Intravascular fluid catheter with minimal internal fluid volume

Patent metadata

Field	Value
Publication number	US-11759608-B2
Application number	US-202016805033-A
Country	US
Kind code	B2
Filing date	Feb 28, 2020
Priority date	Aug 24, 2011
Publication date	Sep 19, 2023
Grant date	Sep 19, 2023

Abstract

A catheter-based/intravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic or/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the wall of the blood vessel to a prescribed depth. The ability to provide PeriVascular injection so as to only affect the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in the adventitia or outside the adventitia of the renal artery.

First claim

What is claimed is:

1. A method comprising:
providing a system comprising a catheter body, a first guide tube, a second guide tube, a third guide tube, a first injection needle, a second injection needle, and a third injection needle, the first injection needle disposed within a lumen of the first guide tube, the second injection needle disposed within a lumen of the second guide tube, the third injection needle disposed within a lumen of the third guide tube;
simultaneously advancing the first guide tube, the second guide tube, and the third guide tube to curve outward toward a target wall of a target vessel but not penetrate the target wall of the target vessel;
simultaneously advancing the first injection needle, the second injection needle, and the third injection needle to penetrate the target wall, guided by the first guide tube, the second guide tube, and the third guide tube, each injection needle extending beyond the respective guide tube until further advancement of the injection needles is prevented; and
delivering an ablative fluid through the first injection needle, the second injection needle, and the third injection needle to form an ablation zone of ablative fluid for each injection needle, wherein the ablation zones of ablative fluid intersect to form an ablative ring of ablative fluid around a circumference of the target vessel.

2. The method of claim 1 , further including visualization of a radiopaque marker.

3. The method of claim 1 , further including visualization of a radiopaque marker of the first guide tube.

4. The method of claim 1 , further including visualization of a radiopaque marker of the first injection needle.

5. The method of claim 1 , further including visualization of a radiopaque wire within the first injection needle.

6. The method of claim 1 , further including evaluating electrical activity with the first injection needle.

7. The method of claim 1 , further including measuring electrical activity within the target wall with the first injection needle.

8. The method of claim 1 , wherein the first and second injection needles advance at least 0.5 mm beyond the respective guide tubes.

9. The method of claim 1 , wherein the first and second injection needles advance between 0.5 mm and 4 mm beyond the respective guide tubes.

10. The method of claim 1 , wherein the first and second injection needles advance between 2 mm and 3 mm beyond the respective guide tubes.

11. A method comprising:
providing a system comprising a catheter body, a first guide tube, a second guide tube, a third guide tube, a first injection needle, a second injection needle, and a third injection needle, the first injection needle disposed within a lumen of the first guide tube, the second injection needle disposed within a lumen of the second guide tube, the third injection needle disposed within a lumen of the third guide tube;
simultaneously advancing the first guide tube, the second guide tube, and the third guide tube to curve outward against a target wall but not penetrate the target wall;
simultaneously advancing the first injection needle, the second injection needle, and the third injection needle relative to and within the lumens of the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate the target wall, each injection needle extending beyond the respective guide tube to penetrate the target wall at a preset distance; and
delivering an ablative fluid through the first injection needle, the second injection needle, and the third injection needle to produce a ring of ablative fluid causing circumferential damage in nerve tissue near the target wall.

12. The method of claim 11 , further including visualization of the first guide tube, the second guide tube, or the first and second guide tubes.

13. The method of claim 11 , further including visualization of the first injection needle, the second injection needle, or the first and second injection needles.

14. The method of claim 11 , wherein the preset distance is 0.5 mm.

15. The method of claim 11 , wherein the preset distance is between 0.5 mm and 4 mm.

16. The method of claim 11 , wherein the preset distance is between 2 mm and 3 mm.

17. The method of claim 11 , wherein the preset distance is determined prior to advancing the system in a body of a patient.

18. The method of claim 11 , wherein the preset distance is determined by a measurement of anatomy of a patient.

19. A method comprising:
providing a system comprising a catheter body, three guide tubes, three injection needles, each injection needle adapted to move distally and proximally relative to and within a lumen of a respective guide tube of the three guide tubes;
simultaneously advancing the three guide tubes against a target wall but not penetrate the target wall;
simultaneously advancing the three injection needles, each injection needle advancing relative to the respective guide tube of the three guide tubes to penetrate the target wall, each injection needle extending beyond the respective guide tube up to a maximum distance; and
delivering an ablative fluid through the three injection needles to form a ring of ablative fluid causing ablation of sympathetic nerve fibers beyond the target wall.

20. The method of claim 19 , wherein each injection needle advances at least 0.5 mm beyond the respective guide tube.

Assignees

• Ablative Solutions Inc

Inventors

• Fischell David R
• Fischell Tim A

Classifications

• A61B5/24

  Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof · CPC title

• A61M31/00 Primary

  Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) · CPC title

• A61M25/0084 Primary

  being one or more injection needles · CPC title

• A61M25/0606

  "Over-the-needle" catheter assemblies, e.g. I.V. catheters · CPC title

• A61M2210/12

  Blood circulatory system · CPC title