CARDIAC VALVE DELIVERY DEVICES AND SYSTEMS

• US 20180110622A1
• Filed: 05/13/2016
• Published: 04/26/2018
• Est. Priority Date: 05/14/2015
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: GREGG, Peter, WALLACE, Dan, GROGAN, Aaron, CRISOSTOMO, Crissly
• Granted Patent: US 10,849,746 B2
• Time in Patent Office: Days
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument

Abstract

A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tether. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tether in place.

Claims

1. A method of delivering a prosthetic mitral valve comprising:

extending a prosthetic delivery device into a heart with the prosthetic mitral valve collapsed within a sheath of the delivery device;

pulling the sheath proximally to expose at least a distal anchor of the prosthetic valve, thereby allowing the distal anchor to self-expand to an expanded annular configuration on a first side of the mitral valve annulus;

pulling the valve proximally to seat the distal anchor in the expanded annular configuration against a mitral valve annulus;

loosening a plurality of tethers of the delivery device so as to allow the proximal anchor to self-expand to an expanded annular configuration on a second side of the mitral valve annulus, the expansion of the proximal anchor causing the proximal anchor to move towards the distal anchor and capture tissue of the mitral valve annulus between the proximal anchor and the distal anchor;

pulling the sheath further proximally to allow the tethers to release from the proximal anchor; and

removing the delivery device from the heart.

2. The method of claim 1, wherein the step of pulling the sheath further proximally releases distal ends of the tethers.

3. The method of claim 1, further comprising releasing a proximal end of at least one tether if a distal end of the at least one tether becomes tangled.

4. The method of claim 1, wherein distal ends of the tethers are configured to fit within pockets of the delivery device, and wherein the step of pulling the sheath further proximally releases the distal ends of the tethers.

5. The method of claim 4, wherein the distal ends of the tethers include enlarged features configured to fit within the pockets.

6. The method of claim 5, wherein the enlarged features are cones or spheres.

7. The method of claim 1, further comprising:

tightening the plurality of tethers to re-collapse the proximal anchor before the step of pulling the sheath further proximally;

moving the distal anchor to a new position against the mitral valve annulus; and

re-loosening the plurality of tethers so as to allow the proximal anchor to self-expand to an expanded annular configuration on a second side of the mitral valve annulus, the expansion of the proximal anchor causing the proximal anchor to move towards the distal anchor and capture tissue of the mitral valve annulus between the proximal anchor and the distal anchor.

8. A method of delivering a prosthetic mitral valve comprising:

extending a prosthetic delivery device into a heart with the prosthetic mitral valve collapsed within a sheath of the delivery device;

sliding the sheath to expose at least a proximal anchor of the prosthetic valve and allowing the proximal anchor to self-expand to an expanded annular configuration on a first side of the mitral valve annulus;

allowing a distal anchor of the prosthetic valve to self-expand on a second side of the mitral valve annulus after allowing the proximal anchor to self-expand, the expansion of the distal anchor causing the distal anchor to move towards the proximal anchor and capture tissue of the mitral valve annulus between the proximal anchor and the distal anchor; and

removing the delivery device from the heart.

9. The method of claim 8, wherein sliding the sheath comprises sliding the sheath distally.

10. The method of claim 8, wherein sliding the sheath to expose at least a proximal anchor of the prosthetic valve allows the proximal anchor to self-expand to an expanded annular configuration.

11. The method of claim 8, wherein allowing the distal anchor to self-expand comprises loosening a plurality of tethers of the delivery device that are coupled to the distal anchor.

12. A method of delivering a prosthetic mitral valve comprising:

extending a prosthetic delivery device into a heart with the prosthetic mitral valve collapsed within a proximal sheath and a distal sheath of the delivery device, wherein the distal sheath is configured to telescope over a portion of the proximal sheath;

sliding the proximal sheath proximally to expose at least a proximal anchor of the prosthetic valve and allowing the proximal anchor to self-expand to an expanded annular configuration on a first side of the mitral valve annulus;

allowing a distal anchor of the prosthetic valve to self-expand on a second side of the mitral valve annulus after allowing the proximal anchor to self-expand by extending the distal sheath, the expansion of the distal anchor causing the distal anchor to move towards the proximal anchor and capture tissue of the mitral valve annulus between the proximal anchor and the distal anchor; and

removing the delivery device from the heart.

13. The method of claim C1, wherein sliding the proximal sheath to expose at least a proximal anchor of the prosthetic valve allows the proximal anchor to self-expand to an expanded annular configuration after loosening a plurality of tethers of the delivery device that are coupled to the proximal anchor.

14. The method of claim C2, wherein allowing the distal anchor of the prosthetic valve to self-expand comprises sliding the distal sheath in a distal direction.

15. The method of claim C3, wherein the plurality of tethers are further tensioned to completely free the plurality of tethers from the proximal anchor.

16. A delivery device comprising:

a central elongate structure comprising an annular member at a distal end thereof, the annular member including a plurality of pockets extending radially therearound;

a sheath configured to slide over the central elongate structure;

a plurality of tethers extending through the central elongate structure, each tether including a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tether in place;

a handle connected to the elongate structure, the sheath, and the plurality of tethers; and

a control on the handle configured to move the sheath proximally and distally over the central elongate structure.

17. The delivery device of claim 16, wherein the feature is a cone or a sphere.

18. The delivery device of claim 16, wherein the feature is radiopaque.

19. The delivery device of claim 16, wherein the handle further comprises a locking mechanism configured to prevent the control from moving the sheath past a set distance, thereby preventing the features from releasing from the pockets.

20. The delivery device of claim 19, wherein the locking mechanism is releasable so as to allow the sheath to move past the set distance to release the features from the pockets.

21. The delivery device of claim 16, wherein the handle further comprises a tether controller configured to provide tension or release tension to each of the plurality of tethers.

22. The delivery device of claim 21, wherein the handle further comprises a tether lock having an open and closed position configured to prevent further loosening or tensioning of the tether when the tether lock is in the closed position.

23. The delivery of device of claim 21, wherein the handle further comprises a secondary release knob coupled to the tether controller for allowing the plurality of tethers to be released at their proximal ends.

26. The delivery device of claim 16, further comprising a grasper that is configured to magnetically couple to the delivery device through the series of magnetic strips, the grasper comprising:

a coupling aperture adapted to couple to a support arm; and

a grasper knob that when turned is adapted to move the delivery device in an axial direction for placing a prosthetic valve.

27. The delivery device of claim 16, further comprising an outer sheath configured to cover a distal portion of the delivery device for maintaining an incision site during a prosthetic valve placement procedure.

28. The delivery device of claim 27, wherein the outer sheath further comprises an annular groove at its distal end for coupling to an incision site boundary when the incision site boundary is cinched together.

29. The delivery device of claim 16, further comprising a prosthetic valve loading aid for placing the prosthetic valve into the sheath.

24. The delivery device of 23, further comprising a ratcheting assembly configured to prevent forward and back driving of the tether controller, the ratcheting assembly comprising:

a plurality of ratchets coupling the tether controller and the secondary release knob;

two beads symmetrically disposed in two channels within the secondary release knob, wherein the two beads are maintained at the bottom of the two channels with corresponding springs, and wherein tension to the two beads may be released with corresponding actuators; and

three wells adjacent to the bottom of each of the two channels such that only one well is exposed to the bottom of each of the two channels at any one time;

wherein a location of each bead in one of the three wells of each channel corresponds to limiting tether controller movement in one direction, limiting tether controller movement in an opposite direction, or allowing the tether controller to move in the first or the second direction.

25. The delivery device of claim 24, further comprising a series of magnetic strips along one side of the device.