Device for surgical repair, closure, and reconstruction

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.

FIELD OF THE INVENTION

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

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.

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.

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.

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.

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.

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.

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.

U.S. Pat. Nos. 6,893,452 to Jacobs and 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.

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

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.

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.

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.

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.

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.

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.

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.

The invention is further directed to a process of engaging a first and second surgical fastener for connecting a patient'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.

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.

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.

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.

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.

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.

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.

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.

DETAILED DESCRIPTION OF THE INVENTION

Referring now toFIG. 1, there is illustrated a perspective view of a first embodiment of the disclosed invention10. As illustrated, the invention10includes a first strap14and a second strap30. The first strap14and the second strap30include distal ends62and63and proximal ends18and34, respectively. The straps14and30are planar and made of a pliable material having dorsal surfaces20and36and a ventral surface22and38. The dorsal surface20and36of the straps14and30are smooth while the ventral surfaces22and38include a plurality of tissue attachment points or small barbs24and40which project downward from the ventral surface22and38and curve toward the proximal end18and34. In one preferred embodiment, the straps14and30have a length of about 4 cm and a width of about 0.5 cm. In other embodiments, the straps14and30may be larger or smaller to accommodate a wound, illustrated at48. Although the shape of the straps14,30may include planar sides as illustrated inFIG. 1, it is within the scope of the present invention for each strap to have a rounded configuration.

As shown inFIG. 1andFIGS. 2aand2b, the proximal end18of the first strap14is tapered along its planar sides, and the ventral surface22is composed of a plurality of small teeth or ratchets26. The ratcheted surface may comprise about between 1 and 20 mm of the proximal end18of the first strap14. Between the end of the ratcheted surface and the beginning of the barbs24, there is a gap space16on the ventral surface22, which is smooth and has no protuberances.

FIG. 1andFIGS. 2cand2dillustrate a preferred version of the second strap30. In this version the proximal end34of the second strap30terminates in a buckle42. However, in other versions, the proximal end34may 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 buckle42and the most proximal of the barbs40is a gap space32marked by a smooth region of the ventral surface.

As illustrated inFIG. 1the invention10is deployed in a lesion or wound48. In use, the first strap14and the second strap30of the device10are placed on either side of the wound48in an orientation perpendicular to the axis of the wound56. In a preferred embodiment, the straps14and30are inserted underneath the epidermis directly above the fascia50of the surrounding tissue. The distal end62and63of each strap14and30are directed away from the lesion while the proximal ends18and34of the straps14and30are situated at about the midline56of the wound48. The straps14and30are displaced on either side of the wound48such that the gap space16and32of each strap14and30is generally behind the edge of the wound48. The barbs24and40are then gently embedded in the underlying tissue, which in a preferred version of the invention is the fascia50, so that the straps14and30engage the tissue.

FIG. 1shows the barbs24and40of the straps14and30engaged in the fascia50with the barbs24and40pointed toward the midline56of the wound48. The two straps14and30are connected at their proximal ends18and34and adjusted to a desired tightness. Illustrated is one preferred version of the invention showing the straps14and30that are tightened by pulling the proximal end18of the first strap14through the buckle42along the path designated by the arrow19. The buckle42is then tightened by urging it distally on the ratchets26of the first strap14. Tightening or putting tension on the proximal ends18and34of the straps14and30pulls the underlying fascia50of the wound together, allowing a smooth joining of the tissue surrounding the wound48.

When the wound is large or the tissue is delicate, multiple straps14and30may be needed. When multiple straps are used, the straps14and30are deployed on either side of the wound48. When all the straps14and30are deployed along the length of the lesion, the tapered, proximal end18of each first strap14is inserted into the buckle42of the respective second strap30until the locking tongue44engages the ratchets26of the first strap14. In a particularly preferred version, the locking action of the first proximal end18in the buckle42is like that of a nylon tie such that once the tongue44, illustrated inFIG. 2d, is engaged with the ratchets26, the tension on the straps14and30can be increased by pulling the proximal end18through the buckle42in the direction of the arrow19. The process of pulling the proximal end18of the first strap14through the buckle42of the second strap30of each of the respective first14and second30pair of straps, allows the opposing sides of the wound48to be brought close enough to begin tightening the individual straps in a sequential fashion until the opposing sides of the wound48are brought together.

Because the barbs24and40continue into the tissue surrounding the wound along the length of the straps14and30, the tension loaded on the straps14and30is transferred to the underlying tissue assuring a smooth juxtaposition of the opposing sides of the wound48. It will be appreciated that depending on the size of the wound48, more or less straps14and30may be needed. For example, a very large wound48will require a large number of straps14and30while a small wound48will require one or a few straps14and30. Similarly, very delicate or visible tissue may require many small straps14and30while tough or concealed tissues may require fewer large straps14and30.

As shown inFIG. 1, the barbs24and40are conical in shape, ending at a point. The barbs24and40are 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 barbs24and40may have a slightly different shape, depending on the particular tissue to be used in. For example, straps to be used in adipose tissue52may have barbs24and40that are longer and broader because the tissue is soft while barbs24and40to be used in muscle54or connective tissue, such as the fascia50, may be shorter and narrower because those tissues are tough, and the barbs24and40do not need to project far into the tissue to embed. Nevertheless, the barbs24and40should 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 barb24and40per row along the horizontal axis of the straps14and30, in other exemplary versions, there may be several barbs24and40per row arranged along the ventral surface22and38of the straps14and30.

FIGS. 2a-dillustrate a particularly preferred version of the proximal ends18and34of the first and second straps14and30.FIGS. 2aand2bshow a side and ventral elevation, respectively, of the proximal end18of the first strap14. As shown, the first strap14is tapered toward the proximal end18and has a series of small ratchet-like protrusions26on its ventral surface22while the dorsal surface20is flat.FIGS. 2cand2dshow a side and ventral elevation, respectively, of the proximal end34of the second strap30.FIG. 2cshows the dorsal surface36and the ventral surface38with the buckle42terminating the proximal end34of the second strap30.FIG. 2dillustrates the ventral surface38of the proximal end34of the second strap30with the buckle42terminating the proximal end and a locking tongue44situated within the buckle42.

Methods to aid in deployment of the invention10are also included. For example,FIG. 3aillustrates the strap14inside a trochar60. For the purposes of the drawing, only the second strap14is illustrated. However, both the first strap14and the second strap30are deployed with the trochar60and will have similar dimensions with comparable distal ends62and63as shown inFIG. 1. The trochar60is a cylindrical tube having walls64fabricated from a material stiff enough to use as an applicator. In particularly preferred versions, the trochar60may be made of, plastic or metal and will have a diameter slightly greater than the width of the straps14and30it is used to deploy. While in the trochar60, the barbs24and40are flexed upward due to the slightly greater length of the barbs compared to the height of the trochar60. The trochar60may serve both to store the straps14and30in and as an applicator for the straps14and30. In situations where the trochar60is disposable, the straps would come stored in the trochar. In situations where the trochar60is reloadable, the straps14and30and the trochar60may be stored separately.

FIG. 3billustrates the movement of the barbs24and40downward, shown by the arrows70, as the straps14and30are slid out of the opening61of the trochar60. In a preferred version of the invention, the straps14and30are deployed by sliding the end of the trochar60containing the distal end62of the strap14and30between the fascia50and the overlying adipose layer52of the tissue of the wound48(shown inFIG. 1). The distal ends62or63of the straps14or30are then urged out of the trochar60from the proximal end18or34in the direction of the arrow66, deploying the most distal barbs24and40into the fascia50. The trochar60is then pulled off the remainder of the strap14or30, in the direction of the arrow68, embedding the barbs24and40in the underlying fascia50. This process is repeated for the opposing strap such that the proximal end18of the first strap14and the proximal end34of the second strap30abut each other at about the midline56of the wound48. The proximal end18of the first strap14is then inserted in the buckle42of the second strap and tightened by pulling the first strap14in the direction of the arrow19as previously described.

It is a further facet of the invention10that while, in a preferred embodiment, the straps14and30are deployed subcutaneously in the fascia50, as shown in FIG.1., the straps may also be deployed on the surface of the skin with the barbs24and40engaged with the epidermis. The straps14and30may 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.

It is yet another facet of the invention10and of the other embodiments described in this disclosure that the straps14and30are made out of any hypoallergenic material and may be resorbable or permanent. In some instances, the straps14and30may not be resorbable and will remain engaged in the lesion or wound48, 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.

Reference is now made toFIGS. 4-9for a second embodiment of the invention, which is directed to a wound closure device including a tissue-connecting strap100for connecting wound tissue. Advantageously, the tissue-connecting strap100can act upon itself thereby eliminating the necessity of mating straps of different configurations. Referring now toFIGS. 4a-f, the tissue-connecting strap100is a one-piece unit sectioned into a tissue insertion tongue102at the proximal end106of the tissue-connecting strap100and a forked or U-shaped engagement clasp104at the distal end108of the tissue-connecting strap100. The insertion tongue102is defined by an upper side110, which is generally smooth and preferably slightly curved. The lower side112is again generally smooth, but is defined by a series of attachment points or barb elements114having a base connected to the lower side and a pointed end. Although the figures illustrate ordered rows of barb elements114beginning at the distal end106and continuing along the lower side112of the tissue-connecting strap100, it is within the scope of the present invention to have at least one barb element on the lower side112and more barbs than illustrated in the figures. In addition, the barb elements114may be present in precise rows of one, two, three or more barbs114as illustrated in the figures or the barb elements114may be presented in a staggered configuration. As best illustrated inFIG. 4c, the barb elements114include a primary barb116in which the end of the barb is directed toward the proximal end108of the tissue-connecting strap100. The purpose of the primary barb116is to assist the securing of the tissue-connecting strap100in the fascia or skin area. Additionally, there is contemplated a secondary barb118, generally smaller than the primary barb and pointing in the general direction of the distal end106. The primary purpose of the secondary barb118is to assist in the “setting” of the tissue-connecting strap100in the skin tissue and to prevent the tissue-connecting strap100from backing out of the tissue in an opposite direction once the strap100has been set in the tissue.

The engagement clasp104is integrally connected to the insertion tongue102and is generally U-shaped with an upper side120, a lower side122and a connecting side wall124. The side126opposite the side wall124is open, defining a cavity128. In addition, there is a cut-away area130on the lower side122of the engagement clasp104to assist in the engagement operation of two tissue-connecting straps100.

Referring more specifically toFIGS. 4b,4cand6, the upper interior wall132and lower interior wall134are defined by a plurality of small teeth or ratchets136which are there for the purpose of engaging a paired tissue connecting strap100in a manner to be described further on. The ratchets136are disposed in horizontal configuration, extending from the side wall124to the opening126on both the upper interior wall132and lower interior wall134. It is within the scope to include at least one row of ratchets136in the engagement clasp104area. Preferably, multiple rows of connecting mechanisms such as ratchets136are included to provide increased securing or gripping tension between the tissue-connecting straps100once engaged. In addition, while the ratchets136are generally triangular in shape with the dorsal ridge of the ratchet136ending in the cavity such that the dorsal ridge of the ratchets136on the upper interior wall132face the dorsal ridge of the ratchets136on the lower interior wall134, the ratchets136are preferably configured to lean or extend in the direction of the distal end106of the tissue-connecting strap100in order to increase the engagement tension of two tissue-connecting straps100once engaged.

While ratchets136are 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.

Referring toFIG. 4f, the shape of the width of the tissue-connecting strap100is preferably generally curved in a concave fashion, as illustrated inFIG. 4f, to prevent accidental disengagement of the tissue-connecting strap100once the strap is placed in the skin tissue.

As illustrated inFIGS. 4aand4e, there is also a midline marker138to assist in the proper engagement of two tissue-connecting straps100.

Reference is now made toFIGS. 5-9for a description of the process of engaging the tissue-connecting strap100. As illustrated inFIGS. 5 and 6, two identical tissue-connecting straps100may be used for the wound closure device. In operation, the insertion tongue102is inserted into the skin layer (not shown), preferably in the fascia in similar fashion as is illustrated inFIG. 1, with the distal end106extending into the skin tissue layer. An identical tissue-connecting strap100is then placed on the opposite wall of the wound in similar fashion. Once the two tissue-connecting straps100are placed such that the proximal ends108are facing each other, the tissue-connecting straps100can be engaged for wound closure. Engagement can be achieved in at least two ways. First, the tissue-connecting straps100can be pressed together such that the openings126of each of the tissue-connecting straps100are facing each other somewhat in parallel alignment with the midline markers138of each of the tissue-connecting straps100also in alignment. The engagement clasp can then be slidably inserted upon each other through the openings106such that the ratchets136of each of the tissue-connecting straps100engage upon each other, thereby preventing disengagement by forces pulling at the distal ends106of each of the engaged connecting straps. The curved structure of the tissue-connecting straps100and the side walls124act to prevent lateral disengagement of the tissue-connecting straps100. Although engagement is achieved when one or two rows of ratchets136are engaged, stronger engagement is achieved when all of the rows of ratchets136are engaged such that the midline markers138of each of the tissue-connecting straps100are in alignment as illustrated inFIG. 5.

As illustrated inFIG. 6, the configuration of engagement shows the ratchets136of the upper interior wall132of the right tissue-connecting strap100to be engaged with the ratchets136of the lower interior wall134of the left tissue-connecting strap100. Because the tissue-connecting straps100are identical in configuration, the engagement can be reversed whereby the ratchets136of the upper interior wall132of the left tissue-connecting strap100is engaged with the ratchets136of the lower wall134of the right tissue-connecting strap100without any diminishing effect on the engagement.

Reference is now made toFIGS. 7 and 8for further illustrations showing the tissue-connecting straps100in complete engagement. Referring now toFIGS. 4d,6,8,9aand9b, the tissue-connecting strap100can be further defined by a tool engagement slot140, which is a generally inwardly curved area between the upper side110of the insertion tongue102and the upper side120of the engagement clasp. As illustrated inFIGS. 9aand9b, the present invention contemplates a wound closure system having two identical tissue-connecting straps100and an engagement tool142. The contemplated engagement tool142has a typical scissors-shaped configuration with finger slots144and146, a hinged joint148and extension arms150. Situated at the distal end of the extension arms150are triangular hooks152for latching each of the two engagement slots140of the tissue-connecting straps100. The hooks152of the engagement tool142grasp each tissue-connecting strap100at the tool engagement slot140in order to close the tissue-connecting straps100upon each other. As illustrated, the engagement tool142can easily gauge each of the tool engagement slots140of the separated tissue-connecting straps100, even if misaligned, to bring the tissue-connecting straps100together in aligned engagement by bringing the finger slots144and146together in the direction of the arrows154until the midline markers138of each of the tissue-connecting straps100are in direct alignment.

Reference is now made toFIGS. 10-15for 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 strap200, as illustrated inFIG. 10, with a proximal end202and a distal end204. As illustrated inFIG. 10, the proximal end202preferably has a tapered end. The male connecting strap200includes an elongated strap206and an engagement clasp208integrally connected at an area210which can be defined by the tool engagement slot212similar to the tool engagement slot140inFIG. 8in the second embodiment.

The engagement clasp208is defined by forked opening consisting of an upper planar side214in which the outer wall216is generally smooth in configuration and the inner wall218includes ratchets similar to the rows of ratchets136in the second embodiment of this invention. Likewise, there is a lower planar side220in general parallel engagement with the upper planar side214. The lower planar side220includes a generally smooth outer wall222and a ratcheted inner wall224. The sides214and220remain in parallel engagement because of an end wall226defined by the tool engagement slot212. Although not shown, it is within the scope of the present invention to provide the engagement clasp208with a side wall connecting the upper planar side214and the lower planar side220, similar to side wall124illustrated in the second embodiment andFIG. 4a.

Illustrated inFIG. 11is the female connector230defined by a hinged engagement clasp232at the proximal end234and the forked engagement clasp236, which is similar in configuration to the engagement clasp208of the male connecting strap200. Like the male connecting strap200, the forked engagement clasp236is located at the distal end238of the female connector230and includes a tool engagement slot212, an upper planar side240, including a generally smooth outer wall242, a ratcheted inner wall244, a lower planar side246with a generally smooth outer wall248and a ratcheted inner wall250.

As illustrated inFIG. 11, the hinged engagement clasp232is defined by a rotating hinge bar252rotatably connected to the receiving platform254by a hinge256. Preferably, the hinge engagement clasp232is a one-piece extruded plastic or polymer material in which the hinge bar252is connected to the receiving platform254by a plastic memory hinge molded with the extruded device which allows the rotation of the hinge bar252from an open position as illustrated inFIG. 11to a closed position. The receiving platform254is defined by one or more posts258which are designed to engage with a complementary post receptor260located on the hinge bar252.

Referring now toFIG. 12, there is illustrated a tissue-connecting strap262which is designed to engage either the engagement clasp208of the male connecting strap200or the engagement clasp236of the female connector230. In either configuration, the tissue-connecting strap262is identical in structure. Therefore, the tissue-connecting strap262can be used for either the male connecting strap200or the female connector230. The tissue-connecting strap includes a tissue insertion tongue264similar in shape and structure as the tissue insertion tongue102in the second embodiment and a forked engagement clasp266similar in shape and structure to the engagement clasp208and236of the male connecting strap200and female connector230, respectively. As illustrated inFIGS. 13 and 14, the tissue-connecting strap262is first designed for placement into the tissue in similar fashion as that described with respect to the second embodiment. Once the tissue-connecting strap262is placed into the tissue at opposite sides of the wound, the female connector230engages the tissue-connecting strap262, as illustrated inFIG. 13.

It is within the scope of the third embodiment to use an engagement tool142as illustrated inFIGS. 9aand9bfor engagement of the female connector230to the tissue-connecting strap262. Likewise, and as illustrated inFIG. 14, the male connecting strap200engages the tissue-connecting strap262by similar means as described with respect toFIG. 13.

It is within the scope of the present invention to eliminate the tissue-connecting and the engagement clasps208and236of the male connecting strap200and female connector230, respectively, in favor of a molded strap in which the male connecting strap200includes the tissue-connecting strap262integrally connected thereon and the female connector230includes the tissue-connecting strap262integrally connected thereon.

Once the male connecting strap200and female connector230are placed in the wound tissue, the proximal end202of the male connecting strap200is urged through the slot257in the hinge engagement clasp232. The strap200can then continue to be pulled through the slot257to the desired tension. Once the desired tension is achieved, the hinge bar252can rotate such that the complementary post receptors260engage with the posts258on the receiving platform254thereby placing the male connecting strap200in locking engagement with the female connector230. If desired, any extended portion of the male connecting strap200can then be removed by scissors or the like. In this manner, the female connector230and the tissue-connecting strap262of the male connecting strap200may be placed in remote locations on the patient's body.

In addition to the use of the male connecting strap200and the female connector230, 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.

Referring now toFIG. 15, there is illustrated a method for both coarse and fine adjustment of the length of the engagement strap206. As illustrated inFIG. 15, the female connector230is placed in half engagement with the tissue-connecting strap262such that approximately one-half of the rows of ratchets136are in engagement as illustrated by the position of the distal end235of the female connector230. In this manner, the proximal end202of the engagement strap206can be urged in a direction to and through the distal end235of the female connector230until desired tension is achieved on the engagement strap206. Once desired tension is achieved, the hinge bar252is rotated upon its hinge256such that the host receptors260engage with the posts258thereby locking the engagement strap206in engagement with the female connector230. Once this occurs, the end of the strap206can be trimmed if desired. If fine tune adjustment now needs to be made to increase the tension of the engagement strap206, the engagement tool142(not illustrated inFIG. 15) can be placed on the tool engagement slots212in order to tighten the connection between the slots212thereby increasing the tension of the engagement strap206.

It is within the scope of the present invention to have the engagement strap206of any desired length. Therefore, the female connectors230could feasibly be placed within the fascia area of the tissue in the front midline section of a patient. The male connecting strap200could then be engaged, by means of the tissue-connecting strap262, along the back or spinal area of the patient. The engagement strap260could then extend around the torso of the patient, engage the female connector230, 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.

Reference is now made toFIGS. 16-19for examples of various uses of the wound closure devices of the present invention. Referring now toFIGS. 16 and 17, there is illustrated a system of using the device of the present invention for breast augmentation. Illustrated inFIG. 16is 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 inFIG. 16, the device is a one-piece strap300, which includes tissue insertion tongues302at both ends of the strap300. The tissue insertion tongues302are similar in shape and design as that described with reference to tissue insertion tongues102with respect to the second embodiment and illustrated inFIG. 4a. The tissue insertion tongues102are connected to each other by means of a flexible tape304. 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 inFIG. 17, the strap300is 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 tongues302is placed in securing engagement in the fascia layer of the skin at a desired location designated at312above the breast310. The tape304is then surgically placed beneath the skin layer of the breast in such a way as to engage the breast310for lifting. Tension is then placed on the tape304by raising the second tissue insertion tongue above the breast310in order to lift the breast310to 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 location314.

While the tape304, as illustrated inFIG. 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 tape304is replaced by an engagement strap206. In this manner, one of the tissue insertion tongues302would be replaced by a female connector230and tissue-connecting strap262combination. The other tissue insertion tongue302would be replaced by a male connecting strap200and tissue connecting strap262combination. In this manner, the engagement strap206can be of any indeterminate length. However, the length can be adjusted as described with respect to the second embodiment.

Reference is made toFIG. 18, which illustrates a patient350with a series of wound closure devices352applied to the face354and neck356of the patient350. The wound closure devices352can include any of the first, second or third embodiments of the present invention and can be attached to the surface of the face354or neck356of the patient350, 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 device352can equally be used for plastic surgery, such as face or neck lifts. In this manner, one end of the wound closure device352can be securely placed at a desired location on the face354or neck356. Tension can then be applied to the wound closure device352thereby lifting or pulling the skin of the patient350. The other end of the wound closure device352can 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 face354or neck356. While the wound closure devices352are described inFIG. 18with respect to only the face354and neck356of the patient350, the devices352have equal application throughout the patient's body.

Referring now toFIG. 19, the device of the present invention is illustrated in use to illustrate an abdominoplasty procedure. As illustrated inFIG. 19, the straps300are similar to those described and illustrated with respect toFIGS. 16 and 17and comprise a tape304and tissue insertion tongues302. In operation, the outer skin layer of the patient350is surgically removed along incision lines360and362and folded along fold line364. One or more of the straps300can then be put in place as illustrated inFIG. 19by placement of the tissue insertion tongue302on one side of the patient. The strap300is then placed along the stomach area of the patient as illustrated inFIG. 19, tension is applied to the strap300and then the tissue insertion tongue on the other end of the strap300is secured in the fascia on the other side of the patient. The tension action from the straps300lifts the stomach area for the end result. As with the embodiment shown inFIGS. 16-19, the strap300can be replaced by the device illustrated in the third embodiment of this disclosure.

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.

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.

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.

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.