Valve delivery system having an integral displacement component for managing chordae tendineae in situ and methods of use thereof

• US 10,368,988 B2
• Filed: 11/09/2016
• Issued: 08/06/2019
• Est. Priority Date: 11/09/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Jones, Tim
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/346,955
• Publication Number:
  US 20180125642A1
• Time in Patent Office: 1,000 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Embodiments hereof relate methods of delivering a valve prosthesis to an annulus of a native valve of a heart. A valve delivery system is introduced into a ventricle of the heart via a ventricular wall of the heart. The valve delivery system has a displacement component at the distal portion thereof. The valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has a first outer diameter. While the valve prosthesis is in the delivery configuration, the displacement component of the valve delivery system is radially expanded into an expanded state in which the displacement component has a second outer diameter greater than the first outer diameter. The valve delivery system is advanced towards the annulus of the native valve of the heart with the displacement component in the expanded state to displace chordae tendineae.

Claims

1. A method of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae, the method comprising the steps of:

introducing a valve delivery system into a ventricle of the heart via a ventricular wall of the heart, the valve delivery system having the valve prosthesis at a distal portion thereof and a displacement component at the distal portion thereof, wherein the valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has the first outer diameter, wherein the displacement component includes a hollow casing that houses a balloon, the balloon when deflated being entirely disposed within a chamber defined by the hollow casing, the hollow casing forming a distalmost tip of the valve delivery system;

radially expanding the displacement component of the valve delivery system into an expanded state in which the displacement component has the second outer diameter greater than the first outer diameter, wherein the valve prosthesis is in the delivery configuration and the balloon when inflated is disposed outside of the hollow casing;

advancing the valve delivery system towards the annulus of the native valve of the heart with the displacement component in the expanded state, wherein the second outer diameter is of a dimension that prevents the displacement component from passing through openings between chordae in the ventricle so that the displacement component in the expanded state pushes chordae in the ventricle radially outward away from the valve delivery system; and

deploying the valve prosthesis into apposition with the annulus of the native valve.

2. The method of claim 1, further comprising the step of:

at least partially radially collapsing the displacement component prior to the step of deploying the valve prosthesis.

3. The method of claim 1, wherein the step of deploying the valve prosthesis into apposition with the annulus of the native valve occurs with the displacement component in the expanded state.

4. The method of claim 1, wherein the first outer diameter is not greater than an outer diameter of an outer shaft of the valve delivery system and the second outer diameter is greater than the outer diameter of the outer shaft.

5. The method of claim 1, wherein the valve delivery system includes an outer shaft and an inner shaft concentrically slideably disposed within the outer shaft, the hollow casing being coupled to a distal end of the inner shaft.

6. The method of claim 5, wherein the inner shaft extends through the valve prosthesis and a delivery capsule is coupled to a distal end of the outer shaft, the delivery capsule being disposed over the valve prosthesis when the valve prosthesis is in its delivery configuration to compressively retain the valve prosthesis in a crimped engagement with the inner shaft.

7. The method of claim 5, wherein when the displacement component is in its delivery state, the balloon in extends around the inner shaft which extends through the hollow casing.

8. The method of claim 1, wherein the hollow casing includes a port formed therein to permit the balloon to deploy outside of the chamber defined by the hollow casing and thereby provide the displacement component with its expanded state.

9. The method of claim 8, further comprising the step of:

at least partially radially collapsing the displacement component prior to the step of deploying the valve prosthesis, wherein the balloon retracts back into the chamber via the port when radially collapsed.

10. The method of claim 9, wherein the balloon retracts back into the chamber defined by the hollow casing via a suction force created by removal of inflation fluid from an interior of the balloon.

11. The method of claim 8, further comprising the step of:

at least partially radially collapsing the displacement component prior to the step of deploying the valve prosthesis, wherein the balloon remains outside of the hollow casing when radially collapsed.

12. The method of claim 1, wherein the balloon is coupled to a distal end of a tubular component that extends along an exterior surface of the inner shaft, the tubular component defining an inflation lumen therethrough.

13. A method of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae, the method comprising the steps of:

introducing a valve delivery system into a ventricle of the heart via a ventricular wall of the heart, the valve delivery system having the valve prosthesis at a distal portion thereof and a displacement component at the distal portion thereof, wherein the valve prosthesis is in a delivery configuration and the displacement component is in a delivery state in which the displacement component has the first outer diameter, wherein the displacement component includes a hollow casing that houses a balloon, the balloon when deflated being entirely disposed within a chamber defined by the hollow casing, the hollow casing forming a distalmost tip of the valve delivery system;

radially expanding the displacement component of the valve delivery system into an expanded state in which the displacement component has the second outer diameter greater than the first outer diameter, wherein the valve prosthesis is in the delivery configuration and the balloon deploys through a port formed in the hollow casing such that when inflated the balloon is disposed outside of the hollow casing;

advancing the valve delivery system towards the annulus of the native valve of the heart with the displacement component in the expanded state, wherein the second outer diameter is of a dimension that prevents the displacement component from passing through openings between chordae in the ventricle so that the displacement component in the expanded state pushes chordae in the ventricle radially outward away from the valve delivery system; and

deploying the valve prosthesis into apposition with the annulus of the native valve.

14. The method of claim 13, further comprising the step of:

at least partially radially collapsing the displacement component prior to the step of deploying the valve prosthesis, wherein the balloon retracts back into the chamber via the port when radially collapsed.

15. The method of claim 14, wherein the balloon retracts back into the chamber defined by the hollow casing via a suction force created by removal of inflation fluid from an interior of the balloon.

16. The method of claim 13, further comprising the step of:

at least partially radially collapsing the displacement component prior to the step of deploying the valve prosthesis, wherein the balloon remains outside of the hollow casing when radially collapsed.

17. The method of claim 13, wherein the step of deploying the valve prosthesis into apposition with the annulus of the native valve occurs with the displacement component in the expanded state.

18. The method of claim 13, wherein the valve delivery system includes an outer shaft and an inner shaft concentrically slideably disposed within the outer shaft, the hollow casing being coupled to a distal end of the inner shaft, and wherein the first outer diameter of the displacement component is not greater than an outer diameter of the outer shaft and the second outer diameter is greater than the outer diameter of the outer shaft.

19. The method of claim 18, wherein the inner shaft extends through the valve prosthesis and the hollow casing, and wherein a delivery capsule is coupled to a distal end of the outer shaft, the delivery capsule being disposed over the valve prosthesis when the valve prosthesis is in its delivery configuration to compressively retain the valve prosthesis in a crimped engagement with the inner shaft.

20. The method of claim 13, wherein the balloon is coupled to a distal end of a tubular component that extends along an exterior surface of the inner shaft, the tubular component defining an inflation lumen therethrough.