Devices and methods for transcatheter heart valve delivery

• US 9,060,860 B2
• Filed: 03/07/2013
• Issued: 06/23/2015
• Est. Priority Date: 08/18/2011
• 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: Morris, Benjamin E., Bielefeld, Eric E., Furnish, Gregory R., Thomas, Ralph Joseph, Le, Khoi, Knippel, Bradley Charles, Glazier, Valerie J.
• Primary Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US13/788,820
• Publication Number:
  US 20130297011A1
• Time in Patent Office: 838 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 606/108, 606/139, 606/142, 606/143, 606/191, 606/200
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/962 having an outer sleeve

Abstract

A delivery device for a collapsible prosthetic heart valve includes an operating handle and a catheter assembly. The operating handle may include a housing defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath operatively connected to the carriage assembly. Movement of the carriage assembly in the longitudinal direction in the movement space may move the distal sheath between the closed condition and the open condition. The coupling assembly may have an engaged position in which rotation of the deployment actuator moves the carriage assembly, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly.

Claims

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

an operating handle, including;

a housing defining a movement space therein;

a carriage assembly moveable in a longitudinal direction within the movement space;

a deployment actuator coupled to the housing and rotatable relative to the housing; and

a coupling assembly rotationally fixed to the deployment actuator, the coupling assembly having an engaged position in which rotation of the deployment actuator moves the carriage assembly in the longitudinal direction, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly in the longitudinal direction; and

a catheter assembly, including;

a first shaft around which a compartment is defined, the first shaft being operatively connected to the housing, the compartment being adapted to receive the valve in an assembled condition; and

a distal sheath operatively connected to the carriage assembly, the distal sheath being moveable between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve,

wherein movement of the carriage assembly in the longitudinal direction in the movement space moves the distal sheath between the closed condition and the open condition,

wherein the carriage assembly includes a threaded rod extending from a body of the carriage assembly and into threaded engagement with the coupling assembly, and

wherein the coupling assembly includes a split nut having a plurality of threaded split nut portions, the split nut having an engaged position in which threads of the split nut portions are engaged with the threaded rod and a disengaged position in which the threads of the split nut portions do not engage the threaded rod.

2. The delivery device of claim 1, wherein rotation of the deployment actuator in a first direction moves the carriage assembly proximally in the longitudinal direction in the movement space, and rotation of the deployment actuator in a second direction opposite the first direction moves the carriage assembly distally in the longitudinal direction in the movement space.

3. The delivery device of claim 1, wherein the split nut portions each are linearly slideable away from one another and away from the threaded rod.

4. The delivery device of claim 3, wherein the coupling assembly includes a ring coupled to the split nut portions, the ring having cam surfaces, the split nut portions being slideable along the cam surfaces when the split nut portions move between the engaged and disengaged positions.

5. The delivery device of claim 1, wherein the deployment actuator is a knob rotatable about a central axis that extends parallel to the longitudinal direction.

6. The delivery device of claim 1, wherein the carriage assembly includes a toothed rack extending from a body of the carriage assembly and into threaded engagement with the coupling assembly.

7. The delivery device of claim 1, wherein the deployment actuator is a knob rotatable about a central axis that extends perpendicular to the longitudinal direction.

8. The delivery device of claim 1, wherein the operating handle further includes a resheathing lock having a lock position and a release position, the resheathing lock in the lock position limiting movement of the carriage assembly in the longitudinal direction to a stop position in the movement space, and the resheathing lock in the release position permitting movement of the carriage assembly beyond the stop position.

9. The delivery device of claim 8, wherein movement of the carriage assembly to the stop position moves the distal sheath to a condition between the closed condition and the open condition so that the valve is not fully deployed.

10. The delivery device of claim 8, wherein the compartment has a first length and the stop position in the movement space corresponds to a travel distance of the carriage assembly, the travel distance being less than the first length.

11. The delivery device of claim 10, wherein the collapsible prosthetic heart valve has a second length, and wherein the travel distance is between about 80% and about 90% of the second length.

12. The delivery device of claim 1, wherein the catheter assembly further includes an outer shaft attached to the distal sheath and operatively connected to the carriage assembly, the outer shaft at least partially surrounding the first shaft.

13. The delivery device of claim 1, wherein the operating handle further includes a mechanism adapted to move the first shaft proximally relative to the housing.

14. The delivery device of claim 1, wherein the first shaft is attached to the distal sheath and operatively connected to the carriage assembly, the catheter assembly further including an outer shaft connecting the housing to the compartment and at least partially surrounding the first shaft.

15. The delivery device of claim 1, wherein the catheter assembly further includes an atraumatic tip having a lumen extending longitudinally therethrough and an insert located within the lumen, the first shaft having an outwardly flared distal end that is fixed between a distal end of the insert and material forming the atraumatic tip.

16. The delivery device of claim 15, wherein the insert has a plurality of ribs, each rib extending continuously or discontinuously around a circumference of the insert.

17. The delivery device of claim 15, wherein the atraumatic tip has an outer surface that is concavely tapered in a longitudinal direction thereof.

18. 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, the operating handle including a housing defining a movement space therein, a carriage assembly moveable in first and second longitudinal directions within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator, the operating handle further including a threaded rod extending from the carriage assembly and into threaded engagement with the coupling assembly, the coupling assembly including a split nut having a plurality of threaded split nut portions, the split nut having an engaged position in which threads of the split nut portions are engaged with the threaded rod and a disengaged position in which the threads of the split nut portions do not engage the threaded rod;

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

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 carriage assembly of the operating handle in the first longitudinal direction along a first portion of the movement space; and

fully deploying the valve by continuing movement of the carriage assembly in the first longitudinal direction along a second portion of the movement space.

19. The method of claim 18, wherein the deployment actuator is longitudinally constrained relative to the housing, and the partially deploying step includes rotating the deployment actuator.

20. The method of claim 19, wherein the split nut portions each are linearly slideable away from one another and away from the threaded rod, the method further comprising moving the split nut portions from the disengaged position to the engaged position.

21. The method of claim 20, wherein the coupling assembly includes a ring coupled to the split nut portions, the ring having cam surfaces, and the step of moving the split nut portions includes sliding the split nut portions along the cam surfaces from the disengaged position to the engaged position.

22. The method of claim 19, wherein the deployment actuator is a knob rotatable about a central axis that extends parallel to the first and second longitudinal directions.

23. The method of claim 18, wherein the operating handle further includes a toothed rack extending from the carriage assembly and into engagement with the coupling assembly, the deployment actuator being longitudinally constrained relative to the housing, and the partially deploying step includes rotating the deployment actuator.

24. The method of claim 23, wherein the deployment actuator is a knob rotatable about a central axis that extends perpendicular to the first and second longitudinal directions.

25. The method of claim 18, wherein the catheter assembly further includes a first shaft around which the compartment is defined and an outer shaft connecting the carriage assembly to the distal sheath and at least partially surrounding the first shaft, the first shaft is fixedly connected to the housing, the distal sheath is operatively connected to the carriage assembly, and the steps of partially deploying the valve and fully deploying the valve each include moving the outer shaft proximally relative to the housing.

26. The method of claim 18, wherein the catheter assembly further includes a first shaft around which the compartment is defined and an outer shaft connecting the housing to the compartment and at least partially surrounding the first shaft, the first shaft and the distal sheath are operatively connected to the carriage assembly, and the steps of partially deploying the valve and fully deploying the valve each include moving the first shaft distally relative to the housing.

27. The method of claim 18, wherein the operating handle further includes a resheathing lock having a lock position and a release position, the resheathing lock in the lock position limiting movement of the carriage assembly in the first longitudinal direction to a stop position in the movement space, and the resheathing lock in the release position permitting movement of the carriage assembly in the first longitudinal direction beyond the stop position.

28. The method of claim 18, further comprising resheathing the valve by moving the carriage assembly in the second longitudinal direction opposite the first longitudinal direction.

29. The method of claim 18, wherein the target location is the native aortic annulus of the patient.

30. The method of claim 18, wherein the inserting step includes inserting the distal sheath of the catheter assembly through a femoral artery of the patient.

31. The method of claim 18, wherein the inserting step includes inserting the distal sheath of the catheter assembly through the apex of the heart of the patient.

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

a first shaft around which a compartment is defined, the first shaft extending in a longitudinal direction and having an outwardly flared portion at a distal end thereof, the compartment being adapted to receive the valve in an assembled condition;

an outer shaft surrounding at least a longitudinal portion of the first shaft, the outer shaft being slidable relative to the first shaft in the longitudinal direction;

a distal sheath attached to one of the first shaft and the outer shaft and surrounding a longitudinal portion of the first shaft, the distal sheath being moveable in the longitudinal direction between a closed condition covering the compartment and an open condition uncovering the compartment for deployment of the valve, the distal sheath being operatively connected to a carriage assembly; and

an atraumatic tip attached to the distal end of the first shaft, the atraumatic tip having a lumen extending longitudinally therethrough and an insert located within the lumen, the outwardly flared portion of the first shaft being fixed between a distal end of the insert and material forming the atraumatic tip,

wherein the carriage assembly is moveable in first and second opposite directions and includes a threaded rod extending from the carriage assembly and into threaded engagement with a coupling assembly, the coupling assembly including a split nut having a plurality of threaded split nut portions, the split nut having an engaged position in which threads of the split nut portions are engaged with the threaded rod and a disengaged position in which the threads of the split nut portions do not engage the threaded rod.

33. The delivery device of claim 32, wherein the insert has a plurality of ribs, each rib extending continuously or discontinuously around a circumference of the insert.

34. The delivery device of claim 32, wherein the atraumatic tip has an outer surface that is concavely tapered in the longitudinal direction.