Intra-aortic balloon catheter and insertion sheath

• US 6,346,092 B1
• Filed: 12/14/1998
• Issued: 02/12/2002
• Est. Priority Date: 12/14/1998
• Status: Expired due to Term

• Current Assignee: Datascope Corporation (Getinge AB)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Leschinsky, Boris
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/210,922
• Time in Patent Office: 1,156 Days
• Field of Search: 604/96.01, 604/103, 604/104, 604/536, 604/539, 604/97.1, 604/97.02, 604/97.03, 604/98.01, 604/98.02, 604/99.01, 604/99.02, 604/101.01, 604/101.02, 604/101.03, 604/101.04, 604/101.05, 604/915-921, 606/191-194
• US Class Current: 604/96.01
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance

Abstract

An improved intra-aortic balloon catheter system comprising an insertion sheath, having an expandable distal end, and a tapered balloon membrane capable of being removed through said insertion sheath upon completion of therapy. The outer diameter of the balloon membrane in a wrapped state is smaller than the outer diameter of the outer tube.

Claims

1. A balloon catheter comprising an outer tube, a tip, and a balloon membrane, a proximal portion of the balloon membrane is attached to the outer tube and a distal portion of the balloon membrane is connected to the tip, said balloon membrane is inserted into a body lumen in a wrapped state, the outer diameter of a substantial portion of the balloon membrane in its wrapped state is smaller than the outer diameter of the outer tube.

2. The balloon catherer as claimed in claim 1 wherein the balloon membrane is capable of being pulled through a distal end of an insertion sheath, a distal end of said insertion sheath having one or more scores.

3. The balloon catherer as claimed in claim 1 wherein the balloon membrane is capable of being pulled through a distal end of an insertion sheath, a distal end of said insertion sheath being expansible.

4. The balloon catheter as claimed in claim 1 wherein the balloon membrane has a taper such that the balloon membrane in a deflated state can be pulled through a distal end of an insertion sheath.

10. The balloon catherer as claimed in claim 1 wherein the balloon catherer is an intra-aortic balloon catherer and wherein a distal end of the balloon membrane and the outer tube are connected to a tip.

11. The balloon catheter as claimed in claim 3 wherein the distal end of the insertion sheath is expansible.

12. The balloon catheter as claimed in claim 3 wherein the distal end of the insertion sheath has one or more scores.

13. The balloon catherer as claimed in claim 1 wherein the balloon membrane is capable of being pulled through a distal end of an insertion sheath having an inner surface, a distal end of said inner surface having a truncated cone shape.

14. The balloon catherer as claimed in claim 1 further comprising a tip and an inner tube disposed within an outer surface of the outer tube, the tip, a distal end of the balloon membrane, and a distal end of the inner tube are connected.

15. The balloon catherer as claimed in claim 1 wherein the balloon membrane is capable of being pulled through a distal end of an insertion sheath having an outward lip.

5. An insertion sheath for a medical device, said medical device having a balloon membrane which is inserted in a compact state into a body lumen and which can be pulled through a distal end of an insertion sheath in a secondary state larger than the compact state it was originally inserted in, said insertion sheath having proximal, medial, and distal sections, said medial section being substantially non-expensible, said distal section being expansible so as to allow withdrawal of the medical device with the balloon membrane in the secondary state.

6. The insertion sheath as claimed in claim 5 comprising a tube having a one or more scores on its distal end.

7. A method for removing a balloon catheter from a body lumen after use of said balloon catheter,

said balloon catheter being inserted into a vessel through an insertion sheath,

said balloon catheter comprising an outer tube and a balloon membrane, at least a proximal portion of said balloon membrane is attached to the outer tube,

said insertion sheath having proximal, medial, and distal sections, said medial section being substantially non-expansible, said distal section being expansible,

said method comprising pulling the balloon catheter through a distal end of the insertion sheath with sufficient force so as to expand the distal end of the insertion sheath and pull the balloon catheter through the medial section of the insertion sheath.

8. The method as claimed in claim 7 wherein the balloon membrane has a taper on a proximal end.

9. The method as claimed in claim 7 wherein the balloon catherer further comprises a tip connected to a distal end of the balloon membrane.

20. The method as claimed in claim 7 wherein the insertion sheath comprises a tube having one or more scores on a distal end.

21. The method as claimed in claim 7 wherein the balloon catherer further comprises a tip and an inner tube disposed within an outer surface of the outer tube, the tip, a distal end of the balloon membrane, and a distal end of the inner tube are connected.

16. An insertion sheath for a medical device, said medical device having an outer tube and a balloon membrane at least partially attached to said outer tube, said medical device being inserted in a compact state into a body lumen, an inner surface of a distal end of the insertion sheath having a truncated cone shape which allows the medical device to be pulled through a distal end of the insertion sheath in a state larger than the compact state it was originally inserted in.

17. The insertion sheath as claimed in claim 16 wherein the medical device is an intra-aortic balloon catheter, the insertion sheath is tubular, and the balloon membrane is folded in the compact state.

18. An insertion sheath for a medical device, said medical device having an outer tube and a balloon membrane at least partially attached to said outer tube, said medical device being inserted in a compact state into a body lumen, a distal end of the inesertion sheath having an outward lip so as to allow the medical device to be pulled through a distal end of the insertion sheath in a state larger than the compact state it was originally inserted in. compact state it was originally inserted in, a distal end of the insertion sheath has an outward lip.

19. The insertion sheath as claimed in claim 18 wherein the medical device is an intra-aortic balloon catheter, the insertion sheath is tubular, and the balloon membrane is tubular in the compact state.