Surgical stapling device with tissue gap control

Abstract

A surgical stapling device includes a cartridge assembly for accommodating tissue of different thicknesses. The cartridge assembly includes a channel member and a staple cartridge received in the channel member for movement between positions to vary a size of a tissue gap defined between the staple cartridge and an anvil of the stapling device. The cartridge assembly also includes features formed on a pusher or cartridge body of the staple cartridge of the cartridge assembly to improve staple formation when suturing thin tissue.

Description

Technical Field

[0001] The present disclosure relates to surgical stapling devices, and more particularly to surgical stapling devices including a tool assembly having a cartridge assembly adapted to different tissue thicknesses. Background Art

[0002] Surgical stapling devices for ejecting staples in a quick and efficient manner to join tissues or tissue segments in a variety of surgical procedures (e.g., anastomosis procedures) are well known. Generally, a surgical stapling device includes a tool assembly having a first jaw and a second jaw that respectively support a cartridge assembly and an anvil. The cartridge assembly includes a staple cartridge that supports a plurality of staples. The first jaw and the second jaw are mounted together to allow movement of the tool assembly between an open position and a clamping position. In the clamping position, the staple cartridge of the cartridge assembly and the anvil are supported in side-by-side alignment and include tissue contact surfaces that define a predetermined tissue gap. The tissue gap within the staple cartridge and the size of the staples are set to receive and staple tissue having a thickness within a predetermined range to properly effect hemostasis. If the tissue located between the jaws is outside the predetermined range, i.e., too thick or too thin, the staples may be deformed and not provide effective hemostasis. Additionally, if the clinician misidentifies the tissue thickness, or for a given staple size, the tissue thickness falls near the outer edge of the range, the likelihood of ineffective hemostasis increases.

[0003] There is a continuing need in the art of suturing for a surgical stapling device that can provide effective hemostasis for a wider range of tissue thicknesses. Summary of the Invention

[0004] The present disclosure relates to various aspects of a cartridge assembly of a suturing device adapted to different thicknesses of tissue. In some aspects of the present disclosure, the cartridge assembly includes a channel member and a staple cartridge that is received within the channel member to move between positions relative to the channel member to vary the tissue gap defined between the staple cartridge and the anvil of the suturing device. Other aspects of the present disclosure relate to features formed on a pusher or a cartridge body of the staple cartridge of the cartridge assembly to improve staple formation when suturing thin tissue.

[0005] One aspect of the present disclosure relates to a cartridge assembly that includes a channel member, a staple cartridge, and a spring. The channel member has a proximal portion and a distal portion and includes a sidewall and a bottom wall that define a cavity. The bottom wall defines a knife slot. The staple cartridge is received within the cavity of the channel member and includes a cartridge body, staples, a pusher, and a staple guard. The cartridge body defines a knife slot and staple receiving pits arranged in rows on each side of the knife slot. The staples and the pusher are received within the staple receiving pits, and the pusher is movable within the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits. The staple guard is supported on the cartridge body and is positioned to retain the staples and the pusher within the cartridge body. The spring is fixed to the bottom wall of the channel member in a preloaded state.

[0006] In aspects of the present disclosure, the channel member includes a distal portion and a proximal portion, and the distal portion of the channel member defines an opening extending through the bottom wall of the channel member.

[0007] In some aspects of the present disclosure, the spring includes a wave spring that has a distal portion including a hook that is received within the opening of the channel member to fix the distal portion of the wave spring to the channel member.

[0008] In certain aspects of the present disclosure, the wave spring includes a base portion and two elongated spring legs extending distally from the base portion on opposite sides of the knife slot, and the base portion supports the hook.

[0009] In aspects of the present disclosure, each of the two elongated spring legs includes a proximal portion that is fixed to the bottom wall of the channel member to fix the wave spring to the channel member in a preloaded state.

[0010] In some aspects of the present disclosure, the proximal portion of each of the two elongated spring legs is welded to the bottom wall of the channel member.

[0011] In certain aspects of the present disclosure, the channel member includes a finger extending into the opening, and the hook is received around the finger.

[0012] In aspects of the present disclosure, the base portion is formed separately from the two elongated spring legs, and the two elongated spring legs are fixed to the base portion.

[0013] In some aspects of the present disclosure, the opening is sized to facilitate longitudinal movement of the hook within the opening when the wave spring is compressed beyond the preloaded state.

[0014] In certain aspects of the present disclosure, the channel member includes a distal portion and a proximal portion, and the distal portion of the channel member defines spaced-apart notches on opposite sides of the bottom wall of the channel member.

[0015] In aspects of the present disclosure, the spring includes a wave spring having a distal portion that includes two spaced-apart hooks that are received within the spaced-apart notches of the channel member to secure the distal portion of the wave spring to the channel member.

[0016] In some aspects of the present invention, the hooks are longitudinally movable within the notches of the channel member when the wave spring is compressed beyond the preloaded state.

[0017] In certain aspects of the present disclosure, each pusher of the pushers includes at least one pusher plate, and each staple of the staples includes a rear span and staple legs extending from the rear span.

[0018] In aspects of the present disclosure, each pusher plate of the pusher plates has an upper surface defining a staple channel that receives the rear span of the staple to support the staple on the pusher plate.

[0019] In some aspects of the present disclosure, each pusher plate of the pusher plates includes rounded corner surfaces positioned on each side of the staple channel that are configured to guide the staple legs of the respective staple to the outside of the rear span during staple forming.

[0020] In certain aspects of the present disclosure, each pusher plate of the pusher plates includes chamfered surfaces positioned on each side of the staple channel that are configured to guide the staple legs of the respective staple to the outside of the rear span during staple forming.

[0021] Other aspects of the present disclosure relate to a channel member having a body and a spring. The body has a proximal portion and a distal portion and includes sidewalls and a bottom wall that define a cavity. The bottom wall of the body of the channel member defines a knife slot. The spring is secured to the bottom wall of the channel member in a preloaded state.

[0022] Other aspects of the present disclosure relate to a cartridge assembly that includes a channel member, a staple cartridge, and a wave spring. The channel member has a proximal portion and a distal portion and includes a sidewall and a bottom wall that define a cavity. The bottom wall defines a knife slot. The staple cartridge is received within the cavity of the channel member and includes a cartridge body, staples, a pusher, and a staple shield. The cartridge body defines a knife slot and staple receiving pits arranged in rows on each side of the knife slot. The staples and the pusher are received within the staple receiving pits, and the pusher is movable within the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits. The staple shield is supported on the cartridge body and is positioned to retain the staples and the pusher within the cartridge body. The wave spring is supported on the channel member between the bottom wall of the channel member and the staple shield of the staple cartridge. The wave spring includes a base portion and two spring legs that extend distally from the base portion along opposite sides of the knife slot. The two spring legs are fixed to the bottom wall of the channel member in a preloaded state.

[0023] Other aspects of the present disclosure relate to a cartridge assembly that includes a channel member and a staple cartridge. The channel member has a proximal portion and a distal portion and includes a sidewall and a bottom wall that define a cavity. The bottom wall defines a knife slot. The staple cartridge is received within the cavity of the channel member and includes a cartridge body, staples, a pusher, and a staple shield. The cartridge body defines a knife slot and staple receiving pits arranged in rows on each side of the knife slot. The staples and the pusher are received within the staple receiving pits, and the pusher is movable within the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits. The staple shield is supported on the cartridge body and is positioned to retain the staples and the pusher within the cartridge body. The staple shield includes a bottom wall that supports at least one spring member and defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body. The at least one spring member is positioned to engage the bottom wall of the channel member to facilitate vertical movement of the bottom wall of the staple shield relative to the bottom wall of the channel member.

[0024] In aspects of the present invention, the at least one spring member includes at least one spring member positioned on each side of the knife slot of the staple shield.

[0025] In some aspects of the present disclosure, the at least one spring member includes a plurality of spring members positioned on each side of the knife slot of the staple shield.

[0026] In certain aspects of the present disclosure, each spring member of the plurality of spring members positioned on each side of the knife slot is longitudinally aligned with at least one other spring member of the plurality of spring members.

[0027] In various aspects of the present disclosure, each of a plurality of spring members located on each side of the knife slot is longitudinally aligned with at least two other spring members of the plurality of spring members.

[0028] In some aspects of the present disclosure, the bottom wall of the staple guard includes the at least one spring member.

[0029] In certain aspects of the present disclosure, the at least one spring member is coupled to the bottom wall of the staple guard.

[0030] In various aspects of the present disclosure, the bottom wall of the staple guard defines an opening, and the at least one spring member includes a proximal extension and a distal extension that are received in the opening in the bottom wall of the staple guard to couple the at least one spring member to the staple guard.

[0031] In some aspects of the present disclosure, the at least one spring member is a wave spring.

[0032] Other aspects of the present disclosure relate to a tool assembly including an anvil and a cartridge assembly. The cartridge assembly is coupled to the anvil to facilitate pivotal movement of the tool assembly between an open position and a clamping position. The cartridge assembly includes a channel member and a staple cartridge. The channel member has a proximal portion and a distal portion and includes side walls and a bottom wall that define a cavity. The bottom wall defines a knife slot. The staple cartridge is received in the cavity of the channel member and includes a cartridge body, staples, a pusher, and a staple guard. The cartridge body defines a knife slot and staple receiving pits arranged in rows on each side of the knife slot. The staples and the pusher are received in the staple receiving pits, and the pusher is movable in the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits. The staple guard is supported on the cartridge body and is positioned to hold the staples and the pusher within the cartridge body. The staple guard includes a bottom wall that supports at least one spring member and defines a knife slot that is longitudinally aligned with the knife slot of the cartridge body. The at least one spring member is positioned to engage the bottom wall of the channel member to facilitate vertical movement of the staple cartridge relative to the anvil.

[0033] Other aspects of the present disclosure relate to a staple cartridge that includes a cartridge body, staples, a pusher, and a staple shield. The cartridge body defines a knife channel and staple receiving pits arranged in rows on each side of the knife channel. The staples and the pusher are received in the staple receiving pits, and the pusher is movable in the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits. The staple shield is supported on the cartridge body and is positioned to retain the staples and the pusher within the cartridge body. The staple shield includes a bottom wall that defines a knife channel longitudinally aligned with the knife channel of the channel member. The bottom wall of the staple shield supports spring members positioned on opposite sides of the knife channel of the staple shield.

[0034] Other aspects of the present disclosure will be understood from the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Aspects of the disclosed suturing device are described below with reference to the drawings, in which:

[0036] Figure 1 is a side perspective view of a surgical suturing device including aspects of the present disclosure, with the tool assembly of the suturing device in an open position;

[0037] Figure 2 is Figure 1 an enlarged view indicating a detailed area shown;

[0038] Figure 3 is Figure 2 a side perspective view of the cartridge assembly of the tool assembly shown;

[0039] Figure 3A is Figure 3 an enlarged view indicating an area of the detail shown;

[0040] Figure 4 is Figure 3 a side perspective view of the cartridge assembly shown, with the staple cartridge separated from the channel member of the cartridge assembly;

[0041] Figure 5 is Figure 4 an exploded view of the cartridge assembly shown;

[0042] Figure 5A is a side view of the tool assembly of the suturing device 10, with thin tissue clamped between the anvil and the cartridge assembly;

[0043] Figure 5B is a side view of the tool assembly of the suturing device 10, with thick tissue clamped between the anvil and the cartridge assembly;

[0044] Figure 5CIs a side view of the tool assembly of the suture device 10, in which tissue of non-uniform thickness is clamped between an anvil and a cartridge assembly;

[0045] Figure 5D Is a cross-sectional view taken along Figure 5C Section line 5D-5D;

[0046] Figure 6 Is Figure 5 A top perspective view of the channel member and wave spring of the cartridge assembly shown, in which the wave spring is fixed to the channel member;

[0047] Figure 7 Is Figure 5 A side perspective view of an alternative form of the channel member and wave spring of the cartridge assembly shown, in which these components are separated;

[0048] Figure 8 Is Figure 7 A top perspective view of the channel member and wave spring shown in

[0049] Figure 9 Is a cross-sectional view taken along Figure 8 Section line 9-9;

[0050] Figure 10 Is a sectional view taken along the longitudinal axis of the channel member when the wave spring is fixed to the channel member;

[0051] Figure 11 Is Figure 10 A sectional view of the channel member and wave spring shown, in which a staple cartridge is loaded into the channel member;

[0052] Figure 12 Is Figure 11 An enlarged view showing the detailed area;

[0053] Figure 13 Is when Figure 1 A side sectional view taken along the longitudinal axis of the cartridge assembly when the suture device shown is fired;

[0054] Figure 14 Is Figure 5 A side perspective view of another alternative form of the channel member and wave spring of the cartridge assembly shown, in which these components are separated;

[0055] Figure 15 Is Figure 14 An enlarged bottom perspective view of the distal portion of the assembled channel member and wave spring shown;

[0056] Figure 16 Is Figure 5Top side perspective view of the distal portion of another alternative form of the wave spring of the cartridge assembly shown;

[0057] Figure 17 Is Figure 16 Side view of the distal portion of the wave spring shown;

[0058] Figure 18 Assembled to the channel member Figure 16 Top side perspective view of the wave spring shown;

[0059] Figure 19 Is Figure 5 Top side perspective view of another alternative form of the channel member and wave spring of the cartridge assembly shown;

[0060] Figure 20 Is Figure 19 Top perspective view of the distal portion of the wave spring shown;

[0061] Figure 21 Is Figure 4 Bottom perspective view of an alternative form of the staple cartridge of the cartridge assembly shown;

[0062] Figure 22 Is Figure 21 Side view of the staple cartridge shown;

[0063] Figure 23 Is Figure 4 Bottom perspective view of another alternative form of the staple cartridge of the cartridge assembly shown;

[0064] Figure 24 Is Figure 23 Bottom perspective view of the staple cartridge of the cartridge assembly shown, where the wave spring is separated from the staple guard of the staple cartridge;

[0065] Figure 25 Is Figure 3 Side perspective view of the distal portion of another form of the cartridge assembly shown in;

[0066] Figure 26 Is Figure 25 Enlarged view indicating the detail area shown;

[0067] Figure 27 Is after staple forming looking from the distal ends of the pusher and staple of the cartridge assembly shown in Figure 25 Perspective view;

[0068] Figure 28 Is along Figure 27 Cross-sectional view taken along section line 28 - 28 of;

[0069] Figure 29 Is after staple forming looking from Figure 25A perspective view of an alternative form of the pusher and staples of the cartridge assembly shown looking from the distal end;

[0070] Figure 30 It is along Figure 29 A cross-sectional view taken along section line 30-30;

[0071] Figure 31 for Figure 4 a side perspective view of a portion of an alternative form of a cartridge body of a staple cartridge as shown;

[0072] Figure 32 When the nail is formed Figure 31 A top perspective view of the bin body shown; and

[0073] Figure 33 yes Figure 4 An alternative form of the cartridge body of the staple cartridge shown. DETAILED DESCRIPTION

[0074] The disclosed surgical stapling device will now be described in detail with reference to the accompanying drawings, wherein the same reference numerals in each of the several views represent the same or corresponding elements. However, it should be understood that the disclosed aspects are merely exemplary of the present disclosure and may be embodied in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis for the claims and as a representative basis for teaching those skilled in the art to employ the present disclosure differently with almost any suitable specific structure.

[0075] In this specification, the term "proximal" is generally used to refer to that portion of the device that is closer to the clinician during use of the device in its customary manner, and the term "distal" is generally used to refer to that portion of the device that is farther from the clinician during use of the device in its customary manner. In addition, the term "clinician" is generally used to refer to medical personnel including doctors, nurses, and support staff. In addition, directional terms such as front, back, up, down, top, bottom, and similar terms are used to assist in understanding this specification, and are not used to limit the present disclosure.

[0076] Surgical stapling devices are used in a variety of surgical procedures to treat tissue of various thicknesses. Typically, in a surgical procedure, a surgeon selects the staple size to be used in the surgical procedure based on a variety of factors, such as the tissue to be treated, the type of procedure being performed, personal preference, and personal experience. The present inventors have recognized, in particular, that problems to be solved can include a surgeon selecting a stapling device with a staple size that does not provide effective hemostasis. The present disclosure can help provide a solution to this problem, for example, by providing a cartridge assembly of a stapling device that can accommodate tissue of different thicknesses. Providing a cartridge assembly that can accommodate a wide range of tissue thicknesses can make staple size selection simpler, reduce surgeon error, and thus improve clinical outcomes. Additionally, since fewer options are needed to cover the range of target tissue thicknesses, the present disclosure simplifies logistics and saves costs for hospitals because hospitals do not need to have a large inventory of options.

[0077] The disclosed surgical stapling device includes a tool assembly having a cartridge assembly for accommodating tissue of different thicknesses. The cartridge assembly includes a channel member and a staple cartridge that is received within the channel member for movement between positions relative to the channel member to vary the tissue gap defined between the staple cartridge and the anvil of the stapling device. The cartridge assembly may also include features formed on a pusher or cartridge body of the staple cartridge of the cartridge assembly to improve staple formation when suturing thin tissue.

[0078] Figure 1 A surgical stapling device, generally shown as stapling device 10, is illustrated and includes a handle assembly 12, an elongate body or adapter assembly 14, and a tool assembly 16. The handle assembly 12 is powered and includes a fixed grip 18 and one or more actuation buttons 20. The actuation buttons 20 are operable to actuate various functions of the tool assembly 16 through the adapter assembly 14, including approaching, stapling, and cutting. In certain aspects of the present disclosure, the handle assembly 12 supports a battery (not shown) that provides power to the handle assembly 12 to operate the stapling device 10. Although the stapling device 10 is shown as a powered stapling device, it is contemplated that the disclosed tool assembly 16 is adapted to be used with manually powered surgical stapling devices as well as robotically controlled stapling devices.

[0079] The adapter assembly 14 includes a proximal portion 14a and a distal portion 14b. The proximal portion 14a is coupled to the handle assembly 12, while the distal portion 14b supports the tool assembly 16. In aspects of the present disclosure, the tool assembly 16 forms part of a reload assembly 21 that is removably supported on the distal portion 14b of the adapter assembly 14 and is capable of being replaced after the stapling device 10 has been fired to facilitate reuse of the stapling device 10. It is also contemplated that the tool assembly 16 can be fixedly coupled to the distal portion 14b of the adapter assembly 14.

[0080] The tool assembly 16 of the suturing device 10 includes a cartridge assembly 30 and an anvil 32. The cartridge assembly 30 and the anvil 32 are coupled together such that the tool assembly 16 is pivotable between an open position ( Figure 1 ) and a clamping position. In the clamping position, the anvil 32 and the cartridge assembly 30 are aligned side by side with each other to define a tissue gap for receiving tissue. The anvil 32 includes a tissue engaging surface 32a ( Figure 5A ), which defines staple forming pits (not shown).

[0081] Figures 2 to 5 The cartridge assembly 30, which includes a channel member 34 and a staple cartridge 40, is shown. The channel member 34 includes side walls 36 and a bottom wall 38 ( Figure 4 ), which define a cavity 34a for receiving the staple cartridge 40 ( Figure 5 ). The bottom wall 38 defines a knife slot 38a. In aspects of the present disclosure, the staple cartridge 40 is removably receivable within the cavity 34a of the channel member 34 to permit replacement of the staple cartridge 40 after each firing of the suturing device 10 ( Figure 1 ), thereby facilitating reuse of the suturing device 10 ( Figure 1 ).

[0082] Figure 5 An exploded view of the staple cartridge 40, which includes a cartridge body 42, staples 44, a pusher 46, an actuation sled 48, and a staple guard 50, is shown. The cartridge body 42 of the staple cartridge 40 is received within the cavity 34a defined by the channel member 34 and includes a tissue engaging surface 52. The cartridge body 42 defines a knife slot 54 and a plurality of staple receiving pits 56 arranged in rows on each side of the knife slot 54. The knife slot 54 and the staple receiving pits 56 lead to the tissue engaging surface 52 of the cartridge body 42. In certain aspects of the present disclosure, the tissue engaging surface 52 of the staple cartridge 40 has a stepped configuration having a raised surface adjacent to a central knife slot 54 and a lower surface positioned outside the central knife slot 54 toward the side wall 36 of the channel member 34. Each of the staple receiving pits 56 receives a staple 44 ( Figure 3 ) and at least a portion of one of the pushers 46. In some aspects of the present disclosure, the staples 44 in the inner row of staple receiving pits 56 are shorter in length than the staples 46 in the outer row of staple receiving pits 56. The actuation sled 48 is movable distally from the proximal end of the cartridge body 42 into sequential engagement with the pusher 46 to push the pusher 46 upwardly, as shown in Figure 5 , thereby ejecting the staple 44 from the staple receiving pit 56 of the cartridge body 42 through the tissue engaging surface 52 and into engagement with the anvil 32 ( Figure 1 ).

[0083] The staple guard 50 is fixed to the bottom side of the cartridge body 42 to hold the staples 44, the pusher 46, and the actuating sled 48 within the cartridge body 42. In aspects of the present disclosure, the staple guard 50 includes a flexible connector 58 defining an opening 60 that receives a protrusion 62 formed on the outer surface of the cartridge body 42 to fix the staple guard 50 to the cartridge body 42. In some aspects of the present disclosure, the staple guard 50 further includes a hooked finger 64 that engages a proximal portion of the cartridge body 42 to fix the staple guard 50 to the cartridge body 42. U.S. Patent No. 6,241,139 discloses exemplary aspects of the construction and operation of a staple cartridge of a surgical stapling device.

[0084] The cartridge body 42 of the staple cartridge 40 includes a tab 66, and the channel member defines a window 68 that receives the tab 66. The window 68 is sized to allow the tab 66 of the cartridge body 42 to move vertically within the window 68, but to prevent any significant longitudinal movement of the staple cartridge 40 within the cavity 34a of the channel member 34. In aspects of the present disclosure, the upper end of the window 68 is closed by a rod 68a that prevents the tab 66 from leaving the window 68. In some aspects of the present invention, the tab 66 may have raised wall portions 66a on opposite ends of the tab 66 and / or on the side walls of the tab 66. The raised wall portions 66a allow the cartridge body 42 to pitch ( Figure 5C ) and / or roll ( Figure 5D ) within the cavity 34a of the channel member 34 to account for differences in tissue thickness along the staple line. It should be noted that the tab 66 need not have raised wall portions to accommodate pitching and rolling of the cartridge body 42 within the cavity 34a of the channel member 34. Alternatively, the window 68 and the tab 66 may be sized to facilitate pitching and rolling of the cartridge body 42. Thus, even though the staples 44 are of the same size along each row of staples 44, movement of the cartridge body 42 within the cavity 34a of the channel member 34 allows the formed configuration of the staples to vary along the staple line during a single firing of the stapling device 10.

[0085] The cartridge assembly 30 includes one or more elongate springs or biasing members 70 positioned between the staple guard 50 and the bottom wall 38 of the channel member 34. The biasing member biases the staple cartridge 40 upward within the cavity 34a of the channel member 34 toward the anvil 32. In aspects of the present invention, the biasing member 70 may be an elongate wave spring 72 that is positioned on opposite sides of the knife slot 38a between the staple guard 50 of the staple cartridge 40 and the bottom wall 38 of the channel member 34 and has a sinusoidal configuration along the longitudinal axis of the channel member 34. In aspects of the present disclosure, the wave spring 72 may be spot welded to the channel member 34 and compressed to allow vertical movement of the staple cartridge 40 within the cavity 34a of the channel member 34. In some aspects of the present disclosure, the spot weld 72a ( Figure 6) is positioned on the central portion of the wave spring 70 and the central portion of the channel member 34. However, the wave spring 72 can be spot welded or fixed to the channel member 34 using other fastening techniques at any position along the length of the wave spring 72, which allows the wave spring 72 to be compressed so that the cartridge body 42 can move vertically within the channel member 34.

[0086] When the tissue is positioned between the anvil 32 and the cartridge assembly 30 and the tool assembly 16 moves from the open position to the clamping position, the force of the tissue on the cartridge body 42 of the staple cartridge 40 compresses the biasing member 70 to cause the staple cartridge 40 to move vertically (or towards the bottom wall 38 of the channel member 34) within the cavity 34a of the channel member 34. The amount of movement of the staple cartridge 40 within the cavity 34a of the channel member 34 during clamping and firing of the stapling device 10 ( Figure 1 ) will depend on the thickness of the tissue. More specifically, as the tissue thickness increases, the staple cartridge 40 will move a greater distance downward within the cavity 34a of the channel member 34. When the staple cartridge 40 moves within the channel member 34, the tab 66 moves within the window 68 defined in the side wall 36 of the channel member 34. As described above, the tab 66 and the window 68 allow the staple cartridge 40 to move vertically within the cavity 34a defined by the channel member 34, but prevent longitudinal movement of the staple cartridge 40 within the cavity 34a. When the staple cartridge 40 moves within the channel member 34, the relative position of the pusher 46 relative to the anvil 32 changes, which affects the forming of the staples. More specifically, when clamping thick tissue, the wave spring 72 supporting the staple cartridge 40 compresses to allow the cartridge body 42 to move within the cavity 34a of the channel member 34 to define a first tissue gap G2 ( Figure 5B ) between the tissue engaging surface 52 of the cartridge body 42 and the tissue engaging surface 32a of the anvil 32, and when clamping thin tissue, the wave spring 72 supporting the staple cartridge 40 compresses to allow the cartridge body 42 to move within the cavity 34a of the channel member 34 to define a second tissue gap G1 ( Figure 5A ) between the tissue engaging surface 52 of the cartridge body 42 and the tissue engaging surface 32a of the anvil 32, where the first tissue gap G2 is greater than the second tissue gap G1.

[0087] The staples 44 in the inner row, middle row, and outer row of staples 44 can have the same unformed size. Alternatively, the staples 44 in the inner row, middle row, and outer row of staples 44 can have different unformed sizes in each row of staples. For example, the staples 44 in the inner row of staples 44 can have a smaller unformed size than the staples 44 in the middle row and / or outer row of staples 44. Additionally, the tissue engaging surface 52 ( Figure 5A ) of the cartridge body 42 of the staple cartridge 40 can be planar, or alternatively, the tissue engaging surface 52 can be stepped.

[0088] It should be noted that although the nails 44 in a particular row have the same unformed size, the nails 44 can have different formed sizes. This difference is due to the movement of the cartridge body 42 within the cavity 34a of the channel member 34, which movement is caused by variations in tissue thickness along the length of the staple line. As described above, the cartridge body 42 can swing back and forth within the cavity 34a of the channel member 34. This can occur when the tissue in the distal portion of the tool assembly 16 is thicker than the tissue in the proximal portion of the tool assembly 16, such that the tissue gap in the distal portion of the cartridge body 42 is greater than the tissue gap in the proximal portion of the cartridge body 42.

[0089] Figures 7 to 9 An alternative form of the channel member and wave spring of the cartridge assembly 30 ( Figure 3 ) is shown, generally designated as channel member 134 and wave spring 170. The channel member 134 is similar to the channel member 34 ( Figure 5 ) and includes side walls 136 and a bottom wall 138, which together define a cavity 134a for receiving the staple cartridge 40 ( Figure 4 ). The bottom wall 138 of the channel member defines a knife slot 138a and an opening 140 that extends through the bottom wall 138 of the channel member 134 and is in communication with the knife slot 138a.

[0090] The wave spring 170 includes a base portion 172 and two elongated spring legs 174 that extend from the base portion 170 and are positioned along opposite sides of the knife slot 138a ( Figure 8 ). The base portion 172 of the wave spring 170 supports or includes a hook 176. By positioning the hook 176 of the wave spring 170 to pass through the opening 140, the wave spring 170 is secured to the bottom wall 138 of the channel member 134. More specifically, as Figure 8 and Figure 9 illustrate, the hook 176 is positioned through the opening 140 and engages the outer surface of the channel member 134 to secure the distal end of the wave spring 170 to the channel member 134. The length of the opening 140 in the channel member 134 is greater than the length of the hook 176 of the wave spring 170 to facilitate longitudinal movement of the hook 176 within the opening 140. In aspects of the present disclosure, the bottom wall 138 of the channel member 134 includes fingers 144 ( Figure 9 ) that partially extend across the opening 140, and the hook 176 is received around the fingers 144 to secure the distal portion of the wave spring 170 to the distal portion of the channel member 134.

[0091] Conceivably, other fastening structures or techniques that allow for spring compression within the cavity 134a of the channel member 134 could be used in place of the hook 176 and opening 140 to secure the wave spring 170 to the channel member 134. For example, the wave spring could include pins (not shown), and the channel member 134 could define slots (not shown) that receive the pins.

[0092] When the distal portion of the wave spring 170 is secured to the distal portion of the channel member 134, the two elongated spring legs 174 of the wave spring 170 extend proximally along opposite sides of the knife slot 138a from the base portion 172 of the wave spring 170. Each of the spring legs 174 of the wave spring 170 has a sinusoidal configuration and is compressible to facilitate vertical movement of the staple cartridge 40 within the cavity 134a of the channel member 134.

[0093] Figure 10 The wave spring 170 is shown when secured to the channel member 134 during manufacture of the cartridge assembly 30. In aspects of the present disclosure, when the wave spring 170 is secured to the bottom wall 138 of the channel member 134, the wave spring 170 is preloaded to facilitate placement of the staple cartridge 40 into the cavity 134a of the channel member 134 by a clinician. In aspects of the present disclosure, the wave spring 170 is preloaded into the cavity 134a of the channel member 134 during the manufacturing process by inserting the hook 176 into the opening 140 in the channel member 134 to receive the finger 144, subsequently compressing the wave spring 170 in the direction of arrow "A", and finally welding the proximal portions of the spring legs 174 to the bottom wall 138 of the channel member 134 while the spring legs 174 are partially compressed or preloaded. As shown, when the wave spring 170 is preloaded, the distal portion of the wave spring 170 will move in the direction of arrow "B". Conceivably, other portions of the wave spring 170 could be welded or secured to the channel member 134 at locations other than the proximal portions of the spring legs 174 (e.g., the central portion of the wave spring 170).

[0094] In aspects of the present disclosure, the wave spring 170 is secured to the bottom wall of the channel member 134 in a preloaded state to allow vertical movement of the staple cartridge 40 within the cavity 134a of the channel member 134. In one aspect of the invention, the staple cartridge 40 moves vertically within the cavity 134a of the channel member 134 by about 0.015 inches (0.381 millimeters (mm)) to about 0.025 inches (0.635 millimeters (mm)). In certain aspects of the present disclosure, the wave spring 170 is secured to the bottom wall 138 of the channel member 134 in a preloaded state to allow the staple cartridge 40 ( Figure 4) Move vertically within the cavity 134a of the channel member 134 by approximately 0.020 inches (0.0508 millimeters (mm)). Alternatively, the wave spring 170 and the channel member 134 can be configured to provide a greater range of motion of the staple cartridge 40 within the channel member 134.

[0095] The preloading of the wave spring 170 can be achieved during the manufacturing process by positioning the channel member 134 and the wave spring 170 within a fixture (not shown), pre-compressing the wave spring 170, and then spot welding or securing the proximal portion of the spring leg 174 to the channel member 134 using some other fastening technique.

[0096] Figure 11 and Figure 12 shows the staple cartridge 40 when it is loaded into the cavity 134a of the channel member 134 ( Figure 5 ), where the wave spring 170 is in a preloaded state within the cavity 134a of the channel member 134. When the staple cartridge 40 is loaded into the cavity 134a of the channel member 134, the tab 66 on the cartridge body 42 ( Figure 5 ) of the staple cartridge 40 ( Figure 5 ) is received within the window 168 of the channel member 134. When the staple cartridge 40 is received into the cavity 134a of the channel member 134, the guard 50 is disposed on the wave spring 170, and the tab 66 ( Figure 5A ) of the cartridge body 42 is positioned within the upper end portion of the window 168. When the tool assembly 16 moves to the clamping position near the thin tissue "T1", the tab 66 will be positioned within the upper end portion of the window 168, and the tissue gap "G1" ( Figure 5A ) defined between the staple cartridge 40 of the cartridge assembly and the anvil 32 will be at its minimum distance. When the tool assembly 16 moves to the clamping position near the thick tissue "T2", the tab 66 will be positioned within the lower end portion of the window 168, and the tissue gap "G2" ( Figure 5B ) defined between the staple cartridge 40 of the cartridge assembly and the anvil 32 will be at its maximum distance. As described above, the distance from the bottom surface of the tab 66 to the bottom surface of the window 68 is the maximum distance that the cartridge body 42 can move within the cavity 34a of the channel member 34. It should be noted that pre-compressing the wave spring 170 allows the staple cartridge 40 to be inserted into the cavity 134a of the channel member 134 with minimal force.

[0097] Figure 13 shows the cartridge assembly 30 including the staple cartridge 40 and the channel member 134 when the suturing device 10 ( Figure 1 ) is fired ( Figure 3)。When the suturing device 10 is fired and the clamping member (not shown) is driven through the tool assembly 16, the force applied by the tissue to the tissue engaging surface 52 of the cartridge body 42 of the cartridge 40 causes the cartridge 40 to move downward in the cavity 134a of the channel member 134 in the direction of arrow "C" to accommodate thicker tissue. The degree of movement of the cartridge 40 within the cavity 134a of the channel member 134 will be proportional to the thickness of the tissue compressed between the cartridge 40 and the anvil 32 ( Figure 1 )). As described above, the proximal portion of the spring leg 174 of the wave spring 170 is fixed to the bottom wall 138 of the channel member 134. Thus, when the cartridge 40 moves within the cavity 134a of the channel member 134 during firing to further compress the spring 134 from the preloaded state, the wave spring 170 flattens such that the distal end of the wave spring 170 moves distally in the opening 140 in the channel member 134 in the direction of arrow "D". The dimensions of the hook 176 of the wave spring 170 and the finger 144 of the channel member 134 should be set to prevent the hook 176 from separating from the finger 144 during maximum compression of the wave spring 170.

[0098] Figure 14 and Figure 15 shows an alternative form of the channel member and wave spring of the cartridge assembly 30 ( Figure 3 ), generally shown as channel member 234 and wave spring 270. The channel member 234 is similar to the above-described channel members 34, 134, except that the opening 140 of the channel member 134 ( Figure 7 ) is replaced by two spaced-apart notches 240a, 240b. The wave spring 270 is similar to the wave spring 170 ( Figure 7 ), except that the hook 176 is replaced by two spaced-apart hooks 276a, 276b supported on the base portion 272 of the wave spring 270. Each of the hooks 276a, 276b is received in one of the notches 240a, 240b of the channel member 234, and the spring legs 274 of the wave spring 270 extend proximally from the base portion 272. Providing two spaced-apart notches 240a, 240b and two hooks 276a, 276b allows for better maintenance of the structural integrity of the channel member 234 compared to a single larger opening and one large hook. As described above with respect to the wave spring 170, the wave spring 270 can be fixed to the bottom wall 238 of the channel member 234 in a preloaded state.

[0099] Figures 16 to 18 shows another alternative form of the channel member and wave spring, generally shown as channel member 334 ( Figure 18 ) and wave spring 370. The channel member 334 is similar to the channel member 134 ( Figure 8 ) and includes an opening 340 ( Figure 18)。The wave spring 370 is similar to the spring 170( Figure 7 ), except that the base portion 372 and the hooks 376 are formed separately from each of the spring legs 374, and the spring legs 374 are joined to the base portion 372, for example, by welding or crimping. As described above with respect to the wave spring 170 and the channel member 134, the hooks 376 of the wave spring 370 are fixed to the channel member 334. As Figure 18 shown, when the wave spring 370 is compressed, the hooks 376 can move within the opening 340. As described above with respect to the wave spring 170, the wave spring 370 can be fixed to the bottom wall 338 of the channel member 334 in a preloaded state.

[0100] Figure 19 and Figure 20 show another form of the channel member and the spring, generally shown as the channel member 434 and the spring 470. The channel member 434 is similar to the channel member 34( Figure 4 ) and includes side walls 436 and a bottom wall 438 that define a cavity 438a for receiving the staple cartridge 40( Figure 5 ). The bottom wall 438 supports the spring 470 and defines a knife slot 438a.

[0101] The spring 470 includes a base portion 472 and two spaced-apart elongated semi-circular portions 474 that extend proximally from the base portion 472. The semi-circular portions 474 are positioned on opposite sides of the knife slot 438a and extend along most of the length of the channel member 434. The base portion 472 of the spring 470 includes a central portion 472a that is fixed to the distal portion of the bottom wall 438 of the channel member 434 by spot welding.

[0102] The staple cartridge 40( Figure 5 ) is supported within the cavity 434a of the channel member 438 and rests on the spring 470. When a downward force is applied to the staple cartridge 40, the semi-circular portions 474 of the spring 470 flatten to allow the staple cartridge 40( Figure 5 ) to move vertically within the cavity 434a of the channel member 438 to accommodate different tissue thicknesses.

[0103] Figure 21 and Figure 22 show an alternative form of the staple cartridge, generally shown as the staple cartridge 540. The staple cartridge 540 is similar to the staple cartridge 40( Figure 5 ), and includes a cartridge body 542 and a staple guard 550. The cartridge body 542 defines a staple receiving slot 56( Figure 5 ) and a knife slot 54( Figure 5 ). The staple guard 550 includes a bottom wall 552 that defines a knife slot 552a that aligns with the knife slot 54 in the cartridge body 542( Figure 5)Alignment. The bottom wall 552 includes curved spring members 570 positioned on opposite sides of the knife slot 54. In aspects of the present disclosure, the spring members 570 curve outwardly from the bottom wall 552 of the staple guard 550 along the longitudinal axis of the staple guard 550. In some aspects of the present disclosure, the bottom wall 552 of the staple guard 550 includes a plurality of spring members 570 located on each side of the knife slot 552a. In certain aspects of the present disclosure, the bottom wall 552 of the staple guard 550 includes six spring members 570 located on each side of the knife slot 552a, and each of the spring members 570 is longitudinally aligned with two other spring members 570.

[0104] When the staple cartridge 540 is positioned within a channel member (e.g., channel member 434( Figure 19 ))), the spring members 570 rest on the bottom wall 438 of the channel member 434. When a force is applied to the staple cartridge 540, the spring members 570 flatten to allow the staple cartridge 540 to move vertically within the cavity 438a of the channel member 434 to accommodate tissue of different thicknesses.

[0105] Figure 23 and Figure 24 Another form of the staple cartridge is shown, generally designated as staple cartridge 640. The staple cartridge 640 is similar to the staple cartridge 540( Figure 21 ), and includes a cartridge body 642 and a staple guard 650. The cartridge body 642 defines staple receiving slots 56( Figure 5 ) and a knife slot 54( Figure 5 ). The staple guard 650 includes a bottom wall 652 that defines a knife slot 652a that is aligned with the knife slot 54 in the cartridge body 642( Figure 5 ). The staple cartridge 640 differs from the staple cartridge 540( Figure 21 ) in that the staple guard 650 includes spring members 670 coupled to the bottom wall 652 of the staple guard 650. In aspects of the present disclosure, the spring members 670 are in the form of wave springs 672. Each of the wave springs 672 in the wave spring 672 includes a proximal extension and a distal extension 674 that are received in openings 676 in the bottom wall 652 of the staple guard 650 to secure the spring members 670 to the staple guard 650. In aspects of the present disclosure, the proximal extension and the distal extension 674 are sized to be slidably received in the openings 676 in the staple guard 650 to allow the wave spring 672 to flatten, thereby allowing the staple cartridge 640 to move vertically within the cavity of a channel member (e.g., channel member 434( Figure 19 )) to accommodate tissue of different thicknesses.

[0106] Figures 25 to 28Shows another form of the staple cartridge, generally shown as staple cartridge 740. The staple cartridge 740 includes staples 744 and a pusher 746. The pusher 746 is configured to improve staple formation in cases where the staples 744 may be over-crimped. More specifically, each pusher in the staple pusher 746 ( Figure 27 ) includes one or more pusher plates 750. Each pusher plate in the pusher plate 746 defines a staple channel 752 that is configured to support the rear span 756 of one of the staples 744. The pusher plate 750 also includes chamfered surfaces 754 positioned along opposite sides of the staple channel 752. The chamfered surfaces 754 are configured to guide the legs 758 of the corresponding staple in the staple 744 outside of the rear span 756 of the staple 744 when the staple 744 is formed by the anvil 32 ( Figure 1 ).

[0107] Figure 25 and Figure 26 Shows the tool assembly 16 when the tool assembly 16 is fired together with the pusher 746. When the suturing device 10 ( Figure 1 ) is fired, the pusher 746 is pushed through the staple receiving slot 770 of the cartridge body 772 of the staple cartridge 740. When the pusher 746 reaches the raised position within the cartridge body 772, the pusher plates 750 extend outwardly beyond the tissue engaging surface 774 of the cartridge body 772 to expose the chamfered surfaces 754 of the pusher plates 750. When the tissue to be sutured is thin and the legs 758 of the staple 744 are wound back towards the rear span 756 of the staple 744, the legs 758 engage the chamfered surfaces 754 of the pusher plates 750 to guide the legs 758 of the staple 744 outside of the rear span 756, thereby preventing deformation of the staple 744.

[0108] Figure 29 and Figure 30 Shows an alternative form of the pusher, generally shown as pusher 846. The pusher 846 is similar to the pusher 746 ( Figure 27 ), except that the chamfered surfaces 754 of the pusher plates 750 are replaced by rounded surfaces 854 on the pusher plates 850. The pusher 846 functions in the same manner as the pusher 746 and will not be described further in detail herein.

[0109] Figures 31 to 33 Shows Figure 1 An alternative form of the cartridge body of the suturing device, generally shown as cartridge body 942. The cartridge body 942 defines a knife slot 954 and staple receiving pits 956 positioned on each side of the knife slot 954. The cartridge body 942 also defines fan-shaped pits 958 that are positioned adjacent to each of the staple receiving pits 956. Each of the fan-shaped pits 958 in the fan-shaped pits 958 is configured to direct the legs 960 of the staple 962 towards the anvil 32 ( Figure 1)Wind up upward to prevent the sharp end 960a of the leg 960 of the staple 962 from extending below the rear span 964 of the staple 962.

[0110] Although each aspect of the present disclosure has been described separately, it is contemplated that each aspect of the present disclosure can be used with other aspects of the present disclosure in a single magazine assembly. For example, a magazine assembly having a preloaded wave spring 170, 270, or 370 can also include a pusher 746 or 846 and / or a magazine body 942. Similarly, a magazine assembly including a spring 470 can also include a pusher 746 or 846 and / or a magazine body 942.

[0111] Those skilled in the art will understand that the devices and methods specifically described herein and shown in the drawings are non-limiting exemplary aspects of the present disclosure. It is contemplated that, without departing from the scope of the present disclosure, the elements and features described or illustrated in connection with one exemplary aspect of the present disclosure can be combined with the elements and features of another aspect. Similarly, those skilled in the art will understand additional features and advantages of the present disclosure based on the foregoing aspects of the present disclosure. Accordingly, unless indicated by the appended claims, the present disclosure is not limited by what has been specifically shown and described.

Claims

1. A cartridge assembly, the cartridge assembly comprising: A channel member having a proximal portion and a distal portion, the channel member including side walls and a bottom wall, the side walls and the bottom wall defining a cavity, the bottom wall defining a knife slot; A staple cartridge received within the cavity of the channel member and including a cartridge body, staples, a pusher, and a staple guard, the cartridge body defining a knife slot and staple receiving pits arranged in rows on each side of the knife slot, the staples and the pusher being received within the staple receiving pits, and the pusher being movable within the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits, the staple guard being supported on the cartridge body and positioned to retain the staples and the pusher within the cartridge body, the staple guard including a bottom wall that supports at least one spring member and defines a knife slot longitudinally aligned with the knife slot of the cartridge body, the at least one spring member being positioned to engage the bottom wall of the channel member to facilitate vertical movement of the bottom wall of the staple guard relative to the bottom wall of the channel member.

2. The cartridge assembly according to claim 1, wherein the at least one spring member includes at least one spring member positioned on each side of the knife slot of the staple guard.

3. The cartridge assembly according to claim 2, wherein the at least one spring member includes a plurality of spring members positioned on each side of the knife slot of the staple guard.

4. The cartridge assembly according to claim 3, wherein each spring member of the plurality of spring members positioned on each side of the knife slot is longitudinally aligned with at least one other spring member of the plurality of spring members.

5. The cartridge assembly according to claim 4, wherein each spring member of the plurality of spring members positioned on each side of the knife slot is longitudinally aligned with at least two other spring members of the plurality of spring members.

6. The cartridge assembly according to claim 1, wherein the bottom wall of the staple guard includes the at least one spring member.

7. The cartridge assembly according to claim 1, wherein the at least one spring member is coupled to the bottom wall of the staple guard.

8. The cartridge assembly according to claim 7, wherein the bottom wall of the staple guard defines an opening, and the at least one spring member includes a proximal extension and a distal extension received within the opening in the bottom wall of the staple guard to couple the at least one spring member to the staple guard.

9. The cartridge assembly according to claim 8, wherein the at least one spring member is a wave spring.

10. The cartridge assembly according to claim 9, wherein the at least one spring member includes at least one spring member positioned on each side of the knife slot in the staple guard.

11. A tool assembly, the tool assembly comprising: An anvil; A cartridge assembly, the cartridge assembly being coupled to the anvil such that the tool assembly is pivotable between an open position and a clamping position, the cartridge assembly including a channel member and a staple cartridge, the channel member having a proximal portion and a distal portion and including side walls and a bottom wall, the side walls and the bottom wall defining a cavity, the bottom wall defining a knife slot, the staple cartridge being received in the cavity of the channel member and including a cartridge body, staples, a pusher, and a staple guard, the cartridge body defining a knife slot and staple receiving pits arranged in rows on each side of the knife slot, the staples and the pusher being received in the staple receiving pits, and the pusher being movable in the staple receiving pits from a lowered position to a raised position to eject the staples from the staple receiving pits, the staple guard being supported on the cartridge body and positioned to hold the staples and the pusher within the cartridge body, the staple guard including a bottom wall that supports at least one spring member and defines a knife slot longitudinally aligned with the knife slot of the cartridge body, the at least one spring member being positioned to engage the bottom wall of the channel member to facilitate vertical movement of the staple cartridge relative to the anvil.

12. The tool assembly according to claim 11, wherein the at least one spring member includes at least one spring member positioned on each side of the knife slot of the staple guard.

13. The tool assembly according to claim 12, wherein the at least one spring member includes a plurality of spring members positioned on each side of the knife slot of the staple guard.

14. The tool assembly according to claim 13, wherein each spring member of the plurality of spring members positioned on each side of the knife slot is longitudinally aligned with at least one other spring member of the plurality of spring members.

15. The tool assembly according to claim 14, wherein each spring member of the plurality of spring members positioned on each side of the knife slot is longitudinally aligned with at least two other spring members of the plurality of spring members.

16. The tool assembly according to claim 11, wherein the bottom wall of the staple guard includes the at least one spring member.

17. The tool assembly according to claim 11, wherein the at least one spring member is coupled to the bottom wall of the staple guard.

18. The tool assembly according to claim 17, the bottom wall of the staple guard defining an opening, and the at least one spring member including a proximal extension and a distal extension, the proximal extension and the distal extension being received in the opening in the bottom wall of the staple guard to couple the at least one spring member to the staple guard.

19. The tool assembly according to claim 18, wherein the at least one spring member is a wave spring.

20. A staple cartridge, the staple cartridge comprising: A cartridge body, a staple, a pusher, and a staple guard, the cartridge body defining a knife slot and staple receiving pits arranged in rows on each side of the knife slot, the staple and the pusher being received within the staple receiving pits, and the pusher being movable within the staple receiving pits from a lowered position to a raised position to eject the staple from the staple receiving pits, the staple guard being supported on the cartridge body and positioned to retain the staple and the pusher within the cartridge body, the staple guard including a bottom wall that defines a knife slot longitudinally aligned with the knife slot of the channel member, and the bottom wall of the staple guard supporting spring members positioned on opposite sides of the knife slot of the staple guard.

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