MARKED PRECOATED MEDICAL DEVICE AND METHOD OF MANUFACTURING SAME

• US 20090162531A1
• Filed: 07/11/2008
• Published: 06/25/2009
• Est. Priority Date: 12/21/2007
• Status: Active Grant

• Current Assignee: Innovatech, LLC
• Original Assignee: Innovatech, LLC
• Inventors: Nesbitt, Bruce
• Granted Patent: US 8,231,926 B2
• Time in Patent Office: Days
• US Class Current: 427/2.120
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: B05D 3/0254 After-treatment
• CPC Class Codes: B05D 5/00 Processes for applying liquids or other fluent materials to surfaces to obtain special surface effects, finishes or structures
• 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 7/546 each layer being cured, at least partially, separately
• CPC Class Codes: Y10T 428/31511 Of epoxy ether

Abstract

A medical device, such as a medical wire, which includes a coating applied to the surface of the medical wire. The coating includes a base layer bonded to the surface of the medical wire and an at least partially transparent low-friction top coat applied to the base layer. The base layer includes heat activated pigments that change color when heated above a color shifting temperature. In one embodiment, the color of the pigment in one area contrasts with the color of the pigment in an adjacent area without otherwise affecting the low-friction surface of the coating. The areas of different color created in locations along the length of the low-friction coated medical wire form markings which, as an example, enable a surgeon to determine the length of the medical wire inserted into a body by observing the markings on the portion of the marked medical wire located exterior to the body.

Claims

1. A method of manufacturing a coated medical device, said method comprising:

(a) applying a coating to at least one portion of an outer surface of a medical device, said coating including;

(i) a binder, and

(ii) a plurality of particles of a low-friction material;

(b) curing said coating, said curing causing said plurality of particles to form a low-friction top coat;

(c) applying a plurality of radiopaque particles to at least one portion of the low-friction top coat; and

(d) curing said applied radiopaque particles.

2. The method of claim 1, wherein applying the plurality of radiopaque particles includes applying the plurality of radiopaque particles to a plurality of spaced-apart portions of the low-friction top coat.

3. The method of claim 1, wherein the coating includes a pigment.

4. The method of claim 3, which includes selectively heating a designated quantity of portions of the cured coating such that the pigment of each selectively heated portion of the cured coating is heated above a color shifting temperature to cause the-said_pigment to change from a first color to a second different color without substantially degrading the low-friction material of each selectively heated portion of the cured coating.

5. The method of claim 4, wherein curing said coating includes causing the low-friction particles to migrate from first positions below the pigment in the coating to second positions above the pigment in the coating.

6. The method of claim 4, which includes heating the pigment of each selectively heated portion of the cured coating using an energy source selected from the group consisting of:

a radiant heat, induction energy, hot air, open flame, at least one electric filament, at least one magnet, and at least one laser.

7. The method of claim 4, which includes heating the pigment of each selectively heated portion of the cured coating using conduction from the medical device and which includes heating the medical device using induction.

8. The method of claim 4, wherein the pigment is selected from a group consisting of:

a phthalocyanine blue, a phthalocyanine green, a diarylide yellow, a diarylide orange, a quanacridone, a naphthol, a toluidine red, a carbizole violet, a carbon black, an iron oxide red, an iron oxide yellow, a chrome oxide green, a titanium oxide white, a cadmium red, a ultramarine blue, a moly orange, a lead chromate yellow, a mixed metal oxide, a talc, a calcium carbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrate and silicate, a barium sulfate a mica, a pearl pigment, a kaolin, an aluminum silicate derivative, an antomony trioxide, a metallic pigment, an aluminum flake pigment, and an iron oxide.

9. The method of claim 4, wherein the pigment is selected from a group consisting of a heat activated pigment, an organic pigment, an inorganic pigment, an extender pigment, a magnetic receptive pigment, and a laser excitable pigment.

10. The method of claim 1, wherein the coating includes a plurality of interspersed anti-microbial particles.

11. The method of claim 10, wherein the anti-microbial particles are selected from the group consisting of:

silver particles, glass-silver particles, silver-ceramic particles, and ceramic particles.

12. The method of claim 1, wherein the medical device is selected from the group consisting of:

a medical wire, a medical guide wire, a catheter, a needle, a biopsy device, a cannula, an electrosurgical electrode, a soft tissue needle, a soft tissue tubular device, a probe, and a blade.

13. The method of claim 1, wherein the binder is selected from the group consisting of:

an epoxy, a phenoxy, a phenolic, a polyimide, a polyamide, a polyamide-amide, a polyarylsulfone, polyetheretherketone, polyetherketone, and a polyphenylene sulfide.

14. The method of claim 1, wherein the low-friction material is selected from the group consisting of:

a polytetrafluoroethylene, a fluorinated ethylene propylene, a perfluoroalkoxy, a polyethylene, a silicone, a modified fluoropolymer, an irradiated polymer powder, and an irradiated polymer.

15. The method of claim 1, which includes applying an additional top coat to at least another portion of the low-friction top coat, said additional top coat including a plurality of particles of the low-friction material.

16. The method of claim 1, wherein applying the plurality of radiopaque particles to the at least one portion of the low-friction top coat includes applying the radiopaque particles to form at least one marking selected from the group consisting of:

at least one line parallel to a longitudinal direction of the medical device, at least one line perpendicular to the longitudinal direction of the medical device, at least one line transverse to the longitudinal direction of the medical device and at least one line substantially transverse to the longitudinal direction of the medical device

17. A method of manufacturing a coated medical device, said method comprising:

(a) applying a plurality of radiopaque particles to at least one portion of an outer surface of a medical device;

(b) curing said radiopaque particles;

(c) applying a coating to the at least one portion of the cured radiopaque particles, said coating including;

(i) a binder, and

(ii) a plurality of particles of a low-friction material; and

(d) curing said coating, said curing causing said plurality of particles to form a low-friction top coat on said cured radiopaque particles.

18. The method of claim 17, wherein applying the plurality of radiopaque particles includes applying the plurality of radiopaque particles to a plurality of spaced-apart portions of the outer surface of the medical device.

19. The method of claim 17, wherein the coating includes a pigment.

20. The method of claim 19, which includes selectively heating a designated quantity of portions of the cured coating such that the pigment of each selectively heated portion of the cured coating is heated above a color shifting temperature to cause said pigment to change from a first color to a second different color without substantially degrading the low-friction material of each selectively heated portion of the cured coating.

21. The method of claim 20, wherein curing said coating includes causing the particles to migrate from first positions below the pigment in the coating to second positions above the pigment in the coating.

22. The method of claim 20, which includes heating the pigment of each selectively heated portion of the cured coating using an energy source selected from the group consisting of:

a radiant heat, induction energy, hot air, open flame, at least one electric filament, at least one magnet, and at least one laser.

23. The method of claim 20, which includes heating the pigment of each selectively heated portion of the cured coating using conduction from the medical device and which includes heating the medical device using induction.

24. The method of claim 20, wherein the pigment is selected from a group consisting of:

a phthalocyanine blue, a phthalocyanine green, a diarylide yellow, a diarylide orange, a quanacridone, a naphthol, a toluidine red, a carbizole violet, a carbon black, an iron oxide red, an iron oxide yellow, a chrome oxide green, a titanium oxide white, a cadmium red, a ultramarine blue, a moly orange, a lead chromate yellow, a mixed metal oxide, a talc, a calcium carbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrate and silicate, a barium sulfate a mica, a pearl pigment, a kaolin, an aluminum silicate derivative, an antomony trioxide, a metallic pigment, an aluminum flake pigment, and an iron oxide.

25. The method of claim 20, wherein the pigment is selected from a group consisting of a heat activated pigment, an organic pigment, an inorganic pigment, an extender pigment, a magnetic receptive pigment, and a laser excitable pigment.

26. The method of claim 17, wherein the coating includes a plurality of interspersed anti-microbial particles.

27. The method of claim 26, wherein the anti-microbial particles are selected from the group consisting of:

silver particles, glass-silver particles, silver-ceramic particles, and ceramic particles.

28. The method of claim 17, wherein the medical device is selected from the group consisting of:

a medical wire, a medical guide wire, a catheter, a needle, a biopsy device, a cannula, an electrosurgical electrode, a soft tissue needle, a soft tissue tubular device, a probe, and a blade.

29. The method of claim 17, wherein the binder is selected from the group consisting of:

an epoxy, a phenoxy, a phenolic, a polyimide, a polyamide, a polyamide-amide, a polyarylsulfone, polyetheretherketone, polyetherketone, and a polyphenylene sulfide.

30. The method of claim 17, wherein the low-friction material is selected from the group consisting of:

a polytetrafluoroethylene, a fluorinated ethylene propylene, a perfluoroalkoxy, a polyethylene, a silicone, a modified fluoropolymer, an irradiated polymer powder, and an irradiated polymer.

31. The method of claim 17, wherein applying the plurality of radiopaque particles to the at least one portion of outer surface of the medical device includes applying the radiopaque particles to form at least one marking selected from the group consisting of:

at least one line parallel to a longitudinal direction of the medical device, at least one line perpendicular to the longitudinal direction of the medical device, at least one line transverse to the longitudinal direction of the medical device and at least one line substantially transverse to the longitudinal direction of the medical device

32. A method of manufacturing a coated medical device, said method comprising:

(a) applying a first coating to an outer surface of a medical device, said first coating including;

(i) a first binder,

(ii) a first pigment of a first color, and

(ii) a plurality of particles of a low-friction material;

(b) curing said first coating;

(c) applying a second, different coating to the cured first coating, said second coating including;

(i) a second binder,

(ii) a second pigment of a second color, said second color being of a contrasting hue than the first color, and

(iii) a plurality of particles of the low-friction material;

(d) curing said second coating; and

(e) heating at least one portion of the outer surface of the medical device such that a portion of said cured second coating is removed to cause said at least one portion of the outer surface of the medical device to have said first color, and at least another portion of the outer surface of the medical device to have said second color.

33. The method of claim 32, wherein heating the at least one portion of the outer surface of the medical device includes heating a plurality of spaced-apart portions of the medical device.

35. The method of claim 32, wherein the first pigment is selected from a group consisting of:

a phthalocyanine blue, a phthalocyanine green, a diarylide yellow, a diarylide orange, a quanacridone, a naphthol, a toluidine red, a carbizole violet, a carbon black, an iron oxide red, an iron oxide yellow, a chrome oxide green, a titanium oxide white, a cadmium red, a ultramarine blue, a moly orange, a lead chromate yellow, a mixed metal oxide, a talc, a calcium carbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrate and silicate, a barium sulfate a mica, a pearl pigment, a kaolin, an aluminum silicate derivative, an antomony trioxide, a metallic pigment, an aluminum flake pigment, and an iron oxide.

36. The method of claim 32, wherein the second pigment is selected from a group consisting of:

a phthalocyanine blue, a phthalocyanine green, a diarylide yellow, a diarylide orange, a quanacridone, a naphthol, a toluidine red, a carbizole violet, a carbon black, an iron oxide red, an iron oxide yellow, a chrome oxide green, a titanium oxide white, a cadmium red, a ultramarine blue, a moly orange, a lead chromate yellow, a mixed metal oxide, a talc, a calcium carbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrate and silicate, a barium sulfate a mica, a pearl pigment, a kaolin, an aluminum silicate derivative, an antomony trioxide, a metallic pigment, an aluminum flake pigment, and an iron oxide.

37. The method of claim 32, wherein the coating includes a plurality of interspersed anti-microbial particles.

38. The method of claim 37, wherein the anti-microbial particles are selected from the group consisting of:

silver particles, glass-silver particles, silver-ceramic particles, and ceramic particles.

39. The method of claim 32, wherein the medical device is selected from the group consisting of:

a medical wire, a medical guide wire, a catheter, a needle, a biopsy device, a cannula, an electrosurgical electrode, a soft tissue needle, a soft tissue tubular device, a probe, and a blade.

40. The method of claim 32, wherein the first binder is selected from the group consisting of:

an epoxy, a phenoxy, a phenolic, a polyimide, a polyamide, a polyamide-amide, a polyarylsulfone, polyetheretherketone, polyetherketone, and a polyphenylene sulfide.

41. The method of claim 32, wherein the second binder is selected from the group consisting of:

an epoxy, a phenoxy, a phenolic, a polyimide, a polyamide, a polyamide-amide, a polyarylsulfone, polyetheretherketone, polyetherketone, and a polyphenylene sulfide.

42. The method of claim 32, which includes applying an additional top coat to the at least one portion of the medical device with the second coating removed, said additional top coat including a plurality of particles of the low-friction material.

43. The method of claim 32, which includes applying a plurality of radiopaque particles to at least one portion of one of the cured coatings.

44. The method of claim 32, which includes applying a plurality of radiopaque particles to at least one portion of the outer surface of the medical device.

45. The method of claim 32, wherein heating the at least one portion of the outer surface of the medical device includes removing the cured second coating to form at least one marking selected from the group consisting of:

at least one line parallel to a longitudinal direction of the medical device, at least one line perpendicular to the longitudinal direction of the medical device, at least one line transverse to the longitudinal direction of the medical device and at least one line substantially transverse to the longitudinal direction of the medical device

34. The method of 32, which includes heating the at least one portion of the outer surface of the medical device using an energy source selected from the group consisting of:

a radiant heat, induction energy, hot air, open flame, at least one electric filament, at least one magnet, and at least one laser.