Monitoring, managing and/or protecting system and method for non-targeted tissue

Patent metadata

Field	Value
Publication number	US-9918787-B2
Application number	US-201113101755-A
Country	US
Kind code	B2
Filing date	May 5, 2011
Priority date	May 5, 2010
Publication date	Mar 20, 2018
Grant date	Mar 20, 2018

Abstract

A monitoring, managing and protecting system is provided that includes a monitoring probe working in conjunction with an ablating device. The probe is configured to be positioned in close proximity to a region of non-targeted tissue proximate an ablation site of targeted tissue and to be operatively connected to an electrical response assessment system or component. The probe includes an elongate shaft having proximal and distal ends, with a handle disposed at the proximal end thereof and a tissue monitoring and protecting apparatus disposed at the distal end thereof. The ablating device includes an elongate shaft having proximal and distal ends, with a handle mounted at the proximal end thereof and an ablation element mounted at the distal end thereof. The monitoring probe measures electrical characteristics of the non-targeted tissue and/or of the tissue between the monitoring electrode and the ablation electrode. The electrical response assessment system determines whether the tissue is being damaged based on the electrical measurements. The monitoring, managing and protecting system can notify a practitioner based on the determination, or modify or stop the ablation procedure.

First claim

The invention claimed is:

1. A monitoring, managing and protecting system for providing protection to non-targeted tissue during an ablation of the posterior wall of the atrium, the monitoring system comprising:
a) a monitoring probe comprising a tubular body and a monitoring shaft, wherein said monitoring shaft has a proximal portion, a distal portion, an anterior surface, and a posterior surface;
b) an anchoring device provided at the distal portion of the monitoring shaft, wherein the anchoring device is configured to anchor the monitoring shaft within an esophagus,
wherein the anchoring device comprises at least one of a fluid based structure, a deflectable wire-based structure, and a magnetic-based structure;
c) at least one monitoring electrode, said at least one monitoring electrode configured to be located proximate said non-targeted tissue, wherein the at least one monitoring electrode is configured to acquire an electrical signal from the non-targeted tissue; and
d) an electrical response assessment system, wherein said electrical response assessment system is operatively connected to said at least one monitoring electrode, and said electrical response assessment system is configured to (i) calculate a product of power applied during a duration of the ablation, wherein the product comprises a total energy applied during the duration; (ii) measure a complex impedance according to said electrical signal, said complex impedance having at least a resistance and a reactance or an impedance magnitude and a phase angle, and (iii) determine whether said non-targeted tissue will be damaged before damage occurs based on said calculation of said product of power applied over said duration of the ablation and at least one of said resistance, said reactance, said impedance magnitude, or said phase angle, wherein the electrical response assessment system further determines whether said non-targeted tissue will be damaged before damage occurs by predicting the temperature of a tissue at a predetermined depth below a surface of the non-targeted tissue.

2. The monitoring system in claim 1 , wherein the fluid based structure is an inflatable/deflatable balloon.

3. The monitoring system in claim 2 , wherein the inflatable/deflatable balloon comprises a plurality of segments.

4. The monitoring system in claim 3 , wherein each segment of the inflatable/deflatable balloon contains a different fluid.

5. The monitoring system in claim 1 , wherein the deflectable wire-based structure comprises at least one of an expandable/retractable spring, an expandable/retractable mesh, and an expandable/retractable stent.

6. The monitoring system in claim 5 , wherein the expandable/retractable spring comprises at least one of a coil spring, a semi-elliptic spring, and a cantilever spring.

7. The monitoring system in claim 1 , wherein the magnetic-based structure comprises at least one of a coil, a ferromagnet, a permanent magnet, and an electromagnet.

8. The monitoring system in claim 1 , wherein the at least one monitoring electrode is located on said anterior surface of the distal portion of the monitoring shaft.

9. The monitoring system in claim 1 , wherein the at least one monitoring electrode is on an anterior surface of the distal portion of the anchoring device that is separate from said anterior surface of said monitoring shaft.

10. The monitoring system in claim 1 , wherein the at least one monitoring electrode is a metal electrode, said metal electrode comprising a metalized film.

11. The monitoring system in claim 1 , wherein the at least one monitoring electrode is a conductive polymer electrode.

12. The monitoring system in claim 1 , wherein the at least one monitoring electrode is selected from the group consisting of a ring electrode, a spot electrode, a spiral electrode, an array electrode, a mesh electrode, and a longitudinal electrode.

13. The monitoring system in claim 12 , wherein the at least one monitoring electrode comprises multiple electrodes disposed in a plane perpendicular to a longitudinal axis of said monitoring probe.

14. The monitoring system in claim 13 , wherein one of the multiple electrodes comprises ring electrodes.

15. The monitoring system in claim 1 , further comprising a thermal sensor, wherein said thermal sensor is operatively connected to the electrical response assessment system and said monitoring system is configured to measure the electrical and thermal characteristics of tissue between an anterior wall of the esophagus and a posterior endocardial wall of the atrium.

16. A catheter system for providing esophageal protection during ablation, the catheter system comprising:
a) an esophageal catheter comprising a tubular body having a catheter shaft, wherein the catheter shaft has a proximal portion and a distal portion;
b) an anchoring means provided at the distal portion of the catheter shaft, wherein the anchoring means has an anterior surface and a posterior surface;
c) at least one electrode on the anterior surface of the anchoring means;
d) at least one other electrode configured to be located proximate an atrium; and
e) an electrical response assessment system operatively connected to the at least one electrode on the anchoring means and the at least one other electrode proximate the atrium, said electrical response assessment system configured to: (i) calculate a product of power applied during the duration of the ablation, wherein the product comprises a total energy applied during the duration; (ii) measure a complex impedance of a tissue between the at least one electrode on the anchoring means and the at least one other electrode configured to be located proximate the atrium, the complex impedance including at least a reactance and a resistance or an impedance magnitude and a phase angle; (iii) calculate a metric according to said calculation of said product of power applied during the duration of the ablation and at least one of said reactance, said resistance, said impedance magnitude, or said phase angle of said complex impedance by applying a mathematical algorithm that accepts as input at least said calculation of said product of power applied during the duration of the ablation and said at least one of said reactance, said resistance, said impedance magnitude, or said phase angle of said complex impedance and outputs said metric; and (iv) determine if the tissue between the at least one electrode on the anchoring means and the at least one other electrode configured to be located proximate the atrium is being damaged before damage occurs in an ablation procedure according to said metric, wherein the electrical response assessment system further determines whether the tissue between the at least one electrode on the anchoring means will be damaged before damage occurs by predicting the temperature at a predetermined depth below a surface of the tissue.

17. The catheter system for providing esophageal protection during ablation in claim 16 , further comprising a robotic control and guidance system, said robotic control and guidance system configured to control a position of said at least one other electrode, and comprising an electronic control system, said electronic control system operatively connected to said electrical response assessment system, such that said electrical response assessment system is capable of controlling said at least one other electrode based on the measure of the electrical characteristics of the tissue between the at least one electrode on the anchoring means and the at least one other electrode configured to be located prox

Assignees

• Heimbecher Reed R
• Paul Saurav
• Berns John M
• Schweitzer Jeffrey A
• St Jude Medical Atrial Fibrillation Div Inc

Inventors

• Heimbecher Reed R
• Paul Saurav
• Berns John M
• Schweitzer Jeffrey A

Classifications

• A61B2018/0022

  Balloons · CPC title

• A61B2018/00898

  Alarms or notifications created in response to an abnormal condition · CPC title

• A61B2018/00642

  with feedback, i.e. closed loop control · CPC title

• A61B2018/00714

  Temperature · CPC title

• A61B2018/00875

  Resistance or impedance · CPC title