DELIVERY SYSTEMS FOR PROSTHETIC HEART VALVE

• US 20130030519A1
• Filed: 07/26/2012
• Published: 01/31/2013
• 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, Evans, David J., Chow, Sean, Chia, Christopher
• Granted Patent: US 9,339,384 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 method of implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart, the method comprising:

introducing a delivery device into the body of a patient, the delivery device comprising a handle portion, an elongated shaft extending from the handle portion, the shaft having a distal end portion mounting an inflatable balloon and a prosthetic heart valve in a radially compressed state;

advancing the distal end portion of the delivery device toward the native heart valve until the prosthetic valve is within or adjacent the annulus of the native heart valve;

positioning the prosthetic heart valve at a desired implantation position within the annulus of the native by rotating an adjustment device coupled to the handle portion and the shaft to cause the shaft and the prosthetic valve to move distally and/or proximally relative to the handle portion until the prosthetic heart valve is at the desired implantation position; and

after the prosthetic heart valve has been moved to the desired implantation position, inflating the balloon to cause the prosthetic heart valve to radially expand and engage the annulus of the native heart valve.

2. The method of claim 1, wherein prior to positioning the prosthetic heart valve at a desired implantation position, activating a shaft engagement member that frictionally engages an outer surface of the shaft and prevents longitudinal movement of the shaft relative to the handle portion such that rotation of the adjustment device causes longitudinal movement of the shaft and the prosthetic heart valve.

3. The method of claim 2, wherein the shaft engagement member comprises a collet disposed on the shaft, the collet comprising a plurality of radially flexible fingers surrounding the outer surface of the shaft, wherein activating the shaft engagement member causes the fingers to press against and frictionally engage the outer surface of the shaft.

4. The method of claim 1, wherein the shaft comprises a first shaft and the delivery device comprises a second elongated shaft extending from the handle portion, the first shaft extending co-axially through the second shaft.

5. The method of claim 4, wherein:

when the delivery device is being introduced into the patient'"'"'s body, the prosthetic heart valve is mounted in the compressed state on the first shaft at a first location offset from a second, deployment location on the balloon;

prior to positioning the prosthetic heart valve at the desired implantation position, the prosthetic heart valve is moved longitudinally relative to the first shaft from the first location to the second location on the balloon by moving the second shaft relative to the first shaft in the longitudinal direction, or vice versa; and

rotating the adjustment device to position the prosthetic heart valve at the desired implantation position is effective to move the first shaft and the prosthetic valve distally and/or proximally relative to the second shaft.

6. The method of claim 5, wherein:

the delivery device comprises a mounting member within the balloon, and the first location of the prosthetic heart valve is a location offset from the mounting member and the second location of the prosthetic heart valve is a location surrounding the mounting member; and

when the prosthetic heart valve is moved to the second location surrounding the mounting member, the prosthetic heart valve frictionally engages the balloon such that movement of the first shaft distally and/or proximally relative to second shaft is effective to cause corresponding movement of the prosthetic heart valve relative to the second shaft.

7. The method of claim 1, wherein:

the delivery device comprises a mounting member within the balloon; and

when the prosthetic heart valve is being positioned at the desired implantation position, the prosthetic heart valve is mounted on the balloon in the compressed state surrounding the mounting member such that the frictional engagement of the prosthetic heart valve against the balloon is effective to retain the prosthetic heart valve in place on the balloon as the adjustment device is rotated to move the shaft distally and/or proximally relative to the handle portion until the prosthetic heart valve is at the desired implantation position.

8. The method of claim 7, wherein inflating the balloon comprises injecting pressurized inflation fluid into the balloon, which is allowed to flow from a proximal end portion of the balloon, through the mounting member and into a distal end portion of the balloon.

9. The method of claim 8, wherein the mounting member comprises a coiled wire secured to the shaft within the balloon.

10. The method of claim 1, wherein:

the delivery device comprises a tapered member mounted on the shaft inside the balloon; and

when the prosthetic heart valve is being positioned at the desired implantation position, the prosthetic heart valve is mounted on the balloon in the compressed state on the balloon proximal to the tapered member such that the tapered member shields a distal end of the prosthetic heart valve from contacting leaflets of the native heart valve.

11. 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;

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 though which an inflation fluid in the balloon can flow.

12. The delivery apparatus of claim 11, wherein the mounting member comprises a coiled wired secured to the shaft, and the at least one fluid passageway comprises a lumen of the coiled wire.

13. The delivery apparatus of claim 12, wherein the coiled wire comprises a first section, a second section, and a third section intermediate the first and second sections, wherein the coils of the first and second sections have a pitch that is greater than the pitch of the coils of the third section.

14. The delivery apparatus of claim 11, 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.

15. The delivery apparatus of claim 11, in combination with a prosthetic heart valve mounted on the balloon in a crimped state surrounding the mounting member, wherein the at least one fluid passageway has first and second openings adjacent first and second ends of the prosthetic heart valve, respectively, and allows 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.

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

a handle portion;

an elongated shaft extending from the handle portion, the shaft comprising a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state;

a sliding member disposed on the proximal end portion of the shaft;

the handle portion comprising a rotatable member that is operatively coupled to the sliding member so as to cause translational movement of the sliding member upon rotation of the rotatable member; and

a shaft engagement member disposed on the shaft and coupling the shaft to the sliding member, the shaft engagement member being configured to be manipulated between a first state in which the shaft can move freely in the longitudinal direction relative to the sliding member and the rotatable member and a second state in which the shaft engagement member frictionally engages the shaft and prevents rotational and longitudinal movement of the shaft relative to the sliding member such that rotation of the rotatable member causes corresponding longitudinal movement of the sliding member and the shaft.

17. The delivery apparatus of claim 16, wherein the shaft engagement member comprises a collet.

18. The delivery apparatus of claim 16, wherein the rotatable member comprises a user-engageable rotatable knob.

19. The delivery apparatus of claim 16, further comprising a rotatable knob coupled to the sliding member, the knob being rotatable between a first position and a second position, wherein when the knob is in the first position, the shaft engagement member is caused to frictionally retain the shaft in the first state, and wherein when the knob is in the second position, the shaft engagement member releases the shaft.

20. The delivery apparatus of claim 19, further comprising a biasing member disposed on the shaft between the knob and the shaft engagement member, wherein when the knob is in the first position, the biasing member provides a biasing force that urges the shaft engagement member to frictionally retain the shaft in the first state, and wherein when the knob is in the second position, the biasing force against the shaft engagement member is reduced and the shaft engagement member releases the shaft.