Implantable device and delivery system for reshaping a heart valve annulus

• US 10,555,813 B2
• Filed: 11/15/2016
• Issued: 02/11/2020
• Est. Priority Date: 11/17/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Kristoffersen, Kristian, Rust, Matthew, Glenn, Richard, Daniels, Terry Wayne, Lee, Michael, Macaulay, Patrick
• Primary Examiner(s): Aleman, Sarah W
• Application Number:
  US15/352,288
• Publication Number:
  US 20170135816A1
• Time in Patent Office: 1,183 Days
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Systems, devices and methods related to various heart valve implants and for delivery of those heart valve implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. Anchors secure the implant to tissue and collars are used to decrease the angle between the struts and contract the frame. The implant thus expands from a first size inside of a delivery catheter, to a second and larger deployed size inside the heart to engage and anchor with the tissue, and then to a third and contracted size to re-size the annulus and/or provide a secure fit for a replacement heart valve. Various delivery systems including imaging capabilities for precise delivery, positioning and anchoring of the various implants are further described.

Claims

1. An implant for reducing heart valve regurgitation comprising:

a frame having upper crowns, lower crowns and struts between the upper and lower crowns, the frame having a tissue engaging configuration having a tissue engaging diameter and an annulus remodeling configuration where the frame has an annulus remodeling diameter that is less than the tissue engaging diameter;

a plurality of anchoring members coupled with the lower crowns of the frame for engaging cardiac tissue proximate the heart valve annulus; and

a plurality of collars coupled with the upper crowns of the frame, wherein when force is applied to the collars, the collars slide along the upper crowns and the struts to move the frame from the tissue engaging configuration towards the annulus remodeling configuration and wherein each collar includes at least one flex section configured to reduce friction between the collar and the upper crowns and the struts.

2. The implant of claim 1, wherein the plurality of anchoring members are helically wound anchoring members and the lower crowns of the frame are adapted to threadingly receive the helically wound anchoring members.

3. The implant of claim 2, wherein the helically wound anchoring members further include anchoring heads for engagement with actuators to rotationally advance the helically wound anchoring members in the cardiac tissue to anchor the frame into the cardiac tissue.

4. The implant of claim 3, further comprising abutments on each of the anchor heads to engage with the struts and the lower crowns to limit travel of the helically wound anchoring members.

5. The implant of claim 2, wherein the helically wound anchoring members have sharpened tips to facilitate penetration of the helically wound anchor members into the cardiac tissue.

6. The implant of claim 1, further comprising at least one tab on each of the collars, wherein the tabs are inwardly biased to engage with the upper crowns when the collars are slid over the upper crowns and struts.

7. The implant of claim 6, wherein each of the collars comprises a plurality of the tabs, and wherein the plurality of tabs can be advanced over the upper crowns and struts to selectively vary the annulus remodeling diameter of the frame.

8. The implant of claim 7, wherein the plurality of tabs are vertically disposed on an outwardly facing portion of the collars and comprises a lowermost tab, wherein the lowermost tab is initially disposed and engaged with an underside of the upper crown.

9. The implant of claim 1, further comprising a groove formed on an outwardly facing side of the upper crowns and at least one tab on each of the collars wherein the tabs are inwardly biased to engage with the groove.

10. The implant of claim 1, further comprising a plurality of pusher members that engage with the plurality of collars to forcibly advance the collars over the upper crowns and struts to reduce the diameter of the frame.

11. The implant of claim 1, wherein the at least one flex section on each collar is configured to facilitate advancement of the collars over the upper crowns and struts.

12. The implant of claim 1, wherein the frame defines a longitudinal axis, and wherein the lower crowns and anchoring members received in the lower crowns are inclined outwardly in a distal direction at an angle between about 30°

to about 60°

with respect to a portion of the axis that extends distally below the implant.

13. A delivery system for delivering an implant for reducing heart valve regurgitation, the delivery system comprising:

the implant, wherein the implant comprises;

a frame having upper crowns, lower crowns and struts between the upper and lower crowns, the frame having a tissue engaging configuration with a tissue engaging diameter, and an annulus remodeling configuration where the frame has an annulus remodeling diameter less than the tissue engaging diameter;

a plurality of anchoring members coupled with the lower crowns of the frame for engaging cardiac tissue proximate the heart valve annulus; and

a plurality of collars coupled with the upper crowns of the frame, wherein when force is applied to the collars, the collars slide on the upper crowns and the struts to move the frame from the tissue engaging configuration towards the annulus remodeling configuration and wherein each collar includes at least one flex section configured to reduce friction between the collar and the upper crowns and the struts;

a delivery catheter releasably attached to the implant and configured to deliver the implant to a position proximate the heart valve annulus; and

an imaging catheter comprising a distal end configured to extend proximate the heart valve annulus and to capture one or more images therein of the position of the implant relative to the heart valve annulus.

14. The delivery system of claim 13, further comprising a plurality of actuating members for engaging corresponding anchoring members of the implant to cause the anchoring members to penetrate and advance into the cardiac tissue to anchor the frame in position proximate the heart valve annulus.

15. The delivery system of claim 13, further comprising a plurality of pusher members for engaging corresponding collars of the implant to forcibly advance each collar over its respective upper crown and struts thereby reducing the diameter of the frame and the valve annulus.

16. The delivery system of claim 13, further comprising means for centering the imaging catheter with respect to the implant.

17. The delivery system of claim 13, wherein the distal end of the imaging catheter comprises longitudinally disposed and circumferentially disposed ultrasound transducers.

18. The delivery system of claim 13, wherein the frame defines a longitudinal axis, and wherein the lower crowns and anchoring members received in the lower crowns are inclined outwardly in a distal direction at an angle of approximately 45°

with respect to a portion of the axis that extends distally below the implant.

19. The delivery system of claim 18, further comprising:

a loop encircling the frame proximate its lower crowns; and

a constricting actuator to constrict the loop to facilitate collapse and loading of the implant into the delivery system.

20. The delivery system of claim 19, wherein each of the collars comprises a plurality of tabs that are inwardly biased to engage with corresponding undersides of the upper crowns when the collars are slid over the upper crowns and struts by the pusher members, and wherein after the frame has been anchored into the cardiac tissue, the loop is constricted to determine the desired reduction in diameter of the frame prior to advancing the collars and tabs over the respective upper crowns and struts.

21. A method of reducing the size of an enlarged heart valve annulus comprising the steps of:

delivering an implant in a delivery system to a site above and proximate the enlarged heart valve annulus, the implant having a proximal end and a distal end;

releasing the implant from the delivery system to allow the implant to take on a tissue engaging diameter;

anchoring the distal end of the implant into cardiac tissue proximate and above the enlarged heart valve annulus;

translating a plurality of collars over corresponding upper crowns of the proximal end of the implant to reduce the tissue engaging diameter to an annulus remodeling diameter, thereby reducing the size of the enlarged heart valve annulus, wherein each collar includes at least one flex section configured to reduce friction between the collar and the upper crowns; and

disengaging the anchored and reduced diameter implant from the delivery system.

22. A heart valve replacement implant comprising:

a replacement valve having a plurality of replacement valve leaflets;

a tubular valve housing fixedly attached to the replacement valve leaflets;

a cinch frame connected to and circumferentially surrounding the tubular valve housing, the cinch frame having upper crowns, lower crowns and struts between the upper and lower crowns, the cinch frame configurable between a tissue engaging configuration wherein opposing upper crowns are separated by a tissue engaging diameter and an annulus remodeling configuration wherein opposing upper crowns are separated by an annulus remodeling diameter that is less than the tissue engaging diameter;

a plurality of anchoring members coupled with the upper crowns of the cinch frame for engaging cardiac tissue proximate the heart valve annulus; and

a plurality of collars coupled with the lower crowns of the cinch frame, wherein when force is applied to the collars, the collars slide on the lower crowns and the struts to reconfigure the cinch frame from the tissue engaging configuration towards the annulus remodeling configuration and wherein each collar includes at least one flex section configured to reduce friction between the collar and the upper crowns and the collars.

23. The heart valve replacement implant of claim 22, further comprising a sealing flange on the cinch frame and disposed on the atrial side of the heart valve when the heart valve replacement system is implanted.

24. A heart valve replacement implant comprising:

a replacement valve having a plurality of replacement valve leaflets;

a tubular valve housing fixedly attached to the replacement valve leaflets;

a cinch frame connected to and circumferentially surrounding the tubular valve housing, the cinch frame having upper crowns, lower crowns and struts between the upper and lower crowns, the cinch frame configurable between a tissue engaging configuration wherein opposing lower crowns are separated by a tissue engaging diameter and an annulus remodeling configuration wherein opposing lower crowns are separated by an annulus remodeling diameter that is less than the tissue engaging diameter;

a plurality of anchoring members coupled with the lower crowns of the cinch frame for engaging cardiac tissue proximate the heart valve annulus; and

a plurality of collars coupled with the upper crowns of the cinch frame, wherein when force is applied to the collars, the collars slide on the upper crowns and the struts to reconfigure the cinch frame from the tissue engaging configuration towards the annulus remodeling configuration and wherein each collar includes at least one flex section configured to reduce friction between the collar and the upper crowns and the struts.

25. The heart valve replacement system of claim 24, wherein the tubular valve housing has a proximal end and a distal end, and the upper crowns of the cinch frame have extensions adapted to be received in openings in the proximal end of the valve housing such that the upper crowns and the cinch frame pivot about the proximal end of the valve housing.