CONTACT SENSING SYSTEMS AND METHODS

• US 20160278841A1
• Filed: 06/10/2016
• Published: 09/29/2016
• Est. Priority Date: 03/25/2015
• Status: Active Grant

• Current Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: Advanced Cardiac Therapeutics, Inc. (Medtronic Plc)
• Inventors: Panescu, Dorin, Johnson, Jessi E.
• Granted Patent: US 9,636,164 B2
• Time in Patent Office: 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 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00869 Phase
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/128 generating two or more frequencies
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2218/002 Irrigation
• 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 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

According to some embodiments, a medical instrument comprises an elongate body having a proximal end and a distal end and a pair of electrodes or electrode portions (for example, a split-tip electrode assembly). Systems and methods are described herein that perform contact sensing and/or ablation confirmation based on electrical measurements obtained while energy of different frequencies are applied to the pair of electrodes or electrode portions. The contact sensing systems and methods may calibrate network parameter measurements to compensate for a hardware unit in a network parameter measurement circuit or to account for differences in cables, instrumentation or hardware used.

Claims

1. A system for determining a contact state of a distal end portion of a medical instrument with a target region based, at least in part, on electrical measurements, the system comprising:

a signal source configured to generate at least one signal having a first frequency and a second frequency to be applied to a pair of electrode members of a combination electrode assembly; and

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

process a resulting waveform that formulates across the pair of electrode members to obtain a first electrical measurement at the first frequency;

process a resulting waveform that formulates across the pair of electrode members to obtain a second electrical measurement at the second frequency;

determine a bipolar contact impedance magnitude based on the first electrical measurement;

determine a bipolar contact impedance magnitude and a phase angle based on the second electrical measurement; and

calculate a contact indication value indicative of a state of contact between a distal end portion of a medical instrument and a target region based on a criterion combining;

(i) the impedance magnitude based on the first electrical measurement, (ii) a ratio of the impedance magnitudes based on the first electrical measurement and the second electrical measurement, and (iii) the phase angle based on the second electrical measurement.

2. The system of claim 1, further comprising:

the medical instrument, wherein the medical instrument is an ablation catheter comprising an elongate body having a proximal end and a distal end and wherein the medical instrument comprises the pair of electrode members, the pair of electrode members comprising;

a first electrode member positioned along the elongate body;

a second electrode member positioned adjacent the first electrode member, the first electrode member and the second electrode member being configured to contact tissue of a subject; and

an electrically insulating gap positioned between the first electrode member and the second electrode member, the electrically insulating gap comprising a gap width separating the first electrode member and the second electrode member;

wherein the signal source comprises a source of radiofrequency energy;

wherein the first and second frequencies are between 5 kHz and 1000 kHz;

wherein the second frequency is different than the first frequency;

wherein the second frequency is greater than the first frequency;

wherein the processor is further configured to generate an output indicative of the state of contact based on the calculated contact indication value; and

wherein the processor is further configured to cause the generated output to be displayed on a display in communication with the processor.

3. The system of claim 1, wherein the criterion comprises a weighted combination of the impedance magnitude based on the first electrical measurement, a ratio of the impedance magnitudes based on the first and second electrical measurements, and the phase angle based on the second electrical measurement.

4. The system of claim 1, wherein the first frequency is between 10 kHz and 100 kHz and wherein the second frequency is between 400 kHz and 1000 kHz.

5. The system of claim 1, wherein the first and second electrical measurements comprise current measurements.

6. A system for determining a contact state of an ablation member of a medical instrument with target tissue, the system comprising:

a signal source configured to deliver signals having at least a first frequency and a second frequency to an ablation member of a medical instrument, the ablation member comprising a distal portion and a proximal portion spaced apart from the distal portion,

wherein the signals comprise radiofrequency signals; and

a processing device configured to, upon execution of program instructions stored on a non-transitory storage medium;

process a first resulting waveform across the proximal portion and the distal portion of the ablation member to obtain a first electrical measurement at a first frequency;

process a second resulting waveform across the proximal portion and the distal portion of the ablation member to obtain a second electrical measurement at a second frequency; and

calculate a contact indication value indicative of a level of contact between the ablation member and target tissue based, at least in part, on the first electrical measurement and the second electrical measurement.

7. The system of claim 6, further comprising the medical instrument,

wherein the medical instrument is an ablation catheter comprising an elongate body having a proximal end and a distal end,

wherein the distal portion of the ablation member comprises a first electrode member positioned along the elongate body,

wherein the proximal portion of the ablation member comprises a second electrode member positioned adjacent the first electrode member, and

wherein the ablation member comprises an electrically insulating gap positioned between the first electrode member and the second electrode member, the electrically insulating gap comprising a gap width separating the first electrode member and the second electrode member.

8. The system of claim 6,

wherein the first and second frequencies are between 5 kHz and 1000 kHz;

wherein the second frequency is different than the first frequency;

wherein the second frequency is greater than the first frequency; and

wherein the processing device is further configured to cause the generated output to be displayed on a display in communication with the processing device.

9. The system of claim 6, further comprising an ablative energy source configured to generate and apply power to the ablation member for ablating the target tissue.

10. The system of claim 9, wherein the ablative energy source and the signal source comprise a single source.

11. The system of claim 9, wherein the signal source comprises a first source and the ablative energy source comprises a second source that is separate and distinct from the first source.

12. The system of claim 6, wherein the contact indication value is calculated based on a criterion comprising a weighted combination of an impedance magnitude based on the first electrical measurement, a ratio of the impedance magnitudes based on the first and second electrical measurements, and a phase angle based on the second electrical measurement.

13. The system of claim 6, wherein the first frequency is between 10 kHz and 100 kHz and wherein the second frequency is between 400 kHz and 1000 kHz.

14. The system of claim 6, wherein the output comprises a virtual gauge having a plurality of regions indicative of varying levels of contact, wherein the plurality of regions are represented in different colors, and wherein each of the plurality of regions corresponds to a different range of numerical contact indication values.

15. The system of claim 6, wherein the electrical measurements comprise current measurements.

16. The system of claim 6, wherein the processing device is configured to generate an output indicative of the contact indication value, wherein the output comprises a qualitative output, and wherein the qualitative output comprises a color indicative of the level of contact.

17. A method of determining a contact state of an ablation member of a medical instrument with a target region, the method comprising:

applying at least one signal having a plurality of frequencies to an ablation member positioned along a distal end portion of a medical instrument, the ablation member comprising a proximal portion and a distal portion separated by an electrically-insulating gap;

processing a first resulting waveform that formulates across the proximal portion and the distal portion of the ablation member to obtain at least a first electrical measurement at a first frequency;

processing a second resulting waveform that formulates across the proximal portion and the distal portion of the ablation member to obtain at least a second electrical measurement at a second frequency different from the first frequency; and

calculating a contact indication value indicative of a level of contact between the ablation member and a target region based, at least in part, on the first electrical measurement and the second electrical measurement.

18. The method of claim 17, wherein the first frequency is between 10 kHz and 100 kHz and wherein the second frequency is between 400 kHz and 1000 kHz.

19. The method of claim 17, further comprising causing ablative energy to be delivered by the ablation member sufficient to ablate the target region.

20. The method of claim 17, further comprising generating an output indicative of the contact indication value, wherein the output comprises a qualitative output, and wherein the qualitative output comprises a color indicative of the level of contact.