PHOTOINITIATED TISSUE FILLER

• US 20110002997A1
• Filed: 05/07/2010
• Published: 01/06/2011
• Est. Priority Date: 08/01/2007
• Status: Abandoned Application

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Lee, H. Janice, Elisseeff, Jennifer H., Hillel, Alexander
• Application Number:
  US12/776,313
• Publication Number:
  US 20110002997A1
• Time in Patent Office: Days
• US Class Current: 424/486
• CPC Class Codes: A61K 2800/81 Preparation or application process involves irradiation
• CPC Class Codes: A61K 2800/91 Injection
• CPC Class Codes: A61K 8/02 characterised by special physical form
• CPC Class Codes: A61K 8/8152 Homopolymers or copolymers of esters, e.g. (meth)acrylic acid esters; Compositions of derivatives of such polymers
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

Visible light-activated polymer cosmetic filler preparations useful in a variety of applications are provided. In some embodiments, the photo-activated polymer composition comprises a conventional polymeric material, such as HA, together with a modified, cross-linkable polymer, such as PEG or PEODA, to permit the formation of crosslinks within the polymer matrix in situ on exposure to a visible light source, such as an IPL device. The preparations provide for a more stabilized composition that is contourable during gelation.

Claims

1-36. -36. (canceled)

37. A method of repairing or augmenting soft tissue in a subject, the method comprising a. injecting into a subject in need thereof a composition comprising a biodegradable, polymerizable macromer, the macromer comprising a water soluble polymer modified with one or more biodegradable moieties;

and b. polymerizing the macromer to provide a hydrogel wherein the hydrogel to soft tissue have a normalized compliance ratio of from about 0.05 to about 3, thus repairing or augmenting the soft tissue.

38. The method of claim 37, wherein the compliance ratio is from about 0.1 to about 2.0 relative to the soft tissue.

39. The method of claim 38, wherein the compliance ratio is from about 0.1 to about 1.0 relative to the soft tissue.

40. The method of claim 37, wherein the macromer is polymerized by irradiating through the skin of the subject with visible light.

41. The method of claim 37, wherein the subject is irradiated with visible light for from about 10 seconds to about 120 seconds.

42. The method of claim 41, wherein the subject is irradiated with visible light for at least about 30 seconds.

43. The method of claim 42, wherein the subject is irradiated with visible light for at least about 40 seconds.

44. The method of claim 37, wherein the macromer is polymerized by irradiating the subject with blue-green light.

45. The method of claim 37, wherein the macromer is polymerized by irradiating the subject with thermal energy.

46. The method of claim 37, wherein the water soluble polymer is PEG.

47. The method of claim 46, wherein the PEG has a molecular weight of from about 10,000 to about 35,000 Daltons.

48. The method of claim 37, wherein the macromer is biodegradable.

49. The method of claim 37, wherein the macromer comprises a plurality of hydrolysable linkages.

50. The method of claim 49, wherein the hydrolyzable linkages are selected from the group consisting of esters or carbonates.

51. The method of claim 37, wherein the water soluble polymer is modified with an poly (L-lactide) and poly (trimethylene carbonate) and an acrylate endcap.

52. The method of claim 51, wherein the water soluble polymer is PEG.

53. The method of claim 37, wherein the composition further comprises a photo-initiator.

54. The method of claim 53, wherein the photoinitiator is a dye.

55. The method of claim 54, wherein the dye is eosin.

56. The method of claim 37, wherein the composition further comprises a rheology modifier.

57. The method of claim 56, wherein the rheology modifier is HA or CMC.

58. The method of claim 37, wherein the composition is substantially free of organic solvent.

59. The method of claim 37, wherein the hydrogel has a strain or elongation before fracture substantially similar to the expected strain during normal use of the soft tissue to which it augments or repairs.

60. The method of claim 37, wherein the hydrogel has a strain or elongation before fracture greater than the expected strain during normal use of the soft tissue to which it augments or repairs.

61. The method of claim 37, wherein the hydrogel has a reversible elongation at least about 150% as great as an expected strain of the soft tissue which is augments or repairs.

62. The method of claim 37, wherein the hydrogel has an elastic modulus which is less than about 150 kPa.

63. The method of claim 37, wherein the hydrogen has an ultimate yield stress of from about 500 to about 2,000 psi.

64. The method of claim 37, wherein the macromer is injected subdermally.

65. The method of claim 64, wherein the macromer is polymerized by irradiating least a part of the skin of the subject.

66. The method of claim 65, wherein the skin is irradiated for at least about 30 seconds.

67. The method of claim 66, wherein the macromer is injected intradermally.

68. The method of claim 67, wherein the macromer is polymerized by irradiating at least a part of the skin of the subject.

69. The method of claim 68, wherein the skin is irradiated for at least about 30 seconds.

70. The method of claim 37, further comprising shaping the macromer.

71. The method of claim 70, wherein the macromer is shaped during polymerization of the macromer.

72. The method of claim 71, wherein the macromer is polymerized by irradiating through the skin of the subject.

75. The method of claim 37, wherein the subject is a mammal.

76. The method of claim 75, wherein the subject is a human.

77. The method of claim 37, the method comprising repairing facial tissue.

78. The method of claim 77, the method comprising decreasing the appearance of at least one facial line, wrinkle, crease, or fold.

79. The method of claim 37, the method comprising augmenting breast, lip, cheek, chin, forehead, buttocks, hand, neck or earlobe tissue in a subject.

80. The method of claim 37, the method comprising decreasing the appearance of a dermal dimple.

81. The method of claim 80, wherein the dimple is a component of a scar.

82. The method of claim 37, wherein the composition is administered with a red tinted syringe.

83. The method of claim 37, wherein the soft tissue remains substantially augmented or repaired for at least about 1 month.

84. The method of claim 83, wherein the soft tissue remains substantially augmented or repaired for at least about 2 months.

85. The method of claim 84, wherein the soft tissue remains substantially augmented or repaired for at least about 6 months.

86. The method of claim 37, wherein the hydrogel elicits a mild fibrotic response in the subject.

87. The method of claim 37, wherein the composition comprises a two part system, and wherein the polymerization is initiated via a redox system.

88. The method of claim 87, wherein the polymerization occurs over a period of from about 30 seconds to about 2 minutes.

89. The method of claim 37, wherein the composition further comprises a drug such as an non-steroidal anti-inflammatory, an analgesic, a vitamin such as E, C, A, D or K, an anti-oxidant, an alpha hydroxyl acid such as lactic acid or a polymer capable of releasing such drug, vitamin, anti oxidant or alpha-hydroxyacid or any combination thereof.

90. A method of repairing or augmenting soft tissue in a subject, the method comprising a. injecting into a subject in need thereof a composition comprising a biodegradable, polymerizable macromer, the macromer comprising a water soluble polymer modified with one or more biodegradable moieties;

and b. polymerizing the macromer to provide a hydrogel, thus repairing or augmenting the soft tissue.