Delivery apparatus for prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-11589986-B2
Application number	US-202016991508-A
Country	US
Kind code	B2
Filing date	Aug 12, 2020
Priority date	Sep 8, 2006
Publication date	Feb 28, 2023
Grant date	Feb 28, 2023

Abstract

Embodiments of the present disclosure provide a delivery apparatus for a prosthetic heart valve. Disclosed delivery apparatuses can include a handle, a first shaft extending from the handle, a second shaft disposed around the first shaft, and a valve cover. The valve cover can be coupled to a distal end portion of the first shaft and can be configured to house a prosthetic heart valve in a radially compressed state. The valve cover can have an outer diameter greater than an outer diameter of the second shaft, and the first shaft and valve cover can be movable together in an axial direction relative to the second shaft.

First claim

We claim:

1. A delivery apparatus for delivering a prosthetic heart valve to the heart of a patient for replacing a stenotic native aortic valve, the delivery apparatus comprising:
a handle;
a first shaft extending from the handle and movable axially relative to the handle;
a second shaft disposed around the first shaft and configured to extend into a patient, the second shaft terminating at a free distal end;
a third shaft extending from the handle coaxially through the second shaft;
a valve cover coupled to a distal end portion of the first shaft and configured to entirely house the prosthetic heart valve in a radially compressed state, and wherein the first shaft, the valve cover, and the third shaft are movable together in an axial direction relative to the second shaft;
wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft, wherein the free distal end of the second shaft is configured to be disposed adjacent the valve cover when the delivery apparatus is inserted into the patient;
wherein the valve cover is movable between a first state for covering the prosthetic valve during insertion into a patient's vasculature and a second state in which the valve cover uncovers the entirety of the prosthetic valve, and wherein the free distal end of the second shaft is proximal to a proximal end of the valve cover when the valve cover is in the first state and the second state; and
wherein the entirety of the valve cover has an outer diameter greater than an inner diameter of the second shaft when the valve cover is in the first state and the second state;
wherein the delivery apparatus has sufficient length for advancement over a guide wire through a femoral artery, an iliac artery, and around the aortic arch to the native aortic valve;
wherein the valve cover is flexible to enhance the ability of the delivery apparatus to follow the path of the guide wire as the delivery apparatus is advanced over the guide wire.

2. The delivery apparatus of claim 1 , in combination with a radially expandable and compressible prosthetic heart valve disposed within the valve cover in a radially compressed state, wherein a length of the valve cover is greater than a length of the prosthetic valve such that the valve cover extends over and contacts an outer surface of the prosthetic valve along an entire length of the prosthetic valve.

3. The delivery apparatus of claim 2 in combination with the prosthetic heart valve, wherein the first shaft and the valve cover are movable together relative to the second shaft to uncover the prosthetic heart valve.

4. A medical assembly, comprising:
a delivery apparatus, comprising:
a handle;
a first shaft extending from the handle and movable axially relative to the handle;
a second shaft disposed around the first shaft and configured to extend into a patient, the second shaft terminating at a free distal end,
a third shaft extending from the handle coaxially through the second shaft,
a valve cover coupled to a distal end portion of the first shaft and configured to entirely house a prosthetic heart valve in a radially compressed state, wherein the valve cover has an outer diameter greater than an inner diameter of the second shaft, and wherein the first shaft, the valve cover, and the third shaft are movable together in an axial direction relative to the second shaft, and
an inflatable balloon disposed on the distal end portion of the first shaft beneath the prosthetic heart valve; and

a radially expandable and compressible prosthetic heart valve disposed within the valve cover in a radially compressed state, a length of the valve cover being greater than a length of the prosthetic valve such that the valve cover extends over and contacts an outer surface of the prosthetic valve along an entire length of the prosthetic valve;
wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft, wherein the free distal end of the second shaft is configured to be disposed adjacent the valve cover when the delivery apparatus is inserted into the patient;
wherein the valve cover is movable between a first state for covering the prosthetic valve during insertion into a patient's vasculature and a second state in which the valve cover uncovers the prosthetic valve, and wherein the free distal end of the second shaft is proximal to a proximal end of the valve cover when the valve cover is in the first state;
wherein the first shaft and the valve cover are movable together relative to the second shaft to uncover the prosthetic heart valve; and
wherein the balloon is inflatable from a deflated configuration to an inflated configuration, thereby radially expanding the prosthetic heart valve from the radially compressed state to a radially expanded state.

5. The delivery apparatus of claim 3 in combination with the prosthetic heart valve, wherein the prosthetic heart valve is a self-expanding prosthetic heart valve that radially expands when advanced from the valve cover.

6. The delivery apparatus of claim 1 , wherein the second shaft comprises a steerable portion having an adjustable curvature.

7. The delivery apparatus of claim 6 , further comprising an adjustment mechanism coupled to the steerable portion and configured to adjust a curvature of the steerable portion.

8. The delivery apparatus of claim 6 , wherein the second shaft includes one or more pull wires extending along a length of the second shaft and coupling the steerable portion to an adjustment mechanism in the handle.

9. The delivery apparatus of claim 1 , wherein the first shaft defines an inner lumen through which a guide wire extends.

10. The delivery apparatus of claim 1 , wherein the second shaft cannot slide over the valve cover.

11. A medical assembly for replacing a stenotic native heart valve, comprising:
a delivery apparatus comprising:
a handle,
a first shaft extending from the handle, wherein the first shaft is movable axially relative to the handle,
a second shaft disposed around the first shaft and configured to extend into a patient;
a third shaft extending from the handle coaxially through the second shaft;
a valve cover coupled to a distal end portion of the first shaft, wherein the first shaft and the valve cover are movable together in an axial direction relative to the second shaft and the handle, wherein the third shaft is moveable in the axial direction relative to the second shaft, and wherein the second shaft has an outer diameter greater than an outer diameter of the first shaft and an outer diameter of the third shaft; and

a self-expanding prosthetic heart valve mounted in a radially compressed state within the valve cover for delivery through a patient's vasculature, the prosthetic heart valve comprising a radially compressible and expandable stent and a flexible valve structure mounted within the stent;
wherein the valve cover has a length that is greater than a length of the prosthetic valve such that the valve cover extends over an entirety of the prosthetic valve and an inner surface of a cylindrical section of the valve cover contacts an outer surface of the prosthetic valve to retain the prosthetic valve in the radially compressed state;
wherein the valve cover is movable between a first state for covering and retaining the prosthetic valve in the radially compressed state during insertion into a patient's vasculature and a second state in which the valve cover uncovers the entirety of the prosthetic valve and allows the prosthetic valve to radially expand, wherein a distal edge of the second shaft is proximal to a

Assignees

• Edwards Lifesciences Corp

Inventors

• Marchand Philippe
• Taylor David M
• Milich Robert
• Evans David J
• Chia Christopher
• Cayabyab Ronaldo C
• Bowes Robert

Classifications

• A61M25/0045

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title

• A61M25/005

  with embedded materials for reinforcement, e.g. wires, coils, braids · CPC title

• A61M25/0662

  Guide tubes · CPC title