Devices, systems, and methods for adjustably tensioning artificial chordae tendineae in a heart

Patent metadata

Field	Value
Publication number	US-12419745-B2
Application number	US-202117483206-A
Country	US
Kind code	B2
Filing date	Sep 23, 2021
Priority date	Sep 30, 2020
Publication date	Sep 23, 2025
Grant date	Sep 23, 2025

Abstract

Devices, systems, and method for adjusting and setting tension of an artificial chordae tendineae. The artificial chordae tendineae is coupleable between a leaflet clip and a tissue anchor. A locking assembly, through which the artificial chordae tendineae extends, is shiftable between a tension-adjusting configuration, in which the artificial chordae tendineae is movable to adjust tension on the leaflet, and a tension-setting or locked configuration, in which the artificial chordae tendineae is inhibited or prevented or locked against moving with respect to the locking assembly to set or fix tension on the leaflet.

First claim

What is claimed is:

1. A system for adjusting tension in an artificial chordae tendineae extending between a leaflet of a heart valve and papillary muscle or a heart wall, the system comprising:
a leaflet clip configured to be engaged with a leaflet of a heart valve and with the artificial chordae tendineae;
an anchor configured to be engaged with a papillary muscle or heart wall;
an artificial chordae tendineae extending between the leaflet clip and the anchor; and
a locking assembly associated with the anchor and having a housing with a longitudinal axis and a locking element shaped with respect to the housing to be axially movable but not rotatable within the housing;
wherein:
the artificial chordae tendineae extends through a pathway defined within the locking element of the locking assembly; and
the locking element is configured to be selectively axially shiftable between a tension-adjusting configuration allowing the artificial chordae tendineae to move relative to the locking assembly to increase and decrease tension on the leaflet, and a tension-setting configuration inhibiting movement of the artificial chordae tendineae relative to the locking assembly to set tension on the leaflet.

2. The system of claim 1 , wherein the locking element is movable within a longitudinal cavity defined in the housing to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration.

3. The system of claim 2 , wherein the locking element comprises one of a carriage, a roller, an auger, or a tissue-engaging element movable axially within the longitudinal cavity in the housing.

4. The system of claim 2 , wherein a pathway is defined along the movable locking element along which the artificial chordae tendineae extends axially.

5. The system of claim 4 , wherein:
the longitudinal cavity in the housing defines a locking region and a tension-adjusting region;
the artificial chordae tendineae is movable with respect to the movable locking element when the movable locking element is within the tension-adjusting region;
an exterior portion of the pathway extends along an exterior of the movable locking element; and
one or more portions of the artificial chordae tendineae extending along the exterior portion of the pathway extending along the exterior of the movable locking element are pinched between the movable locking element and the tension-adjusting region when the movable locking element is within the locking region in the longitudinal cavity of the housing to set tension on the leaflet.

6. The system of claim 5 , further comprising a stylet engageable with the movable locking element to move the movable locking element axially to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration.

7. The system of claim 6 , further comprising a coupler configured to couple the stylet and the movable locking element, wherein the artificial chordae tendineae extends axially through the stylet, the coupler, and the movable locking element, and transversely through the movable locking element to the portion of the pathway extending along the exterior of the movable locking element, and transversely through the housing to the leaflet clip.

8. The system of claim 2 , further comprising a stylet engageable with the movable locking element and rotatable to move the movable locking element axially to shift the locking assembly between the tension-adjusting configuration and the tension-setting configuration.

9. The system of claim 2 , wherein:
the anchor comprises a body portion, a tissue-engaging portion extending distally from the body portion, and a locking portion extending proximally from the body portion; and
the housing is a portion of the locking portion of the anchor.

10. A device for adjusting tension of an artificial chordae tendineae, the device comprising:
an artificial chordae tendineae;
a housing defining a longitudinal cavity therein;
a locking assembly positioned in the housing and having an axially movable locking element having a pathway defined therethrough configured for passage of the artificial chordae tendineae therethrough, the locking element positioned within the longitudinal cavity of the housing and shaped with respect to the housing to not be rotatable within the housing, and to be axially movable within and with respect to the longitudinal cavity of the housing between a tension-adjusting configuration allowing the artificial chordae tendineae to move relative to the housing, and a tension-setting configuration inhibiting movement of the artificial chordae tendineae relative to the housing; and
a coupler extending from the movable locking element and configured for engagement with an actuator for rotating to move the movable locking element axially but not rotatably with respect to the housing.

11. The device of claim 10 , further comprising a tissue-engaging element configured to engage tissue of a heart to anchor an end of the artificial chordae tendineae with respect to the heart.

12. The device of claim 10 , wherein the locking assembly comprises one of a carriage, a roller, an auger, or a tissue-engaging element.

13. The device of claim 10 , wherein a pathway is defined along the movable locking element along which the artificial chordae tendineae extends axially.

14. The device of claim 13 , wherein an interior portion of the pathway extends transversely through the movable locking element.

15. The device of claim 14 , wherein an exterior portion of the pathway extends along an exterior of the movable locking element.

16. The system of claim 15 , wherein:
the longitudinal cavity in the housing defines a locking region and a tension-adjusting region;
the artificial chordae tendineae is movable with respect to the movable locking element when the movable locking element is within the tension-adjusting region; and
one or more portions of the artificial chordae tendineae extending along the portion of the pathway extending along the exterior of the movable locking element are pinched between the movable locking element and the tension-adjusting region when the movable locking element is within the locking region to set tension on a leaflet.

17. The device of claim 13 , wherein an exterior portion of the pathway extends along an exterior of the movable locking element.

18. A method of adjusting tension in an artificial chordae tendineae extending between a leaflet of a heart valve and papillary muscle or a heart wall, the method comprising:
extending the artificial chordae tendineae through a housing and a movable locking element of a locking assembly of the artificial chordae tendineae tensioning and locking device, the locking element shaped to move axially but not rotatably within the housing;
moving the artificial chordae tendineae relative to a housing of the locking assembly to increase or decrease tension on the leaflet when the locking assembly is in a tension-adjusting configuration; and
when a desired tension on the leaflet is reached, axially shifting, without rotating, the movable locking element of the locking assembly, with respect to the housing of the locking assembly, into a tension-setting configuration to set tension on the artificial chordae tendineae and on the leaflet.

19. The method of claim 18 , wherein moving the artificial chordae tendineae relative to the housing further comprises coupling a stylet with the movable locking element of the locking assembly to move the movable locking element.

Assignees

• Boston Scient Scimed Inc

Inventors

• Giese Troy A
• Koudela Christopher J
• Rohl James P
• Shuey Daniel
• Killeen Larry M
• Eggert Joel T
• Abbott Aaron

Classifications

• A61F2250/0007

  for adjusting length · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2457 Primary

  Chordae tendineae prostheses · CPC title

• A61B2017/0451

  Cams or wedges holding the suture by friction · CPC title