Tissue diagnosis and treatment using mini-electrodes

• US 10,524,684 B2
• Filed: 10/12/2015
• Issued: 01/07/2020
• Est. Priority Date: 10/13/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Fay, Leon, Hultz, Paul
• Primary Examiner(s): Kim, Eun Hwa
• Application Number:
  US14/881,112
• Publication Number:
  US 20160100884A1
• Time in Patent Office: 1,548 Days
• 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 2018/00351 Heart
• CPC Class Codes: A61B 2018/00357 Endocardium
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00892 Voltage
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2562/0257 Proximity sensors
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6852 Catheters

Abstract

Medical devices and methods for making and using medical devices are disclosed. An example electrophysiology medical device may include a catheter shaft including a distal end portion and a sensing assembly having three or more terminals. The sensing assembly includes one or more current-carrying electrodes and one or more sensing electrodes. The one or more current-carrying electrodes, the one or more sensing electrodes, or both includes a mini-electrode. The mini-electrode is disposed on one of the other electrodes. The medical device may also include a controller coupled to the sensing assembly.

Claims

1. An electrophysiology medical device, comprising:

a catheter shaft including a distal end portion;

a sensing assembly located on the distal end portion, the sensing assembly having three or more terminals;

wherein the sensing assembly includes one or more current-carrying electrodes and more than one sensing electrodes, wherein a first sensing electrode of the more than one sensing electrodes is spaced apart from the one or more current-carrying electrodes by a first distance, wherein a second sensing electrode of the more than one sensing electrodes is spaced apart from the one or more current-carrying electrodes by a second distance, wherein the first distance is different than the second distance;

wherein at least one of the one or more current-carrying electrodes and the one or more sensing electrodes includes one or more mini-electrodes and one or more non-mini electrodes;

wherein at least one of the one or more mini-electrodes is disposed on at least one of the one or more non-mini electrodes; and

a controller coupled to the sensing assembly, the controller configured to

determine a first potential measurement for the first sensing electrode and a second potential measurement for the second sensing electrode, the first potential measurement being inversely proportional to the first distance and the second potential measurement being inversely proportional to the second distance,

determine a scaling factor based on the first distance, the second distance, the first potential measurement, and the second potential measurement, and determine the conductivity of a medium contacting the sensing assembly based on the scaling factor.

2. The medical device of claim 1, wherein the three or more terminals includes four terminals.

3. The medical device of claim 1, wherein one or more of the three or more terminals are disposed along the distal end portion of the catheter shaft.

4. The medical device of claim 1, wherein one or more of the three or more terminals are disposed along a device separate from the catheter shaft.

5. The medical device of claim 1, wherein the one or more current-carrying electrodes includes at least one mini-electrode of the one or more mini-electrodes.

6. The medical device of claim 1, wherein the one or more sensing electrodes includes one mini-electrode of the one or more mini-electrodes.

7. The medical device of claim 1, wherein the one or more current-carrying electrodes includes a mini-electrode of the one or more mini-electrodes and the one or more sensing electrodes includes two mini-electrodes of the one or more mini-electrodes.

8. The medical device of claim 1, wherein the one or more current-carrying electrodes includes two mini-electrodes of the one or more mini-electrodes and the one or more sensing electrodes includes a mini-electrode of the one or more mini-electrodes.

9. The medical device of claim 1, wherein the one or more current-carrying electrodes includes two mini-electrodes of the one or more mini-electrodes and the one or more sensing electrodes includes two mini-electrodes of the one or more mini-electrodes.

10. The medical device of claim 1, wherein the one or more current-carrying electrodes or the one or more sensing electrodes includes an ablation electrode.

11. The medical device of claim 1, wherein the one or more current-carrying electrodes includes an ablation electrode and wherein the one or more sensing electrodes includes an electrode disposed on the ablation electrode.

12. The medical device of claim 1, wherein the one or more sensing electrodes includes an ablation electrode and wherein the one or more current-carrying electrodes includes an electrode disposed on the ablation electrode.

13. The medical device of claim 1, wherein the one or more current-carrying electrodes or the one or more sensing electrodes includes a ring electrode.

14. The medical device of claim 1, wherein the one or more current-carrying electrodes includes an ablation electrode and a ring electrode, and wherein the one or more sensing electrodes includes at least one mini-electrode of the one or more mini-electrodes.

15. The medical device of claim 1, wherein the one or more current-carrying electrodes includes at least one mini-electrode of the one or more mini-electrodes, and wherein the one or more sensing electrodes includes an ablation electrode and a ring electrode.

16. The medical device of claim 1, wherein the one or more current-carrying electrodes includes an ablation electrode and a mini-electrode of the one or more mini-electrodes and wherein the one or more sensing electrodes includes a ring electrode and a mini-electrode of the one or more mini-electrodes.

17. The medical device of claim 1, wherein the one or more current-injecting electrodes includes a ring electrode and a mini-electrode of the one or more mini-electrodes and wherein the one or more sensing electrodes includes an ablation electrode and a mini-electrode of the one or more mini-electrodes.

18. An electrophysiology medical device, comprising:

a catheter shaft including a distal end portion, wherein the distal end portion includes a plurality of electrodes;

wherein the plurality of electrodes includes at least one current-carrying electrode, a first sensing electrode and a second sensing electrode;

wherein at least one of the plurality of electrodes is a mini-electrode and at least one of the plurality of electrodes is a non-mini electrode, wherein one or more of the at least one mini-electrode is disposed on one or more of the at least one non-mini electrode;

wherein the first sensing electrode is spaced from the at least one current-carrying electrode by a first distance;

wherein the second sensing electrode is spaced from the at least one current-carrying electrode by a second distance;

wherein the first distance is different from the second distance; and

a controller coupled to the plurality of electrodes, the controller configured to;

determine a first potential measurement for the first sensing electrode and a second potential measurement for the second sensing electrode, the first potential measurement being inversely proportional to the first distance and the second potential measurement being inversely proportional to the second distance,

determine a scaling factor based on the first distance, the second distance, the first potential measurement, and the second potential measurement, and determine the conductivity of a medium contacting the sensing assembly based on the scaling factor.

19. The medical device of claim 18, further comprising:

wherein the at least one current-carrying electrode and the first and second sensing electrodes are arranged in at least one four-terminal sensing configuration.