Transcatheter mitral valve prosthesis

• US 10,449,042 B2
• Filed: 08/22/2017
• Issued: 10/22/2019
• Est. Priority Date: 05/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation), Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Lane, Randy Matthew, Nyuli, Colin A., Ratz, Jeremy Brent, Quadri, Arshad
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/682,890
• Publication Number:
  US 20170348100A1
• Time in Patent Office: 791 Days
• Field of Search: 623 211, 623 214- 219, 623 238
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/9517 handle assemblies therefor
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient'"'"'s heart.

Claims

1. A delivery system for delivering a prosthetic cardiac valve to a patient'"'"'s heart, said system comprising:

an inner guidewire shaft having a lumen extending therethrough, the lumen adapted to slidably receive a guidewire;

a hub shaft disposed over the inner guidewire shaft, wherein the hub shaft comprises a plurality of slots formed into an outer surface of the hub shaft to create a plurality of discrete recessed regions and disposed adjacent a distal end thereof, the slots configured to receive and hold one or more portions of the prosthetic cardiac valve;

a bell shaft slidably disposed over the hub shaft, the bell shaft having a distal section and a proximal section, wherein the distal section of the bell shaft has a diameter larger than a diameter of the proximal section of the bell shaft;

a sheath slidably disposed over the bell shaft, wherein the sheath is disposed over the larger diameter distal section of the bell shaft during delivery of the prosthetic cardiac valve; and

a handle comprising an actuator adapted to advance and retract the bell shaft and the sheath.

2. The system of claim 1, further comprising the prosthetic cardiac valve, wherein the prosthetic cardiac valve is housed in the sheath in a radially collapsed configuration.

3. The system of claim 2, wherein proximal retraction of the sheath relative to the bell shaft removes a constraint from the prosthetic cardiac valve thereby allowing the prosthetic cardiac valve to self-expand into engagement with the patient'"'"'s native heart tissue.

4. The system of claim 2, wherein the prosthetic cardiac valve is releasably coupled with the hub shaft, and wherein proximal retraction of the bell shaft relative to the hub shaft releases the prosthetic cardiac valve therefrom.

5. The delivery system of claim 1, wherein the prosthetic cardiac valve comprises:

an anchor having an atrial skirt, an annular region, and a ventricular skirt; and

a plurality of prosthetic valve leaflets, each of the leaflets having a first end and a free end,

wherein the first end is coupled with the anchor and the free end is opposite of the first end, and

wherein the prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast.

6. The system of claim 1, wherein the actuator mechanism comprises a rotatable wheel.

7. The system of claim 1, further comprising a tissue penetrating distal tip coupled to the hub shaft, wherein the tissue penetrating distal tip is adapted to pass through and expand an incision in the patient'"'"'s heart.

8. The system of claim 1, further comprising a pin lock mechanism releasably coupled with the handle, wherein the pin lock mechanism limits proximal retraction of the sheath.

9. The system of claim 1, wherein the inner guidewire shaft remains stationary during actuation of the actuator mechanism.

10. The system of claim 1, wherein the hub shaft remains stationary during actuation of the actuator mechanism.

11. The system of claim 1, wherein proximal retraction of the sheath releases a portion of the prosthetic cardiac valve from the delivery system.

12. The system of claim 1, wherein the hub shaft is disposed coaxially over inner shaft.

13. The system of claim 12, wherein the hub shaft is disposed concentrically over inner shaft.

14. The system of claim 1, wherein the bell shaft is disposed coaxially over hub shaft.

15. The system of claim 14, wherein the bell shaft is disposed concentrically over hub shaft.

16. The system of claim 1, wherein the sheath is disposed coaxially over the bell shaft.

17. The system of claim 16, wherein the sheath is disposed concentrically over the bell shaft.

18. The system of claim 1, wherein the handle is located near a proximal end of the delivery system.