Liquid and low melting coatings for stents

• US 20030083740A1
• Filed: 12/21/2001
• Published: 05/01/2003
• Est. Priority Date: 10/22/2001
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Pathak, Chandrashekhar
• Granted Patent: US 7,323,189 B2
• Time in Patent Office: Days
• US Class Current: 623/1.43
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2/16 using chemical substances
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/434 of enzymes
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/04 Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/049 Rubbers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/125 having a macromolecular matrix
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A method for forming liquid coatings for medical devices such as stents and angioplasty balloons is provided. The liquid coatings can be made from biodegradable materials in liquid, low melting solid, or wax forms, which preferably degrade in the body without producing potentially harmful fragments. The liquid coatings may also contain biologically active components, which are released from the coatings through diffusion from the coatings and the degradation of the coatings.

Claims

1. A coated stent comprising a stent and a coating composition comprising a biologically active component and a biodegradable carrier component, the biodegradable carrier having a melting point of about 50°

C. or less.

2. The coated stent of claim 1, further comprising a catheter, wherein the catheter and the coated stent can be coupled to form a treatment assembly.

3. The coated stent of claim 1, wherein the biodegradable carrier has a melting point of from about 35°

C. to about 45°

C.

4. The coated stent of claim 1 wherein the biologicaly active component has a melting point of about 50°

C. or less.

7. The coated stent of claim 1 in which the coating composition is hydrophobic.

8. The coated stent of claim 1 in which the biodegradable carrier is hydrophobic.

9. The coated stent of claim 1 in which the biodegradable carrier is biocompatible.

10. The coated stent of claim 1 in which the biodegradable carrier comprises a polymer.

11. The coated stent of claim 1 in which the biodegradable carrier comprises a polymer having a molecular weight of 50,000 or less.

12. The coated stent of claim 1 in which the biodegradable carrier comprises a non-polymer.

13. The coated stent of claim 1 in which the biodegradable component comprises vitamin E or a derivative thereof.

14. The coated stent of claim 1 wherein the biodegradable carrier comprises vitamin E acetate.

15. The coated stent of claim 1 wherein the biodegradable carrier comprises vitamin E succinate.

16. The coated stent of claim 1 wherein the biodegradable carrier is selected from the group consisting of oleic acid, peanut oil, and cottonseed oil.

17. The coated stent of claim 1 wherein the biodegradable carrier is a selected from the group consisting of polyhydroxy acids, polyanhydrides, polyphosphazenes, biodegradable polyamides, polyalkylene oxalates, polyorthoesters, polyphosphoesters, polyorthocarbonates, and blends or copolymers thereof.

18. The coated stent of claim 1 in which the biologically active component is capable of inhibiting restenosis.

19. The coated stent of claim 1 in which the biologically active component is selected from the group consisting of paclitaxel, actinomycin D, rapamycin, cerivastatin, fluvastatin, simvastatin, lovastatin, atorvastatin, and pravastatin.

20. The coated stent of claim 1, wherein the stent has struts and capillaries, groves, channels engraved in the struts.

21. The coated stent of claim 1, wherein the stent comprises a strut and the strut comprises a surface area enhancing feature.

22. The coated stent of claim 21 wherein the surface enhancing feature is selected from the group consisting of grooves, capillaries, or channels.

23. The coated stent of claim 22 wherein the surface enhancing feature contains at least some of the coating composition.

5. A coated stent comprising a stent and a coating composition that includes a biologically active component and a biodegradable carrier, wherein the biodegradable carrier has a viscosity of from about 0.1 to about 15000 cP.

6. A coated stent comprising a stent and a coating composition that includes a biologically active component and a biodegradable carrier, wherein the coating composition is in a solid state outside of a human body and melts to form a liquid inside of a human body.

24. A method of coating a stent comprising:

providing a stent,

providing a coating composition comprising a biologically active component and a biodegradable carrier having a melting point of about 50°

C. or less, and

applying the coating composition to the stent.

25. The method of claim 24, further comprising the step of expanding the stent to an increased diameter before applying the coating composition to the stent.

26. The method of claim 24 wherein applying the coating composition comprises spraying or painting the coating composition onto the stent, or immersing the stent in the coating composition.

27. A method of coating a stent comprising:

providing a stent,

providing a coating composition comprising a biologically active component and a biodegradable carrier having a viscosity of from about 0.1 to about 15000 cP, and applying the coating composition to the stent.

28. A method of treating restenosis comprising:

deploying a coated stent into a body lumen of a patient, the coated stent comprising a stent and a coating composition comprising a biodegradable carrier having a melting point of about 50°

C. or less and a biologically active component.

29. A method of treating restenosis comprising:

deploying a coated stent into a body lumen of a patient, the coated stent comprising a stent and a coating composition comprising a biodegradable carrier having a viscosity of from about 0.1 to about 15,000 cP and a biologically active component.

30. A method of treating restenosis comprising:

providing a coated stent comprising a stent, a biologically active component and a biodegradable solid carrier, and

deploying the coated stent into a body lumen of a patient, the coating composition changing from a solid to a liquid inside the patient.

31. A method of treating restenosis comprising:

coupling a stent to a catheter,

spraying the catheter and the stent with a coating composition comprising a biologically active component and a biodegradable carrier having a melting point of about 50°

C. or less, and

deploying the coated stent into a body lumen of a patient.