Heart valve delivery system with valve catheter

• US 9,839,514 B2
• Filed: 11/09/2016
• Issued: 12/12/2017
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bourang, Henry, Le, Thanh Huy, Taylor, David M., Sok, Sam, Iobbi, Mario Gabriel, Evans, David J., Khanna, Rajesh A.
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US15/347,505
• Publication Number:
  US 20170056161A1
• Time in Patent Office: 398 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve

Abstract

An assembly for treating a native heart valve can include a prosthetic valve and a delivery apparatus. The prosthetic valve can include an expandable frame, a valve structure, a first end with apertures formed therein, and a second end. The delivery apparatus can include a valve catheter, flexible extension arms, slidable wires, and release members. First ends of the arms can be coupled to a cylindrical coupling element, second ends of the arms can be releasably coupled to the prosthetic valve, and the coupling element can be connected to the distal end of the valve catheter. The slidable wires can extend distally from the distal end of the valve catheter. The release members can be coupled to the distal end of the valve catheter and can extend through a respective aperture of the prosthetic valve, thereby forming a releasable connection between the prosthetic valve and the slidable wires.

Claims

1. An assembly for treating a native valve in a human heart, comprising:

a prosthetic heart valve including an expandable frame, a valve structure, a first end portion, and a second end portion, wherein the first end portion has plurality of apertures formed therein; and

a delivery apparatus, comprising;

a valve catheter having a proximal end portion and a distal end portion;

a cylindrical coupling element connected to the distal end portion of the valve catheter;

a plurality of flexible, shape memory metal extension arms having first and second end portions, wherein the first end portions of the flexible extension arms are coupled to the coupling element, the second end portions of the flexible extension arms are releasably coupled to the prosthetic heart valve, and the flexible extension arms are configured to hold the prosthetic heart valve at a fixed location axially spaced from the distal end portion of the valve catheter such that axial movement of the valve catheter in a proximal direction and a distal direction results in corresponding movement of the prosthetic heart valve in the proximal and distal directions;

a plurality of slidable wires extending distally from the distal end portion of the valve catheter; and

a plurality of release members coupled to the distal end portion of the valve catheter, wherein each of the release members extends through a respective aperture of the prosthetic heart valve, thereby forming a releasable connection between the prosthetic heart valve and the slidable wires.

2. The assembly of claim 1, wherein the delivery apparatus further comprises a knob at a proximal end portion of the delivery apparatus, and the slidable wires are coupled to the knob, wherein the slidable wires are axially moveable relative to the flexible extension arms upon actuation of the knob by a user.

3. The assembly of claim 2, wherein actuation of the knob in one direction pushes the slidable wires distally relative to the valve catheter, and actuation of the knob in another direction pulls the slidable wires proximally relative to the valve catheter.

4. The assembly of claim 1, wherein the slidable wires are circumferentially spaced relative to each other and are circumferentially aligned with the flexible extension arms.

5. The assembly of claim 1, wherein the delivery apparatus further comprises a tubular delivery sleeve, and wherein the flexible extension arms are configured to hold the prosthetic heart valve, to radially expand with the prosthetic heart valve during expansion of the prosthetic heart valve at a treatment site, and to radially contract when relative movement between the delivery sleeve and the valve catheter results in the delivery sleeve being positioned over the flexible extension arms, causing the prosthetic heart valve to collapse from an expanded state to an at least partially collapsed state.

6. The assembly of claim 5, wherein the first end portion of the prosthetic heart valve is retained on the flexible extension arms and the slidable wires when the prosthetic heart valve is releasably connected to the slidable wires by the release members.

7. The assembly of claim 5, wherein the delivery apparatus further comprises a handle portion having an actuation mechanism and a knob, and the delivery sleeve and the valve catheter are adjustably coupled to the actuation mechanism, wherein rotating the knob relative to the valve catheter actuates the actuation mechanism, thereby causing relative axial movement between the delivery sleeve and the valve catheter.

8. The assembly of claim 7, wherein the actuation mechanism comprises a lead screw, and the delivery sleeve is coupled to the lead screw, wherein rotating the knob relative to the valve catheter causes the lead screw to rotate relative to the valve catheter, and produces the relative axial movement between the delivery sleeve and the valve catheter.

9. The assembly of claim 7, wherein the knob of the handle portion is a first knob, and the handle portion further comprises a second knob, wherein the slidable wires are coupled to the second knob, and movement of the second knob relative to the valve catheter causes the slidable wires to move axially relative to the prosthetic heart valve and the flexible extension arms.

10. The assembly of claim 1, wherein the second end portions of the flexible extension arms axially overlap the first end portion of the prosthetic heart valve when the flexible extension arms are releasably coupled to the prosthetic heart valve.

11. The assembly of claim 1, wherein the expandable frame of the prosthetic heart valve is self-expanding.

12. An assembly for treating a native valve in a human heart, comprising:

a prosthetic heart valve including an expandable frame, a valve structure, a first end portion, and a second end portion, wherein the first end portion has plurality of apertures formed therein;

a delivery sleeve having a lumen;

a valve catheter having a proximal end portion and a distal end portion;

a plurality of flexible extension arms coupled to a cylindrical base at proximal end portions of the flexible extension arms and releasably coupled to the prosthetic heart valve at distal end portions of the flexible extension arms, wherein the base is connected to the distal end portion of the valve catheter, wherein the flexible extension arms are configured to hold the prosthetic heart valve at a fixed location axially spaced from the distal end portion of the valve catheter such that axial movement of the valve catheter in a proximal direction and a distal direction is effective to cause corresponding movement of the prosthetic heart valve in the proximal and distal directions, wherein the flexible extension arms are further configured to radially expand with the prosthetic heart valve during expansion of the prosthetic heart valve at a treatment site, and to radially contract when relative movement between the delivery sleeve and the valve catheter results in the delivery sleeve being positioned over the flexible extension arms, causing the prosthetic heart valve to collapse from an expanded state to an at least partially collapsed state when the proximal end portion of the prosthetic heart valve is disposed distally from the delivery sleeve;

a plurality of rods extending distally from the distal end portion of the valve catheter; and

a plurality of release members coupled to the distal end portion of the valve catheter, wherein each of the release members is moveable between a first state and a second state, wherein when the release members are in the first state, each release member extends through a respective aperture of the prosthetic heart valve, thereby releasably retaining the prosthetic heart valve on the rods and the flexible extension arms, and wherein when the release members are in the second state, each release member is removed from its respective aperture, thereby allowing the prosthetic heart valve to be released from the rods and the flexible extension arms.

13. The assembly of claim 12, wherein when the release members are in the second state and the rods are moved axially in a proximal direction relative to the prosthetic heart valve and the flexible extension arms, the valve catheter can be retracted proximally relative to the prosthetic heart valve.

14. The assembly of claim 12, where each rod is circumferentially aligned with and disposed radially inwardly of a respective flexible extension arm.

15. The assembly of claim 12, wherein the distal end portions of the flexible extension arms axially overlap the first end portion of the prosthetic heart valve when the flexible extension arms are releasably coupled to the prosthetic heart valve, and wherein the base axially overlaps with the distal end portion of the valve catheter.