Prosthetic heart valve delivery apparatus

• US 9,155,619 B2
• Filed: 02/24/2012
• Issued: 10/13/2015
• Est. Priority Date: 02/25/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Liu, Jun, Pesce, Luca, Popp, Michael, Alon, David, Jafari, Mohammad, Delgado, Sergio
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): David, Shaun L
• Application Number:
  US13/405,119
• Publication Number:
  US 20120239142A1
• Time in Patent Office: 1,327 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 606/108, 606/200
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer

Abstract

Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Claims

1. A delivery apparatus for implanting a prosthetic valve, comprising:

a handle portion;

a first elongated shaft having a proximal end portion coupled to the handle portion and a distal end portion configured to be inserted into a patient'"'"'s vasculature;

a second elongated shaft extending through the first shaft and having a proximal end portion coupled to the handle portion and a distal end portion configured to be inserted into the patient'"'"'s vasculature, the second shaft being rotatable relative to the first shaft but fixed against axial movement relative to the first shaft, the distal end portion of the second shaft having an outer surface comprising external threads or grooves;

a sheath retaining ring disposed on the threads or grooves of the second shaft and fixed against rotational movement relative to the distal end portion of the second shaft; and

a delivery sheath configured to receive and retain the prosthetic valve in a compressed delivery state, the delivery sheath being connected to the sheath retaining ring;

wherein the second shaft is configured to be rotatable relative to the first shaft such that rotation of the second shaft causes the sheath retaining ring to move axially along the threads or grooves, thereby moving the sheath axially relative to the first and second shafts to deploy the prosthetic valve contained within the sheath.

2. The delivery apparatus of claim 1, wherein the distal end portion of the second shaft comprises a screw having external threads and the sheath retaining ring comprises a nut having internal threads that engage the external threads on the screw.

3. The delivery apparatus of claim 1, wherein the distal end portion of the second shaft comprises a coil having external grooves and the sheath retaining ring comprises a washer that engages the grooves on the coil.

4. The delivery apparatus of claim 1, further comprising:

a third elongated shaft extending through the second shaft and having a proximal end portion and a distal end portion;

a valve-retaining mechanism comprising first and second components on the distal end portion of the third shaft and the distal end portion of the first shaft, respectively, the first and second components cooperating to form a releasable connection with a stent of the prosthetic valve and to prevent rotation of the prosthetic valve relative to the sheath and the first and third shafts as the second shaft is rotated to move the sheath axially to deploy the prosthetic valve.

5. The delivery apparatus of claim 4, wherein:

the first component of the valve-retaining mechanism comprises a plurality of inner prongs;

the second component of the valve-retaining mechanism comprises a plurality of outer prongs, which cooperate with the inner prongs to form a releasable connection with respective retaining arms of the stent.

6. The delivery apparatus of claim 5, wherein the outer prongs extend along and engage an outer surface of the sheath retaining ring to prevent rotation of the retaining ring upon rotation of the second shaft such that the retaining ring is caused to move axially relative to the outer prongs upon rotation of the second shaft.

7. The delivery apparatus of claim 5, wherein the distal end portion of the first shaft comprises a slotted metal tube, and the outer prongs extend from the distal end of the slotted metal tube.

8. The delivery apparatus of claim 4, further comprising a nose cone secured to the distal end portion of the third shaft and configured to abut a distal end of the sheath when the sheath is in a delivery position covering the prosthetic valve.

9. The delivery apparatus of claim 8, wherein the nose cone comprises a plurality of longitudinal grooves spaced around an outer surface of the nose cone to promote radial compression of the nose cone when it is advanced through an introducer sheath.

10. The delivery apparatus of claim 1, wherein the distal end portion of the second shaft comprises an annular projection that engages an inner surface of the first shaft to prevent axial movement of the second shaft relative to the first shaft.

11. The delivery apparatus of claim 1, wherein the sheath comprises a distal end portion comprising a plurality of flaps that are biased radially inwardly and can expand radially outwardly upon deployment of the prosthetic valve from the distal end portion of the sheath.

12. The delivery apparatus of claim 1, wherein a section of the second shaft comprises a plurality of interconnected annular links.

13. The delivery apparatus of claim 12, wherein the section of interconnected annular links is within the distal portion of the second shaft adjacent the external threads or grooves.

14. The delivery apparatus of claim 1,

wherein the handle portion houses a motor that is configured to rotate the second shaft relative to the first shaft when the motor is actuated by a user.

15. The delivery apparatus of claim 14, wherein the handle portion comprises a latch mechanism that is configured to releasably secure the first and second shafts to the handle portion.

16. The delivery apparatus of claim 1, wherein the threads or grooves of the outer surface of the second shaft are adjacent the prosthetic valve.

17. The delivery apparatus of claim 1, wherein the first and second shafts are longer than the sheath.

18. A delivery apparatus for implanting a prosthetic valve, comprising:

a first elongated shaft having a proximal end portion and a distal end portion;

a second elongated shaft extending through the first shaft and having a proximal end portion and a distal end portion, the second shaft being rotatable relative to the first shaft but fixed against axial movement relative to the first shaft;

a third elongated shaft extending through the second shaft and having a proximal end portion and a distal end portion;

a delivery sheath configured to receive and retain the prosthetic valve in a compressed delivery state, the delivery sheath being coupled to the second shaft; and

a valve-retaining mechanism comprising first and second components on the distal end portion of the third shaft and the distal end portion of the first shaft, respectively, the first and second components cooperating to form a releasable connection with a stent of the prosthetic valve;

wherein the second shaft is configured to be rotatable relative to the first shaft such that rotation of the second shaft causes the sheath to move axially relative to the first, second and third shafts to deploy a prosthetic valve contained within the sheath;

wherein the valve-retaining mechanism prevents axial and rotational movement of the prosthetic valve relative to the first and third shafts as the second shaft is rotated to move the sheath axially to deploy the prosthetic valve.

19. The delivery apparatus of claim 18, wherein the distal end portion of the second shaft comprises a screw and a threaded nut is disposed in the screw, the screw being coupled to the sheath such that rotation of the second shaft causes the nut to move axially along the screw, thereby moving the sheath.

20. The delivery apparatus of claim 19, wherein the second component of the valve-retaining mechanism comprises a plurality of axially extending prongs that prevent rotation of the nut relative to the screw when the second shaft is rotated relative to the first shaft.

21. The delivery apparatus of claim 18, wherein:

the first component of the valve-retaining mechanism comprises a plurality of inner prongs;

the second component of the valve-retaining mechanism comprises a plurality of outer prongs, which cooperate with the inner prongs to form a releasable connection with respective retaining arms of the stent.

22. The delivery apparatus of claim 21, wherein each of the outer prongs has a proximal end, a distal end, and a portion intermediate the proximal and distal ends that is bent inwardly toward the third shaft.

23. The delivery apparatus of claim 21, wherein each of the outer prongs has a proximal end, a distal end, and a portion intermediate the proximal and distal ends that is bent outwardly away from the third shaft.

24. The delivery apparatus of claim 21, wherein the distal end portion of the first shaft comprises a slotted metal tube, and the outer prongs are integrally formed in the slotted metal tube.

25. The delivery apparatus of claim 18, further comprising handle portion, the handle portion comprising a latch mechanism that releasably secures the proximal end portion of the second shaft to the handle portion.

26. The delivery apparatus of claim 18, further comprising a handle portion operatively connected to the second shaft, the handle portion housing a motor that is configured to rotate the second shaft relative to the first shaft when the motor is actuated by a user.

27. The delivery apparatus of claim 18, in combination with a prosthetic valve comprising a stent, the stent comprising a plurality of retaining arms that are secured to the first and second components of the valve-retaining mechanism.

28. The delivery apparatus and prosthetic valve combination of claim 27, wherein the stent comprises a first end at the retaining arms and a second end, opposite the first end, and a plurality of struts arranged in rows and connected to each other so as to form a plurality of first apexes pointing toward the first end of the stent and a plurality of second apexes pointing toward the second end of the stent, wherein each of the first apexes are fixed apexes formed by two adjacent struts in the same row of struts and at least one additional strut in an adjacent row of struts.