Stapling device having a staple cartridge assembly with alignment pins

Abstract

A surgical stapling device (10) includes an anvil assembly (12) and a replaceable staple cartridge assembly (60). The staple cartridge assembly (60) includes a blade (292) and upper alignment pins (70) and lower alignment pins (72) for holding tissue between the anvil assembly (48) and the staple cartridge assembly (60) to ensure that the blade (292) cleanly cuts through the tissue. The staple cartridge assembly (60) includes a staple cartridge body (64) having a guiding structure for guiding the staple cartridge assembly (60) onto a clamping and sliding assembly (42) of the stapling device (10).

Description

Technical Field

[0001] This technology generally relates to surgical stapling devices, and more particularly, to surgical stapling devices having a removable staple cartridge. Background Art

[0002] Surgical stapling devices are commonly used during a variety of surgical procedures to expedite the incision and suturing of tissue and to minimize trauma to the patient. Generally, these stapling devices include a staple cartridge assembly that includes a staple cartridge, which can be replaced after each use of the stapling device to facilitate reuse of the stapling device. These devices also include a knife assembly for cutting tissue and an anvil assembly that supports a cutting plate, which is engaged by the knife assembly to provide a more efficient cutting process. The knife assembly includes a blade having a sharp cutting edge that is driven through the tissue and into the cutting plate to transect or excise the tissue. Generally, the replaceable staple cartridge assembly includes alignment pins that constrain the tissue between the cartridge and the anvil assembly.

[0003] There has been a continuing need in the art for a stapling device that includes a staple cartridge assembly that includes alignment pins that constrain the tissue between the anvil and the staple cartridge assembly to ensure clean cutting of the tissue by the blade. Summary of the Invention

[0004] Aspects of the present disclosure are directed to a surgical stapling device that includes an elongate body, a clamping slide assembly, a tool assembly, and an alignment pin advancement assembly. The elongate body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongate body and includes a U-shaped frame, an anvil assembly, and a reload assembly. The U-shaped frame has a first transverse portion, a second transverse portion, and a longitudinal portion that connects the first transverse portion to the second transverse portion. The second transverse portion defines at least one longitudinal slot. The anvil assembly is supported on the first transverse portion of the U-shaped frame and includes a staple deformation surface that defines a cutter slot and a lower opening. The reload assembly includes a staple cartridge assembly and a shipping cover. The staple cartridge assembly includes a staple cartridge body that defines a cavity, a cutter slot, and a plurality of staple cavities. The staple cartridge assembly also includes a tissue engaging surface, a plurality of staples positioned within the staple cavities, and a first alignment pin. The first alignment pin is movable from a retracted position positioned within the staple cartridge body to a fully advanced position extending from the staple cartridge body and into the lower opening defined in the anvil assembly. The shipping cover is supported on the staple cartridge body and includes a base member that is positioned on the tissue engaging surface of the staple cartridge body to prevent advancement of the first alignment pin and to retain the plurality of staples within the plurality of staple cavities. The clamping slide assembly includes a distal portion and a proximal portion. The distal portion defines a distal staple cartridge support. The clamping slide assembly is movable between a retracted position and an advanced position to move the staple cartridge assembly relative to the anvil assembly between an open position and a clamping position. The alignment pin advancement assembly is supported on the second transverse portion of the U-shaped frame and includes a tube, at least one button, a shaft, and a biasing member. The tube is supported within the second transverse portion of the U-shaped frame for movement between a retracted position and an advanced position relative to the second transverse portion. The shaft is supported within the tube for movement between a retracted position and an advanced position relative to the tube. The biasing member is positioned within the tube to urge the shaft toward its advanced position. The at least one button extends through the at least one longitudinal slot defined within the second transverse portion of the U-shaped frame and is coupled to the tube. The at least one button is movable within the longitudinal slot from a retracted position to an advanced position to move the tube within the second transverse portion between its retracted position and its advanced position. The shaft is aligned with the first alignment pin to urge the first alignment pin toward its advanced position.

[0005] Other aspects of the present disclosure are directed to a surgical stapling device that includes an elongate body and a tool assembly. The elongate body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongate body and includes a U-shaped frame, an anvil assembly, and a staple cartridge assembly. The U-shaped frame has a first transverse portion, a second transverse portion, and a longitudinal portion that connects the first transverse portion to the second transverse portion. The second transverse portion defines at least one longitudinal slot. The anvil assembly is supported on the first transverse portion of the U-shaped frame and includes a staple deformation surface that defines a cutter slot and a lower opening. The staple cartridge assembly includes a staple cartridge body having side walls whose inner surfaces define a cavity. The inner surfaces of the side walls define at least one longitudinal channel. The clamping slide assembly includes a distal portion and a proximal portion. The distal portion defines a distal staple cartridge support. The clamping slide assembly is movable between a retracted position and a deployed position to move the staple cartridge assembly relative to the anvil assembly between an open position and a clamping position. The distal staple cartridge support of the clamping slide assembly has an outer surface that defines at least one guide member. During fastening of the staple cartridge assembly to the distal staple cartridge support of the clamping slide assembly, the at least one longitudinal guide channel of the staple cartridge body receives the at least one guide member of the distal staple cartridge support to properly align the staple cartridge assembly onto the distal staple cartridge support.

[0006] Other aspects of the present disclosure are directed to a surgical stapling device that includes an elongate body and a tool assembly. The elongate body has a proximal portion and a distal portion. The tool assembly is supported on the distal portion of the elongate body and includes a U-shaped frame, an anvil assembly, a staple cartridge assembly, and a clamping slide assembly. The U-shaped frame has a first transverse portion, a second transverse portion, and a longitudinal portion that connects the first transverse portion to the second transverse portion. The anvil assembly is supported on the first transverse portion of the U-shaped frame and includes a staple deformation surface that defines a cutter slot and a lower opening. The staple cartridge assembly includes a staple cartridge body having an alignment pin that includes an elongate shaft and a overmolding supported around the elongate shaft. The alignment pin is movable from a retracted position positioned within the staple cartridge body to a deployed position in engagement with the anvil assembly. The clamping slide assembly includes a distal portion and a proximal portion. The distal portion defines a distal staple cartridge support for supporting the staple cartridge assembly. The clamping slide assembly is movable between a retracted position and a deployed position to move the staple cartridge assembly relative to the anvil assembly between an open position and a clamping position.

[0007] In aspects of the present disclosure, the at least one longitudinal slot includes two longitudinal slots, and the at least one button includes two buttons.

[0008] In some aspects of the present disclosure, the shipping cover includes an engagement portion configured to releasably fasten the shipping cover to the staple cartridge assembly, wherein the shipping cover is removable from the staple cartridge assembly to allow the shaft of the alignment pin advancement assembly to advance the first alignment pin from its retracted position to a partially advanced position in which the first alignment pin is spaced apart from the anvil assembly.

[0009] In certain aspects of the present disclosure, the at least one button is movable within the at least one longitudinal slot to move the first alignment pin from the partially advanced position to the fully advanced position.

[0010] In aspects of the present disclosure, the at least one longitudinal slot includes spaced-apart protrusions, wherein one of the spaced-apart protrusions is positioned to hold the at least one button in its retracted position within the at least one longitudinal slot, and another of the spaced-apart protrusions is positioned to hold the button in its advanced position within the at least one longitudinal slot.

[0011] In some aspects of the present disclosure, the stapling device includes a handle assembly, and the proximal portion of the elongate body is coupled to the handle assembly.

[0012] In certain aspects of the present disclosure, the distal staple cartridge support of the clamping slide assembly includes an outer surface defining at least one guiding member, and the staple cartridge body includes side walls defining the cavity, the side walls including at least one longitudinal guiding channel that receives the at least one guiding member during fastening of the staple cartridge assembly to the distal staple cartridge support of the clamping slide assembly to properly align the staple cartridge assembly on the distal staple cartridge support.

[0013] In aspects of the present disclosure, the at least one guiding member includes two guiding members on the outer surface of the distal staple cartridge support positioned on each side of the distal staple cartridge support, and the at least one longitudinal guiding channel includes two longitudinal guiding channels defined in each of the side walls of the staple cartridge body.

[0014] In some aspects of the present disclosure, the distal staple cartridge support of the clamping slide assembly includes at least one pawl, and the staple cartridge body defines at least one resilient leg and at least one groove, wherein the at least one resilient leg is deformable out of the path of the at least one pawl to allow the at least one pawl to enter the at least one groove to fasten the staple cartridge assembly to the distal staple cartridge support of the clamping slide assembly.

[0015] In certain aspects of the present disclosure, the at least one pawl includes a plurality of pawls, the at least one resilient leg includes a plurality of resilient legs, and the at least one groove includes a plurality of grooves.

[0016] In aspects of the present disclosure, the stapling device includes a second alignment pin spaced apart from the first alignment pin.

[0017] In some aspects of the present disclosure, the second alignment pin includes an elongate shaft and a overmolding supported around the elongate shaft, wherein the second alignment pin is movable from a retracted position located within the staple cartridge body to a deployed position in engagement with the anvil assembly.

[0018] In certain aspects of the present disclosure, the elongate shaft of the second alignment pin is formed of metal and the overmolding is formed of plastic or polymeric material.

[0019] In aspects of the present disclosure, the overmolding is formed of silicone rubber.

[0020] Other features of the present disclosure will be appreciated from the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Aspects of the present disclosure are described below with reference to the accompanying drawings, in which:

[0022] Figure 1 is a side perspective view of a surgical stapling device incorporating aspects of the present disclosure;

[0023] Figure 2 is Figure 1 an enlarged view of the indicated detail area shown in, the enlarged view showing the distal portion of the surgical stapling device in a pre-fired un-clamped position;

[0024] Figure 3 is Figure 1 a side perspective view of the distal portion of the surgical stapling device shown in, the side perspective view showing the reload assembly of the stapling device shown in separated from the clamping slide assembly of the surgical stapling device; Figure 1 the reload assembly of the stapling device shown in;

[0025] Figure 4 is Figure 3 a side perspective exploded view of the reload assembly shown in;

[0026] Figure 5 is a cross-sectional view taken along section line 5-5 of Figure 3 ;

[0027] Figure 6 is Figure 1Side perspective exploded view of the distal frame portion, locking assembly, and lower pin advancement assembly of the surgical stapling device shown therein;

[0028] Figure 7 Is Figure 6 Enlarged perspective view of the lower pin advancement assembly shown therein;

[0029] Figure 8 Is a cross-sectional view taken along the Figure 3 Section line 8-8;

[0030] Figure 9 Is Figure 8 Enlarged view of the detail area shown therein;

[0031] Figure 10 Is a cross-sectional view taken along the Figure 3 Section line 10-10;

[0032] Figure 11 Is the side perspective view of the distal portion of the surgical stapling device when the reload assembly is attached to the clamping slide assembly, Figure 1 Shown therein;

[0033] Figure 12 Is a cross-sectional view taken along the Figure 11 Section line 12-12;

[0034] Figure 13 Is the side perspective view of the distal portion of the surgical stapling device during the first attachment step when the reload assembly is attached to the clamping slide assembly, Figure 1 Shown therein;

[0035] Figure 14 Is a cross-sectional view taken along the Figure 13 Section line 14-14;

[0036] Figure 15 Is Figure 1 Side view of the distal portion of the stapling device shown therein, where the reload assembly is attached to the clamping slide assembly, the shipping cover is removed from the cartridge assembly of the reload assembly, the lower pin advancement assembly is in a partially advanced position, and the stapling device is in an unclamped position;

[0037] Figure 16 Is a cross-sectional view taken along the Figure 13 Section line 16-16;

[0038] Figure 17 Is Figure 1A side view of the distal portion of the stapling device shown therein, where the reload assembly is attached to the clamping slide assembly, the shipping cover is removed from the staple cartridge assembly of the reload assembly, the lower pin advancement assembly is in the fully advanced position, and the stapling device is in the unclamped position;

[0039] Figure 18 is a cross-sectional view taken along Figure 17 section line 18-18 thereof, where the lower pin advancement assembly is in the fully advanced position;

[0040] Figure 19 is a Figure 1 side perspective view of the staple cartridge assembly of the reload assembly of the surgical stapling device shown therein;

[0041] Figure 20 is Figure 19 side perspective view of the clamping slide assembly shown therein, where the clamping slide member is separated;

[0042] Figure 21 is taken along Figure 19 section line 21-21;

[0043] Figure 22 is taken along Figure 19 section line 22-22;

[0044] Figure 23 is Figure 1 side perspective view of the distal portion of the surgical stapling device shown therein, including a staple cartridge assembly of an alternative type having an upper alignment pin;

[0045] Figure 24 is Figure 23 side perspective view of the upper alignment pin of the staple cartridge assembly shown therein;

[0046] Figure 25 is taken along Figure 23 section line 25-25;

[0047] Figure 26 is taken along Figure 25 section line 26-26;

[0048] Figure 27 is Figure 26 magnified view of the detailed area shown therein;

[0049] Figure 28 is Figure 23 another alternative type of the upper alignment pin shown therein; and

[0050] Figure 29 is through includingFigure 28 A cross-sectional view taken of a cartridge assembly of the upper alignment pins shown therein. DETAILED DESCRIPTION

[0051] The disclosed surgical stapling device will now be described in detail with reference to the accompanying drawings, in which like reference numerals represent like or corresponding elements in each of the several views. However, it should be understood that aspects of the present disclosure are merely examples of the present disclosure and may be embodied in various forms. Well-known functions or constructions have not been described in detail to avoid obscuring the present disclosure with unnecessary detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but should be construed only as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to employ the present disclosure in virtually any appropriate detailed structure in a different manner. Additionally, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal and like terms are used to assist in the description and are not intended to limit the present disclosure.

[0052] In this description, the term "proximal" generally refers to the portion of the device that is closer to the clinician, while the term "distal" generally refers to the portion of the device that is farther from the clinician. Additionally, the term "clinician" generally refers to medical personnel including doctors, nurses and support staff.

[0053] Figures 1 to 3 The disclosed surgical stapling device is shown generally as stapling device 10. Stapling device 10 includes a handle assembly 12, an elongate body 14 extending distally from handle assembly 12, and a tool assembly 16 supported on the distal portion of elongate body 14. Elongate body 14 defines a longitudinal axis "X". Handle assembly 12 includes a housing 18 that defines a fixed handle 20 and supports a movable trigger 22. In aspects of the present disclosure, movable trigger 22 is supported by housing 18 to pivot toward fixed handle 20 between a non-actuated position and an actuated position to operate tool assembly 16. Handle assembly 12 also supports buttons 26 (only one shown) positioned on each side of housing 18 that are movable along housing 18 to advance and retract alignment pin pusher 29 ( Figure 3 ). Handle assembly 12 also includes a release button 28 that can be depressed to move tool assembly 16 from a clamped position to an unclamped position. For a more detailed description of a suitable handle assembly 12, see, for example, U.S. Patent No. 6,817,508 ("the '508 patent").

[0054] Stapling device 10 includes a frame 32 extending from handle assembly 12 to tool assembly 16. Frame 32 includes a distal frame portion 34 having a U-shaped configuration. Distal frame portion 34 ( Figure 3) having a first transverse portion 36, a second transverse portion 38, and a longitudinal portion 39 interconnecting the first transverse portion 36 and the second transverse portion 38. The first transverse portion 36 and the second transverse portion 38 are spaced apart from each other to define a gap 40 extending between the first transverse portion 36 and the second transverse portion 38. In some aspects of the present disclosure, the first transverse portion 36 and the second transverse portion 38 are curved along an axis transverse to the longitudinal axis "X" of the elongate body 14 of the stapling device 10. Alternatively, the first transverse portion 36 and the second transverse portion 38 may be linear or composed of a plurality of linear portions positioned at an angle relative to each other.

[0055] The stapling device 10 includes a clamping slide assembly 42 and a pusher 44. The clamping slide assembly 42 is formed by a first clamping slide member 42a and a second clamping slide member 42b, which are coupled together as described in further detail below to define a distal staple cartridge support 46 positioned within the gap 40 of the distal frame portion 34. The clamping slide assembly 42 has a proximal portion that is coupled to the handle assembly 12 and is movable between a retracted position and a deployed position in response to actuation of the movable trigger 22. The pusher 44 also includes a proximal portion that is coupled to the handle assembly 12 and is movable between a retracted position and a deployed position in response to actuation of the movable trigger 22.

[0056] The tool assembly 16 includes an anvil assembly 48 and a reload assembly 50. The anvil assembly 48 is fastened to the first transverse portion 36 of the distal frame portion 34 and includes an anvil 48a having a staple deforming surface 52( Figure 17 ). The staple deforming surface 52 defines a lower opening 54, an upper opening 56, and a cutter slot 58 extending between the lower opening 54 and the upper opening 56, respectively.

[0057] Figures 3 to 5 The reload assembly 50 is shown including a staple cartridge assembly 60 and a shipping cover 62. The staple cartridge assembly 60 is removably supported on the clamping slide assembly 42 and includes a staple cartridge body 64, a staple pusher 66( Figure 5 ), a cutter holder 68( Figure 5 ), an upper alignment pin 70, a lower alignment pin 72, and an upper alignment cover 74. The staple cartridge body 64 defines a cavity 76( Figure 5)), the tissue engaging surface 64a, the tool slot 78, the plurality of staple cavities 80, and the plurality of staples 82. The tool slot 78 and the staple cavities 80 extend through the tissue engaging surface 64a and communicate with the cavity 76. The cavity 76 houses the staple pusher 66 and the tool retainer 68 for movement between a retracted position and a deployed position. The staple pusher 66 includes fingers 84 that are received within the staple cavities 80 such that movement of the staple pusher 80 from its retracted position to its deployed position ejects the staples 82 from the staple cavities 80. The cartridge assembly 60 includes a blade (not shown) that is aligned with the tool slot 78( Figure 4 ) and is movable from a retracted position masked within the cartridge body 64 to a deployed position extending from the tool slot 78 in response to movement of the tool retainer 68 from its retracted position to its deployed position.

[0058] The cartridge body 64 includes a proximal extension 86 that houses the upper alignment pin 70. The cartridge body 64 further defines a through hole 88( Figure 5 ) that houses the lower alignment pin 72. The through hole 88 is aligned with openings 90 and 92 formed in the staple pusher 66 and the tool retainer 68 such that the lower alignment pin 72 extends through the cartridge body 64 along an axis parallel to the longitudinal axis “X” of the elongate body 14( Figure 1 ) of the stapling device 10. The lower alignment pin 72 defines a distal groove 94 and a proximal groove 96. Each of the grooves 94 and 96 houses a flexible washer or ring 98. The ring 98 is fastened to the lower alignment pin 72 and is sized to engage the cartridge body 64 to prevent the lower alignment pin 72 from falling out of or disengaging from the cartridge body 64.

[0059] The shipping cover 62 is releasably coupled to the cartridge assembly 60 and includes a base member 100 and a proximally extending engagement member 102. The base member 100 has a configuration corresponding to the configuration of the cartridge body 64 and is received above the tissue engaging surface 64a. The engagement member 102 includes an elastic C-shaped clip 102a that receives the proximal extension 86 of the cartridge body 64 to fasten the shipping cover 62 to the cartridge body 64. The shipping cover 62 is fastened to the cartridge body 64 until the cartridge assembly 60 is fastened to the clamping slide member 42( Figure 1 ) of the stapling device 10( Figure 3 ) immediately prior to use to prevent the staples 82( Figure 5 ) from falling out of the cartridge body 64 prior to use. The shipping cover 62 also holds the lower alignment pin 72 in a retracted position within the cartridge body 64 until the shipping cover 62 is removed from the cartridge body 64.

[0060] Figures 6 to 10 The stapling device 10 is shown( Figure 1) the distal portion of, said distal portion including a surgical stapling device 10( Figure 1 ) the distal frame portion 34, the latching assembly 110 and the lower pin advancement assembly 112. The longitudinal portion 39 of the distal frame portion 34 defines a groove 114 that houses the latching assembly 110. The latching assembly 110 includes a base member 116, a latching member 118 and a biasing member 120. The base member 116 is received within the groove 114 of the longitudinal portion 39 of the distal frame portion 34 and defines an incision 122. The latching member 118 is supported within the incision 122 and is movable from a first position ( Figure 3 ) that prevents the pusher 44 from moving distally to a second position within the incision 122 that allows the pusher 44 to move distally. For a more detailed description of the operation of an exemplary latching assembly, see, for example, the '508 patent.

[0061] The lower pin advancement assembly 112 is supported within a cylindrical bore 130( Figure 6 ) defined in the second transverse portion 38 of the distal frame portion 34 and includes a tube 132, at least one button 134 (two buttons are shown), a shaft 136 and a biasing member 138. The tube 132 is received within the cylindrical bore 130 and is movable from a retracted position ( Figure 14 ) to a partially advanced position ( Figure 16 ) and then to a fully advanced position ( Figure 18 ). The tube 132 includes a proximal portion that defines a transverse through-hole 140. The second transverse portion 38 of the distal frame portion 34 defines a longitudinal slot 142 that is aligned with the through-hole 140 in the tube 132. The buttons 134 extend through the slot 142 into the through-hole 140 to secure the tube 132 to the buttons. Each of the buttons 134 includes a head portion 144 and a shaft portion 146 that are partially defined by resilient legs 148( Figure 7 ). The resilient legs 148 have end portions 150 that include a tapered surface 152 and a shoulder that defines a stop surface 154. The resilient legs 148 are deformable inwardly to facilitate passage of the legs 148 through the slot 142 in the distal frame portion 34 and the through-hole 140 in the tube 132 to connect the buttons 134 to the tube 132. When the stop surface 154 of the leg 148 of the button 134 passes through the through-hole 140 of the tube 132, the leg 148 quickly returns to its undeformed configuration to secure the resilient leg 148 within the tube 132. In the secured position, the stop surface 154 engages the inner surface of the tube 132. The diameter of the shaft portion 146( Figure 7 ) of the button 134 is less than the length of the slot 142. Thus, the buttons 134 can slide through the slot 142 to longitudinally move the tube 132 within the cylindrical bore 130 of the second transverse portion 38 of the distal frame portion 34 between its retracted and advanced positions.

[0062] The slots 142 in the second transverse portion 38 of the distal frame portion 34 each include spaced-apart protrusions 160a and 160b( Figure 10 ). The protrusions 160a and 160b are positioned to engage the shaft 146 of the button 134 to secure the button 134 in the retracted or advanced position within the slot 142. More specifically, when the button 142 is in its retracted position, the protrusion 160a in the slot 142 of the second transverse portion 38 of the distal frame portion 34 engages the shaft 146 of the button 142 to hold the button 142 and the tube 132 in their retracted positions. Similarly, when the button 142 is in its advanced position, the protrusion 160b in the slot 142 of the second transverse portion 38 of the distal frame portion 34 engages the shaft 146 of the button 142 to hold the button 142 and the tube 132 in their advanced positions.

[0063] The biasing member 138, shown as a helical spring, is positioned within the tube 132( Figure 9 ), and includes a proximal end that engages the shaft 146 of the button 142 and a distal end that engages the shaft 136 of the lower pin advancement assembly 112. The biasing member 138 is supported in a compressed form and urges the shaft 136 of the lower pin advancement assembly 112 toward the advanced position within the tube 132.

[0064] Figure 11 and Figure 12 The reload assembly 50 is shown when fastened to the clamping slide assembly 42 of the stapling device 10. As described above, the reload assembly 50 includes a staple cartridge assembly 60 and a shipping cover 62. When the shipping cover 62 is fastened to the staple cartridge assembly 60, the base member 100 of the shipping cover 62 is received above the tissue engaging surface 64a of the staple cartridge body 64. In this position, the shipping cover 62 is positioned above the opening distal end of the through hole 88 in the staple cartridge body 64 to prevent the lower alignment pin 72 from moving to its advanced position.

[0065] The reload assembly 50 is coupled to the clamping slide assembly 42 by Figure 3 : First, the staple cartridge body 64 is moved along a transverse axis in the direction of arrow "A" in Figure 12 to a position between the first transverse portion 36 and the second transverse portion 38 of the distal frame portion 34, and then the reload assembly 50 is moved along in Figure 13 and Figure 1414. As the reloading assembly 50 is laterally moved in the direction of arrow "A" to a position between the first lateral portion 36 and the second lateral portion 38 of the distal frame portion 34, the lower alignment pin 72 is moved to align with the shaft 136 of the lower pin advancement assembly 112. As the reloading assembly 50 is longitudinally slid to the clamp slide assembly 42 ( Figure 14 ), the engagement between the proximal end of the lower alignment pin 72 and the shaft 136 of the lower pin advancement assembly 112 causes the shaft 136 to be in Figure 14 13. The lower alignment pin 72 is moved proximally in the direction of arrow "C" in FIG. 13 to its retracted position. This movement compresses the biasing member 138 within the tube 132 of the lower pin advancement assembly 112. As described above, the shipping cap 62 prevents the lower alignment pin 72 from moving distally from the through hole 88 in the staple cartridge body 64.

[0066] Figure 15 and Figure 16 Operation of the lower pin advancement assembly 112 is shown after the shipping cover 62 is removed from the staple cartridge assembly 60. When the shipping cover 62 is removed from the staple cartridge assembly 60, the lower alignment pin 72 is now free to move distally in the direction of arrow "D". As described above, the shaft 136 of the lower pin advancement assembly 112 engages the proximal end of the lower alignment pin 72. When the shipping cover 62 is removed from the staple cartridge assembly 60, the biasing member 138 expands within the tube 132 to advance the shaft 136 of the lower pin advancement assembly 112 in the direction of arrow "D" to an advanced position in which it extends from the distal end of the tube 132. As the shaft 136 moves distally, the lower alignment pin 72 moves distally from the internal through hole 88 in the staple cartridge body 64 toward the lower opening 54 in the anvil assembly 48. With the tube 132 in its retracted position, the length of the biasing member 138 and the shaft 136 are such that the lower alignment pin 72 will only move to a partially advanced position ( Figure 16 ), in the partially advanced position, the lower alignment pin 72 is spaced apart from the opening 54 in the anvil assembly 48.

[0067] Figure 17 and 18 The tool assembly 16 is shown when the lower alignment pin 72 is moved from the partially advanced position to its fully advanced position. To move the lower alignment pin 72 from the partially advanced position to the fully advanced position, the button 134 of the lower pin advancement assembly 112 is moved from its retracted position ( ) along the slot 142 formed in the second lateral portion 38 in the direction of arrow "E". Figure 15 ) manually advances to its advanced position ( Figure 17), in the fully advanced position, the lower alignment pin 72 is received within the lower opening 54 in the anvil assembly 48. Advancement of the button 136 of the lower pin advancement assembly 112 causes the tube 132 of the lower pin advancement assembly 112 to move distally within a cylindrical bore 130 defined in the second transverse portion 38 of the distal frame portion 34 ( Figure 18 ) to advance the shaft 136 toward the anvil assembly 48. Advancement of the shaft 136 of the lower pin advancement assembly 112 causes the lower alignment pin 72 to be advanced into the lower opening 54 of the anvil assembly 48. In the advanced position, the lower alignment pin 72 (in combination with the upper alignment pin 70) restricts tissue between the anvil assembly 48 and the cartridge assembly 60 in the path of the blade (not shown) to ensure clean cutting of the tissue when the stapling device 10 ( Figure 1 ) is fired.

[0068] Figures 19 to 22 The clamping slide assembly 42 and the cartridge assembly 60 of the stapling device 10 are shown. As described above, the clamping slide assembly 42 includes a first clamping slide member 42a and a second clamping slide member 42b, which are coupled together to define a distal cartridge support 46 positioned within a gap 40 of the distal frame portion 34 ( Figure 3 ). The clamping slide members 42a and 42b can be coupled or fastened together using rivets or the like. The clamping slide assembly 42 has a proximal portion that is coupled to the handle assembly 12 and is movable between a retracted position and an advanced position in response to actuation of the movable trigger 22. For an exemplary aspect of the proximal portions of the clamping slide members 42a and 42b and a more detailed description of how the clamping slide members 42a and 42b can be associated with the handle assembly 12 ( Figure 1 ), see the '508 patent.

[0069] Each of the clamping slide members 42a and 42b has a distal portion 46a that together forms the distal cartridge support 46 of the clamping slide assembly 42. The distal portions 46a of each of the clamping slide members 42a and 42b include an inner surface 170 and an outer surface 172. The outer surfaces 172 of the clamping slide members 42a and 42b include elongate guide members 174 that define an axis parallel to the longitudinal axis of the elongate body 14 of the stapling device 10 ( Figure 1 ). In aspects of the present disclosure, the guide members 174 include two guide members 174 that are integrally formed with the clamping slide members 42a and 42b and are formed as raised elongate protrusions. Alternatively, the guide members 174 can include one or more guide members 174 that are integral with or separate from the clamping slide members 42a and 42b.

[0070] Each of the clamping slide members 42a and 42b further includes a pawl 180 extending outwardly from the outer surface 172 of the clamping slide members 42a and 42b. As described below, the pawls are positioned to engage the cartridge body 64 of the cartridge assembly 60 to secure the cartridge assembly 60 to the distal cartridge support 46 of the clamping slide assembly 42.

[0071] The cartridge body 64 of the cartridge assembly 60 includes side walls 184 that define a cavity 76 of the cartridge body 64. Each of the side walls 184 includes one or more resilient legs 186 that are fastened to the cartridge body 64 in a cantilever manner and that align with corresponding ones of the pawls 180 of the clamping members 42a and 42b when the reload assembly 50 is fastened to the distal cartridge support 46 of the clamping slide assembly 42. Each of the resilient legs 186 includes a tapered proximal portion 188 and a groove 190 positioned distal to the tapered proximal portion 188. The inner surface of the side walls 184 also defines a longitudinal guide channel 192 that receives the guide members 174 of the clamping slide members 42a and 42b to guide the cartridge assembly 60 onto the distal cartridge support 46 of the clamping slide assembly 42.

[0072] When the reload assembly 50 is fastened to the distal cartridge support 46 of the clamping slide assembly 42 and the cartridge assembly 60 is longitudinally moved toward the clamping slide assembly 42, as Figure 13 and Figure 14 shown, the guide members 174 on the outer surfaces 172 of the clamping slide members 42a and 42b are received within the channels 192 on the inner surface of the side walls 184 of the cartridge body 64 to guide the cartridge assembly 60 onto the distal cartridge support 46 of the clamping slide assembly 42. When the resilient legs 186 engage the pawls 180 of the clamping slide members 42a and 42b, the resilient legs 186 deform outwardly to allow the reload assembly 50 to engage the clamping slide assembly 42 by passing the pawls 180 over the highest point 194 ( Figure 22 ) of the resilient legs 186. When the pawls 180 pass over the highest point of the resilient legs 186, the resilient legs 186 return to their original position such that the pawls 180 move into the grooves 190 of the resilient legs 186.

[0073] Figures 23 to 29 An alternative form of the cartridge assembly is shown generally as cartridge assembly 260. The cartridge assembly 260 is substantially the same as the cartridge assembly 60 ( Figure 3 ) except that the upper alignment pin 270 of the cartridge assembly 260 includes a overmolding 276 as described below.

[0074] The upper alignment pin 270 includes an elongate pin shaft 272, a proximal coupling 274, and an overmolding 276 supported on the distal portion of the shaft 272. The proximal coupling portion 274 is fastened to the proximal end of the elongate pin shaft 272 and is configured to engage an alignment pin driver 31 of the stapling device 10 when the cartridge assembly 260 is coupled to the clamping and sliding assembly 42 ( Figure 1 ) of the stapling device 10 ( Figure 3 )). The alignment pin driver 31 is selectively movable to advance the upper alignment pin 270 from a retracted position ( Figure 3 ) located within the cartridge body 264 to a deployed position received within an upper opening 56 in the staple deforming surface 52 of the anvil assembly 48. For a more detailed description of exemplary aspects of the operation and structure of the alignment pin driver 31, see the '508 patent. Figure 25

[0075] In aspects of the present disclosure, the elongate pin shaft 272 of the upper alignment pin 270 is formed of a metal (such as stainless steel) and has a D-shaped cross-sectional shape and a tapered tip 272a. The elongate pin shaft 272 has a flat side 280 facing inwardly towards the lower alignment pin 290 ( Figure 23 ). In other aspects of the present disclosure, the overmolding 276 has a cylindrical configuration and is formed of a suitable polymeric or plastic material (such as silicone rubber). Alternatively, other construction materials and other overmolding configurations are contemplated. For example, as shown in Figure 28 and Figure 29 , the overmolding 276' may have a flower-shaped configuration.

[0076] The cartridge assembly 260 includes a blade 292 ( Figure 25 ) that is movable within the cartridge assembly 260 between a retracted position and a deployed position from a position recessed within the cartridge body 264 of the cartridge assembly 260 to a position extending from a tool slot 278 defined by the cartridge body 264, as is known in the art. In the cartridge assembly 260, the blade 292 is positioned to move along the flat side 280 of the elongate pin shaft 272 and includes sharp edges 296 and 298 that cut through the overmolding 276 as the blade 292 moves towards its deployed position and returns to its retracted position. Supporting tissue above the overmolding 276 and advancing the blade 292 through the overmolding increases the likelihood that tissue located near the upper alignment pin will be cleanly cut.

[0077] ​Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the present disclosure. It is contemplated that elements and features shown or described in connection with one exemplary embodiment may be combined with elements and features of another exemplary embodiment without departing from the scope of the present disclosure. Similarly, based on the above aspects of the present disclosure, those skilled in the art will appreciate other features and advantages of the present disclosure. Therefore, the present disclosure is not limited by what has been specifically shown and described, unless indicated by the appended claims.

Claims

1. A surgical stapling device, comprising: An elongate body having a proximal portion and a distal portion; A tool assembly supported on the distal portion of the elongate body, the tool assembly comprising: A U-shaped frame having a first transverse portion, a second transverse portion, and a longitudinal portion that connects the first transverse portion to the second transverse portion, the second transverse portion defining at least one longitudinal slot; An anvil assembly supported on the first transverse portion of the U-shaped frame, the anvil assembly comprising a staple deformation surface defining a cutter slot and a lower opening; A reload assembly comprising: A cartridge assembly comprising a cartridge body defining a cavity, a cutter slot, and a plurality of staple cavities, the cartridge assembly further comprising a tissue engaging surface, a plurality of staples positioned within the staple cavities, and a first alignment pin that is movable from a retracted position positioned within the cartridge body to a fully advanced position extending from the cartridge body and into the lower opening defined in the anvil assembly; A shipping cover comprising a base member, the shipping cover supported on the cartridge body, wherein the base member is positioned on the tissue engaging surface of the cartridge body to prevent advancement of the first alignment pin and to retain the plurality of staples within the plurality of staple cavities; A clamping slide assembly having a distal portion and a proximal portion, the distal portion of the clamping slide assembly defining a distal cartridge support, the clamping slide assembly being movable between a retracted position and an advanced position to move the cartridge assembly relative to the anvil assembly between an open position and a clamped position; and An alignment pin advancement assembly supported on the second transverse portion of the U-shaped frame, the alignment pin advancement assembly comprising a tube, at least one button, a shaft, and a biasing member, the tube being supported within the second transverse portion of the U-shaped frame for movement between a retracted position and an advanced position relative to the second transverse portion, the shaft being supported within the tube for movement between a retracted position and an advanced position relative to the tube, the biasing member being positioned within the tube to urge the shaft toward its advanced position, the at least one button extending through the at least one longitudinal slot defined within the second transverse portion of the U-shaped frame and coupled to the tube, the at least one button being movable within the at least one longitudinal slot from a retracted position to an advanced position to move the tube within the second transverse portion between its retracted position and its advanced position; Wherein the shaft is aligned with the first alignment pin to urge the first alignment pin toward its advanced position.

2. The surgical stapling device according to claim 1, wherein the at least one longitudinal slot comprises two longitudinal slots, and the at least one button comprises two buttons.

3. The surgical stapling device according to claim 1, wherein the shipping cover comprises an engagement portion configured to releasably fasten the shipping cover to the cartridge assembly, the shipping cover being removable from the cartridge assembly to allow the shaft of the alignment pin advancement assembly to advance the first alignment pin from its retracted position to a partially advanced position, in which the first alignment pin is spaced apart from the anvil assembly.

4. The surgical stapling device according to claim 3, wherein the at least one button is movable within the at least one longitudinal slot to move the first alignment pin from the partially advanced position to the fully advanced position.

5. The surgical stapling device according to claim 4, wherein the at least one longitudinal slot comprises spaced-apart protrusions, one of the spaced-apart protrusions being positioned to hold the at least one button in its retracted position within the at least one longitudinal slot, and the other of the spaced-apart protrusions being positioned to hold the button in its advanced position within the at least one longitudinal slot.

6. The surgical stapling device according to claim 1, further comprising a handle assembly, the proximal portion of the elongate body being coupled to the handle assembly.

7. The surgical stapling device according to claim 1, wherein the distal cartridge support of the clamping slide assembly comprises an outer surface defining at least one guiding member, and the cartridge body comprises a side wall defining the cavity, the side wall comprising at least one longitudinal guiding channel that receives the at least one guiding member during fastening of the cartridge assembly to the distal cartridge support of the clamping slide assembly to properly align the cartridge assembly on the distal cartridge support.

8. The surgical stapling device according to claim 7, wherein the at least one guiding member includes two guiding members positioned on the outer surface of the distal cartridge support on each side of the distal cartridge support, and the at least one longitudinal guiding channel includes two longitudinal guiding channels defined in each of the side walls of the cartridge body.

9. The surgical stapling device according to claim 8, wherein the distal cartridge support of the clamping sliding assembly includes at least one pawl, and the cartridge body defines at least one resilient leg and at least one groove, the at least one resilient leg being deformable out of the path of the at least one pawl to allow the at least one pawl to enter the at least one groove to fasten the cartridge assembly to the distal cartridge support of the clamping sliding assembly.

10. The surgical stapling device according to claim 9, wherein the at least one pawl includes a plurality of pawls, the at least one resilient leg includes a plurality of resilient legs, and the at least one groove includes a plurality of grooves.

11. The surgical stapling device according to claim 1, further comprising a second alignment pin spaced apart from the first alignment pin, the second alignment pin including an elongate shaft and a overmolding supported around the elongate shaft, the second alignment pin being movable from a retracted position within the cartridge body to a deployed position in engagement with the anvil assembly.

12. The surgical stapling device according to claim 11, wherein the elongate shaft of the second alignment pin is formed of metal and the overmolding is formed of plastic or polymeric material.

13. The surgical stapling device according to claim 12, wherein the overmolding is formed of silicone rubber.

14. A surgical stapling device, comprising: An elongate body having a proximal portion and a distal portion; A tool assembly supported on the distal portion of the elongate body, the tool assembly comprising: A U-shaped frame having a first transverse portion, a second transverse portion, and a longitudinal portion that connects the first transverse portion to the second transverse portion, the second transverse portion defining at least one longitudinal slot; An anvil assembly supported on the first transverse portion of the U-shaped frame, the anvil assembly including a staple deforming surface defining a tool slot and a lower opening; A cartridge assembly including a cartridge body having side walls with inner surfaces defining a cavity, the inner surfaces of the side walls defining at least one longitudinal guide channel; A clamping slide assembly including a distal portion and a proximal portion, the distal portion of the clamping slide assembly defining a distal cartridge support, the clamping slide assembly being movable between a retracted position and a forward position to move the cartridge assembly relative to the anvil assembly between an open position and a clamping position, the distal cartridge support of the clamping slide assembly having an outer surface defining at least one guiding member, wherein during fastening of the cartridge assembly to the distal cartridge support of the clamping slide assembly, the at least one longitudinal guide channel of the cartridge body receives the at least one guiding member of the distal cartridge support to properly align the cartridge assembly onto the distal cartridge support; Wherein the at least one guiding member includes two guiding members on the outer surface of the distal cartridge support positioned on each side of the distal cartridge support, and the at least one longitudinal guide channel includes two longitudinal guide channels defined in each of the side walls of the cartridge body.

15. The surgical stapling device according to claim 14, wherein the distal cartridge support of the clamping and sliding assembly includes at least one pawl, and the cartridge body defines at least one resilient leg and at least one groove, the at least one resilient leg being deformable out of the path of the at least one pawl to allow the at least one pawl to enter the at least one groove to fasten the cartridge assembly to the distal cartridge support of the clamping and sliding assembly.

16. The surgical stapling device according to claim 15, wherein the at least one pawl includes a plurality of pawls, the at least one resilient leg includes a plurality of resilient legs, and the at least one groove includes a plurality of grooves.

17. A surgical stapling device, comprising: An elongate body having a proximal portion and a distal portion; A tool assembly supported on the distal portion of the elongate body, the tool assembly including: A U-shaped frame having a first transverse portion, a second transverse portion, and a longitudinal portion connecting the first transverse portion to the second transverse portion; An anvil assembly supported on the first transverse portion of the U-shaped frame, the anvil assembly including a staple deforming surface defining a tool slot and a lower opening; A cartridge assembly including a cartridge body, a blade, and an alignment pin, the alignment pin including an elongate shaft and an overmolding supported around the elongate shaft, the alignment pin being movable from a retracted position located within the cartridge body to a forward position engaging the anvil assembly, the blade being movable within the cartridge body between a retracted position and a forward position; and A clamping slide assembly including a distal portion and a proximal portion, the distal portion of the clamping slide assembly defining a distal cartridge support for supporting the cartridge assembly, the clamping slide assembly being movable between a retracted position and a forward position to move the cartridge assembly relative to the anvil assembly between an open position and a clamping position; Wherein the elongate shaft of the alignment pin is formed of metal and the overmolding is formed of plastic or polymeric material, and the blade is positioned to cut through a portion of the overmolding as the blade moves between its retracted position and its forward position.

18. The surgical stapling device according to claim 17, wherein the overmolding is formed of silicone rubber.

Images