Abstract:
The invention discloses a device and technique for a sutureless wound closure, which limits the risks of rupture and scarring. The device comprises a two-part strap having short hooks or barbs on the ventral surface. The barbs are curved and flexible such that, when urged in one direction, the barbs do not engage while when urged in the opposite direction, the barbs are pushed downward and engage the tissue of the wound. By deploying one strap on each side of the wound, fastening the two straps in the middle of the wound and tightening the ends, the wound is closed. The tension required to close the wound is distributed along the length of the straps, thus resulting in a cleaner, safer closure.

Description:
FIELD OF THE INVENTION  
         [0001]    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.  
         DESCRIPTION OF THE PRIOR ART  
         [0002]    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.  
           [0003]    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.  
           [0004]    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.  
           [0005]    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.  
           [0006]    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 requires use with a structure dense enough to have the device embedded within it and is thereby limited in its use.  
         SUMMARY OF THE INVENTION  
         [0007]    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.  
           [0008]    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.  
           [0009]    In another preferred embodiment, the invention comprises a wound closure device for connecting tissue having a first flexible strap with a proximal end, distal end, ventral surface and dorsal surface. Also included is a second flexible strap also having a proximal end, distal end, ventral surface and dorsal surface. The proximal end of the second strap terminates in a connector designed and configured to adjustably connect to the proximal end of the first strap. Further, the first strap and the second strap have at least one barb on the ventral surface for engaging the tissue. By inserting each strap on either side of the wound, connecting the straps and adjusting them so as to bring the sides of the wound together, the straps form a wound closure.  
           [0010]    In yet another version of the invention, the device comprises a first and second strap. Each strap includes a ventral surface having at least one barb, and a proximal and distal end. The distal end of each strap is placed in tissue surrounding the wound, and the proximal end of each first strap is designed and configured to be adjustably connected to the proximal end of each second strap. By connecting and adjusting the straps, the device forms a wound closure.  
           [0011]    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.  
           [0012]    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.  
           [0013]    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.  
           [0014]    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.  
           [0015]    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  
       [0016]    [0016]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.  
         [0017]    [0017]FIG. 2 a  is a partial side elevation view of the first strap of the device at the proximal end.  
         [0018]    [0018]FIG. 2 b  is a ventral elevation view of the strap of FIG. 2 a.    
         [0019]    [0019]FIG. 2 c  is a partial side elevation view of the second strap of the device at the proximal end.  
         [0020]    [0020]FIG. 2 d  is a ventral elevation view of the strap of FIG. 2 c.    
         [0021]    [0021]FIG. 3 a  is a side elevation illustrating the flexion of the barbs of the closure device while stored in a trochar.  
         [0022]    [0022]FIG. 3 b  is a 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.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    Referring now to FIG. 1, there is illustrated a perspective view of a preferred 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 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.  
         [0024]    As shown in FIG. 1 and FIGS. 2 a  and  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.  
         [0025]    [0025]FIG. 1 and FIG. 2 c  and  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.  
         [0026]    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.  
         [0027]    [0027]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 .  
         [0028]    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.  
         [0029]    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 .  
         [0030]    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 .  
         [0031]    [0031]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 .  
         [0032]    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.  
         [0033]    [0033]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.  
         [0034]    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.  
         [0035]    It is yet another facet of the invention  10  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.  
         [0036]    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.