Patent Publication Number: US-2021169484-A1

Title: Buttress attachment for surgical stapling instrument

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation application of U.S. patent application Ser. No. 15/181,888, filed Jun. 14, 2016, the disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     Technical Field 
     The present disclosure relates to attachment systems for staple line buttress materials, and more particularly, to systems and methods for detachably securing staple line buttress materials to a surgical stapling instrument. 
     Background of Related Art 
     Surgical stapling instruments are employed by surgeons to sequentially or simultaneously apply one or more rows of fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together. When stapling relatively thin or fragile tissues, it is important to effectively seal the staple line against air or fluid leakage. Additionally, it is often necessary to reinforce the staple line against the tissue to prevent tears in the tissue or pulling of the staples through the tissue. One method of preventing tears or pull through involves the placement of a biocompatible reinforcing material or “buttress” material, between the staple and the underlying tissue. In this method, a layer of buttress material is placed against the tissue and the tissue is stapled in the conventional manner. 
     Accordingly, new systems and methods that are reliable and that enable easy and efficient attachment and removal of a buttress material to the surgical stapling instruments would be desirable. 
     SUMMARY 
     The present disclosure describes attachment structures for securing a buttress material to a surgical stapler that demonstrate a practical approach to meeting the performance requirements and overcoming the usability challenges associated with buttress material attachment and removal. In general, the present disclosure describes a surgical stapler that includes a handle assembly, an elongate member extending from the handle assembly, and an end effector operatively coupled with the handle assembly. 
     In accordance with an embodiment of the present disclosure, there is provided a surgical stapling apparatus. The surgical stapling apparatus includes a handle, a tool assembly, and a staple cartridge. The handle includes an actuation trigger. The tool assembly is operatively coupled to the handle. The tool assembly includes a first jaw member and a second jaw member. The staple cartridge is releasably supported on the first jaw member. The staple cartridge includes first and second buttress materials and a spring member extending from the staple cartridge. The spring member is configured to support the second buttress material away from the first buttress material. 
     In an embodiment, the staple cartridge may include a contact surface configured to receive the first buttress material thereon. In particular, the spring member may extend from the contact surface of the staple cartridge. Furthermore, the spring member may be biased away from the contact surface. 
     In another embodiment, the spring member may be secured with the second buttress material along a length of the second buttress material. 
     In yet another embodiment, the first buttress material may be detachably secured with the staple cartridge. The first buttress material may be secured with the staple cartridge by at least one of a suture, a hook and loop fastener, adhesive, a cap, or a hook. The first buttress material may be detachably secured with the staple cartridge at proximal and distal ends of the first buttress material. 
     In yet another embodiment, the second buttress material may be configured to engage to the anvil. 
     In yet another embodiment, the second buttress material may be secured with the spring member by at least one of a suture, a hook and loop fastener, adhesive, a cap, or a hook. 
     In yet another embodiment, the spring member may extend along opposing sides of the second buttress material. 
     In accordance with another embodiment of the present disclosure, there is provided a reload for use with a surgical stapling apparatus. The reload includes a tool assembly, a staple cartridge, an anvil, and a buttress retention assembly. The tool assembly includes first and second jaw members. The staple cartridge is releasably supported on the first jaw member. The anvil is supported on the second jaw member. The buttress retention assembly includes first and second buttress materials and a spring member configured to support the second buttress material away from the first buttress material. The first buttress material is positionable on the staple cartridge. The spring member extends from the staple cartridge, wherein the second buttress material is biased toward the anvil when the staple cartridge is supported on the first jaw member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiment(s) given below, serve to explain the principles of the disclosure, wherein: 
         FIG. 1  is a perspective view of a surgical stapling instrument supporting a reload; 
         FIG. 2  is a perspective view of the reload of  FIG. 1 ; 
         FIG. 3  is a perspective view of a tool assembly of the reload of  FIG. 1 , illustrating a staple cartridge separated from the tool assembly; 
         FIG. 4  is a side view of the staple cartridge of  FIG. 3  and a buttress retention assembly mounted on the staple cartridge in accordance with an embodiment of the present disclosure; 
         FIG. 5  is a partial side view of the tool assembly of  FIG. 3  including the buttress retention assembly of  FIG. 4 ; 
         FIG. 6  is a bottom view of an anvil of the tool assembly of  FIG. 3  including the buttress retention assembly of  FIG. 4 ; 
         FIG. 7  is a partial cross-sectional view of a distal end of the tool assembly, illustrating tissue positioned between jaw members of the tool assembly; 
         FIG. 8  is a partial cross-sectional view of the distal end of the tool assembly of  FIG. 7 , illustrating actuation of the surgical stapling instrument; 
         FIG. 9  is a perspective view of a stapled and divided tissue section; and 
         FIG. 10  is a cross-sectional view of the stapled and divided tissue section as taken through  10 - 10  of  FIG. 9 . 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present disclosure are 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” refers to that portion of a device that is farther from the user, while the term “proximal” refers to that portion of a device that is closer to the user. 
     With reference to  FIG. 1 , there is provided a surgical stapler  200  for use in stapling tissue and applying a layer of buttress material between staples and underlying tissue. Surgical stapler  200  generally includes a handle  202  and an elongate tubular member  204  extending distally from handle  202 . Surgical stapler  200  further includes a retraction mechanism  217  that can be manually grasped and pulled proximally to retract a firing mechanism of surgical stapler  200 . A reload  106  is removably coupled to a distal end  105  of elongate tubular member  204 . Reload  106  includes a shaft portion  109  and a tool assembly  107  supported on shaft portion  109 . Tool assembly  107  includes first and second jaw members  108 ,  110  which are movable between an open position for positioning tissue “T” ( FIG. 7 ) between first and second jaw members  108 ,  110  and a closed position for clamping tissue “T” between first and second jaw members  108 ,  110  and subsequently stapling tissue “T”. First jaw member  108  releasably supports a staple cartridge  112 , and second jaw member  110  supports an anvil  111 . 
     With continued reference to  FIG. 1 , surgical stapler  200  includes a trigger  236  movably mounted on handle  202 . Actuation of trigger  236  is configured to transition tool assembly  107  from the open position to the closed position and subsequently actuate surgical stapler  200  to apply lines of staples  178  ( FIG. 10 ) to tissue “T”. In order to provide proper orientation of tool assembly  107  relative to tissue “T” to be stapled, surgical stapler  200  is additionally provided with a rotation knob  234  mounted on handle  202 . Rotation of rotation knob  234  about a longitudinal axis “A-A” of surgical stapler  200  rotates tool assembly  107  about longitudinal axis “A-A.” 
     With reference to  FIG. 2 , a driver (not shown) is provided within reload  106  to move tool assembly  107  between the open and closed positions. The driver moves along a longitudinal slot  117  ( FIG. 3 ) defined in staple cartridge  112 . A knife blade (not shown) is associated with the driver to cut tissue “T” captured between anvil  111  and staple cartridge  112  as the driver passes through longitudinal slot  117  defined in staple cartridge  112 . In order to secure staples  178  ( FIG. 7 ) provided by staple cartridge  112  about tissue “T” and first and second buttress materials  302 ,  304  ( FIG. 4 ), anvil  111  is provided with longitudinally arranged rows of staple clinching or forming pockets  44  ( FIG. 7 ). Reference may be made to U.S. Patent Application Publication No. 2014/0263550, filed on Jan. 31, 2014, entitled “SURGICAL STAPLING APPARATUS,” the entire content of which is incorporated herein by reference, for a detailed discussion of the construction and operation of surgical stapler  200 . 
     With reference to  FIGS. 3 and 4 , there is provided a buttress retention assembly  300  in accordance with an embodiment of the present disclosure. Staple cartridge  112  is detachably supported on first jaw member  108 . Buttress retention assembly  300  is assembled with staple cartridge  112  prior to stapling of tissue “T”. Buttress retention assembly  300  includes first and second buttress material  302 ,  304  and a spring member  306 . First and second buttress materials  302 ,  304  are configured to reinforce and seal staple lines applied to tissue “T” by surgical stapler  200 . Spring member  306  may be, e.g., a coil spring, that provides a substantially flat profile when first and second jaw members are in the closed position. Under such a configuration, the effect of spring member  306  on staple formation is minimized. 
     With reference now to  FIG. 5 , first buttress material  302  is mounted on a contact surface  112   a  of staple cartridge  112 . In particular, first buttress material  302  may be secured with staple cartridge  112  by suture  310 . Alternatively, first buttress material  302  may be detachably secured with staple cartridge  112  by, e.g., adhesive, hook and loop fastener, ultrasonic welding, hook, or a cap. First buttress material  302  may be detachably secured with staple cartridge  112  such that first buttress material  302  is detached from staple cartridge  112  by the stapling force. Alternatively, first buttress material  302  may be securely affixed to staple cartridge  112  such that first buttress material  302  remains securely affixed to staple cartridge  112  during staple formation. 
     Second buttress material  304  is supported by spring member  306  that extends from staple cartridge  112 . Contact surface  112   a  of staple cartridge  112  may include an anchor portion such as, e.g., a bore or a hook, to secure one end of spring member  306  thereto. Spring member  306  is biased away from staple cartridge  112  such that when staple cartridge  112  is placed within first jaw member  108 , spring member  306  having second buttress material  304  mounted thereon is biased toward anvil  111 . Under such a configuration, spring member  306  and second buttress material  304  together define a gap  305  with respect to staple cartridge  112  to receive tissue “T” therein. 
     With reference now to  FIG. 6 , spring member  306  extends along a length of second buttress material  304 . In particular, peripheral portions  304   a  of second buttress material  304  are supported by spring member  306  such that staple formation is unaffected. In addition, second buttress material  304  may be coupled to spring member  306  at, e.g., proximal and distal ends  306   a ,  306   b  of spring member  306 . Second buttress material  304  may be coupled to spring member  306  by, e.g., a suture  310  or a cap  312  ( FIG. 4 ). It is contemplated that spring member  306  may partially extend along the length of second buttress member  304 . The length of spring member  306  may be tailored to provide sufficient biasing force to provide sufficient gap  305  between first and second buttress materials  302 ,  304 . 
     It is further contemplated that second buttress material  304  may be secured with spring member  306  by, e.g., a hook and loop fastener, adhesive, ultrasonic welding, or hook. Second buttress material  304  may be detachably coupled with spring member  306  such that when tissue “T” is stapled, the stapling force disengages second buttress material  304  from spring member  306 . However, it is also contemplated that second buttress material  304  may be securely affixed to spring member  306  such that the stapling force does not separate second buttress material  304  and spring member  306 . 
     It is further contemplated that first and second buttress materials  302 ,  304  may be made from any biocompatible natural or synthetic material. The material from which the buttress material is formed may be bioabsorbable or non-bioabsorbable. It should of course be understood that any combination of natural, synthetic, bioabsorbable and non-bioabsorbable materials may be used to form the buttress material. 
     Some non-limiting examples of materials from which the buttress material may be made include but are not limited to poly(lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyesters, polyethylene glycols, polyethylene oxides, polyacrylamides, polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinyl alcohols, polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyesters, glycerols, poly(amino acids), copoly (ether-esters), polyalkylene oxalates, polyamides, poly (iminocarbonates), polyalkylene oxalates, polyoxaesters, polyorthoesters, polyphosphazenes and copolymers, block copolymers, homopolymers, blends and combinations thereof. 
     In embodiments, natural biological polymers are used in forming the buttress material. Suitable natural biological polymers include, but are not limited to, collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, chitan, chitosan, and combinations thereof. In addition, the natural biological polymers may be combined with any of the other polymeric materials described herein to produce the buttress material. 
     The buttress material may be porous or non-porous, or combinations of porous and non-porous layers. Where the buttress material is non-porous, buttress material may retard or prevent tissue ingrowth from surrounding tissues thereby acting as an adhesion barrier and preventing the formation of unwanted scar tissue. Thus, in embodiments, the buttress material possesses anti-adhesion properties. Techniques for forming non-porous layers from such materials are within the purview of those skilled in the art and include, for example, casting, molding and the like. 
     In embodiments, the buttress material is porous and possesses hemostatic properties. Where the buttress material is porous, it has openings or pores over at least a portion of a surface thereof. Suitable materials for forming the porous layer include, but are not limited to foams (e.g., open or closed cell foams). In embodiments, the pores may be in sufficient number and size so as to interconnect across the entire thickness of the porous layer. In other embodiments, the pores do not interconnect across the entire thickness of the porous layer. In yet other embodiments, the pores do not extend across the entire thickness of the porous layer, but rather are present at a portion of the surface thereof. In embodiments, the openings or pores are located on a portion of the surface of the porous layer, with other portions of the porous layer having a non-porous texture. Those skilled in the art reading the present disclosure will envision other pore distribution patterns and configurations for the porous layer. 
     Where the buttress material is porous, the pores may be formed using any method suitable to forming a foam or sponge including, but not limited to the lyophilization or freeze-drying of a composition. Suitable techniques for making foams are within the purview of those skilled in the art. Porous buttress materials can be at least 0.2 cm thick, in embodiments from about 0.3 to about 1.5 cm thick. Porous buttress materials can have a density of not more than about 75 mg/cm′ and, in embodiments below about 20 mg/cm 2 . The size of the pores in the porous buttress materials can be from about 20 μm to about 300 in embodiments from about 100 μm to about 200 μm. 
     The buttress material may also include a reinforcement member. The reinforcement member may be associated with a porous or non-porous layer or may be positioned between a non-porous layer and a porous layer of the buttress material. Alternatively, the reinforcement member may be positioned entirely within one or more of the individual layers (i.e., embedded within the porous layer, the non-porous layer, or both) of the buttress material. It is also envisioned that the reinforcement member may be positioned at the surface of one of the layers making up the buttress material and, in embodiments, may be positioned at an exterior surface of the buttress material. 
     Some suitable non-limiting examples of reinforcement members include fabrics, meshes, monofilaments, multifilament braids, chopped fibers (sometimes referred to in the art as staple fibers) and combinations thereof. Where the reinforcement member is a mesh, it may be prepared using any technique known to those skilled in the art, such as knitting, weaving, tatting, knipling or the like. Where monofilaments or multifilament braids are used as the reinforcement member, the monofilaments or multifilament braids may be oriented in any desired manner. For example, the monofilaments or multifilament braids may be randomly positioned with respect to each other within the buttress material. As another example, the monofilaments or multifilament braids may be oriented in a common direction within the buttress material. Where chopped fibers are used as the reinforcement member, the chopped fibers may be oriented in any desired manner. For example, the chopped fibers may be randomly oriented or may be oriented in a common direction. The chopped fibers can thus form a non-woven material, such as a mat or a felt. The chopped fibers may be joined together (e.g., by heat fusing) or they may be unattached to each other. The chopped fibers may be of any suitable length. For example, the chopped may be from 0.1 mm to 100 mm in length, in embodiments, 0.4 mm to 50 mm in length. In an illustrative embodiment, the buttress material has randomly oriented chopped fibers that have not been previously fused together embedded within in the buttress material. 
     It is envisioned that the reinforcement member may be formed from any bioabsorbable, non-bioabsorbable, natural, or synthetic material previously described herein and combinations thereof. Where monofilaments or multifilament braids are used as the reinforcement member, any commercially available suture material may advantageously be employed as the reinforcement member. 
     In embodiments, at least one bioactive agent may be combined with the buttress material and/or any of the individual components (the porous layer, the non-porous layer and/or the reinforcement member) used to construct the buttress material. In these embodiments, the buttress material 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. Consequently, bioactive agents may or may not have pharmacological activity per se, e.g., a dye, or fragrance. Alternatively a bioactive agent could be any agent which provides a therapeutic or prophylactic effect such as a compound that affects or participates in tissue growth, cell growth, or cell differentiation. 
     Examples of classes of bioactive agents which may be utilized in accordance with the present disclosure include anti-adhesives, antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics, antihistamines, anti-inflammatories, cardiovascular drugs, diagnostic agents, sympathomimetics, cholinomimetics, antimuscarinics, antispasmodics, hormones, growth factors, muscle relaxants, adrenergic neuron blockers, antineoplastics, immunogenic agents, immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids, lipopolysaccharides, polysaccharides, and enzymes. It is also intended that combinations of bioactive agents may be used. 
     Anti-adhesive or anti-adhesion agents can be used to prevent adhesions from forming between the buttress material and the surrounding tissues opposite the target tissue. Some examples of these agents include, but are not limited to poly(vinyl pyrrolidone), carboxymethyl cellulose, hyaluronic acid, polyethylene oxide, poly vinyl alcohols and combinations thereof. 
     Suitable antimicrobial agents which may be included as a bioactive agent in the buttress material of the present disclosure include triclosan, also known as 2,4,4′-trichloro-2′-hydroxydiphenyl ether, chlorhexidine and its salts, including chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, and chlorhexidine sulfate, silver and its salts, including silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine, polymyxin, tetracycline, aminoglycosides, such as tobramycin and gentamicin, rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, quinolones such as oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin and ciprofloxacin, penicillins such as oxacillin and pipracil, nonoxynol 9, fusidic acid, cephalosporins, and combinations thereof. In addition, antimicrobial proteins and peptides such as bovine lactoferrin and lactoferricin B may be included as a bioactive agent in the bioactive coating of the present disclosure. 
     Other bioactive agents which may be included as a bioactive agent in the buttress material in accordance with the present disclosure include: local anesthetics; non-steroidal antifertility agents; parasympathomimetic agents; psychotherapeutic agents; tranquilizers; decongestants; sedative hypnotics; steroids; sulfonamides; sympathomimetic agents; vaccines; vitamins; antimalarials; anti-migraine agents; anti-parkinson agents such as L-dopa; antispasmodics; anticholinergic agents (e.g. oxybutynin); antitussives; bronchodilators; cardiovascular agents such as coronary vasodilators and nitroglycerin; alkaloids; analgesics; narcotics such as codeine, dihydrocodeinone, meperidine, morphine and the like; non-narcotics such as salicylates, aspirin, acetaminophen, d-propoxyphene and the like; opioid receptor antagonists, such as naltrexone and naloxone; anti-cancer agents; anti-convulsants; anti-emetics; antihistamines; anti-inflammatory agents such as hormonal agents, hydrocortisone, prednisolone, prednisone, non-hormonal agents, allopurinol, indomethacin, phenylbutazone and the like; prostaglandins and cytotoxic drugs; estrogens; antibacterials; antibiotics; anti-fungals; anti-virals; anticoagulants; anticonvulsants; antidepressants; antihistamines; and immunological agents. 
     Other examples of suitable bioactive agents which may be included in the coating composition include viruses and cells, peptides, polypeptides and proteins, analogs, muteins, and active fragments thereof, such as immunoglobulins, antibodies, cytokines (e.g. lymphokines, monokines, chemokines), blood clotting factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4, IL-6), interferons (β-IFN, (α-IFN and γ-IFN), erythropoietin, nucleases, tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth hormone), vaccines (e.g., tumoral, bacterial and viral antigens); somatostatin; antigens; blood coagulation factors; growth factors (e.g., nerve growth factor, insulin-like growth factor); protein inhibitors, protein antagonists, and protein agonists; nucleic acids, such as antisense molecules, DNA and RNA; oligonucleotides; polynucleotides; and ribozymes. 
     In use, with reference back to  FIGS. 3-5 , buttress retention assembly  300  is assembled with staple cartridge  112 . Thereafter, staple cartridge  112  is mounted in first jaw member  108  such that second buttress material  304  and spring member  306  are biased toward anvil  111 . At this time, first and second buttress materials  302 ,  304  define gap  305  to receive tissue “T” therein. With reference now to  FIGS. 7 and 8 , tool assembly  107  is positioned adjacent tissue “T” to be stapled. At this time, the driver (not shown) is in a proximal position relative to longitudinal slot  117  of staple cartridge  112 . Staple cartridge  112  includes staples  178  positioned within respective staple pockets  18 . Staples  178  are of a conventional type and include a backspan  182  having a pair of legs  184  and  186  extending from backspan  182 . Legs  184  and  186  terminate in tissue penetrating tips  188  and  190 . Pushers  192  are located within respective staple pockets  18  and are positioned between staples  178  and the path of a drive bar  194 . 
     With continued reference to  FIGS. 7 and 8 , surgical stapler  200  is initially actuated by movement of trigger  236  relative to handle  202  ( FIG. 1 ) causing the driver to move in the direction of arrow “B” thereby transitioning tool assembly  107  to the closed position. At this time, drive bar  194  advances distally and urges pushers  192  upwardly against backspans  182  of staples  178 , thereby driving staples  178  through first buttress material  302  mounted on contact surface  112   a  of staple cartridge  112 , tissue “T”, and second buttress material  304  mounted on anvil  111  and towards staple clinching pockets  44  in anvil  111 . Tissue penetrating tips  188  and  190  are bent within staple clinching pockets  44  in anvil  111  to thereby secure second buttress material  304  mounted on anvil  111  against tissue “T” while backspan  182  secures first buttress material  302  mounted on staple cartridge  112  against tissue “T”. 
     With reference now to  FIGS. 9 and 10 , upon full actuation of surgical stapler  200 , the knife blade (not shown) associated with surgical stapler  200  and carried by the driver cuts tissue “T”, as well as first and second buttress materials  302 ,  304  on opposing sides of tissue “T”, between the rows of now clinched staples  178 . Upon movement of anvil  111  to the open position spaced apart from staple cartridge  112 , first and second buttress materials  302 ,  304  pull away from respective anvil  111  and staple cartridge  112 . The resulting tissue “T” is divided and stapled with staples  178 . Specifically, first buttress material  302  that was mounted on staple cartridge  112  is secured against tissue “T” by backspans  182  of staples  178 , and second buttress material  304  that was mounted on anvil  111  is secured against tissue “T” by the now clinched tissue penetrating tips  188  and  190  of staples  178 . In this manner, first and second buttress materials  302 ,  304  are stapled to tissue “T” thereby sealing and reinforcing the staple lines created by staples  178 . 
     Persons skilled in the art will understand that the structures and methods specifically described herein and shown in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely as exemplary of particular embodiments. For example, spring member  306  may utilize other types of springs such as, e.g., a torsion spring, that is secured with a proximal end portion of second buttress material  304 . It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, the elements and features shown or described in connection with certain embodiments may be combined with the elements and features of certain other embodiments without departing from the scope of the present disclosure, and that such modifications and variations are also included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not limited by what has been particularly shown and described.