Atrioventricular valve repair using tension

• US 10,617,522 B2
• Filed: 07/06/2017
• Issued: 04/14/2020
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: 4Tech Inc.
• Original Assignee: 4Tech Inc.
• Inventors: Tobis, Idan, Gilmore, Michael
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/642,720
• Publication Number:
  US 20170304051A1
• Time in Patent Office: 1,013 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• 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: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• 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 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 : the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped

Abstract

A system for repairing an atrioventricular valve of a patient is provided. First and second tissue-engaging elements are configured for implantation at first and second implantation sites of the patient, respectively. First and second flexible longitudinal members are coupled at respective first end portions thereof to the first and the second tissue-engaging elements, respective. Each of the first and the second flexible longitudinal members comprises a braided polyester suture or a plurality of wires that are intertwined to form a rope structure. First and second flexible-longitudinal-member-coupling elements are coupled to respective second end portions of the first and the second flexible longitudinal members. The first and the second flexible-longitudinal-member-coupling elements are configured to be couplable together during an implantation procedure to couple together the first and the second flexible longitudinal elements.

Claims

1. A system for repairing an atrioventricular valve of a patient, the system comprising:

first and second tissue-engaging elements, configured for implantation at first and second implantation sites of the patient, respectively;

a first flexible longitudinal member, which is coupled at a first distal end portion thereof to the first tissue-engaging element, and which comprises an element selected from the group consisting of;

a braided polyester suture and a plurality of wires that are intertwined to form a rope structure;

a second flexible longitudinal member, which is coupled at a first proximal end portion thereof to the second tissue-engaging element, and which comprises an element selected from the group consisting of;

a braided polyester suture and a plurality of wires that are intertwined to form a rope structure;

a first flexible-longitudinal-member-coupling element coupled to a second proximal end portion of the first flexible longitudinal member, wherein the first distal and the second proximal end portions of the first flexible longitudinal member are disposed at opposite longitudinal ends of the first flexible longitudinal member; and

a second flexible-longitudinal-member-coupling element coupled to a second distal end portion of the second flexible longitudinal member, wherein the first proximal and the second distal end portions of the second flexible longitudinal member are disposed at opposite longitudinal ends of the second flexible longitudinal member,

wherein the first and the second flexible-longitudinal-member-coupling elements are configured to be couplable together during an implantation procedure to couple together the first and the second flexible longitudinal elements,

wherein the first flexible-longitudinal-member-coupling element comprises one or more male couplings, which are shaped so as to define one or more respective protrusions that protrude radially outward such that the first flexible-longitudinal-member-coupling element defines one or more respective sections distal to the respective protrusions that are narrower than the respective protrusions,

wherein the second flexible-longitudinal-member-coupling element is shaped so as to define a hollow cylinder that is shaped to receive the one or more male couplings of the first flexible-longitudinal-member-coupling element, and

wherein the hollow cylinder is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the hollow cylinder so as to;

allow proximal movement of the one or more protrusions of the first flexible-longitudinal-member-coupling element with respect to the one or more tabs in a proximal direction to push the one or more tabs away from the longitudinal axis, and

thereafter close around one of the one or more narrower sections of the first flexible-longitudinal-member-coupling element, thereby restricting distal movement of the first flexible-longitudinal-member-coupling element with respect to the second flexible-longitudinal-member-coupling element.

2. The system according to claim 1,

wherein the first flexible-longitudinal-member-coupling element comprises a plurality of male couplings, disposed along the first flexible-longitudinal-member-coupling element at respective, different longitudinal sites, and

wherein the hollow cylinder of the second flexible-longitudinal-member-coupling element shaped to receive the male couplings, allow advancement of the male couplings through the hollow cylinder in the proximal direction, and restrict advancement of the male couplings through the hollow cylinder in a distal direction opposite the proximal direction.

3. The system according to claim 2, wherein the first flexible-longitudinal-member-coupling element comprises a flexible chain of interconnected links, which are shaped so as to define the male couplings, respectively.

4. The system according to claim 2, wherein the first flexible-longitudinal-member-coupling element comprises a flexible cable to which the male couplings are fixed at the respective, different longitudinal sites.

5. The system according to claim 1, wherein the one or more male couplings have respective conical features.

6. The system according to claim 1, wherein one of the first and the second tissue-engaging elements comprises a helical tissue anchor.

7. The system according to claim 1, wherein one of the first and the second tissue-engaging elements comprises a radially-expandable stent configured to be implanted in a portion of a blood vessel.

8. The system according to claim 1, wherein the one or more protrusions are shaped so as to provide one or more respective distal shelfs, which have a dimension that is larger than a dimension of the one or more tabs in their resting state and restricts advancement of the one or more male couplings of the first flexible-longitudinal-member-coupling element in a distal direction, such that the one or more tabs, the one or more protrusions, and the one or more shelfs lock the first flexible-longitudinal-member-coupling element with respect to the second flexible-longitudinal-member-coupling element.

9. A method for repairing an atrioventricular valve of a patient, the method comprising:

implanting, at a first implantation site of the patient, a first tissue-engaging element, to which a first distal end portion of a first flexible longitudinal member is coupled, wherein a first flexible-longitudinal-member-coupling element is coupled to a second proximal end portion of the first flexible longitudinal element, wherein the first distal and the second proximal end portions of the first flexible longitudinal member are disposed at opposite longitudinal ends of the first flexible longitudinal member, wherein the first flexible longitudinal element comprises an element selected from the group consisting of;

a braided polyester suture and a plurality of wires that are intertwined to form a rope structure, and wherein the first flexible-longitudinal-member-coupling element comprises one or more male couplings, which are shaped so as to define one or more respective protrusions that protrude radially outward such that the first flexible-longitudinal-member-coupling element defines one or more respective sections distal to the respective protrusions that are narrower than the respective protrusions;

implanting, at a second implantation site of the patient, a second tissue-engaging element, to which a first proximal end portion of a second flexible longitudinal member is coupled, wherein a second tissue-engaging element is coupled to a second distal end portion of the second flexible longitudinal member, wherein the first proximal and the second distal end portions of the second flexible longitudinal member are disposed at opposite longitudinal ends of the second flexible longitudinal member, wherein the second flexible longitudinal element comprises an element selected from the group consisting of;

a braided polyester suture and a plurality of wires that are intertwined to form a rope structure, and wherein the second flexible-longitudinal-member-coupling element is shaped so as to define a hollow cylinder that is shaped to receive the one or more male couplings of the first flexible-longitudinal-member-coupling element; and

coupling together the first and the second flexible-longitudinal-member-coupling elements in situ by inserting the one or more male couplings of the first flexible-longitudinal-member-coupling element into the hollow cylinder, thereby coupling together the first and the second flexible longitudinal members,

wherein the hollow cylinder is shaped so as to define one or more tabs biased to flex toward a central longitudinal axis of the hollow cylinder so as to;

allow proximal movement of the one or more protrusions of the first flexible-longitudinal-member-coupling element with respect to the one or more tabs in a proximal direction to push the one or more tabs away from the longitudinal axis, and

thereafter close around one of the one or more narrower sections of the first flexible-longitudinal-member-coupling element, thereby restricting distal movement of the first flexible-longitudinal-member-coupling element with respect to the second flexible-longitudinal-member-coupling element.

10. The method according to claim 9,

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by pulling one or more of the one or more male couplings through the hollow cylinder.

11. The method according to claim 9,

wherein the first flexible-longitudinal-member-coupling element comprises a plurality of male couplings, disposed along the first flexible-longitudinal-member-coupling element at respective, different longitudinal sites,

wherein hollow cylinder of the second flexible-longitudinal-member-coupling element shaped to receive the male couplings, allow advancement of the male couplings through the hollow cylinder in the proximal direction, and restrict advancement of the male couplings through the hollow cylinder in a distal direction opposite the proximal direction, and

wherein coupling together the first and the second flexible-longitudinal-member-coupling elements comprises tensioning the first and the second flexible longitudinal members by pulling one or more of the one or more male couplings into the hollow cylinder.

12. The method according to claim 11, wherein the male couplings have respective conical features.

13. The method according to claim 11, wherein the first flexible-longitudinal-member-coupling element comprises a flexible chain of interconnected links, which are shaped so as to define the male couplings, respectively.

14. The method according to claim 11, wherein the first flexible-longitudinal-member-coupling element comprises a flexible cable to which the male couplings are fixed at the respective, different longitudinal sites.

15. The method according to claim 9, comprising repairing the atrioventricular valve by applying tension between the first and the second implantation sites using the first and the second flexible longitudinal members.

16. The method according to claim 15, further comprising adjusting a distance between the first and the second implantation sites after repairing the atrioventricular valve.

17. The method according to claim 15, wherein repairing the atrioventricular valve comprises remodeling the atrioventricular valve by drawing together leaflets of the atrioventricular valve by applying tension to the second flexible longitudinal member.

18. The method according to claim 9, wherein implanting the first and the second tissue-engaging elements comprises implanting the first and the second tissue-engaging elements on opposite sides of the atrioventricular valve.

19. The method according to claim 9, wherein one of the first and the second tissue-engaging elements comprises a helical tissue anchor.

20. The method according to claim 9, wherein one of the first and the second tissue-engaging elements comprises a radially-expandable stent, and wherein implanting the one of the first and the second tissue-engaging elements comprises expanding the radially-expandable stent in a portion of a blood vessel.

21. The method according to claim 9, wherein the one or more protrusions are shaped so as to provide one or more respective distal shelfs, which have a dimension that is larger than a dimension of the one or more tabs in their resting state and restricts advancement of the one or more male couplings of the first flexible-longitudinal-member-coupling element in a distal direction, such that the one or more tabs, the one or more protrusions, and the one or more shelfs lock the first flexible-longitudinal-member-coupling element with respect to the second flexible-longitudinal-member-coupling element.