Liquid perfluoropolymers and medical applications incorporating same

• US 20050142315A1
• Filed: 12/22/2004
• Published: 06/30/2005
• Est. Priority Date: 12/24/2003
• Status: Abandoned Application

• Current Assignee: Liquidia Technologies, Inc. (Liquidia Corp.)
• Original Assignee: Liquidia Technologies, Inc. (Liquidia Corp.)
• Inventors: Williams, Michael S., DeSimone, Joseph M.
• Application Number:
  US11/020,779
• Publication Number:
  US 20050142315A1
• Time in Patent Office: Days
• US Class Current: 428/36.900
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: C08L 101/04 containing halogen atoms
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/31544 Addition polymer is perhalogenated

Abstract

Liquid curable perfluoropolyether (PFPE) materials are provided for use as coatings, sealants, flexible fillers, and structural parts for a wide variety of medical applications, particularly where silicone has been utilized conventionally. The PFPE material is oxygen permeable and bacterial impermeable and may contain one or more pharmacological agents elutably trapped therewithin for delivery within the body of a subject.

Claims

1. A method of repairing damage to a skeletal portion of the body of a subject in situ, comprising:

positioning an enclosure adjacent the damaged skeletal portion of a subject;

injecting a liquid PFPE material into the enclosure; and

curing the liquid PFPE material to form a structure that provides support to the skeletal portion of the subject.

2. The method of claim 1, wherein the liquid PFPE material cures to a rigid state.

3. The method of claim 1, wherein the liquid PFPE material cures to a flexible state.

4. The method of claim 1, wherein the damage is a crack in a bone, wherein the enclosure is positioned within the crack, and wherein the liquid PFPE material, upon curing, seals the crack and provides structural support to the bone.

5. The method of claim 1, wherein the skeletal portion is a vertebral body having a nuclear space, wherein the enclosure is positioned within the nuclear space, and wherein the liquid PFPE material, upon curing, provides structural support and restores normal vertebral function to the vertebral body.

6. The method of claim 1, wherein the skeletal portion is a joint, and wherein the liquid PFPE material, upon curing, provides an improved, durable wear surface for the joint.

7. The method of claim 1, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

8. The method of claim 1, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

9. The method of claim 1, wherein the liquid PFPE material comprises curing initiators.

10. The method of claim 1, wherein the PFPE material comprises one or more pharmacological agents elutably trapped therein.

11. The method of claim 1, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

12. The method of claim 1, wherein the liquid PFPE material comprises low viscosity PFPE precursor material.

13. A method of repairing damage to a joint in the body of a subject, comprising:

removing unwanted material from the joint;

positioning an enclosure at the location of the removed material;

injecting a liquid PFPE material into the enclosure; and

curing the liquid PFPE material, wherein the cured PFPE material serves as replacement material for removed original joint material.

14. The method of claim 13, wherein the joint is selected from the group consisting of hips, knees, ankles, phalange joints, elbows, and wrists.

15. The method of claim 13, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

16. The method of claim 13, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

17. The method of claim 13, wherein the liquid PFPE material comprises curing initiators.

18. The method of claim 13, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

19. The method of claim 13, wherein the liquid PFPE material comprises low viscosity PFPE precursor material.

20. An orthopedic apparatus configured to be implanted within the body of a subject, wherein the apparatus comprises an outer surface of oxygen permeable, bacterial impermeable PFPE material.

21. An orthopedic apparatus configured to be implanted within the body of a subject, wherein the apparatus comprises layers of uniaxially and biaxially oriented materials.

22. A method of repairing in situ a prosthetics device deployed in the body of a subject, comprising:

removing material from the prosthetics device;

positioning an enclosure at the location of the removed material;

injecting a liquid PFPE material into the enclosure; and

curing the liquid PFPE material, wherein the cured PFPE material serves as a replacement for or repair of prosthetics device material.

23. The method of claim 22, wherein the material removed from the prosthetics device comprises a surface layer of material.

24. The method of claim 22, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

25. The method of claim 22, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

26. The method of claim 22, wherein the liquid PFPE material comprises low viscosity PFPE precursor material.

27. The method of claim 22, wherein the PFPE material comprises one or more pharmacological agents elutably trapped therein.

28. A bandage configured to be applied to the body of a subject, wherein the bandage comprises oxygen permeable, bacterial impermeable PFPE material.

29. The bandage of claim 28, wherein the PFPE material comprises one or more pharmacological agents elutably trapped therein.

30. A method of applying a bandage to a portion of a body of a subject, comprising:

applying an oxygen permeable, bacterial impermeable liquid PFPE material onto a portion of the body of a subject; and

curing the liquid PFPE material such that the PFPE material forms a protective bandage that facilitates healing of underlying tissue.

31. The method of claim 30, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

32. The method of claim 30, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

33. The method of claim 30, wherein the liquid PFPE material comprises curing initiators.

34. The method of claim 30, wherein applying the liquid PFPE material comprises spraying the liquid PFPE material onto the body of the subject.

35. The method of claim 30, wherein the PFPE material comprises one or more pharmacological agents elutably trapped therein.

36. A surgical suture, comprising oxygen permeable, bacterial impermeable PFPE material, wherein the suture is configured to join tissue.

37. An artificial blood vessel for a subject, comprising oxygen permeable, bacterial impermeable PFPE material.

38. The artificial blood vessel of claim 37, wherein the PFPE material comprises one or more pharmacological agents elutably trapped therein.

39. A method of replacing in situ a portion of a blood vessel within the body of a subject, comprising:

injecting an oxygen permeable, bacterial impermeable liquid PFPE material into a lumen of a portion of an existing blood vessel to form an artificial blood vessel, wherein the existing blood vessel serves as a mold; and

curing the liquid PFPE material to produce a replacement for the blood vessel portion.

40. The method of claim 39, further comprising removing the blood vessel portion.

41. The method of claim 39, wherein the lumen of the existing blood vessel portion is occluded or partially occluded, and wherein the occlusion is removed prior to injecting the oxygen permeable, bacterial impermeable liquid PFPE material into the existing blood vessel lumen.

42. The method of claim 39, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

43. The method of claim 39, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

44. The method of claim 39., wherein the liquid PFPE material comprises curing initiators.

45. The method of claim 39, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

46. The method of claim 39, wherein the liquid PFPE material comprises low viscosity PFPE precursor material.

47. An intraluminal prosthesis having a tubular body portion comprising oxygen permeable, bacterial impermeable PFPE material.

48. The intraluminal prosthesis of claim 47, further comprising a pharmacological agent elutably trapped within the PFPE material, and wherein the PFPE material is configured to allow the pharmacological agent to elute therefrom when the intraluminal prosthesis is deployed within a body of a subject.

49. The intraluminal prosthesis of claim 48, wherein the PFPE material is configured to allow the pharmacological agent to elute at a predetermined rate.

50. The intraluminal prosthesis of claim 47, wherein a plurality of pharmacological agents are elutably trapped within the PFPE material.

51. The intraluminal prosthesis of claim 50, wherein the plurality of pharmacological agents are homogeneously distributed on the tubular body portion.

52. The intraluminal prosthesis of claim 50, wherein the plurality of pharmacological agents are heterogeneously distributed on the tubular body portion.

53. The intraluminal prosthesis of claim 47, wherein the tubular body portion comprises a first end, a second end, and a flow passage defined therethrough from the first end to the second end, wherein the body portion is sized for intraluminal placement within a subject passage, and wherein the body portion is expandable from a first, reduced cross-sectional dimension to a second enlarged cross-sectional dimension so that the body portion can be transported intraluminally to a targeted portion of a passage and then expanded to the second enlarged cross-sectional dimension so as to engage and support the targeted portion of the passage.

54. The intraluminal prosthesis of claim 47, wherein the intraluminal prosthesis comprises a stent.

55. The intraluminal prosthesis of claim 54, wherein the stent comprises erodible material.

56. A medical apparatus having a body portion, wherein the body portion comprises PFPE material.

57. The medical apparatus of claim 56, wherein the PFPE material is coated on one or more selected portions of the body portion.

58. The medical apparatus of claim 56, wherein the medical apparatus is selected from the group consisting of:

adaptors, applicators, aspirators, bandages, bands, blades, brushes, burrs, cables and cords, calipers, carvers, cases and containers, catheters, chisels, clamps, clips, condoms, connectors, cups, curettes, cutters, defibrillators, depressors, dilators, dissectors, dividers, drills, elevators, excavators, explorers, fasteners, files, fillers, forceps, gauges, gloves, gouges, handles, holders, knives, loops, mallets, markers, mirrors, needles, nippers, pacemakers, patches, picks, pins, plates, pliers, pluggers, probes, punches, pushers, racks, reamers, retainers, retractors, rings, rods, saws, scalpels, scissors, scrapers, screws, separators, spatulas, spoons, spreaders, stents, syringes, tapes, trays, tubes and tubing, tweezers, and wires.

59. The medical apparatus of claim 56, wherein the medical apparatus is an implantable apparatus.

60. A method of making a medical apparatus having a body portion, comprising:

applying a liquid PFPE material to one or more portions of the body portion; and

curing the liquid PFPE material to form a coating of PFPE material on the body portion.

61. The method of claim 60, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

62. The method of claim 60, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

63. An implantable electronic device, comprising:

a housing containing one or more electronic components therein; and

a PFPE material forming a hermetic seal around the housing that deters the ingress of moisture into the housing when the electronics device is implanted within the body of a subject.

64. A method of forming a polymeric coating on an interior surface of a hollow organ or tissue lumen, comprising:

applying an oxygen permeable, bacterial impermeable liquid PFPE material to an interior surface of a hollow organ or tissue lumen to be coated; and

curing the PFPE material to form an oxygen permeable, bacterial impermeable polymer coating on the surface.

65. The method of claim 64, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

66. The method of claim 64, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

67. The method of claim 64, wherein the liquid PFPE material comprises curing initiators.

68. The method of claim 64, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

69. The method of claim 64, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

70. A method of repairing in situ a defect in a lung within the body of a subject, comprising:

applying a patch comprising oxygen permeable, bacterial impermeable liquid PFPE material over the defect; and

curing the liquid PFPE material to seal the patch to adjacent lung tissue so as to prevent air leakage therethrough.

71. The method of claim 70, wherein applying a patch comprises spraying liquid PFPE material onto lung tissue.

72. The method of claim 70, wherein the patch is a preformed patch.

73. The method of claim 70, wherein the patch also comprises material selected from the group consisting of collagen, gelatin, albumin, fibrin and elastin.

74. The method of claim 70, wherein the defect results from a surgical procedure.

75. The method of claim 70, wherein the defect results from trauma.

76. The method of claim 74, wherein the surgical procedure is a lung biopsy, a lobectomy, or emphysema surgery.

77. The method of claim 70, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

78. The method of claim 70, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

79. The method of claim 70, wherein the liquid PFPE material comprises curing initiators.

80. The method of claim 70, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

81. The method of claim 70, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

82. The method of claim 70, wherein the PFPE material includes one or more pharmacological agents configured to elute therefrom.

83. A method of implanting an arterio-venous shunt within the body of a subject, comprising:

implanting a mold within the body of a subject, wherein the mold is configured to form a tubular body;

injecting an oxygen permeable, bacterial impermeable liquid PFPE material into the mold;

curing the liquid PFPE material to form a tubular body; and

connecting the tubular body to blood vessels in the body to form a shunt therebetween.

84. The method of claim 83, wherein the PFPE material includes a pharmacological agent, and wherein the PFPE material is configured to allow the pharmacological agent to elute therefrom when the shunt is deployed within a body of a subject.

85. The method of claim 83, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

86. The method of claim 83, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

87. The method of claim 83, wherein the liquid PFPE material comprises curing initiators.

88. The method of claim 83, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

89. The method of claim 83, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

90. A method of implanting an arterio-venous shunt within the body of a subject, comprising:

implanting a tubular body comprising oxygen permeable, bacterial impermeable PFPE material within the body of a subject; and

connecting the tubular body to blood vessels in the body to form a shunt therebetween.

91. The method of claim 90, wherein the tubular body includes a pharmacological agent that is configured to elute therefrom when the shunt is deployed within a body of a subject.

92. A method of forming an arterio-venous shunt within the body of a subject, comprising:

applying an oxygen permeable, bacterial impermeable liquid PFPE material onto a surface of an existing vessel within the body of a subject, wherein the vessel serves as a mold; and

curing the liquid PFPE material to form an arterio-venous shunt.

93. A method of repairing an arterio-venous shunt within the body of a subject, comprising:

applying an oxygen permeable, bacterial impermeable liquid PFPE material onto a surface of a shunt within the body of a subject; and

curing the liquid PFPE material.

94. A method of repairing in situ a defect in a passageway within the body of a patient, comprising:

applying a patch comprising oxygen permeable, bacterial impermeable liquid PFPE material over the defect; and

curing the liquid PFPE material to seal the patch to adjacent tissue so as to prevent leakage therethrough.

95. The method of claim 94, wherein applying a patch comprises spraying liquid PFPE material onto tissue of the passageway.

96. The method of claim 94, wherein the patch is a preformed patch.

97. The method of claim 94, wherein the passageway is a trachea or esophagus.

98. The method of claim 94, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

99. The method of claim 94, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

100. The method of claim 94, wherein the liquid PFPE material comprises curing initiators.

101. The method of claim 94, wherein the PFPE material includes one or more pharmacological agents for treating the passageway.

102. An artificial tissue material for use within the lungs of a patient, comprising a membrane of PFPE material that simulates alveolar action.

103. A material for use within a heart-lung machine, comprising a membrane of PFPE material that enhances gas exchange during artificial respiration.

104. An intraocular implant, comprising an oxygen permeable, bacterial impermeable liquid PFPE material.

105. A contact lens, comprising an oxygen permeable, bacterial impermeable liquid PFPE material.

106. A cochlear implant, comprising an oxygen permeable, bacterial impermeable liquid PFPE material.

107. A method of treating tissue within a body of a subject, comprising:

encapsulating tissue with an oxygen permeable, bacterial impermeable liquid PFPE material; and

curing the PFPE material to form an oxygen permeable, bacterial impermeable polymer coating on the tissue.

108. The method of claim 107, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

109. The method of claim 107, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

110. The method of claim 107, wherein the liquid PFPE material comprises curing initiators.

111. The method of claim 107, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

112. The method of claim 107, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

113. A method of treating tissue within the body of a subject, comprising:

forming a passageway in tissue within the body of a subject;

inserting an oxygen permeable, hyperoxygenated, bacterial impermeable liquid PFPE material in the passageway; and

curing the PFPE material to form an oxygen permeable, bacterial impermeable polymer material that facilitates growth of the tissue and enhances viability of surrounding tissues during healing and angiogenic phase.

114. The method of claim 113, wherein the tissue is heart muscle tissue and wherein the PFPE material facilitates revascularization of the heart muscle tissue.

115. The method of claim 113, wherein inserting and curing PFPE material is performed as part of a transmyocardial revascularization procedure.

116. The method of claim 113, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to light.

117. The method of claim 113, wherein curing the liquid PFPE material comprises exposing the liquid PFPE material to radiation.

118. The method of claim 113, wherein the liquid PFPE material comprises curing initiators.

119. The method of claim 113, further comprising monitoring curing of the PFPE material via a method selected from the group consisting of magnetic resonance imaging (MRI), X-ray fluoroscopy, and ultrasound imaging.

120. The method of claim 113, wherein the liquid PFPE material is a low viscosity PFPE precursor material.

121. The method of claim 113, wherein the PFPE material includes one or more pharmacological agents for treating the tissue.

122. A method of promoting tissue growth within the body of a subject, comprising:

applying an oxygen permeable, bacterial impermeable liquid PFPE material to tissue; and

curing the PFPE material to form an oxygen permeable, bacterial impermeable polymer material that facilitates growth of the tissue.

123. The method of claim 122, wherein the PFPE material includes one or more pharmacological agents for treating the tissue.

124. A method of producing fabric, comprising:

coating a fabric with liquid PFPE material; and

curing the liquid PFPE material to form a fabric having low surface energy.

125. The method of claim 124, wherein the fabric is selected from the group consisting of:

polytetrafluoroethylene, polyamides, polyesters, polyolefins, and Lycra.

126. The method of claim 124, wherein the fabric comprises non-woven material.