Method for painless renal denervation using a peri-vascular tissue ablation catheter with support structures

• US 10,226,278 B2
• Filed: 08/31/2015
• Issued: 03/12/2019
• 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:
  US14/841,662
• Publication Number:
  US 20160058489A1
• Time in Patent Office: 1,289 Days
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• 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 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/046 in liquid form
• 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: 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

Abstract

An intravascular catheter for peri-vascular 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, or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. A method can involve injection of the ablative fluid over an extended time period of at least 10 seconds or with two injections at two different penetration depths to reduce or eliminate patient pain during ablation.

Claims

1. A transvascular method of minimizing pain during the treatment of extravascular tissue, comprising:

providing a catheter having an elongate flexible body, a proximal end, a distal end, and a tissue penetrating element near the distal end;

transvascularly positioning the distal end at a treatment site;

deploying the tissue penetrating element into a vessel wall at a first depth;

desensitizing pain nerves at the first depth;

deploying the tissue penetrating element into the vessel wall at a second depth after desensitizing pain nerves; and

ablating sympathetic nerves at the second depth, the second depth greater than the first depth.

2. The transvascular method of claim 1, further comprising deploying at least three tissue penetrating elements into the vessel wall.

3. The transvascular method of claim 2, wherein deploying the tissue penetrating element into the vessel wall at the first depth comprises advancing a guide tube into contact with the vessel wall, and advancing an injector tube out of the guide tube and into the vessel wall.

4. The transvascular method of claim 3, further comprising centering the catheter in the vessel by advancing three guide tubes into contact with the vessel wall.

5. The transvascular method of claim 1, wherein desensitizing pain nerves comprises injecting a desensitizing agent through the tissue penetrating element.

6. The transvascular method of claim 5, wherein ablating sympathetic nerves comprises injecting an ablative agent through the tissue penetrating element.

7. The transvascular method of claim 6, wherein the desensitizing agent and the ablative agent are the same agent.

8. The transvascular method of claim 5, wherein ablating sympathetic nerves comprises delivering energy to the sympathetic nerves.

9. The transvascular method of claim 5, wherein ablating sympathetic nerves comprises elevating the temperature of the sympathetic nerves.

10. The transvascular method of claim 5, wherein ablating sympathetic nerves comprises lowering the temperature of the sympathetic nerves.

11. The transvascular method of claim 7, wherein the desensitizing agent and the ablative agent are both ethanol.

12. The transvascular method of claim 11, wherein desensitizing pain nerves comprises delivering a first volume of ethanol at a site, and ablating sympathetic nerves comprises delivering a second volume of ethanol at the site.

13. The transvascular method of claim 12, wherein the first volume of ethanol and the second volume of ethanol are injected in a continuous injection rate.

14. The transvascular method of claim 13, wherein the continuous injection rate is no more than 2 ml / minute.

15. The transvascular method of claim 12, wherein delivering the second volume of ethanol does not begin until at least 10 seconds following completion of delivering the first volume of ethanol.

16. The transvascular method of claim 12, wherein the first volume of ethanol is injected at a first rate, and the second volume of ethanol is injected at a second, faster rate.