TRICUSPID VALVE REPAIR SYSTEM

• US 20180146966A1
• Filed: 11/29/2016
• Published: 05/31/2018
• Est. Priority Date: 11/29/2016
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Hernndez, Carlos G., Kalvass, Laura M., Mosher, Scott C., Prabhu, Santosh V., Romitelli, Paolo, Troxler, Lauren G., Van Hoven, Dylan T.
• Granted Patent: US 10,548,614 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/2825 Inserts of different material in jaws
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Devices and methods for use in a cardiac valve repair procedure, particularly a tricuspid valve repair procedure. An interventional clip device includes a pair of distal elements rotatably joined to a coupling member, and a pair of proximal elements resiliently biased toward the distal elements to grasp tissue therebetween. The proximal elements include a plurality of adjustable tines moveable between a retracted configuration and an open configuration to avoid damage to tissue prior to engagement while allowing tines to enhance gripping to targeted tissue when open. A delivery system enables delivery of an interventional clip to a targeted cardiac valve, and includes a support structure for maintaining position relative to the cardiac valve.

Claims

1. An interventional tissue clip device configured for repair of a cardiac valve, the clip device comprising:

a pair of distal elements rotatably joined to a coupling member; and

a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of tissue therebetween, the proximal elements including a plurality of adjustable tines moveable between a retracted configuration and an open configuration, the open configuration positioning the tines more perpendicular to respective longitudinal axes of the proximal elements so as to enable enhanced grasping of tissue by the proximal elements.

2. The device of claim 1, wherein the tines are configured to project more inwardly when in the retracted configuration relative to when in the open configuration.

3. The device of claim 1, wherein the tines are coupled to one or more control lines, and wherein adjusting the tensioning of the one or more control line controls movement of the tines between the open and retracted positions.

4. The device of claim 3, wherein the tines are biased toward a closed configuration, and wherein application of tension to a proximal control line positioned on a proximal side of each proximal element moves the tines toward the open configuration.

5. The device of claim 4, wherein the device further comprises a distal control line positioned on a distal side of each proximal element, and wherein application of tension to the distal control line moves the tines toward the closed configuration.

6. The device of claim 3, wherein the tines are biased toward an open configuration, and wherein release of tension in a distal control line positioned on a distal side of each proximal element allows the tines to move to the open configuration.

7. The device of claim 1, wherein the proximal elements have a length of greater than 10 mm.

8. A method of treating a regurgitant tricuspid valve, the method comprising:

delivering a first clip device to the regurgitant tricuspid valve;

positioning the first clip device so that a pair of distal arms are disposed on a ventricular side of the tricuspid valve and a pair of corresponding proximal arms are disposed on an atrial side of the tricuspid valve, each distal arm being substantially aligned with the corresponding proximal arm so as to enable the grasping of tricuspid valve leaflet tissue therebetween;

positioning the first clip device at a first placement position along a line of coaptation defined by two leaflets of the tricuspid valve; and

deploying the first clip device so as to grasp the two leaflets defining the line of coaptation, the first clip device thereby approximating the two leaflets to reduce movement of the two leaflets apart from one another.

9. The method of claim 8, wherein the first placement position is located at a medial location of the line of coaptation.

10. The method of claim 8, wherein the first placement position is located along the septal-anterior or septal-posterior line of coaptation.

11. The method of claim 8, further comprising:

positioning a second clip device at a second placement position along a line of coaptation defined by two leaflets of the tricuspid valve; and

deploying the second clip device so as to grasp the two leaflets defining the line of coaptation, the second clip device thereby approximating the two leaflets to reduce movement of the two leaflets apart from one another.

12. The method of claim 11, wherein the second placement position is located along the same line of coaptation as the first placement position.

13. The method of claim 11, wherein the second placement position is located along a different line of coaptation from the first placement position.

14. The method of claim 11, wherein the first placement position is medially located along the septal-posterior line of coaptation, and wherein the second placement position is medially located along the septal-anterior line or coaptation.

15. The method of claim 11, wherein the first placement position is located commissurally along the septal-anterior line of coaptation, and wherein the second placement position is located medially along the septal-anterior line or coaptation.

16. The method of claim 11, wherein the first placement position is located commissurally along the septal-anterior line of coaptation, and wherein the second placement position is located medially along the septal-posterior line or coaptation.

17. The method of claim 11, wherein the first placement position is located medially along the septal-anterior line of coaptation, and wherein the second placement position is located commissurally along the septal-posterior line or coaptation.

18. An interventional system configured for treating a regurgitant tricuspid valve, the interventional system comprising:

a guide catheter having a proximal end and a distal end, the guide catheter having a supportable section, the supportable section defining a distal section as the portion of the guide catheter more distal than the supportable section;

an adjustable support structure disposed at the support section, the adjustable support structure configured to expand upon deployment so as to support the guide catheter against adjacent anatomy and to support a desired orientation of the distal section of the guide catheter with respect to the tricuspid valve;

a delivery catheter translatable within the guide catheter, the delivery catheter being extendable distally beyond the distal end of the guide catheter; and

an interventional clip coupled to a distal end of the delivery catheter, the interventional clip being configured to attach to leaflets of the tricuspid valve to approximate the leaflets.

19. The system of claim 18, wherein the interventional clip includes:

a pair of distal elements rotatably joined to a coupling member; and

a pair of proximal elements resiliently biased toward the distal elements, the distal elements being configured to receive the proximal elements so as to enable the grasping of leaflet tissue therebetween, the proximal elements including a plurality of adjustable tines moveable between a retracted configuration and an open configuration, the open configuration positioning the tines more perpendicular to respective longitudinal axes of the proximal elements so as to enable enhanced grasping of tissue by the proximal elements.

20. The system of claim 18, wherein the support structure is configured to abut against the walls of an inferior vena cava upon deployment.