NEO CHORDAE TENDINAE DEPLOYMENT SYSTEM

• US 20190328529A1
• Filed: 07/11/2019
• Published: 10/31/2019
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Pipeline Medical Technologies, Inc.
• Original Assignee: Pipeline Medical Technologies, Inc.
• Inventors: Griswold, Erik, Bishop, Gordon B., McDaniel, Stephen, Pham, Trung Ho, Purcell, Cameron Paul
• Granted Patent: US 10,543,090 B2
• Time in Patent Office: 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. A helical ventricular anchor subassembly is advanceable through the catheter, having a ventricular suture extending proximally through the catheter. A leaflet anchor subassembly is advanceable through the catheter, having a leaflet suture extending proximally through the catheter. From an atrium side, the leaflet anchor subassembly can be anchored to a superior surface of a mitral valve leaflet and a leaflet anchor can be advanced into the mitral valve leaflet to secure the mitral valve leaflet to the leaflet suture. The ventricular anchor subassembly secures the ventricular anchor to a ventricular wall. The leaflet suture and the ventricle suture may be tensioned and connected by a suture lock to form an artificial chordae.

Claims

1. A neo chordae tendinae deployment system, comprising:

a catheter having a proximal end and a distal end;

a helical ventricular anchor subassembly extendable through the catheter, having a ventricular suture extending proximally through the catheter; and

a leaflet anchor deployment subassembly extendable through the catheter, having a radially enlargeable leaflet anchor within the subassembly and having a leaflet suture extending proximally through the catheter.

2. A neo chordae tendinae deployment system as in claim 1, wherein the radially enlargeable leaflet anchor comprises a pledget.

3. A neo chordae tendinae deployment system as in claim 2, wherein the pledget is transformable from an elongate strip configuration to a radially enlarged, axially shortened configuration by proximal retraction of the suture.

4. A neo chordae tendinae deployment system as in claim 1, wherein the radially enlargeable leaflet anchor comprises the leaflet suture positioned between two sheets of material.

5. A neo chordae tendinae deployment system as in claim 1 wherein the radially enlargeable leaflet anchor is carried within a needle having a sharpened end for piercing the leaflet.

6. A neo chordae tendinae deployment system as in claim 5, wherein the leaflet anchor deployment subassembly comprises an elongate tube having a distal end and a central lumen, and a leaflet connector on the distal end.

7. A neo chordae tendinae deployment system as in claim 6, wherein the leaflet connector comprises a helical leaflet anchor.

8. A neo chordae tendinae deployment system as in claim 7, wherein the needle is axially movable with respect to the helical leaflet anchor.

9. A neo chordae tendinae deployment system as in claim 1 further comprising a suture locking subassembly, advanceable through the catheter and configured to connect the ventricular suture to the leaflet suture.

10. A neo chordae tendinae deployment system as in claim 1, wherein the ventricular anchor subassembly comprises an outer tubular sheath having a rotatable anchor driver extending therethrough and a helical ventricular anchor removably carried by the anchor driver.

11. A neo chordae tendinae deployment system as in claim 10, further comprising a hub between the anchor driver and the helical ventricular anchor.

12. A neo chordae tendinae deployment system as in claim 10, further comprising a suture lock guide on a proximal end of the ventricular anchor.

13. A neo chordae tendinae deployment system as in claim 12, wherein the suture lock guide comprises a proximally extending tubular sleeve configured to receive the suture lock.

14. A neo chordae tendinae deployment system as in claim 13, further comprising a radiopaque marker carried by the suture lock guide.

15. A neo chordae tendinae deployment system as in claim 10, further comprising a core wire extending axially through the helical anchor.

16. A neo chordae tendinae deployment system as in claim 15, further comprising a tissue depth indicator carried by the core wire.

17. A neo chordae tendinae deployment system as in claim 16, further comprising a spring to bias the depth indicator in the distal direction.

18. A neo chordae tendinae deployment system as in claim 1, wherein the catheter is dimensioned to simultaneously receive the leaflet anchor deployment subassembly and the ventricular suture therethrough.

19. A neo chordae tendinae deployment system as in claim 18, further comprising a suture lock delivery subassembly.

20. A neo chordae tendinae deployment system as in claim 19, wherein the suture lock delivery subassembly is configured to advance a suture lock simultaneously along the leaflet suture and the ventricular suture.