Methods and devices for transapical delivery of a sutureless valve prosthesis

• US 8,366,767 B2
• Filed: 03/26/2010
• Issued: 02/05/2013
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: JC Medical, Inc.
• Original Assignee: Causper Medical, Inc.
• Inventors: Zhang, Ji
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US12/732,843
• Publication Number:
  US 20100249916A1
• Time in Patent Office: 1,047 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.1, 623/2.11, 623/2.17, 623/2.18
• US Class Current: 623/2.11
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/006 modular

Abstract

A method for delivering a sutureless cardiac valve prosthesis using a transapical approach is provided. The implantation device utilizes movable claspers for both positioning and anchoring the valve prosthesis within the native cardiac valve, minimizing the extent of imaging necessary.

Claims

1. A method for deploying a cardiac valve prosthesis within a native cardiac valve annulus, comprising:

providing an implantation device, comprising;

a valve prosthesis comprising a support frame radially expandable between a compact condition and an expanded condition, said support frame having an outer surface and a longitudinal axis and defining a central orifice about an axis along an inflow-outflow direction, a plurality of flexible leaflets attached to the support frame, and at least one valve clasper movably attached to said support frame wherein said clasper comprises a u-shaped member and two leg members, and wherein said leg members are movable relative to the support frame along the longitudinal axis between a nesting position with the outer surface and an engagement position with the valve annulus; and

a delivery device comprising a control unit, at least one track wire having a proximal end attached to the control unit and a distal end for contact with said at least one valve clasper, a first sheath, wherein the first sheath encases at least a portion of the valve prosthesis in its compact condition, and a second sheath, wherein the second sheath encases the at least one valve clasper; and

inserting at least the distal end of the implantation device into a patient to deploy the valve prosthesis; and

removing the delivery device from the patient.

2. The method of claim 1, wherein the inserting comprises inserting at least the distal end of the implantation device into the heart chamber of a patient and advancing the distal end of the implantation device toward and through a native cardiac valve such that the at least one valve clasper passes through and extends beyond the native cardiac valve;

wherein the leaflets of the native cardiac valve curve away from the distal end of the implantation device.

3. The method of claim 1, wherein the inserting comprises inserting into the left ventricle for deploying into a native aortic valve.

4. The method of claim 1, wherein said inserting comprises inserting the implantation device through an introducer which has been inserted in a heart left ventricle of the patient.

5. The method of claim 1, wherein the implantation device further comprises a valve prosthesis pusher wire having a proximal end fixed to said control unit and a distal end for contact with said valve prosthesis.

6. The method of claim 1, wherein said at least one track wire is hollow, and a locking wire is disposed within said track wire, said locking wire at its proximal end having a locking member to releasably secure said at least one valve clasper to said at least one track wire.

7. The method of claim 1, wherein the support frame is at least partially covered by a covering.

8. The method of claim 7, wherein the at least one valve clasper comprises two leg members and wherein each of the two leg members is at least partially disposed between the support frame and the covering.

9. The method of claim 1, wherein prior to inserting the implantation device into the patient the valve prosthesis is disposed along a distal end portion of the first sheath.

10. The method of claim 1, wherein the first sheath is not straight.

11. The method of claim 1, wherein the method further comprises advancing the implantation device along a guidewire.

12. The method of claim 11, wherein the method further comprises anchoring the at least one valve clasper, wherein said anchoring comprises pulling the at least one track wire in a proximal direction until a u-shaped member of the at least one valve clasper contacts the floor of the native aortic valve sinus.

13. The method of claim 12, wherein the method further comprises adjusting the position of the valve prosthesis such that the distal edge of the valve prosthesis is disposed approximately adjacent to the at least one valve clasper, wherein said adjusting the position of the valve prosthesis comprises pushing the first sheath in a distal direction.

14. The method of claim 13, wherein the method further comprises unattaching the at least one track wire from the at least one valve clasper, wherein said unattaching comprises moving an at least one track wire release switch in a proximal direction.

15. The method of claim 14, further comprising moving the first sheath in a distal direction through the expanded valve prosthesis until the distal edge of the first sheath contacts the proximal edge of the second sheath prior to removing the delivery device from the patient.

16. The method of claim 15, further comprising removing the delivery device, wherein the removing the delivery device from the patient comprises pulling the delivery device in a proximal direction through the introducer until the delivery device is completely removed from the patient.

17. The method of claim 1, wherein when the valve prosthesis is expanded to its expanded condition, at least one native cardiac valve leaflet is disposed between the at least one valve clasper and the valve prosthesis support frame.

18. The method of claim 1, wherein the implantation device further comprises a valve prosthesis pusher wire having a proximal end fixed to a pusher wire controller and a distal end which contacts the proximal edge of the valve prosthesis.

19. The method of claim 18, wherein the method further comprises adjusting the position of the valve prosthesis such that the distal edge of the valve prosthesis is disposed approximately adjacent to the at least one valve clasper, wherein said adjusting the position of the valve prosthesis comprises pushing the first sheath and the pusher wire controller in a distal direction.