Apparatus for controlled heart valve delivery

• US 10,265,169 B2
• Filed: 11/15/2016
• Issued: 04/23/2019
• Est. Priority Date: 11/23/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Desrosiers, John J., Anderson, Amanda K., Bialas, Michael R., Madrid, Gilbert, Popp, Michael J., Nguyen, Thanh V., Liu, Jun, Metchik, Asher L., Patel, Darshin S.
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US15/351,823
• Publication Number:
  US 20170231765A1
• Time in Patent Office: 889 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation

Abstract

A prosthetic implant delivery assembly can include a prosthetic implant and an elongate catheter. The prosthetic implant can include an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent. The catheter can include a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter. The first end portion of the stent can be releasably and pivotably coupled to at least one the arms of the catheter such that the stent can pivot about the at least one of the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter.

Claims

1. A prosthetic implant delivery assembly, comprising:

a prosthetic implant comprising an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent, wherein the first end portion of the stent comprises a plurality of apices which are circumferentially-spaced apart relative to each other, wherein at least some of the apices comprise an aperture;

an elongate catheter having a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter, wherein each of the arms of the catheter comprises an aperture at a distal end of the arm configured to receive a respective apex of the stent; and

a plurality of elongate locking elements extending axially from the distal end of the catheter and corresponding to the arms of the catheter, wherein each of the locking elements is configured to extend through the aperture of a respective apex of the stent,

wherein a length of at least one of the locking elements is different than a length of another locking element, or a length of at least one arm of the catheter is different than a length of another arm such that when the stent is coupled to the catheter by one or more of the locking elements, the longitudinal axis of the stent can be held at a tilted position relative to the longitudinal axis of the catheter.

2. The delivery assembly of claim 1, wherein:

each locking element is axially movable relative to a respective arm of the catheter between a first position and a second position,

in the first position, each locking element extends through the aperture of a respective apex of the stent, thereby releasably coupling the stent to a respective arm of the catheter when the respective apex of the stent is inserted through a respective aperture of the arm, and

in the second position, each locking element is retracted from the aperture of the respective apex of the stent, thereby releasing the respective apex of the stent from the respective arm.

3. The delivery assembly of claim 2, wherein all of the locking elements move together from the first position to the second position.

4. The delivery assembly of claim 2, wherein at least one of the apertures of the arms has a different length than another aperture of the arms.

5. The delivery assembly of claim 1, wherein at least one of the locking elements is axially moveable relative to another locking element.

6. The delivery assembly of claim 1, wherein a length of at least one of the locking elements is different than a length of another locking element, and a length of each of the arms of the catheter is the same length as the other arms such that when the locking elements are retracted relative to the catheter, the at least one of the locking elements releases the stent from the catheter and the another locking element retains the stent to the catheter, wherein partially releasing the stent from the catheter allows the stent to tilt further relative to the longitudinal axis of the catheter than when the stent is coupled to the catheter with all of the locking elements.

7. The delivery assembly of claim 1, wherein the catheter further comprises a plurality of sleeves, and each sleeve is configured to be axially slidable relative to the aperture of a respective arm such that the sleeves can be used to alter an effective size of the apertures of the arms, wherein the effective size of each aperture is the portion of the aperture that is unobstructed by a respective sleeve.

8. The delivery assembly of claim 1, wherein at least one arm of the catheter is axially moveable relative to another arm.

9. The delivery assembly of claim 1, wherein a length of at least one of the locking elements is different than a length of another locking element, and a length of at least one arm of the catheter is different than a length of another arm.

10. The delivery assembly of claim 1, wherein the delivery assembly is configured for implanting the prosthetic implant to a native aortic valve via a retrograde approach.

11. The delivery assembly of claim 1, wherein in the tilted position, the longitudinal axis of the stent can tilt up to 60 degrees relative to the longitudinal axis of the catheter.

12. The delivery assembly of claim 1, wherein in the tilted position, the longitudinal axis of the stent can tilt from 0 degrees to 45 degrees relative to the longitudinal axis of the catheter.

13. A prosthetic implant delivery assembly, comprising:

a prosthetic implant comprising an expandable stent having a plurality of apices circumferentially spaced around a first end portion of the stent, wherein at least some of the apices comprise an aperture;

an elongate catheter comprising a plurality of radially expandable arms extending axially from a distal end of a shaft of the catheter, each arm having a hook portion which extends radially inwardly, wherein the hook portions of the arms releasably engage a respective aperture of the stent, and;

a shaft disposed radially within the catheter, wherein the shaft is movable relative to the catheter; and

an expansion element disposed on a distal end portion of the shaft and radially inwardly relative to the arms of the catheter, wherein the expansion element is movable relative to the arms of the catheter and configured to apply a radial force to the arms of the catheter to move the arms radially outwardly such that the hook portions of the arms disengage the apertures of the stent.

14. The delivery assembly of claim 13, wherein the hook portions of the arms extend radially inwardly and are angled proximally.

15. The delivery assembly of claim 13, wherein the stent is a self-expandable stent.

16. The delivery assembly of claim 13, wherein the arms of the catheter are self-expandable.

17. The delivery assembly of claim 13, wherein the expansion element has a frusto-conical shape.

18. The delivery assembly of claim 13, wherein the delivery assembly is configured such that relative rotational motion between the shaft and the expansion element causes relative axial motion between the expansion element and the arms of the catheter.

19. The delivery assembly of claim 18, wherein the expansion element comprises one or more longitudinally-extending slots, wherein the slots are configured for receiving the arms of the catheter, allowing relative axial motion between the expansion element and the arms, and preventing relative rotational motion between the expansion element and the arms.

20. The delivery assembly of claim 13, wherein the delivery assembly is configured such that relative axial motion between the shaft and the arms causes relative axial motion between the expansion element and the arms of the catheter.

21. The delivery assembly of claim 13, wherein the expansion element is movable relative to the arms of the catheter between a first position and a second position, wherein in the first position, the expansion member is disposed distally relative to the second position and is spaced radially inwardly from the arms of the catheter, and wherein in the second position, the expansion member contacts the arms of the catheter and forces the arms radially outwardly.

22. A prosthetic implant delivery assembly, comprising:

a prosthetic implant comprising an expandable stent portion having a longitudinal axis extending from a first end portion of the stent to a second end portion of the stent, wherein the first end portion of the stent comprises a plurality of apices which are circumferentially-spaced apart relative to each other, wherein at least some of the apices comprise an aperture;

an elongate catheter having a longitudinal axis extending from a proximal end portion of the catheter to a distal end portion of the catheter and a plurality of arms extending axially from the distal end of the catheter, wherein each of the arms of the catheter comprises an aperture at a distal end of the arm configured to receive a respective apex of the stent, and wherein at least one of the apertures of the arms has a different length than another aperture of the arms,

wherein the first end portion of the stent is releasably and pivotably coupled to the arms of the catheter such that the stent can pivot about the arms so that the longitudinal axis of the stent is tilted relative to the longitudinal axis of the catheter, and

wherein the length of each aperture of the arms is the same when the stent is coupled to the arms and when the stent is released from the arms.