Expansion device and method for treating vascular passageways

Patent metadata

Field	Value
Publication number	US-9707078-B2
Application number	US-201414475341-A
Country	US
Kind code	B2
Filing date	Sep 2, 2014
Priority date	Dec 15, 2009
Publication date	Jul 18, 2017
Grant date	Jul 18, 2017

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.

First claim

We claim:

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.

Assignees

• Edwards Lifesciences Corp

Inventors

• Madrid Gilbert
• Winston Matthew T
• Sok Sam
• Franklin Michael D

Classifications

• A61M25/1011

  Multiple balloon catheters · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61M25/10

  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 title

• A61F2/2433 Primary

  using balloon catheter · CPC title

• A61F2/243

  Deployment by mechanical expansion · CPC title