Method for making a drug delivery balloon catheter

• US 5,370,614 A
• Filed: 11/19/1993
• Issued: 12/06/1994
• Est. Priority Date: 01/04/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schwartz, Robert S., Dror, Michael, Amundson, Rodney R., Hull, Vincent W.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/155,402
• Time in Patent Office: 382 Days
• Field of Search: 604/53, 604/96, 604/104, 604/265, 604/890.1, 606/192, 606/194, 606/198
• US Class Current: 604/103.02
• 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

A balloon catheter includes a sheath surrounding the balloon, the sheath having a longitudinal line of weakness and a drug-containing viscous matrix material intermediate between the balloon and the sheath such that when the balloon is positioned and inflated in the body lumen it causes the sheath to burst at the line of weakness and release viscous matrix material onto said body lumen. The device provides accurate placement of the dosage required at the location in need of treatment. The catheter is especially useful in balloon angioplasty procedures.

Claims

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

a. applying a drug-containing viscous matrix material to the exterior of a balloon of a balloon catheter; and

b. applying a sheath having a longitudinal line of weakness over the balloon and the viscous matrix material; and

c. retaining the sheath over the balloon and the viscous matrix material as it is inserted into the body lumen.

2. The method of claim 1 further comprising the step of shrinking the sheath onto the balloon and viscous matrix material.

3. The method of claim 1 further comprising the step of sealing proximal and distal ends of the sheath to the catheter.

4. The method of claim 1 also comprising the step of expanding the sheath prior to applying it over the balloon and viscous matrix material.

5. The method of claim 4 wherein the sheath is expanded by applying a solvent to swell the sheath material.

6. The method of claim 4 wherein the sheath is expanded on a balloon.