Post-Implantation Tensioning in Cardiac Implants

• US 20180221148A1
• Filed: 02/08/2018
• Published: 08/09/2018
• Est. Priority Date: 02/08/2017
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Guidotti, Andrea, Tobis, Idan, Lynn, Kevin, Moran, Chris, Gilmore, Michael
• Granted Patent: US 10,682,229 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/30477 using sharp protrusions, e.g. spikes, for anchoring into connecting prosthetic part

Abstract

A method of treating a heart of a patient is provided. The method includes implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers. Thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, tension is applied between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers. Other embodiments are also described.

Claims

1. A method of treating a heart of a patient, comprising:

implanting a first tissue anchor in cardiac tissue of the patient and a second tissue anchor in the patient, such that the first and the second tissue anchors are coupled together by one or more tethers;

thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue, applying tension between the first and the second tissue anchors using at least a longitudinal portion of the one or more tethers.

2. The method according to claim 1, wherein the one or more tethers are slack before applying the tension.

3. The method according to claim 1, wherein the one or more tethers are one or more first tethers, and wherein applying the tension comprises:

coupling a second tether to a coupling site along the one or more first tethers; and

applying the tension between the first and the second tissue anchors using the at least a longitudinal portion of the one or more first tethers and the second tether.

4. The method according to claim 3, wherein coupling the second tether to the coupling site comprises coupling, to the coupling site, a coupling element that is attached to the second tether.

5. The method according to claim 4, wherein the coupling element comprises a hook.

6. The method according to claim 3, wherein applying the tension comprises coupling the second tether to the second tissue anchor.

7. The method according to claim 6, wherein the second tissue anchor comprises a stent that comprises a plurality of struts, and wherein coupling the second tether to the second tissue anchor comprises coupling, to one or more of the struts, a coupling element that is attached to the second tether.

8. The method according to claim 7, wherein the coupling element comprises a hook.

9. The method according to claim 7, wherein the coupling element is shaped so as to define an opening.

10. The method according to claim 7, wherein at least one of the struts is oriented axially as a backbone, and wherein coupling the coupling element to the one or more of the struts comprises coupling the coupling element to the backbone.

11. The method according to claim 10, wherein the backbone is shaped so as to define one or more hooks, and wherein coupling the coupling element to the backbone comprises coupling the coupling element to one or more of the hooks.

12. The method according to claim 1, wherein a longitudinal portion of the one or more tethers passes through one or more openings of a locking frame so as to form a tether loop, and wherein applying the tension comprises enlarging the tether loop by pulling on the tether loop.

13. The method according to claim 12, wherein the one or more openings are two openings, and wherein the longitudinal portion of the one or more tethers passes through the two openings.

14. The method according to claim 1, wherein applying the tension comprises applying the tension after allowing at least one week for tissue growth on the first tissue anchor.

15. The method according to claim 1, wherein applying the tension comprises applying the tension within two months after implanting the first tissue anchor.

16. The method according to claim 1, wherein implanting the first tissue anchor comprises implanting the first tissue anchor in the vicinity of the tricuspid valve of the patient.

17. The method according to claim 1, wherein implanting the second tissue anchor comprises implanting the second tissue anchor in a blood vessel selected from the group consisting of:

a superior vena cava (SVC), an inferior vena cava (IVC), and a coronary sinus.

18. A method of treating a heart of a patient, comprising:

implanting a first tissue anchor in cardiac tissue of the patient;

thereafter, after allowing at least 24 hours for tissue growth on the first tissue anchor to strengthen anchoring of the first tissue anchor in the cardiac tissue;

implanting a second tissue anchor in the patient;

coupling the first and the second tissue anchors together using one or more tethers; and

applying tension between the first and the second tissue anchors using the one or more tethers.

19. The method according to claim 18,

wherein the one or more tethers are one or more first tethers,

wherein the method further comprises implanting a third tissue anchor in cardiac tissue of the patient, such that the first and the third tissue anchors are coupled together by one or more second tethers,

wherein coupling the first and the second tissue anchors together comprises coupling the first, the second, and the third tissue anchors together using the one or more first tethers and the one or more second tethers, and

wherein applying the tension between the first and the second tissue anchors comprises applying the tension between the first, the second, and the third tissue anchors using the one or more first tethers and the one or more second tethers.

20. The method according to claim 18,

wherein the first tissue anchor comprises a tissue-anchoring element and a first coupling element,

wherein the one or more tethers are attached to the second tissue anchor and comprise a second coupling element, and

wherein coupling the first and the second tissue anchors together using the one or more tethers comprises coupling the second coupling element to the first coupling element.