Apparatus for effective ablation and nerve sensing associated with denervation
An intravascular catheter for nerve activity ablation and/or sensing includes one or more needles advanced through supported guide tubes (needle guiding elements) which expand to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the extra-luminal tissue including the media, adventitia and periadvential space. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. Electrodes near the distal ends of the needles allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered from the needles in or near the adventitia to ablate nerves outside of the media while sparing nerves within the media.
1. A method comprising:
positioning a portion of a catheter within the body of a patient; advancing a first needle guiding element and a second needle guiding element outward from the catheter toward a tissue surface;
advancing a first needle and a second needle through the first needle guiding element and second needle guiding element, respectively, and beyond the tissue surface, wherein a distal end of the first needle guiding element and a distal end of the second needle guiding element are configured to remain positioned against the tissue surface as the first needle and the second needle advance beyond the tissue surface; and
operating the catheter to provide at least one modality of neurolysis or to sense nerve activity from at least one of the first needle and the second needle.
2. The method as in claim 1 , wherein the at least one modality of neurolysis includes injecting an ablative fluid through the first needle.
3. The method as in claim 2 , wherein the at least one modality of neurolysis includes injecting an ablative fluid through the second needle.
4. The method as in claim 3 , wherein the ablative fluid injected from each needle travels circumferentially forming one zone for each needle where the zones approximately intersect to form a ring of neurolysis.
5. The method as in claim 2 , wherein injecting the ablative fluid comprises injecting ethanol.
6. The method as in claim 1 , wherein the at least one modality of neurolysis includes providing ablation of nerves using energy delivered by the first needle.
7. The method as in claim 6 , where the energy delivered is in the radiofrequency spectrum.
8. The method as in claim 6 , where the energy delivered includes providing ultrasonic ablation.
9. The method as in claim 1 , wherein operating the catheter to sense nerve activity uses the first needle and a return.
10. The method as in claim 1 , wherein operating the catheter to sense nerve activity includes sensing nerve activity before ablation and after ablation.
11. The method as in claim 1 , wherein the catheter includes a third needle and a third needle guiding element.
12. The method as in claim 11 , wherein the first, second, and third needle guiding elements are disposed equidistantly around a circumference of the catheter.
13. The method as in claim 1 , wherein operating the catheter to sense nerve activity further includes sensing nerve activity with the first needle and the second needle.
14. The method as in claim 1 , where the catheter includes a connector configured to connect to external electronic equipment.
15. The method as in claim 14 , where the external electronic equipment has a sensing subsystem configured for sensing local nerve activity within the patient.
16. The method as in claim 14 , where the external electronic equipment is configured to be connected to at least one additional electrode in electrical contact with the patient.
17. The method as in claim 1 , where the tissue surface is an interior wall of a target vessel.
18. The method as in claim 1 , where the first needle has a distal electrode.
19. The method as in claim 1 , where the first and second needles are advanced outwardly coaxially through lumens of the first and second needle guiding elements.
20. A method comprising:
positioning a portion of a catheter within a human patient;
advancing a first needle guiding element and a second needle guiding element outward from the catheter toward a luminal surface;
advancing a first needle and a second needle through the first guiding element and the second needle guiding element, respectively, and into the luminal surface, wherein a distal end of the first needle guiding element and a distal end of the second needle guiding element are configured to be positioned against, but not penetrate, the luminal surface as the first needle and the second needle advance into the luminal surface;
wherein the catheter is configured to provide a modality of neurolysis or sense nerve activity.