Drug delivery balloon catheter with line of weakness

• US 5,324,261 A
• Filed: 12/11/1992
• Issued: 06/28/1994
• 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): KRUTER, JEROME
• Application Number:
  US07/989,412
• Time in Patent Office: 564 Days
• Field of Search: 604/265, 604/266, 604/96, 604/101, 604/52, 604/53, 606/192, 606/194
• 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. In a catheter of the type comprising a catheter body and an inflatable balloon positioned along the length of the catheter body;

the improvement comprising;

a sheath over the balloon, the sheath having a longitudinal line of weakness sufficient to cause the sheath to burst at the line of weakness as the balloon is inflated; and

a viscous matrix material intermediate between the balloon and the sheath, said viscous matrix material having a drug or combination of drugs for treatment or diagnostics within a body lumen such that when the balloon is inflated it causes the sheath to burst at the line of weakness and expose the viscous matrix material.

2. The catheter of claim 1 wherein said viscous matrix also includes drug-containing microcapsules.

3. The catheter of claim 1 wherein said viscous matrix has anti-restenosis drugs therein.

4. The catheter of claim 1 wherein said viscous matrix comprises a bioabsorbable polymer selected from the group consisting of polyorthoester, polysaccharide, polyphosphoester, polyglycolic acid, polylactic acid and polyvinyl pyrrolidone.

5. The catheter of claim 1 wherein said viscous matrix material is sealed within the sheath.

6. The catheter of claim 5 wherein the sheath is sealed at its proximal and distal ends to the catheter.

7. The catheter of claim 1 wherein the sheath is made from an elastomeric material.

8. The catheter of claim 7 wherein the elastomeric material is a silicone elastomer.

9. A method for applying a drug to a body lumen comprising the steps of:

a. inserting a dilatation catheter having a drug-containing viscous matrix material on the exterior of a catheter balloon and a sheath having a longitudinal line of weakness over the balloon and viscous matrix material into a body lumen to a point where treatment is desired;

b. bursting the sheath at the line of weakness by expanding said balloon, thereby exposing the viscous matrix material;

c. releasing the exposed viscous matrix material against the lumen wall; and

d. removing said dilatation catheter.