WO2012092306A2

WO2012092306A2 - Device for preventing excessive skin tension

Info

Publication number: WO2012092306A2
Application number: PCT/US2011/067446
Authority: WO
Inventors: Avinoam Nevler
Original assignee: Mednet Gmbh; Klein, David
Priority date: 2010-12-29
Filing date: 2011-12-28
Publication date: 2012-07-05
Also published as: WO2012092306A3

Abstract

A medical device (10) including a first layer (12) including an adhesive layer (15) for application on a wound site, characterised by at least one contracting element (18) applied to the first layer (12) for contraction of the first layer (12) to limit tensile stress thereof.

Description

DEVICE FOR PREVENTING EXCESSIVE SKIN TENSION

FIELD OF THE INVENTION

The present invention relates generally for medical devices intended for treatment of scar formations caused by increased skin tension.

BACKGROUND OF THE INVENTION

Scarring is a natural occurring biological process in living tissues appearing in response to acute or chronic injury as part of the wound healing stages. Most tissues and organs display both scarring and regeneration as natural responses to injury. However, the balance between those two responses varies between the different tissues. Cutaneous injury usually results in scarring and collagen deposition, which undergoes remodeling over months and years and therefore may change in size and color.

Many different factors have been shown to affect the scarring process: infection and bacterial load, overall immunity, nutritional status, local blood supply, etc. One factor, about which numerous studies have been published, is skin tension. Increased skin tension at the time of suture, during initial healing and even in the weeks and months following injury, has been shown to be an important factor in abnormal cutaneous scarring.

In "Hypertrophic Scars and Keloids", Ketchum LD; Clinical Plastic Surgery, 1977 Apr ;4(2): 301-10, it is stated: "In preventing such lesions at the time of the surgery, in addition to the strict adherence to basic surgical principles, every effort should be taken to relieve the wound of tension".

In "A study relating wound tension to scar morphology in the pre-sternal scar using Langers technique", Meyer M et al; British Journal of Plastic Surgery, 1991 May- Jun;44(4):291-4, a connection was studied between wound tension and scar morphology. This study demonstrated that hypertrophic scarring occurred in high tension areas with multidirectional pull forces, but widened scarring occurred from increased uni-axial tension.

"Prevention of hypertrophic scars by long-term paper tape application", Reiffel RS; Journal of Plastic and Reconstructive Surgery, 1995 Dec;96(7): 1715-8 describes the method of preventing hypertrophic scars by long-term application of paper tape in order to reduce or eliminate stretching forces.

In "A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that transverse Langer' s skin tension lines", JA Atkinson et al; Journal of Plastic and Reconstructive Surgery, 2005 Nov;l 16(6)1648-56, results from a medium sized, controlled, randomized trial have shown that long-term application of paper tape has considerably decreased scar volume in relation of the control group.

In US Patent 7683234, there is described an elastic sheet device that purportedly shields the wound site from stress by applying a predetermined tensile stress.

Another widely accepted treatment, also used preventively, for hypertrophic scars is the application of silicone sheets (and other polymer sheets) on the scar site. This is discussed in "Efficacy of a polyurethane dressing versus a soft silicone sheet on hypertrophic scars", W Wigger-Albert et al; Journal of Wound Care, 2009; 18(5):208,210-4; and in "Evolution of silicone therapy mechanism of action in scar management", TA Mustoe; Journal of Aesthetic Plastic Surgery, 2008; 32:82-92. These sheets have been shown to reduce scar volume. (See also "Experience of silicone gel sheets for patients with keloid scars after median sternotomy", M Sakuraba et al; Journal of General Thoracic and Cardiovascular Surgery, 2010; 58:467-70.) These sheets are available as OTC (over the counter) therapeutics and require continuous contact with the wound site for a desired "flattened" result.

SUMMARY OF THE INVENTION

The present invention seeks to provide an improved medical device for preventing scar formation, as is described further in detail hereinbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:

Figs. 1A and IB are simplified top-view and side-view illustrations, respectively, of a medical device for preventing scar formation, in accordance with an embodiment of the present invention;

Fig. 2 is a simplified illustration of a medical device for preventing scar formation, in accordance with another embodiment of the present invention;

Fig. 3 is a simplified illustration of a medical device for preventing scar formation, in accordance with another embodiment of the present invention;

Fig. 4 is a simplified illustration of a medical device for preventing scar formation, in accordance with another embodiment of the present invention;

Fig. 5 is a simplified illustration of a medical device for preventing scar formation, in accordance with another embodiment of the present invention; and Fig. 6 is a simplified illustration of a medical device for preventing scar formation, in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Increased tensile forces on wound site have been shown to be a key factor in forming abnormal scarring. Such scar formation includes hypertrophic scars, keloids and widened scars. Long-term prevention of such forces, using paper or microporous tape, has also been shown to decrease scar size. The devices described herein are designed for preventing, decreasing or limiting the tensile forces affecting the cutaneous wound site, thereby improving scar morphology and appearance.

Reference is now made to Figs. 1A and IB, which illustrate a medical device 10 for preventing scar formation, in accordance with a non-limiting embodiment of the present invention. Device 10 includes a first layer 12 which is applied over the wound (and may overlap the wound from two or more sides). First layer 12 may be paper, microporous or other soft sheet, suitably shaped and sized for efficient application on wound sites. First layer 12 is provided with upper and lower adhesive surfaces 14 and 15, which may initially be covered with liners 16 and 17, respectively. One non-limiting example is 3M double coated tape 9832. First layer 12 does not have to be stretchable, but should be able to stay on the wound site for a prolonged time, such as a week.

Device 10 includes a second layer 18, which serves as a contracting element 18 for contraction of first layer 12. Second layer 18 serves as a security tape for limiting tensile stress. Second layer 18 has an adhesive surface 19, which may initially be covered with a liner 20. One non-limiting example is 3M MICROPORE TAPE 1530, which is a latex-free, hypoallergenic paper tape. The liners of the layers may be of any size and number (one or more).

The contraction mechanism is thus an outer adhesive tape connected to the device which is used after application of the first layer 12 on the wound site, thereby contracting the first layer 12 in the axis of its placement. The combination of the two layers 12 and 18 prevent the wound site from moving and thus does not allow increased skin tension, thereby preventing scar formation. Second layer 18 may be stretched over first layer 12; second layer 18 may be smaller than or the same size as or larger than first layer 12.

In the embodiment of Figs. 1A-1B, the contracting element 18 is on one side of device 10.

In the embodiment of Fig. 2, the contracting element 18 includes one or more adhesive strips, which may be on more than one side of device 10. It is seen that the adhesive surface 14 includes discrete regions of adhesive, but the invention is not limited to this.

In the embodiment of Fig. 3, the contracting element 18 is a fastener type strip, such as VELCRO.

In the embodiment of Fig. 4, the contracting element 18 is a ratchet type contraction, wherein ratchet edges fit into apertures 22 formed in first layer 12. Other mechanisms may be employed as well.

Reference is now made to Fig. 5. The device may be transparent or of colors similar to population skin tones and may have physical or chemical sunlight and UV blocking substances 24, impregnated or otherwise applied to or in the device, to protect the scar from excessive exposure to the sun. The device may include or may be applied on a silicone sheet placed in such a way as to allow silicone contact with the wound site and remote attachment to the skin and contraction of the device.

Reference is now made to Fig. 6. The dressing may be impregnated with chemicals or pharmaceuticals 26 for slow release of substances promoting wound healing.

It is appreciated that various features of the invention which are, for clarity, described in the contexts of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Claims

CLAIMS What is claimed is:

1. A medical device (10) comprising:

a first layer (12) comprising an adhesive layer (15) for application on a wound site;

characterised by at least one contracting element (18) applied to said first layer (12) for contraction of said first layer (12) to limit tensile stress thereof.

2. The medical device (10) according to claim 1, wherein said at least one contracting element (18) comprises an adhesive surface (19) for attachment to said first layer (12).

3. The medical device (10) according to claim 2, wherein said adhesive surface (19) is initially covered with a liner (20).

4. The medical device (10) according to claim 2, wherein said first layer (12) comprises upper and lower adhesive surfaces (14, 15), initially covered with liners (16, 17).

5. The medical device (10) according to claim 1, wherein said at least one contracting element (18) comprises a fastener type strip.

6. The medical device (10) according to claim 5, wherein said fastener type strip is VELCRO.

7. The medical device (10) according to claim 1, wherein said at least one contracting element (18) comprises a ratchet type contraction element that fits into apertures (22) formed in said first layer (12).

8. The medical device (10) according to claim 1, further comprising sunlight or UV blocking substances (24) impregnated or otherwise applied to or in said device (10).

9. The medical device (10) according to claim 1, further comprising chemicals or pharmaceuticals (26) for slow release of substances promoting wound healing.

10. The medical device (10) according to claim 1, wherein said device (10) is transparent.

11. The medical device (10) according to claim 1, wherein said device (10) is skin colored.