Transvascular method of treating hypertension

• US 9,554,849 B2
• Filed: 05/14/2015
• Issued: 01/31/2017
• Est. Priority Date: 10/29/2012
• Status: Active Grant

• Current Assignee: Ablative Solutions, Inc.
• Original Assignee: 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.
• Primary Examiner(s): Hayman, Imani
• Application Number:
  US14/712,861
• Publication Number:
  US 20150245863A1
• Time in Patent Office: 628 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00345 Vascular system
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

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.

Claims

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 three guide tubes comprises advancing the at least three guide tubes along a central buttress which supports the at least three guide tubes.

31. The method of treating hypertension as in claim 23, further comprising fluoroscopically visualizing the at least three guide tubes following advancing the at least three guide tubes.

32. The method of treating hypertension as in claim 23, wherein the at least three guide tubes include a shape memory metal.