IP Library › Granted Patent US 11,160,653
Granted Patent B2
US 11,160,653 · App. 16/498,065 · Granted Nov 2, 2021

Docking elements

Inventors: Netanel Benichou (Hof Carmel, IL); Benjamin Spenser (Hof Carmel, IL); Moran Sobol (Haifa, IL)
Assignee: TRULEAF MEDICAI LTD.
A61F2/2409A61F2/0077A61F2/2418A61F2002/0086A61F2220/0016
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Quick Facts
Patent No.
US 11,160,653
App. No.
16/498,065
Granted
Nov 2, 2021
Kind
B2
Abstract

Apparatus and methods are described for treating a subject with a diseased mitral valve. A docking element ( 100 ) is implanted within the subject's left atrium such that no portion of the docking element extends through the subject's mitral valve. The docking becomes anchored to tissue of the left atrium at least partially via ingrowth of the tissue of the left atrium. The docking element ( 100 ) includes a ring ( 102 ), which is implanted at the subject's mitral valve annulus, and a frame ( 104 ), having a height of at least 15 mm, which extends upwardly from the ring. A prosthetic mitral valve apparatus ( 20 ) is placed at least partially inside the docking element subsequent to the ingrowth of the tissue of the left atrium having occurred, and becomes anchored to the docking element, at least partially by radially expanding against the ring. Other applications are also described.

Claims (22)

1. A method for treating a subject with a diseased mitral valve, the method comprising:

inserting a docking element into a left atrium of the subject, the docking element including a ring, and a frame extending from the ring, the docking element being configured to become anchored to tissue of the left atrium at least partially via ingrowth of the tissue of the left atrium to the docking element;

deploying the docking element within the subject's left atrium, such that (a) no portion of the docking element extends through the subject's mitral valve, (b) the ring is disposed in a vicinity of a mitral valve annulus of the subject, and (c) the frame extends from the ring until at least a height of at least 15 mm from the ring, the frame being configured to radially expand against an inner wall of the left atrium;

leaving the docking element within the subject's left atrium in a deployed state; and

in a subsequent procedure that is performed subsequent to the ingrowth of the tissue of the left atrium to the docking element having occurred,

inserting a prosthetic mitral valve apparatus to inside the ring; and

causing the prosthetic mitral valve apparatus to radially expand against the ring, such that the prosthetic mitral valve apparatus is anchored within the ring,

wherein, subsequent to the docking element being deployed within the subject's left atrium until the insertion of the prosthetic mitral valve apparatus to inside the ring, there is no prosthetic valve implant structure between leaflets of the native mitral valve and the docking element.

2. The method according to claim 1 , wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium, such that at least a portion of the docking element is disposed within a left atrial appendage of the subject.

3. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element into the subject's left atrium transseptally in a direction that is parallel to a longitudinal axis of the frame, and wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that a plane defined by the ring is substantially parallel to the longitudinal axis of the frame.

4. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element into the subject's left atrium transseptally in a direction that is parallel to a longitudinal axis of the frame, and wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that the longitudinal axis of the frame is substantially parallel to a plane defined by the subject's mitral valve annulus.

5. The method according to claim 1 , wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that the frame does not contact tissue of the left atrium in a vicinity of junctions of the left atrium with pulmonary veins of the subject.

6. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element into the subject's left atrium transseptally in a direction that is parallel to a longitudinal axis of the frame, and wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that the ring is disposed in the vicinity of the subject's mitral valve annulus, and such that a plane defined by the ring is substantially parallel to the longitudinal axis of the frame.

7. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element into the subject's left atrium transseptally in a direction that is parallel to a longitudinal axis of the frame, and wherein the deploying of the docking element within the subject's left atrium comprises deploying the docking element such that the longitudinal axis of the frame is substantially parallel to a plane defined by the subject's mitral valve annulus.

8. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element, the frame of the docking element having tissue-ingrowth elements coupled thereto, the tissue-ingrowth elements being configured to encourage tissue ingrowth with respect to the frame.

9. The method according to claim 8 , wherein the inserting the docking element comprises inserting the docking element, the tissue-ingrowth elements including fabric sheets with fibers disposed thereon, the fibers being disposed substantially perpendicularly with respect to the fabric sheets.

10. The method according to claim 1 , wherein the inserting the docking element comprises inserting the docking element, the frame of the docking element being at least partially covered with a fabric layer.

11. The method according to claim 10 , wherein the inserting the docking element comprises inserting the docking element, the fabric layer defining holes therethrough, and wherein the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that the holes defined by the fabric layer are disposed in a vicinity of junctions of the left atrium with pulmonary veins of the subject.

12. The method according to claim 1 , wherein:

the inserting the docking element into the subject's left atrium comprises inserting the docking element into the subject's left atrium, via an interatrial septum of the subject, by advancing the docking element in a lateral direction with respect to the subject's left atrium; and

the deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium without substantially rotating the docking element subsequent to the advancement of the docking element.

13. The method according to claim 12 , wherein the advancing the docking element in the lateral direction with respect to the left atrium comprises advancing the docking element in a direction that is parallel to a longitudinal axis of the frame of the docking element, and wherein deploying the docking element within the subject's left atrium comprises deploying the docking element within the subject's left atrium such that a plane defined by the ring is disposed parallel to the longitudinal axis of the frame.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 26, 2019
From: BENICHOU, NETANEL; SPENSER, BENJAMIN; SOBOL, MORAN
To: TRULEAF MEDICAL LTD.
Reel/Frame 050505/0131 →
Continuity (2)
Provisional Application 62476989 · Mar 27, 2017
Related Publication 20210113330A1 · Apr 22, 2021
Cited By (1)
US 12,588,998