Coated medical device

• US 8,172,793 B2
• Filed: 05/31/2005
• Issued: 05/08/2012
• Est. Priority Date: 10/31/2000
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Bates, Brian L., Ragheb, Anthony O., Stewart, Joseph M. IV, Bourdeau, William J., Choules, Brian D., Purdy, James D., Fearnot, Neal E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): THOMAS, JR, BRADLEY G
• Application Number:
  US11/141,574
• Publication Number:
  US 20050278021A1
• Time in Patent Office: 2,534 Days
• Field of Search: 604/103.02, 604/103.08, 604/103.14, 604/265, 604/509, 606/194, 623/1.44
• US Class Current: 604/103.02
• 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 medical device, comprising:

a medical device having an expandable, percutaneous transluminal angioplasty balloon, the balloon having an outer surface;

a dried layer comprising paclitaxel on the outer surface of the balloon, said layer being the only layer on the balloon; and

wherein the paclitaxel is not incorporated within a containment layer.

5. A medical device according to claim 1, wherein the dried layer consists essentially of paclitaxel.

6. A medical device according to claim 1, wherein the dried layer consists essentially of paclitaxel and at least one other bioactive substance.

7. A medical device according to claim 1, wherein the dried layer consists essentially of paclitaxel and an iodine-containing radiopaque agent.

8. A medical device according to claim 1, wherein the dried layer is characterized by being dried onto the outer surface of the balloon by applying a solution including paclitaxel to the outer surface of the balloon and evaporating solvent from the solution.

2. A medical device for performing angioplasty in a blood vessel of a patient, the medical device comprising:

a medical device adapted for introduction into the vascular system of a patient, the medical device including an angioplasty device;

a dried layer comprising paclitaxel on an outer surface of the angioplasty device, said layer being the only layer on the angioplasty device; and

wherein the paclitaxel is not incorporated within a containment layer.

9. A medical device according to claim 2, wherein the dried layer consists essentially of paclitaxel.

10. A medical device according to claim 2, wherein the dried layer consists essentially of paclitaxel and at least one other bioactive substance.

11. A medical device according to claim 2, wherein the dried layer consists essentially of paclitaxel and an iodine-containing radiopaque agent.

12. A medical device according to claim 2, wherein the dried layer is characterized by being dried onto the outer surface of the angioplasty device by applying a solution including paclitaxel to the outer surface of the angioplasty device and evaporating solvent from the solution.

3. An angioplasty method for delivering paclitaxel to an inner wall of a blood vessel of a patient which comprises introducing into the blood vessel of the patient an angioplasty balloon of a medical device having an expandable, percutaneous transluminal angioplasty balloon, the balloon having an outer surface and a dried layer comprising paclitaxel on the outer surface of the balloon, said layer being the only layer on the balloon, and wherein the paclitaxel is not incorporated within a containment layer;

and deploying the balloon to perform angioplasty on the vessel.

13. A method according to claim 3, wherein the dried layer consists essentially of paclitaxel.

14. A method according to claim 3, wherein the dried layer consists essentially of paclitaxel and at least one other bioactive substance.

15. A method according to claim 3, wherein the dried layer is characterized by being dried onto the outer surface of the balloon by applying a solution including paclitaxel to the outer surface of the balloon and evaporating solvent from the solution.

16. A method according to claim 3, wherein the dried layer consists essentially of paclitaxel and an iodine-containing radiopaque agent.

4. An angioplasty method for delivering paclitaxel to an inner wall of a blood vessel of a patient which comprises introducing into the blood vessel of the patient an angioplasty device of a medical device adapted for introduction into the vascular system of a patient, the medical device including the angioplasty device and a dried layer comprising paclitaxel on an outer surface of the angioplasty device, said layer being the only layer on the angioplasty device, and wherein the paclitaxel is not incorporated within a containment layer;

and deploying the angioplasty device to perform angioplasty on the blood vessel.

17. A method according to claim 4, wherein the dried layer consists essentially of paclitaxel.

18. A method according to claim 4, wherein the dried layer consists essentially of paclitaxel and at least one other bioactive substance.

19. A method according to claim 4, wherein the dried layer consists essentially of paclitaxel and an iodine-containing radiopaque agent.

20. A method according to claim 4, wherein the dried layer is characterized by being dried onto the outer surface of the angioplasty device by applying a solution including paclitaxel to the outer surface of the angioplasty device and evaporating solvent from the solution.