UNFOLDING BALLOON CATHETER FOR PROXIMAL EMBOLUS PROTECTION

• US 20070249998A1
• Filed: 06/28/2007
• Published: 10/25/2007
• Est. Priority Date: 10/21/2003
• Status: Active Grant

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Ramzipoor, Kamal, Ngo, Tra, Nguyen, Hieu, Le, Maggie, Nair, Ajitkumar
• Granted Patent: US 8,444,661 B2
• Time in Patent Office: Days
• US Class Current: 604/96.10
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/3435 using everted sleeves

Abstract

Devices, systems and methods for removing foreign bodies within a body lumen are disclosed. An unfolding balloon catheter may include an elongated shaft having an intussuscepting balloon that can be actuated within a body lumen to capture and retrieve an intravascular device. The balloon may be configured to radially and/or axially expand when inflated, enveloping the intravascular device. In certain embodiments, the balloon may be formed by folding the ends of a distensible member inwardly, and then bonding the ends of the distensible member to the elongated shaft to form an expandable sleeve. An adhesive layer located along a portion of the elongated shaft may be used to temporarily secure the balloon to the elongated shaft.

Claims

1. A medical device for retrieving an intravascular device within a body lumen, comprising:

an elongated shaft having a proximal section and a distal section;

an inflation lumen extending from the proximal section of the elongated shaft to the distal section of the elongated shaft; and

an expandable sleeve coupled to the distal section of the elongated shaft and in fluid communication with the inflation lumen, the expandable sleeve configured to unfold along an adhesive layer disposed about a portion of the elongated shaft for retrieving the intravascular device within said body lumen.

2. The medical device of claim 1, further comprising a retrieval lumen extending from the proximal section of the shaft to an opening at the distal end of the elongated shaft.

3. The medical device of claim 2, wherein the retrieval lumen includes a distal flared region.

4. The medical device of claim 2, wherein the retrieval lumen is operatively coupled to a vacuum source.

5. The medical device of claim 2, wherein the retrieval lumen includes a lubricious coating.

6. The medical device of claim 1, wherein the inflation lumen includes an inflation port disposed through an external wall of the elongated shaft.

7. The medical device of claim 1, wherein the inflation lumen is operatively coupled to a pressure source.

8. The medical device of claim 1, wherein the expandable sleeve is configured to unfold along the adhesive layer when inflated to a sufficient pressure.

9. The medical device of claim 1, wherein the expandable sleeve is configured to radially and axially expand to a pre-defined shape when inflated to a sufficient pressure.

10. The medical device of claim 1, wherein the expandable sleeve is formed of a non-compliant material.

11. The medical device of claim 1, wherein the expandable sleeve is formed of a compliant material.

12. The medical device of claim 1, wherein the expandable sleeve is formed at least in part of polyethylene.

13. The medical device of claim 1, wherein the expandable sleeve includes an inner layer and an outer layer.

14. The medical device of claim 13, wherein the inner layer of the expandable sleeve is thinner than the outer layer of the expandable sleeve.

15. The medical device of claim 13, wherein the expandable sleeve includes cutting means.

16. The medical device of claim 15, wherein said cutting means comprises at least one cutting blade or edge.

17. The medical device of claim 1, wherein said intravascular device is a clot puller.

18. A medical device for retrieving an intravascular device within a body lumen while preventing proximal embolus flow, comprising:

an elongated shaft having a proximal section, a distal section., and an external wall;

an inflation lumen extending from the proximal section of the elongated shaft to the distal section of the elongated shaft, the inflation lumen including an inflation port disposed through the external wall of the elongated shaft;

an expandable sleeve coupled to the distal section of the elongated shaft and in fluid communication with the inflation lumen, the expandable sleeve configured to unfold along an adhesive layer disposed about a portion of the elongated shaft for retrieving the intravascular device within said body lumen; and

a retrieval lumen extending from the proximal section of the shaft to an opening at the distal end of the shaft.

19. The medical device of claim 18, wherein the retrieval lumen includes a distal flared region.

20. The medical device of claim 18, wherein the retrieval lumen is operatively coupled to a vacuum source.

21. The medical device of claim 18, wherein the retrieval lumen includes a lubricious coating.

22. The medical device of claim 18, wherein the inflation lumen is operatively coupled to a pressure source.

23. The medical device of claim 18, wherein the expandable sleeve is configured to unfold along the adhesive layer when inflated to a sufficient pressure.

24. The medical device of claim 18, wherein the expandable sleeve is configured to radially and axially expand to a pre-defined shape when inflated to a sufficient pressure.

25. The medical device of claim 18, wherein the expandable sleeve is formed of a non-compliant material.

26. The medical device of claim 18, wherein the expandable sleeve is formed of a compliant material.

27. The medical device of claim 18, wherein the expandable sleeve is formed at least in part of polyethylene.

28. The medical device of claim 18, wherein the expandable sleeve includes an inner layer and an outer layer.

29. The medical device of claim 28, wherein the inner layer of the expandable sleeve is thinner than the outer layer of the expandable sleeve.

30. The medical device of claim 28, wherein the expandable sleeve includes cutting means.

31. The medical device of claim 30, wherein said cutting means comprises at least one cutting blade or edge.

32. The medical device of claim 18, wherein said intravascular device is a clot puller.