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.

Claims

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.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0039] Figures accompanying the specification show and describe the inventions, as follows:

[0040] FIG. 1 shows a representation of the cardiac conduction system;

[0041] FIG. 2A shows a traditional implantation of TAVI replacement valve, namely a catheter with a collapsed replacement valve attached coaxially around an outside surface positioned within an aortic valve;

[0042] FIG. 2B shows a traditional implantation of TAVI replacement valve, namely expansion of the replacement valve within the aortic valve via a balloon catheter;

[0043] FIG. 2C shows a traditional implantation of TAVI replacement valve, namely the TAVI replacement valve fully expanded and implanted within a native aortic valve;

[0044] FIG. 3A shows expansion of a balloon catheter inside an aortic valve perforated by the improved process to demonstrate the reduced radial pressure due to shorter aortic leaflets;

[0045] FIG. 3B shows an improved implantation of TAVI replacement valve, namely a catheter with a collapsed replacement valve attached coaxially around an outside surface positioned within a perforated aortic valve;

[0046] FIG. 3C shows an improved implantation of TAVI replacement valve, namely expansion of the replacement valve within the aortic valve via a balloon catheter;

[0047] FIG. 4 shows a representative sampling of different stenotic aortic valves;

[0048] FIG. 5 shows a representative sampling of the different stenotic aortic valves that have been perforated by the improved method and disclosed devices;

[0049] FIG. 6A shows a representative procedure using an inventive device inserted apically up through the left ventricle and into the aorta;

[0050] FIG. 6B shows a representative procedure using an inventive device inserted transfemorally through the femoral artery, up through the aorta and down into the aortic valve;

[0051] FIG. 6C shows a representative procedure using an inventive device inserted transaortically through the aorta artery and down into the aortic valve;

[0052] FIG. 7 shows a representation of a preferred embodiment of a device for perforating an aortic valve;

[0053] FIG. 8A shows the preferred embodiment of FIG. 7 in operation, with a punch closed in an aortic valve;

[0054] FIG. 8B shows an enlarged view of the punch of FIG. 8A;

[0055] FIG. 8C shows an enlarged view of a punch control element of FIG. 8A, positioned such that the punch is correspondingly closed, for either insertion or perforation;

[0056] FIG. 9A shows the preferred embodiment of FIG. 7 in operation, with the punch opened in an aortic valve;

[0057] FIG. 9B shows an enlarged view of the punch of FIG. 9A;

[0058] FIG. 9C shows an enlarged view of a punch control element of FIG. 9A, positioned such that the punch is correspondingly opened, after insertion and in anticipation of perforation;

[0059] FIG. 10 shows a another embodiment of the inventive device, where the punch control element is lever and fulcrum system with a spring, in an open position;

[0060] FIG. 11 shows the embodiment of FIG. 10 in a closed position, and further illustrates the internal structure and operation of the punch control element;

[0061] FIG. 12 shows the operation of the embodiment of FIGS. 10 and 11, with the release of the punch control element and corresponding opening of the punch within the aortic valve after insertion of a closed punch.

[0062] FIG. 13 shows the operation of the embodiment of FIGS. 10 and 11, with the closing of the punch control element handle and either corresponding closing of the punch within the aortic valve after insertion of a closed punch, or initial insertion of the punch within the aortic valve.

[0063] FIG. 14 shows an apical embodiment of the aortic valve perforation device;

[0064] FIG. 15A shows the embodiment of FIG. 14, with focus on a stent system, punch control system, and stent control system;

[0065] FIG. 15B shows an enlarged view of the stent system where a stent sheath covers an expandable stent umbrella;

[0066] FIG. 15C shows an enlarged view of a punch receptacle from the embodiment shown in FIG. 14;

[0067] FIG. 15D shows an enlarged view of a stent receptacle from the embodiment shown in FIG. 14;

[0068] FIG. 16A demonstrates the structure and corresponding function of the stent system and stent control system of the embodiment shown in FIG. 14, as the stent sheath is pulled down over the expandable stent umbrella as a stent spindle is removed from the stent receptacle;

[0069] FIG. 16B demonstrates the stent sheath pulled down over the expandable stent umbrella;

[0070] FIG. 16C demonstrates the stent spindle removed from the stent receptacle;

[0071] FIG. 17A demonstrates the structure and corresponding function of the stent system and stent control system of the embodiment shown in FIG. 14, as the stent sheath is pushed up beyond the expandable stent umbrella the a stent spindle enters the stent receptacle;

[0072] FIG. 17B demonstrates the stent sheath pushed above the expandable stent umbrella;

[0073] FIG. 17C demonstrates the stent spindle pushed into the stent receptacle;

[0074] FIG. 17D shows a perspective view of the stent without a mess umbrella;

[0075] FIG. 18A demonstrates the structure and corresponding function of a punch and a punch control system of the embodiment shown in FIG. 14, as a male element of the punch is pulled down to contact a female element and perforate an aortic valve;

[0076] FIG. 18B shows the male and female elements of FIG. 18A joining to form a fusiform punch, and thereby perforate the aortic valve;

[0077] FIG. 18C shows a punch spindle of FIG. 18A pulled out of a punch receptacle causing the male element to be pulled toward the female element;

[0078] FIG. 18D demonstrates the resulting perforation of the aortic valve due to the closing of the male element to the female element;

[0079] FIG. 19A demonstrates the structure and corresponding function of a punch and a punch control system of the embodiment shown in FIG. 14, as the male element of the punch is pushed up away from the female element;

[0080] FIG. 19B shows an enlarged view of the punch, namely the male element pushed away from the female element via operating of the punch control system;

[0081] FIG. 19C shows an enlarged view of the punch control system, where the punch spindle is pushed into the punch receptacle causing the male element to be raised in relation to the female element;

[0082] FIG. 20 shows another embodiment of the apical device, where the male element of the device has teeth along a cutting edge;

[0083] FIG. 21A shows another embodiment of a device for perforating an aortic valve, where the device is configured to be inserted transfemorally or transaortically;

[0084] FIG. 21B shows a perspective view of a punch and stent umbrella of the embodiment shown in FIG. 21A;

[0085] FIG. 21C shows a perspective view of a punch control system and stent control system of the embodiment shown in FIG. 21A;

[0086] FIG. 22 shows an enlarged perspective view of a punch and stent umbrella of the embodiment shown in FIG. 21A; and

[0087] FIG. 23 shows an embodiment of an aortic valve perforation device with a high speed motor and control to rotatably close a punch.

DETAILED DESCRIPTION OF INVENTION

[0088] Various embodiments and aspects of the disclosure are described with reference to details discussed below. The following descriptions and referenced drawings are illustrative of the disclosure and are not to be construed as limiting the disclosure. The drawings are not necessarily to scale. Numerous specific details are described to provide a thorough understanding of various embodiments of the present disclosure. However, in certain instances, well-known or conventional details are not described in order to provide a concise discussion of embodiments of the present disclosure.

[0089] As used herein, spatial and relative terms such as proximal and distal are relative to a user of the methods or devices described herein, unless otherwise stated. For example, a distal end of a tube is the end farthest from a user, whereas a proximal end of the same tube is the end closest to the user.

[0090] A preferred embodiment for the method for improving transcatheter aortic valve implantation is shown in FIGS. 7-9C. This method includes inserting a device 500 through a native aortic valve 526, wherein the device has a punch 502 having a male element 508 and a female element 514 separable along a plane perpendicular to connection. The device 500 may be inserted through the native aortic valve 526 transapically, transaortically, or transfemorally. For reference, FIG. 6A shows an embodiment of the device 200 inserted transapically through an apex 116 of a heart 001, FIG. 6B shows the device 200 inserted transfemorally, and FIG. 6C shows the device 200 inserted transaortically.

[0091] A next step is positioning the punch 502 within the native aortic valve 526, wherein the male element 508 and female element 514 are fusiform, as shown in FIG. 23A. The male 508 and female 514 elements are fusiform during insertion and positioning of the punch 502 in the native aortic valve 526 to minimize the detachment of calcium deposits from the aortic leaflets 528 in the aorta. Otherwise, cutting edges of the male and female elements 510 and 516, respectively, may inadvertently catch on and dislodge calcium from the native aortic valve 526 if not fusiform, thereby increasing the risk of an embolism.

[0092] A further step includes opening the punch 502 within the native aortic valve 526 such that aortic valve leaflets 528 are positioned between the cutting edge 510 of the male element 508 and the cutting edge 516 of the female element 514. FIG. 8 shows the full device 500 as the fusiform punch is positioned within the native aortic valve 526. FIG. 9 shows the punch 502 opened to position the aortic leaflets 528 between the male 508 and female 514 elements.

[0093] A next step includes closing the punch 502 over the aortic valve leaflets 528 so that the male element 508 applies force along the cutting edge 510 to a superior surface 532 of the aortic valve leaflets 528 and the female element 514 applies force along the cutting edge 516 to an inferior surface 530 of the aortic valve leaflets 528.

[0094] Another step includes perforating the native aortic valve 526 via the punch 502 to remove calcium deposits from the native aortic valve. FIG. 5 shows representations of the perforation of the native aortic valve 526 once the device 500 is removed. The perforation of the native aortic valve 526 should leave a circumferential ring of the remaining tissue of the native aortic valve with a preferable length of 2-3 millimeters.

[0095] The final step includes leaving a ring of calcium deposits 534, as shown in FIG. 5, along the circumference of the native aortic valve 526. A semi-rigid ring composed of the remaining aortic valve is useful in stabilizing any TAVI replacement valve during and after implantation. Additionally, less radial pressure is ultimately placed on the heart conduction system as the majority of the calcium deposits are removed from the native aortic valve that would otherwise be folded upward between a replacement valve and aorta. Further, the chance of paravalvular leaks is reduced, as the shortened aortic leaflets make proper insertion of replacement valves easier and more successful.

[0096] FIGS. 3A-3C show the implantation of a TAVI replacement valve after using the process described herein. FIG. 3A shows insertion of a balloon catheter and replacement valve into the perforated aortic valve. FIG. 3B shows the inflation of the catheter and resulting expansion of the replacement valve. FIG. 3C shows the replacement valve implanted over the perforated aortic valve, with the remaining circumferential ring of the aortic valve, with some calcification, providing a structural support for the replacement valve. FIG. 5 shows the same stenotic valves shown in FIG. 4 after the application of the described process for removing calcium deposits from aortic valves.

[0097] Another embodiment for the method for improving transcatheter aortic valve implantation is shown in FIGS. 6A and 18A-18D, which encompasses the preferred embodiment with additional features. This method includes inserting a device through a native aortic valve, wherein the device has a filter umbrella attached to a punch having a male element and a female element separable along a plane perpendicular to connection. The device is inserted transapically in FIG. 6A, through the apex 116 of the heart into the left ventricle 118 and up through the aortic valve 102 and into the aorta 101. However, the device may be inserted transapically, transaortically, or transfemorally.

[0098] The arrangement of elements of the device must change due to direction of bloodflow when the device is inserted transaortically or transfemorally, as compared to transapically. A suitable embodiment of a device 400 for use in inserting via the aorta or femoral artery is show in FIG. 21A. The primary difference between the device when inserted transaortically or transfemorally, as opposed to transapical insertion, is the orientation of the filter umbrella and punch. As the filter umbrella is used to catch any debris, including calcium buildup that is dislodged during perforation of the native aortic valve, and blood flows out of the left ventricle into the aorta through the aortic valve, the filter umbrella must be positioned in the aorta downstream of the aortic valve. In transaortic and transfemoral insertion, the filter umbrella 424 is therefore positioned behind the punch 402 along the device 400 or proximal to the user of the device relative to the punch 402, as demonstrated in FIG. 22. In contrast, the transapical device 200 is oriented such that the filter umbrella 212 is positioned in front of the punch 206, or distal to the user of the device 200 relative to the punch 206, as shown in FIG. 17A.

[0099] A next step is positioning the punch 206 within the native aortic valve, wherein the male element and female elements are fusiform. The male 218 and female 220 elements are fusiform during insertion and positioning of the punch 206 in the native aortic valve to minimize the detachment of calcium deposits from the aortic leaflets before the engagement of the filter umbrella 212 in the aorta. Otherwise, cutting edges of the male and female elements 223 and 225 may inadvertently catch on and dislodge calcium from the native aortic valve, thereby increasing the risk of an embolism.

[0100] The method then includes positioning the filter umbrella 212 in an aorta down-stream of the aortic valve. The filter umbrella is disengaged, or closed, during insertion to prevent any accidental damage to surrounding tissue or dislodgement of calcium deposits, similar to the punch 206. This is achievable through a slidable hood 214, as shown in FIGS. 16A-16B for transapical devices, or a slidable hood 434, as shown in FIG. 21B for transaortic or transfemoral devices.

[0101] A further step is engaging the filter umbrella 212 such that the filter umbrella 212 allows blood to pass beyond the aorta, but catches dislodged calcium particles to prevent such particles from passing through the rest of the body via the aorta. This step is achievable via the slidable hood 214 or 434 sliding over the filter umbrella 212 or 424 such that the filter umbrella 212 or 424 is allowed to expand circumferentially to encompass the circumference of the aorta.

[0102] Another step includes opening the punch 206 within the native aortic valve 221 such that aortic valve leaflets 241 are positioned between the cutting edge 223 of the male element 218 and the cutting edge 225 of the female element 220. FIG. 18A shows the punch 206 opened to position the aortic leaflets between the male 218 and female 220 elements.

[0103] A next step includes closing the punch 206 over the aortic valve leaflets 241 so that the male element 218 applies force along the cutting edge 223 to a superior surface 242 of the aortic valve leaflets 241 and the female element 220 applies force along the cutting edge 225 to an inferior surface 244 of the aortic valve leaflets 241. FIG. 18B demonstrates the closing of the punch 206.

[0104] Another step includes perforating the native aortic valve 221 via the punch 206 to remove calcium deposits from the native aortic valve. FIG. 18D shows the perforating of the native aortic valve 221 by the punch 206.

[0105] The final step includes leaving a ring of calcium deposits 246 along the circumference of the native aortic valve 221. The perforation of the native aortic valve 246 should leave a circumferential ring of the remaining tissue of the native aortic valve with a preferable length of 2-3 millimeters. Further, the perforation is preferably centered such that the resulting circumferential ring of tissue is uniform in radial length. As previously explained, a semi-rigid ring composed of the remaining aortic heart is useful in stabilizing any TAVI replacement valve during and after insertion. Additionally, less radial pressure is ultimately placed on the heart conduction system as the majority of the calcium deposits are removed from the native aortic valve. Further, the chance of paravalvular leaks is reduced, as the shortened aortic leaflets make insertion of replacement valves easier and more successful.

[0106] There are multiple embodiments for removing calcium deposits from aortic valves. A preferred embodiment of a device 500 for improving transcatheter aortic valve implantation is shown in FIG. 7. The device includes a punch 502, having a tip 506 attached to or formed by a male element 508 connected to a distal end of a primary tube 512 and a female element 514, having a proximal end connected to a distal end of a secondary tube 518, which is positioned coaxially around an outer surface of the primary tube 512. The device 500 further includes a punch control element 504, having a punch dial 524 attached to a proximal end of a punch spindle 522, and a punch receptacle 520 with an inner cylindrical area 525 open at a proximal end to accept the punch spindle 522, wherein the punch receptacle is connected to the secondary tube 518 and contains a centered coaxial hole to allow the primary tube 512 to pass through and attach to the punch spindle. As shown in FIGS. 8C and 9C, 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. This action in turn raises and lowers the male element 508 via the primary tube 512 relative to the female element 514, as shown in FIGS. 8B and 9B. The action of raising and lowering the male element 508 allows the device to perforate biological tissue, specifically, valve leaflets. FIGS. 8A and 9A show representations of the entire device 500, as it is operated within a native aortic valve 528.

[0107] The punch 502, primary tube 512, and punch control element 504 can also have a continuous, coaxially-centered hole through each enumerated element such that the device 500 can be run over a guide wire.

[0108] The punch 502 can be made of medical grade plastics or metals, as typically used in similar invasive devices. At least the male element 508 has a cutting edge 510 used to perforate an aortic leaflet or other biological tissue. The cutting edge 510 is typically located around a circumference of the male element 508, and can be shaped in different manners, including, but not limited to, a uniform circle about a plane, a plurality of teeth in sine wave, square, triangle, or sawtooth pattern, or similar orientation.

[0109] The female element 514 can also have a cutting element 516 shaped to accept the pattern of the male cutting element 510 to allow the male 508 and female element to form a fusiform punch 502 during insertion of the device 500 through the aortic valve without snaring or otherwise inadvertently damaging tissue during insertion or positioning of the device. The female element 514 may likewise contain a receptacle for accepting the male cutting element 510.

[0110] The tip 506 is conically shaped to pierce at least the heart at the apex and allow entry of the device 500 into the left ventricle and aortic valve. The tip 506 could also be used to pierce arterial walls, for example the aorta or femoral artery.

[0111] The primary 512 and secondary 518 tubes can be made from medical grade plastics, metals, or combinations thereof. While the secondary tube 518 must be hollow with a diameter large enough for the primary tube 512 to slide through, the primary tube 512 need not be hollow. There is no set length for either the primary tube 512 or the secondary tube 518. However, the primary tube 512 is necessarily longer that the secondary tube 518, and both should be long enough to comfortably allow the insertion and positioning of the punch 502 in the aortic valve, while simultaneously allowing a user to operate the punch control element 504.

[0112] The punch control element 504 can be made from medical grade plastics, metals, or combinations thereof. The punch spindle 522 is preferably reversely-threaded and the inner cylindrical area 525 is preferably threaded to accept the reversely-threaded punch spindle 522. However, other interactions are possible, for example, where the punch spindle 522 slidably engages the cylindrical area 525 and frictional forces from a rubber ring or equivalent maintain punch spindle position within the cylindrical area. The punch dial 524 need not be of any specific shape or size, but only sized and shaped to allow a user to manipulate the punch 502 via the primary tube 512, punch spindle 522, and punch control element 504, generally.

[0113] Another embodiment of a device 600 for improving transcatheter aortic valve implantation is shown in FIGS. 10-13. As shown in FIG. 10, the device includes a punch 602, having with a tip 606 attached to or formed by a male element 608 connected to a distal end of a primary tube 612 and a female element 614 having a proximal end connected to a distal end of a secondary tube 616, which is positioned coaxially around an outer surface of the primary tube 612. The device 600 further includes a punch control element 604, having a first lever housing 618 attached to a first lever 628 and connected to a proximal end of the secondary tube 616, wherein an opening in the first lever housing at a connection point between the secondary tube and the first lever housing allows the primary tube 612 to pass through the first lever housing and through the secondary tube. As shown in FIG. 11, the first lever housing 618 slidably engages a spring housing 624 through an opening in the first lever housing opposite to the opening for the connection point between the secondary tube and first lever housing, such that the primary tube 612 passes continuously through the secondary tube, first lever housing, and spring housing. A spring 626 is attached at an end to the first lever housing 618, and is positioned coaxially within the spring housing 624 and coaxially around the primary tube 612. A second lever housing 620 is attached to the terminal end of each the primary tube 612, the spring 626, and the spring housing 624. The primary tube 612 and the spring 626 attach to the second lever housing 620 through an opening at the connection point between the spring housing 624 and the second lever housing. A second lever 630 is pivotably attached to the second lever housing 624 at an internal fulcrum point 632. The first lever 628 and second lever 630 are pivotably connected at an external fulcrum point 622.

[0114] Force applied to the second lever 630 in a direction toward the first lever 628 causes the second lever to pivot at the external fulcrum point 622. The pivot motion at the external fulcrum point 622 in turn causes the second lever 630 to pivot at the internal fulcrum point 632, where the second lever is attached to the second lever housing 620. The pivoting at the internal fulcrum point 632 causes the second lever housing 620 to pull directly away from the first lever housing 618, thereby stretching the spring 626 and pulling the primary tube 612 in the same direction until the male element 608 mates with the female element 614 preventing further sliding. The spring housing 624 is also pulled in the same direction causing the spring housing to slide within the first lever housing 620. As force on the second lever 630 is reduced, the elastic force from the spring 624 pulls the second lever housing 620 back towards the first lever housing 618, causing the spring housing 624 to slide farther inside the first lever housing 618 and the male element 608 to decouple from the female element 614.

[0115] FIG. 12 shows the device 600 after the punch 602 has been inserted inside an aortic valve 601 and the second lever 630 has been release to allow the male element 608 to separate from the female element 614. Aortic valve leaflets are then positioned between the male element 608 and the female element 614.

[0116] FIG. 13 shows the device 600 perforating the aortic valve 601 as the second lever 630 is moved at the external fulcrum point 622 toward the first lever 628 activating the punch control element 604 and closing the male element 608 against the female element 614. The cutting element 610 of the male element then perforates as the male element 608 is pulled against the female element 614.

[0117] The punch 602, primary tube 612, and punch control element 604 can also have a continuous, coaxially-centered hole through each enumerated element such that the device 600 can be run over a guide wire.

[0118] The punch 602 can be made of medical grade plastics or metals, as typically used in similar invasive devices. At least the male element 608 has a cutting edge 610 used to perforate an aortic leaflet or other biological tissue. The cutting edge 610 is typically located around a circumference of the male element 608, and can be shaped in different manners, including, but not limited to, a uniform circle about a plane, a plurality of teeth in sine wave, square, triangle, or sawtooth pattern, or similar orientation.

[0119] The female element 614 can also have a cutting element 615 shaped to accepted the pattern of the male cutting element 610 to allow a fusiform punch 602 during insert of the device 600 through the body and heart and into the aortic valve without snaring or otherwise inadvertently damaging tissue during insertion or positioning of the device. The female element 614 may likewise contain a receptacle for accepting the male cutting edge 610.

[0120] The tip 606 is conically shaped to pierce at least the heart at the apex and allow entry of the device 600 into the left ventricle and aortic valve. The tip 606 could also be used to pierce arterial walls, for example the aorta or femoral artery.

[0121] The primary 612 and secondary 616 tubes can be made from medical grade plastics, metals, or combinations thereof. While the secondary tube 616 must be hollow with a diameter large enough for the primary tube 612 to slide through, the primary tube 612 need not be hollow. There is no set length for either the primary tube 612 or the secondary tube 616. However, the primary tube 612 is necessarily longer that the secondary tube 616, and both should be long enough to comfortably allow the insertion and positioning of the punch 602 in the aortic valve, while simultaneously allowing a user to operate the punch control element 604.

[0122] The punch control element 604 can be made from medical grade plastics, metals, or combinations thereof. The first lever 628 and second lever 630 do not have a set length, shape or size, but should be long enough for a user to comfortably grasp and operate the levers 628 and 630 in one hand. The spring housing 624 should be of an appropriate diameter to allow the spring 626 to easily expand and contract during use, while simultaneously preventing the spring from bowing or bending substantially outward from the length of the spring.

[0123] The embodiment of the device 600 shown in FIGS. 10-13 can be used both in open-heart and closed-heart surgical operations. Namely, the device 600 can be inserted percutaneously through the femoral artery and up the aorta, or it can be inserted apically in a direct view approach, as well as transaortically.

[0124] Another embodiment of a device 200 is shown in FIGS. 14-19C. FIG. 14 is representative of the device 200. This embodiment includes stent system 208 having a stent sheath 214 attached at a closed end to a distal end of a primary tube 217 having a diameter large enough to allow at least a guide wire to pass coaxially through its center. The stent sheath 214, as shown in FIG. 15A and enlarged in FIG. 15B, is open at an opposite end and positioned coaxially around the primary tube 217 with enough space for a stent 213, a perforated mesh 211, and a secondary tube 216 to be slidably positionable between the stent sheath and primary tube. A tip 210 is connected to, or formed from, the closed end of the stent sheath 214. The stent 213 is covered with the perforated mesh 211 to form a perforated umbrella 212, with the stent attached to a distal end of the secondary tube 216 positioned coaxially around an outer surface of the primary tube 217.

[0125] A punch 206 has a male element 218 connected at a distal end to a proximal end of the secondary tube 216 and connected at a proximal end to a distal end of a tertiary tube 219, which is positioned coaxially around an outer surface of the secondary tube 216, and a female element 220 connected at a proximal end to a distal end of a quaternary tube 222, which is positioned coaxially around an outer surface of the tertiary tube 219.

[0126] The device 200 further includes a punch control element 204, having a punch dial 232 attached to a proximal end of a punch spindle 228, and a punch receptacle 226 with an inner cylindrical area 224 open at a proximal end to accept the punch spindle, wherein the punch receptacle is connected to a proximal end of the quaternary tube 222 and contains a centered coaxial hole to allow the tertiary tube 219, secondary tube 216, and primary tube 217 to pass through. The tertiary tube 219 attaches to the punch spindle 228 at a proximal end.

[0127] The punch dial 232 is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle 228 within the inner cylindrical area 224 of the punch receptacle 226, which raises and lowers the male element 218 via the tertiary tube 217 relative to the female element 220. As shown in FIGS. 18B and 18C, rotably removing the punch spindle 228 from the punch receptacle 226 pulls the male element 218 into contact with the female element 220 for either perforation or fusiform insertion. FIGS. 19B and 19C shows that rotatably depressing the punch spindle 228 into the punch receptacle 226 pushes the male element 218 away from the female element 220 for positioning of valve leaflets between the male and female element in anticipate of perforation. The action of raising and lowering the male element 218 allows the device to perforate biological tissue, specifically, valve leaflets. Further, the punch spindle 228 and punch dial 232 contain a centered coaxial hole to allow the primary and secondary tubes 217 and 216 to pass through.

[0128] The device 200 further includes a stent control element 202, having a stent dial 240 attached to a proximal end of a stent spindle 238, and stent receptacle 234 with an inner cylindrical area 236 open at a proximal end to accept the stent spindle, wherein the stent receptacle connects to a distal end of the secondary tube 216 which contains a centered coaxial hole to allow the primary tube 217 to pass through. The primary tube 217 attaches at a proximal end to the stent spindle 238.

[0129] The stent dial 240 is configured to turn either clockwise or counterclockwise to raise or depress the stent spindle 238 within the inner cylindrical area 236 of the stent receptacle 234, which in turn slides the stent sheath 214 relative to stent 213. FIG. 17C shows the depression of the punch spindle 238 in the punch receptacle 234 to raise the stent sheath 214. FIG. 17A shows the interaction of the stent expansion along the device 200, as a whole. Once the stent sheath 214 slides away from the stent 213 far enough, the stent is exposed and allowed to expand, as shown in FIG. 17B. The expansion of the stent 213 in turn expands the perforated mesh 211 circumferentially to allow the perforated umbrella 212 to encompass the cross-sectional area of an artery. FIG. 17D shows one possible shape of the stent 213. The stent 213 can be shaped in other ways, as long as circumference of the stent can encompass the aorta to catch any debris from passing through and forming embolisms.

[0130] As shown in FIG. 16A, to contract the perforated umbrella 212, the stent dial 240 rotates in the opposite direction such that the stent spindle 238 is pulled out of the stent receptacle 236. FIG. 16C shows the stent spindle 238 rotating out of the stent receptacle 234. The primary tube 217 is thereby pulled in the same direction as the stent spindle 238, and the stent sheath 214 slides back over the stent 213 compressing the stent and perforated mesh 211 between the stent sheath and secondary tube 216, as shown in FIG. 16B.

[0131] The punch 208 can be made of medical grade plastics or metals, as typically used in similar invasive devices. At least the male element 218 has a cutting edge 223 used to perforate an aortic leaflet or other biological tissue, as shown in FIGS. 18B and 18D. The cutting edge 223 is typically located around a circumference of the male element 218, and can be shaped in different manners, including, but not limited to, a uniform circle about a plane, a plurality of teeth in sine wave, square, triangle, or sawtooth pattern, or similar orientation. FIG. 20 shows an embodiment of the device 200 where the male cutting edge 223 has teeth in a sawtooth pattern.

[0132] The female element 220 can also have a cutting element 225 patterned to accepted the pattern of the male cutting element 223 to allow a fusiform punch 208 during insert of the device 200 through the aortic valve without snaring or otherwise inadvertently damaging tissue during insertion or positioning of the device, as shown as FIG. 18B. The female element 220 may likewise contain a receptacle for accepting the male cutting element 223.

[0133] The tip 210 may be conically shaped to pierce at least the heart at the apex and allow entry of the device 200 into the left ventricle and aortic valve. Alternatively, the tip 210 may be flattened with sufficiently rounded edges to prevent damage to tissue during insertion or removal of the device from the body.

[0134] The primary 217, secondary 216, tertiary 219, and quaternary 222 tubes can be made from medical grade plastics, metals, or combinations thereof. There is no set length for any of the tubes 216, 217, 219, and 222. However, the primary tube 217 is necessarily longer that the secondary tube 216, and the tertiary tube 219 is necessarily longer than the quaternary tube 222. All four tubes 216, 217, 219, and 222 should be long enough to comfortably allow the insertion and positioning of the stent system 208 and punch 206 in the aorta and aortic valve, while simultaneously allowing a user to operate the punch control element 204 and the stent control element 202.

[0135] The punch control element 204 can be made from medical grade plastics, metals, or combinations thereof. The punch spindle 228 is preferably reversely-threaded and the inner cylindrical area 224 of the punch receptacle 226 is preferably threaded to accept and secure the reversely-threaded punch spindle. FIG. 15C shows one embodiment of the punch receptacle 226. However, one possible alternate setup has the punch spindle slidably engaging the cylindrical area and frictional forces from a rubber ring or equivalent formed around the punch spindle maintaining the punch spindle position within the cylindrical area. The punch dial 232 need not be of any specific shape or size, but sized and shaped to allow a user to manipulate the punch 202 via the tertiary tube 219, punch spindle 228, and punch control element 204, generally.

[0136] The stent control element 202 can be made from medical grade plastics, metals, or combinations thereof. The stent spindle 238 is preferably reversely-threaded and the inner cylindrical area 236 of the stent spindle 234 is preferably threaded to accept and secure the reversely-threaded punch spindle. FIG. 15D shows one embodiment of the stent receptacle 234. However, an alternative interaction involves the stent spindle slidably engaging the cylindrical area and frictional forces from a rubber ring or equivalent formed around the stent spindle maintaining the stent spindle position within the cylindrical area. The stent dial 240 need not be of any specific shape or size, but sized and shaped to allow a user to manipulate the stent sheath 214 via the primary tube 217, stent spindle 238, and stent control element 202, generally.

[0137] The device 200 may further include a motor assembly 270, as shown in FIG. 23, used to rotatably close the punch 206, in addition to the punch control element 204. The motor assembly 270 includes an operator control element 268 attached to a high speed motor 262, which is attached to the male element 218 via cable 260. The motor assembly 270 can only close the punch 206, whereas the punch control element 204 can both open and close the punch 206. The operator control element 268 activates and deactivates the high speed motor 262, and may be in the form of a foot pedal as seen in FIG. 27, but may also include a button, a hand-held pedal, or other similar device. The cable 260, attached at one end to the male element 218 and at an opposite end to the high speed motor 262, must be of a variable length, such that the male element may be pulled down to the female element 220 to form a fusiform punch 206 and then pushed up via the punch control element 204 to separate the male element from the female element.

[0138] Another embodiment of a device 400 is show in FIGS. 21A-22. Device 400 is similar to device 200 in elements and function, but oriented differently to enter the body and aorta at different locations. The device 400 includes a punch 402 with a male element 412 with a proximal end connected to a distal end of a primary tube 416 and a conically-shaped distal end 410. The punch element 402 further includes a female element 420, having a proximal end connected to a secondary tube 422, which is positioned coaxially around an outer surface of the primary tube 416, which is positioned coaxially around an outer surface of the primary tube.

[0139] A self-expandable stent 426 covered with a perforated mesh 428 forms a stent umbrella 424. The stent 426 is attached to a distal end of a tertiary tube 430 positioned coaxially around an outer surface of the secondary tube. A stent sheath 434 is attached to a distal end of a quaternary tube 432, which is positioned coaxially around an outer surface of the tertiary tube 430. The stent sheath 434 is open at a distal end and positioned coaxially around the tertiary tube 430 with enough space between the stent sheath and tertiary tube to allow the stent 426, perforated mesh 428, and stent umbrella 424 to be slidably positionable between the stent sheath and tertiary tube.

[0140] A stent control element 406 has a stent dial 442 attached to a proximal end of a reversely-threaded stent spindle 440, a stent receptacle 436 with an inner cylindrical area 438 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 tertiary and quaternary tubes 430 and 432, 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 and secondary tube 416 and 422 to pass through. The stent dial 442 is configured to turn either clockwise or counterclockwise to raise or depress the stent spindle 440 within the inner cylindrical area 438 of the stent receptacle 436, which in turn pushes the stent 426 out of the stent sheath 434 allowing expansion of the stent and pulls 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.

[0141] A punch control element 408 includes a punch dial 450 attached to a proximal end of a reversely-threaded punch spindle 448, a punch receptacle 446 with an inner cylindrical area 444 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 416 to pass through and attach to the punch spindle. The punch dial 450 is configured to turn either clockwise or counterclockwise to raise or depress the punch spindle 448 within the inner cylindrical area 444 of the punch receptacle 446, which raises and lowers the male element 412 via the primary tube 416 relative to the female element 420.

[0142] The punch 402 can be made of medical grade plastics or metals, as typically used in similar invasive surgical devices. At least the male element 412 has a cutting edge 414 used to perforate an aortic leaflet or other biological tissue. The cutting edge 414 is typically located around a circumference of the male element 412, and can be shaped in different manners, including, but not limited to, a uniform circle about a plane, a plurality of teeth in sine, square, triangle, or sawtooth pattern, or similar orientation.

[0143] The female element 420 can also have a cutting element 418 patterned to accepted the pattern of the male cutting element 414 to allow a fusiform punch 402 during insert of the device 400 through either the body and heart and into the aortic valve without snaring or otherwise inadvertently damaging tissue during insertion or positioning of the device. The female element 420 may likewise contain a receptacle for accepting the male cutting element 414.

[0144] The tip 410 may be conically shaped to pierce at least the wall of the aorta or femoral artery and allow entry of the device 400 into the aorta and aortic valve. Alternatively, the tip 410 may be flattened with sufficiently rounded edges to prevent damage to tissue during insertion or removal of the device from the body.

[0145] The primary 416, secondary 422, tertiary 430, and quaternary 432 tubes can be made from medical grade plastics, metals, or combinations thereof. There is no set length for any of the tubes 416, 422, 430 and 432. However, the primary tube 416 is necessarily longer that the secondary tube 422, and the tertiary tube 430 is necessarily longer than the quaternary tube 432. All four tubes 416, 422, 430 and 432 should be long enough to comfortably allow the insertion and positioning of the stent system 404 and punch 402 in the aorta and aortic valve, while simultaneously allowing a user to operate the punch control element 408 and the stent control element 406.

[0146] The punch control element 408 can be made from medical grade plastics, metals, or combinations thereof. The punch spindle 448 is preferably reversely-threaded and the inner cylindrical area 444 is preferably threaded to accept and secure the reversely-threaded punch spindle. However, a less preferable interaction between the punch spindle 448 and cylindrical area 444 involves the punch spindle slidably engaging the cylindrical area and frictional forces from a rubber ring or equivalent formed around the punch spindle maintaining the punch spindle position within the cylindrical area. The punch dial 450 need not be of any specific shape or size, but sized and shaped to allow a user to manipulate the punch 402 via the primary tube 416, punch spindle 448, and punch control element 408, generally.

[0147] The stent control element 406 can be made from medical grade plastics, metals, or combinations thereof. The stent spindle 440 is preferably reversely-threaded and the inner cylindrical area 438 is preferably threaded to accept and secure the reversely-threaded punch spindle. However, a less preferable interaction between the stent spindle 440 and cylindrical area 438 involves the stent spindle slidably engaging the cylindrical area and frictional forces from a rubber ring or equivalent formed around the stent spindle maintaining the stent spindle position within the cylindrical area. The stent dial 442 need not be of any specific shape or size, but sized and shaped to allow a user to manipulate the stent sheath 432 via the tertiary tube 430, stent spindle 440, and stent control element 406, generally.