Tethers for Prosthetic Mitral Valve

• US 20130172978A1
• Filed: 12/14/2012
• Published: 07/04/2013
• Est. Priority Date: 12/16/2011
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Schankereli, Kemal, Vidlund, Robert
• Granted Patent: US 9,827,092 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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 2017/0403 Dowels other bone dowels A61B17/68; dowels for connecting prosthetic parts A61F2002/30433
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• 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 2230/0078 hyperboloidal

Abstract

This invention relates to the design and function of a single-tether compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed combats the process of wear on anchoring tethers over time by using a plurality of stent-attached, centering tethers, which are themselves attached to a single anchoring tether, which extends through the ventricle and is anchored to a securing device located on the epicardium.

Claims

1. A system for tethering a prosthetic heart valve comprising a transcatheter prosthetic heart valve, wherein the transcatheter prosthetic heart valve comprises an expandable tubular stent having a cuff and an expandable internal leaflet assembly, wherein said cuff is comprised of wire covered with stabilized tissue or synthetic material, and wherein said leaflet assembly is disposed within the stent and is comprised of stabilized tissue or synthetic material, further comprising wherein the cuff is connected to the tubular stent at the first end of the tubular stent and the second end of the tubular stent comprises a tether nexus structure and a single anchoring tether attached to the tether nexus structure.

2. The system of claim 1, wherein the prosthetic heart valve is elastic and is compressed into a delivery catheter for deployment within a patient, and whereby upon expelling the prosthetic heart valve from the delivery catheter, the valve expands to its functional shape.

3. The system of claim 1, further comprising wherein the tether nexus structure is comprised of two or more tethers emanating from the second end of the tubular stent.

4. The system of claim 1, further comprising wherein the individual tethers of the tether nexus structure are braided together at a central point to form the single anchoring tether.

5. The system of claim 1, further comprising wherein the single anchoring tether extends through the ventricle and is attached to an epicardial tether securing device.

6. The system of claim 5, wherein the securing device is located on the apical region of the epicardium.

7. The system of claim 5, wherein the single anchoring tether is comprised of braided filaments and is secured through the securing device by insertion of the tether into a cap device transversely perforated by one or more pin holes, wherein pins are inserted through such holes and also through the braided filaments.

8. The system of claim 1, wherein the prosthetic heart valve is tethered to the apex of the left ventricle using an interlocking tethering system comprised of a stent-based component and a single-tether distal component that cooperatively engages with the stent-based component to form a secure attachment of the prosthetic heart valve to the apex, and a single-tether proximal component that comprises or attaches to an epicardial tether securing device.

9. The system claim 1, wherein the stent and tethers are formed from the same piece of superelastic or shape-memory metal.

10. The system of claim 9, wherein the metal is a nickel-titanium alloy.

11. The system of claim 1, wherein the tethers are comprised of elastic or any known polymer filament.

12. The system of claim 1, wherein the stent and tethers are laser cut with pre-determined shapes to facilitate collapsing into a catheter delivery system.

13. The system of claim 1, wherein the stabilized tissue is derived from 30 day old bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa.

14. The system of claim 1, wherein the synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene.

15. The system of claim 1, wherein the stabilized tissue or synthetic material is treated with anticoagulant.

17. A method of treating mitral or tricuspid regurgitation in a patient, which comprises the step of surgically deploying the single-tethered prosthetic heart valve of claim 1 into the mitral or tricuspid annulus of the patient.

18. The method of claim 17, wherein the prosthetic heart valve is deployed by directly accessing the heart through the intercostal space, using an apical approach to enter the ventricle, and deploying the prosthetic heart valve into the valve annulus.

19. The method of claim 17, wherein the prosthetic heart valve is deployed by (a) directly accessing the heart through a thoracotomy, sternotomy, or minimally-invasive thoracic, thorascopic, or trans-diaphragmatic approach to enter the left ventricle, (b) directly accessing the heart through the intercostal space, using an approach through the lateral ventricular wall to enter the left ventricle when deploying to the mitral annulus, (c) accessing the left atrium of the heart using a transvenous atrial septostomy approach when deploying to the mitral annulus, (d) accessing the left ventricle of the heart using a transarterial retrograde aortic valve approach when deploying in the mitral annulus, or (e) accessing the left ventricle of the heart using a transvenous ventricular septostomy approach when deploying in the mitral annulus.

16. A prosthetic mitral valve, comprising a transcatheter prosthetic heart valve in a patient using as an anchor a single tether that is anchored within the heart between an apically affixed epicardial securing device and a stent-based fastening system, wherein the transcatheter prosthetic heart valve comprises an expandable tubular stent having a cuff and an expandable internal leaflet assembly, wherein said cuff is comprised of wire covered with stabilized tissue or synthetic material, and wherein said leaflet assembly is disposed within the stent and is comprised of stabilized tissue or synthetic material.