Coated medical device

• US 7,803,149 B2
• Filed: 07/14/2003
• Issued: 09/28/2010
• Est. Priority Date: 07/12/2002
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Burton, David G., Schaeffer, Darin G., Boatman, Scott E., Sturgeon, Jason S., Bates, Brian L., Hoffa, Michael C., Ragheb, Anthony O.
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US10/618,977
• Publication Number:
  US 20040073284A1
• Time in Patent Office: 2,633 Days
• Field of Search: 604/509
• US Class Current: 604/509
• 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 of delivering paclitaxel to an inner wall of a blood vessel of a patient from an implantable medical device having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising the steps of:

providing an angioplasty balloon having a dried layer containing the paclitaxel on the outer surface of the balloon, the balloon being free of a coating atop the dried layer, the balloon being free of a time-release layer, the balloon being free of a containment material and the balloon being free of a containment layer; and

further wherein the balloon has folds, and portions of the dried layer containing paclitaxel are positioned in the folds;

advancing the balloon within the blood vessel to a treatment site within the blood vessel;

inflating the balloon at the treatment site to contact the balloon with an inner wall of the blood vessel;

maintaining the inflated balloon in contact with the inner wall of the blood vessel so as to transfer paclitaxel to the inner wall of the blood vessel;

deflating the balloon after said maintaining; and

removing the deflated balloon from the blood vessel.

2. The method of claim 1, wherein the balloon is inflated at the treatment site with an inflation time of up to about one minute.

3. The method of claim 1, wherein the dried layer further comprises a diagnostic agent.

4. The method of claim 1, wherein the blood vessel is a coronary artery.

5. The method of claim 1, wherein at said providing step, the implantable medical device includes a total of about 5 to about 500 μ

g of the paclitaxel on the outer surface of the balloon.

6. The method of claim 1, wherein the method is performed without implanting a stent within the blood vessel.

7. The method of claim 1, wherein the balloon comprises a material selected from the group consisting of:

a polyamide, polypropylene, PEBAX and polyethylene.

8. The method of claim 1, wherein the dried layer consists essentially of about 5 to about 500 μ

g of paclitaxel deposited on the outer surface of the expandable balloon.

9. The method of claim 1, wherein the implantable medical device is a balloon catheter having an expandable balloon with about 0.2 to about 20 μ

g of paclitaxel or a paclitaxel derivative deposited per mm² of the outer surface of the expandable balloon and a total of about 5 to about 500 μ

g of the paclitaxel or the paclitaxel derivative deposited on the outer surface of the expandable balloon; and

wherein the method further includes at least one of;

percutaneous insertion of the expandable balloon into the patient;

inflation of the balloon at the treatment site with an inflation time of up to about one minute to contact the paclitaxel or the paclitaxel derivative with the inner wall of the blood vessel;

or

maintaining the outer surface of the inflated balloon in contact with the inner wall of the blood vessel for only the period of the inflation of the balloon.

10. The method of claim 1, wherein the implantable medical device is a balloon catheter having an expandable balloon with a total of about 5 to about 500 μ

g of paclitaxel or a paclitaxel derivative deposited on the outer surface of the expandable balloon;

the expandable balloon is percutaneously inserted into the patient;

the balloon is inflated at the treatment site with an inflation time of up to about one minute to contact the paclitaxel or paclitaxel derivative with the inner wall of the blood vessel; and

the outer surface of the inflated balloon is maintained in contact with the inner wall of the blood vessel for only the period of the inflation of the balloon.

11. The method of claim 1, wherein at said providing step, the implantable medical device is a balloon catheter having an expandable balloon with a total of about 0.2 to about 20 μ

g of paclitaxel or a paclitaxel derivative per mm² of the outer surface of the expandable balloon.

12. The method of claim 1, wherein the folds are configured such that they unfurl upon inflation of the balloon, and wherein during said inflating the folds unfurl so as to cause portions of the balloon to come into rotational wiping contact with the inner wall of the blood vessel during which paclitaxel is transferred to the inner wall of the blood vessel.

13. A method of delivering paclitaxel to an inner wall of a blood vessel from a balloon catheter having an expandable balloon with a coating on an outer surface of the balloon, the method comprising:

providing a balloon catheter including a balloon with a dried coating consisting of paclitaxel or a mixture of paclitaxel with another bioactive agent, the dried coating being free of any additional coating atop the dried coating, where the paclitaxel or mixture of paclitaxel with another bioactive agent is not incorporated within a containment layer, and where the balloon has folds and portions of the dried coating are positioned in the folds;

advancing the balloon within the blood vessel to a treatment site;

inflating the balloon to directly contact the paclitaxel or mixture of paclitaxel with another bioactive agent with an inner wall of the blood vessel; and

delivering the paclitaxel or mixture of paclitaxel with another bioactive agent to the inner wall of the blood vessel while maintaining the paclitaxel or mixture of paclitaxel with another bioactive agent in direct contact with the inner wall of the blood vessel while the balloon is inflated.

14. The method of claim 13, where the balloon is attached to a catheter shaft that includes a guide wire lumen and an inflation lumen for inflating the balloon.

15. The method of claim 13, where the paclitaxel or mixture of paclitaxel with another bioactive agent is brought into direct contact with the vessel wall only while the outer surface of the inflated balloon is maintained in contact with the inner wall of the blood vessel.

16. The method of claim 15, where the method is performed without implanting a stent within the blood vessel.

17. The method of claim 13, wherein the folds are configured such that they unfurl upon inflation of the balloon, and wherein during said inflating the folds unfurl so as to cause portions of the balloon to come into rotational wiping contact with the inner wall of the blood vessel during which amounts of the paclitaxel or mixture of paclitaxel with another bioactive agent are transferred to the inner wall of the blood vessel.

18. A method of delivering paclitaxel to an interior wall of a blood vessel from a balloon catheter having an expandable balloon with a paclitaxel coating on an outer surface of the balloon, the method comprising:

providing a balloon catheter without a stent, the balloon catheter having a dried coating consisting of about 5 to about 500 micrograms of a single bioactive coating material consisting of paclitaxel per 25 mm² of the gross outer surface area of the balloon, the balloon catheter being free of any coating atop the paclitaxel, where the paclitaxel is not incorporated within a containment layer and amounts of the paclitaxel are deliverable to the interior wall upon direct contact of the paclitaxel with the interior wall, and where the balloon has folds and amounts of the dried coating are positioned in the folds;

advancing the balloon within the blood vessel to a treatment site within the blood vessel;

inflating the balloon at the treatment site to directly contact the paclitaxel in the coating with the interior wall of the blood vessel and thereby deliver paclitaxel to the interior wall without implanting a stent within the blood vessel.

19. The method of claim 18, wherein the folds are configured such that they unfurl upon inflation of the balloon, and wherein during said inflating the folds unfurl so as to cause portions of the balloon to come into rotational wiping contact with the interior wall of the blood vessel during which paclitaxel is transferred to the interior wall of the blood vessel.

20. A method of delivering paclitaxel to an inner wall of a blood vessel of a patient from an implantable medical device having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising the steps of:

providing an angioplasty balloon having a dried layer of coating material containing paclitaxel on the outer surface of the balloon, wherein the dried layer of coating material is the only layer on the balloon, wherein the balloon has folds configured to unfurl upon inflation of the balloon, and wherein portions of the dried layer are positioned in the folds;

advancing the balloon within the blood vessel to a treatment site within the blood vessel;

inflating the balloon at the treatment site so as to cause the folds to unfurl so that portions of the balloon come into rotational wiping contact with the inner wall of the blood vessel during which amounts of the coating material containing paclitaxel are transferred to the inner wall of the blood vessel;

maintaining the inflated balloon in contact with the inner wall of the blood vessel;

deflating the balloon after said maintaining; and

removing the deflated balloon from the blood vessel.

21. The method of claim 20, wherein the coating material further comprises a diagnostic agent.

22. The method of claim 20, wherein the coating material consists essentially of paclitaxel.

23. The method of claim 20, wherein the coating material further comprises an iodine-containing radiopaque agent.