Prosthetic mitral valve holders

Patent metadata

Field	Value
Publication number	US-12440330-B2
Application number	US-202318365900-A
Country	US
Kind code	B2
Filing date	Aug 4, 2023
Priority date	Nov 3, 2016
Publication date	Oct 14, 2025
Grant date	Oct 14, 2025

Abstract

Valve holders and introducers for delivering a prosthetic heart valve to an implant site are in various embodiments configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a removable activator dial and a removable handle that prevent implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate passing of a prosthetic valve between adjacent ribs of a patient. Valve holders and introducers according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.

First claim

What is claimed is:

1. A valve holder for holding and implanting a prosthetic heart valve, comprising a frame and three flexible valve leaflets that control directional flow of blood through a heart, a stent structure having three flexible commissure posts supporting the valve leaflets, each of the commissure posts having a tip, the valve holder comprising:
a valve holder body having an upper surface, a bottom surface shaped to abut an inflow side of the prosthetic heart valve, and a central axis;
a rotor insertable through the upper surface and positioned in the valve holder body, wherein when the prosthetic heart valve is coupled to the valve holder body, the rotor is rotatable around the central axis to adjust the prosthetic heart valve to a delivery position;
deployment sutures connecting the valve holder to the prosthetic heart valve, each deployment suture being attached to the rotor, routed through one of the commissure post tips and back to be tied off on the valve holder such that rotation of the rotor creates tension in each deployment suture to deflect each commissure post radially inward and adjust the prosthetic heart valve to the delivery position, the deployment sutures all passing over a single cutting guide on the upper surface of the valve holder body;
a guide mounted to the valve holder body and having a central opening;
an activator having a central shaft sized to pass through the central opening of the guide to engage and rotate the rotor around the central axis of the valve holder body; and
a latch configured to abut the guide, the latch being coupled to the valve holder body and having a guard that covers the cutting guide, such that the latch must be removed prior to severing the deployment sutures and converting the prosthetic heart valve from the delivery position to an implant position.

2. The valve holder of claim 1 , wherein the activator has an upper dial that extends outward from the central shaft and has an upper surface.

3. The valve holder of claim 2 , wherein the upper surface of the upper dial has arrow indicia thereon indicating a direction of rotation to adjust the prosthetic heart valve to a delivery position.

4. The valve holder of claim 2 , wherein the upper dial has a scalloped peripheral gripping portion to better permit grasping and rotation.

5. The valve holder of claim 1 , wherein the central shaft of the activator has a radial key sized to pass through a keyway defined within the guide.

6. The valve holder of claim 5 , wherein the key is positioned on a flexible arm of the central shaft and spaced apart from a remainder of the central shaft by gaps on either side such that the flexible arm is bendable relative to the remainder of the central shaft, and wherein the central shaft may be inserted down to engage the rotor by bending the flexible arm inward to permit the key to pass through the central opening of the guide, and the activator may only be detached from the guide by rotating until the key aligns with the keyway.

7. The valve holder of claim 6 , wherein the guide limits rotation of the activator to less than 360°.

8. The valve holder of claim 1 , wherein the latch has an opening aligned with the central opening of the guide through which passes the central shaft of the activator, and the opening of the latch comprises a threaded portion matable with a threaded portion of a delivery handle when the activator is removed from within the latch, guide and rotor.

9. The valve holder of claim 1 , wherein the latch is coupled by a single suture to the valve holder body, and is detached from the valve holder body by severing the single suture.

10. The valve holder of claim 1 , wherein the rotor is ratcheted to only rotate in one direction.

11. A valve holder for holding and implanting a prosthetic heart valve, comprising a frame and three flexible valve leaflets that control directional flow of blood through a heart, a stent structure having three flexible commissure posts supporting the valve leaflets, each of the commissure posts having a tip, the valve holder comprising:
a valve holder body having an upper surface, a bottom surface shaped to abut an inflow side of the prosthetic heart valve, and a central axis;
a rotor insertable into a cavity open to the upper surface of the valve holder body, wherein when the prosthetic heart valve is coupled to the valve holder body, the rotor is rotatable around the central axis to adjust the prosthetic heart valve to a delivery position;
deployment sutures connecting the valve holder to the prosthetic heart valve, each deployment suture being attached to the rotor, routed through one of the commissure post tips and back to be tied off on the valve holder such that rotation of the rotor creates tension in each deployment suture to deflect each commissure post radially inward and adjust the prosthetic heart valve to the delivery position, the deployment sutures all passing over a single cutting guide on the upper surface of the valve holder body;
a guide mounted to the valve holder body via a snap-fit to hold the rotor within the cavity, the guide having a central opening and a keyway on one side thereof;
a latch coupled to the valve holder body and covering the cutting guide such that the latch must be removed prior to severing the deployment sutures and converting the prosthetic heart valve from the delivery position to an implant position; and
an activator having a central shaft with a radial key and sized to pass through the central opening of the guide with the key in the keyway to engage and rotate the rotor around the central axis of the valve holder body.

12. The valve holder of claim 1 , wherein the latch is coupled by a single suture to the valve holder body, and is detached from the valve holder body by severing the single suture.

13. The valve holder of claim 11 , wherein the activator has an upper dial that extends outward from the central shaft and has an upper surface.

14. The valve holder of claim 13 , wherein the upper surface of the upper dial has arrow indicia thereon indicating a direction of rotation to adjust the prosthetic heart valve to a delivery position.

15. The valve holder of claim 13 , wherein the upper dial has a scalloped peripheral gripping portion to better permit grasping and rotation.

16. The valve holder of claim 11 , wherein the key of the activator central shaft is positioned on a flexible arm of the central shaft and spaced apart from a remainder of the central shaft by gaps on either side such that the flexible arm is bendable relative to the remainder of the central shaft, and wherein the central shaft may be inserted down to engage the rotor by bending the flexible arm inward to permit the key to pass through the central opening of the guide, and the activator may only be detached from the guide by rotating until the key aligns with the keyway.

17. The valve holder of claim 16 , wherein the guide limits rotation of the activator to less than 360°.

18. The valve holder of claim 11 , wherein the latch is configured to abut the guide and has an opening aligned with the central opening of the guide through which passes the central shaft of the activator.

19. The valve holder of claim 18 , wherein the opening of the latch comprises a threaded portion matable with a threaded portion of a delivery handle when the activator is removed from within the latch, guide and rotor.

20. The valve holder of claim 11 , wherein the rotor is ratcheted to only rotate in one direction.

Assignees

• Edwards Lifesciences Corp

Inventors

• Conklin Brian S
• Johnson Derrick

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61B2017/00477

  Coupling (A61B2017/0046 takes precedence) · CPC title

• A61B2017/00407

  Ratchet means · CPC title

• A61B2017/00398

  using powered actuators, e.g. stepper motors, solenoids · CPC title