Leaflet capture and anchor deployment system

• US 10,660,753 B2
• Filed: 07/11/2019
• Issued: 05/26/2020
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Pipeline Medical Technologies, Inc.
• Original Assignee: Pipeline Medical Technologies, Inc.
• Inventors: Pham, Trung Ho, Bishop, Gordon B., Griswold, Erik, McDaniel, Stephen, Purcell, Cameron Paul
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US16/509,230
• Publication Number:
  US 20190328527A1
• Time in Patent Office: 320 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• 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: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• 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 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Methods and devices for transvascular prosthetic chordae tendinea implantation are disclosed. A catheter is advanced into the left atrium. From an atrium side, a leaflet connector carried by a distal end of the catheter can be anchored to a superior surface of a mitral valve leaflet. A needle is axially advanceable through the leaflet connector and through the leaflet. A leaflet anchor having a leaflet suture can be advanced out of the needle to secure the mitral valve leaflet to the leaflet suture. A ventricular anchor is anchored to the wall of the ventricle to secure the ventricular wall to a ventricle suture. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

Claims

1. A leaflet anchor deployment system, comprising:

a catheter having a proximal end and a distal end;

a leaflet connector positioned on a distal end of the catheter;

a needle advanceable through the leaflet connector, the needle including a radially enlargeable leaflet anchor preloaded therein and having a suture extending proximally through the catheter; and

wherein the leaflet connector comprises a sharpened tip for piercing the leaflet and wherein the leaflet connector comprises a helical tissue anchor, the leaflet anchor is enlargeable from an axially elongated configuration within the needle to an axially shortened and radially enlarged configuration against the leaflet and wherein the leaflet anchor comprises a fabric pledget having a plurality of transverse folds forming a plurality of stacked panels when in the axially shortened configuration and wherein the pledget comprises two wings which may be rolled around a longitudinal axis of the pledget to produce a reduced cross section conformation.

2. The system of claim 1, further comprising a push wire, for pushing the leaflet anchor out of the needle.

3. The system of claim 1 wherein conversion to the axially shortened and radially enlarged configuration is accomplished by proximal retraction of a leaflet anchor suture.

4. The system of claim 1, wherein the pledget comprises ePTFE.

5. A leaflet anchor deployment system, comprising:

a catheter having a proximal end and a distal end;

a leaflet connector positioned on a distal end of the catheter;

a needle advanceable through the leaflet connector, the needle including a radially enlargeable leaflet anchor preloaded therein and having a suture extending proximally through the catheter; and

wherein the leaflet connector comprises a sharpened tip for piercing the leaflet and wherein the leaflet connector comprises a helical tissue anchor, the leaflet anchor is enlargeable from an axially elongated configuration within the needle to an axially shortened and radially enlarged configuration against the leaflet and wherein the leaflet anchor comprises a fabric pledget having a plurality of transverse folds forming a plurality of stacked panels when in the axially shortened configuration;

wherein the pledget comprises two sheets having a distal section of leaflet anchor suture bonded therebetween.

6. The system of claim 5 wherein the distal section of leaflet anchor suture is flattened between the two sheets.

7. The system of claim 5 wherein the two sheets comprise a plurality of apertures and the leaflet anchor suture extends slidably through the apertures.

8. A leaflet anchor delivery subsystem, comprising:

an elongate flexible tubular body, having a proximal end, a distal end, a central lumen, and a handle at the proximal end of the tubular body, wherein the tubular body axially movably extends through an outer delivery tube;

a deployment needle axially movably advanceable through the central lumen;

a foldable pledget leaflet anchor carried within the deployment needle; and

a leaflet connector carried by the distal end of the tubular body, wherein the deployment needle comprises an elongate flexible shaft which extends proximally to a needle handle,

wherein the needle handle comprises a hemostasis valve.

9. The leaflet anchor delivery subsystem of claim 8, wherein the leaflet connector comprises a helical element.

10. The leaflet anchor delivery subsystem of claim 9, wherein the deployment needle is axially extendable through the helical element.

11. The leaflet anchor delivery subsystem of claim 8, wherein the outer delivery tube comprises a deflection zone and at least one pull wire.

12. The leaflet anchor delivery subsystem of claim 8 wherein the leaflet anchor comprises a pledget.

13. The leaflet anchor delivery subsystem of claim 12, wherein the pledget comprises a plurality of transverse folds forming a plurality of stacked panels when in an axially shortened configuration.

14. The leaflet anchor delivery subsystem of claim of claim 13, wherein the pledget comprises two sheets having a distal section of a leaflet anchor suture bonded therebetween.

15. The leaflet anchor delivery subsystem of claim 13 wherein the distal section of leaflet anchor suture is flattened between the two sheets.

16. The leaflet anchor delivery subsystem of claim of claim 13, further comprising a push wire, for pushing the leaflet anchor out of the needle.

17. The leaflet anchor delivery subsystem of claim of claim 16 wherein the pledget can be converted from the axially shortened and radially enlarged by proximal retraction of a leaflet anchor.