Expansion Device for Treatment of Vascular Passageways

• US 20110144742A1
• Filed: 12/15/2010
• Published: 06/16/2011
• Est. Priority Date: 12/15/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Madrid, Gilbert, Winston, Matthew, Franklin, Michael D., Sok, Sam
• Application Number:
  US12/969,187
• Publication Number:
  US 20110144742A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A delivery system for delivering an expandable member to a treatment location includes an elongate shaft and an expandable member coupled to a distal end of the elongate shaft. The expandable member is moveable between a collapsed configuration and an expanded configuration, and has an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member.

Claims

1. A system for delivering an expansion device to a treatment location within a patient'"'"'s body, the system comprising:

an elongate shaft having a distal end portion; and

an expansion device coupled to the distal end portion of the elongate shaft and moveable between a collapsed configuration and an expanded configuration, the expansion device having a distal end and a proximal end, and the expansion device comprising an inner expandable member and a plurality of outer expandable members,

wherein the plurality of outer expandable members comprise at least five outer expandable members that at least partially surround the inner expandable member and when the expandable member is in the expanded configuration, gaps between adjacent outer expandable members provide perfusion passageways across the expansion device.

2. The system of claim 1, wherein, when the expansion device is in the expanded configuration, the outer expandable members form a generally circular outer profile.

3. The system of claim 1, wherein the inner expandable member can be expanded independently of the plurality of outer expandable members.

4. The system of claim 1, wherein one or more of the plurality of outer expandable members can be expanded independently of the other of the plurality of outer expandable members.

5. The system of claim 1, wherein the plurality of outer expandable members are not fixed relative to an outer surface of the inner expandable member at an area between the proximal and distal ends of the inner expandable member.

6. The system of claim 1, wherein the plurality of outer expandable members are fixed at the proximal and distal ends of the inner expandable member.

7. The system of claim 6, wherein the plurality of outer expandable members are fused to the inner expandable member at the proximal and distal ends of the inner expandable member.

8. The system of claim 1, wherein each outer expandable member comprises a distal end and a proximal end, and the distal and proximal ends of at least one outer expandable member comprises enlarged portions, the at least one outer expandable member being configured to receive a prosthetic device between the enlarged portions at the distal end and the enlarged portions at the proximal end.

9. The system of claim 1, further comprising a prosthetic device in a crimped configuration, the outer expandable members comprising an outer surface configured to receive the prosthetic device.

10. The system of claim 9, wherein the prosthetic device comprises a valve having a plurality of leaflets forming a plurality of commissures, and the valve is configured to be received on the outer surface of the outer expandable members in an orientation where the outer expandable members are spaced apart from one or more of the plurality of commissures of the prosthetic device.

11. The system of claim 1, wherein the inner expandable member has a distal portion, a proximal portion, and an intermediate portion between the distal and proximal ends, and when the inner expandable member is in an expanded configuration, a diameter of the intermediate portion is smaller than a diameter of the distal portion.

12. The system of claim 1, wherein the inner expandable member and outer expandable members comprise balloon members.

13. The system of claim 12, wherein the plurality of outer expandable members comprise seven balloon members.

14. The system of claim 13, wherein the inner expandable member has a diameter of about 10-12 mm and the balloon members have a diameter of about 5-7 mm.

15. The system of claim 13, wherein the inner expandable member has a diameter of about 12-14 mm and the balloon members have a diameter of about 5-7 mm.

16. An expansion device comprising:

an elongate shaft having a distal end portion;

an inner balloon member coupled to the distal end portion of the elongate shaft and moveable between a collapsed configuration and an expanded configuration; and

a plurality of outer balloon members that at least partially surround the inner balloon member, each of the outer balloon members being moveable between a collapsed configuration and an expanded configuration, the outer balloon members having a generally circular cross-sectional shape when in the expanded configuration,

wherein, when the inner balloon member and at least some of the outer balloon members are in the expanded configuration within a body lumen, a plurality of passageways are provided between an outer surface of the expanded inner balloon member and an inner surface of the body lumen to allow blood to flow through the passageways and across the expansion device.

17. The expansion device of claim 16, wherein the outer balloon members comprise an outer surface that is configured to contact and urge against a prosthetic heart valve when in the expanded configuration to expand the prosthetic heart valve into a generally circular cross-sectional shape.

18. The expansion device of claim 17, wherein each outer balloon members has a working length that includes the portion of the outer balloon member that contacts and urges against the prosthetic heart valve, and the working length of at least some of the outer balloon members is shorter than a length of the prosthetic heart valve.

19. The expansion device of claim 18, wherein the outer balloon members are staggered so that at least some of the outer balloon members are not aligned along the length of the inner balloon member.

20. The expansion device of claim 16, wherein the plurality of outer balloon members are fixed to an outer surface of the inner balloon member at the proximal and distal ends of the inner balloon member.

21. The expansion device of claim 16, wherein the passageways have a total cross-sectional area that is equal to or greater than about 0.7 cm² at any location along the length of the inner balloon member.

22. A method for delivering an expandable member through the vasculature of a patient comprising:

providing an expandable member at a distal end of an elongate shaft, the expandable member having a distal end and a proximal end, the expandable member comprising an inner expandable member and a plurality of outer expandable members at least partially surrounding the inner expandable member;

delivering the expandable member to a treatment site;

expanding the inner expandable member in a passageway of the body of the patient;

expanding the plurality of outer expandable members in the passageway; and

permitting blood to pass through a plurality gaps formed between an inner surface of the passageway and outer surfaces of the inner and outer expandable members.

23. The method of claim 23, further comprising:

providing a prosthetic device;

positioning the prosthetic device on the expandable member; and

deploying the prosthetic device within the passageway by the acts of expanding the inner and outer expandable members.

24. The method of claim 23, wherein the act of expanding the inner expandable member is performed independently of the act of expanding the outer expandable members.

25. The method of claim 23, wherein the act of expanding the outer expandable members comprises expanding one or more of the outer expandable members before expanding the other of the outer expandable members.

26. The method of claim 23, wherein the outer expandable members are coupled to the outer surface of the inner expandable member at a distal end and a proximal end of the inner expandable member.

27. The method of claim 27, wherein the outer expandable members are movable relative to the inner expandable member between the distal and proximal ends of the inner balloon member.