Polymer Films for Medical Device Coating

• US 20100228348A1
• Filed: 05/23/2008
• Published: 09/09/2010
• Est. Priority Date: 05/25/2007
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James, Taylor, Douglas
• Granted Patent: US 8,900,651 B2
• Time in Patent Office: Days
• US Class Current: 623/11.110
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: B05D 1/025 using gas close to its critical state
• CPC Class Codes: B05D 1/04 involving the use of an electrostatic field B05D1/025 and B05D1/14 take precedence
• CPC Class Codes: B05D 2401/90 at least one component of the composition being in supercritical state or close to supercritical state
• CPC Class Codes: B05D 5/08 to obtain an anti-friction or anti-adhesive surface rendering particulate materials free-flowing in general, e.g. making them hydrophobic B01J2/30
• CPC Class Codes: B05D 5/083 involving the use of fluoropolymers

Abstract

A method for depositing a coating comprising a polymer and impermeable dispersed solid on a substrate, comprising the following steps: discharging at least one impermeable dispersed solid in dry powder form through a first orifice; discharging at least one polymer in dry powder form through a second orifice; depositing the polymer and/or impermeable dispersed solid particles onto said substrate, wherein an electrical potential is maintained between the substrate and the impermeable dispersed solid and/or polymer particles, thereby forming said coating; and sintering said coating under conditions that do not disrupt the activity and/or function of the substrate. A similar method is provided for depositing a coating comprising a hydrophobic polymer and a water-vapor-trapping material on a substrate.

Claims

1. A method of preparing a coated substrate comprising:

providing a substrate;

depositing on said substrate at least one layer comprising a polymer,

wherein the layer substantially seals the substrate.

2. The method of claim 1, wherein the layer is substantially impermeable to a gas.

3. The method of claim 1, wherein the layer is substantially impermeable to a fluid.

4. The method of claim 1, wherein the layer is substantially impervious to a biological material.

5. The method of claim 1, wherein the polymer is hydrophobic.

6. The method of claim 1, wherein the polymer is at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkynes.

7. The method of claim 1, wherein the polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

8. The method of claim 1, wherein the polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

9. The method of claim 1, wherein the polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

10. The method of claims 1, further comprising:

depositing on said substrate at least one layer comprising an impermeable dispersed solid.

11. The method of claim 1, wherein the layer provides a substantially conformal coating on the substrate.

12. The method of claim 1, wherein the layer provides a coating that is substantially impermeable to leachants from the substrate.

13. The method of claim 12, wherein the impermeable dispersed solid is impermeable to a gas.

14. The method of claim 1, wherein the substrate is a medical device.

15. The method of claim 14, wherein the medical device is an active medical device.

16. The method of claim 1, further comprising depositing on said substrate one or more polymer layers.

17. The method of one of claim 1, further comprising depositing on said substrate one or more impermeable dispersed solid layers.

18. The method of claim 1, comprising depositing 5, 10, 20, 50, or 100 layers of at least one of a polymer and an impermeable dispersed solid.

19. The method of claim 10, comprising depositing said impermeable dispersed solid layer by an e-RESS, an e-SEDS, or an e-DPC process.

20. The method of claim 1, comprising depositing said polymer layer by an e-RESS, an e-SEDS, or an e-DPC process.

21. The method of claim 1, wherein the polymer layer is substantially defect-free.

22. The method of claim 1, comprising depositing a coating formed by the polymer layer and an impermeable dispersed solid layer in combination wherein the coating is substantially defect-free.

23. The method of claim 10, wherein depositing said impermeable dispersed solid layer provides improved adherence of the impermeable dispersed solid to at least one of the substrate and the polymer layer.

24. The method of claim 1, wherein depositing said polymer layer provides improved adherence of the polymer to the substrate.

62. The method of one of claims 1, 25, and 44, wherein the impermeable dispersed solid comprises a nanoparticle.

63. The method of claim 62, wherein the nanoparticle is a polyurethane adhesive nanocomposite.

64. The method of claim 62, wherein the nanoparticle comprises organically modified montmorillonite and polyurethane.

65. The method of one of claims 1, 25, and 44, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

66. The method of one of claims 1, 25, and 44, wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

67. The method of one of claims 1, 25, and 44, wherein the small particle transmission rate across the coating is at most about 0.001%, 0.01%, 0.1%, 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

73. The method of any of claims 1, 25, and 44, wherein at least one of the polymer and the impermeable dispersed solid is electrostatically deposited onto the substrate, wherein the polymer initially forms a coating of individual polymer nanoparticles that subsequently coalesce with adjacent polymer nanoparticles to form a polymer film.

74. The method of claim 73, wherein the polymer film comprises a microstructure.

75. The method of claim 74, wherein the impermeable dispersed solid is are sequestered within said microstructure.

84. A substrate comprising a coating deposited on said substrate according to any of claims 1-83.

25. A method of preparing a coated substrate comprising:

providing a substrate;

depositing on said substrate at least one layer comprising an impermeable dispersed solid and a polymer.

26. The method of claim 25, wherein the layer substantially seals the substrate.

27. The method of claim 25, wherein the layer is substantially impermeable to a gas.

28. The method of claim 25, wherein the layer is substantially impermeable to a fluid.

29. The method of claim 25, wherein the layer is substantially impervious to a biological material.

30. The method of claim 25, wherein the polymer is hydrophobic.

31. The method of claim 25, wherein the polymer is at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkynes.

32. The method of claim 25, wherein the polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

33. The method of claim 25, wherein the polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

34. The method of claim 25, wherein the polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.25, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

35. The method of claim 25, wherein the layer provides a substantially conformal coating on the substrate.

36. The method of claim 25, wherein the layer provides a coating that is substantially impermeable to leachants from the substrate.

37. The method of claim 25, wherein the impermeable dispersed solid is impermeable to a gas.

38. The method of claim 25, wherein the substrate is a medical device.

39. The method of claim 38, wherein the medical device is an active medical device.

40. The method of claim 25, comprising depositing 5, 10, 20, 50, or 100 layers of at least one of a polymer and a impermeable dispersed solid.

41. The method of claim 25, comprising depositing said layer by an e-RESS, an e-SEDS, or an e-DPC process.

42. The method of claim 25, wherein the layer is substantially defect-free.

43. The method of claim 25, wherein depositing said layer provides improved adherence of the layer to the substrate.

44. A method for depositing a coating comprising a polymer on a substrate, comprising the following steps:

discharging at least one polymer in dry powder form through a first orifice;

depositing the polymer onto said substrate, wherein an electrical potential is maintained between the substrate and the polymer particles, thereby forming said coating; and

sintering said coating under conditions that do not substantially disrupt the activity and/or function of the substrate,

wherein the coating substantially seals the substrate.

45. The method of claim 44, further comprising:

discharging at least one impermeable dispersed solid in dry powder form through a second orifice.

46. The method of claim 45, further comprising:

depositing the gas impermeable dispersed solid onto said substrate, wherein an electrical potential is maintained between the substrate and the impermeable dispersed solid.

47. The method of claim 45, wherein the impermeable dispersed solid and/or the polymer becomes electrostatically charged prior to deposition on said substrate.

48. The method of claim 45, wherein the substrate is electrostatically charged.

49. The method of claim 45, wherein the substrate is electrically grounded, and the impermeable dispersed solid and/or the polymer particles are charged.

50. The method of claim 45, wherein said polymer and said impermeable dispersed solid are discharged using a gas based propellant.

51. The method of claim 50, wherein said gas based propellant comprises at least one of the members selected from the group consisting of carbon dioxide, nitrous oxide, hydrofluorocarbons, chlorofluorocarbons, helium, nitrogen, compressed air, argon, and volatile hydrocarbons with a vapor pressure greater than 750 Torr at 20°

C.

52. The method of claim 51, wherein said gas based propellant comprises carbon dioxide.

53. The method of claim 45, wherein the average particle size of said polymer and/or impermeable dispersed solid particles is from about 0.1 micron to about 100 microns.

54. The method of claim 45, wherein the molecular weight range of said polymer is from about 5,000 a.u. to about 100,000 a.u.

55. The method of claim 45, wherein the resistivity of said polymer and/or impermeable dispersed solid dry powders is from about 106 Ω

m to about 1024 Ω

m.

56. The method of claim 45, wherein the moisture content of said polymer and/or impermeable dispersed solid dry powders is less than 5% by weight.

57. The method of claim 45, wherein said first and said second orifices are provided as one single orifice.

58. The method of claim 57, wherein said impermeable dispersed solid and said polymer are mixed together prior to discharging.

59. The method of claim 45, wherein said impermeable dispersed solid and said polymer particles are discharged simultaneously.

60. The method of claim 45, wherein said impermeable dispersed solid and said polymer particles are discharged in succession.

61. The method of claim 45, carried out at a temperature from about 0°

C. to about 80°

C.

68. The method of claim 44, carried out at a pressure from about 0.1 atmospheres to about 73 atmospheres.

69. The method of claim 44, wherein said substrate is a biomedical implant.

70. The method of claim 69, wherein said biomedical implant is selected from the group consisting of a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthalmic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

71. The method of claim 44, wherein said sintering comprises treating said coated substrate with a compressed gas, compressed liquid, or supercritical fluid that is a non-solvent for both the polymer and the impermeable dispersed solid, but a plasticizing agent for the polymer.

72. The method of claim 71, wherein said compressed gas, compressed liquid, or supercritical fluid is carbon dioxide.

76. The method of claim 44, wherein the coating is substantially impermeable to a gas.

77. The method of claim 44, wherein the coating is substantially impermeable to a fluid.

78. The method of claim 44, wherein the coating is substantially impervious to a biological material.

79. The method of claim 44, wherein the polymer is hydrophobic.

80. The method of claim 44, wherein the polymer is at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkyne.

81. The method of claim 44, wherein the polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

82. The method of claim 44, wherein the polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

83. The method of claim 44, wherein the polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

85. A device comprising:

a substrate and

a polymer layer disposed on the substrate

wherein the layer substantially seals the substrate.

86. The device of claim 85, wherein said substrate is a medical device.

87. The device of claim 86, wherein said medical device is selected from a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthalmic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

88. The device of claim 85, wherein the polymer layer is substantially impermeable to a gas.

89. The device of claim 85, wherein the polymer layer is substantially impermeable to a fluid.

90. The device of claim 85, wherein the polymer layer is substantially impervious to a biological material.

91. The device of claim 85, wherein the polymer layer is hydrophobic.

92. The device of claim 85, wherein the polymer layer comprises at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkyne.

93. The device of claim 85, wherein a polymer in the polymer layer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

94. The device of claim 85, wherein a polymer in the polymer layer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

95. The device of claim 85, wherein a polymer in the polymer layer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

96. The device of claim 85, wherein the polymer layer provides a substantially conformal coating on the substrate.

97. The method of claims 85, wherein the polymer layer provides a coating that is substantially impermeable to leachants from the substrate.

98. The device of claim 85, comprising:

at least one layer comprising an impermeable dispersed solid.

99. The device of claim 98, wherein the polymer layer and the impermeable dispersed solid layer in combination provide a substantially conformal coating on the substrate.

100. The device of claims 98, wherein the polymer layer and the impermeable dispersed solid layer in combination provide a coating that is substantially impermeable to leachants from the substrate.

101. The device of claim 98, wherein the impermeable dispersed solid is impermeable to a gas.

102. The device of claim 98, comprising 5, 10, 20, 50, or 100 layers of at least one of a polymer and an impermeable dispersed solid.

103. The device of claim 98, wherein the polymer layer is substantially defect-free.

104. The device of claim 98, wherein a coating formed by the polymer layer and the impermeable dispersed solid layer in combination is substantially defect-free.

105. A device comprising:

a substrate and

a layer disposed on the substrate, said layer comprising a polymer and an impermeable dispersed solid

wherein the layer substantially seals the substrate.

106. The device of claim 105, wherein said substrate is a medical device.

107. The device of claim 105, wherein said medical device is selected from a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthalmic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

108. The device of claim 105, wherein the layer is substantially impermeable to a gas.

109. The device of claim 105, wherein the layer is substantially impermeable to a fluid.

110. The device of claim 105, wherein the layer is substantially impervious to a biological material.

111. The device of claim 105, wherein the layer is hydrophobic.

112. The device of claim 105, wherein the polymer comprises at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkyne.

113. The device of claim 105, wherein a polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

114. The device of claim 105, wherein a polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

115. The device of claim 105, wherein a polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 115, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

116. The device of claim 105, wherein the layer provides a substantially conformal coating on the substrate.

117. The method of claim 105, wherein the layer provides a coating that is substantially impermeable to leachants from the substrate.

118. The device of claim 105, wherein the impermeable dispersed solid is impermeable to a gas.

119. The device of claim 105, comprising 5, 10, 20, 50, or 100 layers of at least one of the polymer and the impermeable dispersed solid.

120. The device of claim 105, wherein the layer is substantially defect-free.

121. A method of preparing a coated substrate comprising:

providing a substrate;

depositing on said substrate at least one layer comprising a water-vapor-trapping material, and

depositing on said substrate at least one layer comprising a hydrophobic polymer.

122. The method of claim 121, wherein the hydrophobic polymer layer and the water-vapor-trapping material substantially seals the substrate.

123. The method of claim 121, wherein the hydrophobic polymer comprises a fluoropolymer.

124. The method of claim 121, wherein the water-vapor-trapping material comprises a silicon based polymer.

125. The method of claim 124, wherein the silicon based polymer comprises native silicon and is metallized with titanium.

126. The method of claim 121, comprising depositing at least a third layer of a hydrophobic polymer encapsulate the water-vapor-trapping material between the hydrophobic polymer layers.

127. The method of claim 126, wherein the hydrophobic polymer comprises a fluoropolymer.

128. The method of claim 126, wherein the water-vapor-trapping material comprises a silicon based polymer.

129. The method of claim 128, wherein the silicon based polymer comprises native silicon and is metallized with titanium.

130. The method of claim 121, comprising depositing multiple alternating layers of a hydrophobic polymer and a water-vapor-trapping material.

131. The method of claim 121, wherein the water-vapor-trapping material comprises a hydrophilic polymer.

132. The method of claim 121, wherein the hydrophobic polymer is at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkyne.

133. The method of claim 121, wherein the hydrophobic polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

134. The method of claim 121, wherein the hydrophobic polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

135. The method of claim 121, wherein the hydrophobic polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

136. The method of claim 121, wherein the water-vapor-trapping material comprises a superabsorbent polymer.

137. The method of claim 121, wherein the hydrophobic polymer layer and the water-vapor-trapping later in combination provide a substantially conformal coating on the substrate.

138. The method of claim 121, wherein the coated substrate is impervious to a biological material.

139. The method of claim 121, wherein the hydrophobic polymer layer and the water-vapor-trapping later in combination provide a coating that is substantially impermeable to leachants from the substrate.

140. The method of claim 121, wherein the impermeable dispersed solid is impermeable to a gas.

141. The method of claim 121, wherein the substrate is a medical device.

142. The method of claim 141, wherein the medical device is an active medical device.

143. The method of claim 121, further comprising depositing one or more water-vapor-trapping material layers.

144. The method of claim 121, further comprising depositing one or more hydrophobic polymer layers.

145. The method of claim 121, comprising depositing 5, 10, 20, 50, or 100 layers of at least one of a water-vapor-trapping material and a hydrophobic polymer.

146. The method of claim 121, comprising depositing said hydrophobic polymer layer by an e-RESS, an e-SEDS, or an e-DPC process.

147. The method of claim 121, comprising depositing said water-vapor-trapping material layer by an e-RESS, an e-SEDS, or an e-DPC process.

148. The method of claim 121, wherein at least one of the hydrophobic polymer and the water-vapor-trapping material comprises a nanoparticle.

149. The method of claim 121, wherein the nanoparticle is a polyurethane adhesive nanocomposite.

150. The method of claim 149, wherein the nanoparticle comprises organically modified montmorillonite and polyurethane.

151. The method of claim 121, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

152. The method of claim 121, wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

153. The method of claim 121, wherein the small particle transmission rate across the coating is at most about 0.001%, 0.01%, 0.1%, 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

154. The method of claim 121, wherein the hydrophobic polymer layer and the water-vapor-trapping material layer is substantially defect-free.

155. The method of claim 121, wherein depositing said hydrophobic polymer layer provides improved adherence of the impermeable dispersed solid to the substrate.

156. The method of claim 121, comprising depositing said water-vapor-trapping material layer provides improved adherence of the water-vapor-trapping material to at least one of the substrate and the hydrophobic polymer.

214. A substrate comprising a coating deposited on said substrate according to any of claims 121-213.

157. A method of preparing a coated substrate comprising:

providing a substrate;

depositing on said substrate at least one layer comprising a hydrophobic polymer and a water-vapor-trapping material.

158. The method of claim 157, wherein the layer substantially seals the substrate.

159. The method of claim 157, wherein the layer is substantially impermeable to a gas.

160. The method of claim 157, wherein the layer is substantially impermeable to a fluid.

161. The method of claim 157, wherein the layer is substantially impervious to a biological material.

162. The method of claim 157, wherein the hydrophobic polymer comprises a fluoropolymer.

163. The method of claim 157, wherein the water-vapor-trapping material comprises a silicon based polymer.

164. The method of claim 163, wherein the silicon based polymer comprises native silicon and is metallized with titanium.

165. The method of claim 157, comprising depositing at least a third layer of a hydrophobic polymer encapsulate the water-vapor-trapping material between the hydrophobic polymer layers.

166. The method of claim 157, comprising depositing multiple alternating layers of a hydrophobic polymer and a water-vapor-trapping material.

167. The method of claim 157, wherein the layer provides a substantially conformal coating on the substrate.

168. The method of claim 157, wherein the layer provides a coating that is substantially impermeable to leachants from the substrate.

169. The method of claim 157, wherein the substrate is a medical device.

170. The method of claim 169, wherein the medical device is an active medical device.

171. The method of claim 157, further comprising depositing one or more water-vapor-trapping material layers.

172. The method of claim 157, further comprising depositing one or more hydrophobic polymer layers.

173. The method of claim 157, comprising depositing 5, 10, 20, 50, or 100 layers of at least one of a water-vapor-trapping material and a hydrophobic polymer.

174. The method of claim 157, comprising depositing said layer by an e-RESS, an e-SEDS, or an e-DPC process.

175. The method of claim 157, wherein at least one of the hydrophobic polymer and the water-vapor-trapping material comprises a nanoparticle.

176. The method of claim 175, wherein the nanoparticle is a polyurethane adhesive nanocomposite.

177. The method of claim 175, wherein the nanoparticle comprises organically modified montinorillonite and polyurethane.

178. The method of claim 157, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

179. The method of claim 157, wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

180. The method of claim 157, wherein the small particle transmission rate across the coating is at most about 0.001%, 0.01%, 0.1%, 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

181. The method of claim 157, wherein the layer is substantially defect-free.

201. The method of claim 178, wherein said sintering comprises treating said coated substrate with a compressed gas, compressed liquid, or supercritical fluid that is a non-solvent for both the water-vapor-trapping material and the hydrophobic polymer, but a plasticizing agent for the water-vapor-trapping material.

202. The method of claim 201, wherein said compressed gas, compressed liquid, or supercritical fluid is carbon dioxide.

203. The method of claim 178, wherein at least one of the hydrophobic polymer and the water-vapor-trapping material comprises a nanoparticle.

204. The method of claim 178, wherein the nanoparticle is a polyurethane adhesive nanocomposite.

205. The method of claim 204, wherein the nanoparticle comprises organically modified montmorillonite and polyurethane.

206. The method of claim 178, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

207. The method of claim 178, wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

208. The method of claim 178, wherein the hydrophobic polymer comprises a fluoropolymer.

209. The method of claim 178, wherein the water-vapor-trapping material comprises a silicon based polymer.

210. The method of claim 178, comprising depositing at least a third layer of a hydrophobic polymer encapsulate the water-vapor-trapping material between the hydrophobic polymer layers.

211. The method of claim 178, comprising depositing multiple alternating layers of a hydrophobic polymer and a water-vapor-trapping material.

212. The method of claim 178, wherein the water-vapor-trapping material comprises a hydrophilic polymer.

213. The method of claim 178 wherein the polymer is hydrophobic.

182. A method for depositing a coating comprising a water-vapor-trapping material and hydrophobic polymer on a substrate, comprising the following steps:

discharging at least one water-vapor-trapping material in dry powder form through a second orifice;

discharging at least one hydrophobic polymer in dry powder form through a first orifice;

depositing the water-vapor-trapping material and/or hydrophobic polymer onto said substrate, wherein an electrical potential is maintained between the substrate and the hydrophobic polymer and/or water-vapor-trapping material particles, thereby forming said coating; and

sintering said coating under conditions that do not substantially disrupt the activity and/or function of the substrate.

183. The method of claim 182, wherein the hydrophobic polymer and/or the water-vapor-trapping material becomes electrostatically charged prior to deposition on said substrate.

184. The method of claim 182, wherein the substrate is electrostatically charged.

185. The method of claim 182, wherein the substrate is electrically grounded, and the hydrophobic polymer and/or the water-vapor-trapping material particles are charged.

186. The method of claim 182, wherein said water-vapor-trapping material and said hydrophobic polymer are discharged using a gas based propellant.

187. The method of claim 186, wherein said gas based propellant comprises at least one of the members selected from the group consisting of carbon dioxide, nitrous oxide, hydrofluorocarbons, chlorofluorocarbons, helium, nitrogen, compressed air, argon, and volatile hydrocarbons with a vapor pressure greater than 750 Torr at 20°

C.

188. The method of claim 186, wherein said gas based propellant comprises carbon dioxide.

189. The method of claim 182, wherein the average particle size of said water-vapor-trapping material and/or hydrophobic polymer particles is from about 0.1 micron to about 100 microns.

190. The method of claim 182, wherein the molecular weight range of said water-vapor-trapping material is from about 5,000 a.u. to about 100,000 a.u.

191. The method of claim 182, wherein the resistivity of said water-vapor-trapping material and/or hydrophobic polymer dry powders is from about 106 Ω

m to about 1024 Ω

m.

192. The method of claim 182, wherein the moisture content of said water-vapor-trapping material and/or hydrophobic polymer dry powders is less than 5% by weight.

193. The method of claim 188, wherein said first and said second orifices are provided as one single orifice.

194. The method of claim 182, wherein said hydrophobic polymer and said water-vapor-trapping material are mixed together prior to discharging.

195. The method of claim 182, wherein said hydrophobic polymer and said water-vapor-trapping material particles are discharged simultaneously.

196. The method of claim 182, wherein said hydrophobic polymer and said water-vapor-trapping material particles are discharged in succession.

197. The method of claim 182, carried out at a temperature from about 0°

C. to about 80°

C.

198. The method of claim 182, carried out at a pressure from about 0.1 atmospheres to about 82 atmospheres.

199. The method of claim 182, wherein said substrate is a biomedical implant.

200. The method of claim 199, wherein said biomedical implant is selected from the group consisting of a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthalmic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

215. A device comprising:

a substrate and

a water-vapor-trapping material layer, and

a hydrophobic polymer layer,

wherein the water-vapor-trapping material layer is disposed on the substrate,

wherein the hydrophobic layer is disposed on the water-vapor-trapping material layer, and

wherein at least one of the water-vapor-trapping material layer and the hydrophobic polymer layer substantially seals the substrate.

216. The device of claim 215, wherein said substrate is an implantable device.

217. The device of claim 216, wherein said implantable device is selected from a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthahnic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

218. A device comprising:

a substrate and

a layer disposed on the substrate, said layer comprising a polymer and an impermeable dispersed solid

wherein the layer substantially seals the substrate.

219. The device of claim 218, wherein said substrate is a medical device.

220. The device of claim 218, wherein the layer provides a substantially conformal coating on the substrate.

221. The device of claim 218, wherein the layer is substantially defect-free.

222. A method of preparing a coated substrate comprising:

providing a substrate;

depositing on said substrate at least one layer comprising a nanoparticle; and

depositing on said substrate at least one layer comprising a polymer,

wherein the depositing of the nanoparticle and the polymer in combination substantially seals the substrate

223. The method of claim 222, wherein the substrate is a medical device.

224. The method of claim 222, further comprising depositing one or more polymer layers.

225. The method of claim 222, further comprising depositing one or more layers of nanoparticles.

226. The method of claim 222, comprising depositing 5, 10, 20, 50, or 100 layers of at least one of a polymer and a nanoparticle.

227. The method of claim 222, comprising depositing said nanoparticle layer by an e-RESS, an e-SEDS, or an e-DPC process.

228. The method of claim 222, comprising depositing said polymer layer by an e-RESS, an e-SEDS, or an e-DPC process.

229. The method of claim 222, comprising depositing said polymer layer in a substantially defect-free manner.

250. The method of one of claims 222, 230, and 234, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

251. The method of one of claims 222, 230, and 234, wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

252. The method of one of claims 222, 230, and 234, wherein the small particle transmission rate across the coating is at most about 0.001%, 0.01%, 0.1%, 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

257. The method of any of claims 222, 230, and 234, wherein at least one of the polymer and the nanoparticle is electrostatically deposited onto the substrate, wherein the polymer initially forms a coating of individual polymer nanoparticles that subsequently coalesce with adjacent polymer nanoparticles to form a polymer film.

258. The method of claim 257, wherein the polymer film comprises a microstructure.

259. The method of claim 257, wherein the impermeable dispersed solid is are sequestered within said microstructure.

260. A substrate comprising a coating deposited on said substrate according to any of claims 222-259.

230. A method of preparing a conformally coated substrate impervious to a biological material comprising:

providing a substrate;

depositing on said substrate at least one layer comprising a nanoparticle and a polymer

wherein depositing the layer substantially seals the substrate

231. The method of claim 230, wherein the substrate is a medical device.

232. The method of claim 230, comprising depositing said layer by an e-RESS, an e-SEDS, or an e-DPC process.

233. The method of claim 230, comprising depositing said layer in a substantially defect-free manner.

235. The method of claim 230, wherein the nanoparticle and/or the polymer becomes electrostatically charged prior to deposition on said substrate.

236. The method of claim 230, wherein the substrate is electrostatically charged.

237. The method of claim 230, wherein the substrate is electrically grounded, and the nanoparticle and/or the polymer particles are charged.

238. The method of claim 230, wherein said polymer and said nanoparticle are discharged using a gas based propellant.

239. The method of claim 230, wherein the average particle size of said polymer particle and/or nanoparticle is from about 0.1 micron to about 100 microns.

240. The method of claim 230, wherein the molecular weight range of said polymer is from about 5,000 a.u. to about 100,000 a.u.

241. The method of claim 230, wherein the resistivity of said polymer and/or nanoparticle dry powders is from about 106 Ω

m to about 1024 Ω

m.

242. The method of claim 230, wherein the moisture content of said polymer and/or nanoparticle dry powders is less than 5% by weight.

243. The method of claim 230, wherein said first and said second orifices are provided as one single orifice.

244. The method of claim 239, wherein said nanoparticle and said polymer are mixed together prior to discharging.

245. The method of claim 230, wherein said nanoparticle and said polymer particles are discharged simultaneously.

246. The method of claim 230, wherein said nanoparticle and said polymer particles are discharged in succession.

247. The method of claim 230, carried out at a temperature from about 0°

C. to about 80°

C.

253. The method of claim 230, carried out at a pressure from about 0.1 atmospheres to about 73 atmospheres.

254. The method of claim 230, wherein said substrate is a biomedical implant.

255. The method of claim 230, wherein said sintering comprises treating said coated substrate with a compressed gas, compressed liquid, or supercritical fluid that is a non-solvent for both the polymer and the impermeable dispersed solid, but a plasticizing agent for the polymer.

256. The method of claim 230, wherein said compressed gas, compressed liquid, or supercritical fluid is carbon dioxide.

234. A method for depositing a coating comprising a polymer and a nanoparticle impervious to small particle transport on a substrate, comprising the following steps:

discharging at least one nanoparticle in dry powder form through a first orifice;

discharging at least one polymer in dry powder form through a second orifice;

depositing the polymer and/or nanoparticle onto said substrate, wherein an electrical potential is maintained between the substrate and the nanoparticle and/or polymer particles, thereby forming said coating; and

sintering said coating under conditions that do not substantially disrupt the activity and/or function of the substrate.

248. The method of claim 343, wherein the nanoparticle is a polyurethane adhesive nanocomposite.

249. The method of claim 345, wherein the nanoparticle comprises organically modified montmorillonite and polyurethane.

261. A device comprising:

a substrate

a layer comprising at least one of a nanoparticle and a polymer disposed on the substrate,

wherein the layer substantially seals the substrate.

262. The device of claim 261, wherein said substrate is a medical device.

263. The device of claim 262, wherein said medical device is selected from a stent (e.g., vascular stents), electrode, catheter, lead, implantable pacemaker, implantable cardioverter, a housing for an implantable pacemaker, a housing for an implantable defibrillator, a housing for an implantable cardioverter, sensor, drug delivery device, therapy delivery device, device comprising telemetry capability, device comprising electrical impulses, diagnostic device, measurement device, joint, screw, rod, ophthalmic implant, femoral pin, bone plate, graft, anastomotic device, perivascular wrap, suture, staple, shuntsfor hydrocephalus, dialysis graft, colostomy bag attachment device, ear drainage tube, lead for pace makers and implantable cardioverters and defibrillators, vertebral disk, bone pin, suture anchor, hemostatic barrier, clamp, screws, plate, clip, vascular implant, tissue adhesive, sealant, tissue scaffolds, shunts, opthalmic implant, prosthetic, shunt, urologic implant, reproductive anatomy device, gastrologic device, neurologic lead, neurologic device, various types of dressings (e.g., wound dressings), bone substitutes, intraluminal devices, and vascular supports.

264. The device of claim 261, wherein the layer is substantially impermeable to a gas.

265. The device of claim 261, wherein the layer is substantially impermeable to a fluid.

266. The device of claim 261, wherein the layer is substantially impervious to a biological material.

267. The device of claim 261, wherein the polymer is hydrophobic.

268. The device of claim 261, wherein the polymer comprises at least one of a polyolefin, a metallocene polyolefins, a styrene polymers, a vinyl polymer, an acrylic polymers, a polyester, a polyalkene, and a polyalkyne.

269. The device of claim 261, wherein the polymer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

270. The device of claim 261, wherein polymer has a bulk density of greater than about 1.00 gram per cubic centimeter (g/cc).

271. The device of claim 261, wherein the polymer has a bulk density of at least about one of 1.01, 1.02, 1.03, 1.05, 1.06, 1.07, 1.08, 1.09, 2.00, 2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.07, 2.08, 2.09, 2.10, 2.11, 2.12, 2.13, 2.14, 2.15, 2.16, 2.17, 2.18, 2.19, 2.20, 2.21, 2.22, 2.23, 2.24, 2.25, 2.26, 2.27, 2.28, 2.29, 2.30, 2.31, 2.32, 2.33, 2.34, 2.35, 2.36, 2.37, 2.38, 2.39, 2.40 grams per cubic centimeter (g/cc).

272. The device of claim 261, wherein the layer provides a substantially conformal coating on the substrate.

273. The device of claim 261, wherein the layer provides a coating that is substantially impermeable to leachants from the substrate.

274. The device of claim 261, wherein the layer provide a substantially conformal coating on the substrate.

275. The device of claim 261, comprising 5, 10, 20, 50, or 100 layers of at least one of a polymer and an nanoparticle.

276. The device of claim 261, wherein the layer is substantially defect-free.