Polymer films for medical device coating

• US 8,900,651 B2
• Filed: 12/04/2008
• Issued: 12/02/2014
• Est. Priority Date: 05/25/2007
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James, Taylor, Douglas
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US12/601,101
• Publication Number:
  US 20100228348A1
• Time in Patent Office: 2,189 Days
• Field of Search: 427/476, 427/483, 427/486
• US Class Current: 427/2.1
• 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 biomedical implant comprising:

providing a biomedical implant;

depositing on said biomedical implant a first layer comprising a hydrophobic polymer;

depositing on said biomedical implant a second layer comprising an impermeable dispersed solid, wherein the impermeable dispersed solid and the hydrophobic polymer are discharged separately through a first and/or second orifice and wherein the impermeable solid is discharged through the first or second orifice as a dry powder and deposited in dry powder form, and

sintering the first and second layers under conditions that do not substantially disrupt the activity and/or function of the biomedical implant thereby forming a coating,

wherein the coating substantially seals the biomedical implant; and

wherein the coating is substantially impermeable to a gas;

the coating is substantially impermeable to a fluid; and

the coating is substantially impervious to a biological material.

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

3. 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, and 2.40 grams per cubic centimeter (g/cc).

4. The method of claim 1, wherein the impermeable dispersed solid is impermeable to a gas.

5. The method of claim 4, wherein at least one of the polymer and the impermeable dispersed solid is electrostatically deposited onto the biomedical implant, wherein the polymer initially forms individual polymer nanoparticles that subsequently coalesce with adjacent polymer nanoparticles to form the coating.

6. The method of claim 1, comprising depositing 5, 10, 20, 50, or 100 layers of the polymer and the impermeable dispersed solid.

7. The method of claim 1, wherein depositing said impermeable dispersed solid provides improved adherence of the impermeable dispersed solid to at least one of the biomedical implant and the hydrophobic polymer.

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

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

10. The method of claim 1 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%.

11. The method of claim 1, wherein said biomedical implant is selected from the group consisting of a stent, 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, shunts for 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, bone substitutes, intraluminal devices, and vascular supports.

12. The method of claim 1, wherein the coating is substantially impermeable to leachants from the biomedical implant.

13. The method of claim 1, wherein the impermeable dispersed solid comprises a nanoparticle that is impervious to small molecule transport, wherein said nanoparticle comprises ceramic, metal, clay, silica, silicon, or metal-oxide.

14. The method of claim 13, wherein said nanoparticle comprises titanium oxide.

15. The method of claim 1, wherein the impermeable dispersed solid comprises an inorganic particle of a micron or sub-micron size.

16. The method of claim 1, wherein a third layer is deposited on said biomedical implant comprising a hydrophobic polymer and the third layer is sintered under conditions that do not substantially disrupt the activity and/or function of the biomedical implant.

17. A method for depositing a coating comprising a hydrophobic polymer on a biomedical implant, comprising the following steps:

forming a coating by

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

b) depositing the hydrophobic polymer onto said biomedical implant, wherein an electrical potential is maintained between the biomedical implant and the polymer particles, thereby forming said coating;

c) discharging at least one impermeable dispersed solid in dry powder form through a second orifice;

d) depositing the impermeable dispersed solid onto said biomedical implant, wherein an electrical potential is maintained between the biomedical implant and the impermeable dispersed solid particles; and

e) sintering said coating under conditions that do not substantially disrupt the activity and/or function of the biomedical implant;

wherein the coating substantially seals the biomedical implant.

18. The method of claim 17, wherein the oxygen transmission rate across the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

19. The method of claim 17 wherein the water vapor permeation through the coating is at most about 1%, 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70%.

20. The method of claim 17 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%.

21. The method of claim 17, wherein said biomedical implant is selected from the group consisting of a stent, 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, shunts for 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, bone substitutes, intraluminal devices, and vascular supports.

22. The method of claim 17, wherein the impermeable dispersed solid is impermeable to a gas, wherein the impermeable dispersed solid is electrostatically deposited onto the biomedical implant.

23. The method of claim 22, wherein the coating comprises a microstructure;

wherein the impermeable dispersed solid is sequestered within said microstructure.

24. The method of claim 17, wherein the polymer layer has a bulk density of at least about 1.00 grams per cubic centimeter (g/cc).

25. The method of claim 24, 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, 20.6, 20.7, 20.8, 20.9, 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).