Devices and Methods for Improving Transcatheter Aortic Valve Implantation

Abstract

A method and device for perforating an aortic valve to remove excessive calcium deposits on aortic valve leaflets improves the implantation of TAVI replacement valves in patients. By removing excessive calcium deposits, the radial pressure exerted by implanted TAVI replacement valves is reduced, such that there is less blood leakage around the valve and less stress on the cardiac conductive system. A device with a fusiform punch is inserted into the aortic valve. The punch is separable such that the aortic valve leaflets are positioned between at least two elements of the punch. The two elements then compress together with the leaflets between them, causing the aortic valve to be perforated. A circumferential ring of the remaining aortic valve and calcium deposits are left to provide stability for the TAVI replacement valve.

I claim: 
     
         1 . A device for removing calcium deposits from an artery valve, comprising:
 a tip acting as a stent steath attached to a distal end of a primary tube having a circumference large enough to at least allow a guide wire to pass through;   a self-expandable stent covered with a perforated mesh, with the self-expandable stent attached to a distal end of a secondary tube positioned coaxially around an outer surface of the primary tube;   a punch system, having a male element, with a proximal end connected to a tertiary tube, and a female element, having a proximal end connected to a quaternary tube, which is positioned coaxially around an outer surface of the tertiary tube, which is positioned coaxially around an outer surface of the secondary tube;   a punch control element connected at a distal end to the quaternary tube, having a punch dial attached to a proximal end of a reversely-threaded punch spindle, a punch receptacle with an inner cylindrical area open at a proximal end and threaded to accept the punch spindle, wherein the punch receptacle contain a centered coaxial hole to allow the tertiary tube to pass through and connect to the punch spindle, and the punch spindle and punch dial contain a centered coaxial hole to allow the primary and secondary tubes to pass through, and wherein the punch dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the punch receptacle, which raises and lowers the male element via the tertiary tube relative to the female element; and   a stent control element, having a stent dial attached to a proximal end of a reversely-threaded stent spindle, a stent receptacle with an inner cylindrical area open at a proximal end and threaded to accept the stent spindle, wherein the stent receptacle contains a centered coaxial hole to allow the primary tube to pass through and attach to the stent spindle, and wherein the stent dial is configured to turn either clockwise or counterclockwise to raise or depress the stent spindle within the inner cylindrical area of the stent receptacle, which in turn raises and lowers the stent sheath relative to the self-expandable stent.   
     
     
         2 . The device of  claim 1 , wherein the male element has teeth positioned along a circumferential edge of the proximal end, and the female element has groves positioned along a circumferential edge of the distal end positioned to accept the teeth of the male element. 
     
     
         3 . The device of  claim 1 , further comprising a motor assembly attached to the male element, where the motor assembly includes a high speed motor attached to the male element via a cable and an operator control element is attached to the high speed motor, wherein the operator control element is configured to active or deactivate the high speed motor, which when activated rotatably closes the male element against the female element. 
     
     
         4 . A device for removing calcium deposits from an artery valve, comprising:
 a punch system, having a tip attached to or formed by a male element with a proximal end connected to a distal end of a primary tube and a conically-shaped distal end, and a female element, having a proximal end connected to a secondary tube, which is positioned coaxially around an outer surface of the primary tube, which is positioned coaxially around an outer surface of the primary tube;   a self-expandable stent covered with a perforated mesh, with the self-expandable stent attached to a distal end of a tertiary tube positioned coaxially around an outer surface of the secondary tube;   a stent sheath attached to a distal end of a quaternary tube positioned coaxially around an outer surface of the tertiary tube;   a stent control element, having a stent dial attached to a proximal end of a reversely-threaded stent spindle, a stent receptacle with an inner cylindrical area open at a proximal end and threaded to accept the stent spindle, wherein a distal end of the stent receptacle is attached to the proximal ends of the secondary and quaternary tubes and contains a centered coaxial hole to allow the tertiary tube to pass through and connect to the stent spindle, and the stent spindle and stent dial contain a centered coaxial hole to allow the primary tube to pass through, and wherein the stent dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the stent receptacle, which in turn raises the stent out of the stent sheath allowing expansion of the stent and lowers the stent into the stent sheath whereby a circumferential edge of the stent sheath causes the stent to contract as the stent spindle is raised; and   a punch control element, having a punch dial attached to a proximal end of a reversely-threaded punch spindle, a punch receptacle with an inner cylindrical area open at a proximal end and threaded to accept the punch spindle, wherein the punch receptacle contains a centered coaxial hole to allow the primary tube to pass through and attach to the punch spindle, and wherein the punch dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the punch receptacle, which raises and lowers the male element via the primary tube relative to the female element.   
     
     
         5 . The device of  claim 4 , wherein the male element has teeth positioned along a circumferential edge of the proximal end and the female element has groves positioned along a circumferential edge of the distal end positioned to accept the teeth of the male element. 
     
     
         6 . The device of  claim 4 , further comprising further comprising a motor assembly attached to the male element, where the motor assembly includes a high speed motor attached to the male element via a cable and an operator control element is attached to the high speed motor, wherein the operator control element is configured to active or deactivate the high speed motor, which when activated rotatably closes the male element against the female element. 
     
     
         7 . A method for improving implantation of transcatheter artery valve replacements, comprising:
 inserting a device through an artery valve, wherein the device has a filter umbrella for catching debris from operation of the device and a punch for perforating the aortic valve;   positioning the punch within the native aortic valve, wherein the male element and female element are fusiform to avoid inadvertent damage to surrounding tissue;   positioning the filter umbrella in an aorta down-stream of blood flow through the artery valve, such that the filter umbrella allows blood to pass beyond the aorta and catches debris;   perforating the aortic valve to remove calcium deposits from the artery valve; and   leaving a ring of calcium deposits along the circumference of the native aortic valve.   
     
     
         8 . The method of  claim 7 , wherein the device is inserted through the native aortic valve transapically. 
     
     
         9 . The method of  claim 7 , wherein the device is inserted through the native aortic valve transfemorally or transaortically. 
     
     
         10 . The method of  claim 8 , wherein the device used includes,
 a tip acting as a stent sheath attached to a distal end of a primary tube having a circumference large enough to at least allow a guide wire to pass through;   a self-expandable stent covered with a perforated mesh, with the self-expandable stent attached to a distal end of a secondary tube positioned coaxially around an outer surface of the primary tube;   a punch system, having a male element, with a proximal end connected to a tertiary tube, and a female element, having a proximal end connected to a quaternary tube, which is positioned coaxially around an outer surface of the tertiary tube, which is positioned coaxially around an outer surface of the secondary tube;   a punch control element connected at a distal end to the quaternary tube, having a punch dial attached to a proximal end of a reversely-threaded punch spindle, a punch receptacle with an inner cylindrical area open at a proximal end and threaded to accept the punch spindle, wherein the punch receptacle contain a centered coaxial hole to allow the tertiary tube to pass through and connect to the punch spindle, and the punch spindle and punch dial contain a centered coaxial hole to allow the primary and secondary tubes to pass through, and wherein the punch dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the punch receptacle, which raises and lowers the male element via the tertiary tube relative to the female element; and   a stent control element, having a stent dial attached to a proximal end of a reversely-threaded stent spindle, a stent receptacle with an inner cylindrical area open at a proximal end and threaded to accept the stent spindle, wherein the stent receptacle contains a centered coaxial hole to allow the primary tube to pass through and attach to the stent spindle, and wherein the stent dial is configured to turn either clockwise or counterclockwise to raise or depress the stent spindle within the inner cylindrical area of the stent receptacle, which in turn raises and lowers the stent sheath relative to the self-expandable stent.   
     
     
         11 . The method of  claim 9 , wherein the male element has teeth positioned along a circumferential edge of the proximal end, and the female element has groves positioned along a circumferential edge of the distal end positioned to accept the teeth of the male element. 
     
     
         12 . The method of  claim 10 , wherein the device used includes,
 a punch system, having a tip attached to or formed by a male element with a proximal end connected to a distal end of a primary tube and a conically-shaped distal end, and a female element, having a proximal end connected to a secondary tube, which is positioned coaxially around an outer surface of the primary tube, which is positioned coaxially around an outer surface of the primary tube;   a self-expandable stent covered with a perforated mesh, with the self-expandable stent attached to a distal end of a tertiary tube positioned coaxially around an outer surface of the secondary tube;   a stent sheath attached to a distal end of a quaternary tube positioned coaxially around an outer surface of the tertiary tube;   a stent control element, having a stent dial attached to a proximal end of a reversely-threaded stent spindle, a stent receptacle with an inner cylindrical area open at a proximal end and threaded to accept the stent spindle, wherein a distal end of the stent receptacle is attached to the proximal ends of the secondary and quaternary tubes and contains a centered coaxial hole to allow the tertiary tube to pass through and connect to the stent spindle, and the stent spindle and stent dial contain a centered coaxial hole to allow the primary tube to pass through, and wherein the stent dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the stent receptacle, which in turn raises the stent out of the stent sheath allowing expansion of the stent and lowers the stent into the stent sheath whereby a circumferential edge of the stent sheath causes the stent to contract as the stent spindle is raised; and   a punch control element, having a punch dial attached to a proximal end of a reversely-threaded punch spindle, a punch receptacle with an inner cylindrical area open at a proximal end and threaded to accept the punch spindle, wherein the punch receptacle contains a centered coaxial hole to allow the primary tube to pass through and attach to the punch spindle, and wherein the punch dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the punch receptacle, which raises and lowers the male element via the primary tube relative to the female element.   
     
     
         13 . The method of  claim 11 , wherein the male element has teeth positioned along a circumferential edge of the proximal end, and the female element has groves positioned along a circumferential edge of the distal end positioned to accept the teeth of the male element. 
     
     
         14 . A device for removing calcium deposits from a valve, comprising
 a punch system, having a male element with a proximal end connected to a distal end of a primary tube and a conically-shaped distal end, a female element, having a proximal end connected to a secondary tube, which is positioned coaxially around an outer surface of the primary tube, which is positioned coaxially around an outer surface of the primary tube;   a punch control element attached to the primary and secondary tubes and end opposite to the punch element, wherein the punch control element is configured to move the male element in relation to the female element.   
     
     
         15 . The device of  claim 14 , further comprising further comprising a motor assembly attached to the male element, where the motor assembly includes a high speed motor attached to the male element via a cable and an operator control element is attached to the high speed motor, wherein the operator control element is configured to active or deactivate the high speed motor, which when activated rotatably closes the male element against the female element. 
     
     
         16 . The device of  claim 14 , wherein the punch control element further comprises:
 a punch dial attached to a proximal end of a reversely-threaded punch spindle, a punch receptacle with an inner cylindrical area open at a proximal end and threaded to accept the punch spindle, wherein the punch receptacle contains a centered coaxial hole to allow the primary tube to pass through and attach to the punch spindle, and wherein the punch dial is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle within the inner cylindrical area of the punch receptacle, which raises and lowers the male element via the primary tube relative to the female element.   
     
     
         17 . The device of  claim 14 , wherein the punch control element further comprises:
 a first lever housing attached to a first lever and connected to a proximal end of the secondary tube, wherein an opening in the first lever housing at a connection point between the secondary tubing and the first lever housing allows the primary tube to pass through the first lever housing and through the secondary tube;   a spring housing slidably engaging the first lever housing through an opening in the first lever housing opposite to the opening for the connection point between the secondary tube and first lever housing;   A spring attached at an end to the first lever housing and positioned coaxially within the spring housing and coaxially around the primary tube;   A second lever housing attached to the terminal end of each the primary tube, the spring, and the spring housing, wherein the primary tube and the spring attach to the second lever housing through an opening at the connection point between the spring housing and the second lever housing; and   A second lever pivotably attached to the second lever housing at an internal fulcrum point, wherein the first lever and second lever are pivotably connected at an external fulcrum point.   
     
     
         18 . The device of  claim 14 , wherein the male element has teeth positioned along a circumferential edge of the proximal end, and the female element has groves positioned along a circumferential edge of the end distal positioned to accept the teeth of the male element.