Devices and bandages for the treatment or prevention of scars and/or keloids and methods and kits therefor

• US 20080033334A1
• Filed: 08/03/2007
• Published: 02/07/2008
• Est. Priority Date: 08/03/2006
• 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: Longaker, Michael, Dauskardt, Reinhold, Gurtner, Geoffrey, Yock, Paul
• Granted Patent: US 7,683,234 B2
• Time in Patent Office: Days
• US Class Current: 602/50
• 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: A61L 15/42 Use of materials characterised by their function or physical properties liquid bandages A61L26/00
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/428 Vitamins, e.g. tocopherol, riboflavin
• 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 device for ameliorating the formation of scars or keloids at a wound site, wherein the device is configured to be removably secured to a skin surface in proximity to the wound site and shield the wound from endogenous or exogenous stress.

2. The device of claim 1 wherein the device is configured to shield the wound from endogenous and exogenous stress.

3. The device of claim 1 wherein the device comprises a polymer.

4. The device of claim 3 wherein the device comprises a silicone polymer or a shape memory polymer.

5. The device of claim 4 comprising a shape memory polymer selected from the group consisting of acrylate-based, styrene-based and epoxy-based shape memory polymers.

6. The device of claim 1 wherein the device is configured to be removably secured to a skin surface with an adhesive material.

7. The device of claim 6 wherein the adhesive material is selected from the group consisting of polyacrylate-based, polyisobutylene-based, and silicone-based pressure sensitive adhesives.

8. The device of claim 1 wherein the device is configured to be removably secured to a skin surface with a skin piercing device.

9. The device of claim 8 wherein the skin piercing device comprises at least one microneedle.

10. The device of claim 1 wherein the device has a shape selected from the group consisting of a rectangle, circle, square, trapezoid, toroid, oval, and segments and combinations thereof.

11. The device of claim 10 wherein the device has the shape of a circle.

12. The device of claim 10 wherein the device has the shape of a toroid.

13. The device of claim 10 wherein the device has a shape of a rectangle.

14. The device of claim 1 wherein at least a portion of the device is made from a transparent material.

15. The device of claim 1 comprising at least one aperture.

16. The device of claim 1 wherein at least a portion of the device is porous.

17. The device of claim 1 wherein the device is configured to actively shield the wound from endogenous stress.

18. The device of claim 1 wherein the device is configured to actively shield the wound from exogenous stress.

19. The device of claim 1 wherein the device is configured to passively shield the wound from endogenous stress.

20. The device of claim 1 wherein the device is configured to passively shield the wound from exogenous stress.

21. The device of claim 1 wherein the device is configured to shield the wound from endogenous stress in a dynamic fashion.

22. The device of claim 1 wherein the device is configured to shield the wound from exogenous stress in a dynamic fashion.

23. The device of claim 1 wherein the device is configured to shield the wound from endogenous stress in a static fashion.

24. The device of claim 1 wherein the device is configured to shield the wound from exogenous stress in a static fashion.

25. The device of claim 1 further comprising an active agent.

26. The device of claim 25 wherein the active agent is selected from the group consisting of a pharmaceutical compound, protein, vitamin and combinations thereof.

27. The device of claim 1 further comprising a mechanism for altering the temperature at the skin surface.

28. The device of claim 27 wherein the mechanism is electrical.

29. The device of claim 27 wherein the mechanism is chemical.

30. The device of claim 27 wherein the mechanism is mechanical.

31. The device of claim 1 wherein the device is occlusive.

32. The device of claim 1 further comprising a mechanism to induce a color change in at least a portion of the device.

33. The device of claim 32 wherein the color change corresponds to a change in device stiffness.

34. The device of claim 32 wherein the color change corresponds to a change in device efficacy.

35. A bandage to ameliorate the formation of a scar or keloid at a wound site, wherein the bandage is configured to be removably secured to a skin surface and wherein the bandage has a first tensile stressed configuration and a second relaxed configuration.

36. The bandage of claim 35 wherein the bandage comprises a polymer.

37. The bandage of claim 36 wherein the polymer comprises a silicone polymer or a shape memory polymer.

38. The bandage of claim 37 wherein the device comprises a shape memory polymer selected from the group consisting of acrylate-based shape memory polymers, styrene-based shape memory polymers, and epoxy-based shape memory polymers.

39. The bandage of claim 35 wherein the first tensile stressed configuration is mechanically induced.

40. The bandage of claim 39 wherein a spring element induces the first tensile stressed configuration.

41. The bandage of claim 35 wherein the first tensile stressed configuration is at least partially induced by a piezoelectric element.

42. The bandage of claim 35 wherein the first tensile stressed configuration is at least partially induced electrostatically.

43. The bandage of claim 35 wherein the bandage is configured to be removably secured to a skin surface with an adhesive material.

44. The bandage of claim 43 wherein the adhesive material is selected from the group consisting of polyacrylate-based, polyisobutylene-based, and silicone-based pressure sensitive adhesives.

45. The bandage of claim 35 wherein the bandage has a shape selected from the group consisting of a rectangle, circle, square, trapezoid, toroid, oval, and segments and combinations thereof.

46. The bandage of claim 45 wherein the bandage has the shape of a circle.

47. The bandage of claim 45 wherein the bandage has the shape of a toroid.

48. The bandage of claim 45 wherein the bandage has the shape of a rectangle.

49. The bandage of claim 35 wherein at least a portion of the bandage is made from a transparent material.

50. The bandage of claim 35 further comprising an active agent.

51. The bandage of claim 50 wherein the active agent is selected from the group consisting of a pharmaceutical compound, protein, vitamin, and combinations thereof.

52. The bandage of claim 35 further comprising a mechanism for altering the temperature at the skin surface.

53. The bandage of claim 52 wherein the mechanism is electrical.

54. The bandage of claim 52 wherein the mechanism is chemical.

55. The bandage of claim 52 wherein the mechanism is mechanical.

56. The bandage of claim 35 wherein the bandage is occlusive.

57. The bandage of claim 35 further comprising a mechanism to induce a color change in at least a portion of the bandage.

58. The bandage of claim 57 wherein the color change corresponds to a change in bandage stiffness.

59. The bandage of claim 57 wherein the color change corresponds to a change in bandage efficacy.

60. The bandage of claim 35 wherein the first configuration is tensile stressed by about 10% relative to its relaxed configuration.

61. The bandage of claim 35 wherein the first configuration is tensile stressed by about 20% relative to its relaxed configuration.

62. The bandage of claim 35 wherein the first configuration is tensile stressed by about 30% relative to its relaxed configuration.

63. The bandage of claim 35 wherein the first configuration is tensile stressed by about 40% relative to its relaxed configuration.

64. The bandage of claim 35 wherein the first configuration is tensile stressed by about 50% relative to its relaxed configuration.

65. The bandage of claim 35 wherein the first configuration is tensile stressed by about 70% relative to its relaxed configuration.

66. The bandage of claim 35 wherein the first configuration is tensile stressed by about 80% relative to its relaxed configuration.

67. The bandage of claim 35 wherein the first configuration is tensile stressed by about 100% relative to its relaxed configuration.

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

at least first, second and third configurations and is configured to be removably secured to a skin surface while in the second configuration and is capable of being activated while in the second configuration to adopt the third configuration, wherein the second configuration is strained relative to the first configuration.

69. The bandage of claim 68 wherein the second configuration is thermally activated to adopt the third configuration.

70. The bandage of claim 69, wherein the third configuration is substantially the same as the first configuration.

71. The bandage of claim 69 wherein the third configuration differs from the second configuration in at least one direction.

72. The bandage of claim 69 wherein the third configuration differs from the second configuration in at least two directions.

73. The bandage of claim 69 wherein the third configuration is at least partially determined by constraint placed on the bandage.

74. The bandage of claim 73 wherein the constraint is affected by skin compliance.

75. The bandage of claim 69 wherein the bandage comprises a polymer.

76. The bandage of claim 75 wherein the bandage comprises a silicone polymer or a shape memory polymer.

77. The bandage of claim 76 wherein the bandage comprises a shape memory polymer selected from the group consisting of acrylate-based shape memory polymers, styrene-based shape memory polymers, and epoxy-based shape memory polymers.

78. The bandage of claim 69 wherein the second configuration is configured to be removably secured to the skin surface with an adhesive material.

79. The bandage of claim 78 wherein the adhesive material is selected from the group consisting of polyacrylate-based, polyisobutylene-based, and silicone-based pressure sensitive adhesives.

80. The bandage of claim 69 wherein the bandage has a shape selected from the group consisting of a rectangle, circle, trapezoid, toroid, oval, and segments and combinations thereof.

81. The bandage of claim 69 wherein at least a portion of the bandage is made from a transparent material.

82. The bandage of claim 69 further comprising an active agent.

83. The bandage of claim 82 wherein the active agent is selected from the group consisting of a pharmaceutical compound, protein, vitamin and combinations thereof.

84. The bandage of claim 69 further comprising a mechanism for altering the temperature at the skin surface.

85. The bandage of claim 84 wherein the mechanism is electrical.

86. The bandage of claim 84 wherein the mechanism is chemical.

87. The bandage of claim 84 wherein the mechanism is mechanical.

88. The bandage of claim 69 further comprising a mechanism to induce a color change in at least a portion of the bandage.

89. The bandage of claim 88 wherein the color change corresponds to a change in bandage stiffness.

90. The bandage of claim 88 wherein the color change corresponds to a change in bandage efficacy.

91. The bandage of claim 69 wherein the second configuration is strained by about 5% relative to the first configuration.

92. The bandage of claim 69 wherein the second configuration is strained by about 10% relative to the first configuration.

93. The bandage of claim 69 wherein the second configuration is strained by about 20% relative to the first configuration.

94. The bandage of claim 69 wherein the second configuration is strained by about 30% relative to the first configuration.

95. The bandage of claim 69 wherein the second configuration is strained by about 40% relative to the first configuration.

96. The bandage of claim 69 wherein the second configuration is strained by about 50% relative to the first configuration.

97. The bandage of claim 69 wherein the second configuration is strained by about 70% relative to the first configuration.

98. The bandage of claim 69 wherein the second configuration is strained by about 100% relative to the first configuration.

99. The bandage of claim 71 wherein the third configuration differs from the first configuration by less than about 10% in at least one direction.

100. The bandage of claim 72 wherein the third configuration differs from the first configuration by less than about 10% in at least two directions.

101. A kit for ameliorating the formation of scars or keloids comprising in packaged combination:

at least two devices, wherein each device is configured to be removably secured to a skin surface in proximity to a wound site and shield the wound from endogenous or exogenous stress.

102. The kit of claim 101 wherein each device is configured to shield the wound from endogenous and exogenous stress.

103. The kit of claim 101 wherein the at least two devices are of a different color.

104. The kit of claim 101 wherein the at least two devices are of a different shape.

105. The kit of claim 101 wherein the shapes are independently selected from the group consisting of a rectangle, circle, square, trapezoid, toroid, oval, and segments and combinations thereof.

106. The kit of claim 101 wherein the at least two devices are of a different size.

107. The kit of claim 101 wherein the at least two devices are of a different thickness.

108. The kit of claim 101 wherein the at least two devices are configured to shield the wound from endogenous stress by different amounts.

109. The kit of claim 101 wherein the at least two devices are configured to shield the wound from exogenous stress by different amounts.

110. The kit of claim 101 further comprising instructions on how to use the kit.

111. The kit of claim 101 further comprising a heat gun.

112. The kit of claim 101 further comprising at least one wound dressing.

113. The kit of claim 101 further comprising at least one wound cleanser.

114. A method for ameliorating the formation of scars or keloids comprising:

applying to skin, in the proximity of a wound, a device configured to shield the wound from endogenous or exogenous stress.

115. The method of claim 114 wherein the device is configured to shield the wound from endogenous and exogenous stress.

116. The method of claim 114 wherein the application of the device occurs during the proliferative phase of wound healing.

117. The method of claim 114 wherein application of the device lasts for a period of at least about 10 days.

118. The method of claim 114 wherein application of the device lasts for a period of at least about 20 days.

119. The method of claim 114 wherein application of the device lasts for a period of at least about 30 days.

120. The method of claim 114 wherein application of the device lasts for a period of at least about 40 days.

121. The method of claim 114 wherein application of the device lasts for a period of at least about 50 days.

122. The method of claim 114 wherein application of the device lasts for a period of at least about 60 days.

123. The method of claim 114 wherein application of the device lasts for a period of at least about 70 days.

124. The method of claim 114 wherein application of the device lasts for a period of at least about 80 days.

125. The method of claim 114 wherein application of the device lasts for a period of at least about 90 days.

126. The method of claim 114 wherein application of the device lasts for a period of at least about 100 days.

127. The method of claim 114 further comprising removing the device after a period of time.

128. The method of claim 127 wherein the period of time is predetermined.

129. The method of claim 114 further comprising applying to skin in the proximity of the wound a second device, wherein the second device is configured to shield the wound from endogenous or exogenous stress.

130. The method of claim 129 wherein the second device is configured to shield the wound from endogenous and exogenous stress.

131. The method of claim 114 further comprising applying to skin in the proximity of the wound a second device, wherein the second device is configured to be removably secured to a skin surface and reduce wound stress in at least one direction.