PATENT ABSTRACT
Endoscopic methods utilize self-retaining sutures to approximate tissue in a cavity of a subject. An endoscopic instrument is provided containing the self-retaining suture. The endoscopic instrument may be provided in combination with an endoscope and/or an endoscopic manipulator. The endoscopic instrument is passed through a cavity wall into a cavity of a patient. The self-retaining suture is deployed, using the endoscopic instrument, into a first tissue portion and a second tissue portion within the cavity. The self-retaining suture may be deployed endoscopically in patterns which include, purse string stitch, alpha stitch, linear stitching, curvilinear stitching, continuous helical stitch, and continuous sinusoidal stitch.

PATENT DESCRIPTION
CLAIM TO PRIORITY 
       [0001]    This application is a continuation of U.S. application Ser. No. 11/307,520, filed Feb. 10, 2006, now pending; which is a divisional of U.S. application Ser. No. 10/065,256, filed Sep. 30, 2002, now U.S. Pat. No. 7,056,331, issued Jun. 6, 2006; which is a continuation-in-part of U.S. application Ser. No. 09/896,455, filed Jun. 29, 2001, now U.S. Pat. No. 6,599,310, issued Jul. 29, 2003. All of the above claimed priority applications are incorporated herein by reference in their entireties. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    This invention relates generally to a method for joining bodily tissue in surgical applications and wound repair, and more particularly to a surgical suturing method for joining bodily tissue using a suture having a plurality of barbs which permit the suture to be pulled through the tissue in one direction but resisting movement of the suture relative to the tissue in the opposite direction. 
         [0003]    Surgical or accidental wounds are typically closed with a length of filament introduced into the tissue by a sharp metal needle attached to one end of the filament. This device is known as a suture. Sutures are used to make stitches to close the wound for holding tissues together for healing and regrowth. Sutures are used in surgical procedures for wound closure, to close the skin in plastic surgery, to secure damaged or severed tendons, muscles or other internal tissues, and in microsurgery on nerves and blood vessels. Generally, the suture needle is caused to penetrate and pass through the tissue pulling the suture through the tissue. The opposing faces of the tissue are then moved together, the needle is removed, and the ends of the suture are tied in a knot. The suture forms a loop as the knot is tied. The knotting procedure allows the tension on the filament to be adjusted to accommodate the particular tissue being sutured and control of approximation, occlusion, attachment or other conditions of the tissue. The ability to control tension is extremely important regardless of the type of surgical procedure being performed. 
         [0004]    Suturing is a time-consuming part of most surgical procedures, particularly in microsurgery and endoscopic surgery where there is insufficient space to properly manipulate the suture. Loop sutures can leave scars where they penetrate skin. For adequate closure of some wounds, the suture material must be of a high tensile strength and thus a large diameter thereby increasing scarring. The loop suture also constricts blood flow to the tissue it surrounds, promoting necrosis of the wound margins which compromises healing and increases infection risks. Further, the tissue is distorted as it is secured by the suture loop due to excess tension on the knots. Localized tensions from the knots are the culprit for scar formation. The bulk of the knots are also an impediment to wound healing in internal applications. 
         [0005]    Alternatives to conventional sutures for wound closure are known, including fasteners such as staples, clips, tacks, clamps and the like. The fasteners are usually positioned transversely across a wound for joining or approximating each side of adjacent tissue layers laterally. Fasteners have relatively high strength and save time, but are not as accurate as sutures and are bulky and may be painful to remove. Fasteners are also generally unsuitable for deeper layers of tissue. Moreover, fasteners do not provide the advantage of adjustable tension obtained by the knotting of a length of suture material. 
         [0006]    Surface adhesive tapes and glues are often used on skin to hold small wounds closed to permit healing. However, these products have relatively low tensile strength and are not useful in many situations. 
         [0007]    Other techniques proposed include electrical coagulation and lasers. However, no acceptable alternative has been found which offers the advantages of suturing and tying in most surgical procedures. 
         [0008]    One possible alternative is a barbed suture. A barbed suture includes an elongated body having one or more spaced barbs projecting from the surface of the body along the length of the body. The barbs are configured to allow passage of the suture in one direction through tissue but resist movement of the suture relative to the tissue in the opposite direction. In wound closure, a barbed suture is passed through tissue at each of the opposed sides of a wound. The wound is closed by pushing the sides of the wound together with the barbs maintaining the sutures in place and resisting movement of the tissue away from this position. The advantage of using barbed sutures is the ability to put tension in the tissue with less slippage of the suture in the wound. The barbed suture spreads out the holding forces evenly thereby significantly reducing tissue distortion. Since knots do not have to be tied, there is a time savings and the elimination of suture knots improves cosmetic effects and promotes wound healing. Barbed sutures also allow better apposition of tissue since the incised or insulted tissues are brought together and secured with almost no movement immediately. Unlike the conventional suturing method wherein tension is applied by pulling on the end of the suture after placement, barbed sutures permit tissue to be approximated and held snug during suturing. This is especially advantageous in closing long incisions. The result is better healing when the tissue levels are harmoniously matched as the cosmetic effect is more pronounced at skin level. Moreover, if there is an accidental breakage of the barbed suture, the wound is minimally disturbed. With conventional sutures, dehiscence would occur. 
         [0009]    Despite the advantages offered by barbed sutures, the tensile strength of a barbed suture is less than a loop suture of equivalent size. This is due to the reduced tensile strength resulting from imparting the barb structure onto the body of the suture, which reduces its effective diameter. This limitation is not significant since larger barbed sutures with greater tensile strength can be utilized. However, the conventional methods for introducing barbed sutures into tissue still do not exhibit the same biomechanical performance of looped sutures. 
         [0010]    For the foregoing reasons there is a need for a suturing method for joining tissue in surgical applications and wound repair which is efficient and expedites the surgical procedure. Ideally, the new method allows a surgeon to suture in an efficient manner to quickly the approximate tissue with appropriate tension. The new method should preserve blood flow, improve wound healing strength, prevent distortion of the tissue and minimize scarring. The method should also incorporate the self-retaining benefits of the barbed suture with the holding power of conventional suturing methods. A particularly useful method would be utilized in surgical applications where space is limited such as microsurgery, endoscopic or arthroscopic surgery. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention provides a way to close wounds, fasten junctions of tissue, tie off wounds, join a foreign element to tissue, mount a device to tissue, alter the position of tissue where there is only a single portion of tissue without a wound or junction, and perform other procedures. The methods of the present invention are performed with a two-way barbed suture. Specifically, the two-way barbed suture includes an elongated body, first and second sharp pointed distal ends for penetrating the tissue, and a plurality of barbs extending from the periphery of the body. The barbs on a first portion of the body between the first end of the suture and a first axial location on the body permit movement of the suture through the tissue in a direction of movement of the first end, and prevent movement of the suture relative to the tissue in a direction opposite the direction of movement of the first end. The barbs on a second portion of the body between the second end of the suture and a second axial location on the body, which is less than the distance from the second end to the first axial location, permit movement of the suture through the tissue in a direction of movement of the second end, and prevent movement of the suture relative to the tissue in a direction opposite the direction of movement of the second end. 
         [0012]    In some embodiments of the present invention an insertion device is used to insert the barbed suture. Such an insertion device is tubular and has leading and trailing ends with openings therein. The suture is initially disposed in the insertion device. The first end of the suture is proximate to the leading end of the insertion device. Where no insertion device is used, the sharp pointed ends of the suture are used to insert the suture in tissue; while these ends may be embodied, or be referred to, as needles herein, it should be understood that the suture may terminate in any type of sharp pointed end. 
         [0013]    Some embodiments provide a method for joining and holding portions of a stomach to each other in the performance of a Nissen fundoplication procedure. The Nissen fundoplication procedure requires grasping the fundus of the stomach at a proximal location and pulling the fundus around the esophagus, wrapping the fundus around the esophagus one time and attaching the proximal stomach to an apposing portion of the stomach. One method that uses the sharp pointed ends of the barbed suture to penetrate tissue comprises the steps of inserting the first pointed end of the suture into tissue of the proximal stomach and pushing the first end of the suture through the stomach tissue until the first end of the suture extends out of the tissue at an exit point on the exterior of the stomach. The first end of the suture is pulled to draw the first portion of the suture through the tissue until the second axial location is proximate to the point of insertion of the first end of the suture. A length of the first portion of the suture is left in the tissue between the point of insertion and exit point of the first end. The proximal stomach is gripped and the fundus is wrapped around the esophagus until the proximal stomach contacts an apposing portion of stomach. The second pointed end of the suture is inserted into tissue of the apposing stomach, and the second end of the suture is pushed through the stomach tissue until the second end of the suture extends out of the tissue at an exit point on the exterior of the stomach. The second end of the suture is pulled to draw the second portion through the tissue until the second axial location is proximate to the point of insertion of the second end of the suture and a length of the second portion of the suture is left in the tissue between the point of insertion and exit point of the second end. 
         [0014]    In another embodiment of a Nissen fundoplication method, an insertion device is used. Again, the fundus is wrapped around the esophagus to form a junction with the apposing portions of stomach. Then the first pointed end of the suture and leading end of the insertion device are inserted into stomach tissue at a point laterally spaced from the junction and on a first side of the junction. The first end of the suture and leading end of the insertion device are pushed through the first side of stomach tissue and penetrate the stomach tissue on a second side of the junction until the portion of the suture between the first and second axial locations is proximate to the junction. The insertion device is removed by gripping and pulling the trailing end, leaving the suture in place. 
         [0015]    Another embodiment for performing a Nissen fundoplication is provided using both sharp pointed ends of the suture, comprising the step of inserting the first pointed end of the suture into the tissue at a first side of the junction formed by the wrapping of the fundus around the esophagus. The first end of the suture is pushed through the tissue until the first end of the suture extends out of the tissue at an exit point in the face of the junction below the surface of the tissue at the first side of the junction. The first end is pulled out of the tissue, drawing the first portion of the suture through the tissue until the second axial location is at the point of insertion of the first end of the suture. A length of the first portion of the suture is left in the tissue between the point of insertion in the first side of the junction and the exit point in the face of the junction at the first side of the junction. The first end of the suture is then inserted into the face of the tissue below the surface of the tissue at a second side of the junction, and is pushed until the first end exits on the second side of the junction longitudinally spaced in a first direction from the insertion point in the first side of the junction. The first end of the suture is pulled out of the tissue and the first portion is drawn to bring the two sides of the junction together to a closed position along the first portion of the suture in the tissue. A length of the first portion of the suture is left in the tissue between the point of insertion in the first side of the junction and the exit point in the second side of the junction. The process is repeated similarly for the second end and second portion of the suture. 
         [0016]    Another method for joining and holding portions of a stomach to each other in the performance of a Nissen fundoplication is provided, using the sharp pointed ends of the suture, which may be needles. The method comprises the steps of inserting the first pointed end of the suture into the stomach tissue below the surface of the stomach tissue at a first face of the junction at an initial point. The first end of the suture is pushed through the stomach tissue along a curvilinear path until the first end of the suture extends from the stomach tissue at an exit point in the first face of the junction. This exit point is longitudinally spaced in a first direction from the insertion point in the first face of the junction. The first pointed end of the suture is gripped and pulled until it is out of the stomach tissue, drawing the first portion of the suture through the stomach tissue until the second axial location is at the point of insertion of the first end of the suture in the first face of the junction, leaving a length of the first portion of the suture in the stomach tissue of the junction. The first pointed end is inserted at a point below the surface of the stomach tissue in a second face of the junction, and pushed through the stomach tissue along a curvilinear path until the first end of the suture extends from the stomach tissue at an exit point in the second face of the junction below the surface of the stomach tissue. Again, the exit point is longitudinally spaced in the first direction from the insertion point in the second face of the junction. Then the first end of the suture is inserted at a point in the first face of the junction below the surface of the stomach tissue, and the above steps may be repeated for advancing along the junction in the first direction as necessary to one end of the junction. These steps are similarly repeated for the second end and second portion of the suture in a second direction. The initial point may be longitudinally spaced from the ends of the junction or adjacent to an end, and the first and second directions may be the opposite or same directions. 
         [0017]    One embodiment provides a method for laparoscopically inserting a barbed suture with a laparoscopic insertion device, similar to the insertion device described above but included in a laparoscopic tool. The first pointed end of the suture and the leading end of the laparoscopic insertion device are inserted through an entry point in the skin, and then through the fat, fascia, muscle, and peritoneum into the abdominal cavity. The first end of the suture and leading end of the insertion device are pushed into the tissue in the abdominal cavity, and the insertion device is pulled at the trailing end to remove the insertion device. Additional embodiments include stabilizing a bowel structure, where the bowel structure is positioned and then stabilized by leaving the inserted suture in place in the bowel tissue and the abdominal wall, and for a closure for a cytostomy, in which the first and second ends and portions of the suture are inserted in urinary bladder muscularis. 
         [0018]    Another embodiment involves a method for performing an anastomosis of the liver bile duct to a bowel structure, the bile duct having one end connected to the liver and a free end after having been severed, and the bowel structure having an opening in its wall made to receive the annular free end of the bile duct. One embodiment is performed with an insertion device as described above, with steps comprising placing the free end of the bile duct in contact with the opening in the bowel structure, and forming a junction at the annular contact area between the bile duct tissue and the bowel structure tissue. The first pointed end of the suture and the leading end of the insertion device are inserted into the tissue on one side of the junction. The first end of the suture and leading end of the insertion device are pushed through the tissue on one side of the junction, through the junction, and penetrate the tissue on the other side of the junction. The insertion device is gripped and pulled at the trailing end to remove the insertion device, leaving the suture in place in both the bile duct tissue and the bowel structure tissue. The previous steps are repeated as necessary to provide an anastomotic seal at the junction. 
         [0019]    In another embodiment, a liver bile duct-to-bowel structure anastomosis is performed with needles. Here, the first pointed end of the suture is inserted into a first tissue at a point spaced from the junction of the duct and bowel structure. The first end of the suture is pushed through the first tissue until the first end of the suture extends out of the first tissue at an exit point and penetrates a second tissue at a face of the junction. The first end of the suture is pushed until the first end of the suture extends out of the second tissue at an exit point spaced from the junction and spaced in a first direction along the circumference of the junction from the point of insertion of the first end of the suture in the first tissue. The first end of the suture is gripped and pulled out of a second tissue to draw the first portion of the suture through the first tissue and the second tissue while bringing the first tissue and the second tissue together to a closed position along the first portion of the suture. This pulling continues until the second axial location is at the point of insertion of the first end of the suture at the one side of the first tissue, leaving a length of the first portion of the suture in the first tissue and the second tissue between the point of insertion and the exit point. Then the first end of the suture is inserted into the second tissue at the exit point of the first end. The first end of the suture is pushed through the second tissue until the first end of the suture extends out of the second tissue at an exit point in the face of the junction and penetrates the first tissue. This pushing continues until the first end of the suture extends out of the first tissue at an exit point spaced from the junction and spaced along the circumference of the junction in the first direction from the immediately preceding point of insertion of the first end of the suture in the first tissue. Then first end of the suture is pulled out of the tissue to draw the first portion of the suture through the second tissue while bringing the first tissue and the second tissue together to a closed position along the first portion of the suture, and leaving a length of the first portion of the suture in the periphery between the point of insertion and the exit point. The above steps for the first end and first portion may be repeated to achieve an anastomotic seal. In addition, the steps described above are repeated similarly for the second end and second portion of the suture in a second direction. 
         [0020]    In another embodiment, a method for tying off an appendiceal stump resulting from the performance of an appendectomy is provided, using needles. The appendix extends from the cecum of the large intestine and has a base with a circumference at the juncture of the appendix and the cecum. The first pointed end of the suture is inserted into tissue of the cecum proximate to the appendix base. The first end of the suture is pushed around the circumference of the base in one direction for at least one half of the circumference of the base until extending through an exit point in the tissue. The second pointed end of the suture is then inserted into tissue of the cecum proximate to the entry point of the first end, and the second end of the suture is pushed along the circumference of the base in the other direction for at least one half of the circumference of the base until extending through an exit point in the tissue. The appendix is excised, leaving the appendiceal stump. Then the ends of the suture are gripped and pulled, causing the suture to tighten around the appendiceal stump, and may invert the stump into the cecum. 
         [0021]    Another embodiment provides a method for joining and holding closed the muscle layers that define the orifice of a Zenker&#39;s Diverticulum using an endoscopic insertion device, similar to the insertion device described above but included in an endoscopic tool. The Zenker&#39;s Diverticulum includes a sac extending from a proximal location of the esophagus near the pharynx, the sac having walls including a muscle layer common to the proximal esophagus. The Zenker&#39;s Diverticulum may first be manually inverted into the esophagus, or left outside the esophagus. The first pointed end of the suture and the leading end of the endoscopic insertion device are inserted through an entry point in the esophageal muscle between the pharynx and the orifice, and spaced from the orifice. The first end of the suture and leading end of the insertion device are pushed through the muscle until the first end of the suture and the leading end of the insertion device extend out of the muscle at the orifice of the sac. Then the first pointed end of the suture and the leading end of the endoscopic insertion device are inserted through an opposing side of the orifice, and are pushed through the muscle until the second axial location is proximate to a central to the point of the orifice. The insertion device is gripped and pulled at the trailing end to remove the insertion device, leaving the suture in place. Optionally, the above steps may be repeated with additional sutures. The muscle on the two sides of the orifice is advanced together as necessary to close the orifice. 
         [0022]    A method is provided for joining and holding closed ulcerative lesions or post-procedural tissue defects on an interior surface of a viscus, using an endoscopic insertion device as described above. The method comprises the step of inserting the first pointed end of the suture and the leading end of the endoscopic insertion device through an entry point in the tissue spaced from and on one side of the lesion. Then the first end of the suture and leading end of the insertion device are pushed through the tissue until the first end of the suture and the leading end of the insertion device extend out of the tissue at the lesion. The first pointed end of the suture and the leading end of the endoscopic insertion device are then inserted through an opposing side of the lesion, and are pushed until the second axial location is proximate to a central to the point of the lesion. The insertion device is gripped and pulled at the trailing end to remove the insertion device, leaving the suture in place. Again, optionally the above steps may be repeated. The tissue on the two sides of the lesion is advanced together to close the lesion. 
         [0023]    In another embodiment, a method is provided for joining and holding closed a wound in urinary bladder muscularis tissue, using needles. The first pointed end of the suture is inserted into the tissue below the surface of the tissue at a first face of the wound at an initial point, which may for example be adjacent to one end or longitudinally spaced from both ends of the wound. The first end of the suture is pushed through the tissue along a curvilinear path until the first end of the suture extends from the tissue at a subcutaneous exit point in the first face of the wound and longitudinally spaced in a first direction from the insertion point in the first face of the wound. The first pointed end of the suture is gripped and pulled out of the tissue, drawing the first portion of the suture through the tissue until the second axial location is at the point of insertion of the first end in the first face of the wound and leaving a length of the first portion of the suture in the tissue of the wound. Then the first pointed end of the suture is inserted at a point below the surface of the tissue in a second face of the wound. The first end is pushed through the tissue along a curvilinear path until the first end extends from the tissue at an exit point in the second face of the wound below the surface of the tissue and longitudinally spaced in the first direction from the insertion point in the second face of the wound. The first end of the suture is inserted at a point in the first face of the wound below the surface of the tissue. The above steps are repeated starting with the insertion of the first end of the suture in the first face of the wound to advance longitudinally along the wound in the first direction until reaching the end of the wound. Further, all of the above steps are repeated for the second end and second portion of the suture, in a second direction, starting with inserting the second end in the second face of the wound below the surface of the tissue and adjacent the initial point of insertion of the first end in the first face of the wound. 
         [0024]    Another method is provided for joining and holding closed a wound in urinary bladder muscularis tissue, also using needles. The first pointed end of the suture is inserted into the muscularis tissue below the surface of the tissue of a first face of the wound at an initial point adjacent an end of the wound. The first end of the tissue is pushed through the tissue along a curvilinear path until the first end of the suture extends from the tissue at an exit point in the first face of the wound below the surface of the tissue and longitudinally spaced from the end of the wound in a direction toward the other end of the wound. The first pointed of the suture is gripped and pulled out of the tissue, drawing the first portion of the suture through the tissue until the second axial location is at the point of insertion of the first end in the first face of the wound and leaving a length of the first portion of the suture in the tissue of the wound. The first end of the suture is then inserted into the second face of the wound below the surface of the tissue. The first end of the suture is pushed through the tissue along a curvilinear path until the first end extends from the tissue at an exit point in the second face of the wound below the surface of the tissue and longitudinally spaced from the insertion point in the second face of the wound toward the other end of the wound. The first end of the suture is inserted into the first face of the wound below the surface of the tissue, and the above steps are repeated starting with pushing the first end through the tissue until extending from an exit point in the first face of the wound, advancing longitudinally along the wound until reaching the other end of the wound. The steps are repeated similarly for the second end and second portion of the suture, starting with inserting the second end of the suture into the tissue of the second face of the wound below the surface adjacent the point of insertion of the first end. 
         [0025]    An embodiment of a method is provided for joining a foreign element and bodily tissue, either of which may be referred to as first matter or second matter, using needles. The foreign element has a periphery and the bodily tissue has a fibrous tissue ring with a face of the fibrous tissue ring defining an opening and apposing a face of the periphery, and holding closed a junction between the element and the tissue. The first pointed end of the suture is inserted into the periphery of the foreign element at a point radially spaced from the face of the fibrous tissue ring. The first end of the suture is pushed through the periphery until the first end of the suture extends out of the periphery at an exit point and penetrates the tissue of a face of the fibrous tissue ring until the first end of the suture extends out of the tissue at an exit point radially spaced from the junction and spaced along the fibrous tissue ring circumference in a first direction from the point of insertion of the first end of the suture on the periphery. The first end of the suture is gripped and pulled, drawing the first portion of the suture through the periphery and the tissue while bringing the periphery and the tissue together to a closed position along the first portion of the suture. This continues until the second axial location is at the point of insertion of the first end of the suture in the periphery and a length of the first portion of the suture is left in the periphery and the tissue between the point of insertion and the exit point. Then the first end of the suture is inserted into the tissue at the exit point of the first end. The first end is pushed through the tissue until the first end extends out of the tissue at an exit point in the face of the fibrous tissue ring and penetrates the periphery until the first end extends out of the periphery at an exit point radially spaced from the junction and spaced along the circumference of the fibrous tissue ring in the first direction from the immediately preceding point of insertion of the first end of the suture in the periphery. The first end of the suture is gripped and pulled out of the periphery, drawing the first portion of the suture through the periphery and tissue while bringing the periphery and the tissue together to a closed position along the first portion of the suture, and leaving a length of the first portion of the suture in the periphery between the point of insertion and the exit point. The above steps are repeated, with each repetition advancing the suture around the circumference of the junction in a first direction. Further, the above steps are repeated similarly for a second end and second portion of the suture, in a second direction. In addition, a similar method may be carried out with the suture first being inserted in the tissue rather than in the periphery of the foreign element. The sutures may extend completely around the circumference of the junction, and may overlap one quarter or more of the circumference. Yet another embodiment provides that the suture enter and exit tissue on the face of the junction, and not exit on the surface of the foreign element or the tissue. Examples of applications of these methods include placement of bioprosthetic heart valves, mechanical prosthetic heart valves, and bioprosthetics for cardiac septal defects. 
         [0026]    Some embodiments include a method of mounting a device to bodily tissue, using needles. The device includes at least one eyelet for securing the device and through which a suture may pass. The method starts with the step of placing the device in a desired position. Then a suture is threaded through the eyelet. The first pointed end of the suture is inserted into tissue and is pushed through the tissue until extending out an exit point. The first end of the suture is gripped and pulled out of the tissue while drawing the first portion of the suture through the tissue, leaving a portion of the suture between the first and second axial locations out of the tissue and leaving a length of the first portion of the suture in the tissue between the point of insertion and exit point of the first end. These steps are repeated for the second end and portion of the suture in a second direction, resulting in the first and second portions of the suture extending in the tissue in generally opposing directions and causing the suture to resist displacement of the device. Examples of devices that may be mounted according to the present invention include catheters, electrodes of cardiac pacemakers, and tumor monitors. The device may be mounted internally, for example, to an organ, or externally to the epidermis. 
         [0027]    Further, methods of performing cosmetic surgery are provided. One embodiment of a procedure using needles begins with inserting the first pointed end at an insertion point on the surface of a person&#39;s body. The first end of the suture is pushed through soft tissue until the first end extends out of the soft tissue at an exit point. The first end of the suture is gripped and pulled to draw the first portion of the suture through the soft tissue until the second axial location is proximate to the point of insertion of the first end of the suture, leaving a length of the first portion of the suture in the soft tissue between the point of insertion and exit point of the first end. The second pointed end of the suture is put in place by repeating these steps for the second end and second portion. The soft tissue is manually grouped and advanced along at least one portion of the suture to provide the desired amount of lift. 
         [0028]    Specific applications of cosmetic surgeries as described above include, for example, facelifts, browlifts, thigh lifts, and breast lifts. In an embodiment of a facelift, the insertion point is approximately at the temporal hairline, and the first end of the suture is pushed through subepidermal tissue to the exit point of on the scalp. The second end of the suture is pushed through subepidermal tissue, the superficial muscular aponeurotic system, or combinations thereof, to the exit point proximate to the nasolabial fold. Tissue is manually grouped and advanced along the second portion of the suture to provide the desired amount of lift. 
         [0029]    In an embodiment of a browlift, the insertion point is on a person&#39;s face above the brow line. The first end of the suture is pushed through subepidermal tissue underneath the forehead, scalp, or both and the exit point of the first end of the suture is on the scalp. The second end of the suture is pushed through subepidermal tissue and the exit point of the second end of the suture is proximate to the brow. The tissue is manually grouped and advanced along the second portion of the suture to provide the desired amount of lift. The insertion may be approximately at the frontal hairline or the midpoint between the brow and frontal hairline. 
         [0030]    Another embodiment of a browlift is provided for use with needles, and again the insertion point is on a person&#39;s face above the brow line. Examples of insertion point locations for browlifts include approximately at the frontal hairline or halfway between the brow and the frontal hairline. The first end of the suture is pushed through subepidermal tissue and the exit point of the first end of the suture is proximate to the brow. The second end of the suture is pushed through subepidermal tissue and the exit point of the second end of the suture is proximate to the brow and spaced from the exit point of the first end of the suture. Then the tissue is manually grouped and advanced along the first and second portions of the suture to provide the desired amount of lift. 
         [0031]    An embodiment of a thigh lift is also provided. For a thigh lift, the insertion point is generally at the inguinal crease. The first end of the suture is pushed cranially through subepidermal tissue until the first end of the suture extends out of the tissue. The second end of the suture is pushed caudally through subepidermal tissue until the second end of the suture extends out of the tissue on the thigh, and then tissues are manually grouped and lifted as desired. 
         [0032]    Further, a method of performing a cosmetic breast lift is provided. The insertion point is at the upper aspect of the breast curvature, and the first end of the suture is pushed through subcutaneous tissue, dermal tissue, and pectoralis muscle until extending out of the tissue at an exit point on the upper portion of the breast. The second end of the suture is pushed caudally through fibrous and fatty tissues until the second end of the suture extends out of the tissue at an exit point along the anterior aspect or the lower curvature of the breast, and the tissue is manually grouped and lifted as desired. 
         [0033]    Embodiments of cosmetic surgery using an insertion device are also provided. In these methods, the first pointed end of the suture and the leading end of the insertion device are inserted at an insertion point. The first end of the suture and the leading end of the insertion device are pushed through tissue beneath the epidermis until reaching an endpoint. Then the insertion device is gripped and pulled at the trailing end to remove the insertion device, leaving the suture in place, and the tissue is manually grouped and advanced along the first portion of the suture to provide the desired amount of lift. This method applies, for example, to a facelift, where the insertion point is in the scalp distal from the temporal hairline. The suture is pushed through the reticular dermis underneath the scalp, and the first end of the suture passes through the temporal hairline, penetrates the facial tissue such as the reticular dermis, the superficial muscular aponeurotic system, or a combination thereof, extending to the nasolobial fold. The method also applies to browlifts, where, for example, the insertion point is in the scalp at a point distal from the frontal hairline; and the suture is pushed through the reticular dermis underneath the scalp until the first end of the suture passes through the frontal hairline, extending to be proximate to the browline. 
         [0034]    Other embodiments are provided for a method for joining and holding closed an axial wound in a blood vessel such as an artery or vein, using an insertion device. The first pointed end of the suture and the leading end of the insertion device are inserted through an entry point in the tissue spaced from and on one side of the wound. The first end of the suture and leading end of the insertion device are pushed through the tissue until penetrating the blood vessel wall on one side of the wound, continuing until extending into the interior of the blood vessel. The first end of the suture and leading end of the insertion device are then pushed through the interior of the blood vessel until the first end of the suture and the leading end of the insertion device penetrate the blood vessel wall on the other side of the wound, continuing through the blood vessel wall and penetrating the tissue on the other side of the wound. The first end of the suture and leading end of the insertion device are pushed through the tissue. In one embodiment, the second axial location is disposed in the blood vessel wall on one side of the wound and the first axial location is disposed in the blood vessel wall on the other side of the wound, resulting in no barbs being disposed in the interior of the blood vessel. The insertion device is gripped and pulled at the trailing end for removal, leaving the suture in place, and the tissue may be advanced on the two sides of the wound together as necessary to close the wound. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0035]    For a more complete understanding of the present invention, reference should now be had to the embodiments shown in the accompanying drawings and described below. In the drawings: 
           [0036]      FIG. 1  is a perspective view of an embodiment of a barbed suture with straight pointed ends for use according to the methods of the present invention; 
           [0037]      FIG. 2  is a perspective view of a barbed suture with curved pointed ends for use according to the methods of the present invention; 
           [0038]      FIGS. 3-6  are plan views of an embodiment of a method according to the present invention for joining two sides of an open wound in tissue; 
           [0039]      FIGS. 7-10  are perspective views of another embodiment of a method according to the present invention for joining two sides of an open wound in tissue; 
           [0040]      FIG. 11  is a perspective view of a prior art method for joining two sides of an open wound in tissue using a spiraling suture path; 
           [0041]      FIGS. 12-15  are perspective views of an embodiment of a method according to the present invention for joining two sides of an open wound in tissue using a spiraling suture path; 
           [0042]      FIGS. 16-18  are perspective views of still another embodiment of a method according to the present invention for joining two sides of an open wound in tissue; 
           [0043]      FIGS. 19 and 20  are plan views of a further embodiment of a method according to the present invention for joining two sides of an open wound in tissue; 
           [0044]      FIG. 21  is a plan view of the embodiment shown in  FIGS. 19 and 20  for use in closing a vascular puncture via cinching of tissues directly above the vessel; 
           [0045]      FIG. 22  is a cross-sectional view of the method shown in  FIG. 21 ; 
           [0046]      FIG. 23  is a side elevation view of a finger with a portion of the outer layer of tissue cut-away to schematically show a severed tendon; 
           [0047]      FIG. 24  is a plan view of the Kessler method for joining two ends of a severed tendon; 
           [0048]      FIGS. 25-28  are perspective views of an embodiment of a method according to the present invention for joining two ends of a severed tendon; 
           [0049]      FIGS. 29-30  are side elevation views of an embodiment of the method according to the present invention for performing a Nissen fundoplication; 
           [0050]      FIG. 31  is another embodiment of a method according to the present invention for performing a Nissen fundoplication; 
           [0051]      FIGS. 32-34  are cut-away perspective views of an embodiment of the method according to the present invention for laparoscopic insertion; 
           [0052]      FIGS. 35-37  are perspective views of two embodiments according to a method of the present invention for performing an anastomosis of a liver bile duct to a portion of a bowel; 
           [0053]      FIGS. 38-39  are perspective views of an embodiment of the method according to the present invention for performing an appendectomy; 
           [0054]      FIGS. 40-42  are vertical cross-section views of an embodiment of the method according to the present invention for performing a Zenker&#39;s Diverticulectomy; 
           [0055]      FIGS. 43-44  are partially sectioned perspective views of an embodiment of the method according to the present invention for closure of ulcerative intestinal lesions or other bowel wall defects; 
           [0056]      FIG. 45-46  are front elevation views of two embodiments of the method according to the present invention for closure of a cystostomy incision in the urinary bladder; 
           [0057]      FIG. 47  is a front elevation view of an embodiment of the method according to the present invention for securing prosthetic heart valves; 
           [0058]      FIG. 48  is a front elevation view of an embodiment of the method according to the present invention for securing a catheter in position; 
           [0059]      FIG. 49  is a perspective view of embodiments of the method according to the present invention for performing cosmetic surgery; 
           [0060]      FIGS. 50-52  are cross-section views of an axial wound closure in a blood vessel according to two embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0061]    As used herein, the term wound means a surgical incision, cut, laceration, severed tissue or accidental wound in human skin or other bodily tissue, or other condition where suturing, stapling, or the use of another tissue connecting device might be required. 
         [0062]    As used herein, the term tissue includes tissues such as skin, bone, muscle, organs, and other soft tissue such as tendons, ligaments and muscle. 
         [0063]    Certain other terminology is used herein for convenience only and is not to be taken as a limitation on the invention. For example, words such as “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” merely describe the configuration shown in the figures. It is understood that the components may be oriented in any direction and the terminology, therefore, should be understood as encompassing such variations unless specified otherwise. 
         [0064]    Referring now to the drawings, wherein like reference numerals designate corresponding or similar elements throughout the several views, there is shown in  FIGS. 1 and 2  a suture for use according to the present invention and generally designated at  40 . The suture  40  includes an elongated body  42  having a plurality of barbs  44  disposed along the length of the body  42 . First and second ends  46 ,  48  of the body  42  terminate in points  50 ,  52  for penetrating tissue. 
         [0065]    The body  42  of the suture  40  is, in one embodiment, circular in cross section. Suitable diameters for the body  42  of the suture  40  range from about 0.001 mm to about 1.0 mm. The body  42  of the suture  40  could also have a non-circular cross-sectional shape which would increase the surface area of the body  42  and facilitate the formation of multiple barbs  44 . 
         [0066]    The length of the suture  40  can vary depending on several factors such as the extent of the wound to be closed, the type of tissue to be joined, the location of the wound, and the like. A suture  40  of proper length is selected for achieving suitable results in a particular application. 
         [0067]    Material for the body  42  of the suture  40  is available in a wide variety of monofilament suture material. The particular suture material chosen depends on the strength and flexibility requirements. In one embodiment, the material for the body  42  is flexible and substantially nonresilient so that the shape of an inserted suture  40  will be determined by the path of insertion and the surrounding tissue. In some applications, however, it may be desirable for at least a portion of the body  42  to have sufficient dimensional stability to assume a substantially rigid configuration during use and sufficient resiliency to return to a predetermined position after deflection therefrom. The portions of the ends  46 ,  48  of the suture  40  adjacent the points  50 ,  52  may be formed of a material sufficiently stiff to enable the points  50 ,  52  to penetrate tissue in which the suture  40  is used when a substantially axial force is applied to the body  42 . Variations in surface texture of the body  42  of the suture  40  can impart different interaction characteristics with tissues. 
         [0068]    The body  42  can be formed of a bioabsorbable material which allows the suture  40  to be absorbed over time into the tissue as the wound heals. Bioabsorbable material is particularly useful in arthroscopic surgery and methods of suturing. Many compositions useful as bioabsorbable materials can be used to make the body  42  of the suture  40  for use in the methods of the present invention. Generally, bioabsorbable materials are thermoplastic polymers. Selection of the particular material is determined by the desired absorption or degradation time period which depends upon the anticipated healing time for the subject of the procedure. Biodegradable polymers and co-polymers range in degradation time from about one month to over twenty-four months. They include, but are not limited to, polydioxanone, polylactide, polyglycolide, polycaprolactone, and copolymers thereof. Other copolymers with trimethylene carbonate can also be used. Examples are PDS II (polydioxanone), Maxon (copolymer of 67% glycolide and 33% trimethylene carbonate), and Monocryl (copolymer of 75% glycolide and 25% caprolactone). Germicides can also be incorporated into the body  42  of the suture  40  which are retained by the suture  40  to provide long lasting germicidal properties. 
         [0069]    The body  42  of the suture  40  can also be formed from non-absorbable material such as nylon, polyethylene terephthalate (polyester), polypropylene, and expanded polytetrafluoroethylene (ePTFE). Alternatively, the suture body  42  can also be formed of metal (e.g. steel), metal alloys, plastic, or the like. 
         [0070]    The plurality of barbs  44  is axially-spaced along the body  42  of the suture  40 . The barbs  44  are oriented in one direction facing toward the first end  46  of the suture  40  for a first portion  54  of the length of the suture and in an opposite direction facing the second end  48  of the suture  40  for a second portion  56  of the suture. The barbs  44  are yieldable toward the body  42 . The barbs  44  on each portion  54 ,  56  of the suture are oriented so as to allow movement of the suture  40  through the tissue in one direction along with the corresponding end  46 ,  48  of the suture  40 . The barbs  44  are generally rigid in an opposite direction to prevent the suture  40  from moving in the tissue in the opposite direction. 
         [0071]    The barbs  44  can be arranged in any suitable pattern, for example, in a helical pattern as shown in  FIGS. 1 and 2 . The number, configuration, spacing and surface area of the barbs  44  can vary depending upon the tissue in which the suture  40  is used, and depending on the composition and geometry of the suture body. The proportions of the barbs  44  may remain relatively constant while the overall length of the barbs  44  and the spacing of the barbs  44  are determined by the tissue being connected. For example, if the suture  40  is intended to be used to connect the edges of a wound in skin or tendon, the barbs  44  can be made relatively short and more rigid to facilitate entry into this rather firm tissue. If the suture  40  is intended for use in fatty tissue, which is relatively soft, the barbs  44  can be made longer and spaced farther apart to increase the holding ability in the soft tissue. Moreover, the ratio of the number of barbs  44  on the first portion  54  of the suture  40  to the number of barbs  44  on the second portion  56 , and the lengths of each portion  54 ,  56 , can vary depending on the application and needs. 
         [0072]    The surface area of the barbs  44  can also vary. For example, fuller-tipped barbs  44  can be made of varying sizes designed for specific surgical applications. For joining fat and relatively soft tissues, larger barbs  44  are desired, whereas smaller barbs  44  are more suited for collagen-dense tissues. There are also situations where a combination of large and small barbs  44  within the same structure will be beneficial such as when a suture  40  is used in tissue repair with differing layer structures. Use of the combination of large and small barbs  44  with the same suture  40  wherein barb  44  sizes are customized for each tissue layer will ensure maximum anchoring properties. 
         [0073]    The barbs  44  may be formed on the surface of the body  42  according to any suitable method, including cutting, molding, and the like. The preferred method is cutting with acute angular cuts directly into the suture body  42  with cut portions pushed outwardly and separated from the body  42  of the suture  40 . The depth of the barbs  44  formed in the suture body  42  depends on the diameter of the suture material and the depth of cut. A particularly suitable device for cutting a plurality of axially spaced barbs  44  on the exterior of suture filaments utilizes a cutting bed, a cutting bed vise, a cutting template, and a blade assembly to perform the cutting. When operated, the cutting device has the ability to produce a plurality of axially spaced barbs  44  in the same or random configuration and at different angles in relation to each other. Various other suitable methods of cutting the barbs  44  have been proposed including the use of a laser. The barbs  44  could also be cut manually. However, manually cutting the barbs  44  is labor intensive, decreases consistency, and is not cost effective. The suture  40  could also be formed by injection molding, extrusion, stamping and the like. The suture  40  can be packaged in any number of desired pre-cut lengths and in pre-shaped curves. 
         [0074]    The ends  46 ,  48  of the suture  40  may be straight ( FIG. 1 ) or curved ( FIG. 2 ). In one embodiment, the ends  46 ,  48  of the suture  40  may be surgical needles secured at each end of the body  42  of the suture  40  so that the body  42  extends between the shank ends of the two needles. The needles are preferably constructed of stainless steel or other surgical grade metal alloy. The needles may be secured to the suture body  42  by means of adhesives, crimping, swaging, or the like, or the joint may be formed by heat shrinkable tubing. A detachable connection may also be employed such that the needles may be removed from the body  42  of the suture  40  by a sharp tug or pull or by cutting. The length of the needles is selected to serve the type of tissue being repaired so that the needles can be completely removed leaving the suture body  42  in the desired position within the tissue. 
         [0075]    Barbed sutures suitable for use according to the methods of the present invention are described in U.S. Pat. No. 5,342,376, entitled Inserting Device for a Barbed Tissue Connector, U.S. Pat. No. 6,241,747, entitled Barbed Bodily Tissue Connector, and U.S. Pat. No. 5,931,855. The contents of U.S. Pat. Nos. 5,342,376, 6,241,747, and 5,931,855 are hereby incorporated by reference. 
         [0076]    According to the present invention, a surgical procedure using barbed sutures  40  is provided for binding together living tissue for healing and regrowth or reconfiguration in vivo. In general, when the suture  40  is used in tissue to repair a wound, the suture is passed through tissue at each of the sides of the wound. The point  50  at one end  46  of the suture  40  is inserted into a first side of a wound such that the point  50  pierces the tissue and the barbs  44  on the end portion  54  of the suture  40  corresponding to the one end  46  yield toward the body  42  to facilitate movement of the suture  40  through the tissue in the direction of insertion. The other end  48  of the suture  40  is also inserted into a side of the wound and advanced through the tissue in like manner. The sides or faces of the wound are then moved together along the suture portions  54 ,  56  within the tissue to close the wound. The barbs  44  of the suture  40  grasp the surrounding tissue on each side of the wound and maintains the edges of the wound in position during healing. The leading ends  46 ,  48  of the suture  40  protruding from the tissue are then cut and discarded. In one embodiment, ends of the suture  40  in the tissue are made to lie below the surface of the skin by first depressing the skin immediately around the ends and severing the suture body  42  closely against the skin. The skin will rise to cover the ends of the suture  40 . 
         [0077]      FIGS. 3-6  show a section of tissue including a portion of a patient&#39;s skin  58  and subcutaneous tissue defining a wound  60  from the surface of the skin  58  down into the tissue. It is understood that the wound  60  in the tissue can be of any configuration and from any anatomical part or organ of the body. Accordingly, depending on the configuration of the wound, the wound may comprise several sides and faces. However, the wounds depicted in the figures are straight incisions in the skin  58  to reduce the complexity of the description of the method of the present invention. It is understood that the applicants do not intend to limit the method of the present invention to the closure of only straight incisions. 
         [0078]    In this embodiment of the method of the present invention, the user, such as a surgeon, selects a suture  40  of sufficient length and having straight ends  46 ,  48 . As noted above, in one embodiment, the ends  46 ,  48  may be surgical needles. 
         [0079]    Referring to  FIG. 3 , the surgeon inserts the needle  46  at the end of the first portion  54  of the suture  40  into the tissue at a point  62  on a first side  64  of the wound  60  and laterally spaced from the face  66  of the wound  60  at the first side  64 . The surgeon advances the needle  46  along a selected substantially straight path through the tissue to extend out of the tissue at a subcutaneous point (not shown) in the first face  66  of the wound  60  and subcutaneously penetrating a point (not shown) in a face  68  of a second side  70  of the wound  60 . The surgeon continues to advance the needle  46  through the tissue until the point  50  of the needle emerges from the tissue at a distal end of the selected path at an exit point  72  on the second side  70  of the wound  60 . The exit point is laterally spaced from the face  68  of the second side  70  of the wound and longitudinally spaced in a first direction from the point of insertion  62  at the first side  64  of the wound  60 . The surgeon grips the exposed portion of the needle  46  and pulls the needle  46  out of the tissue. This action draws the first portion  54  of the suture  40  having barbs  44  for resisting movement in the opposite direction through the tissue until the barbs  44  on the second portion  56  engage the surface of the skin  58  at the insertion point  62  preventing further advancement of the suture  40  through the tissue. A length of the first portion  54  of the suture body  42  is thus positioned in the tissue along the selected path. The faces  66 ,  68  of the wound  60  are approximated by pushing the adjacent sides  64 ,  70  of the tissue together along the first portion  54  of the body  42  of the suture  40  in the tissue. 
         [0080]    The needle  46  is next inserted into the tissue at the exit point  72  and advanced along a substantially straight path through the tissue to extend out of the tissue at a subcutaneous point  74  in the second face  68  of the wound  60  and subcutaneously penetrating a point  76  in the first face  66  of the wound  60 . The surgeon continues to advance the needle  46  through the tissue until the point end  50  emerges from the tissue at a distal end of the selected path at an exit point  78  on the first side  64  of the wound  60  that is laterally spaced from the first face  66  and longitudinally spaced in the first direction from the point of insertion  72  at the second side  70  of the wound  60 . Again the surgeon grips the exposed portion of the needle  46  and pulls the needle  46  out of the tissue, drawing the first portion  54  of the suture  40  through the tissue. 
         [0081]    The previous steps are repeated with the first portion  54  of the suture  40  by inserting the needle  46  into the exit point  78  on the first side  64  of the wound  60  for advancing longitudinally in the first direction along the wound  60  in a zigzag pattern as shown in  FIG. 4 . The number of passes of the needle  46  is chosen in accordance with the size of the wound  60  and the strength required to hold the wound closed. The remaining length of the first portion  54  of the suture  40  protruding from the tissue at a first end  80  of the wound  60  is cut and discarded, leaving the remaining first portion  54  of the suture  40  in the tissue. The faces  66 ,  68  of the wound  60  are approximated by pushing the adjacent sides  64 ,  70  of the tissue together along the body  42  of the suture  40  in the tissue. 
         [0082]    It is understood that the step of approximating the sides  64 ,  70  of the wound  60  can be performed as the suture  40  is advanced or after the end  80  of the wound  60  is reached. Moreover, we do not intend to limit ourselves to the depth of the suture paths shown in the FIGS. as the depth of the suture paths may be determined by the surgeon or the wound to be closed. Further, it is understood that straight ends  46 ,  48  of the suture may also produce more curved transitions as determined by the surgeon. 
         [0083]    The surgeon repeats the steps of this procedure with the second needle  48  on the second portion  56  of the suture ( FIG. 5 ). The initial insertion point  62  of the second needle  48  is at the same initial point of insertion  62  of the first needle  46  at the first side  64  of the wound  60 . The surgeon thus advances the second portion  56  of the suture  40  into the tissue along the wound  60  in a direction toward the other end  82  of the wound  60  using the same zigzag pattern approximating the faces  66 ,  68  of the wound  60 . The remaining length of the second portion  56  of the suture  40  protruding from the skin  58  at the end  82  of the wound  60  is then cut and discarded ( FIG. 6 ). 
         [0084]    An embodiment of the method for joining the sides of an open wound in tissue according to the present invention using a subcuticular stitch is shown in  FIGS. 7-10 . The tissue shown in the figures includes an epidermis  84 , dermis  86 , fat  88 , fascia  90  and muscle  92 . By penetrating the subcutaneous layers only and not the outer skin  58  layer, a wound  60  can be closed to facilitate healing while minimizing scar tissue. 
         [0085]    Referring to  FIG. 7 , the subcuticular stitch method of the present invention uses a barbed suture  40  including curved ends  46 ,  48 . The surgeon begins by inserting the first needle  46  into the tissue below the skin  58  surface at a face  66  on a first side  64  of the wound  60  at an initial insertion point  63  longitudinally spaced from the ends  80 ,  82  of the wound  60 . The surgeon advances the needle  46  through the tissue along a curvilinear path until the point  50  of the needle  46  extends from the tissue at a subcutaneous exit point  73  in the first face  66  of the wound  60  longitudinally spaced toward one end  80  of the wound from the entry point  63  of the needle  46 . The surgeon grips the needle  46  and pulls the needle  46  out of the tissue, drawing the first portion  54  of the suture  40  through the tissue until the barbs  44  on the second portion  56  engage the tissue at the insertion point  63  preventing further advancement of the suture  40  through the tissue. A length of the first portion  54  of the suture body  42  is thus positioned in the tissue along the selected curvilinear path as seen in  FIG. 7 . 
         [0086]    Turning to  FIG. 8 , the surgeon then inserts the needle  46  into the tissue at a subcutaneous entry point (not shown) in the face  68  at the second side  70  of the wound  60 . The surgeon repeats the above steps of pushing the needle  46  through the tissue along a selected curvilinear path so that the point  50  of the needle  46  emerges from a subcutaneous exit point (not shown) in the second face  68  of the wound  60  longitudinally spaced toward the end  80  of the wound  60  from the entry point. The surgeon grips the needle  46  and draws the first portion  54  of the suture  40  into the tissue further along the wound  60 . In this manner, the surgeon advances the first portion  54  of the suture  40  longitudinally along the wound  60  to the one end  80  of the wound in a wave-like or sinusoidal pattern. As noted above, the faces  66 ,  68  of the wound  60  are approximated as the surgeon progresses, or when the end  80  of the wound  60  is reached, by pushing the adjacent sides  64 ,  70  of the tissue together along the body  42  of the suture  40 . The needle  46  along with remaining length of the first portion  54  of the suture  40  is drawn through the surface of the skin  58  at the one end  80  of the wound  60  is cut and discarded ( FIG. 8 ). 
         [0087]    The surgeon repeats the procedure at the other end of the wound ( FIG. 9 ) with the second portion  56  of the suture  40 . The surgeon begins by inserting the second needle  48  into the tissue at a subcutaneous point (not shown) in the second face  68  of the wound  60 . The surgeon advances the second needle  48  along a curvilinear path from the point of initial insertion toward the other end  82  of the wound  60  until the needle  48  emerges from a subcutaneous exit point (not shown) the second face  68  of the wound  60  longitudinally spaced from the initial entry point of the needle  48 . The surgeon then pulls the needle  48  from the tissue, drawing the second portion  56  of the suture  40  into the tissue, and inserts the needle  48  into the first face  66  of the wound  60  at a subcutaneous entry point (not shown) at the first side  64  of the wound  60 . Again, the surgeon advances the needle  48  along a curvilinear path until the needle  48  emerges from a subcutaneous exit point  98  in the face  66  further toward the other end  82  of the wound and draws the needle  48  and suture portion  56  through the tissue.  FIG. 9  shows the needle  48  being drawn a second time from the second face  68  of the wound  60 . Thus, the surgeon advances the second portion  56  of the suture in a sinusoidal pattern to the end  82  of the wound  60  ( FIG. 10 ) and approximates the faces  66 ,  68  of the wound  60 . The length of the second portion  56  of the suture body  42  protruding from the skin  58  at the end of the wound  60  is then cut and discarded. 
         [0088]      FIG. 11  shows a prior art subcutaneous suturing method for closing a wound  60  using a spiraling, corkscrew-shaped stitch pattern. The surgeon begins at one end  80  of the wound by tying a knot  100  in the first loop and advancing the suture in a corkscrew pattern to the other end of the wound  82  where the suture is tied off. Tying the knots at the end and burying them, which is preferred by the surgeon, is technically very challenging, even more so when the incision is almost closed. 
         [0089]      FIGS. 12-15  show a similar corkscrew-shaped stitch pattern for closing a wound  60  according to an embodiment of the method of the present invention. This embodiment is similar to the method described above using a subcutaneous sinusoidal stitch pattern. 
         [0090]    Referring to  FIG. 12 , the surgeon begins by inserting one of the needles  46  into the tissue below the skin  58  surface at a face  66  on a first side  64  of the wound  60  at an initial subcutaneous insertion point  63  longitudinally spaced from the ends  80 ,  82  of the wound  60 . The surgeon advances the needle  46  upward through the tissue along a curvilinear path until the point  50  of the needle  46  extends from the tissue at a subcutaneous exit point  73  in the first face  66  of the wound  60  longitudinally spaced toward one end  80  of the wound and above the entry point  63  of the needle  46 . The surgeon then inserts the needle  46  into the tissue at a subcutaneous entry point  102  in the face  68  at the second side  70  of the wound  60 . The surgeon pushes the needle  46  through the tissue along a selected curvilinear path so that the point  50  of the needle  46  emerges from a subcutaneous exit point  104  in the second face  68  of the wound  60  longitudinally spaced toward the end  80  of the wound  60  and below the entry point  102 . The surgeon repeats these steps ( FIG. 13 ) for advancing the first portion  54  of the suture  40  longitudinally along the wound  60  to the one end  80  of the wound in the spiraling, corkscrew stitch pattern. It is understood that the number and diameter of coils can be varied as desired. At any selected convenient point, the surgeon grips the needle  46  for drawing the first portion  54  of the suture  40  through the tissue until the barbs  44  on the second portion  56  engage the tissue at the insertion point  63  preventing further advancement of the suture  40  through the tissue. The surgeon approximates the faces  66 ,  68  of the wound  60  as the surgeon progresses or when the end  80  of the wound  60  is reached as described above. The remaining length of the first portion  54  of the suture  40  is drawn through the surface of the skin  58  at the one end  80  of the wound  60  and cut and discarded. 
         [0091]    The surgeon repeats the procedure at the other end  82  of the wound  60  with the second portion  56  of the suture  40 . As seen in  FIG. 14 , several coils of the second portion  56  of the suture  40  have been entered into the tissue in a direction toward the other end  82  of the wound  60 . Subcutaneous entry points  106  and exit points  108  in the faces  66 ,  68  of the wound  60  are visible. The surgeon advances the second portion  56  of the suture  40  to the end  82  of the wound  60  ( FIG. 15 ) and approximates the faces  66 ,  68  of the wound  60 . The length of the second portion  56  of the suture body  42  protruding from the skin  58  at the end of the wound  60  is then cut and discarded. 
         [0092]    Another embodiment of a subcutaneous suturing method for joining and holding closed an open wound  60  in tissue according to the present invention is shown in  FIGS. 16-18 . This method also uses a barbed suture  40  having curved pointed ends  46 ,  48 , such as surgical needles. 
         [0093]    Referring to  FIG. 16 , the surgeon begins by inserting the first needle  46  subcutaneously into the tissue at a face  66  on a first side  64  of the wound  60  at an initial insertion point  63  adjacent one end  80  of the wound  60  and pushes the needle  46  through the tissue along a selected curvilinear path until the needle  46  extends from the tissue at a subcutaneous exit point  73  in the first face  66  of the wound  60  longitudinally spaced from the end  80  of the wound  60  in a direction toward the other end  82  of the wound  60 . The surgeon grips the needle  46  and pulls the needle  46  out of the tissue for drawing the first portion  54  of the suture  40  including barbs  44  for resisting movement in the opposite direction through the tissue until the barbs  44  of the second portion  56  engage the first face  66  of the wound  60  at the insertion point  63  preventing further advancement of the suture  40  into the tissue. A length of the first portion  54  of the suture body  42  is thus positioned in the tissue along the selected curvilinear path. 
         [0094]    As further seen in  FIG. 16 , the surgeon next inserts the second surgical needle  48  into the tissue at a subcutaneous entry point (not shown) in the face  68  at the second side  70  of the wound  60  substantially opposite the initial point of insertion  63  of the first needle  46  at the one end  80  of the wound  60 . The surgeon advances the second needle  48  through the tissue along a selected curvilinear path until the needle  48  extends from the tissue at a subcutaneous exit point (not shown) in the second face  68  of the wound  60 . The surgeon then pulls the second needle  48  for drawing the second portion  56  of the suture  40  through the tissue, including barbs  44  for resisting movement in the opposite direction, leaving a length of the second portion  56  of the suture  40  in the tissue at the end  80  of the wound  60 . 
         [0095]    The surgeon repeats the above steps with the first needle  46  and second needle  48  at the second and first sides  64 ,  70 , respectively, of the wound  60 . In this manner, the surgeon advances the suture  40  longitudinally along the wound  60  from the one end  80  of the wound to the other  82  in a shoelace pattern. As seen in  FIG. 17 , several passes of the suture  40  have been entered into the tissue of the wound  60 . The faces  66 ,  68  of the wound  60  are approximated as the surgeon progresses, or when the end  82  of the wound  60  is reached, by pushing the adjacent sides  64 ,  70  of the tissue together along the body  42  of the suture  40 . The lengths of the first portion  54  and second portion  56  of the suture  40  protruding from the skin  58  are cut and discarded ( FIG. 18 ). 
         [0096]    It is understood that the method of the present invention shown in  FIGS. 7-10  can be used to generate a similar stitch pattern if a second suture is used which is entered in the tissue to mirror the path of the first suture. 
         [0097]    Another embodiment of the method according to the present invention for joining the sides  64 ,  70  of tissue in an open wound  60  is shown in  FIGS. 19 and 20 . In this embodiment, the surgeon inserts a first curved or straight end  46  of the suture  40 , such as a needle, into the tissue at a point  62  on a first side  64  of the wound  60  and laterally spaced from the face  66  of the wound  60  at the first side  64 . The surgeon advances the needle  46  through the tissue along a curvilinear path until the needle  46  emerges from the tissue on a second side  70  of the wound at an exit point  72  laterally spaced from the face  68  of the second side  70  of the wound  60  and longitudinally spaced in a first direction from the point of insertion  62 . This path subcutaneously passes through both faces  66 ,  68  of the wound  60 . The surgeon grips the needle  46  and pulls the needle  46  out of the tissue for drawing the first portion  56  of the suture  40  through the tissue until the barbs  44  of the second portion  56  engage the surface of the skin  58  at the insertion point  62  preventing further advancement of the suture  40  into the tissue. The faces  66 ,  68  of the wound  60  are approximated by pushing the adjacent sides  64 ,  70  of the tissue together along the body  42  of the suture  40  in the tissue. The length of the first portion  54  of the body  42  of the suture  40  protruding from the skin  58  is cut and discarded ( FIG. 19 ). 
         [0098]    The surgeon then inserts the second needle  48  into the tissue at the point of insertion  62  of the first needle  46  at the first side  64  of the wound  60 . The surgeon pushes the needle  48  through the tissue along a curvilinear path which substantially mirrors the passage of the first needle  46  until the needle  48  emerges from the tissue at an exit point  110  laterally spaced from the wound and longitudinally spaced in a second direction from the point of insertion  62  such that the paths of the first and second portions  54 ,  56  of the suture  40  overlap. Again, the path of the second needle  48  subcutaneously passes through the faces  66 ,  68  of the wound  60 . The surgeon grips the second needle  48  and pulls the needle  48  from the tissue for drawing the second portion  56  of the suture  40  into the tissue. The length of the second portion  56  of the suture  40  protruding from the skin  58  is cut and discarded, leaving a stitch in the tissue which resembles the Greek letter alpha ( FIG. 20 ). 
         [0099]    This stitch has its greatest benefit in small wound and incision closure. The alpha-shaped stitch can be placed quickly in tissue as compared with conventional loop sutures. Moreover, this stitch pattern has no blood constricting loops, leaves no stitch marks on the surface of the skin, and does not have to be removed from the patient if bio-absorbable material is used. Two or more of the alpha-shaped stitches may be used to close a larger wound. 
         [0100]    A particular application of the alpha-stitch according to the method of the present invention is as a means of restricting bleeding from an arterial opening by constricting the tissue above and around the arterial opening. For example, the introduction and removal of catheters into the femoral artery is typically required when performing cardiac catheterization, percutaneous interventions, and other vascular procedures. These puncture wounds are typically self-sealing after several hours of sustained external pressure at and around the insertion site of the puncture wound.  FIGS. 21 and 22  show the alpha-stitch according to a method of the present invention positioned for performing this function. Note that the path of the suture portions  54 ,  56  is curvilinear with the respect to the skin  58  surface and that the deepest points of the arcs pass immediately above the puncture site  112  in the artery  114 . In this embodiment, the ends  46 ,  48  of the suture  40  are pulled to put tension in the tissue. As the ends  46 ,  48  of the suture  40  are pulled, the tissue embraced by the suture is pulled both inward from the areas lateral to the artery  114  and downward from areas immediately above the artery  114 . This constriction of tissue increases the density of tissue around the arterial puncture site  112  and imparts forces with vectors directed toward the arteriotomy site to limit bleeding. Further, this suture method avoids the need to traverse the artery wall or lumen, thus eliminating the risk of vessel wall dissection and promoting introgenic thrombogenesis. 
         [0101]    The method of the present invention is also useful in binding together partially or completely severed tendons or other internal tissue repairs requiring considerable tensile strength. For example, referring to  FIG. 23 , a finger  120  is shown with a portion of the outer layer of tissue cut-away to schematically show a severed tendon  122 . A Kessler suturing method for joining the two ends  124 ,  126  of the tendon  122  is shown in  FIG. 24 . This method requires the surgeon to apply an intricate stitch pattern and to complete the tendon connection with one or two technically challenging knots  128 . No portion of the suture knot  128  may protrude from the outside surface of the repaired tendon  122  where it could snag the surrounding tendon sheath and impede healing. The knot  128  also presents a particular dilemma since it must be tied between the two ends  124 ,  126  of the tendon  122 , where it can be a barrier between tendon sections that must appose in order to effectively heal. A further limitation of the conventional tendon repair method is that relatively small amounts of tension can stretch the tendon  122 , allowing it to slide along the smooth monofilament fiber and effectively disrupt, or in the case of greater amounts of tension, separate completely at the wound margin. This outcome substantially limits healing even though the suture material remains intact. 
         [0102]    A method according to the present invention for joining the two ends  124 ,  126  of the tendon  122  is shown in  FIGS. 25-28 . Referring to  FIG. 25 , the surgeon begins by inserting the first end  46  of the suture  40 , which may a straight or curved surgical needle, into one end  124  of the tendon  122  and pushing the needle  46  through the tendon  122  along a selected curvilinear path until the point  50  of the needle  46  extends from an exit point  130  in the periphery of the tendon  122  longitudinally spaced from the one end of the tendon  122 . The first needle  46  is gripped and pulled out of the tendon for drawing the first portion  54  of the suture  40  through the tendon  122  leaving a length of the first portion  54  of the suture in the tendon end  124  between the end of the tendon  122  and the exit point  130 . The surgeon reinserts the needle  46  into the periphery of the tendon  122  at an entry point  132  immediately adjacent the exit point  130  and pushes the needle  46  along a selected curvilinear path until the point  50  of the needle  46  exits the other side of the tendon at an exit point  134  that is longitudinally spaced from the entry point  132 . It is understood that the surgeon could use the exit point  130  as the next entry point for the needle  46  if desired. The surgeon pulls the needle  46  out of the tendon for drawing the first portion  54  of the suture  40  through the tendon  122 , reinserts the needle  46  into the side of the tendon  122  at an entry point  136  immediately adjacent the exit point  134  and pushes the needle  46  along a selected curvilinear path back out of the other side of the tendon  122  at an exit point  138  longitudinally spaced from the previous entry point  136 . It is understood that the surgeon makes as many passes as deemed necessary for holding the end  124  of the tendon  122 , or as the length or thickness of the tendon  122  allows, and removes the remaining length of the first portion  54  of the suture  40 . 
         [0103]    As seen in  FIG. 26 , these steps are repeated with the second portion  56  of the suture  40  at the other end  126  of the tendon  122 . The pattern of the second portion  56  of the suture  40  in the second end  126  of the tendon  122  generally mirrors the first portion  54  of the suture  40  in the first end  124  of the tendon  122 , including exit points  130  a,  134  a,  138  a and entry points  132  a,  136  a. The ends  124 ,  126  of the tendon  122  are brought together while maintaining tension on the free ends of the sutures. 
         [0104]    Referring now to  FIG. 27 , a second suture  40   a  is introduced at the second end  126  of the tendon  122 . The first needle  46   a  of the second suture  40   a  is inserted into the end  126  of the tendon  122  and pushed through the tendon  122  along a selected curvilinear path until the needle  46  a extends from an exit point  140  in the periphery of the tendon  122  substantially opposite the first exit point  130   a  of the second portion  56  of the first suture  40 . The needle  46   a  of the second suture  40   a  is pulled out of the tendon  122  for drawing the first portion  54   a  of the second suture  40   a  through the tendon  122  leaving a length of the suture  40   a  in the tendon  122  between the end  126  of the tendon  122  and the exit point  140 . The surgeon repeats the steps. described above by reinserting the needle  46   a  into the tendon  122  at an entry point  142  ( FIG. 28 ) adjacent the exit point  140  and pushing the needle  46   a  along a selected curvilinear path until the needle  46   a  emerges from an exit point  144  in the periphery of the tendon  122  substantially opposite the second exit point  134   a  of the second portion  56  of the first suture  40 . In this manner, the surgeon advances longitudinally along the end  126  of the tendon  122  entering at  146  and exiting at  148 . The previous steps are repeated at the other end  124  of the tendon  122  with the second portion  56   a  of the second suture  40   a . The number of sutures used depends on the size, caliber, and length of the tendon to be repaired. Big tendons will require more than two sutures whereas one may suffice for very small tendons. 
         [0105]    Tendon repair with two sutures according to the present invention exhibits equivalent or better holding power as the prior art technique. Moreover, tendons repaired according to the methods of the present invention maintain their original configuration, profile, contour, and form better when being stretched. 
         [0106]    The method of the present invention may be embodied in many surgical procedures. The procedures include both open surgery as well as endoscopic and laparoscopic surgery. Further, the uses of embodiments of the present invention may include repair of wounds, fastening of tissue junctions formed by the procedures, and positioning of tissue. The surgical procedures described herein are known to those of ordinary skill in the art, and accordingly are described only to a level of detail required to convey the respective embodiments of the method of the present invention. In  FIGS. 29-48 , where various steps of insertion are omitted from a drawing, it should be understood that the description and accompanying text of  FIGS. 1-28  apply to inserting the sutures  40 . 
         [0107]      FIG. 29  shows a stomach  200  prior to performance of a Nissen fundoplication. This procedure is performed on patients who suffer from gastroesophageal reflux disease and do not respond to medical treatment. As shown, the first portions  54  of two respective barbed sutures  40  are inserted into a proximal location of the fundus  202  and into the serosal and muscularis layers, and the respective second portions  56  remain free. The stomach&#39;s fundus  202  is pulled behind and wrapped  206  around the esophagus  204 . The respective second portions  56  are then advanced similarly into the apposing part  208  of the stomach  200 , as shown in  FIG. 30 . 
         [0108]    The same result in fastening may be achieved by performing the procedure in a different order. The fundus  202  may be pulled and wrapped  206  behind the esophagus  204  first, and then temporarily clamped or stapled in placed while the first and second portions  54 ,  56  are inserted in the configuration shown in  FIG. 30 . Other sequences may also be used and remain within the scope of the present invention. 
         [0109]    The barbed suture  40  may also be inserted as shown in  FIG. 31 , in either a sinusoidal or coiled configuration as previously described. The curved insertion is performed subsequent to pulling and wrapping  206  the fundus  202  behind the esophagus  204 , and then clamping or stapling in place. 
         [0110]      FIG. 32  shows a laparoscopic insertion device  220  used to stabilize a bowel structure  222  in position in advance of performing an anastomosis, whereby an end-to-end surgical connection of hollow organs is conventionally performed. The laparoscopic insertion device  220  comprises a tubular body in which the barbed suture  50  is disposed, with holes at the leading and trailing ends, similar to that disclosed in U.S. Pat. No. 5,342,376 to Ruff, the contents of which were previously incorporated by reference herein. The insertion device  220  penetrates using the point  50  of the suture to pierce the epidermis  84 , dermis  86 , fat  88 , fascia  90 , muscle  92 , and the peritoneum  94  before passing into the abdominal cavity  224 . The insertion device  220  then passes into the bowel structure  222 . A laparoscopic grasping tool  226  is shown to be holding the bowel structure in position until the suture is in place. It should be noted that the bowel structure  222  may also be stabilized by placement of a barbed suture  40  from the inside of the structure  222 . 
         [0111]    In  FIG. 33 , the laparoscopic insertion device is removed by pulling it outward  228 , exposing the suture  40 , while the pointed end  50  of the suture  40  is retained by its barbs against the removal force of the insertion device  220 . The suture  40  is in place in  FIG. 34 . When the procedure that gave rise to the need to tie the bowel structure  222  in place is complete, the suture may be cut at an exposed point  229 . As shown, the trailing end of the suture  40  extends through the epidermis  84  at the point of initial insertion, and the suture  40  may be cut at point  229  to allow that portion of the suture  40  to be removed by pulling on the trailing end. 
         [0112]    Optionally, the barbed suture pointed end  50  may continue through the bowel structure  222  tissue, into the abdominal cavity  224 , and through any number of desired selected layers of the peritoneum  94 , muscle  92 , fascia  90 , fat  88 , dermis  86 , and epidermis  84 . If the suture  40  passes through the epidermis  84  and is to be left in place, the suture  40  may be cut off such that the end of the suture  40  resides beneath the epidermis  84 . Alternatively, in a method similar to that described for  FIG. 34 , when the procedure that gave rise to the need to tie the bowel structure  222  in place is complete, the suture  40  may be cut at the exposed point  229  and in addition at another exposed point along the suture  40  on the opposite side of the bowel structure  222 , allowing removal of both ends of the suture  40 . 
         [0113]    A portion of the biliary system is shown in  FIG. 35 . The liver  230  is shown in partial section view, and the gallbladder  232 , bowel  234 , and stomach  200  are the other organs that are shown. The barbed suture of the present invention may be used to perform a Rodney Smith procedure with Roux-en-Y for the anastomosis of the bowel  234  to the liver  230 . In such an operation, the bile duct  236  may be cut, for example, at point  237  and anastomized to the bowel  234  at an incision in the bowel  234  at point  238 . The sutures  40  may be inserted as shown in  FIG. 36  with either an insertion device or with needles as previously discussed. The remaining portion of the bile duct  239  is removed and the wound at the end where it connects to the bowel  234  is sutured closed, which may also be done with sutures  40  of the present invention. In addition, barbed sutures can be placed in a curvilinear path, as shown in  FIG. 37  by proceeding with the suture around the bile duct  236  and the opening in the bowel. The first insertion point of the suture may be either in the bowel or the bile duct. 
         [0114]    The appendix  240  is being removed from the cecum  242  of the large intestine in  FIG. 38 . Prior to cutting of the appendix  240 , the suture  40  must be placed so that it will be ready to tie off the appendiceal stump  244 . The suture  40  may be placed using a curved insertion device (not shown), or with curved needles  46 ,  48 . The barbed suture  40  is placed around the base of the appendix  240  by inserting the first end of the first portion of the suture at an insertion point  62  ( FIG. 39 ) and pushing the first portion  54  in one direction through the muscularis and serosal layers of the cecum  242  around the base for at least one half of the circumference. Then the second portion  56  is likewise placed by inserting at the insertion point  62  and pushing the second portion  56  in the other direction through the muscularis and serosal layers of the cecum  242  around the base for at least until the second portion  56  crosses the first portion  54 . The appendix  240  is then removed, and the stump  244  is inverted while the suture  40  is pulled taut, similar to a purse-string as well as the alpha stitch shown in  FIGS. 19-22 . 
         [0115]    Although  FIG. 38  shows both needles  50 ,  52  and respective suture end portions  54 ,  56  extending from the cecum  242 , having both end portions  54 ,  56  extend from the cecum  242  is optional. With the use of an insertion device of the nature of that shown in  FIG. 33 , for example (device  220 ), one end may be left embedded in the cecum  242  and the other end may be pulled to invert the appendiceal stump  244  with the purse-string or alpha stitch. 
         [0116]      FIGS. 40-42  show three stages of the procedure for a Zenker&#39;s Diverticulectomy. A Zenker&#39;s Diverticulum  260  is a sac that protrudes from the esophagus  262  below the pharynx  264 . The Diverticulum  260  is the herniation of the mucdsal sac between the fibers of the pharyngeal constrictor muscle and the cricopharyngeal muscle  266 . The Diverticulum forms an orifice  268  to the lumen  270  of the esophagus  262 , and is shown in its initial untreated position in  FIG. 40 . 
         [0117]    In  FIG. 41  the Diverticulum  260  is inverted and pulled into the esophagus  262  through the orifice  268  using an endoscopic grasping tool  272 . An endoscopic insertion device  274 , similar to the laparoscopic insertion device  220  of  FIGS. 32-34 , is used as shown in  FIG. 42  to insert the barbed suture  40  into the cricopharyngeal muscle  266  above the orifice  268 , exiting at the orifice, and then again penetrating the muscle  266 . The muscle  266  on both sides of the orifice  268  is approximated to close the orifice. The Diverticulum  260  is then endoscopically cut and removed (not shown). Alternatively, the stitch used to close the orifice  268  may be a purse-string type or alpha type, as shown in  FIGS. 38 and 39 . Multiple sutures may be used to close the orifice. Further, the procedure of suturing closed the orifice may be performed in a similar manner without inverting the Diverticulum  260  into the esophagus  262 . In this alternative the Diverticulum remains outside the esophagus  262  and is not excised. 
         [0118]    The viscus structure  300  shown in  FIGS. 43-44  has an ulcerative lesion  302  on its inside wall  304 . An endoscopic camera  306  (scope) allows the procedure to be performed, and an endoscopic insertion device (not shown) in a separate tube within the scope inserts the sutures  40  as previously described. The scope  306  may approach the lesion  302  through the anus or the oropharynx. The tissue on each side of the lesion  302  is approximated and the endoscopic devices are removed as shown in  FIG. 44 . 
         [0119]      FIGS. 45 and 46  respectively show a closure of a cystostomy incision in a urinary bladder  320 . The closure is shown as having a curvilinear path, and may be inserted in such a curvilinear path similarly to the sinusoidal method ( FIG. 45 ) or coil method ( FIG. 46 ) previously discussed and shown by  FIGS. 7-10  and  FIGS. 12-15 , respectively, although other methods discussed herein may also be used. The suture  40  passes through the muscularis layer of the bladder in a bidirectional fashion. 
         [0120]    A replacement heart valve  340  is shown in  FIG. 47 . The annular cuff  342  of the heart valve  340  forms the periphery of the valve. The cuff  342  is joined to fibrous heart tissue  344  that forms a ring in the location where the valve  340  is placed. Two sutures  40   a ,  40   b  are shown, respectively having first portions  54   a  and  54   b  that pass through the cuff  342  and tissue  344  in one direction and second portions  56   a  and  56   b  that proceed in the other direction. Threading of the sutures  40   a ,  40   b  is performed similarly to the sinusoidal and coil methods previously discussed, and may start from either the cuff  342  or the tissue  344 . 
         [0121]    Various configurations may be used to install the valve  340  in accordance with the knowledge of one of ordinary skill in the art, such as only one suture for the full periphery of the valve, or multiple sutures that each include a portion of the valve&#39;s periphery, and providing redundancy of sutures as appropriate. The replacement heart valve may be a bioprosthetic valve or an artificial prosthetic mechanical valve. In addition, this method may be used on any foreign element that has a periphery and requires attachment to tissue, for example, a patch for closing a septal defect in the, heart. 
         [0122]    The method according to the present invention may also be used to secure devices to tissue, both inside and outside of a body. A central line device  360 , as used for intravenous access, is shown in  FIG. 48 , and is attached to a person&#39;s leg  362 . Examples of other devices that are required to be secured include catheters and monitors; tumor monitors in particular are an example of an internal device that may benefit from the method of the present invention. Eyelets  364  a,  364  b are provided on the device  360  and the suture  40  passes through each eyelet  364  a,  364  b before penetrating and passing through tissue of the leg  362  in a manner similar to that previously described, and being pulled snug to secure the device  360 . 
         [0123]    To facilitate removal of the barbed suture  40 , the suture  40  may be cut at a point within the central portion  366 , separating the portions of the suture  40  with opposing barbs. Then the separate sections  54 ,  56  of the suture  40  may be removed by pulling on an exposed portion in the direction that the barbs allow movement of the suture  40  through the tissue. This method of removal is not limited to the use shown in  FIG. 48 , but may apply to any use of the barbed suture. 
         [0124]    The barbed sutures of the present invention may also be used in a variety of cosmetic surgery applications. Such applications include but are not limited to facelifts, browlifts, breast lifts, and thigh lifts. In each of the procedures, once the sutures are in place and as tension is maintained on the free ends of the suture (not shown in the figures referenced below), the engaged tissues are manually grouped and advanced toward the insertion point to achieve the desired lifting effect. The tissue into which the sutures are inserted are soft tissue, meaning any tissue that is not an organ or a vessel. Multiple sutures may be used for further augmentation or maintenance of lift. 
         [0125]    A facelift and two methods of browlifts are shown in  FIG. 49 . One end  380  of a barbed suture  382  is inserted using a needle (not shown) at the temporal hairline at point  384  and advanced through the subepidermal tissue underneath the scalp, exiting distally. Subepidermal tissue comprises the papillary dermis, reticular dermis, subcutaneous tissue, or any combination thereof. The other end  386  is inserted at the same location and extended towards the nasolabial fold  388 , engaging the subepidermal tissue, the superficial muscular aponeurotic system, or both, and exiting distally. As tension is maintained on the free ends (not shown) of the suture  382 , the engaged tissues on the lower end  386  are manually grouped and advanced toward the insertion point  384  to achieve the desired lifting effect. The procedure is repeated on the opposite side of the face. Similar procedures may be performed to provide the lifts made in other locations with barbed sutures  390 ,  400 . 
         [0126]    In addition, the barbed sutures may be applied with the use of an insertion device as previously discussed. For example, the barbed sutures  382 ,  390  shown in  FIG. 49  may be put in place using an insertion device from either end of the respective suture. 
         [0127]    One method of performing a browlift is shown with one end  408  of a barbed suture  410  being inserted at point  412  at the hairline (for nonreceding hairlines, as depicted) or at the midpoint between the hairline and the eyebrow (for receding hairlines, not shown). This end  408  is advanced through the subepidermal tissue towards and on through the scalp. The other end  414  is inserted at the same point and advanced through the subepidermal tissue in the opposite direction, exiting at the inferior aspect  416  of the brow. The procedure is repeated on the opposite side of the forehead, but for convenience herein a different method is shown in the same figure. Once again, the suture  410  may be put in place with the use of an insertion device from either end. 
         [0128]    A second method of performing a browlift is shown in  FIG. 49  with one end  420  of a barbed suture  422  being inserted at point  424  at the hairline (for nonreceding hairlines, as depicted) or between the hairline and the eyebrow (for receding hairlines, not shown). This end  420  is advanced through the subepidermal tissue, exiting at the inferior aspect  426  of the brow. The other end  428  is inserted at the same point and is also advanced through the subepidermal tissue, but at a slight angle to the path taken by the first end  420  and also exiting at the inferior aspect  426  of the brow. This results in the approximate inverted vee-shaped configuration shown. The procedure may be repeated across the forehead. 
         [0129]    Barbed sutures of the present invention may similarly be used as a tissue-sculpting device to perform a thigh or breast lifting procedure. These procedures are similar to those shown for the facelift and browlift of  FIG. 49 , and accordingly no additional drawings are required but respective descriptions are as follows. 
         [0130]    To perform a thigh lift, multiple sutures are inserted by needle at the inguinal crease, spaced approximately 0.5-1.5 cm apart, beginning at the lateral aspect of the pubic triangle and extending medially approximately 180 degrees to the vicinity of the gluteal fold. The suture is advanced approximately 8 cm cranially through the subepidermal tissue. The opposite end of the suture is inserted in the same location and similarly advanced approximately 8 cm caudally. After exiting through the skin distally at each end, tension is maintained on the free ends of the suture, and the engaged tissues are manually grouped and advanced toward the insertion point to achieve the desired lifting effect. The process is repeated with multiple sutures around the semi-circumference of the thigh, and then repeated on the opposite thigh. 
         [0131]    To perform a breast lift using a barbed suture of the present invention, one end of the barbed suture is inserted by needle into the skin at the upper aspect of the breast curvature. The needle is advanced such that the medial barbs engage the subcutaneous and dermal tissues, while the distal barbs engage the pectoralis muscle (and where possible, the periosteum of the clavicle), and then exit distally through the skin. The other end of the suture is inserted at the same point by needle, and advanced caudally through the fibrous and fatty tissues of the breast exiting at various points along the lower curvature of the breast. Additional sutures are similarly inserted at a variety of appropriately spaced locations along the breast. As tension is maintained on the free suture ends, the breast is lifted along the axis of the suture, with the barbs locking the lift into place. Lifting is continued until the desired effect is achieved. Results from such a procedure may benefit from the use of a barbed suture with longer barbs than may be necessary in other procedures, in order to grasp fatty breast tissue effectively. 
         [0132]    In  FIG. 50 , an insertion device  500  is shown in a procedure to close an axial wound in a blood vessel, such as an artery or vein. The wound  112  is similar to that shown in  FIG. 22 , but the method is different in that the method of  FIG. 22  uses needles and does not penetrate the artery  114 , rather constricting the tissue above and around the arterial opening. The insertion device  500  of  FIG. 50  comprises a tubular body in which the barbed suture  50  is disposed. The wound  112  may be a puncture in an artery  114  as occurs as the result of the introduction and removal of catheters, as discussed in the text accompanying  FIG. 22 . The sharp pointed end  50  of the suture  40  is pushed with the leading end of the insertion device  500  through the skin  58  and tissue  70  on one side of the artery  114 , through the artery wall on one side of the wound  112 , into the interior  504  of the blood vessel  114 , through the artery wall on the other side of the wound  112 , and into the tissue  64  on the other side of the wound  112 . The trailing end of the insertion device  500  is then pulled on to remove the insertion device  500 , leaving the suture  40  in place. 
         [0133]    Two embodiments of a suture left in place by an insertion device are shown in  FIGS. 51 and 52 . In  FIG. 51 , the portion  506  of the suture  40  in the interior  504  of the artery  114  has barbs. The embodiment of  FIG. 52  omits barbs in the interior  504  of the artery  114 , and the barbs are omitted for a portion  508  that extends into the artery  114  wall. The portion  508  without barbs could extend less or more than shown, and into the tissue  70 ,  64 , so long as there are no barbs inside the artery  114 . To reduce the chance of clotting of blood on or around the suture, an antithrombotic agent may be applied on the suture. Although  FIGS. 50-51  show the suture  40  with the pointed end  50  embedded in tissue  70 ,  64 , the suture  40  may also be put into place with the pointed end  50 , or both ends, extending out of the skin  58 , where the end or ends may be cut. 
         [0134]    The invention is further illustrated by the following non-limiting examples. 
       Example 1 
       [0135]    A straight incision wound, about 1.5 cm deep, was created in each of four samples of cadaveric porcine skin tissue. The tissue samples measured 4 cm by 10 cm. Each incision was centered on the skin sample so that the wound was 4 cm long from end to end. 
         [0136]    Each wound was closed according to a different suture method using identical barbed sutures made from monofilament PDS (polydioxanone) size 0. One wound was closed according to the method shown in U.S. Pat. Nos. 5,342,376 and 6,241,747, without using the inserting device (the Ruff method). Seven sutures were placed along the length of the wound and running generally perpendicularly to the faces of the wound. When placed, the sutures dipped below the incision line thus engaging subcutaneous tissue below the incision and the ends of the sutures engaged some dermis. A second wound was closed using seven needle-tipped sutures placed along the length of the wound in the dermis and running generally perpendicularly to the faces of the wound similar to the method shown in U.S. Pat. No. 5,931,855 (the Buncke method). In both methods, the length of each suture buried under the skin was approximately 6 cm. A third wound was closed using the zigzag stitch pattern in the dermis as described above and shown in  FIGS. 3-6 . The number of passes resulted in four entry/exit points on each side of the wound. A fourth wound was closed using the corkscrew-shaped stitch pattern described above and shown in  FIGS. 12-15 . The number of passes resulted in seven complete loops with the tops of the loops engaged in the dermis. The tissues were held together only by the sutures. 
         [0137]    Biomechanical strength testing was carried out as follows. Each sample was positioned so that the surface of the tissue sample was substantially vertical and the incision was generally horizontal. The bottom edge of the sample was immovably secured. The upper edge of the sample was attached to a Berkley digital fish scale (0-50 lb.) The scale was then raised vertically generating tension across the wound. The scale was raised until the tissues totally separated. The peak force required to separate the incision was recorded as the breaking strength. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Suture Method 
                 Breaking Strength(lbs) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Ruff Method 
                 4.5 
               
               
                   
                 Buncke Method 
                 8.5 
               
               
                   
                 Zigzag Method 
                 18.3 
               
               
                   
                 Corkscrew Method 
                 16.5 
               
               
                   
                   
               
             
          
         
       
     
       Example 2 
       [0138]    Seven incisions were made at various locations on each of three dogs. The length of the incisions ranged from ½ inch to 4 inches and the depth of the incisions from the dermis to the muscular level. The incisions were closed with barbed sutures made from monofilament PDS (polydioxanone) size 0 and conventional sutures&#39; according to the following scheme with the locations randomized: 
         [0000]    
       
         
               
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                 Tissue Level 
                 Barbed Suture Method 
                 Conventional Suture Method 
               
               
                   
               
             
             
               
                 Dermis 
                 Alpha, Zigzag 
                 Simple interrupted loop stitches 
               
               
                   
                   
                 [2-0 nylon, 2-0 silk] 
               
               
                 Subcuticular 
                 Corkscrew 
                 Simple continuous loop stitches 
               
               
                   
                   
                 [3-0 PDS] 
               
               
                 Subcutaneous 
                 Corkscrew 
                 Simple continuous loop stitches 
               
               
                   
                   
                 [3-0 PDS] 
               
               
                 Muscular 
                 Corkscrew 
                 Simple continuous loop stitches 
               
               
                   
                   
                 [3-0 PDS] 
               
               
                   
               
             
          
         
       
     
         [0139]    More than one alpha-shaped stitch was used for longer incisions. 
         [0140]    The dogs were housed for two weeks. Daily clinical and necropsy observations were performed on all surgical sites. With the exception that three of six sites closed by nylon sutures had some sutures chewed out by the dog, all incisions healed normally and no dehiscence occurred. The other three sites closed with nylon sutures had a railroad-tile appearance, one site in particular being very pronounced. None of the topical skin sites closed with barbed sutures had such an appearance. This example shows the efficacy of barbed sutures in an in vivo model. 
         [0141]    The methods of the present invention have a number of advantages, including improving the biomechanical performance of barbed sutures. The curvilinear placement paths of the suture, as contrasted with linear insertion, provide substantially increased strength for holding the edges of a wound together. Moreover, the insertion of a single suture with curvilinear techniques replaces the insertion of a plurality of sutures. The new methods provide an efficient means for a surgeon to close a wound, reducing the time necessary to place the suture and the trauma to the patient. Surgeons can quickly and easily utilize the suturing methods during any type of surgery to quickly join the edges of a wound in tissue without threading and tying numerous individual stitches. The new suture methods are performed in a manner similar to conventional suturing thus realizing the advantages thereof. The methods minimize damage to tissue when inserted and minimize scarring or tissue necrosis across the wound. The sutures can be placed in the tissue in a manner to control and adjust the tension on the suture or the compression of the tissue. 
         [0142]    Although the present invention has been shown and described in considerable detail with respect to only a few exemplary embodiments thereof, it should be understood by those skilled in the art that we do not intend to limit the invention to the embodiments since various modifications, omissions and additions may be made to the disclosed embodiments without materially departing from the novel teachings and advantages of the invention, particularly in light of the foregoing teachings. For example, the methods of the present invention can be used alone or with other closure methods, such as topical skin adhesives to aid in holding the position of the tissue. Accordingly, we intend to cover all such modifications, omission, additions and equivalents as may be included within the spirit and scope of the invention as defined by the following claims.