SKIN TREATMENT DEVICES AND METHODS WITH PRE-STRESSED CONFIGURATIONS

• US 20120046586A1
• Filed: 04/18/2011
• Published: 02/23/2012
• 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
• Granted Patent: US 9,248,049 B2
• Time in Patent Office: Days
• US Class Current: 602/42
• 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 silicone layer having a durometer in the range of about 30 to about 50 and a thickness in the range of about 100 microns to about 500 microns, wherein the silicone layer has a relaxed configuration and a strained configuration, the strained configuration having at least about a 40% strain relative to the relaxed configuration;

a polymeric backing layer attached to the silicone layer;

an adhesive layer attached to the silicone layer, the adhesive layer comprising a silicone pressure sensitive adhesive configured to resist silicone relaxation of the silicone sheet for at least 24 hours, the silicone pressure sensitive adhesive having a T-peel release force test value greater than about 125 kg/m and a blunt probe tack test value greater than about 0.45 kg; and

a clamp mechanism configured to releasably maintain the silicone layer in its strained configuration.

2. The system of claim 1, wherein the clamp mechanism further comprises a polymeric sheet.

3. The system of claim 2, wherein the polymeric sheet is configured to vary the strain in the silicone layer.

4. The system of claim 1, wherein the T-peel release force test value of the silicone pressure sensitive adhesive is at least about 286 kg/m.

5. The system of claim 1, wherein the blunt probe tack test value of the silicone pressure sensitive adhesive is at least about 0.5 kg.

6. The system of claim 1, wherein the silicone layer comprises tapered edges.

7. A system for treating a patient, comprising:

a first structure comprising a first layer having a relaxed configuration and a strained configuration, the strained configuration having a strain that is at least 40% relative to the relaxed configuration, and a second layer comprising an adhesive configured to resist relaxation of the first layer from the strained configuration to the relaxed configuration for at least 24 hours; and

a second structure configured to releasably maintain the first in the strained configuration.

8. The system of claim 7, wherein the second structure comprises an attachment structure.

9. The system of claim 7, wherein the second structure is further configured to affix the first structure to a skin surface while the first structure is in the strained configuration.

10. The system of claim 7, wherein the attachment structure is further configured to be attached to the edges of the first structure.

11. The system of claim 7, wherein the second structure comprises a polymer sheet configured to be attached to the first structure.

12. The system of claim 11, wherein the polymer sheet has a greater stiffness than the first structure.

13. The system of claim 7, wherein the adhesive is polyacrylate-based or polyisobutylene-based.

14. The system of claim 7, wherein the adhesive is a pressure sensitive adhesive.

15. The system of claim 14, wherein the pressure sensitive adhesive is a silicone-based adhesive.

16. The system of claim 15, wherein the adhesive has a T-peel release force test value greater than about 125 kg/m.

17. The system of claim 16, wherein the adhesive has a T-peel release force test value of at least about 286 kg/m.

18. The system of claim 15, wherein the adhesive has a blunt probe tack test value greater than about 0.45 kg.

19. The system of claim 18, wherein the adhesive has a blunt probe tack test value of at least about 0.5 kg.

20. The system of claim 7, wherein the second layer is configured with a central adhesive-free region.

21. The system of claim 7, wherein the first layer comprises at least one optically transparent section.

22. The system of claim 7, wherein the first layer is a silicone layer.

23. The system of claim 7, wherein the first layer has a non-uniform thickness.

24. The system of claim 23, wherein the first layer comprises at least one tapered edge.

25. The system of claim 7, 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.

26. The system of claim 7, wherein the strained configuration is a biaxially strained configuration.

27. The system of claim 7, wherein the first layer has a durometer of at least about 30.

28. The system of claim 7, wherein the first layer has a durometer of at least about 40.

29. The system of claim 7, wherein the first layer has a durometer of at least about 50.

30. The system of claim 7, wherein the first layer has a thickness in the range of about 100 microns to about 500 microns.

31. The system of claim 7, wherein the first structure and the second structure are integrally formed.

32. The system of claim 31, wherein the second structure comprises a mesh or wire.