Coated medical device

• US 9,814,865 B2
• Filed: 02/28/2014
• Issued: 11/14/2017
• Est. Priority Date: 10/31/2000
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Bates, Brian L., Ragheb, Anthony O., Stewart, IV, Joseph M., Bourdeau, William J., Choules, Brian D., Purdy, James D., Fearnot, Neal E.
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US14/193,312
• Publication Number:
  US 20140178563A1
• Time in Patent Office: 1,355 Days
• Field of Search: 427 224, 427 228, 427 21, 604265, 60410308, 604266
• 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 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0025 differing in roughness
• CPC Class Codes: A61F 2250/0026 differing in surface structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0081 Prosthesis for animals
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• 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 2300/606 Coatings
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 : Macromolecular materials
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 : Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/1031 : Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2250/00 : Specially adapted for animals
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Claims

1. A method for making a drug-coated angioplasty catheter, comprising:

applying a solution of a lipophilic drug directly to a surface of a balloon wall of a balloon of an angioplasty catheter, and drying the solution to form a coating of the lipophilic drug directly on the balloon wall to provide an outermost surface over the balloon, wherein said solution comprises a solvent, said lipophilic drug, and an iodine-containing radiopaque agent, and said lipophilic drug is selected from prostacyclin and prostacyclin analogues, rapamycine, colchicine, and paclitaxel.

2. The method of claim 1, wherein the lipophilic drug is paclitaxel.

3. The method of claim 2, wherein the solution consists of said solvent, paclitaxel, and said radiopaque agent.

4. The method of claim 1, wherein the solution consists of said solvent, said lipophilic drug, and said radiopaque agent.

5. The method of claim 1, also comprising processing said angioplasty catheter to be suitable for insertion into a patient with said coating providing said outermost surface.

6. The method of claim 1, wherein said solvent is ethanol.

7. A method of claim 1, wherein said solution consists of ethanol, paclitaxel, and an iodine-containing radiopaque agent, and said applying is by immersing said balloon surface into said solution.

8. The method of claim 1, wherein the lipophilic drug is rapamycine.

9. A method for making a drug-coated angioplasty device, comprising:

applying a solution of a lipophilic drug directly to a surface of a balloon of an angioplasty device, said solution comprising a solvent, said lipophilic drug, and an iodine-containing radiopaque agent, and drying the solution to form a coating of the lipophilic drug directly on the surface of said balloon to provide an outermost surface over said balloon, wherein said lipophilic drug is selected from prostacyclin and prostacyclin analogues, rapamycine, colchicine, and paclitaxel.

10. The method of claim 9, wherein the lipophilic drug is paclitaxel.

11. The method of claim 10, wherein the solution consists of said solvent, paclitaxel, and said radiopaque agent.

12. The method of claim 9, wherein the solution consists of said solvent, said lipophilic drug, and said radiopaque agent.

13. The method of claim 9, also comprising rendering said angioplasty device suitable for insertion into a patient with said coating providing said outermost surface.

14. The method of claim 9, wherein said surface is a balloon wall surface of the angioplasty device.

15. The method of claim 9, wherein the lipophilic drug is rapamycine.

16. A method for making an angioplasty device useful for applying a lipophilic drug to a wall of a vascular vessel of a patient, the angioplasty device comprising a balloon having an outermost surface for contact with the wall of the vascular vessel, the method comprising:

processing an angioplasty device so as to be suitable for insertion into a patient to perform an angioplasty, wherein the processed angioplasty device comprises a balloon having an outermost coating comprising a lipophilic drug, the outermost coating positioned on a portion of the balloon that contacts the wall of the vascular vessel upon conduct of an angioplasty procedure with the angioplasty device;

wherein said processing includes applying an amount of a solution comprising a solvent, said lipophilic drug, and an iodine-containing radiopaque agent directly to the balloon to form said outermost coating, and wherein said lipophilic drug is selected from prostacyclin and prostacyclin analogues, rapamycine, colchicine, and paclitaxel.

17. The method of claim 16, wherein said lipophilic drug is paclitaxel.

18. The method of claim 16, wherein the solution consists of said solvent, paclitaxel, and said radiopaque agent.

19. The method of claim 16, wherein the solution consists of said solvent, said lipophilic drug, and said radiopaque agent.

20. The method of claim 16, wherein the lipophilic drug is rapamycine.

21. A method for making a drug-coated angioplasty catheter, comprising:

applying a solution of a lipophilic drug directly to a surface of a balloon wall of a balloon of the angioplasty catheter and drying the solution to form a coating comprising the lipophilic drug directly on the balloon wall to provide an outermost surface over the balloon, wherein said solution comprises a solvent, said lipophilic drug, and an iodine-containing radiopaque agent, and said lipophilic drug is selected from prostacyclin and prostacyclin analogues, rapamycine, colchicine, and paclitaxel.

22. A method for making a drug-coated angioplasty device, comprising:

applying a solution of a lipophilic drug directly to a surface of a polymeric balloon wall of a balloon of an angioplasty device and drying the solution to form a coating of the lipophilic drug directly on the polymeric balloon wall to provide an outermost surface over the balloon, wherein said solution comprises a solvent, said lipophilic drug, and an iodine-containing radiopaque agent, and said lipophilic drug is selected from prostacyclin and prostacyclin analogues, rapamycine, colchicine, and paclitaxel.