Skin treatment devices and methods with pre-stressed configurations

Patent metadata

Field	Value
Publication number	US-9248049-B2
Application number	US-201113089105-A
Country	US
Kind code	B2
Filing date	Apr 18, 2011
Priority date	May 29, 2003
Publication date	Feb 2, 2016
Grant date	Feb 2, 2016

Abstract

Devices, bandages, kits and methods are described that can control or regulate the mechanical environment of a wound to ameliorate scar and/or keloid formation. The mechanical environment of a wound includes stress, strain, and any combination of stress and strain. The control of a wound's mechanical environment can be active, passive, dynamic, or static. The devices are configured to be removably secured to a skin surface in proximity to the wound site and shield the wound from endogenous and/or exogenous stress.

First claim

What we claimed is:

1. A system for treating a patient, comprising:
a first structure comprising a first layer comprising a planar sheet having a relaxed configuration and a strained configuration, the strained configuration having a predetermined strain, and a second layer comprising an adhesive configured to removably adhere to an epidermal skin surface and to resist relaxation of the first layer from the strained configuration to the relaxed configuration; and
a second structure configured to releasably maintain the first structure in the strained configuration as the first structure is initially adhered to a skin surface and to permit stress transfer from the strained configuration of the first structure to the skin surface when the second structure is released.

2. The system of claim 1 , wherein the adhesive is a pressure sensitive adhesive.

3. The system of claim 2 , wherein the pressure sensitive adhesive is a silicone-based adhesive.

4. The system of claim 3 , wherein the adhesive has a T-peel release force test value greater than 125 kg/m.

5. The system of claim 4 , wherein the adhesive has a T-peel release force test value of at least 286 kg/m.

6. The system of claim 3 , wherein the adhesive has a blunt probe tack test value greater than 0.45 kg.

7. The system of claim 6 , wherein the adhesive has a blunt probe tack test value of at least 0.5 kg.

8. The system of claim 1 , wherein the second structure comprises a polymer sheet configured to be attached to the first structure.

9. The system of claim 8 , wherein the polymer sheet has a greater stiffness than the first structure.

10. The system of claim 1 , wherein the first structure and the second structure are integrally formed.

11. The system of claim 10 , wherein the second structure comprises a mesh or wire.

12. The system of claim 1 , wherein the first layer has a non-uniform thickness.

13. The system of claim 12 , wherein the first layer comprises at least one tapered edge.

14. The system of claim 1 , wherein the second structure comprises an attachment structure.

15. The system of claim 1 , wherein the first structure further comprises edges, and the second structure is further configured to be attached to the edges of the first structure.

16. The system of claim 1 , wherein the adhesive is polyacrylate-based or polyisobutylene-based.

17. The system of claim 1 , wherein the second layer is configured with a central adhesive-free region.

18. The system of claim 1 , wherein the first layer comprises at least one optically transparent section.

19. The system of claim 1 , wherein the first layer is a silicone layer.

20. The system of claim 1 , wherein the adhesive is configured to resist relaxation of the first layer from the strained configuration to the relaxed configuration for at least 3 days.

21. The system of claim 1 , wherein the strained configuration is a biaxially strained configuration.

22. The system of claim 1 , wherein the first layer has a durometer of at least 30.

23. The system of claim 1 , wherein the first layer has a durometer of at least 40.

24. The system of claim 1 , wherein the first layer has a durometer of at least 50.

25. The system of claim 1 , wherein the first layer has a thickness in a range of 100 microns to 500 microns.

26. The system of claim 1 , wherein the predetermined strain is at least a 20% strain relative to the relaxed configuration.

27. The system of claim 1 , wherein the predetermined strain is at least a 30% strain relative to the relaxed configuration.

28. The system of claim 1 , wherein the predetermined strain is at least a 20% strain relative to the relaxed configuration.

29. The system of claim 1 , wherein the adhesive is a contiguous adhesive layer.

30. The system of claim 1 , wherein the adhesive is an adhesive layer substantially covering the second layer.

31. The system of claim 1 , wherein the second structure is further configured to permit stress transfer from the strained configuration of the first structure to the skin surface at and external to the second layer, when the second layer is released.

32. A system for treating a patient, comprising:
a silicone layer having a durometer in a range of 30 to 50 and a thickness in a range of 100 microns to 500 microns, wherein the silicone layer has a relaxed configuration and a strained configuration, the strained configuration having a predetermined strain;
a polymeric backing layer attached to the silicone layer;
an adhesive layer attached to the silicone layer, the adhesive layer comprising a pressure sensitive adhesive configured to resist relaxation of the silicone layer for at least 24 hours, the pressure sensitive adhesive having a T-peel release force test value greater than 125 kg/m and a blunt probe tack test value greater than 0.45 kg; and
a mechanism configured to releasably maintain the silicone layer in its strained configuration.

33. The system of claim 32 , wherein the mechanism further comprises a polymeric sheet.

34. The system of claim 33 , wherein the polymeric sheet is configured to vary the strain in the silicone layer.

35. The system of claim 32 , wherein the T-peel release force test value of the pressure sensitive adhesive is at least 286 kg/m.

36. The system of claim 32 , wherein the blunt probe tack test value of the pressure sensitive adhesive is at least 0.5 kg.

37. The system of claim 32 , wherein the silicone layer comprises tapered edges.

38. The system of claim 32 , wherein the predetermined strain is at least a 20% strain relative to the relaxed configuration.

39. The system of claim 32 , wherein the predetermined strain is at least a 30% strain relative to the relaxed configuration.

40. The system of claim 32 , wherein the predetermined strain is at least a 40% strain relative to the relaxed configuration.

Assignees

• Gurtner Geoffrey C
• Dauskardt Reinhold H
• Longaker Michael T
• Yock Paul
• Univ Leland Stanford Junior

Inventors

• Gurtner Geoffrey C
• Dauskardt Reinhold H
• Longaker Michael T
• Yock Paul

Classifications

• G01N33/57557

  of other specific parts of the body, e.g. brain · CPC title

• G01N33/57535

  of the large intestine, e.g. colon, rectum or anus · CPC title

• C07K5/1008

  the side chain containing 0 or 1 carbon atoms, i.e. Gly, Ala · CPC title

• C07K5/06113

  Asp- or Asn-amino acid · CPC title

• C07K5/0806

  the side chain containing 0 or 1 carbon atoms, i.e. Gly, Ala · CPC title