Devices and methods for minimally invasive repair of heart valves

• US 10,080,659 B1
• Filed: 12/29/2011
• Issued: 09/25/2018
• Est. Priority Date: 12/29/2010
• Status: Active Grant

• Current Assignee: NeoChord, Inc.
• Original Assignee: NeoChord, Inc.
• Inventors: Zentgraf, John, Parins, David Joseph, Sarini, Arun, Speziali, Giovanni
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): HOLLM, JONATHAN A
• Application Number:
  US13/340,185
• Time in Patent Office: 2,462 Days
• Field of Search: 623 124, 623 126, 623 21- 242
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• 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 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06114 Packages or dispensers for needles or sutures packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/0042 with special provisions for gripping
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0406 : Pledgets
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/3419 : Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3425 : for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/349 : Trocar with thread on outside
• CPC Class Codes: A61B 2090/034 : abutting on parts of the device itself
• CPC Class Codes: A61B 5/0044 : for the heart
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61M 2039/064 : Slit-valve
• CPC Class Codes: A61M 2039/0653 : Perforated disc
• CPC Class Codes: A61M 37/0015 : by using microneedles

Abstract

Methods and apparatus for heart valve repair utilize a heart valve repair device including a generally annular ring-like structure and a net structure. The ring-like structure is seated in the valve annulus with the net structure extending from the ring-like structure through the coaptation zone between leaflets. The net structure can then be anchored to a heart structure with a suture. Net structure extending between leaflets helps prevent prolapse of leaflets and can aid in coaptation.

Claims

1. A method of repairing a heart valve, the heart valve including a native valve annulus and at least a pair of native valve leaflets, comprising:

seating a generally annular, ring-like structure in the native valve annulus above the native valve leaflets;

extending a net structure across a coaptation zone defined between the native valve leaflets, the net structure consisting of a fabric-like mesh having a generally open configuration having a greater amount of uncovered open areas than fabric areas, the fabric-like mesh positioned between the native valve leaflets and over at least a portion of a top surface of at least one of the native valve leaflets defining the coaptation zone such that the net structure functions to allow the native valve leaflets to open and close while inhibiting prolapse of the native valve leaflets without promoting in-growth of leaflet tissue into the net structure, and wherein the net structure is attached to the ring-like structure with a plurality of loops, each of the loops defined by an uncovered open area of the fabric-like mesh and arranged around an outer surface of at least a portion of the ring-like structure adjacent one or more other of the loops; and

anchoring the net structure at one or more locations below the native valve leaflets.

2. The method of claim 1, wherein the generally, annular ring-like structure comprises a ring.

3. The method of claim 1, wherein the generally annular ring-like structure comprises a partial ring.

4. The method of claim 1, further comprising altering the shape of the ring-like structure and net structure to fold the ring-like structure and net structure into a catheter for delivery to the valve.

5. The method of claim 1, wherein the net structure extends around only a portion of the ring-like structure.

6. The method of claim 1, wherein the fabric-like mesh defines a plurality of separate unconnected net segments separately attached to the ring-like structure.

7. The method of claim 1, wherein the step of seating a generally annular, ring-like structure in the valve annulus includes engaging a plurality of hooks on the ring-like structure with the annulus.

8. The method of claim 1, wherein the step of seating a generally annular, ring-like structure in the valve annulus including positioning the ring-like structure such that it is retained in the annulus via an outwardly extending spring force generated by the ring-like structure.

9. The method of claim 1, the step of anchoring the net structure at one or more locations below the valve leaflets includes anchoring the net structure to a heart structure with at least one suture.

10. A system for use in repairing a heart valve, comprising:

a generally annular ring-like structure, the ring-like structure dimensioned to be seated in a native annulus of a valve above a pair of native valve leaflets in the valve that define a coaptation zone;

an open net structure consisting of a fabric-like mesh having a greater amount of uncovered open areas than fabric areas, the fabric-like mesh threaded along an outer surface of the ring-like structure such that the uncovered open areas extend from the ring-like structure over at least a portion of a top surface of at least one of the native valve leaflets when the ring-like structure is seated in the native annulus of the valve and extend between the pair of native valve leaflets within the coaptation zone to inhibit prolapse of the native valve leaflets while otherwise enabling normal opening and closing of the native valve leaflets, wherein the net structure is not configured to promote in-growth of leaflet tissue into the net structure, and wherein the fabric-like mesh includes a plurality of loops each defined by an uncovered open area of the fabric-like mesh and arranged adjacent to one or more of the other loops around an outer surface of at least a portion of the ring-like structure; and

at least one suture adapted to extend from the net structure to anchor the net structure below the valve leaflets.

11. The system of claim 10, wherein the generally, annular ring-like structure comprises a ring.

12. The system of claim 10, wherein the generally annular ring-like structure comprises a partial ring.

13. The system of claim 10, wherein the net structure extends around only a portion of the ring-like structure.

14. The system of claim 10, wherein the fabric-like mesh defines a plurality of separate unconnected net segments separately connected to the ring-like structure.

15. The system of claim 10, wherein the generally annular, ring-like structure includes a plurality of hooks adapted to engage the annulus to retain the ring-like structure in the annulus.

16. The system of claim 10, wherein the generally annular, ring-like structure generates an outwardly extending spring force to retain the ring-like structure in the annulus.