INTEGRATED HEART VALVE DELIVERY SYSTEM

• US 20080065011A1
• Filed: 09/10/2007
• Published: 03/13/2008
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Evans, David J., Milich, Robert, Chia, Christopher, Bowes, Robert Royal, Cayabyab, Ronaldo C., Marchand, Philippe, Taylor, David M.
• Granted Patent: US 8,568,472 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

Embodiments of the present disclosure provide a delivery apparatus for delivering a prosthetic heart valve to a native valve site via the human vasculature. The delivery apparatus is particularly well-suited for advancing a prosthetic valve through the aorta (i.e., in a retrograde approach) for replacing a stenotic aortic valve.

Claims

1. An apparatus for delivering a prosthetic valve through the vasculature of a patient comprising:

a balloon catheter comprising an elongated shaft and a balloon connected to a distal end portion of the shaft, the balloon being adapted to carry the valve in a crimped state and being inflatable to deploy the valve at an implantation site in the patient'"'"'s body;

a guide catheter comprising an elongated shaft extending over the balloon catheter shaft, the shaft of the guide catheter comprising a steerable section, the guide catheter further comprising an adjustment mechanism operatively coupled to the steerable section, the adjustment mechanism being configured to adjust the curvature of the steerable section and the portion of the balloon catheter shaft extending through the steerable section; and

a nose catheter comprising an elongated shaft extending through the balloon catheter shaft and a nose piece connected to a distal end of the nose catheter shaft, the nose piece having an internal bore adapted to receive at least a distal end portion of the balloon in a deflated state during delivery of the valve;

wherein the balloon catheter, the guide catheter, and the nose catheter are configured to move longitudinally relative to each other.

2. The apparatus of claim 1, wherein the guide catheter comprises a cover connected to a distal end of the guide catheter shaft, the cover being adapted to extend over the valve during delivery.

3. The apparatus of claim 1, wherein the nose piece and the cover can be positioned to completely enclose the valve and the balloon in its deflated state during delivery.

4. The apparatus of claim 1, further comprising locking mechanism configured to retain the balloon catheter at selected longitudinal positions relative to the guide catheter.

5. The apparatus of claim 1, further comprising locking mechanism configured to retain the nose catheter at selected longitudinal positions relative to the balloon catheter.

6. The apparatus of claim 1, wherein the nose catheter shaft has a lumen adapted to receive a guide wire so that the nose catheter, the balloon catheter, and the guide catheter can be advanced together over the guide wire.

7. The apparatus of claim 1, wherein the nose piece is adapted to completely cover the valve during delivery.

8. The apparatus of claim 7, wherein the nose piece is adapted to substantially cover the balloon during delivery.

9. The apparatus of claim 1, wherein the adjustment mechanism comprises a pivotable lever and a pull wire having a proximal end portion coupled to the lever and a distal end portion fixedly secured at a distal end portion of the steerable section such that pivoting of the lever is effective to apply a pulling force on the pull wire, which in turn causes the steerable section to bend.

10. The apparatus of claim 4, wherein the balloon catheter shaft has a proximal end portion formed with a plurality of longitudinally spaced-apart grooves and the locking mechanism comprises a latch member connected to the guide catheter, the latch member being engageable with the grooves and adapted to retain the balloon catheter from moving longitudinally relative to the guide catheter when the latch member is aligned with and engages a selected groove.

11. The apparatus of claim 10, wherein the latch member and the grooves permits rotational movement of the balloon catheter relative to the guide catheter when the latch member engages one of the grooves.

12. A method of implanting a prosthetic valve at an implantation site in a patient'"'"'s body, the method comprising:

placing the valve on an inflatable balloon of a balloon catheter of a delivery apparatus;

inserting at least a distal end portion of the balloon in a nose piece of a nose catheter of the delivery apparatus;

inserting the balloon catheter and the nose catheter into the body and advancing the same through the patient'"'"'s vasculature;

moving the nose catheter distally relative to the balloon catheter to uncover the portion of the balloon inside the nose piece; and

deploying the valve at the implantation site by inflating the balloon.

13. The method of claim 12, wherein prior to inserting the balloon catheter and the nose catheter into the body, inserting at least a proximal end portion of the balloon in a cover of a guide catheter of the delivery apparatus and the act of inserting the balloon catheter and the nose catheter comprises inserting the balloon catheter, the nose catheter, and the guide catheter into the body and advancing the same through the patient'"'"'s vasculature, and prior to deploying the valve, moving the guide catheter proximally relative to the balloon catheter to uncover the portion of the balloon inside the cover.

14. The method of claim 13, wherein the act of advancing comprises adjusting the curvature of a portion of the delivery apparatus to steer the valve through the patient'"'"'s vasculature.

15. The method of claim 12, wherein the act of inserting the balloon catheter and the nose catheter into the body is accomplished without the use of an introducer sheath.

16. The method of claim 12, wherein the act of inserting at least a distal end portion of the balloon in the nose piece comprises inserting the balloon into the nose piece so that the valve is completely covered by the nose piece.

17. A method of implanting a prosthetic valve at an implantation site in a patient'"'"'s body, the method comprising:

placing the valve in a crimped state on the distal end portion of an elongated delivery apparatus;

advancing the delivery apparatus through the patient'"'"'s vasculature;

subsequent to the act of advancing the delivery apparatus, moving the crimped valve onto an inflatable balloon on the distal end portion of the delivery apparatus; and

deploying the valve at the implantation site by inflating the balloon.

18. The method of claim 17, wherein the delivery apparatus comprises a nose catheter having a nose piece located adjacent and distal to the crimped valve and the act of moving the crimped valve onto the balloon comprises retracting the nose catheter to cause the nose piece to push the crimped valve onto the balloon.

19. The method of claim 17, wherein the act of moving the valve onto the balloon comprises moving the valve over a tapered wedge and then onto the balloon, the wedge partially expanding the valve before it is placed on the balloon.

20. An introducer sheath comprising:

an elongated tubular sleeve having a lumen and adapted to be inserted into a patient'"'"'s vasculature;

a seal housing comprising an inner bore in communication with the lumen of the sleeve and one or more sealing valves housed in the bore; and

an end piece coupled to the sealing housing opposite the sleeve and comprising a loader tube extending into the bore, the end piece being moveable along a length of the seal housing to move the loader tube from a first position spaced from the one or more sealing valves to a second position wherein the loader tube extends through the sealing valves.

21. The introducer sheath of claim 47, wherein the end piece is rotatable relative to the sealing housing to move the end piece along said length of the seal housing.

22. The introducer sheath of claim 47, wherein the end piece has an opening and houses a seal adjacent the opening to sealingly engage an endovascular delivery apparatus through the opening and the seal.