WOUND CLOSURE INVOLVING SILICONE

Apparatus and methods of closing wounds using one or more plates comprising silicone which can be either sutured to the opposing edges of a wound or affixed to the opposing edges of the wound using rigid legs which penetrate tissue adjacent to the wound. The plate is brought into contact with the tissue as the wound is closed such that the plate compresses the tissue during healing.

DETAILED DESCRIPTION

The wound closure devices disclosed herein facilitate the immediate application of silicone to a wound by incorporating it into a skin closure device. Various embodiments of the skin closure device disclosed herein offer additional advantages, such as ease of application, prevention of wound desiccation, and mitigation of the scarring caused by conventional wound closure methods.

Clinical results indicate that the use of a plate containing silicone in addition to a suture to close a wound inhibits the progression and development of hypertrophic and keloid scars in preliminary clinical results. (Stupak et al, at the time of filing at press, Ear, Nose and Throat Journal, 2013) As described in U.S. patent application Ser. No. 13/407,476, incorporated herein by reference, the inventor of the devices disclosed herein describes a sutured wound closure device using this immediate application of silicone with wound edge tension redistribution. The benefits of the incorporation of silicone into wound closure can also be obtained if a silicone plate is incorporated into a device having stiff, staple-style appendages which are driven into skin adjacent to the wound and used to close the skin and bring the skin into contact with the silicone plate during healing.

Staples are a conventional wound closure system. A wound can typically be closed with staples faster than with suturing. Staples are typically made of steel or titanium, but can be made partially or completely out of stiff, resilient polymers. As with suturing, however, staples create narrow bands of pressure across a healing wound, resulting in the exacerbation of scarring.

Disclosed herein is a wound closure device2that has a central bridge portion4which includes a plate6, which can be joined to a spine8or can be used instead of a spine. The plate6has a substantial surface area. The distal surface10of the plate6contacts the surface12of skin bearing a wound14when the device is in use. The surface area better distributes pressure across the surface of a healing wound instead of concentrating it at the points where legs of a conventional staple enter the skin or in a narrow track across the top of the wound. The plate also has a compressive effect which further inhibits scarring in part by keeping wound edges together and flat. The plate covers the wound, and therefore can prevent desiccation. Finally, the plate preferably comprises silicone which inhibits scarring. The wound closure device may be used for scar prevention in delicate scar revision, facial, cosmetic or flap surgery, and may also aid in closure of difficult high tension wounds.

The central bridge portion4comprises a plate6. It may be any size or shape, so long as it has a width that exceeds the width of the legs16and provides a relatively large surface area which can contact the surface of the wound. It may be square, or it may be rectangular or oblong. It may be sized to cover a larger wound or portion of a wound with a single device. The plate may be composed of a thin sheet of hard-grade silicone. It may also be made of a thin sheet of more flexible silicone. The silicone may be adhered to or may partially or completely envelope a metal or polymer component such as a spine8, which lends rigidity, resilience, deformability to the bridge portion. The spine8may be a thin metal strip, as shown inFIGS. 8,9, and10, or it may have a size or shape which is more commensurate with the size and shape of the plate6.

Two or more opposing legs16are used to affix the wound closure device to the skin and to draw the edges of a wound together in order to close the wound. The legs16should preferably be bent, for example in right angles as shown inFIG. 1, or in a more curved configuration as shown inFIG. 3, but they may also be straight. The device may have two opposing legs or it may employ multiple legs, as shown inFIGS. 5 and 6. Especially if the device has multiple legs, individual legs can be adjusted during healing in order to redistribute tension and further manage healing in a manner which minimizes scarring. The legs may be joined to or integral with a metal spine, or they may be joined to the bridge portion or central plate.

Skin closure devices may be positioned before use with their legs16splayed in either straight or partially bent configurations so that they are generally nearly parallel to the bridge portion4, as shown inFIGS. 4,6,8, and10. When the devices are used, a specialized apparatus is used to force the legs into a flexed position so that they penetrate the skin at an appropriate angle so that the legs simultaneously pull the skin together, close the wound, and bring the plate into contact with wounded skin. The legs may be bent at approximately 90 degree angles when splayed in their pre-insertion position. The legs may then be bent 90 degrees further at the joint where they interface with the spine or plate in order to insert them into skin, bringing the opposing edges of the wound together, as shown inFIGS. 10 and 11. The device maintains this post-insertion shape for the duration of healing. It is removed by again deforming it so that the legs can be retracted out of the skin.

As shown inFIGS. 3,4, and6, the plate6and bridge portion4may remain straight and the legs16may be individually flexed up into a pre-insertion position and downward into an insertion position for use as shown inFIG. 5. The legs may be individually bent into insertion position whether they are joined to a spine or not, but, as shown inFIGS. 8,9, and10, the legs16may be integral with or joined to a spine8, and the spine may be bent in order to cause the legs to assume pre-insertion positions. If the plate is rigid, as shown inFIG. 8, the spine8may be affixed to the proximal surface18of the plate6at an approximately central point20so that when the spine is bent into a pre-insertion position, the legs form an M shape and angle away from the proximal surface18of the plate6. As shown inFIG. 10, if the plate is flexible, a substantial portion of the spine8may be affixed to the proximal surface18of the plate6and when the spine8is bent into a pre-insertion configuration, the plate will be bent as well.

The procedure used to place and operate this device has not been described in the previous medical literature or prior art. The device may be used in a soft-tissue incision, wound, or to close a tissue flap to intact tissue. This may be used with endoscopic guidance for any tissue or body cavity, as no knot tying is required.

The procedure itself begins with appropriate anesthesia for the patient. Once adequate subcutaneous or submucosal stitches are placed if necessary, the device may be used. The device should be used instead of mucosal or cutaneous sutures, in areas where there may be a high risk for scarring or increased risk of vascular compromise to tissue, such as the corner of a rotational flap where maximal tension occurs, or where previous scars have already been excised. The practitioner approximates the edges of the wound, and then uses an apparatus to place one or more wound closure devices proximate to one another until the wound is closed. The apparatus used to place the device can preferably be used to modify the position of any one leg in order to change the tension distribution to accommodate changes in the tissue due to edema or healing.

Referring now toFIGS. 12-15, in an additional embodiment, a wound closure device comprises a suture80with a surgical needle78on its free end, harnessed to a plate82. The plate82may be composed of a silicone sheet or molded plate. Its size and shape may vary depending on the shape and size of the wound and its anatomic site. The plate should have sufficient rigidity to exert pressure on the healing wound, thus limiting scar progression through compression. The plate may include one or more portals90such as eyeholes or notches which direct the suture from a first or wound-facing side of the plate94to the second or top side of the plate96. It may also include a mechanism for fastening the suture to the plate, such as a cleat92or other fastener for suture securing. In an alternate embodiment, shown inFIG. 15, the plate may have two or more portals90, and no attached suture. In this embodiment, the suture can be knotted on top of the device.

The device is used to proximate the edges of a wound to close the wound, and can then compress the surface of the closed wound, with tension distributed along the full area of the plate instead of the very narrow width of the suture thread as with conventional suturing. Because of the dynamic attachment of the suture to the plate via the eyehole or notch, pulling from the tissue will result in additional compression from the plate.

In addition, because of the portal fastener components, the suture may be secured without tying a knot, and can have its tension adjusted during the healing process in order to accommodate changes in the tissue caused by edema or healing. Because no suture tying is required, the device can be used for both external and endoscopic procedures where there is limited access to the surgeon for tying knots. Because there is less risk of train-track scarring, the suture plate may be left in place longer, allowing more silicone exposure to the wound, more immobilization, and more support during healing, as well as the prevention of moisture loss from the environment

The procedure itself begins with appropriate anesthesia for the patient. Once adequate subcutaneous or submucosal stitches are placed if necessary, the device may be used. The device should be used instead of mucosal or cutaneous sutures, in areas where there may be a high risk for scarring or increased risk of vascular compromise to tissue, such as the corner of a rotational flap where maximal tension occurs, or where previous scars have already been excised.

The needle78and suture80harnessed to the plate80is introduced into the tissue of one edge84of the wound88, and subsequently passed through an additional edge86of the wound88as in normal mucosal or dermal skin. Care must be taken to pass through a significant amount of the substance of the subdermal or submucosal tissue to permit adequate eversion and closure.

Once passed through, the needle78and suture80are pulled in a direction away from the tissue. Due to a “pulley” effect, the plate is subsequently urged toward the tissue and into position proximal to the wound88at the same time that the edges of the wound84,86are proximated. Before the plate contacts the tissue, the needle and suture are fed through the portal90, the needle and suture are pulled again, until the plate is maneuvered into position flush with the tissue plane, as shown inFIG. 14, the closed wound88at its midpoint (as a flag would be raised on a flagpole).

The wound closes just as the plate becomes flush with the tissue. The desired level of tension is kept on the needle end of the suture, and it is fed into the fastener92or tied to secure its position and tension. For additional security, a second fastener, perhaps a v-shaped cut-out in the plate, may be used as well. Optional features are also possible on the plate. A single plate may have multiple sutures and their respective portals or cleats in parallel, as shown inFIG. 16. This would allow one plate to cover a longer incision. The plate may be flat, curved, or oblong shape, depending on the tissue needing repair.

Whether attached to wounded skin with sutures, legs, or other means, the wound closure devices described herein provide compression to the wound edges, maintain the tissues in an appropriate position for healing, and may additionally help protect the wound and help keep the wound moist and clean. Additionally, the use of silicone in contact with the healing tissue immediately upon wound closure further inhibits hypertrophic and keloid scarring. The wound closure devices provide a secured, occlusive dressing that is both rapidly applied and can be partially or completely transparent for visualization of the wound.

The terms and expressions which have been used in this specification are intended to describe the invention, not limit it. The scope of the invention is defined and limited only by the following claims.