Integrated heart valve delivery system

• US 8,568,472 B2
• Filed: 09/10/2007
• Issued: 10/29/2013
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marchand, Philippe, Taylor, David M., Evans, David J., Chia, Christopher, Cayabyab, Ronaldo C., Bowes, Robert Royal, Milich, Robert Jr.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US11/852,977
• Publication Number:
  US 20080065011A1
• Time in Patent Office: 2,241 Days
• Field of Search: 623/2.11, 623/2.1, 623/1.1, 623/1.11, 623/1.12, 606/108
• US Class Current: 623/2.11
• 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 crimped prosthetic valve comprising a stent portion supporting a valve structure;

a balloon catheter comprising an elongated shaft, a balloon connected to a distal end portion of the shaft, the balloon being adapted to carry the prosthetic valve in a crimped state and being inflatable to deploy the prosthetic valve at an implantation site in the patient'"'"'s body, the elongate shaft of the balloon catheter further comprising a distal end portion extending distally of the balloon and an annular tapered wedge secured to the distal end portion of the elongate shaft, the tapered wedge distal of the balloon, the tapered wedge having a narrower distal end and a wider proximal end, the tapered wedge dimensioned to expand the crimped prosthetic valve when the prosthetic valve is urged thereagainst, the crimped prosthetic valve disposed on the distal end portion of the balloon catheter distal of the tapered wedge;

a guide catheter comprising an elongated shaft extending over the balloon catheter shaft, the shaft of the guide catheter comprising a selectively steerable section for facilitating advancement through the vasculature of the patient, 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, movement of the adjustment mechanism causing a substantially 1;

1 movement of the steerable section;

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 a shoulder dimensioned to engage a distal end of the crimped prosthetic valve during delivery of the prosthetic valve, the nose piece having an outer layer and an inner layer, the outer layer softer than the inner layer; and

a cover secured to and extending distally from the distal end of the guide catheter, the cover and nose piece dimensioned to cover the crimped prosthetic valve and the balloon,

wherein the balloon catheter, the guide catheter, and the nose catheter are configured to move longitudinally relative to each other such that the cover may be advanced relative to the prosthetic valve for exposing the prosthetic valve, the balloon catheter may be advanced relative to the nose catheter to push the crimped prosthetic valve over the tapered wedge and onto the balloon, and the balloon catheter may be advanced relative to the guide catheter for deploying the prosthetic valve at a treatment site.

2. The apparatus of claim 1, wherein the cover is 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 crimped prosthetic valve and the balloon in its deflated state during delivery.

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

5. 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.

6. The apparatus of claim 5, 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.

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

8. 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.

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

10. The apparatus of claim 9, wherein the nose piece is adapted to substantially cover the balloon during delivery.

11. 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.

12. The apparatus of claim 1, wherein the cover is dimensioned to abut against a proximal end surface of the nose piece.

13. The apparatus of claim 1, wherein the nose piece comprises a flexible material.

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

a balloon catheter comprising an elongated shaft, a balloon disposed at a distal end portion of the elongate shaft, the balloon proximal of a distal end of the elongate shaft thereby defining a distal end portion of the elongate shaft distal of the balloon, the balloon inflatable to expand a prosthetic valve disposed thereon, the distal end of the elongate shaft dimensioned to carry a crimped prosthetic valve thereon;

a tapered wedge secured distal of the balloon on the distal end portion of the elongate shaft, the tapered wedge dimensioned to expand the crimped prosthetic valve when the prosthetic valve is pushed thereagainst;

a guide catheter comprising an elongate shaft extending over the balloon catheter shaft, a distal portion of the guide catheter selectively steerable; and

a nose piece disposed at a distal end of a nose catheter, the nose catheter comprising an elongate shaft extending through the balloon catheter shaft;

wherein the balloon catheter, the guide catheter, and the nose catheter are longitudinally slidable relative to each other such that the balloon catheter is advanceable relative to the nose catheter for pushing a crimped prosthetic valve disposed on the distal end portion of the elongate shaft of the balloon catheter over the tapered wedge and onto the balloon, and the balloon catheter is advanceable relative to the guide catheter for deploying the prosthetic valve at a treatment site.

15. The apparatus of claim 14, wherein the nose piece is dimensioned to cover the tapered wedge.

16. The apparatus of claim 14, further comprising a cover secured to and extending distally from a distal end of the guide catheter, the cover and nose piece dimensioned to cover the crimped prosthetic valve and the balloon.

17. The apparatus of claim 14, further comprising a crimped prosthetic valve disposed on the distal end portion of the elongate shaft of the balloon catheter.

18. The apparatus of claim 17, wherein the prosthetic valve comprises a stent portion supporting a valve structure.

19. The apparatus of claim 14, further comprising an adjustment mechanism coupled to the steerable section of the guide catheter, the adjustment mechanism operable to adjust a curvature of the steerable section.

20. The apparatus of claim 14, wherein the nose piece comprises an outer layer and an inner layer, the outer layer softer than the inner layer.

21. The apparatus of claim 14, wherein a longitudinal position of the balloon catheter is lockable relative to the guide catheter.

22. The apparatus of claim 14, wherein a longitudinal position of the nose catheter is lockable relative to the balloon catheter.

23. The apparatus of claim 14, wherein the nose piece has a shoulder dimensioned to engage a distal end of the crimped prosthetic valve disposed on the distal end portion of the elongate shaft of the balloon catheter.