Universal Linear Surgical Suture Support

Abstract

A universal linear surgical suture support is disclosed. A surgical support carrier assembly includes a support carrier and a support material. The support carrier has a body, a distal end, and a lateral side; the carrier has at least one distal extension post at the distal end, at least one first lateral extension post at the first lateral side, and at least one second lateral extension post at the second lateral side. The support carrier has an inner edge adjacent to the distal end and a proximally extending hook extending from the inner edge. The support material has an elongated shape, a distal end, and a first lateral side and a second lateral side; the support material has at least one opening at the distal end, at least one first side opening adjacent to the first lateral side of the support, and at least one second side opening adjacent to the second lateral side of the support.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 668,858, filed on May 9, 2018, and U.S. Provisional Patent Application No. 62 / 668,851, filed on May 9, 2018, the entire contents of each of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present application relates to a surgical buttress assembly, a surgical suturing device and a buttress assembly, and a method of assembling a buttress to a surgical stapler, and more particularly to an endoscopic surgical buttress, an endoscopic surgical stapler, and an assembly and a kit. Background Art

[0004] As medical and hospital costs continue to increase, surgeons are constantly striving to develop advanced surgical techniques. Advances in the surgical field often involve the development of surgical techniques that involve less invasive surgical procedures and reduce overall patient trauma. In this way, hospital stays can be significantly reduced, thereby reducing hospital and medical costs.

[0005] The present disclosure includes but is not limited to use with endoscopic surgery, which is a great improvement that reduces the invasiveness of surgical procedures and improves recovery time. In general, endoscopic surgery involves resection through, for example, the body wall, observation and / or surgery on the ovaries, uterus, gallbladder, intestines, kidneys, appendix, etc. There are many common endoscopic surgical procedures, including, for example, arthroscopy, laparoscopy (pelvicoscopy), gastroenteroscopy, and laryngobronchoscopy. In general, a trocar is used to form an incision through which endoscopic surgery is performed, and the trocar is used with a cannula assembly to form a passage in the abdominal space and maintain pneumoperitoneum. The trocar tube or cannula device extends into the abdominal wall and remains therein to provide a passage for endoscopic surgical tools. A camera or endoscope is inserted through a relatively large diameter trocar tube, which is generally located at the naval incision and allows visual inspection and magnification of the body cavity. The surgeon can then perform diagnostic and therapeutic procedures at the surgical site with the aid of specialized instruments such as forceps, cutting knives, applicators, etc. designed to fit through additional cannulas. Thus, as opposed to large incisions through major muscles (typically 12 inches or more), patients undergoing endoscopic surgery receive more cosmetic incisions between 5 and 10 millimeters in size. As a result, recovery is much faster, and patients require less anesthesia than with traditional surgery. Additionally, because the surgical field is greatly magnified, the surgeon is better able to dissect blood vessels and control blood loss. Because the incisions are smaller, heat and water losses are greatly reduced. To address the specific needs of endoscopic and / or laparoscopic surgical procedures, endoscopic surgical suturing devices have been developed and disclosed in the following patents, for example: U.S. Pat. No. 5,040,715 (Green et al.); U.S. Pat. No. 5,307,976 (Olson et al.); U.S. Pat. No. 5,312,023 (Green et al.); U.S. Pat. No. 5,318,221 (Green et al.); U.S. Pat. No. 5,326,013 (Green et al.); and U.S. Pat. No. 5,332,142 (Robinson et al.).

[0006] In many surgical procedures (including those involved in open and endoscopic surgery), it is often necessary to perform tissue suturing. It is particularly challenging during endoscopic surgery because there is a small opening through which tissue suturing must be completed. The instrument for this purpose can include two elongated members, which are used to capture or clamp tissue respectively. Surgical devices in which tissue is first grasped or clamped between relative jaw structures and then engaged by surgical fasteners are well known in the art. Typically, one of the members carries a fastener bin that accommodates a plurality of staples arranged in at least two lateral rows, and the other member has an anvil that defines a surface for forming staple legs when staples are driven from the staple bin. The fastener is typically in the form of a surgical staple, but a two-part polymer fastener may also be used. In general, the suturing operation is performed by a cam bar or wedge that travels longitudinally through the staple bin, wherein the cam bar acts on a staple pusher to eject staples in sequence from the staple bin. The knife can travel between the rows of staples to longitudinally cut and / or open the stapled tissue between the rows. Such instruments are disclosed, for example, in U.S. Pat. Nos. 3,079,606 and 3,490,675.

[0007] Later, a stapler was disclosed in U.S. Pat. No. 3,499,591 that applies double rows of staples on each side of the incision. This is achieved by providing a disposable loading unit in which a cam member moves through an elongated guide path between two sets of staggered staple-bearing grooves. The staple drive member is located in the groove and is positioned so as to contact the longitudinally moving cam member to perform ejection of the staples from the staple cartridge of the disposable loading unit. The assignee of the present application, USSurgical, has been manufacturing and selling endoscopic suturing instruments for several years. Examples of such instruments include the Multifire ENDO GIA TM 30 AND ENDO GIA TM Endoscopic Surgical Instruments. Other examples of such staplers are disclosed in U.S. Patent Nos. 4,429,695 and 5,065,929.

[0008] Some endoscopic surgical staplers have a stapler jaw that is integral to the stapler handle, and the surgical staple cartridge is removable and replaceable for continued use on the same patient. In other configurations, a surgical suturing reloading unit has a stapler jaw and a body that can be attached to the suturing handle. The reloading unit can be used, removed, and replaced with a reloading unit having a new set of staples ready to be fired. A reloading unit having a stapler buttress material pre-attached to the jaw has been developed as an Endo GIA TM Reinforced reloading unit.

[0009] However, the surgical suturing buttress can be provided separately from the suturing device. The buttress can be used with circular surgical staplers, linear surgical staplers for open surgery, endoscopic instruments, and other types of staplers and instruments.

[0010] Surgical buttress materials can be used in combination with these instruments as reinforcement to staple lines to further promote the correct formation of staples while reducing distortion / deformity caused by any misalignment or abnormal or uneven tissue. Surgical buttresses can provide support for weakened tissues or assist in resolving differences in tissue thickness. These instruments provide significant clinical benefits. Nevertheless, improvements can also be made, for example, by reducing the complexity of manufacturing and / or application, or by expanding the range of application of buttress materials.

[0011] A surgical buttress for use with a surgical suturing device having a jaw is disclosed in U.S. Pat. No. 8,348,130 to Shah et al., the entire disclosure of which is incorporated herein by reference in its entirety. The buttress disclosed therein has a first main body portion and a second main body portion. The first main body portion can be applied to a first jaw, which can be a staple cartridge of the suturing device, and the second main body portion can be applied to a second jaw, which can be a staple anvil. It is also disclosed that the first main body portion of the buttress can be attached to a staple cartridge replacement. When the staple cartridge is attached to the surgical suturing device, the second main body portion can be attached to the staple anvil.

[0012] Improvements in surgical buttresses are desired to permit reuse of certain instruments or portions thereof and to allow surgical stapling instruments and other devices to be configured in a variety of ways. Summary of the invention

[0013] In one aspect of the present disclosure, a surgical buttress carrier assembly includes a buttress carrier and a buttress material. The buttress carrier has a body, a distal end, and lateral sides; the carrier has at least one distal extension post at the distal end, at least one first lateral extension post at the first lateral side, and at least one second lateral extension post at the second lateral side. The first lateral side is opposite to the second lateral side. The buttress carrier has an inner edge adjacent to the distal end and a proximal extension hook extending from the inner edge. The buttress material has an elongated shape, a distal end, and a first lateral side and a second lateral side; the buttress material has at least one opening at the distal end, at least one first side opening adjacent to the first lateral side of the buttress, and at least one second side opening adjacent to the second lateral side of the buttress. The at least one distal opening receives the at least one distal extension post, the at least one first side opening receives the at least one first lateral extension post, and the at least one second side opening receives the at least one second lateral extension post.

[0014] In the surgical buttress carrier assembly, the at least one distally extending post may include a first distal post and a second distal post, the at least one first laterally extending post may include a first lateral post and a second lateral post, and the at least one second laterally extending post may include a third lateral post and a fourth lateral post. In other embodiments, there are four posts on one lateral side, four posts on another lateral side of the carrier, and two posts on the distal end, with the buttress material having corresponding openings.

[0015] In one embodiment, a surgical buttress carrier assembly has a buttress material having first and second distal openings, first and second side openings, and third and fourth side openings.

[0016] The buttress carrier may extend from a proximal end of the buttress material to a distal end of the buttress material.The buttress carrier may have a shape corresponding to a shape of at least one of an anvil stapler jaw and a cartridge stapler jaw.

[0017] In yet another aspect, a staple cartridge assembly includes a staple cartridge body that accommodates a plurality of staples in staple retaining slots, accommodates a staple pusher, and defines a knife slot. The assembly includes a support member carrier having a body, a distal end, and lateral sides, the carrier having at least one distally extending post at the distal end, at least one first laterally extending post at a first lateral side, and at least one second laterally extending post at a second lateral side, wherein the first lateral side is opposite the second lateral side, the support member carrier having an inner edge adjacent to the distal end, and a proximally extending hook extending from the inner edge that engages with the knife slot of the staple cartridge body. The component has a support material having an elongated shape, a distal end, and a first lateral side and a second lateral side, the support material having at least one distal opening at the distal end, at least one first side opening adjacent to the first lateral side of the support, and at least one second side opening adjacent to the second lateral side of the support, the at least one distal opening receiving the at least one distal extension column, the at least one first side opening receiving the at least one first lateral extension column, and the at least one second side opening receiving the at least one second lateral extension column.

[0018] The at least one distally extending post may include a first distal post and a second distal post, the at least one first laterally extending post may include a first lateral post and a second lateral post, and the at least one second laterally extending post may include a third lateral post and a fourth lateral post.

[0019] The at least one opening may include a first distal opening and a second distal opening, the at least one first side opening may include a first side opening and a second side opening, and the at least one second side opening may include a third side opening and a fourth side opening. In other embodiments, the carrier may have two distally extending posts, four laterally extending posts on a first lateral side, and four laterally extending posts on a second lateral side, and the buttress material has a corresponding set of openings.

[0020] The buttress carrier may extend from the proximal end of the buttress material to the distal end of the buttress material.The buttress carrier may have a shape corresponding to the shape of a staple cartridge stapler jaw or anvil jaw.

[0021] On the other hand, a method of using a surgical stapler includes: grasping a first support member carrier assembly having a support member material; sliding the first support member carrier assembly in a proximal direction onto an anvil of the surgical stapler, firing staples from a staple magazine of the endoscopic surgical stapler; longitudinally dividing the support member material while dividing tissue; grasping a first portion of the support member material and grasping a second portion of the support member material and moving the first portion and the second portion laterally away from each other and away from the anvil, and removing the support member carrier and the surgical stapler from the surgical site.

[0022] The method may include sliding a second support carrier assembly onto a staple cartridge jaw of a surgical stapler.

[0023] On the other hand, a method of reloading a surgical stapling instrument includes: providing a staple cartridge assembly having a buttress material preloaded thereon; providing a buttress carrier assembly having a carrier and buttress material; engaging the staple cartridge assembly with a first jaw of the surgical stapling instrument; and engaging the buttress carrier assembly with a second jaw of the surgical stapling instrument having a staple anvil.

[0024] In the method, the buttress material may define an opening, and the carrier may have a post disposed in the opening to retain the buttress material on the carrier.

[0025] In yet another aspect, a surgical buttress carrier assembly includes a buttress carrier and a buttress material. The buttress carrier has a body and lateral sides, the carrier having a plurality of distal extension arms on each lateral side. The lateral sides include a first lateral side and a second lateral side, the first lateral side being opposite to the second lateral side. The buttress material has an elongated shape, a distal end, and a first lateral side and a second lateral side, the buttress material having a plurality of openings on the first lateral side of the buttress and the second lateral side of the buttress. The plurality of openings correspond to the plurality of distal extension arms. The buttress carrier assembly has an elongated member extending from a proximal side of the buttress carrier, and when the elongated member is pulled, the buttress carrier is separated from the buttress material.

[0026] The elongated member can be integral with the support material or separate and attached to the support material. The elongated member can be a suture. In one example, there are at least three distal extension arms on the first lateral side and at least three distal extension arms on the second lateral side. In another example, there are at least three openings on the first lateral side of the support and at least three openings on the second lateral side of the support.

[0027] The buttress carrier can extend from the proximal end of the buttress material to the distal end of the buttress material. The buttress carrier can flexibly conform to the shape of one selected from the anvil stapler jaw and the staple cartridge stapler jaw.

[0028] In another aspect, a surgical buttress component includes an elongated member, a folded portion, and a buttress portion, the folded portion folded over the buttress portion. The component forms an elongated tubular shape for receiving a selected one of an anvil stapler jaw and a cartridge stapler jaw, the component further comprising a feature selected from the group consisting of: a perforation, an elongated opening, and a weakened line separating the buttress portion from the folded portion.

[0029] The buttress component may be formed of a buttress material. The buttress component may be formed of a material selected from the group consisting of: a woven fabric, a nonwoven fabric, and a mesh. The buttress material may be formed of a bioabsorbable polymer. The elongated member may be long enough to extend the length of the endoscopic shaft of the endoscopic stapler and may be made of the same material as the buttress material. The elongated member is accessible outside the patient's body.

[0030] The elongated member may be a suture attached to the folded portion. The folded portion may be formed from more than one material segment. The folded portion may be made from the same material as the support material. Furthermore, the folded portion may be made from the same sheet of material as the support portion. The folded portion may be welded to form a tubular shape and / or attached to the support material.

[0031] On the other hand, a method of forming a surgical suture support member includes: providing a support material; forming at least one feature selected from the group consisting of: a perforation, an opening, and a weakened line, wherein the at least one feature defines a support portion and a folded portion; forming a slender member extending away from the support portion and the folded portion, the slender member being formed from the support material; folding the folded portion onto the support portion; and attaching the folded portion to itself or to the support portion to form a tubular shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The above and other aspects, features and advantages of the present disclosure will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0033] Figure 1 is a perspective view of an exemplary endoscopic surgical stapler according to the present disclosure;

[0034] Figure 2 is a diagram showing the sequence of firing of fasteners during a fastener application operation. Figure 1 An enlarged perspective view of an exemplary end effector of a surgical stapler;

[0035] Figure 2A yes Figure 2 A bottom perspective view of a distal portion of an exemplary anvil of an end effector shown in FIG.

[0036] Figure 3 is a perspective view of a support carrier assembly according to certain aspects of the present disclosure;

[0037] Figure 4 yes Figure 3 A perspective view of a support carrier assembly shown in FIG. 1 , the support carrier assembly being assembled with a jaw opening of an endoscopic suturing instrument;

[0038] Figure 5is a top view of a buttress material attached to a foam material by a linear row of staples;

[0039] Figure 6 is a top view of a buttress material attached to a foam material by linear rows of staples, wherein spaced apart portions of the buttress material are laterally displaced;

[0040] Figure 7 is a perspective view of a support carrier assembly attached to each jaw of an endoscopic stapling instrument;

[0041] Figure 8 yes Figure 7 A cross-sectional view of the distal end of the support carrier assembly and the jaws of the endoscopic suturing instrument shown in FIG.

[0042] Fig. 9 is a perspective view of an endoscopic suturing instrument having a support member disposed thereon according to several aspects of the present disclosure;

[0043] Fig.10 yes Fig. 9 A perspective view of an end effector of an instrument showing a support member component disposed thereon;

[0044] Fig.11 yes Fig. 9 and Fig.10 A perspective view of a support component separated from the device;

[0045] Fig.12 yes Figure 9-11 A plan view of the support member component in an unfolded state;

[0046] Fig.13 is a perspective view of an end effector of an endoscopic surgical stapling instrument according to another aspect of the present disclosure, and the endoscopic surgical stapling instrument has a support member disposed thereon. DETAILED DESCRIPTION

[0047] Specific embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the accompanying drawings and as described throughout the following description, and as in the conventional manner when relative positioning on an object is involved, the term "proximal" refers to the end of the device closer to the user, while the term "distal" refers to the end of the device farther from the user. In the following description, well-known functions or configurations are not described in detail to avoid obscuring the present disclosure in unnecessary detail.

[0048] Referring now to the drawings, in which like reference numerals designate identical or substantially similar parts throughout the several views, Figure 1A surgical stapling device 10 is shown. According to the present disclosure, the surgical stapling device 10 includes a housing 20 or handle and an elongated member 30 extending from the housing 20. An end effector 40 is disposed on one end of the elongated member 30. The end effector 40 includes first and second jaws 50, 60. The first jaw 50 is in the form of an anvil assembly, and the second jaw 60 receives a staple cartridge 62 (which may or may not be removable and replaceable). Figure 1 and Figure 2 , the staple cartridge 62 includes a cartridge housing 64 defining a longitudinal axis and including a tissue contacting surface 65 having a plurality of rows of staple retaining slots (also referred to herein as stapler slots and fastener slots) 66 formed therein that receive a plurality of fasteners or staples 70. Figure 2A As best shown in FIG. 1 , a plurality of staples 70 may be formed into a closed shape by fastener pockets 52 defined in a tissue contacting surface 54 of a first jaw 50 (anvil assembly).

[0049] The staple cartridge 62 defines a linear row of staple retaining slots 66 on either side of the knife slot 60a. The anvil has a corresponding linear row of staple pockets / recesses on either side of the knife slot 50a. Figure 2A During the firing of the staple 70, the staple firing mechanism moves distally through the staple cartridge and the anvil, ejecting the staple from the slot and driving it into the anvil pocket. The staple firing mechanism moves distally, interacts with the staple pusher, and the pusher drives the staple out of the slot 66. Figure 2 The staples 70 shown in the figure are supported by the pusher. The anvil pocket 52 is specially formed to bend the legs of the staples into a closed B-shape. The anvil 50 has a rear surface 51 opposite to the tissue contact surface 54, and the jaw 60 has a rear surface 61 opposite to the tissue contact surface 65 of the staple cartridge. See the example of an endoscopic stapler in U.S. Pat. No. 8,256,656 to Milliman et al., the entire contents of which are incorporated herein by reference in their entirety.

[0050] As in Figure 3 As best shown in FIG. 2 , surgical buttress material 202 is attached to a buttress carrier 204 to form a buttress carrier assembly 200. (As used herein, a "buttress" includes gauze, a pad, a buttress, or a staple line reinforcement structure). Buttress carrier 204 has a body 206 and at least one post 210 extending distally from body 206, the body having a distal end 208. Body 206 can be formed from a thin sheet of plastic or polymeric material, and post 210 can be integrally formed with the body. In the example shown, two distal posts 210a and 210b are disposed on the buttress carrier body.

[0051] The support carrier body 206 can be molded, cut, extruded or otherwise formed from a plastic / polymer material. The material for the carrier body can also be a thin metal sheet or foil. The carrier body defines a proximally facing hook 214 (at the inner edge 212 of the distal end 208 of the carrier body) Figure 8 206 is best shown in FIG. 20 . The hook 214 snaps into or otherwise engages the knife groove / slot to hold the sleeve on the staple cartridge or anvil after firing. The engagement of the hook 214 should be strong enough so that the carrier body 206 does not remain at the surgical site after firing the staples, but is removed with the surgical stapler.

[0052] The body 206 has two lateral sides 206a and 206b, and has at least one post 220 on each lateral side. The first side 206a of the body has at least one first side post 222, and the second side 206b has at least one second side post 224. In the example shown, the first side 206a has a first post 221, a second post 222, a third post 223, and a fourth post 224 extending laterally away from the body 206, while the second side 206b has a fifth post 225, a sixth post 226, a seventh post 227, and an eighth post 228 extending laterally away from the body. The first, second, third, and fourth posts extend in a direction opposite to the direction in which the fifth, sixth, seventh, and eighth posts extend. The posts may be slightly tilted upward (or downward), tilted away from the support material, to further assist in retaining the support material on the carrier 204.

[0053] In an embodiment, at least a portion of the surgical buttress 202 may be made of a biodegradable material selected from the group consisting of natural collagen materials, gut, and synthetic resins, including those derived from alkylene carbonates, trimethylene carbonate, tetramethylene carbonate, caprolactone, valerolactone, dioxanone, polyanhydrides, polyesters, polyacrylates, polymethyl methacrylate, polyurethanes, glycolic acid, lactic acid, glycolide, lactide, polyhydroxybutyrate, polyorthoesters, polyhydroxyalkanoates, homopolymers thereof, and copolymers thereof. In an embodiment, at least a portion of the surgical buttress 110 may be made of a non-biodegradable material selected from the group consisting of polyolefins, polyethylene, polydimethylsiloxane, polypropylene, copolymers of polyethylene and polypropylene, blends of polyethylene and polypropylene, ultra-high molecular weight polyethylene, polyamides, polyesters, polyethylene terephthalate, polytetrafluoroethylene, polyether esters, polybutylene, polytetramethylene ether glycol, 1,4-butanediol, and polyurethane.

[0054] The support material can be a nonwoven material, a mesh material, a woven material and / or a molded or extruded sheet formed by a meltblowing or meltspinning process. The support material 202 has a distal end 230 that defines at least one opening 232 that corresponds to one or more distal posts 210 in the support carrier 204. In the example shown, the support material has a distal end that defines two openings: a first distal opening 230a for receiving a first distal post 210a and a second distal opening 230b for receiving a second distal post 210b. In an alternative example, the post can be used to pierce the support material and form an opening. However, the post is preferably non-invasive to the tissue and has a rectangular shape with rounded corners (although other shapes can be used).

[0055] The support material 202 has a lateral side opening 240 to correspond to the side post 220. The support material 202 defines a first side opening 242 adjacent to one lateral edge 245 of the support material 202 and a second side opening 244 adjacent to another lateral edge 246 of the support material 202 to correspond to the post. In the illustrated example, the support material 202 has a first opening 251, a second opening 252, a third opening 253, and a fourth opening 254 adjacent to one lateral edge 245, and a fifth opening 255, a sixth opening 256, a seventh opening 257, and an eighth opening 258 adjacent to another lateral edge 246 of the support material. As discussed further below, the support material 202 can include perforations or weakened areas adjacent to the lateral portion of the support having an opening, and / or adjacent to the distal portion of the support material having one or more openings. The perforations and / or weakened areas can facilitate the removal of any excess material.

[0056] The surgical buttress is provided and / or sold separately as a surgical buttress carrier assembly 200 including buttress material 202 and buttress carrier 204. In other examples, the surgical buttress and buttress carrier are provided and / or sold separately and assembled by the user.

[0057] Regardless of the type with a replaceable staple cartridge or the type with a replaceable suture reloading portion, the surgical stapling instrument can be packaged together with a surgical buttress disposed on the tissue contacting surface of the staple cartridge and a buttress disposed on the tissue contacting surface of the staple anvil (see Figure 4 ) and is held thereon by a buttress carrier 204 extending over the opposing surface 61 of the corresponding staple cartridge 62 or the opposing or rear surface 51 of the anvil 50. Accordingly, in such an example, the buttress carrier is used to stabilize the buttress material, etc., during transportation.

[0058] Advantageously, the buttress carrier assembly 200 sold separately can be applied to any endoscopic nail anvil or nail magazine. The buttress carrier assembly 200 with the surgical buttress material 202 attached to the buttress carrier 204 is removed from its packaging. The user grasps the buttress carrier 204 and manipulates the assembly 200 to the surgical stapling instrument 300. It may be useful to make the buttress carrier 204 slightly harder than the buttress material 202 to facilitate the manipulation of the assembly. In addition, the buttress carrier 204 may include tabs, handles or other features, or a textured surface for gripping and manipulation.

[0059] Component 200 is slid onto the stapler jaw. Component 200 of elongated shape corresponds to the stapler jaw, which is conducive to easy application. Buttress material 202 is naturally arranged to the tissue contact surface of the adjacent staple cartridge or anvil. The shape of buttress carrier 204 can prompt the correct application of the component because it corresponds to the curved shape of the rear portion of the jaw. Hook 214 can be omitted from carrier 204, and in this case, component 200 is held on the jaw by the friction between carrier 204 and the jaw and between buttress material 202 and the jaw. Alternatively, component 200 can be attached to the instrument jaw using an adhesive, bound on the instrument jaw using sutures, or attached by some other methods.

[0060] Once the assembly 200 is applied to each jaw, the stapling instrument 300 is introduced into the surgical site through a trocar or other access device, as the buttress is typically applied to both the staple cartridge jaw 304 and the anvil jaw 306 when a surgical buttress is used. The stapler 300 is operated as usual and staples are fired into the tissue, transecting the tissue. As the tissue is transected, the buttress material 202 is also divided into a first portion 202a and a second portion 202b. Figure 5 In the example shown in , the separated support material 202 includes a distal tab 260 that is still attached to the tissue. The distal tab 260 can remain in the patient's body or can be removed using a scalpel or surgical scissors. In any example disclosed herein, the support material 202 can include perforations adjacent to the portion of the support having an opening so that excess material can be removed.

[0061] To remove buttress material 202 from stapling apparatus 300 and carrier 204, first buttress portion 202a is grasped and moved laterally, and second buttress portion 202b is moved in a lateral direction opposite to the first portion (see FIG. Figure 5 and Figure 6 ). In this manner, the buttress material slides out of the stapler 300 and the carrier 204. The carrier 204 may be removed using the stapling instrument 300, or may be removed separately.

[0062] In any of the embodiments disclosed herein, the carrier can be shaped to correspond to the particular jaw with which it is to be assembled (see Figure 4 In one example, the carrier 304 has a shape corresponding to the rear side of the anvil 306, and the carrier 204 corresponds to the rear side of the jaw of the staple cartridge. Figure 7 and Figure 8 In the embodiment, the profile of the nail anvil is lower and more curved in shape than the nail cartridge jaw, which is deeper and can be round or more rectangular in shape. In other examples, the carrier 204 can include perforations to facilitate removal from the instrument after use.

[0063] exist Figure 8 In the embodiment, the buttress carrier 204 is disposed on the cartridge jaw, and the buttress carrier 304 is disposed on the anvil 50. The buttress carrier 204 has a hook 214 that engages with the knife slot 60a, and the buttress carrier 304 has a hook 314 that engages with the knife slot 50a.

[0064] Figure 4 The support member carrier assembly on the staple cartridge jaw 304 and the anvil jaw 306 of the surgical stapler is shown. In an instrument with a removable and replaceable staple cartridge assembly, the staple cartridge assembly may have a support member preloaded thereon by the manufacturer. In these cases, the user may utilize a separately packaged support member carrier assembly 200 that is ready to be installed on the anvil of the instrument. Using the support member carrier assembly discussed above, surgical support member material may be attached to the surgical staple anvil. In this way, the surgical suturing instrument may be reused on the same patient by reloading with a staple cartridge assembly that has a new group of staples and new support member material ready to fire. As discussed above, the support member carrier assembly is conveniently applied to the stapler anvil of the stapler.

[0065] In any embodiment disclosed herein, the staple cartridge assembly accommodates surgical fasteners other than staples.In addition, the staple cartridge assembly with the buttress carrier assembly can be arranged to be used with an open stapling instrument, a circular stapling instrument, or other types of instruments.

[0066] In any embodiments disclosed herein, the support carrier assembly 200 can include or be used with sutures, straps with Velcro or other attachment features, adhesives, and the like.

[0067] In any embodiments disclosed herein, the surgical buttress material 202 can contain brachytherapy, chemotherapy, other medical materials or drugs, or can be used with them. The buttress material can have pockets, holes, or other features for holding brachytherapy particles with the buttress, or the brachytherapy particles or materials can be incorporated into one or more sutures that penetrate or pass through the buttress material or are otherwise attached thereto. A coating with brachytherapy material can be applied to the buttress material by spraying or dipping. Chemotherapeutic drugs or agents can be incorporated into the material of the buttress, coated thereon, or applied as part of the suture or suture or other features.

[0068] In general, a linear stapler (including open and endoscopic devices) can have two elongated members, which are used to capture or clamp tissue, respectively. Typically, one of the members carries a staple cartridge that accommodates a plurality of staples arranged in at least two transverse rows, and the other member has an anvil that defines a surface for forming staple legs when staples are driven from the staple cartridge. In general, the suturing operation is performed by a cam bar that moves longitudinally through the staple cartridge, wherein the cam bar acts on a staple pusher to eject staples in sequence from the staple cartridge. The cutter can travel between the rows of staples to longitudinally cut and / or open the tissue sutured between the rows of staples. Such an apparatus is disclosed, for example, in U.S. Patent No. 6,202,914, the entire contents of which are incorporated herein by reference in their entirety.

[0069] Some staplers apply double rows of staples on each side of the incision. This is achieved by providing a disposable loading unit in which a cam member moves through an elongated guide path between two sets of staggered staple-bearing grooves. The staple drive member is located within the groove and is positioned so as to contact the longitudinally moving cam member to perform ejection of the staples from the staple cartridge of the disposable loading unit. An example of such a stapler is disclosed in U.S. Patent No. 5,065,929, the entire contents of which are incorporated herein by reference in their entirety.

[0070] Some of the instruments described above are designed for use in conventional surgical procedures, where the surgeon directly manually accesses the surgical site. However, in endoscopic or laparoscopic surgical procedures, surgery is performed through a small incision or through a narrow cannula inserted through a small entry wound in the skin. To meet the specific needs of endoscopic and / or laparoscopic surgical procedures, endoscopic surgical suturing devices have been developed and are disclosed, for example, in U.S. Pat. No. 5,865,361, the entire contents of which are incorporated herein by reference in their entirety.

[0071] It is further contemplated that the surgical support can be configured to be used with a circular suturing device or a semicircular suturing device. Surgical suturing devices for applying annular arrays of staples or fasteners to tissues are well known in the art. These devices typically include a tool for controlling the interval between the fastener assembly and the anvil member at the distal end of the device. The fastener assembly generally includes a circular array of fasteners (such as staples), and the anvil member includes a tool for completing circular suturing (usually a barrel member array that fastens the staples after the staples are discharged from the fastener assembly), or may include a locking member for a suturing ring. Typically, the tool for advancing or retracting the anvil relative to the fastener assembly includes a wing nut type mechanism or a rotatable knob member located at the proximal end of the instrument, both of which engage with a worm gear arrangement device in the handle mechanism so that the anvil member is slowly and methodically advanced toward the fastener assembly.

[0072] In use, the circular instrument is positioned in the cavity of an organ (such as the stomach, esophagus or intestine) to perform suturing. The tissue is positioned between the anvil and the fastener assembly and is usually tied, for example, by a purse-string suture. Thereafter, the anvil member is advanced toward the fastener assembly by rotating a rotatable knob or wing nut assembly at the proximal end of the instrument to hold the tissue between the anvil member and the fastener assembly. When the staples or fasteners are ejected from the fastener assembly, the circular cutter usually removes unwanted tissue at the suture site after applying the staples. The instrument is then removed from the cavity of the organ.

[0073] Circular instruments are disclosed, for example, in US Pat. No. 5,915,616, the entire contents of which are incorporated herein by reference in their entirety.

[0074] In another U.S. Patent No. 5,137,198 to Nobis et al. ("Nobis"), a fastener applying apparatus is disclosed that includes a staple cartridge that is advanced toward an anvil assembly by an advancement mechanism. The advancement mechanism includes: a first actuator member that is used to advance the staple cartridge toward the anvil assembly at an accelerated rate; and a second actuator member that is spaced apart from the first actuator member and is used to advance the staple cartridge toward the anvil assembly in an incremental manner. Another example of a surgical stapler is disclosed in U.S. Patent No. 5,964,394, the entire contents of which are incorporated herein by reference in their entirety.

[0075] In yet another embodiment, the buttress component 500 can be formed of a buttress material and can include an elongated member 502, a folded portion 504, and a buttress portion 506. The buttress portion 506 is attached to the folded portion and separated from the folded portion by a perforation feature 508. The elongated member 502 is long enough to extend the length of the endoscopic shaft 602 of the endoscopic stapler 600 and is accessible outside the patient's body. Alternatively or additionally, the suture is attached to the elongated member, or to the folded portion 504. When the folded portion is folded onto the buttress portion, a tubular shape 510 is formed. The tubular shape 510 is large enough and shaped to facilitate receiving the staple anvil 604 or the staple cartridge jaw 606 of the stapler. When the elongated member 502 is pulled, the folded portion and the elongated member are separated from the buttress portion. The perforation feature can be omitted. The folded portion can be one or more material segments and can be made of the same material as the buttress material, or made of a different material. One or more folded portions may be welded, or an adhesive may be used, to form the tubular shape. Alternatively, the support material may be similarly attached to one or more folded portions or to itself.

[0076] from Fig. 9 As can be seen in the figure, the buttress component 500 is arranged on the anvil of the endoscopic suturing instrument. The folded portion 502 is arranged around the side 604a of the anvil opposite to the tissue contact side 604b. The elongated member 502 extends downward along the shaft 602 of the instrument and can terminate in a handle 602a or other graspable portion.

[0077] Perforation feature 508 may be a small pinhole in the buttress material, a larger opening 508a in the buttress material, or formed by a separate member attaching buttress portion 506 to folded portion 504. Perforation feature 508 may be a single feature, such as a line of weakness in one or more materials. Fig.10 In the embodiment, a larger opening is shown, and the buttress material is a nonwoven polyglycolide material, but other biocompatibles, bioabsorbables, wovens, nonwovens, meshes, polymers and copolymers can be used. The opening can be formed using a laser, a cutting blade or other methods. The material used for the buttress material can be as discussed above. In one example, component 500 is made of a piece of nonwoven polyglycolic acid and is laser cut to form the features discussed herein.

[0078] The folded portion 504 may be welded to itself or to the support portion 506. Fig.11 As shown in FIG. 5 , the first folded portion 512 is welded to the second folded portion 514 on either side of the support portion. The elongated member 502 may be integral with the support portion and / or one or more folded portions. Fig.11, the elongated member 502 is attached to the folded portion (at 513 ) by welding and may be the same material as one or more of the folded portions and / or the support portion 506 .

[0079] The entire support member component may be formed from a single sheet of material. Fig.12 As shown in , a starting material 520 is cut from a sheet and a perforated feature 508 is formed therein. The component 500 has a first folded portion 512, a second folded portion 514, a support portion 506, and an elongated member 502. The folded portions 512, 514 can be folded before the component 500 is placed on or around the anvil 604, or folded when the component 500 is applied to the anvil 604. One or more folded portions and the support portion can be attached to each other by welding, using an adhesive, by tying with sutures, etc.

[0080] In order to remove the suturing instrument after firing the staples, the elongated member 502 is pulled and the support portion is separated from the folded portion. The instrument, one or more folded portions, and the elongated member can be removed from the surgical site together or individually. Therefore, the support portion is sutured to the tissue and the rest of the components are torn apart from the support portion.

[0081] In another embodiment of the present disclosure, a support assembly 800 has a carrier 802, a support material 804, and an elongated member 606. Fig.13 As shown, the elongated member 606 may be a suture 608, or may be an extension of and integral with the carrier 802. The carrier 802 may be formed from a very thin sheet of material, such as ABS (acrylonitrile butadiene styrene) plastic, mylar, polyester, or any biocompatible material. Preferably, the carrier 802 is very thin, such as about 0.003 to about 0.008 thousandths of an inch. For example, the carrier 802 may be a thin, flexible polyester sheet having a thickness of about 0.006 thousandths of an inch.

[0082] The carrier 802 is formed to have an elongated shape and flexibly conform to the shape of the staple instrument anvil 604. The long sides 604a and 604b have distal extension arms 808 for directly engaging the buttress material 804. The buttress material 804 has sides 804a and 804b extending upward from the tissue contacting surface of the anvil 604. After firing the instrument, the sides 804a and 804b can be separated from the rest of the buttress material 804 and can provide perforations or weakened lines. The buttress material 804 has openings 805 on both sides of the buttress material 804 for receiving the arms 808 of the carrier 802.

[0083] After firing the suturing apparatus, pull the elongated member 606 and separate the carrier from the buttress material 804. Remove the buttress material and the elongated member from the surgical site. The arm has a hook shape in the distal direction of the stapler instrument end effector, and the buttress material can be held by the shape of the arm, or some adhesive can be used. In addition, some adhesive can be used to hold the buttress assembly 800 or the buttress component 500 on the suturing apparatus, or friction can be relied on to hold. The elongated member 606 can be a part of the carrier, or can be attached to the carrier, or sutures 812 can be used.

[0084] Although several embodiments of the present disclosure have been shown in the accompanying drawings, it is not intended to limit the present disclosure thereto, as it is intended that the present disclosure be as broad as the art will allow and the specification should be read in the same manner. Therefore, the above description should not be interpreted as limiting, but merely as an illustration of the preferred embodiments. Therefore, the scope of the embodiments should be determined by the appended claims and their legal equivalents, rather than by the examples given.

Claims

1. A surgical buttress component comprising an elongated member, a foldable portion and a buttress portion, the buttress portion being integral with the foldable portion, the elongated member extending longitudinally from and attached to the foldable portion, the foldable portion folded onto the buttress portion to form an elongated tubular shape for receiving a selected one of an anvil stapler jaw and a cartridge stapler jaw, the buttress portion and the foldable portion being separated from each other by a feature selected from the group consisting of a perforation and a weakening line, whereby pulling the elongated member separates the buttress portion from the foldable portion and the elongated member, wherein the buttress component is formed of a single sheet of material, wherein the foldable portion is composed of a first foldable portion and a second foldable portion on either side of the buttress portion and separated therefrom by the perforation or the weakening line, the elongated member extending from one of the foldable portions.

2. The surgical buttress component of claim 1, wherein: The support member is formed from a support material.

3. The surgical buttress component of claim 2, wherein: The buttress component is formed of a material selected from the group consisting of: a woven fabric, a nonwoven fabric, and a mesh.

4. The surgical buttress component of claim 2, wherein: The buttress material is formed from a bioabsorbable polymer.

5. The surgical buttress component of claim 1 , wherein: The elongated member is long enough to extend the length of the endoscopic shaft of the endoscopic stapler.

6. The surgical buttress component of claim 1, wherein: The elongated member is accessible outside the patient's body.

7. The surgical buttress component of claim 1, wherein: The elongated member is a suture attached to the foldable portion.

8. The surgical buttress component of claim 1, wherein: The foldable portion is one or more material sections.

9. The surgical buttress component of claim 1, wherein: The foldable portion is made of the same material as the support portion.

10. The surgical buttress component of claim 1, wherein: The foldable portion is made from the same sheet of material as the support portion, or the elongated member is made from the same sheet of material as the support portion, or one or more of the foldable portions and the elongated member are made from the same sheet of material as the support portion.

11. The surgical buttress component of claim 1 , wherein: The foldable portion is welded to form the tubular shape.

12. The surgical buttress component of claim 1, wherein: The foldable portion is attached to the support portion.

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