1. Technical Field
The present disclosure relates to systems and methods for wound closure. More particularly, the present disclosure relates to a surgical patch system for closing a wound during minimally invasive surgery.
2. Description of Related Art
Puncture wounds, wounds that pierce through tissue, may result from trauma or may be intentionally created in order to provide access to a body cavity during surgical procedures. During endoscopic surgical procedures, for example, a trocar device is utilized to puncture the peritoneum to provide an access port by way of a cannula through the abdominal wall. Generally, a trocar and/or cannula is placed through the abdominal wall for introduction of surgical instrumentation which is necessary to carry out the surgical procedure. In this manner, the surgeon may introduce a surgical instrument such as a grasper, scissor, clip applier, stapler or any other surgical instrument which may be necessary during the particular surgical procedure. Once the procedure is complete, it is necessary to close the wound.
Techniques for repairing wounds are widespread in medicine. Wound closure devices, such as sutures, staples, and other repair devices, like mesh or patch reinforcements, are frequently used for repair. Modern muscle reinforcement techniques may involve placement of an implant, such as a surgical mesh, near the injured tissue or defect to support the defect. The implant is either placed over the defect (anterior repair) or more often, under the defect (posterior repair).
Accordingly, a surgical patch system for closing a wound includes a first surgical patch, a second surgical patch, a cord operably associated with the first and second surgical patches, and a port operably associated with the second surgical patch. The first surgical patch is positionable adjacent internal tissue of an underlying tissue site of an open wound. The second surgical patch is positionable adjacent external tissue relative to the underlying tissue site of the open wound. The external tissue is adjacent the internal tissue. The port is positioned to enable the application of negative pressure to the open wound.
The cord is mounted to the first surgical patch. The cord is configured and dimensioned to interconnect the first and second surgical patches. In embodiments, the cord may be a suture. The suture may be barbed. The cord, the first surgical patch, and/or the second surgical patch may include a bioactive agent.
The second surgical patch includes a cover feature adapted for contact with the open wound in order to promote fluid communication therebetween. The port includes a one-way valve. The one way valve is dimensioned to permit the reception and passage of the cord. The one way valve may be configured and dimensioned to engage an instrument configured and dimensioned to apply negative pressure to the open wound.
One or both of the first and second surgical patches includes a plurality of layers. One or more of the layers of one or both the first and second surgical patches is an adhesive layer. One or more of the layers of one or both the first and second surgical patches is an anti-adhesive layer. In embodiments, one or both of the first and second surgical patches may be bioabsorbable.
In one aspect, a surgical patch system for closing a wound includes a delivery tube configured and dimensioned to permit reception and passage of the first surgical patch into the underlying tissue site. The surgical patch system also includes an inner tube configured and dimensioned to pass the first surgical patch through the delivery tube into the underlying tissue site. The first surgical patch is repositionable between a closed condition for passage through the delivery tube and an open condition for mounting to the internal tissue of the underlying tissue site of the open wound.
In another aspect, a method for closing a wound includes advancing a first surgical patch having one or more cords mounted thereto into an underlying tissue site; affixing the first surgical patch to internal tissue of an open wound; affixing the one or more cords to a second surgical patch; affixing the second surgical patch to external tissue of the open wound; and applying negative pressure to at least one of the first and second surgical patches. One step includes threading the one or more cords through a one way valve mounted to the second surgical patch. The method includes inserting one or more of a hydrogel, an adhesive, and a bioactive agent into the open wound. The method also includes sealing the open wound while drawing blood and nutrients to the open wound via negative pressure through the one way valve mounted to the second surgical patch for further promoting the healing of the open wound.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
The present disclosure relates to devices, systems, and methods for minimally invasive surgeries such as, endoscopic, laparoscopic, arthroscopic, endoluminal and/or transluminal placement of one or more surgical patches at a surgical site. As used herein the term “surgical patch” is used to refer to any type of patch or mesh for use in surgical procedures, such as, for example, patches that can be attached to the abdominal wall. As used herein the term “laparoscopic deployment device” is used to refer to a deployment device that may be used during minimally invasive surgeries described above.
In the drawings and in the description that follows, the term “posterior,” as is traditional, will refer to an area that is situated under, below, or behind the defect, while the term “anterior” will refer to an area that is situated over, above, or in front of the defect.
Laparoscopic surgical procedures are minimally invasive procedures that are carried out within the body cavity through use of access ports in conjunction with elongated surgical devices. An initial opening in the body tissue enables passage of the endoscopic or laparoscopic device to the interior of the body. Openings include natural passageways of the body or openings that are created by a tissue piercing device such as a trocar. During laparoscopic procedures, narrow punctures or incisions are made minimizing trauma to the body cavity and reducing patient recovery time. Although described herein with reference to laparoscopic surgery, the method may be applied to any type of surgery.
Referring now in specific detail to the drawings, in which like numbers identify similar or identical elements,
With continued reference to
The cord 130 may be mounted to either of the first surgical patch 110 and/or the second surgical patch 120. In certain embodiments, the cord 130 may be integrally formed with the first surgical patch 110 or may be mounted thereto (e.g., fastened, tied-off, adhered, etc.) The cord 130 is configured and dimensioned to interconnect the first and second surgical patches 110, 120. The cord 130 may define a lumen therethrough 132 and may include perforations 134 for permitting passage of fluids (e.g., bioactive agents, adhesives, etc. described in greater detail hereinbelow) therethrough (see
Each surgical patch 110, 120 may be any type of surgical patch for use in tissue repair and suitable for use in situ. Each surgical patch 110, 120 may be any suitable shape. For example, alternative embodiments of surgical patch systems may include circular (
During laparoscopic surgery, each surgical patch 110, 120 may also be rolled, folded, or otherwise oriented in order to form a shape more appropriate for transfer through any suitable laparoscopic device known in the art. Furthermore, each surgical patch 110, 120 and/or the cord 130 may be made of multiple fibers, or may be made of a single fiber. The fibers may be a monofilament or multi-filament.
Suitable polymers which may be used to construct implants disclosed herein include, for example, synthetic materials, natural materials (e.g., biological) and combinations thereof. Suitable materials include, polyolefins such as polyethylene (including ultra high molecular weight polyethylene) and polypropylene including atactic, isotactic, syndiotactic, and blends thereof; polyethylene glycols; polyethylene oxides; ultra high molecular weight polyethylene; copolymers of polyethylene and polypropylene; polyisobutylene and ethylene-alpha olefin copolymers; fluorinated polyolefins such as fluoroethylenes, fluoropropylenes, fluoroPEGSs, and polytetrafluoroethylene; polyamides such as nylon, Nylon 6, Nylon 6,6, Nylon 6,10, Nylon 11, Nylon 12, and polycaprolactam; polyamines; polyimines; polyesters such as polyethylene terephthalate, polyethylene naphthalate, polytrimethylene terephthalate, and polybutylene terephthalate; polyethers; polybutester; polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylic polymers; methacrylics; vinyl halide polymers and copolymers, such as polyvinyl chloride; polyvinyl alcohols; polyvinyl ethers such as polyvinyl methyl ether; polyvinylidene halides such as polyvinylidene fluoride and polyvinylidene chloride; polychlorofluoroethylene; polyacrylonitrile; polyaryletherketones; polyvinyl ketones; polyvinyl aromatics such as polystyrene; polyvinyl esters such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers; acrylonitrile-styrene copolymers; ABS resins; ethylene-vinyl acetate copolymers; alkyd resins; polycarbonates; polyoxymethylenes; polyphosphazine; polyimides; epoxy resins; aramids; rayon; rayon-triacetate; spandex; silicones; and copolymers and combinations thereof. Additionally, non-biodegradable polymers and monomers may be combined with each other to create a core of a fiber, for example a fiber possessing a core-sheath configuration.
Additionally, biodegradable synthetic or natural materials may be employed. As used herein, the term “biodegradable” includes both bioabsorbable and bioresorbable materials. By biodegradable, it is meant that the materials decompose, or lose structural integrity under body conditions (e.g., enzymatic degradation, hydrolysis) or are broken down (physically or chemically) under physiologic conditions in the body (e.g., dissolution) such that the degradation products are excretable or absorbable by the body.
Suitable bioabsorbable polymers may comprise implants of the present disclosure that include, but are not limited to polymers selected from the group consisting of aliphatic polyesters; polyamides; polyamines; polyalkylene oxalates; poly(anhydrides); polyamidoesters; copoly(ether-esters); poly(carbonates) including tyrosine derived carbonates; poly(hydroxyalkanoates) such as poly(hydroxybutyric acid), poly(hydroxyvaleric acid), and poly(hydroxybutyrate); polyimide carbonates; poly(imino carbonates) such as such as poly(bisphenol A-iminocarbonate and the like); polyorthoesters; polyoxaesters including those containing amine groups; polyphosphazenes; poly(propylene fumarates); polyurethanes; polymer drugs such as polydiflunisol, polyaspirin, and protein therapeutics; biologically modified (e.g., protein, peptide) bioabsorbable polymers; and copolymers, block copolymers, homopolymers, blends, and combinations thereof.
More specifically, for the purpose of this invention, aliphatic polyesters include, but are not limited to, homopolymers and copolymers of lactide (including lactic acid, D-,L- and meso lactide); glycolide (including glycolic acid); epsilon-caprolactone, p-dioxanone (1,4-dioxan-2-one); trimethylene carbonate (1,3-dioxan-2-one); alkyl derivatives of trimethylene carbonate; Δ-valerolactone; β-butyrolactone; γ-butyrolactone; ε-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one (including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione); 1,5-dioxepan-2-one; 6,6-dimethyl-1,4-dioxan-2-one; 2,5-diketomorpholine; pivalolactone; α,α diethylpropiolactone; ethylene carbonate; ethylene oxalate; 3-methyl-1,4-dioxane-2,5-dione; 3,3-diethyl-1,4-dioxan-2,5-dione; 6,8-dioxabicycloctane-7-one; and polymer blends and copolymers thereof.
Other suitable biodegradable polymers include but are not limited to poly(amino acids) including proteins such as collagen (I, II and III), elastin, fibrin, fibrinogen, silk, and albumin; peptides including sequences for laminin and fibronectin (RGD); polysaccharides such as hyaluronic acid (HA), dextran, alginate, chitin, chitosan, and cellulose; glycosaminoglycan; gut; and combinations thereof. Collagen as used herein includes natural collagen such as animal derived collagen, gelatinized collagen, or synthetic collagen such as human or bacterial recombinant collagen.
Additionally, synthetically modified natural polymers such as cellulose and polysaccharide derivatives, including alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitrocelluloses, and chitosan may be utilized. Examples of suitable cellulose derivatives include methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxybutyl methyl cellulose, cellulose acetate, cellulose propionate, cellulose acetate butyrate, cellulose acetate phthalate, carboxymethyl cellulose (CMC), cellulose triacetate, and cellulose sulfate sodium salt. These may be collectively referred to herein, in embodiments, as “celluloses.”
Additionally, the surgical device may comprise any or all of emulsifying agents, solubilizing agents, wetting agents, plasticizers, active agents, water soluble inert fillers, preservatives, buffering agents, coloring agents, and stabilizers. Addition of a plasticizer to the formulation can improve flexibility. The plasticizer or mixture of plasticizers may be polyethylene glycol, glycerol, sorbitol, sucrose, corn syrup, fructose, dioctyl-sodium sulfosuccinate, triethyl citrate, tributyl citrate, 1,2-propylenglycol, mono-, di- or triacetates of glycerol, or natural gums.
Each surgical patch 110, 120 and/or the cord 130 may be formed using any method suitable to forming surgical patch structures, including but not limited to knitting, weaving, non-woven techniques, lyophilization and the like. Suitable techniques for making each surgical patch 110, 120 and/or the cord 130 are within the purview of those skilled in the art.
The surgical patch system 100 may include a 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. Alternatively a bioactive agent could be any agent that provides a therapeutic or prophylactic effect, a compound that affects or participates in tissue growth, cell growth, cell differentiation, an anti-adhesive compound, a compound that may be able to invoke a biological action such as an immune response, or could play any other role in one or more biological processes. It is envisioned that the bioactive agent may be applied to the each surgical patch 110, 120 and/or the cord 130 in any suitable form, e.g., films, powders, liquids, gels, and the like.
Examples of non-limiting 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; nucleic acids (DNA, RNA) lipopolysaccharides; polysaccharides; platelet activating drugs; clotting factors; and enzymes. It is also intended that combinations of bioactive agents may be used.
In certain embodiments, anti-adhesive agents can be used to prevent adhesions from forming between at least one surface of the surgical patch 110 and/or the cord 130 and the surrounding tissues opposite the target tissue (see
Suitable antimicrobial agents which may be included as a bioactive agent include: antimicrobial proteins and peptides such as bovine lactoferrin and lactoferricin B; cationic peptides, and metal-chelating peptides; phospholipid copolymers including phosphoryl choline containing polymers; 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.
Other bioactive agents, which may be included as a bioactive agent 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; anti-spasmodics; 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; chemotherapeutics, 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 surgical patch system 100 of the present disclosure include: viruses and cells; peptides, polypeptides and proteins, as well as analogs, muteins, and active fragments thereof; 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 such as fibrin, thrombin, fibrinogen, synthetic thrombin, synthetic fibrin, synthetic fibrinogen; 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); bone morphogenic proteins; TGF-B; protein inhibitors; protein antagonists; protein agonists; nucleic acids, such as antisense molecules, DNA, RNA, RNAi; oligonucleotides; polynucleotides; and ribozymes.
Other bioactive agents which may be utilized in accordance with the present disclosure include drugs, amino acids, peptides, polypeptides, proteins, polysaccharides, muteins, immunoglobulins, antibodies, cytokines (e.g., lymphokines, monokines, chemokines), blood clotting factors, hemopoietic factors, interleukins (1 through 18), 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, fibrin, thrombin, fibrinogen, synthetic thrombin, synthetic fibrin, synthetic fibrinogen, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth hormone, luteinizing hormone releasing factor), vaccines (e.g., tumoral, bacterial and viral antigens); somatostatin; antigens; blood coagulation factors; growth factors (e.g., nerve growth factor, insulin-like growth factor); bone morphogenic proteins, TGF-B, protein inhibitors, protein antagonists, and protein agonists; nucleic acids, such as antisense molecules, DNA, RNA, RNAi; oligonucleotides; polynucleotides; cells, viruses, and ribozymes.
One or both surgical patches 110, 120 may include a cover feature 122 centrally secured thereto. Each surgical patch 110, 120 may be adapted for contact with the open wound “W” in order to promote fluid communication therebetween and may be adapted to resist adhesion to the open wound “W,” but in embodiments, may adhere to the tissue surface “Te.” The cover feature 122 may be formed of a textile, sponge, foam, porous, absorbent material or any combination thereof to enable the absorption of fluids and/or the passage of fluids therethrough. Similarly, the cover feature 122 may comprise and open or closed cell foam. In this manner, the cover feature 122 may absorb fluid emanating from the open wound “W,” create hemostasis, or provide fluid (e.g., growth factors, etc.) to the open wound “W.” As best shown in
From
In operation, the first surgical patch 110 is repositionable from an open condition to a closed condition (e.g., rolled, folded, etc.) for passage through the delivery tube 140 (see
As illustrated in
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/302,269, filed Feb. 8, 2010, the entire disclosure of which is incorporated by reference herein.
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