Abstract:
The present disclosure is directed to a method and system for the repair of ventral hernias. The method includes the steps of providing a needle; providing a barbed suture having a distal end attached to said needle; providing a surgical mesh; rolling said surgical mesh, said barbed suture, and said needle to form a rolled mesh having said needle oriented substantially parallel to a longitudinal axis of said rolled mesh; transferring said rolled mesh into a body cavity via a laparoscopic device; unrolling and laying said surgical mesh under a ventral hernia in an abdominal wall; threading said needle and barbed suture through said surgical mesh and said abdominal wall; and trimming said barbed suture.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/264,922, filed on Nov. 30, 2009, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to methods and systems for the application of a surgical mesh. More particularly, the present disclosure relates to systems and methods for the in situ application of a hernia mesh during minimally invasive surgery. 
         [0004]    2. Background of Related Art 
         [0005]    Meshes are used during both laparoscopic and open surgery for repair of many types of defects and or injuries. For example, surgical meshes are used as catheter and cannula cuffs, for vascular anastomosis reinforcement, as wound dressings, for chest wall closure, as urinary incontinence slings, and for repair of hernias. Surgical meshes are used to provide support to surrounding tissue and as a supplement to standard suturing. 
         [0006]    Hernias that appear at the site of a prior surgical incision or due to a defect in the abdominal wall are often called ventral hernias. Ventral hernias typically occur when an organ protrudes through the muscular wall holding organs in place, often at the site of a previous incision. Any prior abdominal operation, where there is incomplete scar formation or healing of the tissue, may develop a ventral hernia. 
         [0007]    Ventral hernias occur more commonly along a straight line from the xiphoid process of the breastbone down to the pubic bone, and are more complex in these regions. Ventral hernias in this area have a high rate of recurrence if repaired via a simple suture technique under tension. For this reason, it is especially advised that ventral hernias be repaired via a tension free repair method using a mesh. 
         [0008]    Open surgical repairs of ventral hernias may be difficult and complicated operations. The weakened tissue of the abdominal wall is re-incised and during repair the weakened tissue may be reinforced using a prosthetic mesh. The large incision required to perform this surgery may lead to complications, such as infection. In addition, large incisions required for open repair are commonly associated with significant postoperative pain. 
         [0009]    Minimally invasive surgery for ventral hernias has shown several benefits including quicker recovery and shorter hospital stays, as well as a significantly reduced risk of infection and hernia recurrence. These benefits are due to both the smaller incision size and the reduced amount of time required to perform the surgery as compared to open surgery. 
         [0010]    Whether open or minimally invasive, the use of trans-abdominal suture knots and tacks to secure the mesh to the tissue may create significant postoperative pain. In the case of trans-abdominal sutures, the suture is sub-fascially knotted in place. These sub-fascial knots may be a significant source of post operative pain. At times, the sub-facial knot may be located over abdominal nerves causing additional pain. Therefore, methods and systems for reducing surgical time and use of sub-fascial knots or tacks are needed. 
       SUMMARY 
       [0011]    The present disclosure includes a method of laparoscopic repair of a ventral hernia. The method may include providing a needle, a barbed suture having a distal end attached to the needle and surgical mesh. In embodiments, the barbed suture may be attached to the surgical mesh at a proximal end of the barbed suture. The surgical mesh, barbed suture, and needle may be rolled to form a rolled mesh with the needle oriented substantially parallel to a longitudinal x-axis of the rolled mesh. In embodiments, the barbed suture may be attached to the surgical mesh prior to rolling the mesh. In embodiments, the barbed suture may be attached to the surgical mesh through a loop at a proximal end of the barbed suture or with a suture tie at a proximal end of the barbed suture. The rolled mesh may then be transferred into a body cavity via a laparoscopic device. The laparoscopic device may be, for example, a trocar. Following transfer, the rolled mesh may be unrolled and laid under a ventral hernia in an abdominal wall. The needle and barbed suture may then be threaded through the surgical mesh and the abdominal wall and then the barbed suture may be trimmed. In embodiments, the threading step may include performing a second threading back along a path of the previous threading. In embodiments, the second threading may be perpendicular to a path of the previous threading. 
         [0012]    The present disclosure also includes a hernia repair system. The hernia repair system may include a surgical mesh, a needle, and a barbed suture having a distal end attached to the needle and a proximal end attached to the surgical mesh. The surgical mesh may also include loops through which the needle may be threaded. In embodiments, the surgical mesh and barbed suture may be rolled to form a rolled mesh having a needle oriented substantially parallel to a longitudinal axis of the rolled mesh. The barbed suture and surgical mesh may be bioabsorbable and/or non-bioabsorbable. The barbed suture and/or surgical mesh may include a bioactive agent, such as, analgesics, antispasmodics, and/or anesthetics. 
         [0013]    The present disclosure also includes a method of laparoscopic repair of a ventral hernia. The method may include providing a surgical mesh; providing a barbed suture having a proximal end attached to the surgical mesh; rolling the surgical mesh and the barbed suture to form a rolled mesh; transferring the rolled mesh into a body cavity via a laparoscopic device; unrolling and laying the surgical mesh under a ventral hernia in an abdominal wall; attaching a needle to the barbed suture; threading the needle and the barbed suture through the surgical mesh and the abdominal wall; and trimming the barbed suture. The threading step may include the step of performing a second threading back along a path of or perpendicular to a path of the previous threading. The laparoscopic device may be a trocar. The method can also include the step of attaching the barbed suture to the surgical mesh prior to the rolling step. The barbed suture may be attached at a proximal end of the barbed suture. The attachment may be through a loop at a proximal end of the barbed suture or with a suture tie at a proximal end of said barbed suture. 
         [0014]    The disclosure also includes a hernia repair system including a surgical mesh; a barbed suture having a proximal end attached to the surgical mesh. The surgical mesh and the barbed suture may be rolled to form a rolled mesh. The barbed suture and surgical mesh may be bioabsorbable and/or non-bioabsorbable. The barbed suture and/or the surgical mesh may include a bioactive agent. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0015]    The foregoing objects and advantages of the disclosure will become more apparent from the reading of the following description in connection with the accompanying drawings, in which: 
           [0016]      FIG. 1A  illustrates an embodiment of a hernia repair system of the disclosure; 
           [0017]      FIG. 1B  illustrates another embodiment of a hernia repair system of the disclosure; 
           [0018]      FIGS. 2A and 2B  illustrate embodiments of a mesh of the hernia repair system of  FIG. 1 ; 
           [0019]      FIGS. 3A and 3B  illustrate embodiments of a barbed suture of the hernia repair system  FIG. 1 ; 
           [0020]      FIG. 4  illustrates an embodiment of a mesh of the hernia repair system of  FIG. 1 ; 
           [0021]      FIG. 5A  is a schematic illustration of a tear in an abdominal wall; 
           [0022]      FIG. 5B  is a schematic illustration of a ventral hernia; 
           [0023]      FIG. 5C  is a schematic illustration of an incision and laparoscopic transfer of a hernia repair system of the disclosure; 
           [0024]      FIG. 5D  is a schematic illustration of an abdominal wall during repair with the hernia repair system of the disclosure; 
           [0025]      FIG. 5E  is a schematic illustration of a tear in an abdominal wall following repair with the hernia repair system of the disclosure; 
           [0026]      FIGS. 6A and 6B  are schematic illustrations depicting various methods for securing the mesh with barbed sutures in accordance with the present disclosure; 
           [0027]      FIG. 7A  illustrates another embodiment of a hernia repair system; and 
           [0028]      FIG. 7B  is a schematic illustration showing a repair of an umbilical hernia with the hernia repair system of  FIG. 7A . 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    The present disclosure relates to devices, systems, and methods for minimally invasive surgeries such as, endoscopic, laparoscopic, arthroscopic, endoluminal and/or transluminal placement of a surgical mesh at a surgical site. As used herein the term “surgical mesh” is used to refer to any type of patch for use in surgical procedures, such as, for example, meshes that require suturing to the abdominal wall. Although described herein with reference to a ventral hernia mesh, the method of the disclosure may be used in any surgical repair. 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. 
         [0030]    In the drawings and in the description that follows, the term “proximal,” as is traditional, will refer to an end of a device that is closer to the user, while the term “distal” will refer to the end of the device that is further from the user. 
         [0031]    Laparoscopic surgical procedures are minimally invasive procedures, which 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, which 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. 
         [0032]    Referring now in specific detail to the drawings, in which like numbers identify similar or identical elements,  FIG. 1A  illustrates an embodiment of a hernia repair system and is generally designated  100 . The hernia repair system  100  includes a mesh  102 , which is suitable for use in situ. The mesh  102  includes barbed sutures  104 ,  106 ,  108 , and  110 , each having respective barbs  104   a,    106   a,    108   a,  and  110   a.  Each barbed suture  104 ,  106 ,  108 , and  110  includes a respective needle  114 ,  116 ,  118 , and  120  attached to a distal end thereof The proximal end of each barbed suture  104 ,  106 ,  108 , and  110  may be attached to the mesh  102  at respective fixation points  122 ,  124 ,  126 , and  128 . 
         [0033]    Although illustrated with four barbed sutures and needles, any number of barbed sutures and needles sufficient to secure the mesh to the tissue may be included in the hernia repair system. In embodiments, there may be one barbed suture per corner. In other embodiments, there may be one barbed suture every 3 centimeters around the perimeter of the mesh. Still in other embodiments, where the mesh is non-rectangular (See  FIG. 1B ) i.e., triangular, circular, etc., there may be one barbed suture approximately every 3 centimeters around the perimeter of the mesh. 
         [0034]    With continued reference to  FIG. 1A , the barbed sutures  104 ,  106 ,  108 ,  110 , may be attached to the mesh  102  immediately prior to performing the surgical procedure or may be attached to the mesh  102  during manufacturing. 
         [0035]    With reference to  FIG. 1B , the barbed sutures  104 ,  106 ,  108 ,  110  may be aligned on the mesh in such a manner that barbs  104   a,    106   a,    108   a,    110   a  secure, attach or stick respecting sutures  104 ,  106 ,  108 ,  110  to the mesh  102 . Although barbed sutures  104 ,  106 ,  108 ,  110  are shown attached to respective needles  114 ,  116 ,  118 ,  120 , in some embodiments, the barbed sutures do not include a needle affixed thereto. The mesh  102  may also include an anti-adhesion barrier  130  surrounding the edges of the mesh  102 . 
         [0036]    As shown in  FIG. 2 , the mesh  102  may be any type of mesh for use in surgical repair. Although shown as rectangular or circular in shape, the mesh  102  may be any suitable shape and may include one or more layers. Mesh  102  may be made of multiple fibers  200 , or may be made of a single fiber. The fibers  200  may be a monofilament or multi-filament. 
         [0037]    The fibers  200  forming the mesh  102  may be made from a natural material or a synthetic material. The fibers  200  may be biodegradable or non-biodegradable. It should of course be understood that any combination of natural, synthetic, bioadegradable and non-biodegradable materials may be used to form the fibers  200 . The term “biodegradable” as used herein is defined to include 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 or hydrolysis) or are broken down (physically or chemically) under physiologic conditions in the body such that the degradation products are excretable or absorbable by the body. 
         [0038]    Representative natural biodegradable polymers include: polysaccharides, such as alginate, dextran, chitin, hyaluronic acid, cellulose, collagen, gelatin, fucans, glycosaminoglycans, and chemical derivatives thereof (substitutions and/or additions of chemical groups, for example, alkyl, alkylene, hydroxylations, oxidations, and other modifications routinely made by those skilled in the art); and proteins, such as albumin, casein, zein, silk, and copolymers and blends thereof, alone or in combination with synthetic polymers. 
         [0039]    Synthetically modified natural polymers include cellulose derivatives, such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitrocelluloses, and chitosan. 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, cellulose triacetate, and cellulose sulfate sodium salt. These are collectively referred to herein as “celluloses.” 
         [0040]    Representative synthetic degradable polymers include polyhydroxy acids prepared from lactone monomers, such as glycolide, lactide, caprolactone, ε-caprolactone, valerolactone, and δ-valerolactone, as well as pluronics, carbonates (e.g., trimethylene carbonate, tetramethylene carbonate, and the like), dioxanones (e.g., 1,4-dioxanone and p-dioxanone), 1, dioxepanones (e.g., 1,4-dioxepan-2-one and 1,5-dioxepan-2-one), and combinations thereof. Polymers formed therefrom include: polylactides; poly(lactic acid); polyglycolides; poly(glycolic acid); poly(trimethylene carbonate); poly(dioxanone); poly(hydroxybutyric acid); poly(hydroxyvaleric acid); poly(lactide-co-(ε-caprolactone-)); poly(glycolide-co-(ε-caprolactone)); polycarbonates; poly(pseudo amino acids); poly(amino acids); poly(hydroxyalkanoate)s; polyalkylene oxalates; polyoxaesters; polyanhydrides; polyortho esters; and copolymers, block copolymers, homopolymers, blends, and combinations thereof. 
         [0041]    Some non-limiting examples of suitable non-bioabsorbable materials from which the fibers  200  may be made include: polyolefins, such as 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 and polycaprolactam; polyamines; polyimines; polyesters, such as polyethylene terephthalate and polybutylene terephthalate; aliphatic polyesters; polyethers; polyether-esters, such as polybutester; polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylic polymers and copolymers; modacrylics; 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; 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 etheylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; alkyd resins; polycarbonates; polyoxymethylenes; polyphosphazine; polyimides; epoxy resins; aramids, rayon; rayon-triacetate; spandex; silicones; and combinations thereof. 
         [0042]    The mesh  102  may be formed using any method suitable to forming mesh  102  structures, including but not limited to knitting, weaving, non-woven techniques, and the like. Suitable techniques for making the mesh are within the purview of those skilled in the art. In embodiments, the mesh  102  has a three dimensional structure, such as the knitted textiles described in U.S. Pat. Nos. 7,021,086 and 6,443,964 the entire contents of which are incorporated by reference herein. 
         [0043]    In embodiments, the mesh  102  may be permanent, such as, for example, a polypropylene mesh. These types of meshs are available under the tradenames: PARIETEX™, PERMACOL™, and SURGIPRO™ manufactured by and commercially available from Tyco Healthcare Group LLP dba Covidien AG, Mansfield, Mass. The PERMACOL™ mesh may be used with or without a collagen coating. Another mesh that may be used is the PARIETENE™, mesh commercially available from Sofradim, Treivoux, France. 
         [0044]    The mesh  102  may be any shape or size suitable for covering the herniated area and securing the mesh  102  to surrounding tissue. The mesh  102  may be preformed to a certain size, such as, for example, a 9 cm diameter round mesh or 50 cm×50 cm square mesh. In embodiments, the mesh  102  may be cut to a particular size and shape as needed. 
         [0045]    With reference to  FIGS. 3A and 3B , barbed suture  300  may be similar to or the same as barbed sutures  104 ,  106 ,  108 ,  110 . For example, the suture can be made from a variety of polymers that may be biodegradable or non-biodegradable, such as those listed above for fibers  200 . Biodegradable barbed sutures are described in U.S. patent application Ser. No. 11/556,002, filed Nov. 2, 2006, the entire content of which is incorporated herein by reference. 
         [0046]    In embodiments, the barbed suture may include an elongated body having a barb, and first, second, and third portions being cut at first, second and third angles respective to a longitudinal axis of the elongated body to form the barb, i.e., a compound barbed suture. A compound barbed suture may be formed by providing a suture having a longitudinal axis and farming a compound barb along the suture wherein the compound barb defines an inner surface, which includes at least a first portion disposed at a first orientation relative to the longitudinal axis, a second portion disposed at a second orientation relative to the longitudinal axis, and a third portion disposed at a third orientation relative to the longitudinal axis. In embodiments, at least one of the first, second, and third portions may be substantially linear. In embodiments, at least one of the first, second, and third portions may be substantially non-linear. 
         [0047]    In some embodiments, barbs may be formed by making acute angular cuts directly into the suture body, with cut portions pushed outwardly and separated from the body of the suture. The depth of the barbs thus formed in the suture body may depend on the diameter of the material and the depth of the cut. 
         [0048]    As shown in  FIG. 3B , the barbed suture may be a compound barb suture. The compound barb  320  includes two portions  320   a,    320   b  which are disposed at two angles, α″ and β″ relative to a longitudinal axis A-A of the medical device. More specifically, the compound barb  320  includes a first portion  320   a  formed from the elongate body  310  at a first angle α″, which is from about 0 degrees to about 90 degrees, in embodiments, from about 30 degrees to about 40 degrees, and in further embodiments, from about 31 degrees to about 38 degrees, relative to a longitudinal axis A-A of the elongate body  310 . The second portion  320   b  is formed from the elongate body  310  at a second angle β″ which is from about 0 degrees to about 90 degrees, in embodiments, from about 1 degree to about 10 degrees and in further embodiments, from about 1 degree to about 8 degrees relative to the longitudinal axis A-A of the elongate body  310 . 
         [0049]    The elongate body  310  of the barbed suture  300  is in direct contact with tissue “T”. The elongate body  310  may be in direct contact with tissue “T” for any length “L” of the barbed suture  300  and is not limited to the contact length “L” as shown in  FIG. 3B . 
         [0050]    In embodiments, a method of forming a compound barb on a suture includes: forming a first cut in the suture, the first cut having a first ratio of cut depth to diameter of the suture; forming a second cut in the medical device the second cut having a second ratio of cut depth to diameter of the suture; and forming a third cut in the medical device, the third cut having a third ratio of cut depth to diameter of the suture. 
         [0051]    In embodiments, the compound barb  320  and elongated body (suture)  310  and a first ratio of cut depth, which is approximately 1% to about 40%, and in certain embodiments, about 10% to about 30% of the diameter of the elongate body  310 . 
         [0052]    Compound barbs  320  may include a first ratio of cut depth, which is approximately 1% to about 40%, and in certain embodiments, about 10% to about 30% of the diameter of the elongate body  310 . Compound barb  320  may include a second ratio of cut depth of approximately 5% to about 50%, and in certain embodiments, about 15% to about 45% of the diameter of elongated body  310 . Compound barb  320  may include a third ratio of cut depth of approximately 15% to about 50%, and in some embodiments, from about 30% to about 50% the diameter of elongated body  14 . In one embodiment, a plurality of barbs are formed at successive intervals along the longitudinal axis of the suture  300 . 
         [0053]    The compound barbed suture of  FIG. 3B  may be formed, for example, using a cutting element. The cutting element may generate ultrasonic energy, which is converted to mechanical energy by the cutting element. This mechanical energy causes displacement of the tool at an ultrasonic frequency powered by an ultrasonic generator. The ultrasonic frequency may range in embodiments from about 1 kHz to about 100 kHz; from about 10 kHz to about 90 kHz; or from about 15 kHz to about 50 kHz. The ultrasonic signal amplitude may range from about 1μ to about 125μ; in embodiments from about 15μ to about 60μ. 
         [0054]    The ratio of the cut depth and the angle of the barbs relative to the suture are variable based on the signal amplitude of ultrasonic energy applied to the cutting element. For example, as the ultrasonic amplitude is increased, the ratio of the cut depth to the diameter and the angle of the barbs are decreased. As the ultrasonic amplitude is decreased, the ratio of the cut is increased. The method described above as well as the cutting element are described in U.S. patent application Ser. No. 12/178,361 filed Jul. 23, 2008, the entire content of which is incorporated herein by reference. 
         [0055]    As shown in  FIGS. 3A and 3B , an embodiment of a barbed suture capable of use with the aspects of the present disclosure is shown generally as suture  300 . Although shown as a monofilament thread, it is envisioned that suture  300  may be formed from braided threads, multifilament threads and the like. 
         [0056]    Although shown having a circular cross-sectional geometry, the cross-sectional geometry of suture  300  may be of any suitable shape. 
         [0057]    With continued reference to  FIGS. 3A and 3B , barbed suture  300  may be formed using any technique within the purview of those skilled in the art, such as, for example, extrusion, molding and/or solvent casting. In some embodiments, suture  300  may include a yarn made of more than one filament, which may contain multiple filaments of the same or different materials. Where suture  300  is made of multiple filaments, suture  300  may be made using any known technique such as, for example, braiding, weaving or knitting. Filaments may also be combined to produce a non-woven suture. Suture  300  may be drawn, oriented, crinkled, twisted, commingled or air entangled to form yarns as part of the suture forming process. In one embodiment, a multifilament suture may be produced by braiding. The braiding may be done by any method within the purview of those skilled in the art. 
         [0058]    Suture  300  includes a plurality of barbs  302  formed along a length thereof Barbs  302  are radially and longitudinally spaced along suture  300  and may be formed using any suitable method. Barbs  302  on suture  300  may extend in the same direction along the entire length thereof, or may instead extend in one direction on a first half of suture  300  and may extend in an opposite direction on a second half of suture  300 . Proximal end  300   a,  or distal end  300   b,  of suture  300  may include a sharpened tip or needle (not shown) configured for penetrating tissue. The needle may be any surgical needle as are known to those of skill in the art. In embodiments, the needle may be a straight needle. Either or both ends  300   a,    300   b  of suture  300  may include a fixation device (not shown). Non-limiting examples of suitable fixation devices  306  include surgical pins, screws, suture anchors, nails, and the like. In embodiments, the suture  300  may be attached to the mesh  100  by looping the barbed suture through the mesh. A barbed suture such as is disclosed in U.S. patent application Ser. No. 12/361,962, filed Jan. 29, 2009, the entire content of which is incorporated herein by reference. A compound barbed suture is available commercially as V-LOC™ from Tyco Healthcare Group, LLP (dba Covidien AG, Mansfield, Mass.). 
         [0059]    Either or both of the mesh and barbed suture may include a bioactive agent. The bioactive agent may be added to the barbed suture as disclosed in U.S. application Ser. No. 11/899,852, filed Sep. 6, 2007, the entire content of which is incorporated by reference herein. 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 mesh or barbed suture in any suitable form, e.g., films, powders, liquids, gels, and the like. 
         [0060]    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; platelet activating drugs; clotting factors; and enzymes. It is also intended that combinations of bioactive agents may be used. 
         [0061]    Anti-adhesive agents can be used to prevent adhesions from forming between the mesh and the surrounding tissues opposite the target tissue. In addition, anti-adhesive agents may be used to prevent adhesions from forming between the coated implantable medical device and the packaging material. Some examples of these agents include, but are not limited to hydrophilic polymers such as poly(vinyl pyrrolidone), carboxymethyl cellulose, hyaluronic acid, polyethylene oxide, poly vinyl alcohols, and combinations thereof. 
         [0062]    Suitable antimicrobial agents which may be included as a bioactive agent 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. 
         [0063]    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. 
         [0064]    Other examples of suitable bioactive agents, which may be included in the mesh or suture 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. 
         [0065]    With reference to  FIG. 4  mesh  102  of the hernia repair system  100  may be rolled with barbed sutures  402 ,  404  such that respective needles  406 ,  408  thereof may be oriented parallel to a longitudinal X-axis of mesh  102 . Barbed sutures  402 ,  404  may be similar to or the same as barbed sutures  102 ,  104 ,  106 ,  108 , and/or  300 . Barbed sutures  402 ,  404 , may be attached to mesh  102  at fixation points (not shown) in a manner as described above. For example, by looping barbed sutures  402 ,  404  through mesh  102 , or with a fixation device. Needles  406 ,  408  may be similar to or the same as needles  114 ,  116 ,  118 ,  120 . Any number of barbed sutures and needles may be oriented along a longitudinal x-axis of the rolled mesh  102 . In embodiments, the needles may be threaded through the mesh  102  along the longitudinal X-axis of the rolled mesh  102  to secure the needles during transport. 
         [0066]    Rolling, folding, or otherwise orienting the mesh with the barbed sutures and needles parallel to the longitudinal x-axis of the rolled mesh  102  forms a shape more suitable for transfer through a laparoscopic device during laparoscopic surgery. Laparoscopic devices are known in the art and include, for example, the devices disclosed in U.S. Patent Application Publication No. 2006/0229640, filed Mar. 29, 2005; U.S. Patent Application Publication No. U.S. 2006/0200170, filed Mar. 7, 2005; and U.S. Patent Application Publication No. 2006/0200169, filed Mar. 7, 2005, the entire contents of which are incorporated by reference herein. 
         [0067]    The hernia repair system of the present disclosure provides a single system for transfer of needles, sutures, and mesh needed to perform repair of the hernia. This reduces the time required for separate insertion of each of these tools. Instead, the surgeon may insert the hernia repair system, unroll the mesh, thread the barbed sutures through the abdominal wall where the barbs of the suture may grip the rectus abdominal muscle, and cut the sutures. The traditional use of two sutures per fixation point may be replaced by the use of one barbed suture. There is no need for separate attachment and knotting of the suture to the mesh. This may reduce the time required to complete the surgical procedure. Additionally, the barbed sutures unidirectionally secure the mesh to the tissue, i.e., the barbs prevent the suture from movement in the direction opposite the direction of their insertion. Accordingly, the mesh may be secured to the tissue by the barbed suture and there may be no need for knotting or tacking of the suture. 
         [0068]    Trans-abdominal suture knots and tacks used to secure meshes to tissue may create significant postoperative pain. In the case of trans-abdominal sutures, the suture is sub-fascially knotted in place. These sub-fascial knots may be a significant source of post-operative pain. At times, the sub-facial knot may be located over abdominal nerves causing additional pain. Use of the hernia repair system of the present disclosure prevents the need for sub-fascial and/or trans-abdominal suture knots, thereby eliminating post-operative pain caused by these knots. 
         [0069]    Referring now to  FIGS. 5A-5E , a method of using hernia repair system  100  to perform a surgical repair procedure is shown and described. With reference to  FIG. 5A , a ventral hernia may involve a tear  501 , in the abdominal wall  500 . Abdominal wall  500  is defined by an external side  500   a  and internal side  500   b.  A surface tissue  502 , which covers the external side  500   a  of abdominal wall  500 , may or may not be immediately effected by this tear  501 . An internal organ  504  located below the internal side  500   b  of the abdominal wall  500  may not protrude until some form of exertion or use of the muscle located at the abdominal wall  500  forces the internal organ  504  into the tear  501 . Depending on the size and location of the tear  501 , exertion may not be needed to cause the organ to protrude. As shown in  FIG. 5B , a hernia occurs when internal organ  504  protrudes into the tear  501  of abdominal wall  500 . Oftentimes the protrusion creates a bulge  506  in the surface tissue  502 . 
         [0070]    In order to correct the defect, as depicted in  FIG. 5C , an incision  508  may be made through surface tissue  502  and/or abdominal wall  500  in close proximity to tear  501  and a hernia repair system  100 , including rolled mesh  102  as described above, may be inserted using trocar  510  or similar laparoscopic device. As shown in  FIG. 5D , the hernia repair system  100  is unrolled and placed above tear  501  on external side  500   a  of abdominal wall  500 . In other embodiments, hernia repair system  100  may be placed beneath tear  501  on internal side  500   b  of abdominal wall. In still other embodiments, a hernia repair system  100  may be positioned above and below tear  501  on both sides of abdominal wall  500 . The needles (not shown) may be used to thread barbed sutures  104 ,  106 ,  108 ,  110  through the mesh  102  and the abdominal wall  500 . As depicted in  FIG. 5E  hernia repair system  100  seals abdominal wall  500  returning internal organ  504  to its original location and repairing protrusion  506 . 
         [0071]    As shown in  FIGS. 6A and 6B , various methods of securing the mesh  102  to the peritoneum  500   b  of the abdominal wall  500  with a barbed suture  600  may be used by the surgeon. As shown in  FIG. 6A , the surgeon may thread the barbed sutures  600 ,  608  from respective fixation points  602 ,  610 , into the abdominal wall  500 , through the rectus muscle  604 , and through the surface tissue  502 . In embodiments, as shown in  FIG. 6B , barbed sutures  606 ,  614 , may be threaded from respective fixation points  612 ,  618  into the abdominal wall  500 , through the rectus muscle  604 , and then threaded at an angle under the surface tissue  502 . Although shown at an angle of 90 degrees in  FIG. 6B , the barbed suture may be angled in any direction. 
         [0072]    Depicted in  FIGS. 7A and 7B , is a mesh  700  for repair of umbilical hernias. The mesh  700  includes a central opening  702 . Barbed sutures  704 ,  706  may be attached to the umbilical mesh at attachment points  708 ,  710 , respectively around opening  702 . The mesh  700  may be secured beneath the abdominal wall  712  and barbed sutures  704 ,  706  may be pulled through the abdominal wall  712 , thereby securing the mesh  700  to the abdominal wall  712 . 
         [0073]    While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the present disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the present disclosure.