Expansion device and method for treating vascular passageways

• US 9,707,078 B2
• Filed: 09/02/2014
• Issued: 07/18/2017
• Est. Priority Date: 12/15/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Winston, Matthew T., Franklin, Michael D., Madrid, Gilbert, Sok, Sam
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/475,341
• Publication Number:
  US 20140371847A1
• Time in Patent Office: 1,050 Days
• 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

Method 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. Embodiments of the expandable member are moveable between a collapsed configuration and an expanded configuration, and have an inner expandable member and a plurality of outer expandable members that at least partially surround the inner expandable member, and are suitable for delivering prosthetic heart valves and performing vavuloplasties.

Claims

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

delivering in an unexpanded state an expandable member at a distal end of an elongate shaft to a treatment site, 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, wherein the plurality of outer expandable members are not fixed relative to an outer surface of the inner expandable member at an area between proximal and distal ends of the inner expandable member, and each outer expandable member comprises a main section and at least one substantially narrowed section, the at least one substantially narrowed section distal and/or proximal of the main section, the main section of each outer expandable member extending along in contact with the outer surface of the inner expandable member when the expandable member is in the unexpanded state;

positioning a prosthetic device in a crimped state on the expandable member;

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

expanding the plurality of outer expandable members in the passageway, wherein expansion of the inner and outer expandable members expands the prosthetic device at the treatment site; and

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

2. The method of claim 1, wherein positioning the prosthetic device comprises positioning a prosthetic heart valve.

3. The method of claim 1, wherein positioning the prosthetic device on the expandable member comprises repositioning the prosthetic device in the crimped state from a location different from a location of the expandable member onto the expandable member.

4. The method of claim 1, wherein delivering an expandable member to a treatment site comprises advancing the expandable member through a guide catheter.

5. The method of claim 1, wherein delivering the expandable member to a treatment site comprises delivering the expandable member to a heart valve and performing a valvuloplasty.

6. The method of claim 1, wherein expanding the inner expandable member is performed independently of expanding the outer expandable members.

7. The method of claim 1, wherein expanding the outer expandable members comprises expanding one or more of the outer expandable members before expanding the other of the outer expandable members.

8. The method of claim 1, 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.

9. The method of claim 8, wherein the outer expandable members are movable relative to the inner expandable member between the distal and proximal ends of the inner expandable member.

10. A method for deploying a prosthetic heart valve without rapid pacing in a patient in need thereof, the method comprising:

positioning a prosthetic heart valve in a crimped state on an expansion device of a delivery system, the expansion device disposed at a distal end portion of a balloon catheter, the expansion device comprising;

an inner expandable member and a plurality of outer expandable members at least partially surrounding the inner expandable member, the plurality of outer expandable members not fixed relative to an outer surface of the inner expandable member between proximal and distal ends of the inner expandable member, each outer expandable member comprising a main section and at least one substantially narrowed section, the at least one substantially narrowed section distal or proximal of the main section, wherein positioning the prosthetic heart valve in the crimped state on the expansion device comprises crimping the prosthetic heart valve at a location of the delivery system other than the expansion device and repositioning the prosthetic heart valve onto the expansion device;

advancing the prosthetic heart valve through the vasculature to a native heart valve;

expanding the inner expandable member;

expanding the outer expandable members, thereby forming a plurality of gaps in the expansion device; and

permitting blood flow through a plurality of gaps, thereby deploying the prosthetic heart valve in the native heart valve without rapid pacing.

11. The method of claim 10, wherein advancing the prosthetic heart valve through the vasculature comprises advancing the prosthetic heart valve through a guide catheter.

12. The method of claim 10, wherein the delivery system further comprises a nose cone.

13. The method of claim 10, further comprising repositioning the prosthetic heart valve.

14. The method of claim 10, wherein expanding the inner expandable member is performed independently of expanding the outer expandable members.

15. A method for performing a valvuloplasty without rapid pacing in a patient in need thereof, the method comprising:

positioning an expansion device disposed at a distal end portion of a balloon catheter, the expansion device comprising;

an inner expandable member and a plurality of outer expandable members at least partially surrounding the inner expandable member, the plurality of outer expandable members not fixed relative to an outer surface of the inner expandable member between proximal and distal ends of the inner expandable member, each outer expandable member comprising a main section and at least one substantially narrowed section, the at least one substantially narrowed section distal or proximal of the main section;

advancing the expansion device through the vasculature to a native heart valve;

expanding the inner expandable member;

expanding the outer expandable members, thereby forming a plurality of gaps in the expansion device, wherein expanding the outer expandable members comprises expanding one or more of the outer expandable members before expanding the other of the outer expandable members; and

permitting blood flow through a plurality of gaps, thereby performing a valvuloplasty of the native heart valve without rapid pacing.

16. The method of claim 15, wherein expanding the inner expandable member is performed independently of expanding the outer expandable members.