Abstract:
A device and technique for a sutureless wound closure, which limits the risks of rupture and scarring, is described. The device includes a one-piece surgical fastener generally shaped in a curve along the width of the surgical fastener. The fastener includes a tissue insertion tongue with a plurality of tissue attachment points for fixing the fastener to skin tissue. The fastener also includes a clasp for engaging an identical surgical fastener. The surgical fastener can also be a two-piece structure including a male connecting strap and a female connector. Both pieces include a tissue-connecting mechanism for fixing to skin tissue. The female connector includes an engagement clasp for securing the male connecting strap to the female connector.

Description:
RELATED APPLICATIONS  
       [0001]     This application is a continuation-in-part to U.S. patent application Ser. No. 10/607,650, filed Jun. 27, 2003, in the name of Dennis D. Garvin, and entitled “Device for Sutureless Wound Closure,” the contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to a surgical fastener and technique for its use. Specifically, the invention is directed to a device to close wounds without the use of sutures.  
         [0003]     This application claims priority to U.S. Provisional Patent Application No. 60/720,779, filed Sep. 27, 2005, in the names of Dennis D. Garvin and Jeffrey P. Wong, entitled “Device for Surgical Repair, Closure, and Reconstruction,” the contents of which are incorporated herein by reference.  
       DESCRIPTION OF THE PRIOR ART  
       [0004]     Classical techniques to close wounds and incisions use sutures, basically using a needle and thread to sew the wound closed. While this technique acts to stitch the respective sides of the lesion together, it has several drawbacks. First, the tension required to pull the sides together is localized at the point of the stitch. This results in a tendency of the skin to tear around the stitch. Second, the skin may pouch out or sacculate between the stitches, greatly increasing the susceptibility of the wound to infection. Third, because the two sides of the wound are not evenly juxtaposed, scarring along the path of the sutures is increased. In addition, the placement of sutures requires deployment of needle and filament and afterward the tying off of the ends of the filament. This process is time consuming and requires workspace allowing dexterous manipulation.  
         [0005]     Prior devices and techniques have been developed in an attempt to resolve these problems. These techniques range from superficial wound closure techniques to internal repair techniques. For example, U.S. Pat. No. 3,971,384 to Hasson describes a surgical closure device designed to bring the two edges of a wound or incision together. A piece of surgical tape is secured on each side of the wound. One piece of tape has an anchor for a tie strip secured to it while the other piece of tape has a slide secured to it. The tie strip has ratchet teeth on its dorsal surface such that the strip is inserted through the anchor end, across the wound and into the ratchet. The tape is then tightened and locked with the ratchet, bringing the two sides of the wound together. U.S. Pat. No. 4,924,866 to Yoon describes a device for closing wounds comprising two arms connected by a hinged joint. The arms have a single pair of “skin engaging members” on the ventral surface such that when the device is placed over the wound, the members enter the skin, pulling the wound together underneath the joint.  
         [0006]     While the devices described by Hasson and Yoon are directed to sutureless methods of wound closure, they suffer from certain defects. In particular, Hasson is limited to superficial applications where the tape can stick and, further, by the strength and size of the tape. The described device can receive no more force from the opposing sides of the wound than the tape can hold. In addition, the size of the device is limited by the size of the tape. The device of Yoon is similarly handicapped. First, the device is limited in its pliability by the structure of the arms. Second, the device is limited in its wound closure ability due to the limited number of “skin engaging members” in relatively close proximity to the wound. Third, because there is no ratcheting element, the sides of the wound must first be properly juxtaposed and aligned before its insertion as there is no second chance for its deployment.  
         [0007]     Other devices have been described for internal tissue repair or reconstruction. They include U.S. Pat. No. 6,241,747 to Ruff, which describes a barbed tissue connector for closing tissue wounds. The connector comprises an elongated shaft with pointed ends and a multitude of circumferentially placed barb-like points along the length of the shaft. The shaft has a midline with the barbs on either side pointing away from the midline and toward the respective ends. In use, the tip of one end is inserted into one side of the wound. The wound is spread apart and the other end of the device inserted. After each end is inserted into the wound, the tissue is pressed together with the fingers to fully engage the barbs and bring the sides of the lesion into express contact. Because the device of Ruff has no dorsal or ventral surface, it must be placed deep enough in the lesion such that the tip of the circumferential barbs remains within the skin. Such means of insertion adds to the trauma already experienced by the tissue.  
         [0008]     U.S. Patent Application Publication 0058966 to Tormala et al. describes a surgical fastener or implant for repairing tissue wounds, particularly torn menisci in the knee. The invention comprises a shaft with an arrow-like point on one end and a blunted barb on the other end. The barbs on both ends of the shaft are directed such that they point toward the ends of the shaft, thereby facilitating insertion and discouraging its removal. The barbed end of the device is passed through both ends of the cartilage where the ends are locked onto the shaft by the inwardly pointed ridges of the blunt end. The device described by Tormala et al. requires use with a structure dense enough to have the device embedded within it and is thereby limited in its use.  
         [0009]     U.S. Pat. No. 5,584,859 to Brotz is directed to a wound closure device for connecting tissue comprising integrated straps. The straps in Brotz are part of a whole, single device. The device, once constructed, essentially becomes a frame for immobilizing the wound tissue. The device encompasses two wound closure straps and a center body in one piece for holding the straps in place. The center body is necessary and integral to the closure device in Brotz.  
         [0010]     U.S. Pat. No. 4,730,615 to Sutherland is directed to a sternum closure device with a head portion, a tail portion and a flexible spine portion. The tail portion is threaded through the sternum and brought back to a proximal head.  
         [0011]     U.S. Pat. No. 6,893,452 to Jacobs and No. 6,645,226 and 6,485,503 to Jacobs, et al. are directed to surgical devices used to fixate soft tissue to both soft tissue and bone. The devices are meant to secure tissue to another fixed portion of tissue post-operatively. The devices include a plurality of attachment points connected to a backing that can be manipulated to close wounds, join soft tissue or bone, or create anastomoses. However, none of the patents disclose a device to close lacerations or wounds.  
         [0012]     Furthermore, the prior art neither discloses nor contemplates a wound closure device using two straps or complementary wound closing devices that are pulled together to bring together the opposite sides of a wound.  
       SUMMARY OF THE INVENTION  
       [0013]     The present invention is directed to a sutureless wound closure device that eliminates the pocketing and rupture associated with traditional sutures. Further, the device allows the tension, of pulling the opposing sides of the wound together, to be spread over a large area of the adjacent tissue. Also, the device is easy to use and does not further increase the trauma already experienced by the underlying tissue.  
         [0014]     In a preferred embodiment, the invention comprises a wound closure device for connecting tissue comprising a first and second strap, each strap including a ventral barbed surface. The straps are adjustably connectable to one another, whereby the straps form a wound closure.  
         [0015]     Specifically, the invention is directed to a wound closure device for connecting tissue comprising at least one pair of isolated first and second flexible straps wherein the first flexible strap has a proximal end with a male connector and a distal end, a ventral surface and dorsal surface. The second flexible strap has a proximal end with a female connector and a distal end, a ventral surface and a dorsal surface. The female connector is configured to adjustably connect to the male connector of the first strap, wherein the first strap and the second strap have at least one barb on the ventral surface for engaging the tissue.  
         [0016]     The present invention is further directed to a method for closing a skin wound with a wound closure device, the device including at least one pair of isolated first and second flexible straps wherein the first flexible strap has a proximal end for the male connector and a distal end, and a ventral surface and a dorsal surface; and the second flexible strap has a proximal end with a female connector and a distal end, and a ventral surface and a dorsal surface, wherein the female connector is configured to adjustably connect to the male connector of the first strap, wherein the first strap and the second strap have at least one barb on the ventral surface for engaging the tissue and whereby the straps form a wound closure. The method is directed to placing the first strap and the second strap of the device on either side of the wound in an orientation generally perpendicular to the axis of the wound, wherein the second ends of each of the first and second straps are inserted into the surrounding skin of the wound, preferably the fascia, thereby situating the proximal ends of each of the first and second straps about the midline of the wound, such that the barbs of each of the first and second straps embed in the skin. The male connector is connected to the female connector of each of the first and second straps, and the straps are then adjusted to a desired tightness. Preferably, the female connector comprises a buckle, and the male connector comprises a ratcheted surface to accommodate the buckle.  
         [0017]     The invention is also directed to a one-piece surgical fastener for connecting tissue comprising a tissue insertion tongue having an first upper side, a second lower side, a proximal end, a distal end, and at least one tissue attachment point; and an engagement clasp at the distal end of the tissue insertion tongue having a connecting mechanism for engaging a similar one-piece surgical fastener.  
         [0018]     Further, the invention is directed to a surgical fastener system comprising at least one pair of separate, mating and identical one-piece surgical fasteners for connecting tissue, the surgical fasteners comprising a tissue insertion tongue having a first upper side, a second lower side, a proximal end, a distal end, and at least one tissue attachment point; and an engagement clasp at the distal end of the tissue insertion tongue having a connecting mechanism for engaging a similar one-piece surgical fastener.  
         [0019]     The invention is also directed to a one-piece surgical fastener for connecting tissue comprising a tissue insertion tongue having an first upper side, a second lower side, a proximal end, a distal end; at least one tissue attachment point, wherein the at least one tissue attachment point has a base and a pointed end wherein the end of the tissue attachment point is directed to the proximal end of the tissue insertion tongue, wherein the tissue attachment point comprises a primary tissue attachment point and a secondary tissue attachment point wherein the secondary tissue attachment point extends from the primary tissue attachment point; and an engagement clasp at the distal end of the tissue insertion tongue having a connecting mechanism for engaging a similar one-piece surgical fastener, wherein the engagement clasp comprises a connecting area including an upper plate and a lower plate defining a cavity therein, wherein the connecting mechanism comprises at least one row of ratchets extending from the upper plate of the engagement clasp and at least one row of ratchets extending from the lower plate of the engagement clasp, wherein the ratchets are generally triangular in shape having a dorsal ridge ending in the cavity such that the dorsal ridge of the ratchets on the upper plate face the dorsal ridge of the ratchets on the lower plate.  
         [0020]     The invention is further directed to a process of engaging a first and second surgical fastener for connecting a patient&#39;s tissue wherein the surgical fastener comprises a tissue insertion tongue having a first upper side, a second lower side, a proximal end, a distal end, and at least one tissue attachment point; and an engagement clasp having a first end at the distal end of the tissue insertion tongue and a second end, wherein the engagement clasp includes a connecting mechanism for engaging a similar one-piece surgical fastener, the process comprising: inserting the insertion tongue of the first surgical fastener into the skin layer of a patient; inserting the insertion tongue of the second surgical fastener into the skin layer of the patent such that the second ends of engagement clasps of the first and second surgical fasteners align; engaging the engagement clasps of the first and second surgical fasteners such that the connecting mechanisms of the first and second surgical fasteners are interconnected to prevent disengagement.  
         [0021]     The invention is further directed to a surgical fastener for connecting tissue, comprising a male connecting strap having a proximal end, a distal end, and a tissue-connecting mechanism at the distal end; a female connector having a proximal end and a distal end and an engagement clasp at the proximal end and a tissue-connecting mechanism at the distal end, wherein the engagement clasp comprises a buckle for securing the male connecting strap.  
         [0022]     The advantages of the invention are manifold. First, from a clinical standpoint, the invention helps to limit rupture of the wound. Second, from a cosmetic standpoint, the invention greatly limits scarring by reinforcing the subcutaneous fascia and eliminating sutures. Third, due to the above two advantages, the invention greatly reduces infection. Fourth, the invention is less painful and the patient heals faster than traditional wound closure methods because staples or sutures, piercing through the underlying muscle, are not required.  
         [0023]     The device may be particularly advantageous for closing laparoscopic port sites, closing the sternum after cardiac surgery, and reinforcing traditional suture closings. Other applications include, but are not limited to, the restoration of damaged anatomy such as for stress incontinence and orthopedic repair of tendons and ligaments. Still other applications include, but are not limited to the moving, lifting, compressing, or reinforcing tissue for use in abdominoplasty, facelifts, breast lifts, and abdominal cinching. Some of these applications also pertain to animals.  
         [0024]     The invention can also be used in most settings and locales from acute and field conditions to chronic conditions treated in care facilities. For example, the invention can be used for closure of small laparoscopy ports, which is difficult, particularly in obese patients. In these conditions, standard suturing through a small skin incision is very difficult and takes significant time or requires a larger skin incision to be made. Thus, the invention can make more demanding procedures easier and allow time-consuming procedures to be performed in more urgent situations.  
         [0025]     The invention also allows greater blood flow to the healing tissue. When a conventional stitch is used under high tensions, it results in blood being cut off to the tissue encircled by the loop of the stitch. In contrast, by using the present invention, this problem is alleviated. Allowing greater blood flow to the incision reduces scarring and results in much better results, particularly with cosmetic surgery.  
         [0026]     Further, the straps can be modified. Such modifications can allow the use of the invention in tightening waistlines, which have been stretched by injury, surgery or childbirth. The straps can also be applied to the top of a hernia repair to reduce risk of recurrence or adapted to facilitate a sternotomy closure, which would stabilize the chest and reduce discomfort after open-heart surgery.  
         [0027]     The objects and advantages of the invention will appear more fully from the following detailed description of the preferred embodiment of the invention made in conjunction with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0028]      FIG. 1  is a perspective view of the first strap being inserted into the connector of the second strap and adjusted, thereby closing the wound.  
         [0029]      FIG. 2   a  is a partial side elevation view of the first strap of the device at the proximal end.  
         [0030]      FIG. 2   b  is a partial ventral elevation view of the strap of  FIG. 2   a.    
         [0031]      FIG. 2   c  is a partial side elevation view of the second strap of the device at the proximal end.  
         [0032]      FIG. 2   d  is a partial ventral elevation view of the strap of  FIG. 2   c.    
         [0033]      FIG. 3   a  is a partial side elevation view illustrating the flexion of the barbs of the closure device while stored in a trochar.  
         [0034]      FIG. 3   b  is a partial perspective view of the device being deployed out of the trochar, shown in a cut-away view, with the barbs of the device being unflexed.  
         [0035]      FIG. 4   a  is a dorsal perspective view of a second embodiment of a tissue-connecting strap of the present invention.  
         [0036]      FIG. 4   b  is a ventral perspective view of the tissue-connecting strap of  FIG. 4   a.    
         [0037]      FIG. 4   c  is a ventral plan view of the tissue-connecting strap of  FIG. 4   a.    
         [0038]      FIG. 4   d  is a side elevation view of the tissue-connecting strap of  FIG. 4   a.    
         [0039]      FIG. 4   e  is a dorsal elevated view of the tissue-connecting strap of  FIG. 4   a.    
         [0040]      FIG. 4   f  is a cross-sectional view of the tissue-connecting strap taken at lines  4   f - 4   f  in  FIG. 4   d.    
         [0041]      FIG. 5  is an elevated dorsal view illustrating two opposed tissue-connecting straps joined together.  
         [0042]      FIG. 6  is a side elevated view showing two tissue-connecting straps joined together taken at lines  6 - 6  of  FIG. 5 .  
         [0043]      FIG. 7  is a dorsal perspective view showing two tissue-connecting straps joined together.  
         [0044]      FIG. 8  is a side elevated view showing two tissue-connecting straps joined together.  
         [0045]      FIG. 9   a  is a side elevated view illustrating a strap closure device releasably connected to the two tissue-connecting straps.  
         [0046]      FIG. 9   b  is a perspective view illustrating the strap closure device releasably connecting the two tissue-connecting straps.  
         [0047]      FIG. 10  is a perspective view of a third embodiment of a closure device illustrating the male connector strap.  
         [0048]      FIG. 11  is a perspective view illustrating the female connector adapted for use with the male connector strap of  FIG. 10 .  
         [0049]      FIG. 12  is a dorsal perspective view of the tissue-connecting strap for use with the male connector strap and the female connector.  
         [0050]      FIG. 13  is a partial dorsal perspective view illustrating the tissue connecting strap connected to the female adapter.  
         [0051]      FIG. 14  is a partial dorsal perspective view illustrating the tissue connecting strap attached to the male connector strap.  
         [0052]      FIG. 15  is a partial dorsal perspective view illustrating the tissue-connecting strap connected to the female adapter, and the placement of the male connecting strap within the female connector.  
         [0053]      FIG. 16  is a side elevated view illustrating a fourth embodiment of the sutureless closure device.  
         [0054]      FIG. 17  is a front elevated view illustrating the use of the strap of  FIG. 16  during breast augmentation.  
         [0055]      FIG. 18  is a front elevated view illustrating the use of tissue-connecting straps on a patient requiring facial plastic surgery or laceration repair.  
         [0056]      FIG. 19  is a side elevated view illustrating the use of multiple tissue-connecting straps of  FIG. 16  in abdominal surgery and abdominoplasty. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0057]     Referring now to  FIG. 1 , there is illustrated a perspective view of a first embodiment of the disclosed invention  10 . As illustrated, the invention  10  includes a first strap  14  and a second strap  30 . The first strap  14  and the second strap  30  include distal ends  62  and  63  and proximal ends  18  and  34 , respectively. The straps  14  and  30  are planar and made of a pliable material having dorsal surfaces  20  and  36  and a ventral surface  22  and  38 . The dorsal surface  20  and  36  of the straps  14  and  30  are smooth while the ventral surfaces  22  and  38  include a plurality of tissue attachment points or small barbs  24  and  40  which project downward from the ventral surface  22  and  38  and curve toward the proximal end  18  and  34 . In one preferred embodiment, the straps  14  and  30  have a length of about 4 cm and a width of about 0.5 cm. In other embodiments, the straps  14  and  30  may be larger or smaller to accommodate a wound, illustrated at  48 . Although the shape of the straps  14 ,  30  may include planar sides as illustrated in  FIG. 1 , it is within the scope of the present invention for each strap to have a rounded configuration.  
         [0058]     As shown in  FIG. 1  and  FIGS. 2   a  and  2   b , the proximal end  18  of the first strap  14  is tapered along its planar sides, and the ventral surface  22  is composed of a plurality of small teeth or ratchets  26 . The ratcheted surface may comprise about between 1 and 20 mm of the proximal end  18  of the first strap  14 . Between the end of the ratcheted surface and the beginning of the barbs  24 , there is a gap space  16  on the ventral surface  22 , which is smooth and has no protuberances.  
         [0059]      FIG. 1  and  FIGS. 2   c  and  2   d  illustrate a preferred version of the second strap  30 . In this version the proximal end  34  of the second strap  30  terminates in a buckle  42 . However, in other versions, the proximal end  34  may terminate in any other form of connector, which may be capable of adjustably connecting the two straps such as VELCRO, adhesives or clips. Between the buckle  42  and the most proximal of the barbs  40  is a gap space  32  marked by a smooth region of the ventral surface.  
         [0060]     As illustrated in  FIG. 1  the invention  10  is deployed in a lesion or wound  48 . In use, the first strap  14  and the second strap  30  of the device  10  are placed on either side of the wound  48  in an orientation perpendicular to the axis of the wound  56 . In a preferred embodiment, the straps  14  and  30  are inserted underneath the epidermis directly above the fascia  50  of the surrounding tissue. The distal end  62  and  63  of each strap  14  and  30  are directed away from the lesion while the proximal ends  18  and  34  of the straps  14  and  30  are situated at about the midline  56  of the wound  48 . The straps  14  and  30  are displaced on either side of the wound  48  such that the gap space  16  and  32  of each strap  14  and  30  is generally behind the edge of the wound  48 . The barbs  24  and  40  are then gently embedded in the underlying tissue, which in a preferred version of the invention is the fascia  50 , so that the straps  14  and  30  engage the tissue.  
         [0061]      FIG. 1  shows the barbs  24  and  40  of the straps  14  and  30  engaged in the fascia  50  with the barbs  24  and  40  pointed toward the midline  56  of the wound  48 . The two straps  14  and  30  are connected at their proximal ends  18  and  34  and adjusted to a desired tightness. Illustrated is one preferred version of the invention showing the straps  14  and  30  that are tightened by pulling the proximal end  18  of the first strap  14  through the buckle  42  along the path designated by the arrow  19 . The buckle  42  is then tightened by urging it distally on the ratchets  26  of the first strap  14 . Tightening or putting tension on the proximal ends  18  and  34  of the straps  14  and  30  pulls the underlying fascia  50  of the wound together, allowing a smooth joining of the tissue surrounding the wound  48 .  
         [0062]     When the wound is large or the tissue is delicate, multiple straps  14  and  30  may be needed. When multiple straps are used, the straps  14  and  30  are deployed on either side of the wound  48 . When all the straps  14  and  30  are deployed along the length of the lesion, the tapered, proximal end  18  of each first strap  14  is inserted into the buckle  42  of the respective second strap  30  until the locking tongue  44  engages the ratchets  26  of the first strap  14 . In a particularly preferred version, the locking action of the first proximal end  18  in the buckle  42  is like that of a nylon tie such that once the tongue  44 , illustrated in  FIG. 2   d , is engaged with the ratchets  26 , the tension on the straps  14  and  30  can be increased by pulling the proximal end  18  through the buckle  42  in the direction of the arrow  19 . The process of pulling the proximal end  18  of the first strap  14  through the buckle  42  of the second strap  30  of each of the respective first  14  and second  30  pair of straps, allows the opposing sides of the wound  48  to be brought close enough to begin tightening the individual straps in a sequential fashion until the opposing sides of the wound  48  are brought together.  
         [0063]     Because the barbs  24  and  40  continue into the tissue surrounding the wound along the length of the straps  14  and  30 , the tension loaded on the straps  14  and  30  is transferred to the underlying tissue assuring a smooth juxtaposition of the opposing sides of the wound  48 . It will be appreciated that depending on the size of the wound  48 , more or less straps  14  and  30  may be needed. For example, a very large wound  48  will require a large number of straps  14  and  30  while a small wound  48  will require one or a few straps  14  and  30 . Similarly, very delicate or visible tissue may require many small straps  14  and  30  while tough or concealed tissues may require fewer large straps  14  and  30 .  
         [0064]     As shown in  FIG. 1 , the barbs  24  and  40  are conical in shape, ending at a point. The barbs  24  and  40  are designed to be pliable yet have stiffness such that they can pierce tissues ranging from muscle to skin to fat. Such barbs can be made from nylon, plastics and resorbable polymers such as polyglycolic acid and poly-L lactic acid, for instance. The barbs  24  and  40  may have a slightly different shape, depending on the particular tissue to be used in. For example, straps to be used in adipose tissue  52  may have barbs  24  and  40  that are longer and broader because the tissue is soft while barbs  24  and  40  to be used in muscle  54  or connective tissue, such as the fascia  50 , may be shorter and narrower because those tissues are tough, and the barbs  24  and  40  do not need to project far into the tissue to embed. Nevertheless, the barbs  24  and  40  should generally be about between 2.5 mm long and 4.0 mm long and have a circumference around the base of about 2-3 mm. Further, while one exemplary version of the invention has only one barb  24  and  40  per row along the horizontal axis of the straps  14  and  30 , in other exemplary versions, there may be several barbs  24  and  40  per row arranged along the ventral surface  22  and  38  of the straps  14  and  30 .  
         [0065]      FIGS. 2   a - d  illustrate a particularly preferred version of the proximal ends  18  and  34  of the first and second straps  14  and  30 .  FIGS. 2   a  and  2   b  show a side and ventral elevation, respectively, of the proximal end  18  of the first strap  14 . As shown, the first strap  14  is tapered toward the proximal end  18  and has a series of small ratchet-like protrusions  26  on its ventral surface  22  while the dorsal surface  20  is flat.  FIGS. 2   c  and  2   d  show a side and ventral elevation, respectively, of the proximal end  34  of the second strap  30 .  FIG. 2   c  shows the dorsal surface  36  and the ventral surface  38  with the buckle  42  terminating the proximal end  34  of the second strap  30 .  FIG. 2   d  illustrates the ventral surface  38  of the proximal end  34  of the second strap  30  with the buckle  42  terminating the proximal end and a locking tongue  44  situated within the buckle  42 .  
         [0066]     Methods to aid in deployment of the invention  10  are also included. For example,  FIG. 3   a  illustrates the strap  14  inside a trochar  60 . For the purposes of the drawing, only the second strap  14  is illustrated. However, both the first strap  14  and the second strap  30  are deployed with the trochar  60  and will have similar dimensions with comparable distal ends  62  and  63  as shown in  FIG. 1 . The trochar  60  is a cylindrical tube having walls  64  fabricated from a material stiff enough to use as an applicator. In particularly preferred versions, the trochar  60  may be made of, plastic or metal and will have a diameter slightly greater than the width of the straps  14  and  30  it is used to deploy. While in the trochar  60 , the barbs  24  and  40  are flexed upward due to the slightly greater length of the barbs compared to the height of the trochar  60 . The trochar  60  may serve both to store the straps  14  and  30  in and as an applicator for the straps  14  and  30 . In situations where the trochar  60  is disposable, the straps would come stored in the trochar. In situations where the trochar  60  is reloadable, the straps  14  and  30  and the trochar  60  may be stored separately.  
         [0067]      FIG. 3   b  illustrates the movement of the barbs  24  and  40  downward, shown by the arrows  70 , as the straps  14  and  30  are slid out of the opening  61  of the trochar  60 . In a preferred version of the invention, the straps  14  and  30  are deployed by sliding the end of the trochar  60  containing the distal end  62  of the strap  14  and  30  between the fascia  50  and the overlying adipose layer  52  of the tissue of the wound  48  (shown in  FIG. 1 ). The distal ends  62  or  63  of the straps  14  or  30  are then urged out of the trochar  60  from the proximal end  18  or  34  in the direction of the arrow  66 , deploying the most distal barbs  24  and  40  into the fascia  50 . The trochar  60  is then pulled off the remainder of the strap  14  or  30 , in the direction of the arrow  68 , embedding the barbs  24  and  40  in the underlying fascia  50 . This process is repeated for the opposing strap such that the proximal end  18  of the first strap  14  and the proximal end  34  of the second strap  30  abut each other at about the midline  56  of the wound  48 . The proximal end  18  of the first strap  14  is then inserted in the buckle  42  of the second strap and tightened by pulling the first strap  14  in the direction of the arrow  19  as previously described.  
         [0068]     It is a further facet of the invention  10  that while, in a preferred embodiment, the straps  14  and  30  are deployed subcutaneously in the fascia  50 , as shown in  FIG. 1 ., the straps may also be deployed on the surface of the skin with the barbs  24  and  40  engaged with the epidermis. The straps  14  and  30  may also be used internally in most situations where conventional stitches are used such as during exploratory surgery or resections, and with most tissues, including connective tissues, such as tendons, cartilage, ligaments and adipose tissue.  
         [0069]     It is yet another facet of the invention  10  and of the other embodiments described in this disclosure that the straps  14  and  30  are made out of any hypoallergenic material and may be resorbable or permanent. In some instances, the straps  14  and  30  may not be resorbable and will remain engaged in the lesion or wound  48 , such as permanent sutures are, or until the care provider elicits their removal. In other versions of the invention, the straps may be made of resorbable materials such as those described in U.S. Pat. No. 4,968,317 to Tormala et al. or U.S. Pat. No. 4,898,186 to Ikada et al., both hereby incorporated by reference for their description of such materials.  
         [0070]     Reference is now made to  FIGS. 4-9  for a second embodiment of the invention, which is directed to a wound closure device including a tissue-connecting strap  100  for connecting wound tissue. Advantageously, the tissue-connecting strap  100  can act upon itself thereby eliminating the necessity of mating straps of different configurations. Referring now to  FIGS. 4   a - f , the tissue-connecting strap  100  is a one-piece unit sectioned into a tissue insertion tongue  102  at the proximal end  106  of the tissue-connecting strap  100  and a forked or U-shaped engagement clasp  104  at the distal end  108  of the tissue-connecting strap  100 . The insertion tongue  102  is defined by an upper side  110 , which is generally smooth and preferably slightly curved. The lower side  112  is again generally smooth, but is defined by a series of attachment points or barb elements  114  having a base connected to the lower side and a pointed end. Although the figures illustrate ordered rows of barb elements  114  beginning at the distal end  106  and continuing along the lower side  112  of the tissue-connecting strap  100 , it is within the scope of the present invention to have at least one barb element on the lower side  112  and more barbs than illustrated in the figures. In addition, the barb elements  114  may be present in precise rows of one, two, three or more barbs  114  as illustrated in the figures or the barb elements  114  may be presented in a staggered configuration. As best illustrated in  FIG. 4   c , the barb elements  114  include a primary barb  116  in which the end of the barb is directed toward the proximal end  108  of the tissue-connecting strap  100 . The purpose of the primary barb  116  is to assist the securing of the tissue-connecting strap  100  in the fascia or skin area. Additionally, there is contemplated a secondary barb  118 , generally smaller than the primary barb and pointing in the general direction of the distal end  106 . The primary purpose of the secondary barb  118  is to assist in the “setting” of the tissue-connecting strap  100  in the skin tissue and to prevent the tissue-connecting strap  100  from backing out of the tissue in an opposite direction once the strap  100  has been set in the tissue.  
         [0071]     The engagement clasp  104  is integrally connected to the insertion tongue  102  and is generally U-shaped with an upper side  120 , a lower side  122  and a connecting side wall  124 . The side  126  opposite the side wall  124  is open, defining a cavity  128 . In addition, there is a cut-away area  130  on the lower side  122  of the engagement clasp  104  to assist in the engagement operation of two tissue-connecting straps  100 .  
         [0072]     Referring more specifically to  FIGS. 4   b ,  4   c  and  6 , the upper interior wall  132  and lower interior wall  134  are defined by a plurality of small teeth or ratchets  136  which are there for the purpose of engaging a paired tissue connecting strap  100  in a manner to be described further on. The ratchets  136  are disposed in horizontal configuration, extending from the side wall  124  to the opening  126  on both the upper interior wall  132  and lower interior wall  134 . It is within the scope to include at least one row of ratchets  136  in the engagement clasp  104  area. Preferably, multiple rows of connecting mechanisms such as ratchets  136  are included to provide increased securing or gripping tension between the tissue-connecting straps  100  once engaged. In addition, while the ratchets  136  are generally triangular in shape with the dorsal ridge of the ratchet  136  ending in the cavity such that the dorsal ridge of the ratchets  136  on the upper interior wall  132  face the dorsal ridge of the ratchets  136  on the lower interior wall  134 , the ratchets  136  are preferably configured to lean or extend in the direction of the distal end  106  of the tissue-connecting strap  100  in order to increase the engagement tension of two tissue-connecting straps  100  once engaged.  
         [0073]     While ratchets  136  are the preferred connecting mechanisms, it is within the scope of the present invention to provide alternative connecting mechanisms herein. Non-limiting examples of engaging devices include light curing epoxy including the entire electromagnetic spectrum from gamma rays, x-rays, ultraviolet, visible, infrared, microwave radio waves to ultra low frequencies for permanently or temporarily connecting the two straps; DC electrical curing epoxy for permanently or temporarily connecting two connecting straps; magnetic forces to bond the straps permanently or temporarily; ultrasonic energy to bond the straps permanently or temporarily; vibration energy to bond the straps permanently or temporarily; heat, including conduction, convection and radiation forces to bond straps permanently or temporarily; and adhesives, glues, epoxy using either a pressure force or a chemical reaction to bond the straps permanently or temporarily.  
         [0074]     Referring to  FIG. 4   f , the shape of the width of the tissue-connecting strap  100  is preferably generally curved in a concave fashion, as illustrated in  FIG. 4   f , to prevent accidental disengagement of the tissue-connecting strap  100  once the strap is placed in the skin tissue.  
         [0075]     As illustrated in  FIGS. 4   a  and  4   e , there is also a midline marker  138  to assist in the proper engagement of two tissue-connecting straps  100 .  
         [0076]     Reference is now made to  FIGS. 5-9  for a description of the process of engaging the tissue-connecting strap  100 . As illustrated in  FIG. 5  and  6 , two identical tissue-connecting straps  100  may be used for the wound closure device. In operation, the insertion tongue  102  is inserted into the skin layer (not shown), preferably in the fascia in similar fashion as is illustrated in  FIG. 1 , with the distal end  106  extending into the skin tissue layer. An identical tissue-connecting strap  100  is then placed on the opposite wall of the wound in similar fashion. Once the two tissue-connecting straps  100  are placed such that the proximal ends  108  are facing each other, the tissue-connecting straps  100  can be engaged for wound closure. Engagement can be achieved in at least two ways. First, the tissue-connecting straps  100  can be pressed together such that the openings  126  of each of the tissue-connecting straps  100  are facing each other somewhat in parallel alignment with the midline markers  138  of each of the tissue-connecting straps  100  also in alignment. The engagement clasp can then be slidably inserted upon each other through the openings  106  such that the ratchets  136  of each of the tissue-connecting straps  100  engage upon each other, thereby preventing disengagement by forces pulling at the distal ends  106  of each of the engaged connecting straps. The curved structure of the tissue-connecting straps  100  and the side walls  124  act to prevent lateral disengagement of the tissue-connecting straps  100 . Although engagement is achieved when one or two rows of ratchets  136  are engaged, stronger engagement is achieved when all of the rows of ratchets  136  are engaged such that the midline markers  138  of each of the tissue-connecting straps  100  are in alignment as illustrated in  FIG. 5 .  
         [0077]     As illustrated in  FIG. 6 , the configuration of engagement shows the ratchets  136  of the upper interior wall  132  of the right tissue-connecting strap  100  to be engaged with the ratchets  136  of the lower interior wall  134  of the left tissue-connecting strap  100 . Because the tissue-connecting straps  100  are identical in configuration, the engagement can be reversed whereby the ratchets  136  of the upper interior wall  132  of the left tissue-connecting strap  100  is engaged with the ratchets  136  of the lower wall  134  of the right tissue-connecting strap  100  without any diminishing effect on the engagement.  
         [0078]     Reference is now made to  FIGS. 7 and 8  for further illustrations showing the tissue-connecting straps  100  in complete engagement. Referring now to  FIGS. 4   d ,  6 ,  8 ,  9   a  and  9   b , the tissue-connecting strap  100  can be further defined by a tool engagement slot  140 , which is a generally inwardly curved area between the upper side  110  of the insertion tongue  102  and the upper side  120  of the engagement clasp. As illustrated in  FIGS. 9   a  and  9   b , the present invention contemplates a wound closure system having two identical tissue-connecting straps  100  and an engagement tool  142 . The contemplated engagement tool  142  has a typical scissors-shaped configuration with finger slots  144  and  146 , a hinged joint  148  and extension arms  150 . Situated at the distal end of the extension arms  150  are triangular hooks  152  for latching each of the two engagement slots  140  of the tissue-connecting straps  100 . The hooks  152  of the engagement tool  142  grasp each tissue-connecting strap  100  at the tool engagement slot  140  in order to close the tissue-connecting straps  100  upon each other. As illustrated, the engagement tool  142  can easily gauge each of the tool engagement slots  140  of the separated tissue-connecting straps  100 , even if misaligned, to bring the tissue-connecting straps  100  together in aligned engagement by bringing the finger slots  144  and  146  together in the direction of the arrows  154  until the midline markers  138  of each of the tissue-connecting straps  100  are in direct alignment.  
         [0079]     Reference is now made to  FIGS. 10-15  for a third embodiment of the present invention, which contemplates a wound closure device for connecting tissues. Unlike the second embodiment, the third embodiment includes a male connecting strap  200 , as illustrated in  FIG. 10 , with a proximal end  202  and a distal end  204 . As illustrated in  FIG. 10 , the proximal end  202  preferably has a tapered end. The male connecting strap  200  includes an elongated strap  206  and an engagement clasp  208  integrally connected at an area  210  which can be defined by the tool engagement slot  212  similar to the tool engagement slot  140  in  FIG. 8  in the second embodiment.  
         [0080]     The engagement clasp  208  is defined by forked opening consisting of an upper planar side  214  in which the outer wall  216  is generally smooth in configuration and the inner wall  218  includes ratchets similar to the rows of ratchets  136  in the second embodiment of this invention. Likewise, there is a lower planar side  220  in general parallel engagement with the upper planar side  214 . The lower planar side  220  includes a generally smooth outer wall  222  and a ratcheted inner wall  224 . The sides  214  and  220  remain in parallel engagement because of an end wall  226  defined by the tool engagement slot  212 . Although not shown, it is within the scope of the present invention to provide the engagement clasp  208  with a side wall connecting the upper planar side  214  and the lower planar side  220 , similar to side wall  124  illustrated in the second embodiment and  FIG. 4   a.    
         [0081]     Illustrated in  FIG. 11  is the female connector  230  defined by a hinged engagement clasp  232  at the proximal end  234  and the forked engagement clasp  236 , which is similar in configuration to the engagement clasp  208  of the male connecting strap  200 . Like the male connecting strap  200 , the forked engagement clasp  236  is located at the distal end  238  of the female connector  230  and includes a tool engagement slot  212 , an upper planar side  240 , including a generally smooth outer wall  242 , a ratcheted inner wall  244 , a lower planar side  246  with a generally smooth outer wall  248  and a ratcheted inner wall  250 .  
         [0082]     As illustrated in  FIG. 11 , the hinged engagement clasp  232  is defined by a rotating hinge bar  252  rotatably connected to the receiving platform  254  by a hinge  256 . Preferably, the hinge engagement clasp  232  is a one-piece extruded plastic or polymer material in which the hinge bar  252  is connected to the receiving platform  254  by a plastic memory hinge molded with the extruded device which allows the rotation of the hinge bar  252  from an open position as illustrated in  FIG. 11  to a closed position. The receiving platform  254  is defined by one or more posts  258  which are designed to engage with a complementary post receptor  260  located on the hinge bar  252 .  
         [0083]     Referring now to  FIG. 12 , there is illustrated a tissue-connecting strap  262  which is designed to engage either the engagement clasp  208  of the male connecting strap  200  or the engagement clasp  236  of the female connector  230 . In either configuration, the tissue-connecting strap  262  is identical in structure. Therefore, the tissue-connecting strap  262  can be used for either the male connecting strap  200  or the female connector  230 . The tissue-connecting strap includes a tissue insertion tongue  264  similar in shape and structure as the tissue insertion tongue  102  in the second embodiment and a forked engagement clasp  266  similar in shape and structure to the engagement clasp  208  and  236  of the male connecting strap  200  and female connector  230 , respectively. As illustrated in  FIGS. 13 and 14 , the tissue-connecting strap  262  is first designed for placement into the tissue in similar fashion as that described with respect to the second embodiment. Once the tissue-connecting strap  262  is placed into the tissue at opposite sides of the wound, the female connector  230  engages the tissue-connecting strap  262 , as illustrated in  FIG. 13 .  
         [0084]     It is within the scope of the third embodiment to use an engagement tool  142  as illustrated in  FIGS. 9   a  and  9   b  for engagement of the female connector  230  to the tissue-connecting strap  262 . Likewise, and as illustrated in  FIG. 14 , the male connecting strap  200  engages the tissue-connecting strap  262  by similar means as described with respect to  FIG. 13 .  
         [0085]     It is within the scope of the present invention to eliminate the tissue-connecting and the engagement clasps  208  and  236  of the male connecting strap  200  and female connector  230 , respectively, in favor of a molded strap in which the male connecting strap  200  includes the tissue-connecting strap  262  integrally connected thereon and the female connector  230  includes the tissue-connecting strap  262  integrally connected thereon.  
         [0086]     Once the male connecting strap  200  and female connector  230  are placed in the wound tissue, the proximal end  202  of the male connecting strap  200  is urged through the slot  257  in the hinge engagement clasp  232 . The strap  200  can then continue to be pulled through the slot  257  to the desired tension. Once the desired tension is achieved, the hinge bar  252  can rotate such that the complementary post receptors  260  engage with the posts  258  on the receiving platform  254  thereby placing the male connecting strap  200  in locking engagement with the female connector  230 . If desired, any extended portion of the male connecting strap  200  can then be removed by scissors or the like. In this manner, the female connector  230  and the tissue-connecting strap  262  of the male connecting strap  200  may be placed in remote locations on the patient&#39;s body.  
         [0087]     In addition to the use of the male connecting strap  200  and the female connector  230 , the present invention contemplates a variety of connecting mechanisms including, but not limited to: a buckle fixed to the first strap for mating with a ratchet fixed to the second strap similar to that disclosure with respect to the first embodiment; two strips of material, each attached to its respective strap for connection by twisting the strips together, thereby pulling the straps together; a button-in-hole assembly known to the art wherein a hitch is attached to one strap for engagement with one of a series of holes on the other strap; serration (one strap having a serrated end that is pulled through a fixation hole at the end of the other strap); knot tying first and second strips of material, each attached to its respective strap; a hook-and-loop fastener; a tapered nail with a head (brad) for holding the straps together; a string of pearl-like plastic beads on one strap for engagement with a lock ring on the other; entrapment with an eccentric cam; light curing epoxy including the entire electromagnetic spectrum from gamma rays, x-rays, ultraviolet, visible, infrared, microwave radio waves to ultra low frequencies for permanently or temporarily connecting the two straps; DC electrical curing epoxy for permanently or temporarily connecting the two straps; magnetic forces to bond the straps permanently or temporarily; ultrasonic energy to bond the straps permanently or temporarily; vibration energy to bond the straps permanently or temporarily; heat, including conduction, convection and radiation forces to bond straps permanently or temporarily; and adhesives, glues, epoxy using either a pressure force or a chemical reaction to bond the straps permanently or temporarily.  
         [0088]     Referring now to  FIG. 15 , there is illustrated a method for both coarse and fine adjustment of the length of the engagement strap  206 . As illustrated in  FIG. 15 , the female connector  230  is placed in half engagement with the tissue-connecting strap  262  such that approximately one-half of the rows of ratchets  136  are in engagement as illustrated by the position of the distal end  235  of the female connector  230 . In this manner, the proximal end  202  of the engagement strap  206  can be urged in a direction to and through the distal end  235  of the female connector  230  until desired tension is achieved on the engagement strap  206 . Once desired tension is achieved, the hinge bar  252  is rotated upon its hinge  256  such that the host receptors  260  engage with the posts  258  thereby locking the engagement strap  206  in engagement with the female connector  230 . Once this occurs, the end of the strap  206  can be trimmed if desired. If fine tune adjustment now needs to be made to increase the tension of the engagement strap  206 , the engagement tool  142  (not illustrated in  FIG. 15 ) can be placed on the tool engagement slots  212  in order to tighten the connection between the slots  212  thereby increasing the tension of the engagement strap  206 .  
         [0089]     It is within the scope of the present invention to have the engagement strap  206  of any desired length. Therefore, the female connectors  230  could feasibly be placed within the fascia area of the tissue in the front midline section of a patient. The male connecting strap  200  could then be engaged, by means of the tissue-connecting strap  262 , along the back or spinal area of the patient. The engagement strap  260  could then extend around the torso of the patient, engage the female connector  230 , be tightened to a desired tension, and locked in place with the desired tension remaining intact. As will be described later in this disclosure, the device of the third embodiment has a specific use not only for wound closures, but also for plastic surgery or facial or body augmentation.  
         [0090]     Reference is now made to  FIGS. 16-19  for examples of various uses of the wound closure devices of the present invention. Referring now to  FIGS. 16 and 17 , there is illustrated a system of using the device of the present invention for breast augmentation. Illustrated in  FIG. 16  is a strap for use in plastic surgery, such as breast augmentation, abdominoplasty, or other procedures involving tightening or adding tension to various areas in the body. As illustrated in  FIG. 16 , the device is a one-piece strap  300 , which includes tissue insertion tongues  302  at both ends of the strap  300 . The tissue insertion tongues  302  are similar in shape and design as that described with reference to tissue insertion tongues  102  with respect to the second embodiment and illustrated in  FIG. 4   a . The tissue insertion tongues  102  are connected to each other by means of a flexible tape  304 . It is within the scope of the present invention to provide a tape of any desired width, length, thickness or flexibility depending on the present needs. For example, the tape could be one-quarter inch in width or less up to and beyond one inch in width. Preferably, the tape is flexible and made of materials described herein. As illustrated in  FIG. 17 , the strap  300  is designed to be placed under the outer skin layer so that it will not be shown on the surface. In operation, one of the tissue insertion tongues  302  is placed in securing engagement in the fascia layer of the skin at a desired location designated at  312  above the breast  310 . The tape  304  is then surgically placed beneath the skin layer of the breast in such a way as to engage the breast  310  for lifting. Tension is then placed on the tape  304  by raising the second tissue insertion tongue above the breast  310  in order to lift the breast  310  to the desired location. Once the desired location is achieved, the tissue insertion tongue is placed in securing engagement within the fascia layer of the skin at location  314 .  
         [0091]     While the tape  304 , as illustrated in  FIG. 16 , is designed to be of a specific length, it is within the scope of the present invention to apply the system of the third embodiment such that the tape  304  is replaced by an engagement strap  206 . In this manner, one of the tissue insertion tongues  302  would be replaced by a female connector  230  and tissue-connecting strap  262  combination. The other tissue insertion tongue  302  would be replaced by a male connecting strap  200  and tissue connecting strap  262  combination. In this manner, the engagement strap  206  can be of any indeterminate length. However, the length can be adjusted as described with respect to the second embodiment.  
         [0092]     Reference is made to  FIG. 18 , which illustrates a patient  350  with a series of wound closure devices  352  applied to the face  354  and neck  356  of the patient  350 . The wound closure devices  352  can include any of the first, second or third embodiments of the present invention and can be attached to the surface of the face  354  or neck  356  of the patient  350 , as illustrated, or below the surface, as described herein. While the illustration is described with respect to a wound closure device for wound repair, the device  352  can equally be used for plastic surgery, such as face or neck lifts. In this manner, one end of the wound closure device  352  can be securely placed at a desired location on the face  354  or neck  356 . Tension can then be applied to the wound closure device  352  thereby lifting or pulling the skin of the patient  350 . The other end of the wound closure device  352  can then be inserted into the skin fascia location and locked in place according to the methods described in this disclosure, thereby keeping the tension applied to the wound closure device addressing the skin of the face  354  or neck  356 . While the wound closure devices  352  are described in  FIG. 18  with respect to only the face  354  and neck  356  of the patient  350 , the devices  352  have equal application throughout the patient&#39;s body.  
         [0093]     Referring now to  FIG. 19 , the device of the present invention is illustrated in use to illustrate an abdominoplasty procedure. As illustrated in  FIG. 19 , the straps  300  are similar to those described and illustrated with respect to  FIGS. 16 and 17  and comprise a tape  304  and tissue insertion tongues  302 . In operation, the outer skin layer of the patient  350  is surgically removed along incision lines  360  and  362  and folded along fold line  364 . One or more of the straps  300  can then be put in place as illustrated in  FIG. 19  by placement of the tissue insertion tongue  302  on one side of the patient. The strap  300  is then placed along the stomach area of the patient as illustrated in  FIG. 19 , tension is applied to the strap  300  and then the tissue insertion tongue on the other end of the strap  300  is secured in the fascia on the other side of the patient. The tension action from the straps  300  lifts the stomach area for the end result. As with the embodiment shown in  FIGS. 16-19 , the strap  300  can be replaced by the device illustrated in the third embodiment of this disclosure.  
         [0094]     The present invention also contemplates a wound closure device for connecting tissue comprising a strap having a ventral barbed surface. The device preferably has two parallel tiers of material, each tier having an end connected to the strap at a junction. The inner surface of each tier is ratcheted for releasable engagement with the connector of a second strap. This would allow for adjusting the two straps if it was accidentally pulled too tight. The straps ratchets can be disengaged by moving them perpendicular to the ratcheting direction in one or both perpendicular directions. Other versions could be fabricated such that no direction could disengage the two straps. Only permanently destroying the bond would disengage the straps.  
         [0095]     The present invention also contemplates a wound closure system having two identical wound closure devices and an engagement tool. A preferred version has a tool engagement slot at the connector junction. The engagement tool has two triangular hooks for latching each of two engagement slots at the connector junction of each wound closure device. The pivots allow misaligned devices to come together and latch. The tool does not necessarily need to be triangular. The engagement tool “hooks” into each strap individually so the two straps can be pulled together. The tool finds the “engagement” slot in each device by pivoting on several axes. The pivots of the tool and the engagement slot allow misaligned closure devices to be pulled together. The closure devices do not have to be parallel to each other for the ratchets to hold. There is an angle in which the two straps will stay connected even though the ratchets are not in parallel engagement.  
         [0096]     A repair device is also contemplated which comprises first and second anchor devices each having barbs for engagement with tissue, wherein a locking ring is attached to the first anchor device and a strip of material such as mesh or tape is attached to the second anchor device. In use, the anchors are set in tissue and the strip of material is threaded through the locking ring. Pulling or releasing a string attached to the strip of material may adjust the tension in the strip of material.  
         [0097]     It is understood that the invention is not confined to the particular construction and arrangement of parts herein illustrated and described but embraces such modified forms thereof as come within the scope of the following claims.