Percutaneous heart valve delivery systems

• US 9,668,859 B2
• Filed: 04/12/2013
• Issued: 06/06/2017
• Est. Priority Date: 08/05/2011
• Status: Active Grant

• Current Assignee: California Institute of Technology, Regents of the University of California (University of California)
• Original Assignee: California Institute of Technology, Regents of the University of California (University of California)
• Inventors: Kelley, Gregory S., Kheradvar, Arash, Gharib, Morteza
• Primary Examiner(s): RODJOM, KATHERINE MARIE
• Application Number:
  US13/862,302
• Publication Number:
  US 20130310923A1
• Time in Patent Office: 1,516 Days
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

Abstract

Embodiments described herein address the need for improved catheter devices for delivery, repositioning and/or percutaneous retrieval of the percutaneously implanted heart valves. One embodiment employs a plurality of spring-loaded arms releasably engaged with a stent frame for controlling expansion for valve deployment. Another embodiment employs a plurality of filaments passing through a distal end of a pusher sleeve and apertures in a self-expandable stent frame to control its state of deployment. With additional features, lateral positioning of the stent frame may also be controlled. Yet another embodiment includes plurality of outwardly biased arms held to complimentary stent frame features by overlying sheath segments. Still another embodiment integrates a visualization system in the subject delivery system. Variations on hardware and methods associated with the use of these embodiments are contemplated in addition to those shown and described.

Claims

1. A medical device comprising:

an elongate sleeve having a distal end and a proximal end;

a plurality of apertures in the sleeve adjacent the distal end;

an elastic stent frame comprising a plurality of struts, each strut including a proximal aperture,

wherein the proximal aperture in each strut together form a plurality of proximal apertures of the stent frame, wherein the stent frame further comprises a plurality of distal apertures, each distal aperture being in one of the plurality of struts of the stent frame; and

a plurality of filaments, each filament received within the sleeve from the proximal end, passing out of and looping over the sleeve, passing through one of the strut distal apertures, running directly along a length of one of the struts, passing through one of the strut proximal apertures, and passing through one of the sleeve apertures and into the sleeve.

2. The device of claim 1, further comprising a valve connected to the stent frame.

3. The device of claim 1, wherein the sleeve comprises a distal proximal shoulder for abutting the stent frame during advancement.

4. The device of claim 1, further comprising a sheath to cover the stent frame.

5. The device of claim 4, where the sheath is connected to a handle adapted to advance the sheath to cover the stent frame or retract the sheath to uncover the stent frame.

6. The device of claim 5, wherein the handle is adapted to select and actuate the sheath to intermediate states between full advancement and full retraction.

7. The device of claim 6, wherein retraction of the sheath allows a distal end of the stent frame to expand, and advancement of the sheath compresses the distal portion of the stent frame.

8. The device of claim 1, wherein two ends of each filament pass through the proximal end of the sleeve.

9. The device of claim 8, wherein the two ends of each filament are connected to a handle adapted to actuate the filaments.

10. The device of claim 9, wherein the handle is adapted to select and actuate a proximal portion of the stent frame between states of full expansion for deployment and full compression for retrieval.

11. The device of claim 10, wherein the handle is adapted to select and actuate the proximal end of the stent frame to intermediate states between full compression and full expansion.

12. The delivery system of claim 1, further comprising a handle at the proximal end, the handle including a pivot fitment, the filaments connected to the pivot fitment spaced in a radial orientation matching a radial orientation of the filaments at the stent frame.

13. The delivery system of claim 12, wherein the pivot fitment rides on a spherical bearing surface.

14. The delivery system of claim 12, further comprising a joystick to actuate the fitment.

15. The delivery system of claim 12, further comprising an implant model to actuate the fitment, the model at least substantially resembling the stent frame in appearance.

16. The delivery system of claim 15, wherein the model is a scale replica of the stent frame in an expanded state.

17. A medical device delivery system comprising:

an elongate sleeve having a distal end and a proximal end, a plurality of apertures in the sleeve adjacent the distal end;

an elastic stent frame comprising a plurality of struts, each strut including an aperture, wherein the aperture in each strut together form a plurality of proximal apertures of the stent frame, wherein the stent frame further comprises a plurality of distal apertures, each distal aperture being in one of the plurality of struts of the stent frame;

a plurality of filaments, each filament received within the sleeve from the proximal end, passing out and looping over the sleeve, passing through one of the proximal strut apertures, directly running along the length of one of the struts to, and passing through one of the distal apertures, and passing through one of the sleeve apertures and into the sleeve; and

a handle at the proximal end, the handle including a pivot fitment, the filaments connected to the pivot fitment spaced in a radial orientation matching a radial orientation of the filaments at the stent frame.

18. The delivery system of claim 17, wherein the filaments pass out of the distal end of the sleeve.

19. The delivery system of claim 17, wherein the pivot fitment rides on a spherical bearing surface.

20. The delivery system of claim 17, further comprising a joystick to actuate the fitment.

21. The delivery system of claim 17, further comprising an implant model to actuate the fitment, the model at least substantially resembling the stent frame in appearance.

22. The delivery system of claim 21, wherein the model is a scale replica of the stent frame in an expanded state.