Integrated heart valve delivery system

Patent metadata

Field	Value
Publication number	US-10278815-B2
Application number	US-201816017465-A
Country	US
Kind code	B2
Filing date	Jun 25, 2018
Priority date	Sep 8, 2006
Publication date	May 7, 2019
Grant date	May 7, 2019

Abstract

An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

First claim

We claim:

1. A method, comprising:
inserting a distal end portion of a delivery apparatus and a prosthetic valve into a body of a patient, the delivery apparatus having a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending coaxially through the first shaft and having a proximal portion and a distal end portion, the proximal portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft, the prosthetic valve comprising a metallic stent and a flexible valvular structure mounted within the stent, wherein the prosthetic valve is radially crimped around the second shaft with an inlet end portion of the prosthetic valve retained within the nose piece and an outlet end portion of the prosthetic valve retained within the valve cover, wherein the nose piece comprises an abutment member disposed within an interior bore of the nose piece and having an abutment surface engaging the inlet end portion of the prosthetic valve so as to limit axial movement of the prosthetic valve within the bore of the nose piece;
advancing the delivery apparatus through the patient's vasculature until the radially compressed prosthetic valve is positioned within the native aortic annulus;
retracting the first shaft relative to the second shaft so as to retract the valve cover relative to the outflow end portion of the prosthetic valve;
advancing the second shaft distally relative to the first shaft by turning an adjustment knob of the delivery apparatus to advance the nose piece distally relative to the inflow end portion of the prosthetic valve; and
radially expanding the prosthetic valve within the native aortic annulus.

2. The method of claim 1 , wherein the act of retracting the first shaft to retract the valve cover relative to the outlet end portion of the prosthetic valve is performed prior to the act of advancing the second shaft to advance the nose piece distally relative to the inlet end portion of the prosthetic valve.

3. The method of claim 1 , wherein the prosthetic valve comprises a self-expandable valve.

4. The method of claim 3 , wherein radially expanding the prosthetic valve comprises allowing the prosthetic valve to self-expand.

5. The method of claim 1 , further comprising adjusting the position of the prosthetic valve within the native annulus.

6. The method of claim 5 , wherein the act of adjusting the position of the prosthetic valve is performed prior to the act of advancing the second shaft to advance the nose piece distally relative to the inlet end portion of the prosthetic valve.

7. The method of claim 1 , further comprising unlocking a retaining mechanism by removing a projection from a corresponding groove on the proximal end portion of the second shaft, the retaining mechanism configured to selectively prevent axial movement of the second shaft relative to the first shaft.

8. A method, comprising:
inserting a distal end portion of a delivery apparatus and a prosthetic heart valve into the vasculature of a patient, the delivery apparatus comprising a handle, first and second shafts extending from the handle, the second shaft extending coaxially through the first shaft, a valve cover coupled to a distal end portion of the first shaft, and a nose piece coupled to a distal end portion of the second shaft, wherein the prosthetic valve comprises a metallic stent and a flexible valvular structure mounted within the stent and the prosthetic valve is radially crimped around the second shaft with an inlet end portion of the prosthetic valve retained within the nose piece and an outlet end of the prosthetic valve retained within the valve cover;
advancing the distal end portion of the delivery apparatus and the prosthetic valve through the patient's vasculature until the prosthetic valve is positioned within the native aortic annulus, wherein a retaining mechanism of the delivery apparatus retains the second shaft and the nose piece from moving relative to the handle during the act of advancing;
retracting the first shaft relative to the second shaft so as to retract the valve cover relative to the distal end portion of the prosthetic valve;
unlocking the retaining mechanism to permit axial movement of the second shaft relative to the handle;
advancing the second shaft distally relative to the first shaft and the handle using an adjustment knob of the delivery apparatus to advance the nose piece distally relative to the inflow end portion of the prosthetic valve; and
radially expanding the prosthetic valve within the native aortic annulus.

9. The method of claim 8 , wherein the prosthetic valve is a self-expandable prosthetic valve.

10. The method of claim 9 , wherein radially expanding the prosthetic valve comprises allowing the valve to radially self-expand.

11. The method of claim 8 , wherein the act of unlocking the retaining mechanism further comprises removing a projection from a corresponding groove on the proximal end portion of the second shaft.

12. The method of claim 8 , further comprising adjusting the position of the prosthetic valve within the native annulus.

13. The method of claim 8 , wherein the wherein the act of retracting the first shaft to retract the valve cover relative to the outlet end portion of the prosthetic valve is performed prior to the act of advancing the second shaft to advance the nose piece distally relative to the inlet end portion of the prosthetic valve.

14. A method, comprising:
inserting a prosthetic heart valve and a distal end portion of a delivery apparatus into the body of a patient, the prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, and the delivery apparatus comprising a handle, a first shaft extending distally from the handle, a valve cover coupled to a distal end portion of the first shaft, a second shaft extending distally from the handle and extending co-axially though the first shaft, a nose piece coupled to a distal end portion of the second shaft, wherein the second shaft is placed in tension to hold a proximal end portion of the nose piece against a distal end portion of the valve cover and the prosthetic valve is radially crimped around the second shaft with an inlet portion of the prosthetic valve retained within the nose piece and an outlet portion of the prosthetic valve retained within the valve cover;
advancing a distal end portion of the delivery apparatus and the prosthetic valve through the patient's vasculature to reach a selected implantation location wherein the prosthetic valve is positioned within the native aortic annulus;
retracting the first shaft relative to the second shaft so as to retract the valve cover proximally relative to the prosthetic valve;
advancing the second shaft distally relative to the first shaft to advance the nose piece distally relative to the prosthetic valve; and
radially expanding the prosthetic valve within the native aortic annulus.

15. The method of claim 14 , further comprising releasing a retaining mechanism configured to prevent the prosthetic valve from deploying.

16. The method of claim 15 , wherein the act of releasing the retaining mechanism is performed prior to the act of advancing the second shaft distally relative to the first shaft to advance the nose piece distally relative to the prosthetic valve.

17. The method of claim 15 , wherein the act of releasing the retaining mechan

Assignees

• Edwards Lifesciences Corp

Inventors

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

Classifications

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61M39/0613

  with means for adjusting the seal opening or pressure (A61M39/0693 takes precedence) · CPC title

• A61M25/005

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

• A61F2/958

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

• A61M25/0662

  Guide tubes · CPC title