DELIVERY SYSTEMS AND METHODS FOR TRANSCATHETER PROSTHETIC VALVES

• US 20150196393A1
• Filed: 08/14/2012
• Published: 07/16/2015
• Est. Priority Date: 07/30/2012
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyme Holdings Incorporated
• Inventors: Vidlund, Robert, Schankereli, Kemal, Lozonschi, Lucian, Lutter, Georg
• Granted Patent: US 9,675,454 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

This invention relates to a delivery apparatus and method for deployment of a mitral valve replacement.

Claims

1. A delivery apparatus for a transcatheter valve replacement, comprising a handle having a actuator and an actuator spring, a tensioning unit mounted for reciprocal motion responsive to the operation of the actuator, a traveller strap removably mounted within a strap mount of the tensioning unit, a catheter removably held by a catheter mount connected to a distal end of the traveller strap, a pusher unit having a distal end that is partially disposed within said catheter, and a proximal end that engages a pusher mount on the handle.

2. The delivery apparatus of claim 1, wherein the traveller strap is plastic or metal.

3. The delivery apparatus of claim 1, wherein the traveller strap engages the tensioning unit using a friction mount.

4. The delivery apparatus of claim 1, wherein the traveller strap has a plurality of teeth thereon and engages the the tensioning unit via a pawl to constitute a ratchet component.

5. The delivery apparatus of claim 1, wherein the pusher unit is about 12 to about 38 cm in length.

6. The delivery apparatus of claim 1, wherein the pusher unit is about 60 to about 150 cm in length.

7. The delivery apparatus of claim 1, wherein the catheter contains a mitral valve replacement prosthesis.

8. The delivery apparatus of claim 7, wherein the pusher unit is a hollow tube for carrying valve anchoring tethers attached to the mitral valve replacement prosthesis.

9. A method of delivering a transcatheter mitral valve replacement to the mitral annulus of a heart, comprising deploying into the mitral annulus a transcatheter mitral valve prosthesis using the delivery apparatus of claim 1, wherein the transcatheter mitral valve prosthesis is made from an expandable metal stent body having valve leaflets disposed therein, said stent body covered with a synthetic material or stabilized pericardial tissue, said the valve leaflets made from stabilized pericardial tissue, said expandable metal stent body having an optional atrial cuff, said cuff optionally having a covering made from a synthetic material or stabilized pericardial tissue, said transcatheter mitral valve prosthesis deployed via catheter in a compressed state and expanding upon ejection from the catheter.

12. The method of claim 1, wherein the prosthetic valve replacement being delivered is a mitral valve.

10. A method of improving the deployment of a mitral valve replacement in a patient, comprising the step of fastening one or more tethers to a tether anchor of a mitral valve prosthesis that is deployed within the mitral annulus, wherein the mitral valve prosthesis is made from an expandable metal stent body having valve leaflets disposed therein, said stent body covered with a synthetic material or stabilized pericardial tissue, said the valve leaflets made from stabilized pericardial tissue, said expandable metal stent body having an optional atrial cuff, said cuff optionally having a covering made from a synthetic material or stabilized pericardial tissue, wherein a distal end of the one or more tethers is anchored in the left ventricle, wherein the one or more tethers are pre-threaded through the expandable metal stent body, and wherein the one or more tethers are tightened by a catheter tool positioned in the left atrium that pulls the atrially located proximal end of the one or more tethers just prior to the step of fastening the one or more tethers to create a fixed length.

11. A method of deploying a valve replacement in a patient, comprising the steps of:

(i) accessing the left ventricle with a catheter using a transvenous approach;

(ii) anchoring a distal end of at least one tether to the septal wall between the right ventricle and the left ventricle;

(iii) withdrawing the catheter from the left ventricle into the left atrium wherein the action of withdrawing the catheter having at least one tether disposed therein that is anchored unsheaths a valve prosthesis that was compressed into the catheter and was advanced within the catheter to the left atrium, wherein the valve prosthesis is made from an expandable metal stent body having valve leaflets disposed therein, said stent body covered with a synthetic material or stabilized pericardial tissue, said the valve leaflets made from stabilized pericardial tissue, said expandable metal stent body having an optional atrial cuff, said cuff optionally having a covering made from a synthetic material or stabilized pericardial tissue;

(iv) positioning the unsheathed valve prosthesis for deployment into the annulus;

(v) tightening the at least one tether using a catheter tool positioned in the left atrium and pulling the atrially located proximal end of the at least one tether; and

(vi) fastening the at least one tether to a tether anchor of the valve prosthesis that is deployed within the valve annulus to to create a fixed length for the at least one tether, wherein a distal end of the at least one tether is anchored in the left ventricle, wherein the at least one tether is pre-threaded through the expandable metal stent body.