Apparatus and method of assessing transvascular denervation

• US 8,909,316 B2
• Filed: 06/06/2011
• Issued: 12/09/2014
• Est. Priority Date: 05/18/2011
• Status: Active Grant

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ng, Kok-Hwee
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/153,838
• Publication Number:
  US 20120296329A1
• Time in Patent Office: 1,282 Days
• Field of Search: 600/373, 600/381, 600/393, 600/377, 600/554, 606/41, 607/44, 607/116, 607/118, 607/124, 607/126, 607/148
• US Class Current: 600/381
• 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 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00226 extending from a surface, i.e. Blisters
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure

Abstract

A catheter apparatus for assessing denervation comprises: an elongated catheter body; a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from and contractible inwardly toward the longitudinal axis of the catheter body; one or more ablation elements disposed on the deployable structure to move outwardly and inwardly with the deployable structure; one or more stimulation elements spaced from each other and disposed on the deployable structure to move with the deployable structure, the stimulation elements being powered to supply nerve stimulating signals to the vessel; and one or more recording elements spaced from each other and from the stimulation elements, the recording elements being disposed on the deployable structure to move with the deployable structure, the recording elements configured to record response of the vessel to the nerve stimulating signals.

Claims

1. A catheter apparatus for assessing denervation comprising:

an elongated catheter body having a proximal end and a distal end, a longitudinal axis extending in a longitudinal direction between the distal end and the proximal end;

a deployable structure coupled to the catheter body, the deployable structure being deployable outwardly from the longitudinal axis of the catheter body to a deployed arrangement and contractible inwardly toward the longitudinal axis of the catheter body to a contracted arrangement, the deployable structure comprising a deployable sleeve, wherein at least a portion of the catheter body is disposed inside the deployable sleeve, and an anti-occlusion feature configured to permit fluid flow in a vessel of a patient between a proximal end and a distal end of the deployable structure in the deployed arrangement;

one or more ablation elements disposed on the deployable sleeve to move outwardly and inwardly with the deployable sleeve, the one or more ablation elements being powered to apply ablation energy to the vessel;

one or more stimulation elements spaced from each other and disposed on the deployable sleeve to move outwardly and inwardly with the deployable sleeve, the one or more stimulation elements being powered to supply nerve stimulating signals to the vessel; and

one or more recording elements spaced from each other and from the one or more stimulation elements, the one or more recording elements being disposed on the deployable sleeve to move outwardly and inwardly with the deployable sleeve and being configured to record evoked electrical responses of the vessel in response to the nerve stimulating signals.

2. The catheter apparatus of claim 1,

wherein the one or more stimulation elements are proximal relative to the one or more recording elements.

3. The catheter apparatus of claim 1,

wherein a most distal ablation element of the one or more ablation elements is no more distal than at least one of the stimulation elements and a most proximal ablation element of the one or more ablation elements is no more proximal than at least one of the one or more recording elements.

4. The catheter apparatus of claim 1,

wherein at least one of the ablation elements is also a stimulation element or a recording element.

5. The catheter apparatus of claim 1,

wherein the one or more recording elements are spaced from one of the one or more stimulation elements by one of a longitudinal spacing, a lateral spacing, or a combined longitudinal and lateral spacing.

6. The catheter apparatus of claim 1,

wherein the one or more recording elements are configured to record revoked electrical responses of the vessel in response to the nerve stimulating signals by direct contact with a luminal wall of the vessel.

7. The catheter apparatus of claim 1,

wherein the deployable sleeve comprises an electrically insulative material.

8. The catheter apparatus of claim 1,

wherein the portion of the catheter body disposed inside the deployable sleeve includes a plurality of holes for fluid to pass therethrough to facilitate pushing the deployable sleeve radially outwardly relative to the catheter body in the deployed arrangement.

9. The catheter apparatus of claim 8, further comprising:

a plurality of draw strings extending from inside the portion of the catheter body disposed inside the deployable sleeve through the plurality of holes to the deployable sleeve to draw the deployable sleeve radially inwardly relative to the catheter body in the contracted arrangement.

10. A catheter apparatus for assessing denervation comprising:

an elongated catheter body having a proximal end and a distal end, a longitudinal axis extending in a longitudinal direction between the distal end and the proximal end;

a structure coupled to the catheter body, the structure comprising a deployable sleeve, wherein at least a portion of the catheter body is disposed inside the deployable sleeve, and an anti-occlusion feature configured to permit fluid flow in a vessel of a patient between a proximal end and a distal end of the structure when the structure is in a deployed arrangement;

one or more ablation elements disposed on the deployable sleeve and being powered to apply ablation energy to the vessel;

one or more stimulation elements spaced from each other and disposed on the deployable sleeve, the one or more stimulation elements being powered to supply nerve stimulating signals to the vessel;

one or more recording elements spaced from each other and from the one or more stimulation elements, the one or more recording elements being disposed on the deployable sleeve and being configured to record evoked electrical responses of the vessel in response to the nerve stimulating signals; and

wherein the portion of the catheter body disposed inside the deployable sleeve is configured to facilitate deployment of the deployable sleeve outwardly from the longitudinal axis of the catheter body to move the one or more ablation elements, the one or more stimulation elements, and the one or more recording elements outwardly to the deployed arrangement, and wherein the structure comprises a mechanism to contract the structure inwardly toward the longitudinal axis of the catheter body to move the one or more ablation elements, the one or more stimulation elements, and the one or more recording elements inwardly to a contracted arrangement.

11. The catheter apparatus of claim 10,

wherein at least one of the one or more ablation elements is also a stimulation element or a recording element.

12. The catheter apparatus of claim 10,

wherein a most distal ablation element of the one or more ablation elements is no more distal than at least one of the stimulation elements and a most proximal ablation element of the one or more ablation elements is no more proximal than at least one of the one or more recording elements.

13. The catheter apparatus of claim 10,

wherein the one or more recording elements are configured to record evoked electrical responses of the vessel in response to the nerve stimulating signals by direct contact with a luminal wall of the vessel.

14. The catheter apparatus of claim 10,

wherein the deployable sleeve comprises an electrically insulative material.

15. The catheter apparatus of claim 10,

wherein the portion of the catheter body disposed inside the deployable sleeve includes a plurality of holes for fluid to pass therethrough.

16. The catheter apparatus of claim 15,

wherein the mechanism to contract the structure inwardly toward the longitudinal axis of the catheter body to move the one or more ablation elements, the one or more stimulation elements, and the one or more recording elements inwardly to the contracted arrangement comprises a plurality of draw strings extending from inside the portion of the catheter body disposed inside the deployable sleeve through the plurality of holes to the deployable sleeve to draw the deployable sleeve radially inwardly relative to the catheter body in the contracted arrangement.

17. The catheter apparatus of claim 10,

wherein the anti-occlusion feature comprises a plurality of rib channels connecting a lumen of the portion of the catheter disposed inside the deployable sleeve to an enclosed interior of the deployable sleeve between an outer shell of the deployable sleeve and an inner shell of the deployable sleeve.

18. The catheter apparatus of claim 17,

wherein the outer shell of the deployable sleeve is semi-compliant, and wherein the inner shell of the deployable sleeve is noncompliant.