Skin treatment devices and methods with pre-stressed configurations

• US 9,248,049 B2
• Filed: 04/18/2011
• Issued: 02/02/2016
• Est. Priority Date: 05/29/2003
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Gurtner, Geoffrey C., Dauskardt, Reinhold H., Longaker, Michael T., Yock, Paul
• Primary Examiner(s): HAWTHORNE, OPHELIA ALTHEA
• Application Number:
  US13/089,105
• Publication Number:
  US 20120046586A1
• Time in Patent Office: 1,751 Days
• Field of Search: 602 41- 59, 606213-216, 606/201, 128888-889, 206/570, 424443-449, 523/105, 523/111, 523/122
• US Class Current: 1/1
• CPC Class Codes: A61F 13/00051 Accessories for dressings
• CPC Class Codes: A61F 13/00059 provided with visual effects, e.g. printed or colored
• CPC Class Codes: A61F 13/0233 characterised by the oclusive layer skin contacting layer
• CPC Class Codes: A61F 13/0243 characterised by the properties of the skin contacting layer, e.g. air-vapor permeability
• CPC Class Codes: A61F 2013/00123 with elastic indicator
• CPC Class Codes: A61F 2013/00127 fixation means
• CPC Class Codes: A61F 2013/00153 coloured or with decoration pattern or printing
• CPC Class Codes: A61F 2013/00182 with transparent part
• CPC Class Codes: A61F 2013/0028 applying of mechanical pressure; passive massage
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 47/64 Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent peptidic linkers A61K47/65
• CPC Class Codes: A61K 47/67 Enzyme prodrug therapy, e.g. gene directed enzyme drug therapy [GDEPT] or VDEPT
• CPC Class Codes: B82Y 5/00 Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
• CPC Class Codes: C07K 5/0606 the side chain containing heteroatoms not provided for by C07K5/06086 - C07K5/06139, e.g. Ser, Met, Cys, Thr
• CPC Class Codes: C07K 5/06113 Asp- or Asn-amino acid
• CPC Class Codes: C07K 5/0806 the side chain containing 0 or 1 carbon atoms, i.e. Gly, Ala
• CPC Class Codes: C07K 5/081 the side chain containing O or S as heteroatoms, e.g. Cys, Ser
• CPC Class Codes: C07K 5/1008 the side chain containing 0 or 1 carbon atoms, i.e. Gly, Ala
• CPC Class Codes: C07K 7/02 Linear peptides containing at least one abnormal peptide link
• CPC Class Codes: C07K 9/005 containing within the molecule the substructure with m, n > 0 and m+n > 0, A, B, D, E being heteroatoms; X being a bond or a chain, e.g. muramylpeptides
• CPC Class Codes: G01N 2333/95 : Proteinases, i.e. endopeptidases (3.4.21-3.4.99)
• CPC Class Codes: G01N 2500/00 : Screening for compounds of potential therapeutic value
• CPC Class Codes: G01N 33/57407 : Specifically defined cancers
• CPC Class Codes: G01N 33/57419 : of colon

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.

Claims

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.