Surgical stapler and related methods

Abstract

To provide a surgical stapler and a related method.SOLUTION: Surgical staplers, methods, and cutting mechanisms therefor are disclosed. The cutting mechanism includes an elongate member having a length and a height, a proximal portion, a distal portion, and an elongate slot extending a portion of the length of the elongate member. The distal portion has a cutting surface. The elongate slot has a distal slot portion, an intermediate slot portion, and a proximal slot portion. The distal slot portion is disposed one of higher or lower than the intermediate slot portion. The proximal slot portion is disposed at the other of a higher position or a lower position than the intermediate slot portion. The cutting mechanism further includes a first clamp member adjacent the distal portion of the elongate member.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 781,074, filed December 18, 2018, entitled "SURGICAL STAPLER AND RELATED METHODS," the entire disclosure of which is incorporated herein by reference for all appropriate purposes.

[0002] The present invention relates to surgical staplers. More particularly, but not by way of limitation, embodiments of the present invention relate to staplers, actuators, and needles. [Background technology]

[0003] Numerous surgical staplers are known in the industry. Some designs include a cartridge for supporting multiple needles therein. An anvil rotatable relative to the cartridge is also provided to assist in needle formation during needle deployment. However, there remains a need for better control during deployment and / or other new and useful improvements. Summary of the Invention [Means for solving the problem]

[0004] An exemplary cutting mechanism for a surgical stapler includes an elongated member having a length and a height, a proximal portion, a distal portion, and an elongated slot extending a portion of the length of the elongated member. The distal portion has a cutting surface. The elongated slot has a distal slot portion, a middle slot portion, and a proximal slot portion, the distal slot portion being positioned either higher or lower than the middle slot portion, and the proximal slot portion being positioned either higher or lower than the middle slot portion. The exemplary cutting mechanism further includes a first clamp member adjacent the distal portion of the elongated member.

[0005] An exemplary surgical stapler includes a cartridge containing at least one staple, an anvil movable relative to the cartridge, and the cutting mechanism described above. The cutting mechanism is movable relative to the cartridge between a proximal position and a distal position. The exemplary surgical stapler further includes a sled for expelling the at least one needle. The elongated member engages with the sled during a first movement from the proximal position to the distal position, thereby expelling the at least one needle during the first movement.

[0006] An exemplary method of operating a surgical stapler having an anvil movable relative to a staple cartridge is provided. The method includes positioning a cutting mechanism at a proximal position, where the cutting mechanism engages with the anvil at a first position on the cutting mechanism, thereby positioning the stapler in an open configuration in which the anvil and cartridge are configured to be spaced apart. The method also includes positioning the cutting mechanism at an intermediate position, where the cutting mechanism engages with the anvil at a second position on the cutting mechanism, thereby positioning the stapler in a trocar configuration in which the anvil and cartridge are configured to be fully clamped together. The method also includes positioning the cutting mechanism at a distal position, where the cutting mechanism engages with the anvil at a third position on the cutting mechanism, thereby positioning the stapler in a tissue clamping configuration in which the anvil and cartridge are configured to be substantially parallel to each other and have a tissue gap therebetween. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 1 is a perspective view of a surgical stapler in an open configuration. [Figure 2] FIG. 2 is a side view of the stapler of FIG. [Figure 3] 3 is a perspective view of an end effector for the stapler of FIG. 1; [Figure 4]FIG. 4 is an exploded perspective view of the stapler of FIG. [Figure 5] FIG. 5 is a perspective view of the stapler of FIG. 1 in a trocar configuration. [Figure 6] FIG. 6 is a side view of the stapler of FIG. [Figure 7] 7 is a side view illustrating a portion of an I-beam suitable for use in the stapler of FIG. [Figure 8] 8 is a cross-sectional view of the stapler of FIG. 1 in a storage configuration. [Figure 9] FIG. 9 is a cross-sectional view of the components of FIG. 8 in a pre-stapling configuration. [Figure 10] FIG. 10 is a cross-sectional view of the components of FIG. 8 in a post-stapling configuration. [Figure 11] FIG. 11 is a cross-sectional view of the components of FIG. 8 in a post-stapling I-beam storage configuration. [Figure 12] 12 is a perspective view of an I-beam suitable for use in the stapler of FIG. 1; FIG. [Figure 13] FIG. 13 is a perspective view of the I-beam of FIG. 12 in a separated state. [Figure 14] 14 is a perspective view of an I-beam suitable for use in the stapler of FIG. 1; FIG. [Figure 15] 15 is a plan view of an anvil suitable for use in the stapler of FIG. [Figure 16] 16 is a plan view of the proximal portion of the anvil of FIG. 15; [Figure 17] FIG. 17 is a cross-sectional view illustrating the needle portion in the containment structure. [Figure 18] FIG. 18 is a cross-sectional view of the components illustrated in FIG. [Figure 19] FIG. 19 is a side view of the components illustrated in FIG. [Figure 20] FIG. 20 is a cross-sectional view of the components illustrated in FIG. [Figure 21] FIG. 21 is a cross-sectional view of the components illustrated in FIG. [Figure 22] FIG. 22 is a cross-sectional view of the components illustrated in FIG. [Figure 23] FIG. 23 is a side view of the components illustrated in FIG. [Figure 24] FIG. 24 is a cross-sectional view of the components illustrated in FIG. [Figure 25] FIG. 25 is a cross-sectional view of the components illustrated in FIG. [Figure 26] FIG. 26 is a perspective view of a surgical stapler. [Figure 27] 27 is a side view of the stapler of FIG. 26. FIG. [Figure 28] FIG. 28 is a side view of the stapler after deformation. [Figure 29] FIG. 29 is a perspective view of a surgical stapler. [Figure 30] 30 is a side view of the surgical stapler of FIG. 28. FIG. [Figure 31] 31 is a rear view of the surgical stapler of FIG. 28. FIG. [Figure 32] FIG. 32 is a side view of an exemplary stapler. [Figure 33] FIG. 33 is a side view of an exemplary stapler. [Figure 34] FIG. 34 is a side view of the stapler of FIG. 32 after deformation. DETAILED DESCRIPTION OF THE INVENTION

[0008] 1-3, a surgical stapler 100 will now be described. The stapler 100 may have an upper jaw or anvil 102 and a lower jaw 104, which together form an end effector connected to the distal end of an elongated shaft 106. One or both jaws 102, 104 may be movable relative to the other jaw 102, 104 between a trocar configuration, an open configuration, and a tissue clamping configuration, which will be described later herein.

[0009] One jaw 104 may house multiple needles (not shown) therein for translation toward the other jaw 102 and deformation to staple tissue clamped between the jaws 102, 104. Those skilled in the art will recognize that the jaw 104 may include a housing and cartridge for holding the needles, or, as shown, the jaw 104 may be a single piece for housing the needles and / or pusher and may be operably coupled to the elongate member 106.

[0010] As shown in FIG. 4 , stapler 100 may include an upper jaw or anvil 102, a lower jaw 104 having a cartridge 108 that houses staple pushers 112 (and needles, not shown), and a slide plate 110. Those skilled in the art will readily recognize that the terms “cartridge housing” or “housing” may be used interchangeably with the term “slide plate.” Stapler 100 may also include an elongated member 114 that translates to sever tissue clamped between jaws 102, 104. Elongated member 114 may include or otherwise engage upper clamping member 116 and lower clamping member 118 during the clamping action of jaws 102, 104. Member 114 may also engage a sled 120 during the stapling action to translate one or more staple pushers 112. A spring insert 122 and / or spring 124 may be provided to assist in opening and / or closing the jaws 102, 104 in the manner described herein.

[0011] 5 and 6 show a stapler 100 in a trocar configuration, as will be described in more detail herein.

[0012] 7 and 8 show details of stapler 100 in a storage or open configuration and further describe the operation of stapler 100. Starting in the storage configuration, a distal portion of anvil 102 is moved or rotated away from cartridge or jaw 104, while a proximal portion of anvil 102 is compressed against jaw 104. That is, a pin 126 within anvil 102 may slide and rotate into engagement with an elongated slot in jaw 104 or cartridge 108, and in the storage position, pin 126 may engage an underside of elongated slot 128 while the distal portion of anvil 102 is spaced away from jaw 104. In some embodiments, as seen most clearly in FIGS. 4 and 15 , a pair of pins 126 on anvil 102 may engage a pair of slots 128 on jaw 104 or cartridge 108 to limit translational movement of the proximal portion of anvil 102. Further details of this functionality can be found in commonly owned U.S. Patent No. 10,143,474, issued December 4, 2018, to Bucciaglia et al.

[0013] 7 and 8 , and with simultaneous reference to FIGS. 12 , 13 , and 14 , elongated member 114 is configured to push sled 120 (not shown) that engages staple pusher 112 to fire the needles. Sled 120 may be permanently attached to lower clamping member 118 and may provide tissue compression and spacing control during needle firing. Once elongated member 114 has completed one stroke, it may be retracted, leaving sled 120 and lower clamping member 118 at a distal portion of stapler 100. Although other means of capturing sled 120 are contemplated, in some embodiments, one or more detents (not shown) may be located at a distal portion of cartridge 108, sliding wall 110, or jaw 104 to capture sled 120 at the distal portion.

[0014] By disengaging the lower clamping member 118 before retracting the elongated member 114, the elongated member 114 does not clamp the jaws 102, 104 of the device during the retraction motion. One advantage of disengaging the lower clamping member 118 before retraction is that it can reduce the force required to retract the elongated member 114, which can be a primary driver for the handle design in some surgical staplers. For example, some surgical staplers currently on the market include a separate lever that the user must pull back (using a second hand) to retract the member. Other staplers require an additional trigger operation to retract the member. Still others rely on a motor to drive and / or retract the member.

[0015] Another advantage of disengaging lower member 118 from elongate member 114 is that if stapler 100 malfunctions or is fired into an obstacle and / or member 114 becomes stuck mid-stroke, the user has the ability to disengage member 114 from lower clamp or jaw 104 and release the tissue. In existing staplers, if the drive member becomes stuck mid-stroke and cannot be retracted, the tissue must be severed from the jaws.

[0016] 9 and 10 show an example of member 114 moving distally with sled 120, upper clamp member 116, and lower clamp member 118. FIG. 11 shows elongated member 114 retracting with upper clamp member 116, after which sled 120 and lower clamp member 118 are disengaged and positioned at a distal portion of stapler 100. Those skilled in the art will recognize that although upper clamp member 116 and lower clamp member 118 are described herein with specific features, the situation may be reversed, with lower clamp member 118 disengaged and upper clamp member 116 remaining at a distal portion of anvil 102. Those skilled in the art will also recognize that while the elongated member 114 illustrated in Figures 9-11 includes slots (described in further detail herein) to aid in manipulation of the jaws 102, 104, this feature is not necessary for the functionality of the upper and lower clamping members 116, 118, the detachable sled 120, and / or the detachable lower clamping member 118. See, for example, Figures 12 and 13, which illustrate a member 114 without a slot.

[0017] In some embodiments, stapler 100 may include an escape mechanism (not shown) to provide the user with the ability to withdraw member 114 if member 114 becomes stuck mid-stroke.

[0018] 14-25 , in some embodiments, the elongated member 114 may include a slot 132 that engages with a cross member 130 on the anvil 102 to control the anvil 102. For example, the cross member 130 may be disposed on a proximal portion of the anvil 102, and the elongated member 114 may actuate the anvil 102 to rotate and translate within the vertical pivot slot 128. In some embodiments, the member 114 may open the anvil 102 as the member 114 moves proximally. Distal movement of the member 114 may close the anvil 102. Closing the anvil 102 may cause the anvil to pass through three different configurations: Position 1: open; Position 2: zero gap / trocar position; and Position 3: tissue gap / clamp position. These configurations are described in more detail below. Actuating the anvil 102 in this manner eliminates the need for an additional actuator to effect anvil movement.

[0019] 17 and 18, when member 114 is pulled proximally, anvil pin or cross member 130 can be forced or cammed downward within slot 132 to open anvil 102 or place stapler 100 in a first configuration. Anvil 102 rests at the bottom of one or more pivot slots 128 such that one or more anvil pins 126 abut a lower portion of slot 128, as shown in FIG.

[0020] Turning to FIG. 20 , as member 114 is pushed distally toward Position 2, a pin or cross member 130 in anvil 102 slides higher within slot 132 to a position that positions anvil 102 to pass through a trocar (zero tissue gap). As shown in FIGS. 21 and 22 , spring 124 and / or elastomer 122 urges anvil 102 downward within pivot slot 128 of lower jaw 104 or cartridge 108, urging anvil 102 to this position, with stapler 100 in the trocar configuration or second configuration. See also FIG. 23 . Those skilled in the art will also recognize that slot 132 may include an angle between Positions 1 and 2. This angle may be selected to control the linear stroke required to move between Positions 1 and 2.

[0021] 24 and 25, as member 114 is pushed further distally to position 3, pin or cross member 130 in anvil 102 is pushed further upwardly within slot 132, thereby applying a clamping force at the distal end of anvil 102. Figure 24 shows stapler 100 in a tissue clamping configuration, or third configuration.

[0022] Returning now to FIG. 14 , in some embodiments, a cutting mechanism 140 for a surgical stapler, such as the stapler 100 illustrated in FIG. 1 , may include an elongated member 114 having a length and a height, a proximal portion 142, a distal portion 144, and an elongated slot 132 extending a portion of the length of the elongated member 114. The distal portion 144 has a cutting surface 146, such as for severing tissue clamped between the jaws 102, 104 of the stapler 100. The elongated slot 132 may have a distal slot portion 150, an intermediate slot portion 152, and a proximal slot portion 154. The distal slot portion 150 may be either higher or lower than the intermediate slot portion 152. The proximal slot portion 154 may be located either higher or lower than the intermediate slot portion 152. In some embodiments, a vertical gap is provided between the distal slot portion 150 and the intermediate slot portion 152. The vertical spacing may be a function of the desired tissue gap, which may be greater than, less than, or equal to the gap that the I-beam 114 imposes on the housing and anvil during deployment. The upper clamping member 116 may be adjacent to the distal portion 144 of the elongate member 114. The lower clamping member 118 may be adjacent to the distal portion 144 of the elongate member 114. As shown in FIG. 13 , one of the upper clamping member 116 or the lower clamping member 118 may be detachable from the elongate member 114, and the other of the upper clamping member 116 or the lower clamping member 118 may be fixed to the elongate member 114.

[0023] In some embodiments, the surgical stapler includes a cutting mechanism as described above and a sled 120 for expelling the needle, the sled 120 being translated distally by the elongated member 114, and the sled 120 and lower clamping member 118 being positioned at the distal portion of the stapler while the needle is expelled.

[0024] A method of operating a surgical stapler may include (1) placing the cutting mechanism in a proximal position, thereby placing the stapler in an open configuration; (2) placing the cutting mechanism in an intermediate position, thereby placing the stapler in a trocar configuration; and (3) placing the cutting mechanism in a distal position, thereby placing the stapler in a tissue clamping configuration.

[0025] 26-28, a surgical needle is shown. In some embodiments, the needle 2600 can have a backspan 2602 disposed between a pair of staple legs 2604. The legs 2604 can form an angle with respect to the backspan. The backspan 2602 and legs 2604 can be formed by bending wire or metal components, as is known in the art.

[0026] In some embodiments, the backspan 2602 has a length L. The length L may be substantially aligned with the intended staple line. The length L may be greater than the width of the backspan 2602. In some embodiments, the length L is greater than about 3 millimeters. In some embodiments, the length is greater than about 4 millimeters. In some embodiments, the length L is about 5 millimeters. In some embodiments, the length L of the backspan 2602 is greater than the length of one or more of the legs 2604.

[0027] The bend between the backspan 2602 and one or both legs 2604 may be a recess 2606. The recess 2606 may be a portion cut out of the material forming the backspan 2602 and legs 2604, and may be referred to herein as a notch. The notch may be formed by displacing material (such as by a stamping operation) or by removing material.

[0028] In some embodiments, the recesses 2606 affect the folding direction of the associated staple leg 2604. The recesses 2606 may reduce the incidence of leg buckling and / or may reduce the force required to fold the leg 2604 relative to the backspan 2602.

[0029] In some embodiments, the recesses 2606 are positioned to cause the legs 2604 to form inward (eg, flush with or parallel to the backspan 2602) after stapling.

[0030] In some embodiments, the recesses 2606 may be circumferentially disposed around the legs 2604 to form legs that span the backspan 2602 .

[0031] 29-31 , in some embodiments, the needle 2800 may include a flattened backspan 2802 and one or more rounded legs 2804. The combination of a rounded wire and a flat wire may better accommodate tissue variability. For example, if the tissue being stapled is thick, the backspan 2802 may be flattened and displaced into an area where the staple gap is large. If the tissue is thin relative to the formed staple gap, the staple legs 2804 may approach the tissue wall and the rounded corners may pinch and secure it. Additionally, a flat backspan has more contact area with the tissue and therefore does not slide around on the tissue.

[0032] 32 , in some embodiments, the needle 2600 may include a textured surface 2610. The textured surface 2610 may be positioned and configured to promote coagulation around the portion of the needle that remains in contact with the stapled tissue. For example, the textured surface 2610 may be a surface proximal to where the backspan 2602 transitions into the legs 2604. In some embodiments, one or both legs 2604 may include a proximal leg 2604a proximal to the backspan 2602 and a distal leg 2604b distal to the backspan 2602, with some or all of the proximal leg 2604a having the textured surface 2610 and the distal leg 2604b not having the textured surface. In some embodiments, the proximal leg 2604a has a larger envelope cross-section than the distal leg 2604b to ensure that the proximal leg 2604a remains in contact with the tissue after stapling. In some embodiments, the majority of the surface of the distal legs 2604b and backspan 2602 is untextured.

[0033] In some embodiments, some or all of the surface area intended to contact the stapled tissue may be textured. In some embodiments, the textured surface 2610 is provided by mechanical (e.g., knurling, stamping, blasting, etc.), chemical (e.g., etching, etc.), and / or other energy (e.g., EDM, laser, etc.) methods.

[0034] In some embodiments, and as shown in FIG. 33 , a portion or all of the needle 2600 may be coated with a clotting agent 2612, which may be referred to herein as a clotting agent. In some embodiments, one or more textured surfaces 2610 are partially or completely coated with the clotting agent 2612. The clotting agent 2612 may include, for example, an active absorbable collagen hemostatic agent, such as that sold by CRBard under the trade name Avitene®, to promote clot formation. The clotting agent 2612 may be provided to promote platelet aggregation and / or the release of proteins to form fibrin. The clotting agent 2612 may include hemostatic granules, such as those sold by Celox Medical under the trade name Celox®, and / or other clotting agents, such as, for example, silver nitrate.

[0035] 33 and 34, the one or more recesses 2606 can be located a distance from the point of attachment between the backspan 2602 and one or more legs 2604. That is, the location and / or notch size of the recesses 2606 on the legs 2604 can be controlled to achieve a desired gap G between the legs and backspan of the formed staple. In some embodiments, the recesses 2606 are located between the proximal leg 2604a and the distal leg 2604b.

[0036] In some embodiments, the needle 2600 may be configured to pierce tissue only once with each staple leg 2604. That is, the needle 2600 may be configured to wrap, or otherwise pierce, the staple legs 2604 to prevent the needle 2600 from penetrating tissue stapled with the same leg 2604 twice. Applicant believes that limiting tissue piercing is particularly beneficial when needling the vasculature.

[0037] 28 , the needle 2600 may be configured to form a flattened staple shape after stapling that has a gap between any portion of the staple leg 2604 and the backspan 2602 that is less than about 0.012 inches (0.3048 mm) or less than 0.31 mm. In some embodiments, the gap is greater than 0.002 inches (0.0508 mm) and less than about 0.006 inches (0.1524 mm). In some embodiments, the gap G is between about 0.004 inches (0.1016 mm) and about 0.006 inches (0.1524 mm). In some embodiments, the gap G is about 0.005 inches (0.127 mm). In some embodiments, the gap is between 0.09 mm and 0.16 mm. In some embodiments, the gap is less than about 0.004 inches (0.1016 mm) or less than 0.12 mm. This results in the staple legs being "flattened" to provide a consistent tissue gap and distribute clamping pressure evenly across the tissue, as opposed to arched legs which create a variable tissue gap.

[0038] In some embodiments, as shown in FIG. 34 , the needle 2600 may be configured to have a gap G greater than 0.012 inches (0.3048 mm), such as when joining thick tissue is desired. In some embodiments, one or more legs 2604 may have a proximal leg 2604a and a distal leg 2604b configured to provide the tissue gap G. In some embodiments, the tissue gap G may be greater than 0.012 inches (0.3048 mm). In some embodiments, the tissue gap G may be less than 0.012 inches (0.3048 mm). In some embodiments, the tissue gap G may be greater than 0.006 inches (0.1524 mm). In some embodiments, the tissue gap G may be less than 0.006 inches (0.1524 mm). The tissue gap G may be between about 1 mm and about 2.5 mm for some thick tissue applications. Those skilled in the art will recognize that the placement of one or more recesses 2606 controls the size of the gap G. Those skilled in the art will recognize that the size of the gap G can be related to the length of the needle leg.

[0039] The following clauses set forth further exemplary aspects that are useful in understanding the appended claims.

[0040] Clause (1): A cutting mechanism for a surgical stapler, the cutting mechanism having an elongated member having a length and a height, a proximal portion, a distal portion, and an elongated slot extending a portion of the length of the elongated member, the distal portion having a cutting surface, the elongated slot having a distal slot portion, an intermediate slot portion, and a proximal slot portion, the distal slot portion being positioned at one of a higher position and a lower position than the intermediate slot portion, and the distal slot portion being positioned at the other of a higher position and a lower position than the intermediate slot portion, and further comprising a first clamp member adjacent to the distal portion of the elongated member.

[0041] Clause (2) The cutting mechanism of clause (1), wherein the distal portion is configured to releasably engage a second clamping member adjacent the distal portion of the elongate member.

[0042] Clause (3) The cutting mechanism of clause 2, wherein the first clamp member is an upper clamp member secured to the elongated member and the second clamp member is a lower clamp member, the upper clamp member and the lower clamp member being configured to limit a space between the upper clamp member and the lower clamp member.

[0043] Clause (4) The cutting mechanism of clause 1, wherein the second clamping member further comprises a sled configured to engage one or more staple pushers.

[0044] Clause (5) A surgical stapler comprising: a cartridge containing at least one needle; an anvil movable relative to the cartridge; a cutting mechanism according to claim 1 movable between a proximal position and a distal position relative to the cartridge; and a sled for pushing the at least one needle, wherein the elongated member is configured to engage with the sled during a first movement from the proximal position to the distal position, thereby pushing the at least one needle during the first movement.

[0045] Clause (6) A surgical stapler as described in clause 5, wherein the elongated member is configured to disengage from the sled during the second movement from the distal position to the proximal position, thereby placing the sled at a distal position of the cartridge.

[0046] Clause (7) A surgical stapler as described in clause 5, wherein the first clamp member of the cutting mechanism is an upper clamp member fixed to the elongated member, and the second clamp member is a lower clamp member, and the upper clamp member and the lower clamp member are configured to limit the space between the upper clamp member and the lower clamp member.

[0047] Clause (8) The surgical stapler according to clause 5, wherein the thread is secured to the second clamping member.

[0048] Clause (9) The surgical stapler according to clause 5, further comprising a resilient member configured to bias the anvil toward or away from the cartridge.

[0049] Clause (10) The surgical stapler according to clause 5, further comprising a resilient member configured to bias the anvil toward the cartridge.

[0050] Clause (11) A surgical stapler according to clause 9 or clause 10, characterized in that when the elongated member is in an intermediate position between the proximal position and the distal position, the elastic member and the first clamping member cooperate to position the anvil in the tissue clamping structure.

[0051] Clause (12) A method of operating a surgical stapler having an anvil movable relative to a staple cartridge, the method including: positioning a cutting mechanism at a proximal position where the cutting mechanism engages with the anvil at a first position on the cutting mechanism, thereby positioning the stapler in an open configuration where the anvil and cartridge are spaced apart; positioning the cutting mechanism at an intermediate position where the cutting mechanism engages with the anvil at a second position on the cutting mechanism, thereby positioning the stapler in a trocar configuration where the anvil and cartridge are fully clamped; and positioning the cutting mechanism at a distal position where the cutting mechanism engages with the anvil at a third position, thereby positioning the stapler in a tissue clamping configuration where the anvil and cartridge are substantially parallel to each other and have a tissue gap therebetween.

[0052] Clause (13) The method according to clause 12, wherein the first position is distal and lower than the second and third positions, and the second position is distal and lower than the third position.

[0053] Each of the various elements disclosed herein may be implemented in a variety of ways. The present disclosure should be understood to encompass each such variation, whether it be a variation of any apparatus embodiment, method, or process embodiment, or merely a variation of any of these elements. In particular, it should be understood that the terms describing each element may be expressed in equivalent apparatus or method terms, even if only the function or result is the same. Such equivalent, broader, or more general terms should be considered to be encompassed in the description of each element or operation. Such terms may be substituted where necessary to make explicit the implicitly broad scope to which the present invention is entitled.

[0054] While merely an example, it should be understood that any action can be expressed as a means for taking that action or as an element that causes that action. Similarly, each physical element disclosed should be understood to encompass a disclosure of the action that the physical element facilitates. With regard to this last aspect, a disclosure of a "fastener" should be understood to encompass a disclosure of the act of "fastening," whether or not explicitly discussed, and conversely, if there were only a disclosure of the act of "fastening," such disclosure should be understood to encompass a disclosure of a "fastening mechanism." All such variations and alternative terms should be understood to be expressly included herein.

[0055] Furthermore, any claim that recites "at least one of A, B, and C" shall be construed to read as an apparatus requiring only "A." It shall also be construed to read as an apparatus requiring only "B." The claim shall also be construed to read as an apparatus requiring only "C."

[0056] Similarly, the claim should be read as: apparatus requiring "A+B." The claim should also be read as: apparatus requiring "A+B+C," etc.

[0057] Additionally, the claims are to be construed such that any relative language (e.g., perpendicular, straight, parallel, flat, etc.) is understood to include the statement "any manufacturing tolerances are large, within reasonable manufacturing tolerances at the time the device was manufactured or at the time of the invention."

[0058] Those skilled in the art will readily recognize that numerous modifications and substitutions may be made in the invention, its use, and its configuration to achieve substantially the same results as those achieved by the embodiments described herein.

[0059] Accordingly, it is not intended that the invention be limited to the exemplary forms disclosed, and many modifications, variations, and alternative constructions are within the scope and spirit of the invention as expressed in the appended claims.

Claims

1. A surgical staple, comprising: a pair of staple legs; a backspan disposed between the pair of staple legs, the backspan transitioning to the pair of staple legs at a bend; one of the bends includes a recess configured to reduce the force required to move one of the staple legs in a single direction relative to the backspan during stapling of tissue; The surgical staple is configured to pierce tissue only once with the staple legs during stapling of the tissue.

2. 2. The surgical staple of claim 1, wherein the recess in one of the bends is configured to reduce the force required to move one of the staple legs through a bend in one of the bends having the recess.

3. The surgical staple of claim 1 , wherein the surgical staple is configured to form a tissue gap between one of the staple legs and the backspan to clamp the tissue.

4. The surgical staple of claim 3 , wherein the tissue gap is less than 0.3048 mm.

5. The surgical staple of claim 3 , wherein the tissue gap is greater than 0.3048 mm.

6. The surgical staple of claim 1 , wherein the backspan includes a flat surface for engaging tissue after stapling of the tissue.

7. The surgical staple of claim 1 , further comprising a textured surface.

8. The surgical staple of claim 1 , further comprising a coagulant coating.

9. A surgical stapler comprising a cartridge, the cartridge housing the surgical staple of any one of claims 1 to 8.

10. 1. A method for manufacturing a surgical staple, comprising: Providing a wire; bending the wire to form a pair of staple legs and a backspan between the pair of staple legs, the formed backspan transitioning to each of the staple legs at a respective bend, at least one of the bends having a recess; the recess is formed by displacing or removing material from the wire; the recess formed in at least one of the bends is configured to reduce the force required to move one of the staple legs in a single direction relative to the backspan during surgical stapling.

11. 11. The method of claim 10, wherein the recess in at least one of the bends is configured to reduce the force required to move one of the staple legs through a bend in at least one of the bends having the recess.

12. 11. The method of claim 10, wherein the surgical staple is configured to form a tissue gap between one of the staple legs and the backspan to clamp tissue, the tissue gap being less than 0.3048 mm.

13. 11. The method of claim 10, wherein the surgical staple is configured to form a tissue gap between one of the staple legs and the backspan to clamp tissue, the tissue gap being greater than 0.3048 mm.

14. 11. The method of claim 10, further comprising providing a textured surface by mechanical, chemical, and / or other energetic treatment.

15. The method of claim 10, further comprising coating at least a portion of the surgical staple with a coagulant.

Images