Extra-anatomic aortic valve placement

• US 20060142848A1
• Filed: 02/16/2006
• Published: 06/29/2006
• Est. Priority Date: 09/12/2000
• Status: Abandoned Application

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Application Number:
  US11/355,732
• Publication Number:
  US 20060142848A1
• Time in Patent Office: Days
• US Class Current: 623/1.260
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method for extra-anatomic valve placement includes creating an aperture through the patient'"'"'s heart that extends from a location outside of the patient'"'"'s heart and into a left ventricle of the heart. A valve is mounted at least partially within the aperture and a continuous path is provided for fluid communication from the mounted valve and into the patient'"'"'s aorta. The method can be implemented in the absence of cardio pulmonary bypass.

Claims

1. A method for extra-anatomic aortic valve placement, comprising:

creating an aperture through the patient'"'"'s heart that extends from a location outside of the patient'"'"'s heart and into a left ventricle of the heart;

mounting a valve at least partially within the aperture; and

providing a continuous path for fluid communication from the mounted valve and into the patient'"'"'s aorta.

2. The method of claim 1, further comprising obstructing the aperture to inhibit blood loss through the aperture during at least the mounting of the valve.

3. The method of claim 2, wherein the obstructing of the aperture further comprises:

inserting a balloon catheter into the aperture such that a balloon thereof resides within the left ventricle; and

inflating the balloon such that a proximal portion of the inflated balloon engages a ventricular peripheral portion of the aperture to substantially seal the aperture.

4. The method of claim 3, wherein the balloon catheter comprises a Foley catheter.

5. The method of claim 1, further comprising attaching a sheet of a substantially biocompatible material to the heart in overlying relation to the aperture, the aperture extending through the sheet.

6. The method of claim 5, wherein the sheet comprises a natural tissue material.

7. The method of claim 5, wherein the aperture that extends through the sheet is created substantially concurrently with the creation of the aperture through the patient'"'"'s heart.

8. The method of claim 1, wherein the providing the continuous path further comprises attaching a length of a flexible conduit between the valve and the aorta.

9. The method of claim 8, wherein the valve further comprises a generally cylindrical sidewall portion that extends between an inflow portion and an outflow portion, at least some of the outflow portion extending outwardly from an exterior surface of the patient'"'"'s heart after the mounting of the valve within the aperture, the flexible conduit being attached between the outflow portion of the valve and the patient'"'"'s descending aorta.

10. The method of claim 8, wherein the flexible conduit comprises a natural tissue material.

11. The method of claim 10, wherein the natural tissue material comprises animal pericardium.

12. The method of claim 1, wherein the mounting of the valve further comprises:

providing an implanter having a barrel that contains the valve configured in reduced cross-sectional dimension relative to an expanded cross-sectional dimension of the valve;

discharging the valve from the barrel of the implanter into the aperture of the patient'"'"'s heart; and

expanding the valve within the aperture from the reduced cross-sectional dimension toward the expanded cross-sectional dimension, such that an exterior portion of the valve engages adjacent tissue of the patient'"'"'s heart to mitigate movement of the valve relative to the adjacent tissue.

13. The method of claim 12, wherein the valve expands automatically in response to being discharged from the barrel of the implanter.

14. The method of claim 12, wherein the valve further comprises a generally cylindrical sidewall portion that extends between an inflow end portion and an outflow portion, at least some of the outflow portion extending outwardly from the patient'"'"'s heart after the expanding of the valve.

15. The method of claim 14, wherein the valve further comprises a plurality of elongated support features extending generally axially between the opposed ends of the support, the support features being interconnected at ends of the support, and a tissue valve mounted within the support so as to expand radially commensurately with the support in response to the expanding of the valve.

16. The method of claim 15, wherein the valve further comprises a flange that extends radially outwardly from an exterior surface of the outflow portion of the valve, the flange being connected to the patient'"'"'s heart.

17. The method of claim 12, wherein prior to the mounting of the valve, the method further comprising:

inserting a balloon catheter into the aperture such that a balloon thereof resides within the left ventricle; and

inflating the balloon such that a proximal portion of the inflated balloon engages a ventricular peripheral portion of the aperture to substantially seal the aperture and mitigate blood loss through the aperture during at least the mounting of the valve, an elongated tubular member of the catheter extending through the valve and through the implanter.

18. The method of claim 1, occurring in the absence of cardiopulmonary bypass.

19. The method of claim 1, wherein the aperture is created through the apex of the patient'"'"'s heart.

20. A method for extra-anatomic aortic valve placement comprising:

creating an aperture through the patient'"'"'s heart that extends from a location outside of the patient'"'"'s heart and into a left ventricle of the heart;

obstructing the aperture to inhibit blood loss through the aperture;

mounting a valve at least partially within the aperture while the aperture is obstructed; and

attaching a length of a flexible conduit between an outflow end of the valve and the patient'"'"'s aorta to provide for substantially unidirectional flow of blood from the left ventricle, through the conduit and into the patient'"'"'s aorta, the method being performed in the absence of cardio pulmonary bypass.

21. The method of claim 20, wherein the obstructing is performed using a balloon catheter having an elongated tubular member, wherein the mounting further comprises:

providing an implanter having a barrel that contains the valve configured in reduced cross-sectional dimension relative to an expanded cross-sectional dimension of the valve;

discharging the valve from the barrel of the implanter into the aperture of the patient'"'"'s heart while the tubular member of the catheter extends through the valve and at least partially through the implanter; and

expanding the valve within the aperture from the reduced cross-sectional dimension toward the expanded cross-sectional dimension, such that an exterior portion of the valve engages adjacent tissue of the patient'"'"'s heart to mitigate movement of the valve relative to the adjacent tissue.

22. A system for extra-anatomic valve placement, the system comprising:

means for creating an aperture through the patient'"'"'s heart that extends from a location outside of the patient'"'"'s heart and into a left ventricle of the heart;

means for obstructing the aperture to inhibit blood loss through the aperture;

valve means for, when mounted at least partially within the aperture, providing substantially unidirectional flow of blood from the left ventricle and through the means for providing; and

means for, when connected between the valve means and the patient'"'"'s aorta, providing for fluid communication along a continuous path from the left ventricle into the patient'"'"'s aorta.