Methods of ablating tissue using a catheter injection system

• US 9,795,441 B2
• Filed: 07/31/2015
• Issued: 10/24/2017
• Est. Priority Date: 04/22/2011
• Status: Active Grant

• Current Assignee: Ablative Solutions, Inc.
• Original Assignee: Ablative Solutions, Inc.
• Inventors: Fischell, David R., Fischell, Tim A.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/814,962
• Publication Number:
  US 20150335384A1
• Time in Patent Office: 816 Days
• Field of Search: 600471
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• 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 2018/143 multiple needles
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16

Abstract

At the present time, physicians often treat patients with atrial fibrillation (AF) using radiofrequency (RF) catheter systems to ablate conducting tissue in the wall of the Left Atrium of the heart around the ostium of the pulmonary veins. These systems are expensive and take time consuming to use. The present invention circular ablation system CAS includes a multiplicity of expandable needles that can be expanded around a central axis and positioned to inject a fluid like ethanol to ablate conductive tissue in a ring around the ostium of a pulmonary vein quickly and without the need for expensive capital equipment. The expansion of the needles is accomplished by self-expanding or balloon expandable structures. The invention includes centering means so that the needles will be situated in a pattern surrounding the outside of the ostium of a vein. Also included are members that limit the distance of penetration of the needles into the wall of the left atrium. The present invention also has application to ablating tissue around the ostium of a renal artery for the treatment of hypertension.

Claims

1. A method of treating a target tissue, the method including:

advancing an ablation system through a target vessel until a distal end of the ablation system lies near the target tissue, the ablation system including a distal portion with tubes and injection needles, the ablation system designed to allow injection of ablative fluid through the injection needles;

centering the ablation system with respect to the target vessel by expanding an expandable structure of the ablation system outward with respect to a lumenal wall of the target vessel;

causing the tubes and injection needles to expand outward around a circumference of the ablation system;

advancing the injection needles at least partially through the lumenal wall of the target vessel and into the target tissue; and

injecting ablative fluid into the target tissue through the injection needles.

2. The method of claim 1 wherein the ablative fluid comprises ethyl alcohol.

3. The method of claim 1 further including retracting the tubes into a body of the ablation system.

4. The method of claim 1 wherein the ablation system comprises at least 3 tubes and at least 3 injection needles.

5. The method of claim 1 wherein the expandable structure is a manually expandable structure and centering the ablation system includes manual expansion of the expandable structure.

6. The method of claim 1 wherein the expandable structure is self-expanding.

7. The method of claim 1 further including retracting the distal portion of the ablation system back into a guiding catheter.

8. The method of claim 1 further including limiting the penetration of the injection needles into the target tissue.

9. The method of claim 1 wherein the expandable structure comprises a balloon.

10. The method of claim 1 wherein the expandable structure is expanded to a diameter 1 mm to 4 mm less than the diameter of the target vessel.

11. The method of claim 1 wherein the target tissue is within the lumenal wall of the target vessel.

12. A method of treating a target tissue, the method including:

advancing an ablation system through a target vessel until a distal end of the ablation system lies near the target vessel, the ablation system including a distal portion with tubes and injection needles, the ablation system designed to allow injection of ablative fluid through the injection needles;

centering the ablation system with respect to the target vessel by expanding an expandable structure of the ablation system outward with respect to a lumenal wall of the target vessel;

advancing the injection needles at least partially through the lumenal wall and into the target tissue; and

injecting ablative fluid into the target tissue through the injection needles.

13. The method of claim 12 where the ablative fluid comprises ethyl alcohol.

14. The method of claim 12 further including retracting the tubes into a body of the ablation system.

15. The method of claim 12 wherein the ablation system comprises at least 3 tubes and at least 3 injection needles.

16. The method of claim 12 wherein the expandable structure is a manually expandable structure and centering the ablation system includes manual expansion of the expandable structure.

17. The method of claim 12 wherein the expandable structure is self-expanding.

18. The method of claim 12 further including retracting the distal portion of the ablation system back into a guiding catheter.

19. The method of claim 12 further including limiting the penetration of the injection needles into the target tissue.

20. The method of claim 12 wherein the expandable structure comprises a balloon.

21. The method of claim 12 wherein the expandable structure is expanded to a diameter 1 mm to 4 mm less than the diameter of the target vessel.

22. The method of claim 12 wherein the target tissue is within the lumenal wall of the target vessel.