DELIVERY SYSTEMS AND METHODS FOR TRANSCATHETER PROSTHETIC VALVES
First Claim
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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.
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Abstract
This invention relates to a delivery apparatus and method for deployment of a mitral valve replacement.
167 Citations
12 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.
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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.
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11. A method of deploying a valve replacement in a patient, comprising the steps of:
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(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.
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Specification