Orientation determination based on temperature measurements

• US 9,592,092 B2
• Filed: 07/19/2016
• Issued: 03/14/2017
• Est. Priority Date: 11/19/2014
• Status: Active Grant

• Current Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Advanced Cardiac Therapeutics, Inc. (Medtronic Plc)
• Inventors: Panescu, Dorin, Johnson, Jessi E., Schultheis, Eric Andrew, Koblish, Josef Vincent
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US15/214,358
• Publication Number:
  US 20160324568A1
• Time in Patent Office: 238 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1206 Generators therefor
• 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 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• 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 2018/00672 lower
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• 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 2018/128 : generating two or more frequencies
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2562/046 : in a matrix array
• CPC Class Codes: A61B 5/01 : Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/068 : using impedance sensors
• CPC Class Codes: A61B 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• 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

According to some embodiments, a medical instrument (for example, an ablation device) comprises an elongate body having a proximal end and a distal end, an energy delivery member positioned at the distal end of the elongate body, a first plurality of temperature-measurement devices carried by or positioned within the energy delivery member, the first plurality of temperature-measurement devices being thermally insulated from the energy delivery member, and a second plurality of temperature-measurement devices positioned proximal to a proximal end of the energy delivery member, the second plurality of temperature-measurement devices being thermally insulated from the energy delivery member.

Claims

1. A system for determining orientation of a distal tip of an ablation device with respect to tissue, the system comprising:

a hardware processor configured to, upon execution of instructions stored on a computer-readable storage medium;

receive signals indicative of temperature from a first plurality of temperature sensors positioned along and isolated from contact with a distal member of a combination electrode assembly of an ablation device while energy is being delivered by the combination electrode assembly, the combination electrode assembly comprising the distal member and a proximal member spaced apart from the distal member by an electrically-insulating gap;

receive signals indicative of temperature from a second plurality of temperature sensors positioned along and isolated from contact with the proximal member of the combination electrode assembly while energy is being delivered by the combination electrode assembly;

determine temperature measurements from the signals received from the first plurality of temperature sensors and the second plurality of temperature sensors;

determine a trend of dominance of the temperature measurements;

determine an orientation of a distal tip of the ablation device with respect to tissue based on the trend of dominance; and

generate an output indicative of the orientation to be output to a display; and

a radiofrequency energy source configured to provide energy to the combination electrode assembly through one or more conductors extending from the radiofrequency energy source to the combination electrode assembly.

2. The system of claim 1,

wherein the orientation is determined from one of three orientation options,

wherein the three orientation options are:

perpendicular, parallel and oblique,

wherein the display comprises a graphical user interface, and

wherein the output comprises one or more graphical images indicative of the orientation.

3. The system of claim 1, wherein the processor is further configured to adjust one or more treatment parameters based on the orientation.

4. The system of claim 3, wherein the one or more treatment parameters comprise one or more of:

duration of treatment, power level, target temperature, and maximum temperature.

5. The system of claim 1, wherein the orientation is determined from one of three orientation options, and wherein the three orientation options are:

perpendicular, parallel and oblique.

6. The system of claim 5, wherein the orientation is determined to be parallel if the temperature measurements from both the first plurality of temperature sensors and the second plurality of temperature sensors become dominant, wherein the orientation is determined to be perpendicular if the temperature measurements from the first plurality of temperature sensors become dominant, and wherein the orientation is determined to be oblique if combinations of the temperature measurements from the first plurality of temperature sensors and the second plurality of temperature sensors become dominant.

7. The system of claim 1, further comprising the ablation device.

8. The system of claim 1, further comprising the display.

9. A system for determining orientation of a distal tip of an ablation device with respect to tissue, the system comprising:

a hardware processor configured to, upon execution of instructions stored on a computer-readable storage medium;

receive signals indicative of temperature from a distal group of temperature-measurement devices positioned along a distal member of a combination electrode assembly of an ablation device while energy is being delivered by the combination electrode assembly, the combination electrode assembly comprising the distal member and a proximal member spaced apart from the distal member by a gap;

receive signals indicative of temperature from a proximal group of temperature-measurement devices positioned along the proximal member of the combination electrode assembly while energy is being delivered by the combination electrode assembly;

determine temperature measurements from the signals received from the distal group of temperature-measurement devices and the proximal group of temperature-measurement devices;

determine which of the temperature measurements become dominant over time; and

determine an orientation of a distal tip of the ablation device with respect to tissue based on the determination of which temperature measurements become dominant over time; and

a radiofrequency energy source configured to provide energy to the combination electrode assembly through one or more conductors extending from the radiofrequency energy source to the combination electrode assembly.

10. The system of claim 9, wherein the processor is further configured to adjust one or more treatment parameters based on the orientation, and wherein the one or more treatment parameters comprise one or more of:

duration of treatment, power level, target temperature, and maximum temperature.

11. The system of claim 9, wherein the processor is further configured to cause an identification of the orientation to be output to a display.

12. The system of claim 11, wherein the orientation is selected from one of three orientation options, and wherein the three orientation options are:

perpendicular, parallel and oblique.

13. The system of claim 12, wherein the orientation is determined to be parallel if the temperature measurements from both the proximal group of temperature-measurement devices and the distal group of temperature-measurement devices become dominant, wherein the orientation is determined to be perpendicular if the temperature measurements from the distal group of temperature-measurement devices become dominant, and wherein the orientation is determined to be oblique if combinations of the temperature measurements from the distal group of temperature-measurement devices and the proximal group of temperature-measurement devices become dominant.

14. The system of claim 11, further comprising the display.

15. A method of determining an orientation of a distal tip of an ablation device with respect to tissue, the method comprising:

receiving signals indicative of temperature from a first plurality of temperature sensors positioned along a distal member of a combination electrode assembly of an ablation device while energy is being delivered by the combination electrode assembly;

receiving signals indicative of temperature from a second plurality of temperature sensors positioned along a proximal member of the combination electrode assembly while energy is being delivered by the combination electrode assembly, the proximal member being separated from the distal member by a gap;

determining, by execution of instructions stored on a non-transitory storage medium by a hardware processor, temperature measurements from the signals received from the first plurality of temperature sensors and the second plurality of temperature sensors; and

determining, by execution of instructions stored on a non-transitory storage medium by a hardware processor, which of the temperature measurements become dominant over time;

determining, by execution of instructions stored on the non-transitory storage medium by the hardware processor, an orientation of a distal tip of the ablation device with respect to tissue based on the determination of which temperature measurements become dominant over time.

16. The method of claim 15, wherein the orientation is determined from one of three orientation options and wherein the three orientation options are:

perpendicular, parallel and oblique.

17. The method of claim 16, further comprising generating an output indicative of the orientation, wherein the output comprises one or more graphical images.

18. The method of claim 16, wherein the orientation is determined to be parallel if the temperature measurements from both the first plurality of temperature sensors and the second plurality of temperature sensors become dominant, wherein the orientation is determined to be perpendicular if the temperature measurements from the first plurality of temperature sensors become dominant, and wherein the orientation is determined to be oblique if combinations of the temperature measurements from the first plurality of temperature sensors and the second plurality of temperature sensors become dominant.

19. The method of claim 15, further comprising generating an alarm if the orientation changes during energy delivery.