Liquid and low melting coatings for stents

• US 7,323,189 B2
• Filed: 12/21/2001
• Issued: 01/29/2008
• Est. Priority Date: 10/22/2001
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Ev3 Peripheral Inc. (Medtronic Plc)
• Inventors: Pathak, Chandrashekhar
• Primary Examiner(s): Azpuru; Carlos A.
• Application Number:
  US10/027,374
• Publication Number:
  US 20030083740A1
• Time in Patent Office: 2,230 Days
• Field of Search: 424/423
• US Class Current: 424/423
• 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 nonpolymeric carrier component, the nonpolymeric carrier component selected from the group consisting of Vitamin E, Vitamin E acetate, Vitamin E succinate, oleic acid, peanut oil and cottonseed oil, and wherein the nonpolymeric carrier component has a melting point of about 50°

C. or less and wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%.

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 carrier has a melting point of from about 35°

C. to about 45°

C.

4. The coated stent of claim 1 wherein the biologically 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 nonpolymeric carrier component is hydrophobic.

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

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

11. 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.

12. The coated stent of claim 1, wherein the stent comprises struts and the struts comprise capillaries, grooves, and channels engraved in the struts.

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

14. The coated stent of claim 13, wherein the surface enhancing feature is selected from the group consisting of grooves, capillaries, or channels.

15. The coated stent of claim 14 wherein the surface enhancing feature contains at least some of the coating composition.

18. The method of claim 13, wherein applying the coating composition comprises spraying or painting the coating composition onto the stent, or immersing the stent in the coating composition.

5. A coated stent comprising a stent and a coating composition that includes a biologically active component and a nonpolymeric carrier, component wherein the nonpolymeric carrier component has a viscosity of from about 0.1 to about 15000 cP less and wherein the coating composition comprises a nonpolymeric carrier component by weight in the range from 50–

99.9%.

6. A coated stent comprising a stent and a coating composition that includes a biologically active component and a nonpolymeric carrier, component, 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.

16. A method of coating a stent comprising:

providing a stent,

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

C. or less, and wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%; and

applying the coating composition to the stent.

17. The method of claim 16, further comprising the step of expanding the stent to an increased diameter before applying the coating composition to the stent.

19. A method of coating a stent comprising:

providing a stent,

providing a coating composition comprising a biologically active component and a nonpolymeric carrier component having a viscosity of from about 0.1 to about 15000 cP, and, wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%; and

applying the coating to the stent.

20. 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 biologically active component and a nonpolymeric carrier having a melting point of about 50°

C. or less and wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%.

21. A method of treating restenosis comprising:

deploying a coated stent into a body lumen of a patient, the coated stenting comprising a stent and a coating composition comprising a biologically active component and a nonpolymeric carrier component having a viscosity of from about 01. to about 15,000 cP and wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%.

22. A method of treating restenosis comprising:

providing a coated stent comprising a stent, a biologically active component and a coating composition comprising a nonpolymeric carrier component and wherein the coating composition comprises the nonpolymeric carrier component by weight in the range from 50–

99.9%; 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.

23. 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 nonpolymeric carrier component having a melting point of about 50°

C. or less, and

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