Patent Grant
7708180
The present invention relates, in general, to tissue fastening devices, and more particularly, to tissue fastening devices using a combination of staples and adhesives.
Adhesives and sealants have been contemplated to supplement or replace staple based transaction devices for many years. The primary challenges in accomplishing this are control of getting the adhesive into the correct location at the correct time as well as preventing it from adhering the stapler itself to the treatment site. Adhesives have proven themselves as great short term bonding/sealing mechanisms. Staples on the other have proven themselves a very good long term tissue apposition mechanisms. Therefore the best of both worlds would be to use staples to fasten and adhesives in combination with adhesive initiators to seal the juncture of tissue or tissue cuts.
The primary challenge in the creation of a hybrid adhesive/staple deploying system is the positioning of the adhesive into only the areas of desired adhesion and controlling where the adhesive bonds to the area.
Closure Medical is conducting an FDA clinical trial using a cyanoacrylate adhesive as an internal vascular tissue sealant and internal surgical adhesive. Some adhesives such as the cyanoacrylates, stick well to tissue, but like metallic fasteners, the fastener itself can become a local barrier to tissue regrowth through the fastener. For internal body use of surgical adhesives, the adhesive is used sparingly, not on top of the wound as in external use, but actually in the cut areas of the wound. By minimizing the glue areas across the wound, the surgeon is assured of maximum areas of tissue regrowth and minimal areas of the adhesive barrier. As the tissue regrows together and heals, the adhesive areas within the wound are encapsulated with healed tissue. Thus, internal adhesives are ideal for short term needs to hold cut tissue together so that healing can occur, and can remain as a long term fastener to provide additional strength to the healed tissue. Additionally, the adhesives can be biocompatible, bioabsorbable, and/or flexible, inside the body.
Tissue fastening can be either short term or long term duration. Short term duration fasteners can include a bandage, tape, removable staples, removable suture, adhesives, or absorbable stitches that are meant to provide temporary support until natural healing can occur.
Longer duration fasteners must remain in or on the body, possibly for the life of the patient. Longer duration fasteners include biocompatible implantables such as suture, staples, clips, tacks, clamps, pins, and the like. These long duration fasteners could be inserted subcutaneously in a surgical procedure and, after the patient has healed, cannot be removed without additional surgery. Longer term fasteners can provide short term and long term reinforcement for high force loads that can be 200-400% of normal forces. These high force loads could be caused by violent vomiting, coughing, and, in some cases, chronic overeating. For chronic overeaters that have undergone bariatric surgery to create a small stomach pouch, it is highly likely that a patient will “overload” the new pouch by attempting to eat the same large portions of food imbibed before the surgery.
Adhesives have been used topically as a short term fastener for wound repair. Closure Medical has developed a 2-octyl cyanoacrylate compound with a long carbon chain (eight carbons) that is biocompatible, has good bonding strength, and has received FDA approval for topical use. For short duration topical wound closure, the edges of the wound are brought together and at least one layer of the adhesive is applied along the surface of the wound line to form a barrier that holds the wound edges together. The cyanoacrylate adhesive also acts as a microbial barrier, keeping bacteria out and is eventually removed. Cyanoacrylate adhesives are described in United States Application 20040190975 by Goodman et al. which is herein incorporated by reference in its entirety.
Closure Medical is conducting an FDA clinical trial using a cyanoacrylate adhesive as an internal vascular tissue sealant and internal surgical adhesive. Some adhesives such as the cyanoacrylates, stick well to tissue, but like metallic fasteners, the fastener itself can become a local barrier to tissue regrowth through the fastener. For internal body use of surgical adhesives, the adhesive is used sparingly, not on top of the wound as in external use, but actually in the cut areas of the wound. By minimizing the glue areas across the wound, the surgeon is assured of maximum areas of tissue regrowth and minimal areas of the adhesive barrier. As the tissue regrows together and heals, the adhesive areas within the wound are encapsulated with healed tissue. Thus, internal adhesives are ideal for short term needs to hold cut tissue together so that healing can occur, and can remain as a long term fastener to provide additional strength to the healed tissue. Additionally, the adhesives can be biocompatible, bioabsorbable, and/or flexible, inside the body.
Adhesives used to hold buttress materials to linear and circular surgical devices are known, such as that taught in U.S. Pat. No. 6,592,597 to Grant et al. entitled “Foam Buttress For Stapling Apparatus” as well as U.S. 2005/0228446 by D. Mooradian et al. entitled “Circular Stapler Buttress Combination”, both of which are incorporated by reference herein in their entirety.
Consequently, a significant need exists for a surgical device that can staple and cut tissue, can simply and easily place an adhesive initiator at desired sites to attract and set an adhesive about a junction or cut line in the tissue, can prevent unwanted adhesive migration away from the desired adhesion areas, and can ensure a seal across the cut line or tissue junction.
The invention overcomes the above-noted and other deficiencies of the prior art by providing a surgical stapling instrument for clamping and stapling tissue. The surgical stapling instrument has a handle, and a first and a second opposed tissue clamping members connected to the handle. At least one of the first and second opposed tissue clamping members are movable between an open position for receiving tissue and a closed position for stapling tissue therebetween. The first clamping member includes a plurality of staples disposed therein in an array, and the second clamping member comprises an anvil for forming the staples. Also provided is a first portion of biocompatible material containing an adhesive initiator. The first portion of biocompatible material is releasably attached to one of the first and second opposed tissue clamping members. A second portion of biocompatible material contains a fluid adhesive and is releasably attached to the other of the first and second opposed tissue clamping members. A knife is operably movable between the first and a second opposed tissue clamping members. Wherein when the tissue is clamped and stapled, the knife cuts the tissue and the first and second portions of material and the adhesive is released. The cut provides a passage for migration of the adhesive from the second portion of material to the adhesive initiator to initiate hardening of the adhesive across the cut.
In another aspect of the invention, a method for securing a first and a second portion of tissue together with a plurality of staples and an adhesive is disclosed. The method includes a first step of placing a portion of material containing an adhesive initiator between a first portion and a second portion of tissue. The second step comprises, clamping the material and the first and second portion of tissue between a first and a second clamping member of a surgical device with at least an edge of the material exposed. The third step includes stapling the two portions of tissue together with the portion of material therebetween with the plurality of staples in an array. The last step includes applying an adhesive about the exposed material and the two portions of tissue to initiate the adhesive and secure the two portions of tissue together.
In yet another aspect of the invention, a method for sealing a first portion and a second portion of tissue together with a plurality of staples and an adhesive is disclosed. The first step comprises clamping the first portion and the second portion of tissue between a first portion of buttress and between a second portion of buttress with a surgical stapling device. The first portion of buttress contains an adhesive initiator. The second step is stapling the first portion and the second portion of tissue between the first portion of buttress and the second portion of buttress by applying a plurality of fasteners in an array. The third step is cutting the tissue and the buttress about the array of staples with a knife of the surgical device. And the last step is sealing the cut tissue and buttress together by applying an adhesive across the cut and initiating the adhesive by contacting the adhesive with the adhesive initiator in the first portion of buttress.
These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
Surgical stapling devices are well known in the art for clamping onto tissue and placing a plurality of fasteners in an array into the tissue. Knives can also be included in the surgical stapling device and are used to sever or cut tissue within the array of staples. Such stapling devices can be circular, linear, arcuate, or any other shape and are commonly used to resects or transect tissue, can perform an anastomosis on luminal structures such as intestines, can resects lung tissue, or be used in any one of a number of other surgeries. Using an adhesive initiator impregnated material (such as a buttress or matrix) in combination with a stapling device and an adhesive offers advantages as will be described below.
In
The first clamping member 35 can have a removable staple cartridge 56 containing a plurality of surgical fasteners or staples 57 therein covered by the first portion of material 36. The second clamping member 45 may contain a plurality of opposing staple pockets 47 for the formation of the staples 57 therein and releasably covered by the second portion of material 46 containing an adhesive 47. When the second clamping member 35 is clamped on tissue, the staple pockets 47 align with the array of staples 57 in the cartridge 56, and when the surgical device 25 is fired, the staples 57 are driven upwards through the tissue and the materials to form the staples 57 in the staple pockets 47.
Buttress and Mesh Materials
Buttress and mesh materials are sheet-like fabric or foam reinforcing structures and are well known in the art for backing up staple or suture lines, and as hernia mesh support structures and the like. Buttress and mesh materials can be biocompatible to be implanted in the body, can be penetrated with surgical fasteners, and can be absorbable or non-absorbable. In the above example, two different portions of buttress material can used. The first portion of material 36 may be a closed cell foam buttress material containing an adhesive initiator 38, and the second portion of material 46 can be a sponge type open cell buttress material containing a fluid polymer adhesive 48 sealed within by sealed surface 49.
Buttress materials can include VICRYL™, produced by Ethicon, Inc., Somerville N.J., “DEXON™”, produced by Sherwood-Davis and Geck, St. Louis, Mo., and TEFLON™, produced by E.I. DuPont de Nemours & Co., Wilmington, Del. Additionally, other buttress materials include animal material such as tanned bovine pericardium, biocompatible elastomers such as .epsilon.-caprolactone glycolide produced by Ethicon Inc., Gargrave, England, or any one of a number of suitable buttress materials. Suitable .epsilon.-caprolactone glycolide materials or foams are described in U.S. Pat. No. 5,468,253 hereby incorporated by reference.
Alternately, the first or second portion of material 36, 46 could be a mesh structure or matrix 337 (not shown) having a plurality of openings 336. Such a matrix 337 could be a foam material containing openings 336, or a mesh, or a threadlike structure. The first or second portion of material 36, 46 could include porosities or at least one capillary action inducing feature or a wicking feature to draw adhesive 48 or initiator 38 to or into the material. These wicking features can include a pore, a void, a weave, a bubble, an open cell, a mesh, or any other feature that can induce capillary action or wicking action. Wicking properties of structure 26 (not shown) can ensure openings 27 (not shown) remain clear of adhesive to allow tissue growth therethrough
Thus, for example, the first portion of material 36 can be a mesh structure coated in an adhesive initiator 38, and the second portion of material 46 could be a mesh structure surrounded by a viscous adhesive 48 and sealed within a pouch 49a.
In addition to the materials above, suitable absorbable materials for a mesh or buttress structure can include but are not limited to bioabsorbable materials such as polylactic acid, polyglycolic acid, polyglactin, polydioxanone, polyglyconate, whey protein, cellulose gum, starch, and gelatin. Non-absorbable materials suitable for mesh or buttress can include but are not limited to materials such as silk, nylon, polypropylene, braided polyester, polybutester, polyethylene, and polyetheretherketones (PEEK).
Thus, the above first portion of material 36 and second portion of material 46 could be a fibrous pad, a foam, a matrix, a mesh or any other structure that can contain an adhesive initiator 38 or an adhesive 48. The first portion of material 36 and second portion of material 46, can, for example, have wicking properties such that when placed on tissue, can wick adhesive 48 thereto.
Attaching Buttress and Mesh Materials to a Stapling Device
Buttress materials can be releasably attached to the surgical device 25 in a variety of ways such as but not limited to a releasable adhesive such as that described in U.S. Pat. No. 6,592,597 by Grant et al. which is hereby incorporated by reference in its entirety.
Additionally, other methods of attachment such as anvil carriers could be used such as that described in U.S. Pat. No. 6,656,193 by Grant et al. which is also hereby incorporated by reference in its entirety. The above methods of releasably attaching buttress materials are not meant to be limiting in any way and any other devices and methods of attachment are within the scope of the invention.
Adhesives
Adhesive 48 could be, but is not limited to polymerizable and/or cross-linkable materials such as a cyanoacrylate adhesive. The adhesive 48, for example, may be a monomeric (including prepolymeric) adhesive composition, a polymeric adhesive composition, or any other compound that can adhere to tissue. In embodiments, the monomer may be a 1,1-disubstituted ethylene monomer, e.g., an .alpha.-cyanoacrylate. When cross linked or polymerized, the cyanoacrylate can change from a liquid to a solid. Polymerized adhesives 48a for example, can be formulated to be flexible to rigid and could be spongy. If desired, adhesive 48 an be a single part or dual part adhesive, and/or can contain additives such as alternate compounds. Polymerization of the adhesive 48 can occur from, but is not limited to, exposure to moisture or adhesion initiators 104.
Adhesive Initiators
Particular adhesive initiators 38 for particular monomers may be readily selected by one of skill in the art without undue experimentation. Control of the molecular weight distribution of the applied adhesive can be enhanced by selection of the concentration and functionality of the initiator or accelerator vis-a-vis the selected monomer. Suitable polymerization initiators and accelerators for cyanoacrylate compositions include, but are not limited to, base compositions, detergent compositions; surfactants, including nonionic surfactants such as polysorbate 20 (e.g., Tween 20™; ICI Americas), polysorbate 80 (e.g., Tween 80™; ICI Americas), and poloxamers; cationic surfactants such as tetrabutylammonium bromide; anionic surfactants, including quaternary ammonium halides such as benzalkonium chloride or its pure components, and benzethonium chloride; stannous octoate (tin (II) 2-ethylhexanoate), and sodium tetradecyl sulfate; and amphoteric or zwitterionic surfactants such as dodecyldimethyl(3-sulfopropyl) ammonium hydroxide, inner salt; amines, imines, and amides, such as imidazole, tryptamine, urea, arginine and povidine; phosphines, phosphites and phosphonium salts, such as triphenylphosphine and triethyl phosphite; alcohols such as ethylene glycol; methyl gallate; inorganic bases and salts, such as sodium bisulfite, magnesium hydroxide, calcium sulfate and sodium silicate; sulfur compounds such as thiourea and polysulfides; polymeric cyclic ethers such as monensin, nonactin, crown ethers, calixarenes and polymeric epoxides; cyclic and acyclic carbonates, such as diethyl carbonate; phase transfer catalysts such as Aliquat™ 336 (General Mills, Inc., Minneapolis, Minn.); organometallics; manganese acetylacetonate; radical initiators and radicals, such as di-t-butyl peroxide and azobisisobutyronitrile; and bioactive compounds or agents. Other examples of adhesives 48 and adhesive initiators 38 may be found in United States Application 20040190975 by Goodman et al. which is herein incorporated by reference in its entirety.
Lung tissue comprises thin air sacs or bladders in combination with vascular structures to ensure the oxygenation of blood. As a consequence, severing or cutting lung tissue can include small bleeders and/or air leaks. In
Circular Stapler with Dual Rings of Buttress or Matrix
Turning now to
When the movable second clamp member 245 moves from the open position of
A method of performing an anastomosis with circular stapler 225 and first initiator ring 236 and second adhesive ring 246 is shown in
In
In
In
In
Alternately, the first initiator ring can be a matrix ring 236a impregnated with or coated with the adhesive initiator 38 (not shown). When the adhesive 48 contacts the adhesive initiator 38 on the matrix ring 236a, polymerization of the adhesive is initiated.
As shown in
It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.
For example, an adhesive filled sponge can have a coating to seal the adhesive therein and the coating can be coated with an adhesive initiator, or any other combination or embodiment of dispensable adhesive, adhesive initiator, and a buttress and/or matrix is within the scope of this invention to those skilled in the art.
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