Intravascular catheter with peri-vascular nerve activity sensors

Patent metadata

Field	Value
Publication number	US-12343148-B2
Application number	US-202318358444-A
Country	US
Kind code	B2
Filing date	Jul 25, 2023
Priority date	Oct 25, 2013
Publication date	Jul 1, 2025
Grant date	Jul 1, 2025

Abstract

An intravascular catheter for peri-vascular nerve activity sensing or measurement includes multiple needles advanced through supported guide tubes (needle guiding elements) which expand with open ends around a central axis 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 perivascular space. The system also may include means to limit and/or adjust the depth of penetration of the needles. 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. The addition of an injection lumen at the proximal end of the catheter and openings in the needles adds the functionality of ablative fluid injection into the perivascular space for an integrated nerve sending and ablation capability.

First claim

What is claimed is:

1. A catheter for placement into a vessel of a human body comprising:
a catheter body having a central lumen;
at least two needle guiding elements comprising a curved shape adapted to advance outwardly from the catheter body toward an interior wall of a target vessel;
at least two needles adapted to advance outwardly, guided by the at least two needle guiding elements to penetrate the interior wall of the target vessel, wherein the at least two needle guiding elements are configured to maintain their position against the interior wall of the target vessel as the at least two needles penetrate the interior wall of the target vessel to a target tissue; and
a structure to reduce the internal volume of the catheter, wherein the structure extends the entire length of the catheter, wherein the structure comprises an insulated wire.

2. The catheter of claim 1 , wherein the structure comprises a wire.

3. The catheter of claim 1 , wherein the catheter is configured to inject a volume of between 0.15 ml and 0.6 ml of ablative fluid.

4. The catheter of claim 1 , wherein the internal volume of the catheter is less than 0.5 ml.

5. The catheter of claim 1 , wherein the catheter is configured to inject a volume of 0.3 ml of ablative fluid.

6. The catheter of claim 1 , wherein the structure is within the central lumen.

7. A catheter for placement into a target vessel of a human body comprising:
a catheter body having a lumen for fluid delivery;
at least two needle guiding elements comprising a curved shape adapted to advance outwardly from the catheter body toward the interior wall of the target vessel;
at least two needles, each needle comprising a lumen for fluid delivery, the at least two needles adapted to advance outwardly, guided by the at least two needle guiding elements to penetrate the interior wall of the target vessel, wherein the at least two needle guiding elements are configured to maintain their position against the interior wall of the target vessel as the at least two needles penetrate the interior wall of the target vessel; and
wherein an injection of about 0.6 ml is sufficient to fill the needed volume including the sympathetic nerves, where the fluid delivered comprises a hygroscopic fluid.

8. The catheter of claim 7 , where the fluid delivered comprises a lipophilic fluid.

9. The catheter of claim 7 , where the fluid delivered is configured to spread within the peri-vascular space.

10. The catheter of claim 7 , where the injection is configured such that the volume would not harm a kidney if accidentally discharged into a renal artery.

11. The catheter of claim 7 , further comprising a means to provide feedback on the effectiveness of ablation.

12. A method, comprising:
providing a catheter having a catheter body with a proximal end, a distal end, and a first needle and a second needle;
providing a first guiding element and a second guiding element, the first needle coaxial with the first guiding element and the second needle coaxial with the second guiding element;
positioning the distal end of the catheter within a patient;
advancing the first guiding element and the second guiding element outwardly from the catheter body toward a vessel wall;
advancing the first needle through the first guiding element and into the vessel wall and advancing the second needle through the second guiding element and into the vessel wall, wherein the first guiding element and the second guiding element are configured to maintain their position against the vessel wall as the first needle and the second needle are advanced into the vessel wall; and
injecting a volume of less than 1 ml of ablative fluid, wherein the success of ablation is assessed during the procedure.

13. The method of claim 12 , wherein the ablative fluid is ethanol.

14. The method of claim 12 , wherein the ablative fluid produces a multiplicity of ablation zones that intersect to form an ablative ring around the circumference of the target vessel.

15. The method of claim 12 , further comprising monitoring activity of sympathetic nerves being ablated.

16. The method of claim 12 , wherein the ablative fluid comprises a lipophilic fluid.

17. The method of claim 12 , wherein the ablative fluid comprises a hygroscopic fluid.

18. The method of claim 12 , wherein the ablative fluid is configured to spread within a peri-vascular space.

19. The catheter of claim 1 , wherein the catheter is configured to inject a volume of ablative fluid comprising ethanol.

Assignees

• Ablative Solutions Inc

Inventors

• Fischell David R
• Fischell Tim A
• Ghazarossian Vartan
• Almany Steven

Classifications

• A61B5/6852 Primary

  Catheters · CPC title

• A61B2090/3966

  Radiopaque markers visible in an X-ray image · CPC title

• A61B5/4035

  Evaluating the autonomic nervous system · CPC title

• A61B5/201

  Assessing renal or kidney functions · CPC title

• A61M2025/0095

  being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes · CPC title