Device for Filtering of Blood During Removal of Heart Valve Stenosis and Method of Removing Heart Valve Stenosis

• US 20090069841A1
• Filed: 11/21/2008
• Published: 03/12/2009
• Est. Priority Date: 05/23/2006
• Status: Active Grant

• Current Assignee: Gunnar M. Pah
• Original Assignee: Gunnar M. Pah
• Inventors: Pah, Gunnar M.
• Granted Patent: US 7,727,254 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

The invention relates to a device and a method for the removal of a heart valve stenosis, in which a filter catheter is arranged in a vessel section located downstream of the heart valve, and a valvuplasty catheter is arranged in the area of the heart valve. The filter catheter has in one embodiment of the invention at its distal end a radial filter which is unfolded radially until it fits up against the vessel wall. The catheter lumen is closed in such a way that blood must flow through the filter. After the filter has been unfolded, the valvuplasty catheter is inflated in the area of the heart valve to remove the heart valve stenosis, while debris and plaque which are released are collected in the filter. In an alternative membrane, the filter catheter may be sealed relative to the vessel wall by means of a sealing element, while an external filter is connected to the filter catheter to filter debris and plaque from the blood.

Claims

1. A device for the filtering of blood during removal of a heart valve stenosis comprising:

a filter catheter including a catheter lumen and at its distal end, for filtering the blood to be found downstream behind a heart valve, a filter which moves distally into and out of the filter catheter, wherein the filter is designed to expand radially to an extended state in which the filter fits up against a blood vessel wall, and

a balloon catheter which is guided through the catheter lumen of the filter catheter from a proximal end to the distal end, wherein the balloon catheter includes at its distal end a balloon for removal of a heart valve stenosis,

and

wherein the catheter lumen has a diameter of approximately 4 to 7 millimeters (mm).

2. A device according to claim 1, wherein, in the extended state, the filter is funnel-shaped, with the filter expanding towards the distal end.

3. A device according to claim 1, wherein the filter catheter has a greater circumference at a distal end section, in which the filter is stored, than over the rest of its length, the diameter of the catheter lumen being constant over a length of the filter catheter.

4. A device according to claim 1 wherein the filter has a supporting framework made of a memory material, comprising a ring which, after pushing out, fits up against the wall of the blood vessel.

5. A device according to claim 4, wherein the supporting framework comprises axial struts of memory material.

6. A device according to claim 1, wherein in the extended state the filter has a roughly parabolic convex or concave shape.

7. A device according to claim 1, wherein a proximal end of the filter catheter is connected to a heart-lung machine and/or an external filter.

8. A device according to claim 1, wherein the filter catheter includes at its distal end a seal unit for sealing a distal end of the filter catheter relative to an adjacent blood vessel wall.

9. A device according to claim 9, wherein the seal unit has an inflatable sealing element.

10. A device for the filtering of blood during removal of a heart valve stenosis comprising:

a filter catheter including a catheter lumen and at its distal end, for filtering the blood to be found downstream behind a heart valve, a filter which moves distally into and out of the filter catheter, wherein the filter is designed to expand radially to an extended state in which the filter fits up against a blood vessel wall, and

a balloon catheter which is guided through the catheter lumen of the filter catheter from a proximal end to the distal end, wherein the balloon catheter includes at its distal end a balloon for removal of a heart valve stenosis, and

wherein the filter catheter has a greater circumference at a distal end section, in which the filter is stored, than over the rest of its length, the diameter of the catheter lumen being constant over a length of the filter catheter.

11. A device according to claim 10, wherein, in the extended state, the filter is funnel-shaped, with the filter expanding towards the distal end.

12. A device according to claim 10, wherein a proximal end of the filter catheter is connected to a heart-lung machine and/or an external filter.

13. A method of removing a heart valve stenosis, comprising:

inserting and then positioning a filter catheter in a vessel section downstream of a heart valve and against the direction of flow of the blood, wherein the filter catheter has at its distal end a radial filter;

radially unfolding the radial filter to fit against the vessel wall and close the catheter lumen to direct blood through the filter;

inserting and positioning a balloon catheter in the area of the heart valve through an open catheter lumen of the filter catheter; and

after the unfolding of the filter, inflating a balloon of the balloon catheter in an area of the heart valve to remove the heart valve stenosis, while collecting released debris and plaque with the filter.

14. A method according to claim 13, further comprising, after collecting the debris and plaque in the filter, drawing the filter into the filter catheter and then removing the filter catheter.

15. A method according to claim 14, further comprising firstly removing the balloon catheter and then the filter catheter.

16. A method according to claim 14, further comprising simultaneously removing the balloon catheter and the filter catheter.

17. A method according to claim 14, further comprising using a seal unit at the distal end of the filter catheter to seal space between the filter catheter and a blood vessel wall to direct blood to flow through the catheter lumen.

18. A method according to claim 17, further comprising feeding blood from the catheter lumen to to a heart-lung machine with an external filter.

19. A method according to claim 17, further comprising inflating an inflatable seal element of the seal unit at the distal end of the filter catheter.

20. A method according to claim 19, further comprising:

before the filter is retracted into the filter catheter, inflating the seal element, and after retraction of the filter, blood is carried away through the lumen of the filter catheter, after which the seal element is deflated and the filter catheter is removed.