Buttress Retainer for EEA Anvil

[0001] 1. Technical Field

[0002] The present disclosure relates to a surgical instrument for applying surgical fasteners or staples to body tissue, and more particularly, to a surgical buttress assembly for use with an end-to-end anastomosis stapling apparatus.

[0003] 2. Background of Related Art

[0004] Anastomosis is a surgical joining of separate hollow organ sections. Typically, an anastomosis procedure follows surgery in which a diseased or defective section of hollow tissue is removed and the remaining end sections are joined. Depending on the desired anastomosis procedure, the end sections may be joined by either circular, end-to-end or side-to-side organ reconstruction methods.

[0005] In a circular anastomosis procedure, the two ends of the organ sections are joined by means of a stapling instrument which drives a circular array of staples through the end section of each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free the tubular passage. Typically, these instruments include an elongated shaft having a handle portion at a proximal end to actuate the instrument and a staple holding component disposed at a distal end. An anvil assembly including an anvil shaft with attached anvil head is mounted to the distal end adjacent the staple holding component. Opposed end sections of the organ to be stapled are clamped between the anvil head and the staple holding component. The clamped tissue is stapled by driving a plurality of staples from the staple holding component so that the ends of the staples pass through the tissue and are deformed by the anvil head.

[0006] In use, one end section of the organ is secured about the anvil assembly and the other end section of the organ is held in place adjacent the staple holding component. The shaft of the anvil assembly is removably connected to the instrument. Once the anvil shaft is secured to the instrument, the anvil is drawn into close approximation to the staple holding component. The instrument is then fired to cause the staples to pass through tissue of both sections of the organ and deform against the anvil. During the firing step, a circular knife is advanced to cut tissue inside the staple line, thereby establishing a passage between the two sections of the organ. After firing, the instrument is typically removed by withdrawing the anvil through the staple line, after which the surgeon will carefully inspect the surgical site to ensure a proper anastomosis has been achieved.

[0007] While circular staplers are helpful in a number of surgical procedures, complications such as anastomotic leak, tear of tissue during stapler extraction, bleeding, and other complications may arise. In order to remedy or reduce incidents of such complications, buttress or reinforcing materials have been utilized. However, due to inherent difficulties in positioning and securing such materials with the underlying surgical instrument, a need exists for a buttress material that can be safely and effectively positioned on an anvil assembly of the surgical instrument.

[0008] In accordance with an embodiment of the present disclosure, there is provided an apparatus for joining two hollow organ sections with an annular array of surgical staples. The apparatus includes a staple cartridge assembly, an anvil assembly, and a buttress assembly. The staple cartridge assembly includes a plurality of surgical staples in an annular array. The anvil assembly includes an anvil member and a shaft extending therefrom. The anvil member includes a proximal surface defining a plurality of staple pockets for deforming the surgical staples. The anvil assembly is movable relative to the staple cartridge assembly between spaced apart and approximated positions to adjustably clamp tissue between the staple cartridge and anvil assemblies. The buttress assembly includes a cut ring configured to engage a knife member, a buttress member, and a retaining member. The cut ring is secured with the anvil member. The buttress member is disposed in a superposed relation with the plurality of staple pockets defined in the anvil member. The retaining member has an attaching member configured to be secured with the cut ring to secure the buttress member between the cut ring and the retaining member, and to position the buttress member relative to the anvil assembly.

[0009] In an embodiment, the proximal surface of the anvil member may further define a recess defined radially inward of the plurality of staple pockets. The recess may be configured and dimensioned to securely receive the cut ring therein. In particular, the cut ring may be configured to engage an inner wall of the recess to provide securement of the cut ring thereagainst.

[0010] In another embodiment, the buttress member may have an annular configuration. The buttress member may include a bore configured and dimensioned to receive the attaching member of the retaining member therethrough. The attaching member may be a boss extending distally from the retaining member.

[0011] In yet another embodiment, the cut ring may define a bore configured and dimensioned to receive the boss. The boss may be secured to the bores of the cut ring through heat staking. The cut ring may include a proximal face having a base portion and a raised portion extending proximally from the base portion. The raised portion may be configured and dimensioned to engage the knife member. In an embodiment, the raised portion may be substantially flush with the proximal surface of the anvil member. In addition, the raised portion may be disposed at a peripheral portion of the cut ring.

[0012] In still yet another embodiment, the retaining member may have an annular configuration. The retaining member may be in a superposed relation with the buttress member. The retaining member may be concentrically aligned with the anvil member. A radially outer peripheral portion of the buttress member may be flush with a peripheral edge of the anvil member. The retaining member may be configured to engage a proximal face of the buttress member. The buttress member may be made of a biodegradable material.

[0013] In still yet another embodiment, the knife member may be concentrically arranged with the plurality of surgical staples in the staple cartridge assembly. The knife member may be movable relative to the staple cartridge assembly, wherein the retaining member is disposed radially inward of the knife member when the knife member is actuated to engage the buttress member. The buttress member may be concentrically aligned with the plurality of staple pockets and may be interposed between the cut ring and the retaining member. The buttress member and the cut ring may be concentrically arranged with each other.

[0020] Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal,” as is conventional, will refer to that portion of the instrument, apparatus, device or component thereof which is farther from the user while, the term “proximal,” will refer to that portion of the instrument, apparatus, device or component thereof which is closer to the user. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.

[0021] With reference to FIG. 1, a surgical stapling apparatus 10 for performing circular anastomosis of hollow organs is shown. Surgical stapling apparatus 10 drives a circular array of staples (not shown) through the end sections of each organ and simultaneously fires an cylindrical knife 76 to core any tissue interior of the driven circular array of staples to free the tubular passage, and thereby joining two ends of the organ. Surgical stapling apparatus 10 includes a handle assembly 20 having a pair of pivotable actuating handle members 22 and an advancing means 24 including a rotatable grip member 26, an elongate body portion 30 extending distally from handle assembly 20, and a head portion 50 including an anvil assembly 60, a staple cartridge assembly 70, and a surgical buttress assembly 100 (FIG. 3) in accordance with an embodiment of the present disclosure. The components of surgical stapling apparatus 10 are generally formed from thermoplastics including polycarbonates, and metals including stainless steel and aluminum. The particular material selected to form a particular component will depend upon the strength requirements of the particular component. The staples may be of a conventional type and may include a backspan having a pair of legs extending from the backspan. The legs terminate in tissue penetrating tips.

[0022] Handle assembly 20 can be actuated to approximate anvil assembly 60 relative to staple cartridge assembly 70 and to apply a pair of annular arrays of staples through tissue. In order to properly position tissue in head portion 50, rotatable grip member 26 may be rotated to move anvil assembly 60 axially relative to staple cartridge assembly 70 between a spaced apart position and an approximated position in which anvil assembly 60 is positioned adjacent staple cartridge assembly 70 to clamp tissue therebetween. Handle members 22 may be squeezed to fire the staples through tissue to join two segments “T₁,” “T₂” (FIG. 5) of tubular tissues together, as will be discussed in detail below.

[0023] Elongate body portion 30 is constructed to have a slightly curved/bent shape along its length. However, elongate body portion 30 may also be straight, as well as flexible to bend to any configuration. The length, shape and/or the diameter of elongate body portion 30 may be varied to suit a particular surgical procedure.

[0024] With reference to FIGS. 1-4, head portion 50 includes a staple cartridge assembly 70, an anvil assembly 60, and a surgical buttress assembly 100 detachably secured with anvil assembly 60. Staple cartridge assembly 70 may be fixedly connected to a distal end portion of elongate body portion 30 or may be configured to concentrically fit within the distal end portion of elongate body portion 30. In particular, staple cartridge assembly 70 defines a pair of annular arrays of staple receiving slots 72 having a staple disposed in each one of staple receiving slots 72. In addition, staple cartridge assembly 70 includes a cylindrical knife 76 concentrically arranged with the pair of annular array of staples and a plurality of staple pushers (not shown) each disposed in staple receiving slot 72 to eject the staple through slot 72. The staples travel through slots 72 and tissue toward anvil assembly 60.

[0025] Cylindrical knife 76 includes a distal rim defining a knife blade adapted to cut tissue and portions of surgical buttress assembly 100. Upon actuation of handle members 22, cylindrical knife 76 is moved distally to cut tissue and portions of buttress member 110, and the plurality of pushers are moved distally to eject the staples disposed in staple receiving slots 72 therethrough, toward anvil assembly 60.

[0026] With particular reference to FIGS. 2 and 3, positioned distally of staple cartridge assembly 70 is anvil assembly 60 including an anvil member 62 and a shaft 64 extending proximally from anvil member 62. Anvil member 62 includes a plurality of staple pockets 65 for receiving and deforming the staples. Shaft 64 is configured to be detachably received in approximation shaft 75 (FIG. 1) disposed in elongate body portion 30. Approximation shaft 75 is operatively coupled with rotatable grip member 26 of handle assembly 20, whereby rotation of rotatable grip member 26 moves approximation shaft 75 axially. Such axial movement of approximation shaft 75 is imparted to anvil assembly 60 detachably coupled with approximation shaft 75. In this manner, anvil assembly 60 is movable axially relative to staple cartridge assembly 70 between a spaced apart position and an approximated position in which anvil assembly 60 is positioned adjacent staple cartridge assembly 70 to adjustably clamp tissue between anvil assembly 60 and staple cartridge assembly 70.

[0027] With continued reference to FIGS. 2 and 3, surgical buttress assembly 100 includes a ring member, such as a cut ring 99, that is concentrically disposed within a recess 63 defined in anvil member 62, a buttress member 110, and a retaining member 120 concentrically arranged with buttress member 110. Cut ring 99 is configured to engage cylindrical knife 76. Buttress member 110 is provided to reinforce and seal staple lines applied to tissue by surgical stapling apparatus 10. Retaining member 120 is configured to secure buttress member 110 with anvil member 62. The ring member or cut ring resiliently engages the knife The cut ring is desirably made from a soft plastic that the knife cuts into, and improves the quality of the cut through the tissue.

[0028] Buttress member 110 is fabricated from a biocompatible material which is bio-absorbable or non-absorbable, as well as natural or synthetic materials. It should be understood that any combination of natural, synthetic, bio-absorbable, and non-bioabsorbable materials may be used to form buttress member 110.

[0029] In addition, buttress member 110 may be porous, non-porous, or combinations thereof. It is also envisioned that buttress member 110 described herein may contain a plurality of layers in which any combination of non-porous and porous layers may be configured. For example, buttress member 110 may be formed to include multiple non-porous layers and porous layers that are stacked in an alternating manner. In another example, buttress member 110 may be formed in a “sandwich-like” manner wherein the outer layers of buttress member 110 include porous layers and the inner layers are non-porous layers. Examples of multi-layered buttress members are disclosed in U.S. Patent Application Publication No. 2009/0001122, filed on Jun. 27, 2007, entitled “Buttress and Surgical Stapling Apparatus,” the entire disclosure of which is incorporated by reference therein.

[0030] In particular, the use of non-porous layers in buttress member 110 may enhance the ability of buttress member 110 to resist tears and perforations during the manufacturing, shipping, handling, and stapling processes. In addition, the use of a non-porous layer in the surgical buttress may also retard or inhibit tissue ingrowth from surrounding tissues, and thereby acting as an adhesion barrier and inhibiting the formation of unwanted scar tissue.

[0031] In addition, at least one bioactive agent may be combined with buttress member 110. The agent may be disposed on a surface of the surgical buttress and/or impregnated therein. In these embodiments, buttress member 110 can also serve as a vehicle for delivery of the bioactive agent. The term “bioactive agent,” as used herein, is used in its broadest sense and includes any substance or mixture of substances that have clinical use.

[0032] With particular reference to FIG. 3, anvil member 62 includes recess 63 defined radially inward of the pair of annular arrays of staple pockets 65. Recess 63 is configured to receive cut ring 99 therein. Ring member or cut ring 99 includes a proximal surface 99a having a base portion 99b and a raised portion 99c extending proximally from base portion 99b. Raised portion 99c is disposed at a peripheral portion of cut ring 99. Cut ring 99 defines a center aperture 99e configured and dimensioned to receive shaft 64 therethrough. Raised portion 99c (FIG. 4) has a substantially flat surface (e.g., planar surface that is perpendicular to a longitudinal axis of shaft 64) configured to facilitate coring of tissue and buttress member 110 by cylindrical knife 76. When cut ring 99 is disposed within recess 63, raised portion 99c is substantially flush with proximal surface 66 of anvil member 62. Base portion 99b defines a pair of diametrically opposed bores 99f (each extending in a direction parallel to the longitudinal axis) configured to receive respective, axially extending bosses 121 extending from retaining member 120. A side wall 99g of cut ring 99 may be provided with an adhesive or friction fit configuration with recess 63 of anvil member 62 to provide securement therewith.

[0033] With continued reference to FIGS. 2-4, buttress member 110 has an annular profile configured to be concentrically aligned with anvil member 62. Buttress member 110 is mounted on a proximal surface 66 of anvil member 62, and retaining member 120 is disposed proximal of buttress member 110. The annular profile of buttress member 110 is configured and dimensioned to at least be flush with an outer peripheral edge of anvil member 62 when mounted thereon.

[0034] Buttress member 110 defines a central aperture 110a configured to receive shaft 64 therethrough and a pair of diametrically opposing apertures 110b configured to receive the respective bosses 121 of retaining member 120. Buttress member 110 is configured and dimensioned to engage raised portion 99c of cut ring 99 and proximal surface 66 of anvil member 62. Buttress member 110 is in a superposed relation with the pair of annular arrays of staple pockets 65 defined in anvil member 62. In an embodiment, raised portion 99c of cut ring 99 may be disposed radially inward of central aperture 110a of buttress member 110 to improve securement of buttress member 110 with cut ring 99. Under such a configuration, raised portion 99c may be configured and dimensioned to be substantially flush with buttress member 110.

[0035] Retaining member 120 is configured to secure buttress member 110 to anvil assembly 60. In particular, retaining member 120 has an annular profile configured to be concentrically aligned with buttress member 110 and cut ring 99. An inner diameter of retaining member 120 is substantially identical to an inner diameter of central aperture 110a of buttress member 110. Retaining member 120 includes one or more retaining members, such as a pair of diametrically opposing bosses 121. The bosses are configured and dimensioned to be received through the respective apertures 110b of buttress member 110 and into bores 99f of cut ring 99. Bosses 121 each extend in a direction substantially parallel to the longitudinal axis of shaft 64 of anvil assembly 60.

[0036] Each of the pair of bosses 121 is fixed, e.g., heat-staked, into the respective bores 99f and apertures 110b. The bosses may also have a snap fit relationship with the bores and/or apertures. In this manner, buttress member 110 is secured with cut ring 99, which, in turn, is secured with anvil member 62. Alternatively, bores 99f and apertures 110b may be configured and dimensioned to provide a tight or friction fit interface against the respective bosses 121 to enable securement of buttress member 110 with anvil member 62. Moreover, retaining member 120 may be affixed to a proximal surface 112 of buttress member 110 by, for example, over molding, ultrasonic welding, melt pressing or melt pressing in conjunction with other polymers or with adhesives. In an embodiment, raised portion 99c of cut ring 99 may be configured and dimensioned to be received within central apertures 110a, 120a of buttress member 110 and retaining member 120, respectively, to improve securement of buttress member 110 and retaining member 120 with cut ring 99. Under such a configuration, retaining member 120 is substantially flush with raised portion 99c and extends radially outward from raised portion 99c of cut ring 99.

[0037] With particular reference now to FIG. 4, buttress member 110 is in a superposed relation with the pair of annular arrays of staple pockets 65 defined in anvil member 62. In particular, an outer diameter of retaining member 120 is smaller than an outer diameter of cut ring 99, and in particular, smaller than an outer diameter of raised portion 99c. In addition, the outer diameter of retaining member 120 is smaller than an inner diameter of cylindrical knife 76 such that severing of a portion of retaining member 120 by cylindrical knife 76 may be eliminated.

[0038] In operation, when the staples are ejected through the pair of annular arrays of staple receiving slots 72, the legs of each staple penetrate through tissue and buttress member 110 into staple pockets 65. Under such a configuration, retaining member 120 is not affected by the staple formation. In this manner, upon actuation of handle members 22, a portion of buttress member 110 is stapled with tissue to reinforce tissue, and the remaining portions of buttress member 110 and retaining member 120 are cut and detached from the portion of buttress member 110 stapled with tissue.

[0039] With reference now to FIG. 5, surgical stapling apparatus 10 is used in an anastomosis procedure to effect joining of, for example, two opposing intestinal sections “T₁,” “T₂.” The anastomosis procedure is typically performed using minimally invasive surgical techniques including laparoscopic means and instrumentation. Initially, a diseased intestinal section is removed. Thereafter, anvil assembly 60 is inserted to the operative site either through a surgical incision or transanally and is positioned within the intestinal section “T₁.” Elongate body portion 30 of surgical stapling apparatus 10 including staple cartridge assembly 70 is inserted transanally into the other intestinal section “T₂.” Intestinal sections “T₁,” “T₂” are then temporarily secured about their respective components (e.g., shaft 64 of anvil assembly 60 and the distal end of elongate body portion 30) by conventional means such as a purse string suture “P.”

[0040] Thereafter, the clinician maneuvers anvil assembly 60 until the proximal end of shaft 64 is inserted into the distal end of approximation shaft 75 disposed in elongate body portion 30 of surgical stapling apparatus 10. Shaft 64 engages approximation shaft 75 to be operable as a unitary construct. Anvil assembly 60 and elongate body portion 30 are then approximated to approximate intestinal sections “T₁,” “T₂.” Surgical stapling apparatus 10 is then fired, effecting stapling of intestinal sections “T₁,” “T₂” to one another, while cylindrical knife 76 cuts a portion of buttress member 110 and tissue disposed radially inward of cylindrical knife 76, and thereby detaching retaining member 120 and an inner portion of buttress member 110 from the portion of buttress member 110 that is clamped (approximated) between a distal surface of staple cartridge assembly 70 and proximal surface 66 of anvil assembly 60 to complete the anastomosis.

[0041] Examples of instruments for performing circular anastomosis of hollow organs and methods of use are described in U.S. Pat. Nos. 6,053,390; 5,588,579; 5,119,983; 5,005,749; 4,646,745; 4,576,167; and 4,473,077, each of which is incorporated herein in its entirety by reference.

[0042] Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplifications of particular embodiments. It is to be understood, therefore, that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.