WO1998026838A1

WO1998026838A1 - Surgical healing mesh

Info

Publication number: WO1998026838A1
Application number: PCT/US1997/023589
Authority: WO
Inventors: Serjan D. Nikolic; Theodore L. Parker
Original assignee: Vidacare International, Inc.
Priority date: 1996-12-18
Filing date: 1997-12-18
Publication date: 1998-06-25
Also published as: AU5711698A

Abstract

A wound healing device includes an energy delivery surface that is at least partially positionable in an interior of a wound. The energy delivery surface is coupled to a film which is positioned around the wound. Delivery of energy to the wound results in a healing of the wound.

Description

SURGICAL HEALING MESH

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to the U.S. provisional application entitled SURGICAL HEALING MESH, Serial No. 60/033,672, filed December

18, 1996, and invented by Serjan Nicholic and Theodore L. Parker.

BACKGROUND OF THE INVENTION Field of the Invention The present invention relates to a wound healing device, and more particularly to a wound healing device which positions an energy delivery device into at least a portion of a wound and delivers energy to the wound.

Description of Related Art Often it is necessary to very quickly to stop bleeding from an artery during surgery as well as other times when the artery has been nicked. One method of stopping blood flow from the artery is to apply pressure directly to the artery with the use of one's fmger.

Mechanical devices for effecting non-invasive compression of arteries include the use of pressure cuffs. Typically, the cuff includes a strip of non- elastic material to be wrapped around a limb. An elastic inflatable bladder is superimposed on the non-elastic material. When the bladder is inflated pressure exerted by all parts of the enwrapment on the limb is increased. U.S. Patent No. 3,171,410 discloses a pneumatic dressing which exemplifies traditional pressure cuff devices.

Other mechanical devices have been used for decades to achieve hemostasis. Many of these have been based on a C- or U-shaped clamp that use a ratcheting effect to allow the operator to apply or release pressure to the puncture site. These clamps have proven to be efficient alternatives to manual compression for control of bleeding after the removal of transfemoral sheaths.

One C-clamp device features a rigid footplate, as disclosed in U.S. Patent

No. 3,799,249 (hereafter the '249 patent). The apparatus of the '249 patent is used to exert non-calibrated and unevenly distributed pressure to the body surface overlying an artery. The use of C-clamps can also cause hematomas and they can only be used for a limited time.

U.S. Patent No. 3,625,219 discloses a transparent rubber membrane clamped to a transparent plastic plate to form an expandable pressure chamber. Clamping screws are used to maintain various members of the chamber support structure in place, and must be loosened to adjust the position of the chamber relative the area to which pressure is to applied.

Further, another type of mechanical device is disclosed in U.S. Patent

No. 4,233,980 (hereafter the ^*980 patent). In the '980 patent an inflatable bladder is formed with two sheets of transparent, non-elastic material that provide lateral restraint. The bladder is inflated by the introduction of a fluid.

Vertical expansion is accomplished by the separation of the two sheets of material due to inflation. The bladder is typically mounted on a pressure plate.

The pressure plate is mounted on a positioning arm. Pressure-sensitive adhesives (hereafter PSAs) are used for a variety of industrial, consumer, and medical applications. PSAs are characterized as being normally tacky and exhibit instant tack when applied to a substrate. A variety of polymers have been used to manufacture PSAs, for example acrylic and methacrylic ester homo- or copolymers, butyl rubber-based systems, silicones, urethanes, vinyl esters and amides, olefin copolymer materials, natural or synthetic rubbers, and the like.

Flexible polymeric film materials are also known such as described in

European Patent Application No s. 0107915 and 0147119, and

PCT/GB91/00496, all of which are incorporated herein by reference, to disclose materials with particular moisture vapor transmission rates which might be used as backing materials in connection with the certain aspects of the present invention. Film materials which have moisture vapor transmission rates generally compatible with human skin are most preferred.

S.C. Temin, Encyclopedia o Polymer Science and Engineering, Vol. 13, at 345-68 (1988), and Handbook of Pressure-Sensitive Adhesive Technology (Donates Satas ed., 1982) both provide a comprehensive overview of medical and other adhesives, and are incorporated herein by reference.

A PCT publication WO91/14462, published October 3, 1991, refers to medical devices comprised of a substrate with a particular moisture vapor transmission rate with an adhesive thereon which is tacky at skin temperature but less tacky or not tacky at room temperature. A similar medical adhesive device is disclosed in WO91/14461. The disclosure of both of these PCT publications is incorporated herein by reference to the extent they disclose such devices including particular backing layers, adhesives and methods of use and manufacture. It would be desirable to provide a wound healing device that positions an

RF conductor into at least a portion of a wound.

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a wound closure device that delivers energy to a wound.

Another object of the present invention is to provide a wound closure device that provides for the delivery of RF energy to a wound.

Yet another object of the present invention is to provide a wound closure device that includes an RF electrode. These and other objects of the invention are achieved in a wound healing - device. The device includes an energy delivery surface that is at least partially positionable in an interior of a wound. The energy delivery surface is coupled to a film which is positioned around the wound. Delivery of the energy to the wound results in a healing of the wound. BRTEF DESCRIPTION OF THE FIGURES FIG. 1 illustrates the wound closure device of the present invention. FIG. 2 illustrates the positioning of the wound closure device of FIG. 1 at a wound site.

DETAILED DESCRIPTION Referring now to FIGURE 1, a wound closure apparatus 100 of the present invention includes an energy delivery device 102 with an energy delivery surface 104 that is at least partially positionable in an interior of an incision or wound 106. Wound healing device also includes a bioabsorbable conductive mesh 108, a shrinkable film 110, a temperature monitoring and control device 112, and an energy source 114. Energy delivery device 102 may be an electrode. Energy source 114 may be a battery strip. Suitable sources of energy include RF, light, resistive heating, ultrasound, microwave, and other electromagnetic energy sources. In another embodiment the energy source 114 is not physically coupled to shrinkable film 110.

Wound closure apparatus 100 includes a conductive mesh 108 which may be made of a bio-absorbable conductive material. Conductive mesh 108 may be at least partially covered with bioactive substance, including but not limited to collagen glue, or other wound healing promotion materials, in combination with the application of energy. In one preferred embodiment, RF energy is used. In various embodiments, 1 to 3 watts of energy is delivered to wound 106 and tissue is heated to a temperature in the range of 40 to 42 degrees Celsius for 48 to 72 hours. Conductive mesh 108 is coupled to shrinkable film 110. Shrinkable film

110 maintains conductive mesh 108 at least partially in wound 106 and may also provide a force pulling the skin together to approximate the sides of wound 106 and thus promote healing.

In one embodiment, shrinkable film 110 may provide a tensile force and can be a uniaxially oriented rectangular film or an elastic film support member which can relax back to a predefined size (length and width). If the length to width ratio is small, a biaxially oriented film, such as a shrink wrap film, may be used, which is caused to relax to provide the desired force and inward tension across wound 106. In the case of a "circular" wound, a round biaxially oriented support is used. To create an inward tension, shrinkable film 110 is in a relaxed state and returns to its pre-oriented size and geometry. Because the oriented film "remembers" its initial state, a film that can shrink by a prescribed amount can be provided. This feature is a commonly specified property of shrink wrap tubing, where a 2:1, 2.5: 1, etc. shrink ratio is specified. For example, a 1 inch diameter shrink wrap tubing specified as a 2: 1 material will shrink to precisely 0.5 inches diameter after it is relaxed.

A method for relaxing the oriented film, tube, etc., is by the use of heat applied to the material. Suitable materials for shrinkable film 110 include polyethylene, such as Raychem CGPE-105, Cryolite D-940 (W.R. Grace), and polyvinyl chloride (PVC).

FIGURE 2 shows the actual placement of wound closure apparatus 100 across wound 106. Arrows depict the tension force 202 applied to wound 106 in terms of a closure mechanism. Low-powered resistive heating 204 speeds the healing process. In one embodiment, energy delivery devices 102 are coupled to shrinkable film 110. Energy delivery devices 102 are coupled to conductive mesh 108. Alternatively, energy delivery devices 102 are positioned in conductive mesh 108, which provides for the transfer of energy from energy delivery devices 102 through conductive mesh 108 to wound 106. In an alternative embodiment, energy delivery devices 102 can be individually positioned within conductive mesh 108 and then coupled to energy source 114. The coupling can be through film 110 but it is not necessary. There are various embodiments for the positioning of energy delivery devices 102.

The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art.

What is claimed is:

Claims

1. A wound closure apparatus for closing a wound and promoting healing of the wound, comprising: a conductive mesh configured to be at least partially inserted into the wound; an energy delivery device coupled to conductive mesh, the energy delivery device capable of delivering an energy through the conductive mesh and into the wound; and an energy source coupled to the energy delivery device.

2. The wound closure apparatus of claim 1, wherein the conductive mesh is bioabsorbable.

3. The wound closure apparatus of claim 1, wherein the conductive mesh is partially covered with a bioactive substance capable of promoting healing of the wound.

4. The wound closure apparatus of claim 3, wherein the bioactive substance is collagen glue.

5. The wound closure apparatus of claim 1, wherein the energy delivery device is an electrode.

6. The wound closure apparatus of claim 1, wherein the energy is RF energy.

7. The wound closure apparatus of claim 1, wherein the energy is light.

8. The wound closure apparatus of claim 1, wherein the energy is resistive heating.

9. The wound closure apparatus of claim 1, wherein the energy is microwave.

10. The wound closure apparatus of claim 1, wherein the energy is ultrasound.

11. The wound closure apparatus of claim 1, wherein the energy source includes a battery strip.

12. The wound closure apparatus of claim 1, further comprising: a shrinkable film coupled to the energy delivery device, the shrinkable film configured to be placed over a wound and capable of applying an inward tension force to the wound to close the wound.

13. The wound closure apparatus of claim 12, wherein the shrinkable film is made of polyethylene.

14. The wound closure apparatus of claim 12, wherein the shrinkable film is made of polyvinyl chloride.

15. The wound closure apparatus of claim 1, further comprising: a temperature monitoring device coupled to the energy delivery device.

16. The wound closure apparatus of claim 15, further comprising: a temperature control device coupled to the temperature monitoring device, the temperature control device capable of controlling the temperature of the energy delivery device.

17. A wound closure apparatus for closing a wound and promoting healing of the wound, comprising: a conductive mesh configured to be at least partially inserted into the wound; an energy delivery device coupled to conductive mesh, the energy delivery device capable of delivering an energy through the conductive mesh and into the wound; an energy source coupled to the energy delivery device, the energy source configured to deliver an energy of a suitable frequency and power to promote healing of the wound; and a shrinkable film coupled to the energy delivery device, the shrinkable film configured to be placed over a wound and capable of applying an inward tension force to the wound to close the wound.

18. The wound closure apparatus of claim 17, wherein the conductive mesh is bioabsorbable.

19. The wound closure apparatus of claim 17, wherein the conductive mesh is partially covered with a bioactive substance capable of promoting healing of the wound.

20. The wound closure apparatus of claim 19, wherein the bioactive substance is collagen glue.

21. The wound closure apparatus of claim 17, wherein the energy delivery device is an electrode.

22. The wound closure apparatus of claim 17, wherein the energy is RF energy.

23. The wound closure apparatus of claim 17, wherein the energy is light.

24. The wound closure apparatus of claim 17, wherein the energy is resistive heating.

25. The wound closure apparatus of claim 17, wherein the energy is microwave.

26. The wound closure apparatus of claim 17, wherein the energy is ultrasound.

27. The wound closure apparatus of claim 17, wherein the energy source includes a battery strip.

28. The wound closure apparatus of claim 17, wherein the shrinkable film is made of polyethylene.

29. The wound closure apparatus of claim 17, wherein the shrinkable film is made of polyvinyl chloride.

30. The wound closure apparatus of claim 17, further comprising: a temperature monitoring device coupled to the energy delivery device.

31. The wound closure apparatus of claim 30, further comprising: a temperature control device coupled to the temperature monitoring device, the temperature control device capable of controlling the temperature of the energy delivery device.