Methods and apparatuses for deploying minimally-invasive heart valves

• US 9,572,663 B2
• Filed: 03/10/2014
• Issued: 02/21/2017
• Est. Priority Date: 09/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Heneveld, Scott H. Sr., Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Prone, Christopher D
• Application Number:
  US14/203,258
• Publication Number:
  US 20140194977A1
• Time in Patent Office: 1,079 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion

Abstract

Methods and systems for delivering and deploying a prosthetic heart valve include a deployment mechanism coupled to the prosthetic heart valve, the deployment mechanism having a longitudinal shaft that when rotated in a first direction, expands the prosthetic heart valve from a contracted state to an expanded state, and optionally, when rotated in a second direction opposite the first direction, re-contracts the prosthetic valve from the expanded state. Embodiments of the deployment mechanism include a pinion gear that engages a gear track on the prosthetic heart valve.

Claims

1. A method for deploying a prosthetic valve in a patient'"'"'s native aortic valve, the method comprising:

percutaneously advancing through a patient'"'"'s vasculature a distal end portion of an elongate delivery system, a prosthetic valve in a contracted configuration disposed on the distal end portion, the prosthetic valve comprising a radially contractible and expandable tubular stent made from a nickel-titanium alloy and a plurality of leaflets secured to the stent, the plurality of leaflets made from bovine pericardium, the stent coupled to a deployment mechanism disposed on the distal end portion, the deployment mechanism comprising a longitudinally extending shaft and proximal and distal retaining components coupled to proximal and distal end portions of the stent, the shaft rotatable with respect the proximal and distal retaining components;

positioning the prosthetic valve in an annulus of a native aortic valve;

rotating the shaft of the deployment mechanism in a first direction, thereby expanding the prosthetic valve to a final expanded configuration within the annulus of the native aortic valve; and

actuating lockout features on the prosthetic valve to lock the prosthetic valve in the final expanded configuration.

2. The method of claim 1, further comprising:

before rotating the shaft of the deployment mechanism in the first direction, rotating the shaft in the first direction to expand the prosthetic valve from the contracted configuration to an initial expanded configuration;

rotating the shaft in a second direction opposite the first direction, thereby re-contracting the prosthetic valve from the initial expanded configuration; and

repositioning the prosthetic valve.

3. The method of claim 1, further comprising disengaging the delivery system from the prosthetic valve and removing the delivery system from the patient.

4. The method of claim 3, wherein disengaging the delivery system further comprises disengaging at least a portion of the deployment mechanism.

5. The method of claim 1, wherein percutaneously advancing the prosthetic valve comprises percutaneously advancing the prosthetic valve over a guide wire.

6. The method of claim 1, wherein the prosthetic valve is self-expandable.

7. A method for deploying a prosthetic valve in a patient'"'"'s native aortic valve, the method comprising:

percutaneously advancing through a patient'"'"'s vasculature a distal end portion of an elongate delivery system, a prosthetic valve in a contracted configuration disposed on the distal end portion, the prosthetic valve comprising a radially contractible and expandable tubular stent and a plurality of leaflets secured to the stent, the stent coupled to a deployment mechanism disposed on the distal end portion, the deployment mechanism comprising a longitudinally extending shaft, the shaft rotatable about a longitudinal axis thereof;

positioning the prosthetic valve in an annulus of a native aortic valve; and

rotating the shaft of the deployment mechanism in a first direction, thereby expanding the prosthetic valve to a final expanded configuration within the annulus of the native aortic valve,

wherein the shaft further comprises a set of gear teeth and the stent comprises a gear track positioned to engage the gear teeth.

8. A method for deploying a prosthetic valve in a patient'"'"'s native aortic valve, the method comprising:

percutaneously advancing through a patient'"'"'s vasculature a distal end of an elongate delivery system, a prosthetic valve in a contracted configuration disposed on the distal end portion, the prosthetic valve comprising a radically contractible and expandable tubular stent and a plurality of leaflets secured to the stent, the stent coupled to a deployment mechanism disposed on the distal end portion, the deployment mechanism comprising a longitudinally extending shaft, the shaft rotatable about a longitudinal axis thereof;

positioning the prosthetic valve in an annulus of a native aortic valve; and

rotating the shaft of the deployment mechanism in a first direction, thereby expanding the prosthetic valve to a final expanded configuration within the annulus of the native aortic valve,

wherein the shaft comprises a distal set of gear teeth and a proximal set of gear teeth, and the stent comprises a distal gear track and a proximal gear track, the distal set of gear teeth positioned to engage the distal gear track and the proximal set of gear teeth positioned to engage the proximal gear track.

9. A method for deploying a prosthetic valve in a patient'"'"'s native aortic valve, the method comprising:

advancing a prosthetic valve through a patient'"'"'s vasculature, the prosthetic valve comprising a radially contractible and expandable tubular stent body made from a nickel-titanium alloy and a plurality of leaflets made from bovine pericardium, the prosthetic valve coupled to a deployment mechanism positioned along a distal end portion of an elongate delivery system, the deployment mechanism comprising a plurality of retaining mechanisms and a rotatable shaft, the shaft being rotatable with respect to the retaining mechanisms;

positioning the prosthetic valve adjacent an annulus of a native aortic valve;

rotating the shaft relative to the retaining mechanisms for causing the prosthetic valve to expand in the annulus of the native aortic valve; and

locking the prosthetic valve in a final expanded configuration;

wherein the retaining mechanisms remain circumferentially fixed with respect to at least a portion of the stent body while the shaft is rotated to provide regulated expansion of the prosthetic valve in the annulus of the native aortic valve.

10. The method of claim 9, wherein the retaining mechanisms are axially displaced for disengaging the retaining mechanisms from the stent body.

11. The method of claim 10, wherein the retaining mechanisms comprise tabs and the stent body comprises slots.

12. The method of claim 9, wherein the elongate delivery system is advanced over a guidewire for advancing the prosthetic valve through the patient'"'"'s vasculature.

13. The method of claim 9, wherein the shaft is rotated using a proximal operating handle.

14. The method of claim 9, wherein the prosthetic valve partially self-expands before rotating the shaft.

15. The method of claim 9, wherein the prosthetic valve is advanced through the patient'"'"'s vasculature while visualizing at least one radiopaque marker located on the stent body.

16. The method of claim 9, wherein the shaft is capable of being rotated in an opposite direction for contracting the prosthetic valve and modifying the position of the prosthetic valve before locking the prosthetic valve in the final expanded configuration.