Skin treatment devices and methods with pre-stressed configurations

• US 9,248,051 B2
• Filed: 03/07/2013
• 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 Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: Gurtner, Geoffrey C., Dauskardt, Reinhold H., Longaker, Michael T., Yock, Paul
• Primary Examiner(s): HAWTHORNE, OPHELIA ALTHEA
• Application Number:
  US13/789,237
• Publication Number:
  US 20130184629A1
• Time in Patent Office: 1,062 Days
• Field of Search: 602 41- 59, 606213-216, 606/201, 128888-889, 206/570, 424443-449, 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 to ameliorate the formation of scars, comprising:

a polymeric layer and an adhesive thereon, wherein the adhesive is configured to removably adhere the polymeric layer to an epidermal skin surface, wherein the polymeric layer is configured to have a stressed configuration and a relaxed configuration;

wherein the polymeric layer is strained to a predetermined strain level in the stressed configuration, and

a release structure configured to maintain the predetermined strain of the stressed configuration in the polymeric layer prior to securing the polymeric layer to an epidermal skin surface and configured to be manipulated to release strain from the polymeric layer.

2. The system of claim 1, wherein the adhesive is selected to reduce adhesive creep properties when applied to a skin surface.

3. The system of claim 2, wherein the adhesive has a T-peel release force test value greater than about 125 kg/m.

4. The system of claim 2, wherein the adhesive has a blunt probe tack test value of greater than about 0.45 kg.

5. The system of claim 1, wherein the release structure further comprises a sheet structure and an attachment structure configured to couple the polymeric layer.

6. The system of claim 5, wherein the sheet structure is stiffer than the polymeric layer.

7. The system of claim 1, further comprising an active agent.

8. The system of claim 7, wherein the active agent is selected from the group consisting of a pharmaceutical compound, protein, vitamin and combinations thereof.

9. The system of claim 1, wherein the polymeric layer comprises a sheet.

10. The system of claim 1, wherein the polymeric layer comprises an elastomer.

11. The system of claim 1, wherein the release structure comprises a spring element.

12. The system of claim 1, wherein the release structure comprises an extending element.

13. The system of claim 1, wherein the release structure is further configured to create the strain of the stressed configuration.

14. The system of claim 1, wherein the polymeric layer comprises at least one aperture.

15. The system of claim 1, wherein the polymeric layer comprises an occlusive polymeric layer.

16. The system of claim 1, wherein the polymeric layer has a shape selected from the group consisting of a rectangle, circle, trapezoid, toroid, oval, and segments and combinations thereof.

17. The system of claim 1, wherein the polymeric layer comprises a laminate layer or multiple layers.

18. The system of claim 1, further comprising a temperature mechanism, comprising an electrical mechanism or exothermic chemical reaction mechanism.

19. The system of claim 1, wherein the polymeric layer has a width and a length that are each greater in the stressed configuration than in the relaxed configuration.

20. The system of claim 1, wherein the polymeric layer is thermally activated.

21. A system to ameliorate the formation of a scar or keloid at a wound site, wherein the system comprises:

a prestrained bandage device configured to be removably secured to a skin surface, wherein the bandage device comprises a planar sheet comprising a first layer having a first tensile stressed configuration and a second relaxed configuration, and a second layer disposed on the first layer comprising an adhesive configured to resist relaxation of the first layer from the first tensile stressed configuration to the second relaxed configuration for about 20 minutes; and

a release structure configured to releasably maintain the first layer in the first tensile stressed configuration;

wherein the first tensile stressed configuration has a predetermined amount of pre-strain.

22. The system of claim 21, further comprising a mechanical strain inducing element configured to induce a strain in the first layer.

23. The system of claim 22, wherein the mechanical strain inducing element comprises a spring.

24. The system of claim 22, wherein the mechanical strain inducing element comprises an extending element.

25. The system of claim 22, wherein the mechanical strain inducing element comprises a piezo-electric element.

26. The system of claim 22, wherein the release structure comprises a mechanical release structure.

27. The system of claim 21, further comprising an active agent.

28. The system of claim 27, wherein the active agent is selected from the group consisting of a pharmaceutical compound, protein, vitamin and combinations thereof.

29. The system of claim 21, wherein the first layer comprises at least one aperture.

30. The system of claim 21, wherein at least a portion of the prestrained bandage device is porous.

31. The system of claim 21, wherein the first layer comprises an occlusive polymeric layer.

32. The system of claim 21, wherein the first layer has a shape selected from the group consisting of a rectangle, circle, trapezoid, toroid, oval, and segments and combinations thereof.

33. The system of claim 21, wherein the first layer comprises multiple layers joined together.

34. The system of claim 21, further comprising a temperature mechanism, comprising an electrical mechanism or exothermic chemical reaction mechanism.

35. The system of claim 21, wherein the first layer has a width and a length that are each greater in the stressed configuration than in the relaxed configuration.

36. The system of claim 21, wherein the first layer is thermally activated.