Delivering a Constricting Cord to a Cardiac Valve Annulus Using Balloon-Assisted Positioning

• US 20180071098A1
• Filed: 09/08/2017
• Published: 03/15/2018
• Est. Priority Date: 09/15/2016
• Status: Active Grant

• Current Assignee: Cardiac Implants LLC
• Original Assignee: Cardiac Implants LLC
• Inventors: ALON, David
• Granted Patent: US 10,695,179 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2/2433 using balloon catheter
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

Claims

1. An apparatus for delivering an annulus ring or a cinching cord to the vicinity of an annulus, the apparatus comprising:

an elongated core having a distal end and a channel that runs through the core in a proximal-to-distal direction;

at least four support arms mounted to the core that extend distally beyond the distal end of the core;

at least four anchor launchers, each of the anchor launchers having a distal end, wherein each of the anchor launchers is supported by a respective one of the support arms,

a first shaft disposed within the channel, the first shaft having a first inflation lumen;

an inflatable first balloon mounted to the first shaft and connected to the first inflation lumen so as to permit inflation of the first balloon via the first inflation lumen, wherein the first balloon is configured so that when the first balloon is inflated at a first position, the first balloon will push the support arms away from each other;

a second shaft slidably disposed within the channel, the second shaft having a second inflation lumen; and

an inflatable second balloon mounted to the second shaft and connected to the second inflation lumen so as to permit inflation of the second balloon via the second inflation lumen, wherein the second balloon is disposed distally beyond the first balloon.

2. The apparatus of claim 1, wherein the first shaft is slidably disposed within the channel, and the first balloon is movable to the first position by slidably adjusting a position of the first shaft.

3. The apparatus of claim 2, wherein the first balloon is movable to a second position that is within the channel and proximal of the support arms by slidably adjusting a position of the first shaft.

4. The apparatus of claim 1, further comprising an outer sleeve disposed around the core, the outer sleeve having a distal end,

wherein the outer sleeve is slidable with respect to the core between an extended position and a retracted position,

wherein, when the outer sleeve is in the extended position, the support arms, the anchor launchers, and the first balloon are disposed within the outer sleeve, and

wherein, when the outer sleeve is in the retracted position, the anchor launchers and at least a portion of the support arms extend distally beyond the distal end of the outer sleeve.

5. The apparatus of claim 4, further comprising a nosecone that is movable between a proximal position and a distal position, such that when the nosecone is in the proximal position and the outer sleeve is in the extended position, the nosecone is disposed at the distal end of the outer sleeve.

6. The apparatus of claim 5, wherein the second shaft extends distally beyond the nosecone and the second balloon is located distally beyond the nosecone.

7. The apparatus of claim 5, wherein the nosecone is mounted to the second shaft, and the nosecone is movable between the proximal position and the distal position by slidably adjusting a position of the second shaft.

8. The apparatus of claim 5, wherein the first shaft is slidably disposed within the channel, wherein the first balloon is movable to the first position by slidably adjusting a position of the first shaft, wherein the second shaft extends distally beyond the nosecone and the second balloon is located distally beyond the nosecone, wherein the nosecone is mounted to the second shaft, and wherein the nosecone is movable between the proximal position and the distal position by slidably adjusting a position of the second shaft.

9. The apparatus of claim 5, further comprising a third shaft slidably disposed within the channel, wherein the nosecone is mounted to the third shaft, and the nosecone is movable between the proximal position and the distal position by slidably adjusting a position of the third shaft.

10. The apparatus of claim 5, wherein the nosecone is located distally beyond the second balloon.

11. The apparatus of claim 1, further comprising:

a cinching cord; and

at least four anchors, wherein each of the anchors is disposed in a respective one of the anchor launchers and connected to the cinching cord,

wherein the support arms are configured to hold the distal ends of the anchor launchers at positions that correspond to a shape of the annulus, with the distal ends of the anchor launchers distributed about a perimeter of the shape of the annulus.

12. The apparatus of claim 1, further comprising:

an annulus ring; and

at least four anchors, wherein each of the anchors is disposed in a respective one of the anchor launchers and connected to the annulus ring,

wherein the support arms are configured to hold the distal ends of the anchor launchers at positions that correspond to a shape of the annulus, with the distal ends of the anchor launchers distributed about a perimeter of the shape of the annulus.

13. The apparatus of claim 1, wherein the at least four support arms comprises at least eight support arms, and wherein the at least four anchor launchers comprises at least eight anchor launchers.

14. The apparatus of claim 1, wherein the annulus is a mitral valve annulus.

15. The apparatus of claim 1, wherein the annulus is a tricuspid valve annulus.

16. A method for implanting an annulus ring or a cinching cord to a heart valve annulus or into tissue adjacent to the annulus, wherein the annulus is disposed between an atrium and a ventricle of the heart and wherein the heart has an apex, the method comprising:

delivering an assembly into the atrium, wherein the assembly includes (a) the annulus ring or the cinching cord, (b) a plurality of anchors connected to the annulus ring or the cinching cord, and (c) a plurality of anchor launchers configured to launch the anchors into the annulus or into the tissue adjacent to the annulus, wherein the assembly is supported by a supporting member;

positioning the assembly such that the annulus ring or the cinching cord is adjacent to the annulus or the tissue adjacent to the annulus on the atrium side of the annulus;

advancing an inflatable balloon into the ventricle, wherein the balloon is supported by the supporting member;

inflating the balloon while the balloon is in the ventricle;

adjusting a position of the balloon within the ventricle so that when a selected portion of the cardiac cycle occurs while the balloon is inflated, forces on the balloon will urge the balloon toward the apex of the heart, which will urge the supporting member toward the apex of the heart, which will urge the annulus ring or the cinching cord towards the annulus or towards the tissue adjacent to the annulus;

determining a time when the selected portion of the cardiac cycle is occurring while the inflated balloon is at the adjusted position;

triggering the anchor launchers so that the anchor launchers launch the anchors into the annulus or into the tissue adjacent to the annulus during the selected portion of the cardiac cycle while the inflated balloon is at the adjusted position.

17. The method of claim 16, wherein the determining comprises detecting when the supporting member is being pulled in a distal direction.

18. The method of claim 16, wherein the advancing comprises sliding a shaft to which the inflatable balloon is mounted in a distal direction with respect to the supporting member.

19. The method of claim 16, wherein the positioning comprises inflating an additional balloon between a plurality of support arms that support the anchor launchers so that the additional balloon pushes the support arms away from each other.

20. The method of claim 16, wherein the delivering comprises:

introducing the annulus ring or the cinching cord, the anchors, and the anchor launchers into the atrium while the cinching cord, the anchors, and the anchor launchers are collapsed within an outer sleeve; and

retracting the outer sleeve so that the cinching cord, the anchors, and the anchor launchers extend beyond a distal end of the outer sleeve.

21. The method of claim 16, wherein the valve annulus is a mitral valve annulus.

22. The method of claim 16, wherein the valve annulus is a tricuspid valve annulus.

23. A method for implanting an annulus ring or a cinching cord to a tricuspid valve annulus or into tissue adjacent to the annulus, the method comprising:

delivering an assembly into a right atrium, wherein the assembly includes (a) the annulus ring or the cinching cord, (b) a plurality of anchors connected to the annulus ring or the cinching cord, and (c) a plurality of anchor launchers configured to launch the anchors into the annulus or into the tissue adjacent to the annulus, wherein the assembly is supported by a supporting member;

positioning the assembly such that the annulus ring or the cinching cord is adjacent to the annulus or the tissue adjacent to the annulus on the right atrium side of the annulus;

advancing an inflatable balloon in a deflated state into a pulmonary artery, wherein the balloon is supported by the supporting member;

inflating the balloon while the balloon is in the pulmonary artery, so as to anchor the balloon at a location;

adjusting a position of the assembly while the balloon remains anchored at the location so as to press the annulus ring or the cinching cord towards the annulus or towards the tissue adjacent to the annulus;

launching the anchors into the annulus or into the tissue adjacent to the annulus after the adjusting;

deflating the balloon; and

withdrawing the assembly.

24. The method of claim 23, wherein the pulmonary artery is a right pulmonary artery.

25. The method of claim 23, wherein the pulmonary artery is a left pulmonary artery.

26. The method of claim 23, wherein the advancing comprises sliding a shaft to which the inflatable balloon is mounted in a distal direction with respect to the supporting member.

27. The method of claim 23, wherein the positioning comprises inflating an additional balloon between a plurality of support arms that support the anchor launchers so that the additional balloon pushes the support arms away from each other.

28. The method of claim 23, wherein the delivering comprises introducing the annulus ring or the cinching cord, the anchors, and the anchor launchers into the right atrium while the cinching cord, the anchors, and the anchor launchers are collapsed within an outer sleeve.