Heart valve sealing devices and delivery devices therefor

• US 10,507,108 B2
• Filed: 01/14/2019
• Issued: 12/17/2019
• Est. Priority Date: 04/18/2017
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Delgado, Sergio, Dixon, Eric Robert, Taylor, David M.
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US16/247,114
• Publication Number:
  US 20190142579A1
• Time in Patent Office: 337 Days
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• 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 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0008 : Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0045 : Omega-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2240/00 : Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61L 27/04 : Metals or alloys

Abstract

A mitral valve repair system includes a delivery sheath, a mitral valve repair device, and an actuator. The mitral valve repair device is disposed in the delivery sheath in an extended condition. The mitral valve repair device is movable out of the delivery sheath while in the extended condition. The actuator is coupled to the mitral valve repair device, such that retracting the actuator reduces a length of the mitral valve repair device from the extended condition.

Claims

1. A mitral valve repair system comprising:

a delivery sheath;

a mitral valve repair device comprising;

a coaption portion;

a pair of inner paddles connected to the coaption portion;

a pair of outer paddles, each connected to one of the inner paddles; and

a pair of gripping members, each having a fixed arm fixed to one of the inner paddles and a movable arm connected to the fixed arm;

wherein the mitral valve repair device is disposed in the delivery sheath in an extended condition where;

the pair of inner paddles and the attached fixed arms of the pair of gripping members extend distally away from the coaption portion;

the pair of outer paddles extend distally from the pair of inner paddles;

wherein the mitral valve repair device is movable out of the delivery sheath while in the extended condition;

an actuator coupled to the mitral valve repair device, such that retracting the actuator reduces a length of the mitral valve repair device from the extended condition.

2. The mitral valve repair system of claim 1 wherein the mitral valve repair device is configured to be moved out of the delivery shaft into a left atrium of a human heart in the extended condition.

3. The mitral valve repair system of claim 1 wherein retracting the actuator simultaneously reduces the length and increases a width of the mitral valve repair device from the extended condition.

4. The mitral valve repair system of claim 1 wherein the pair of inner paddles become disposed alongside the coaption element when the mitral valve repair device is moved to a closed position.

5. The mitral valve repair system of claim 1 wherein the gripping members are in a closed condition in the delivery sheath while the mitral valve repair device is in the extended condition.

6. A mitral valve repair system comprising:

a delivery sheath;

a mitral valve repair device comprising;

a coaption portion;

a pair of inner paddles connected to the coaption portion;

a pair of outer paddles, each connected to one of the inner paddles; and

a pair of gripping members, each having a fixed arm fixed to one of the inner paddles and a movable arm connected to the fixed arm;

wherein the mitral valve repair device is disposed in the delivery sheath in an extended condition where;

the pair of inner paddles and the attached fixed arms of the pair of gripping members extend distally away from the coaption portion;

the pair of outer paddles extend distally from the pair of inner paddles;

wherein the mitral valve repair device is movable out of the delivery sheath while in the extended condition;

an actuator coupled to ends of the pair of outer paddles of the mitral valve repair device, such that retracting the actuator moves the mitral valve repair device to a closed condition;

wherein the mitral valve repair device is shorter in the closed condition than in the extended condition;

wherein the mitral valve repair device is wider in the closed condition than in the extended condition.

7. The mitral valve repair system of claim 6 wherein the pair of inner paddles become disposed alongside the coaption element when the mitral valve repair device is moved from the extended condition to the closed condition.

8. The mitral valve repair system of claim 6 wherein the mitral valve repair device is configured to be moved out of the delivery shaft into a left atrium of a human heart in the extended condition.

9. The mitral valve repair system of claim 6 wherein the gripping members are in a closed condition in the delivery sheath while the mitral valve repair device is in the extended condition.

10. The mitral valve repair system of claim 9 wherein the gripping members remain in the closed condition while the mitral valve repair device is closed from the extended condition to the closed condition.

11. A mitral valve repair system comprising:

a delivery sheath;

a mitral valve repair device disposed in the delivery sheath in an extended condition;

wherein the mitral valve repair device comprises a coaption element, a pair of inner paddles connected to the coaption element, a pair of outer paddles that extend from the pair of inner paddles, and a pair of gripping members, each having a fixed arm fixed to one of the inner paddles and a movable arm connected to the fixed arm;

wherein the pair of outer paddles are spaced apart from a distal end of the coaption element by the pair of inner paddles when the mitral valve repair device is in the extended condition;

wherein each of the gripping members has an open end that faces away from the coaption portion when the mitral valve repair device is in the extended condition;

wherein the mitral valve repair device is movable out of the delivery sheath while in the extended condition;

an actuator coupled to the mitral valve repair device, such that retracting the actuator moves the mitral valve repair device to a closed condition;

wherein the pair of inner paddles are disposed alongside the coaption element when the mitral valve repair device is in the closed condition; and

wherein each of the outer paddles is disposed alongside an inner paddle when the mitral valve repair device is in the closed condition.

12. The mitral valve repair system of claim 11 wherein the mitral valve repair device is configured to be moved out of the delivery shaft into a left atrium of a human heart in the extended condition.

13. The mitral valve repair system of claim 11 wherein the gripping members are in a closed condition while the mitral valve repair device is in the extended condition in the delivery sheath.

14. The mitral valve repair system of claim 13 wherein the gripping members remain in the closed condition when the mitral valve repair device is closed from the extended condition to the closed condition.

15. A mitral valve repair system comprising:

a delivery sheath;

a mitral valve repair device comprising;

a pair of inner paddles;

a pair of outer paddles, each connected to one of the inner paddles; and

a pair of gripping members, each having a fixed arm fixed to one of the inner paddles and a movable arm connected to the fixed arm;

wherein the mitral valve repair device is disposed in the delivery sheath in an extended condition where;

the pair of inner paddles and the attached fixed arms of the pair of gripping members extend distally;

the pair of outer paddles extend distally from the pair of inner paddles;

wherein the mitral valve repair device is movable out of the delivery sheath while in the extended condition;

an actuator coupled to the mitral valve repair device, such that retracting the actuator reduces a length of the mitral valve repair device from the extended condition.

16. The mitral valve repair system of claim 15 wherein the mitral valve repair device is configured to be moved out of the delivery shaft into a left atrium of a human heart in the extended condition.

17. The mitral valve repair system of claim 15 wherein retracting the actuator simultaneously reduces the length and increases a width of the mitral valve repair device from the extended condition.