracted position. Momentum. Also, the proximal end of the thrust bar 70 includes a notch 104, which is configured to accommodate the distal end of the launch link 106, which will be described in more detail below.

With reference to FIGS. 4-6, 12 and 13, the handle drive assembly 110 is a bilink assembly 111 including a swivel trigger 16, a front link 112 and a rear link 114, a bell-shaped crank 96, a launch link. Includes 106, clamp claws 108, and firing claws 110. Further, a release mechanism 26 including a release button 150 and a release lever 152 is provided on the main body 12.

The swivel trigger 16 is swivelly secured around the pivot member 116 between the semi-molds 12a and 12b of the body. Alternatively, a pivot pin can be used to rotatably support the trigger 16 between the body halves. The trigger 16 includes a cushioned grip 16a, which may be secured to the trigger 16 as described above with respect to the stationary handle 14, and a rear extension 115 placed beneath the bilink assembly 111. There is. The rear link 114 of the bilink assembly 111 is rotatably secured to the rear end of the pivot pin 113 extending between the frame members 28a and 28b, and swayably to the rear end of the front link 112 by the pivot pin 118. It has a front end. Note that the release button 150 is also rotatably secured to the pivot pin 113. I want to be. The front end of the front link 112 is rotatably fixed to the clamp sliding members 66a and 66b by pins 88. When the trigger 16 turns around the pivot member 116, the rear extension 115 places the bilink assembly 111 in a position where the longitudinal axes of the anterior link 112 and the posterior link 114 are not aligned, the anterior link 112 and the posterior. The longitudinal axis of the link 114 is urged to a position where it is substantially aligned. At this substantially aligned position, the links 112 and 114 are moved to an overcenter position that has slightly passed the actual alignment. If the bilink assembly is moved to a position slightly overcentered or passed through the aligned position, the bilink assembly 111 will not return to the unaligned position until engaged by the release mechanism 26. Let's go. Since the rear end of the rear link 114 is fixed within the body 12, when the bilink assembly 111 is moved from the unaligned position to the aligned position, the anterior link 112 advances distally and clamps. Moving members Advance 66a and 66b distally. The advancement of the clamp sliding members 66a and 66b correspondingly advances the cartridge assembly 20 and brings the anvil assembly 22 and the cartridge assembly 20 closer to each other, respectively.

Referring to FIGS. 4 and 15, thrust bar 70 includes an elongated slot 103 in front. The rivet 116 extending between the clamp sliding members 66a and 66b also extends through slot 103. When the clamp sliding members 66a and 66b are advanced from the retracted position to the advanced position, the rivet 116 engages with the front end of the slot 103 to advance the thrust bar 70 at the same time as the clamp sliding members 66a and 66b. As shown in FIG. 15, slot 103 is of a length that allows the thrust bar 70 to advance distally beyond the approach position, independent of the clamp sliding members 66a and 66b.

With reference to FIGS. 4 and 14, the bell crank 96 is rotatably secured between the body frame members 28a and 28b by the pivot member 134. As described above, the link 94 of the bell crank 96 is releasably located within the C-clip 126 of the alignment pin extruder 68. The bell-shaped crank 96 includes a pair of separated side walls 96a and 96b. Each side wall includes a cam member 138a extending inward, which cam member is configured to be housed in a cam slot 140 formed at the proximal ends of the clamp sliding members 66a and 66b. As the clamp sliding members 66a and 66b are moved forward distally, the wall limiting the cam slot 140 engages the cam member 138 to swivel the bell-shaped crank 96 around the pivot member 134. When the bell-shaped crank 96 is swiveled, the post 94 urges the pin extruder 68 distally, advancing the abutting member 96 through the guide channel 60 and advancing the alignment pin 38 with the anvil assembly 22. Engage. The cam slot 140 is The bell crank 96 is rapidly advanced during the initial advance of the ramp sliding members 66a and 66b, and the alignment pin extruder 68 and alignment pin 38 are rapidly advanced during the initial stage of approach. ..

With reference to FIGS. 4 and 13, the release mechanism 26 includes a release button 150 and a release lever 152. As mentioned above, the release button 150 includes a rear end that is swivelly secured to the pivot pin 113. The pivot pin 113 is fixed between the frame members 28a and 28b. The front end of the release button 150 includes a slot 154 measured to slidably accommodate a rod 156 formed at the rear end of the release lever 152. The front end of the release lever 152 is rotatably fixed between the main body halves 12a and 12b. The engaging member 158 projects downward from the bottom of the release lever 152, and the release button 150 is pressed to move the bilink assembly 111 from a substantially aligned overcenter position to a non-aligned position. Is arranged to abut the bilink assembly 111 when urged.

With reference to FIGS. 4 and 10-12, the surgical staple fastening device 10 includes a claw assembly that includes a clamp claw 108 and a firing claw 110. The clamp claw 108 is rotatably secured around the pivot member 170 in the semicircular slot 172 in the frame 28a. The spring 172 is fixed between the clamp claw 108 and the frame 28a and urges the clamp claw 108 so that it rotates clockwise when viewed in FIG. The clamp claw 108 includes a cam surface 176 having a recess 178 arranged to engage the engaging cam member 180 formed in the extension 115 of the trigger 16. When the cam member 180 on the trigger 16 is placed in the recess 178 of the cam surface 176 (this happens after the clamp sliding members 66a and 66b have moved approximately 3/4 of the approach stroke), the trigger 16 springs. 182 prevents it from returning to the uncompressed position. Thus, the cartridge assembly 20 and the anvil assembly 22 are said to have been released by the surgeon. Even if it is, it will be maintained at the 3/4 approach position. The firing claw 110 is rotatably fixed around the pivot member 184 in a semicircular slot 186 formed in the frame 28b. The spring 186 is fixed between the firing claw 110 and the frame 28b to urge the firing claw clockwise when viewed in FIG. The firing claw 110 includes a cam surface 190 having a recess 192 for engaging with a cam member 194 formed on the opposite side of the extension of the triger 16. As the trigger 16 moves through the firing stroke, the cam member 194 moves into the recess 192 and locks the trigger 16 to the compressed position after firing is complete. This provides the surgeon with an audible and visual indicator that the launch has been completed. Further operation of the claw assembly will be described in detail of the operation of the surgical staple fastening device 10 described below.

Next, the operation of the surgical staple fastening device will be described with reference to FIGS. 15 to 20A. The movement of various parts will be described from the viewpoint of looking at the instrument when it is positioned in the referenced figure.

Figures 15-15C show the surgical stapler before use. As shown, the cartridge assembly 20 and the anvil assembly 22 are in a separated relationship, the trigger 16 is in the uncompressed position, and the clamp sliding members 66a, 66b and the thrust bar 70 are in the retracted position (note that the thrust bar 70 is in the retracted position). Pins 80a and 80b are located at the front ends of slots 78a, 78b of clamp sliding members 66a, 66b and slots 102a, 102b of thrust bar 70). When the thrust bar 70 is in the retracted position, the front end of the firing claw 106 is located in front of the notch 104 in the thrust bar 70. The device 10 cannot be fired at this position because the link 106 cannot engage the notch 104. Alignment pin extruder 68 and alignment pin 38 are also in the retracted position, post of bell crank 96 The 94 is engaged in the C-shaped clip 126 of the alignment pin extruder 68. In this regard, the surgeon can manually advance the alignment pin extruder 68 and alignment pin 38 by pushing the thumb button 24 toward the anterior end of slots 122 formed in the body halves 12a and 12b. Will. This operation will remove the post 94 from the C-clip 126.

16 to 16C show the surgical staple fastening device 10 when the trigger 16 is in the approaching stroke. As shown, the trigger 16 is moved in the direction indicated by the arrow "A" so that the bilink assembly 11 is urged from the unaligned position to the substantially aligned position. Move the extension 115. Since the rear link 114 is fixed to the main body 12 around the pin 113, the front link 112 extends forward. The front link 112 is fixed to the clamp sliding members 66a and 66b. When the front link 112 extends forward, the clamp sliding members 66a and 66b are advanced from the retracted position to the forward or approaching position in the direction indicated by the arrow "B". Note the positions of pins 80a and 80b in slots 78a, 78b and 102a, 102b. As mentioned above, the rivet 116 extends through the slot 103 formed in the thrust bar 70 between the clamp sliding members 66a and 66b. The rivet 116 is slotted as the clamp sliding members 66a and 66b advance. Engage with the front end of slot 103 formed in bar 70 to advance thrust bar 70 at the same time. As the clamp sliding members 66a and 66b move forward, the engagement between the cam slot 140 and the cam member 138 causes the bell crank 96 to swivel around the pivot member 134 and distal the pin extruder 68. To advance the alignment pin 38 into the notch 30c of the anvil assembly 22.

Referring to FIG. 16B, when the trigger 16 turns in the direction indicated by the arrow A, the cam member 180 of the trigger 16 rides on the cam surface 176 against the bias of the spring 174. As the trigger 16 turns to advance the clamp sliding members 66c and 66b through approximately 3/4 of the approach stroke, the cam member 180 snaps into the cam recess 178 to achieve approximately 3/4 approach. It provides an auditory and tactile indicator of that. In this regard, the cam member 180 is arranged in the cam recess 178 to prevent the spring from returning the trigger 16 to the uncompressed position without activating the release mechanism. The operation of the release mechanism will be described in detail below.

17 to 17C show the surgical stapler 10 in a fully close position with the trigger 16 in the compressed position. As shown, the extension 115 of the trigger 16 is swiveled to swivel the bilink assembly 111 to a substantially aligned position (slight overcenter position), and the clamp sliding assembly is a cartridge. Assembly 20 and anvil assembly 22 are fully advanced so that they are in close proximity. Again, note the positions of the pins 80a, 80b of the clamp sliding slots 78a, 78b and the thrust bar slots 102a, 102b. Since the pins 80a and 80b are located at the proximal ends of the clamp sliding members 78a and 78b, only the thrust bar 70 can move further distally. Manually advance the alignment pin extruder before approaching If so, the post 94 is disengaged from the C-shaped clip 126, and by advancing the clamp sliding members 66a and 66b to the completely advanced position, the post 94 of the bell-shaped crank 96 is moved in the opposite direction and the C-shaped clip. It leads to engagement with 126. Therefore, when the clamp sliding members 66a and 66b return to the retracted position, the cam slot 140 of the clamp sliding members 66a and 66b turns the bell crank 96 in the direction of moving the pin extruder 68 to the retracted position.

Referring to FIG. 17B, the trigger 16 is swiveled to remove the cam member 180 from the cam recess 178 of the clamp claw 108. As the bilink assembly moves overcenter to a substantially aligned position, the rear link 114 engages the abutting member 200 formed on the clamp claw 108 and the firing claw 110, causing the clamp claw and firing claw to antagonize. Rotate approximately 10 ° clockwise. This rotation removes the cam surface 176 from the path of the cam member 180 as the trigger 16 returns to the uncompressed position.

Referring to FIG. 17C, the cam member 180'formed on the trigger 16 facing the cam member 180 is here located on the cam surface 190 of the firing claw 110. When the trigger 16 is released by the surgeon and returned to the uncompressed position by the spring 182, the cam member 180'moves along the backside 190a of the cam surface 190. When the cam member 180'reaches the bottom edge on the back side, the cam member 180' moves beyond the nodule 220 formed on the firing claw 110. Movement of the cam member 180'over nodule 220 provides an audible click and tactile indicator that the surgical stapler 10 is in a ready-to-launch position.

FIGS. 18-18C show the surgical staple stopper 10 in a fully close position where the trigger 16 is in the uncompressed position. As shown, with the thrust bar 70 in the advanced position, the notch 104 aligns with the launch link 106 so that movement through the launch stroke of the trigger 16 in turn advances the thrust bar 70. With reference to FIG. 18C, the cam member 180'is in turn placed below the cam surface 190 of the firing claw 110.

19-C 19C show the surgical stapler 10 after the trigger 16 has been moved through the firing stroke. As shown, the thruster bar 70 is advanced distally to eject the staples from the cartridge assembly 20. The pins 80a and 80b are in turn adjacent to the rear ends of slots 102a and 102b. In particular, referring to FIG. 19C, the cam member 180'of the trigger 16 moves up the cam surface 190 and is placed in the recess 192. The engagement of the cam member 180'and the recess 192 prevents the spring 183 from returning the trigger 16 to the uncompressed position, providing the surgeon with a visual indicator that the surgical device has been fired. The movement of the cam member 180'into the recess 192 also provides an audible indicator that the device has fired.

FIG. 20 shows the surgical staple fastening device 10 after the device has been fired and the release button 26 has been pressed to return the two-link assembly 111 to the out-of-alignment position. When the two-link assembly 111 moves in the opposite direction at the overcenter, the spring 71 returns the thrust bar 70 and the clamp sliding members 66a, 66b in the proximal direction to return the links 112 and 114 to the out-of-alignment position.

As shown in FIG. 20A, the interlock 42 is typically urged by the extruder assembly 54 to a position within the recess 40. After the cartridge assembly 20 has been fired, the extruder assembly 54 is no longer in a position to urge the interlock 42 into the recess 40. The interlock 42 will extend from the recess 40 and prevent the thrust bar 70 from advancing distally until a new cartridge is inserted into the surgical stapler 10.

FIG. 21 shows tissue 300 with a row of staples 310 applied therein. FIG. 22 shows tissue 300 after it has been cut with a scalpel (not shown).

It will be appreciated that the examples disclosed herein can be varied. For example, the components of a surgical stapler can be made of any material that is suitable for surgical use and has the required strength properties. Therefore, the above description should not be construed in a limited way, but as merely an example of a preferred embodiment. Those skilled in the art will envision other changes within the scope and spirit of the claims.