Expandable catheter system for peri-ostial injection and muscle and nerve fiber ablation

• US 10,172,663 B2
• Filed: 01/13/2016
• Issued: 01/08/2019
• 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): Schmidt, Emily
• Application Number:
  US14/994,681
• Publication Number:
  US 20160235464A1
• Time in Patent Office: 1,091 Days
• CPC Class Codes: A61B 18/06 caused by chemical reaction , e.g. moxaburners
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00285 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 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• 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 5/283 Invasive
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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

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, or the aortic wall. The present invention also has an important application to ablate tissue around the ostium of one or both renal arteries, for the ablation of the sympathetic nerve fibers and/or other afferent or efferent nerves going to or from each kidney in order to treat hypertension.

Claims

1. A circumferential ablation system comprising:

a catheter body comprising a fluid injection lumen;

an injector manifold;

a sheath;

at least two injector tubes, each injector tube comprising a proximal end and a distal end, the proximal ends of the at least two injector tubes attached to the injector manifold, the injector manifold configured to move the at least two injector tubes simultaneously, each injector tube comprising an injector tube lumen and an injector needle at the distal end of the respective injector tube, each injector tube lumen in fluid communication with the fluid injection lumen; and

one or more structures initially disposed within the sheath and configured to move outward from the sheath, the one or more structures movable outward beyond the diameter of the sheath toward a target tissue, the at least two injector tubes and the injector manifold movable relative to the one or more structures and along a longitudinal axis of the sheath,

wherein the one or more structures comprise a shape memory material.

2. The circumferential ablation system of claim 1, wherein the one or more structures comprise a nickel titanium alloy.

3. The circumferential ablation system of claim 1, wherein the one or more structures assume a preset shape upon removal of a constraint.

4. The circumferential ablation system of claim 3, wherein the constraint is the sheath.

5. The circumferential ablation system of claim 1, wherein the sheath has a closed position and an open position, where the sheath in the closed position extends to completely cover the injector needles of the at least two injector tubes.

6. The circumferential ablation system as recited in claim 1, wherein the one or more structures have a predetermined deployed cross-sectional diameter for centering of the circumferential ablation system within a vessel.

7. A circumferential ablation system comprising:

a body portion comprising a fluid injection lumen;

an injector manifold;

a sheath;

at least two injector tubes fixed relative to the injector manifold, the injector manifold configured to move the at least two injector tubes, each of the injector tubes comprising an injector tube lumen and an injector needle at a distal end of the respective injector tube, each injector tube lumen in fluid communication with the fluid injection lumen; and

a mechanical structure initially disposed within the sheath and configured to move outward from the sheath, the mechanical structure movable outward beyond the sheath toward a target tissue, the at least two injector tubes and the injector manifold movable relative to the mechanical structure and along a longitudinal axis of the sheath.

8. The circumferential ablation system of claim 7, wherein the mechanical structure comprises a nickel titanium alloy.

9. The circumferential ablation system of claim 7, wherein the at least two injector tubes assume a preset shape upon removal of a constraint.

10. The circumferential ablation system of claim 9, wherein the constraint is the sheath.

11. The circumferential ablation system of claim 7, wherein the sheath has a closed position and an open position, where the sheath in the closed position extends to completely cover the injector needles.

12. The circumferential ablation system as recited in claim 7, wherein the mechanical structure has a predetermined deployed cross-sectional diameter for centering of the circumferential ablation system within a vessel.

20. The circumferential ablation system of claim 7, wherein each injector needle extends distally a fixed distance relative to a flattened surface configured to engage the tissue.

13. A circumferential ablation system comprising:

a catheter body comprising a fluid injection lumen;

an injector manifold disposed within the catheter body;

at least two injector tubes fixedly coupled with the injector manifold, the injector manifold configured to move the at least two injector tubes to ensure uniform expansion of the at least two injector tubes relative to a tissue, each of the injector tubes comprising an injector tube lumen and an injector needle at the distal end of the respective injector tube, each injector tube lumen in fluid communication with the fluid injection lumen;

a mechanical centering structure, the mechanical centering structure configured to ensure that the at least two injector tubes extend circumferentially, the at least two injector tubes and the injector manifold configured to slide independently relative to the mechanical centering structure and along a central axis of the catheter body.

14. The circumferential ablation system of claim 13, wherein the mechanical centering structure comprises a shape memory material.

15. The circumferential ablation system of claim 13, wherein the mechanical centering structure assumes a preset shape upon removal of a constraint.

16. The circumferential ablation system of claim 15, wherein the constraint is a sheath.

17. The circumferential ablation system of claim 13, wherein the at least two injector tubes assume a preset shape upon removal of a constraint.

18. The circumferential ablation system as recited in claim 13, wherein the mechanical centering structure has a predetermined deployed cross-sectional diameter for centering of the circumferential ablation system within a vessel.

19. The circumferential ablation system as recited in claim 13, wherein each injector needle penetrates the tissue the same pre-set distance.