Transvascular method of treating hypertension

Patent metadata

Field	Value
Publication number	US-9554849-B2
Application number	US-201514712861-A
Country	US
Kind code	B2
Filing date	May 14, 2015
Priority date	Oct 29, 2012
Publication date	Jan 31, 2017
Grant date	Jan 31, 2017

Abstract

An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel. A method of treating hypertension involves injecting an ablative fluid such as ethanol deep into zones in the wall of the renal artery such that the zones of fluid merge to form a circumferential ablation ring at a depth which ablates sympathetic nerves while minimizing injury to interior layers of the vessel wall.

First claim

What is claimed is:

1. A method of treating hypertension, comprising:
positioning a distal portion of a delivery catheter within a renal artery;
advancing at least three guide tubes from the delivery catheter until a distal end of each of the at least three guide tubes touch an inside wall of the renal artery, wherein advancing at least three guide tubes further comprises advancing at least three guide tubes without inflating a balloon;
advancing at least three injection needles through the at least three guide tubes and into a peri-vascular space outside of an inside surface of the renal artery; and
injecting an ablative fluid through the at least three injection needles to form at least three ablative fluid zones in the peri-vascular space;
wherein the at least three ablative fluid zones intersect to form an ablation ring around a circumference of and outside of the inside surface of the renal artery.

2. The method of treating hypertension as in claim 1 , wherein injecting the ablative fluid comprises injecting ethanol.

3. The method of treating hypertension as in claim 1 , wherein injecting the ablative fluid comprises injecting from 0.1 ml to 3.0 ml of the ablative fluid.

4. The method of treating hypertension as in claim 1 , wherein injecting the ablative fluid comprises injecting a volume of less than 0.5 ml of the ablative fluid.

5. The method of treating hypertension as in claim 1 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 0.5 mm to 4 mm beyond an internal elastic lamina.

6. The method of treating hypertension as in claim 1 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 4 mm to 8 mm beyond an internal elastic lamina.

7. The method of treating hypertension as in claim 1 , further comprising permitting perfusion in a vessel across the distal portion of the delivery catheter, following advancing the at least three guide tubes.

8. The method of treating hypertension as in claim 1 , wherein advancing the at least three guide tubes comprises advancing the at least three guide tubes along a central buttress which supports the at least three guide tubes.

9. The method of treating hypertension as in claim 1 , further comprising fluoroscopically visualizing the at least three guide tubes following advancing the at least three guide tubes.

10. The method of treating hypertension as in claim 1 , wherein advancing at least three guide tubes further comprises advancing at least three guide tubes from at least three openings in the delivery catheter.

11. The method of treating hypertension as in claim 1 , wherein the three ablative fluid zones extend from the distal ends of the at least three guide tubes.

12. The method of treating hypertension as in claim 1 , wherein the at least three guide tubes include a shape memory metal.

13. A method of treating hypertension, comprising:
positioning a distal portion of a delivery catheter within a renal artery;
advancing at least three guide tubes from the delivery catheter until a distal end of each of the at least three guide tubes touch an inside wall of the renal artery, wherein the at least three guide tubes form a curve upon removal of a restraint;
advancing at least three injection needles through the at least three guide tubes and into a peri-vascular space outside of an inside surface of the renal artery; and
injecting an ablative fluid through the at least three injection needles to form at least three ablative fluid zones in the peri-vascular space;
wherein the at least three ablative fluid zones intersect to form an ablation ring around a circumference of and outside of the inside surface of the renal artery.

14. The method of treating hypertension as in claim 13 , wherein injecting the ablative fluid comprises injecting ethanol.

15. The method of treating hypertension as in claim 13 , wherein injecting the ablative fluid comprises injecting from 0.1 ml to 3.0 ml of the ablative fluid.

16. The method of treating hypertension as in claim 13 , wherein injecting the ablative fluid comprises injecting a volume of less than 0.5 ml of the ablative fluid.

17. The method of treating hypertension as in claim 13 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 0.5 mm to 4 mm beyond an internal elastic lamina.

18. The method of treating hypertension as in claim 13 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 4 mm to 8 mm beyond an internal elastic lamina.

19. The method of treating hypertension as in claim 13 , further comprising permitting perfusion in a vessel across the distal portion of the delivery catheter, following advancing the at least three guide tubes.

20. The method of treating hypertension as in claim 13 , wherein advancing the at least three guide tubes comprises advancing the at least three guide tubes along a central buttress which supports the at least three guide tubes.

21. The method of treating hypertension as in claim 13 , further comprising fluoroscopically visualizing the at least three guide tubes following advancing the at least three guide tubes.

22. The method of treating hypertension as in claim 13 , wherein the at least three guide tubes include a shape memory metal.

23. A method of treating hypertension, comprising:
positioning a distal portion of a delivery catheter within a renal artery;
advancing at least three guide tubes from the delivery catheter until a distal end of each of the at least three guide tubes touch an inside wall of the renal artery, wherein the at least three guide tubes are self-expanding;
advancing at least three injection needles through the at least three guide tubes and into a peri-vascular space outside of an inside surface of the renal artery; and
injecting an ablative fluid through the at least three injection needles to form at least three ablative fluid zones in the peri-vascular space;
wherein the at least three ablative fluid zones intersect to form an ablation ring around a circumference of and outside of the inside surface of the renal artery.

24. The method of treating hypertension as in claim 23 , wherein injecting the ablative fluid comprises injecting ethanol.

25. The method of treating hypertension as in claim 23 , wherein injecting the ablative fluid comprises injecting from 0.1 ml to 3.0 ml of the ablative fluid.

26. The method of treating hypertension as in claim 23 , wherein injecting the ablative fluid comprises injecting a volume of less than 0.5 ml of the ablative fluid.

27. The method of treating hypertension as in claim 23 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 0.5 mm to 4 mm beyond an internal elastic lamina.

28. The method of treating hypertension as in claim 23 , wherein injecting the ablative fluid comprises injecting the ablative fluid at a distance of between 4 mm to 8 mm beyond an internal elastic lamina.

29. The method of treating hypertension as in claim 23 , further comprising permitting perfusion in a vessel across the distal portion of the delivery catheter, following advancing the at least three guide tubes.

30. The method of treating hypertension as in claim 23 , wherein advancing the at least

Assignees

• Ablative Solutions Inc

Inventors

• Fischell David R
• Fischell Tim A
• Ragland Robert Ryan
• Kent Darrin James
• Denison Andy Edward
• Johnson Eric Thomas
• Burke Jeff Alan
• Hayden Christopher Scott
• Fischell Robert E

Classifications

• A61B2018/00982

  combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes · CPC title

• A61B5/0071

  by measuring fluorescence emission · CPC title

• A61B2018/00166

  Multiple lumina · CPC title

• A61M2005/1585

  Needle inserters · CPC title

• A61B2218/002

  Irrigation · CPC title