Transvascular delivery systems

Patent metadata

Field	Value
Publication number	US-11116632-B2
Application number	US-202017076705-A
Country	US
Kind code	B2
Filing date	Oct 21, 2020
Priority date	Aug 22, 2008
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

A handle assembly for a transvascular prosthetic heart valve delivery apparatus including a handle housing, a main shaft extending distally from the handle housing, the main shaft configured to be coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, a screw engagement latch that is adjustable between an engaged position and a disengaged position. In the engaged position, the latch can couple the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing. In the disengaged position, the latch can decouple the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing without rotation of the control knob.

First claim

We claim:

1. A transvascular prosthetic heart valve delivery apparatus, comprising:
a handle assembly comprising a handle housing, a screw shaft, a control knob that is rotatable relative to the handle housing and the screw shaft, and a screw engagement latch that is adjustable between an engaged position and a disengaged position;
a main shaft extending distally from the handle housing, the main shaft coupled to a distal valve sheath that is configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath;
a valve shaft extending distally from the handle housing within the main shaft, the valve shaft configured to be releasably coupled to a proximal end of the prosthetic heart valve; and
an inner shaft extending distally from the handle housing within the valve shaft, the inner shaft configured to extend through the prosthetic heart valve and coupled to a nosecone distal to the prosthetic heart valve;
wherein in the engaged position, the latch couples the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft to move axially relative to the handle housing and the valve shaft;
wherein in the disengaged position, the latch decouples the control knob from the screw shaft such that the main shaft can move axially relative to the handle housing and the valve shaft without rotation of the control knob; and
wherein the handle assembly is operable to independently move the main shaft and the inner shaft axially relative to the valve shaft, including being operable to move the main shaft proximally relative to the valve shaft to uncover the prosthetic heart valve from the valve sheath and allow the prosthetic heart valve to radially expand, and including being operable to move the inner shaft proximally relative to the valve shaft to retract the nosecone toward the valve shaft after the prosthetic heart valve is radially expanded.

2. The apparatus of claim 1 , wherein the screw shaft comprises first threads, and wherein in the engaged positioned, the latch couples the control knob to the screw shaft via the first threads.

3. The apparatus of claim 2 , wherein the latch comprises at least one flange that engages with the first threads of the screw shaft when the latch is in the engaged position.

4. The apparatus of claim 3 , wherein rotating the control knob causes rotation of the at least one latch flange engaged with the first threads, which causes relative axial motion between the control knob and the screw shaft.

5. The apparatus of claim 1 , further comprising a spring coupled to the latch, wherein the spring biases the latch toward the engaged position.

6. The apparatus of claim 5 , wherein moving the latch to the disengaged position includes compressing the spring, and wherein moving the latch to the engaged position includes allowing the spring to expand.

7. The apparatus of claim 1 , wherein the engaged position allows for fine control of axial movement of the main shaft relative to the handle housing via rotation of the control knob, and wherein the disengaged position allows for coarse axial movement of the main shaft relative to the handle housing without rotation of the control knob.

8. The apparatus of claim 1 , wherein when the latch is in the engaged position, rotation of the control knob in a first direction causes the valve sheath to move proximally relative to the prosthetic heart valve to uncover the prosthetic heart valve, and rotation of the control knob in a second direction causes the valve sheath to move distally relative to the prosthetic heart valve to re-cover the prosthetic heart valve.

9. The apparatus of claim 1 , wherein the screw shaft is fixed rotationally relative to the housing.

10. The apparatus of claim 1 , wherein the control knob is positioned around the screw shaft.

11. The apparatus of claim 1 , wherein the latch is fixed rotationally relative to the control knob.

12. The apparatus of claim 1 , wherein the latch translates linearly relative to the control knob as the latch moves between the engaged position and the disengaged position.

13. The apparatus of claim 1 , wherein the latch comprises a radially inner surface that is positioned radially outward of the screw shaft when the latch is in the disengaged position such that the radially inner surface of the latch does not engage the screw shaft and allows relative axial motion between the screw shaft and control knob without rotation of the control knob.

14. The apparatus of claim 1 , wherein the engaged position allows for micro control of actuation of the valve sheath and the disengaged position allows for macro control of actuation of the valve sheath.

15. A transvascular delivery apparatus for a prosthetic heart valve, comprising:
a handle;
a main shaft extending distally from the handle;
a valve sheath coupled to a distal portion of the main shaft, the valve sheath configured to retain a prosthetic heart valve in a radially compressed state within the valve sheath;
a valve shaft extending distally from the handle within the main shaft, the valve shaft being releasably connectable to a proximal end of the prosthetic heart valve; and
an inner shaft extending distally from the handle housing within the valve shaft, the inner shaft configured to extend through the prosthetic heart valve and coupled to a nosecone distal to the prosthetic heart valve;
wherein the handle is operable to independently move the main shaft and the inner shaft axially relative to one another and to the valve shaft;
wherein the handle comprises:
a handle housing;
a screw shaft;
a control knob that is rotatable relative to the handle housing and the screw shaft;
a screw engagement latch that is adjustable between an engaged position and a disengaged position;

wherein in the engaged position, the latch couples the control knob to the screw shaft such that rotation of the control knob relative to the handle housing causes the main shaft and valve sheath to move axially relative to the handle housing and the valve shaft; and
wherein in the disengaged position, the latch decouples the control knob from the screw shaft such that the main shaft and valve sheath can move axially relative to the handle housing and the valve shaft without rotation of the control knob.

16. The apparatus of claim 15 , wherein the engaged position allows for fine control of axial movement of the main shaft and valve sheath via rotation of the control knob, and wherein the disengaged position allows for coarse axial movement of the main shaft and valve sheath relative to the handle housing without rotation of the control knob.

17. The apparatus of claim 15 , wherein when the latch is in the engaged position, rotation of the control knob in a first direction causes the valve sheath to move proximally relative to the prosthetic heart valve to uncover the prosthetic heart valve, and rotation of the control knob in a second direction causes the valve sheath to move distally relative to the prosthetic heart valve to re-cover the prosthetic heart valve.

18. The apparatus of claim 15 , wherein the handle further comprises a spring coupled to the latch, wherein the spring biases the latch toward the engaged position, and wherein moving the latch to the disengaged position includes compressing the spring, and wherein moving the latch to the engaged position includes allowing the spring to expand.

19. The apparatus of claim 15 , wherein the screw shaft is fixed rotationally relative to the housing, t

Assignees

• Edwards Lifesciences Corp

Inventors

• Alon David
• Benichou Netanel
• Meiri Oded

Classifications

• A61F2/2433

  using balloon catheter · CPC title

• A61F2230/0054

  V-shaped · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2002/9534

  for repositioning of stents · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title