Delivery systems for prosthetic heart valve

• US 9,795,477 B2
• Filed: 04/22/2016
• Issued: 10/24/2017
• Est. Priority Date: 07/27/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tran, Tri D., Cayabyab, Ronaldo C., Evans, David J., Chow, Sean, Chia, Christopher
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): IGBOKO, CHIMA U
• Application Number:
  US15/136,735
• Publication Number:
  US 20160235532A1
• Time in Patent Office: 550 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0021 differing in coefficient of friction
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation

Abstract

Described herein are systems and methods from delivering prosthetic devices, such as prosthetic heart valves, through the body and into the heart for implantation therein. The prosthetic devices delivered with the delivery systems disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery system to a radially expanded state for implantation using an inflatable balloon of the delivery system. Exemplary delivery routes through the body and into the heart include transfemoral routes, transapical routes, and transaortic routes, among others.

Claims

1. A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart, the apparatus comprising:

an elongated shaft comprising a proximal end portion and a distal end portion;

an inflatable balloon mounted on the distal end portion of the shaft; and

a valve mounting member disposed on the distal end portion of the shaft within the balloon and configured to facilitate frictional engagement between the prosthetic heart valve and the balloon when the prosthetic heart valve is mounted in a radially compressed state on the balloon and surrounding the mounting member, the mounting member comprising at least one longitudinally extending fluid passageway through which an inflation fluid in the balloon can flow, the fluid passageway extending from a proximal end portion to a distal end portion of the mounting member, wherein inflation fluid outside of the mounting member can flow inwardly through the proximal end portion of the mounting member, into and through the fluid passageway, and then outwardly through the distal end of the mounting member into space within the balloon outside of the mounting member; and

a tapered member mounted on the shaft inside the balloon adjacent the distal end portion of the mounting member, the tapered member configured to shield a distal end of a prosthetic heart valve from contacting leaflets of the native heart valve when the prosthetic heart valve is mounted on the balloon in a crimped state surrounding the mounting member, wherein the tapered member comprises a proximal opening and a radially extending slot that allow the inflation fluid from the distal end portion of the mounting member to flow through the proximal opening and the slot into the space within the balloon outside of the mounting member.

2. The delivery apparatus of claim 1, wherein the mounting member is contained completely within the balloon.

3. The delivery apparatus of claim 1, wherein the mounting member comprises a coiled wire secured to the shaft, and the at least one fluid passageway comprises a lumen of the coiled wire.

4. The delivery apparatus of claim 3, wherein the coiled wire comprises a first section, a second section, and a third section intermediate the first and second sections, wherein coils of the first and second sections have a pitch that is greater than a pitch of coils of the third section.

5. The delivery apparatus of claim 3, wherein the coiled wire defines the proximal and distal end portions of the mounting member and the inflation fluid can flow through spaces between coils within the proximal and distal end portions of the coiled wire.

6. The delivery apparatus of claim 1, wherein the mounting member comprises an inner wall mounted on the shaft and an outer wall radially spaced from the inner wall, and the at least one fluid passageway comprises at least one lumen defined between the inner and outer walls.

7. The delivery apparatus of claim 1, in combination with a prosthetic heart valve mounted on the balloon in a crimped state surrounding the mounting member, wherein the first and second end portions of the mounting member comprise first and second openings, respectively, adjacent first and second ends of the prosthetic heart valve, respectively, and allow inflation fluid in the balloon to flow from a first region of the balloon proximal to the first end of the prosthetic valve, inwardly through the first opening, through the fluid passageway, outwardly through the second opening and into a second region of the balloon distal to the second end of the prosthetic valve.

8. The delivery apparatus of claim 1, wherein the distal end portion of the mounting member extends into the proximal opening of the tapered member.

9. A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart, the apparatus comprising:

an elongated shaft comprising a proximal end portion and a distal end portion;

an inflatable balloon mounted on the distal end portion of the shaft; and

a valve mounting member comprising a coiled wire coaxially disposed on the distal end portion of the shaft within the balloon and configured to facilitate frictional engagement between the prosthetic heart valve and the balloon when the prosthetic heart valve is mounted in a radially compressed state on the balloon and surrounding the coiled wire, the coiled wire comprising a proximal end portion, a distal end portion, and a lumen extending from the proximal end portion to the distal end portion through which an inflation fluid in the balloon can flow, wherein inflation fluid outside of the coiled wire can flow inwardly through spaces between coils within the proximal end portion of the coiled wire, into and through the lumen, and then outwardly through spaces between coils within the distal end portion of the coiled wire into space within the balloon outside of the coiled wire; and

a tapered member mounted on the shaft inside the balloon adjacent the distal end portion of the coiled wire, the tapered member configured to shield a distal end of a prosthetic heart valve from contacting leaflets of the native heart valve when the prosthetic heart valve is mounted on the balloon in a crimped state surrounding the coiled wire, wherein tapered member comprises a proximal opening and a radially extending slot that allow the inflation fluid from the distal end portion of the coiled wire to flow through the proximal opening and the slot into the space within the balloon outside of the coiled wire.

10. The delivery apparatus of claim 9, wherein the coiled wired comprises an intermediate portion between the proximal and distal end portions, the coils of the proximal and distal end portions having a pitch that is greater than a pitch of coils of the intermediate portion.

11. The delivery apparatus of claim 9, wherein the distal end portion of the coiled wire extends into the proximal opening of the tapered member.

12. The delivery apparatus of claim 9, wherein the coiled wire is contained completely within the balloon.