Releasable coatings on balloon catheters

• US 5,102,402 A
• Filed: 01/04/1991
• Issued: 04/07/1992
• Est. Priority Date: 01/04/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Trescony, Paul, Dror, Michael
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US07/637,436
• Time in Patent Office: 459 Days
• Field of Search: 604/96, 604/99, 604/101, 604/265, 604/266, 604/51-53
• US Class Current: 604/265
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Balloon catheters are prepared to include a coating of body affecting chemicals on the exterior of the balloon. The coating releases from the balloon when the balloon is inflated into contact with the lumen to be treated. The device provides accurate placement of the dosage required at the location in need of treatment. The coating preferably includes drugs in microcapsules or microspheres. The catheters are especially useful in balloon angioplasty procedures.

Claims

1. In a balloon angioplasty catheter of the type comprising a catheter body and a balloon positioned along the length of the catheter body, said balloon including means for remotely inflating and deflating said balloon;

the improvement comprising;

(a) a plurality of microcapsules on the exterior of said balloon, each of said microcapsules carrying a drug or combination of drugs for treatment or diagnostics within a body lumen when said catheter is positioned and inflated therewithin such that the drug or drugs may be released from said microcapsules.

2. The catheter of claim 1 wherein said drug or drugs are selected from the group consisting of restenosis limiting drugs, plaque deposition preventing drugs, anti-smooth muscle cell proliferation drugs and diagnostic dyes.

3. The catheter of claim 1 wherein said drug or drugs are selected from the group consisting of antiplatelet drugs, anticoagulant drugs, anti-inflammatory drugs, antimetabolite drugs and combinations of said drugs.

4. In a dilatation catheter of the type comprising a catheter body and a dilatation balloon positioned along the length of the catheter body;

the improvement comprising;

(a) a plurality of microcapsules on the exterior of said balloon, each of said microcapsules carrying a drug which may affect the interior of a lumen when said catheter is positioned and inflated therewithin such that said microcapsules rupture to release their contents.

5. The catheter of claim 4 wherein said drug or drugs are selected from the group consisting of restenosis limiting drugs, plaque deposition preventing drugs, anti-smooth muscle cell proliferation drugs and diagnostic dyes.

6. The dilatation catheter of claim 4 wherein said drug is selected from the group consisting of antiplatelet drugs, anticoagulant drugs, anti-inflammatory drugs, antimetabolite drugs and combinations of said drugs.

7. The dilatation catheter of claim 4 wherein said microcapsules are attached to said balloon surface by an adhesive.

8. The dilatation catheter of claim 4 wherein said microcapsules are attached to said balloon surface by solvent welding.

9. The dilatation catheter of claim 4 wherein said microcapsules are held to said balloon within folds of said balloon formed when said balloon is deflated.

10. In a dilatation catheter of the type comprising a catheter body and a dilatation balloon positioned along the length of the catheter body;

the improvement comprising;

(a) a plurality of microcapsules on the exterior of said balloon, each of said microcapsules carrying a drug which may affect the interior of a lumen when said catheter is positioned and inflated therewithin such that said microcapsules will release from said balloon upon inflation of said balloon.

11. The dilatation balloon catheter of claim 10 wherein said microcapsules carry a plaque-affecting chemical therewithin.

12. A method for limiting acute or chronic lumen closure in an animal lumen comprising the steps of:

(a) inserting a dilatation catheter having a plurality of drug-containing microcapsules on the exterior of the catheter balloon into a lumen at the point where treatment is desired;

(b) expanding said balloon against the walls of the lumen to break open and release the contents of the microcapsules against the lumen wall; and

(c) removing said dilatation catheter.

13. A method for forming a balloon angioplasty catheter capable of supplying drug or drugs to a body lumen, said method comprising the steps of:

(a) obtaining a catheter having a balloon;

such that said drug is released onto a lumen during a balloon angioplasty procedure and

(b) applying a plurality of drug-containing microcapsules to the exterior of said balloon.

14. The method of claim 13 wherein said step for applying microcapsules to said balloon consists of adhering microcapsules to said balloon.

15. The method of claim 13 wherein said step for applying microcapsules to said balloon consists of solvent welding microcapsules to said balloon.

16. The method of claim 13 wherein said step for applying microcapsules to said balloon consists of inflating said balloon and dusting drug-containing microcapsules onto said balloon and then deflating said balloon to trap said microcapsules in folds formed by the walls of said deflated balloon.

17. A method for treating the interior of a body lumen comprising the steps of:

(a) inserting a balloon catheter having a balloon having an external coating of drug containing microcapsules into a lumen to be treated and positioning said balloon of said catheter next to the lumen wall needing treatment;

(b) expanding said balloon against the lumen wall to cause said microcapsules to rupture and release their contents; and

(c) removing said balloon catheter.

18. In a balloon angioplasty catheter of the type comprising a catheter body and a dilation balloon positioned along the length of the catheter body;

the improvement comprising;

(a) a releasable drug-carrying coating consisting of microcapsules in the exterior of said balloon, said drug of the type which may affect the interior of a lumen when said catheter is positioned and inflated therewithin in a balloon angioplasty procedure such that said coating is released from the balloon onto the lumen.

19. The dilatation catheter of claim 18 wherein said drug is selected from the group consisting of anti-smooth muscle cell proliferation drugs, antiplatelet drugs, anticoagulant drugs, anti-inflammatory drugs, anti-metabolite drugs and combinations of said drugs.

20. The dilatation catheter of claim 18 wherein said microcapsules are attached to said balloon surface by solvent welding.

21. The dilatation catheter of claim 18 wherein said microcapsules are attached to said balloon surface by an adhesive.