MITRAL VALVE DELIVERY DEVICE

• US 20170325954A1
• Filed: 05/11/2017
• Published: 11/16/2017
• Est. Priority Date: 05/13/2016
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Perszyk, Brian Joseph
• Granted Patent: US 10,624,740 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

A delivery device for a collapsible prosthetic heart valve may include a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The operating handle may include a first lead screw fixedly coupled to the proximal segment, a second lead screw coupled to the distal segment, a knob rotatable relative to a housing of the operating handle and threadedly engaged with the first lead screw, and a coupling assembly. The coupling assembly may have a first condition in which rotation of the knob in one direction moves the first lead screw but not the second lead screw, and a second condition in which rotation of the knob in the one direction simultaneously moves the first lead screw and the second lead screw.

Claims

1. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

a catheter assembly including an inner shaft around which a compartment is defined, and a distal sheath having a proximal segment and a distal segment together configured to enclose the compartment; and

an operating handle coupled to the catheter assembly, the operating handle including;

a housing defining a movement space therein;

a first lead screw fixedly coupled to the proximal segment of the distal sheath and moveable in first and second opposite longitudinal directions within the movement space;

a second lead screw coupled to the distal segment of the distal sheath and moveable in the first and second longitudinal directions within the movement space;

a knob coupled to the housing and rotatable relative to the housing, the knob being threadedly engaged with the first lead screw; and

a coupling assembly having a first condition in which rotation of the knob in one direction moves the first lead screw in the first longitudinal direction and does not move the second lead screw in the first or second longitudinal directions, and a second condition in which rotation of the knob in the one direction simultaneously moves the first lead screw in the first longitudinal direction and the second lead screw in the second longitudinal direction.

2. The delivery device of claim 1, wherein the second lead screw has an elongated bore configured to receive at least a portion of the first lead screw therein.

3. The delivery device of claim 1, wherein the coupling assembly is configured to be selectively threadedly engaged with and disengaged from the second lead screw.

4. The delivery device of claim 1, wherein in the first condition of the coupling assembly, rotation of the knob in another direction opposite the one direction moves the first lead screw in the second longitudinal direction and does not move the second lead screw in the first or second longitudinal directions, and in the second condition of the coupling assembly, rotation of the knob in the another direction simultaneously moves the first lead screw in the second longitudinal direction and the second lead screw in the first longitudinal direction.

5. The delivery device of claim 1, wherein the coupling assembly includes a split nut having a plurality of threaded split nut portions, the split nut portions each being slideable away from one another and away from the second lead screw, the split nut having an engaged position in which threads of the split nut portions are engaged with the second lead screw and a disengaged position in which the threads of the split nut portions do not engage the second lead screw.

6. The delivery device of claim 1, wherein the inner shaft is fixedly coupled to the distal segment of the distal sheath and removably coupled to the second lead screw.

7. The delivery device of claim 1, wherein the coupling assembly includes an interference member that in the first condition of the coupling assembly limits movement of the first lead screw in the first longitudinal direction from an initial position to a limit position, and that in the second condition of the coupling assembly permits movement of the first lead screw in the first longitudinal direction beyond the limit position.

8. The delivery device of claim 1, wherein the coupling assembly includes a releasable lock that in the first condition of the coupling assembly prevents movement of the second lead screw in the second longitudinal direction, and that in the second condition of the coupling assembly permits movement of the second lead screw in the second longitudinal direction.

9. The delivery device of claim 1, wherein the first lead screw has external threads with a first pitch and the second lead screw has external threads with a second pitch, the first pitch being different than the second pitch.

10. An operating handle for a delivery device for a collapsible prosthetic heart valve, the operating handle comprising:

a housing defining a movement space therein;

a first lead screw moveable in first and second opposite longitudinal directions within the movement space;

a second lead screw moveable in the first and second longitudinal directions within the movement space;

a knob coupled to the housing and rotatable relative to the housing, the knob being threadedly engaged with the first lead screw; and

a coupling assembly having a first condition in which rotation of the knob in one direction moves the first lead screw in the first longitudinal direction and does not move the second lead screw in the first or second longitudinal directions, and a second condition in which rotation of the knob in the one direction simultaneously moves the first lead screw in the first longitudinal direction and the second lead screw in the second longitudinal direction.

11. A method of delivering a collapsible prosthetic heart valve in a patient, the method comprising:

providing a delivery device having a catheter assembly and an operating handle, the catheter assembly including a compartment adapted to receive the valve in an assembled condition and a distal sheath slidable relative to the compartment, the operating handle including a housing defining a movement space therein and first and second lead screws each movable in first and second opposite longitudinal directions within the movement space;

loading the valve into the compartment of the catheter assembly and covering the compartment and the valve with proximal and distal segments of the distal sheath;

inserting the catheter assembly into the patient so that the valve is positioned at a target location within the patient;

partially deploying the valve by moving the first lead screw in the first longitudinal direction within the movement space; and

fully deploying the valve by simultaneously continuing movement of the first lead screw in the first longitudinal direction within the movement space and moving the second lead screw in the second longitudinal direction within the movement space.

12. The method of claim 11, further comprising, after partially deploying the valve, coupling the movement of the first lead screw in the first longitudinal direction with the movement of the second lead screw in the second longitudinal direction.

13. The method of claim 12, wherein the coupling step includes moving portions of a split nut into threaded engagement with external threads of the second lead screw.

14. The method of claim 12, wherein the step of partially deploying the valve includes moving the first lead screw in the first longitudinal direction from an initial position to a limit position defined by an interference member, and the step of fully deploying the valve includes moving the interference member to enable the first lead screw to move in the first longitudinal direction beyond the limit position.

15. The method of claim 11, wherein the steps of partially deploying the valve and fully deploying the valve are performed by rotating a knob in a single direction.

16. The method of claim 11, wherein the collapsible prosthetic heart valve is a self-expanding prosthetic mitral valve, the target location is a native mitral valve annulus, and the step of partially deploying the valve releases anchor arms adjacent native mitral valve leaflets of the patient.

17. The method of claim 11, wherein the step of partially deploying the valve includes moving the proximal segment of the distal sheath in a proximal direction to partially uncover the valve, and the step of fully deploying the valve includes moving the proximal segment of the distal sheath in the proximal direction and the distal segment of the distal sheath in the distal direction to completely uncover the valve.

18. The method of claim 11, wherein the delivery device further includes an inner shaft around which the compartment is defined, the inner shaft being fixedly coupled to the distal segment of the distal sheath and removably coupled to the second lead screw, the method further comprising, after the step of fully deploying the valve, uncoupling the inner shaft from the second lead screw and moving the inner shaft relative to the housing to completely cover the compartment with the distal segment of the distal sheath.

19. The method of claim 11, wherein the second lead screw has an elongated bore configured to receive at least a portion of the first lead screw therein, and the steps of partially deploying the valve and fully deploying the valve each include moving the first lead screw within the elongated bore of the second lead screw.

20. The method of claim 11, wherein the step of fully deploying the valve includes moving the first lead screw a first distance in the first longitudinal direction and moving the second lead screw a second distance in the second longitudinal direction, the first distance being different than the second distance.