Delivery system for prosthetic heart valve

• US 10,588,744 B2
• Filed: 08/30/2016
• Issued: 03/17/2020
• Est. Priority Date: 09/04/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rupp, Kevin D., Le, Tung T., Le, Thanh Huy, Gray, Brian C., Froimovich Rosenberg, Alejandro J., Lindstrom, Jeff, Nguyen, Kim D., Tran, Sonny
• Primary Examiner(s): Aleman, Sarah W
• Application Number:
  US15/252,110
• Publication Number:
  US 20170065415A1
• Time in Patent Office: 1,295 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes 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. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

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:

a handle portion;

an elongated shaft extending from and movable relative to 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;

the handle portion comprising a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly, the gear assembly engaging the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion, the control member having a grip portion;

the handle portion further comprising a steering assembly including a rotatable member coupled to the handle portion, the steering assembly being configured to adjust a curvature of the elongated shaft;

wherein the control member is configured such that the grip portion of the control member is movable distally and proximally of the rotatable member of the steering assembly by longitudinal motion of the control member.

2. The delivery apparatus of claim 1, wherein the gear assembly is a compound gear including a first gear operatively connected to the control member and a second gear operatively connected to the elongated shaft.

3. The delivery apparatus of claim 2, wherein the first and second gears are situated on opposite sides of the elongated shaft and coupled to a gear shaft extending transverse to the elongated shaft such that the gear assembly is self-centering relative to the elongated shaft.

4. The delivery apparatus of claim 3, wherein the gear assembly further comprises:

a first rack gear member coupled to the control member and comprising a plurality of teeth configured to engage the first gear; and

a second rack gear member coupled to the elongated shaft on the opposite side of the elongated shaft from the first rack gear member, the second rack gear member comprising a plurality of teeth configured to engage the second gear.

5. The delivery apparatus of claim 2, wherein the gear assembly provides a gear reduction ratio that produces slower movement of the shaft relative to the control member.

6. The delivery apparatus of claim 5, wherein the gear reduction ratio is from about 1.1:

1 to about 5;

1.

7. The delivery apparatus of claim 1, wherein the control member is a lever member operable with a thumb or finger.

8. The delivery apparatus of claim 7, wherein the lever member is movable in a slot defined in the handle portion, and the lever member includes a locking member operable to engage and disengage one or more cogs disposed along the slot when the lever member is released and depressed, respectively, relative to the handle portion.

9. The delivery apparatus of claim 1, wherein the elongated shaft is a balloon catheter, and further comprising a steerable guide catheter disposed coaxially about the balloon catheter.

10. The delivery apparatus of claim 9, wherein the rotatable member of the steering assembly is coupled to a proximal end portion of the steerable guide catheter by a pull wire such that rotation of the rotatable member adjusts a curvature of a distal end portion of the steerable guide catheter.

11. The delivery apparatus of claim 10, wherein the steering assembly further comprises a pull wire attachment member and a tension member movably disposed on a threaded shaft coupled to the rotatable member.

12. The delivery apparatus of claim 11, wherein the steering assembly further comprises a ramp member operable to guide the pull wire radially away from an outer diameter of the balloon catheter to a height of the attachment member.

13. The delivery apparatus of claim 10, wherein the lever member comprises an arm that extends out of the handle portion and the grip portion is located at a distal end portion of the arm such that the grip portion and the rotatable member are substantially co-located along a longitudinal axis of the balloon catheter so as to be operable with one hand.

14. The delivery apparatus of claim 10, further comprising at least one guide member extending parallel to the threaded shaft and operatively connected to the pull wire attachment member and the tension member to prevent rotation of the pull wire attachment member and the tension member as they move on the threaded shaft.

15. A method of implanting a radially compressible and expandable prosthetic heart valve in a native 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 and movable relative to the handle portion, the shaft comprising a proximal end portion coupled to the handle portion and a distal end portion mounting 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 aortic arch, wherein the act of advancing comprises pushing the handle portion distally so as to push the delivery device distally through the patient toward the native heart valve;

steering the delivery device through the aortic arch by rotating a rotatable member of a steering assembly, the rotatable member being coupled to the handle portion, rotation of the rotatable member causing adjustment of a curvature of the elongated shaft;

axially positioning the prosthetic heart valve at a desired implantation position by moving a grip portion of a lever member coupled to the handle portion, the lever member engaging a gear assembly operable to convert longitudinal motion of the lever member to rotational motion of the gear assembly, the gear assembly engaging the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion, the grip portion of the lever member being movable proximally and distally of the rotatable member of the steering assembly; and

after the prosthetic heart valve has been moved to the desired implantation position, radially expanding the prosthetic heart valve to engage the annulus of the native heart valve.

16. The method of claim 15, wherein radially expanding the prosthetic heart valve further comprises inflating a balloon mounted on the distal end portion of the elongated shaft.

17. The method of claim 15, wherein moving the lever member further comprises depressing the lever member relative to the handle portion such that a locking member is disengaged from the handle portion to allow axial movement of the lever member.

18. The method of claim 15, wherein axially positioning the prosthetic heart valve further comprises moving the lever member such that longitudinal motion of the lever member causes rotational motion of a gear assembly coupled to the lever member and to the elongated shaft.

19. The method of claim 15, wherein the lever member and the rotatable member are substantially co-located along a longitudinal axis of the elongated shaft to facilitate one-handed operation.

20. The method of claim 15, further comprising angularly positioning the prosthetic heart valve at a desired implantation angle by rotating the rotatable member.

21. 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 balloon catheter shaft extending from the handle portion, the balloon catheter shaft including a proximal end portion coupled to the handle portion and a distal end portion, the balloon catheter shaft further comprising a balloon mounted on the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state;

a steerable guide shaft disposed coaxially about the balloon catheter shaft and including a proximal end portion coupled to the handle portion and a distal end portion;

a positioning assembly including a lever member coupled to the proximal end portion of the balloon catheter shaft and movable longitudinally with respect to the handle portion, the lever member engaging a gear assembly operable to convert longitudinal motion of the lever member to rotational motion of the gear assembly, the gear assembly engaging the balloon catheter shaft such that longitudinal motion of the lever member causes corresponding rotational motion of the gear assembly and longitudinal motion of the balloon catheter shaft with respect to the guide shaft and the handle portion, the lever member having a grip portion;

a steering assembly including a rotatable member and a pull wire having a proximal end portion operatively connected to the rotatable member and a distal end portion fixed to the distal end portion of the guide shaft such that rotation of the rotatable member adjusts curvatures of the respective distal end portions of the guide shaft and the balloon catheter shaft;

wherein the rotatable member of the steering assembly and the lever member of the positioning assembly are substantially co-located along a longitudinal axis of the balloon catheter shaft such that the grip portion of the lever member is movable distally and proximally of the rotatable member of the steering assembly by longitudinal motion of the control member and the rotatable member and the lever member are operable with one hand.

22. The delivery apparatus of claim 21, further comprising a protective cover that encapsulates the balloon and a portion of the distal end of the balloon catheter shaft, the cover defining a cavity shaped to accommodate the balloon and balloon catheter shaft assembly.