Methods of determining catheter orientation

• US 9,993,178 B2
• Filed: 10/12/2017
• Issued: 06/12/2018
• Est. Priority Date: 03/15/2016
• Status: Active Grant

• Current Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: EPIX Therapeutics, Inc. (Medtronic Plc)
• Inventors: Panescu, Dorin, Koblish, Josef Vincent, Chun, Donghoon, Johnson, Jessi E., Schultheis, Eric Andrew
• Primary Examiner(s): GIULIANI, THOMAS ANTHONY
• Application Number:
  US15/782,714
• Publication Number:
  US 20180078170A1
• Time in Patent Office: 243 Days
• Field of Search: 606 34, 606 38, 606 41, 606 42, 607 99, 607102, 607113, 607115, 607116, 607122
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• 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 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• 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 2018/00136 with polymer
• CPC Class Codes: A61B 2018/00178 Electrical connectors
• CPC Class Codes: A61B 2018/00297 Means for providing haptic feedback
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/0066 without feedback, i.e. open loop control
• 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 2018/00755 : Resistance or impedance
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• 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 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00904 : Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00988 : Means for storing information, e.g. calibration constants, or for preventing excessive use, e.g. usage, service life counter
• CPC Class Codes: A61B 2034/104 : Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• 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 5/015 : By temperature mapping of body part
• CPC Class Codes: A61B 5/0538 : invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/061 : Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/065 : Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• 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
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Systems, devices and methods of determining orientation of a distal end of a medical instrument (e.g., electrode-tissue orientation of an RF ablation catheter) are described herein. One or more processors may be configured to receive temperature measurements from each of a plurality of temperature-measurement devices distributed along a length of the distal end of the medical instrument and determine the orientation from a group of two or more possible orientation options based on whether temperature measurement values or characteristics of temperature response determined from the temperature measurement values satisfy one or more orientation criteria.

Claims

1. A method of determining an orientation of a distal end of an ablation catheter with respect to a target region, the method comprising:

receiving signals indicative of temperature from a plurality of temperature sensors distributed along the distal end of the ablation catheter at a first plurality of time points over a first period of time;

determining temperature measurement values at each of the first plurality of time points for each of the plurality of temperature sensors;

at each time point of the first plurality of time points, determining an orientation of the distal end of the ablation catheter relative to the target region based on a first set of orientation criteria applied to the determined temperature measurement values;

receiving signals indicative of temperature from the plurality of temperature sensors at a second plurality of time points over a second period of time after the first period of time;

determining temperature measurement values at each of the second plurality of time points for each of the plurality of temperature sensors;

determining an orientation of the distal end of the ablation catheter relative to the target region based on a second set of orientation criteria applied to the determined temperature measurement values at each of the second plurality of time points, the second set of orientation criteria being different than the first set of orientation criteria.

2. The method of claim 1:

wherein the first period of time corresponds to a temperature rise phase and wherein the second period of time corresponds to a steady state phase,

wherein the first period of time is between 1 and 20 seconds after initial application of ablative energy,

wherein the first set of orientation criteria comprises comparisons of time-based characteristics of temperature responses of at least two of the plurality of temperature sensors, and

wherein the second set of orientation criteria comprises comparisons of temperature measurement values of at least two of the plurality of temperature sensors.

3. The method of claim 1, wherein the first period of time is between 1 and 20 seconds after initial application of ablative energy.

4. The method of claim 1, wherein the first set of orientation criteria comprises time-dependent conditions.

5. The method of claim 1, wherein the second set of orientation criteria comprises static conditions.

6. The method of claim 1, wherein the first set of orientation criteria comprises comparisons of time-based characteristics of temperature responses of at least two of the plurality of temperature sensors.

7. The method of claim 1, wherein the second set of orientation criteria comprises comparisons of temperature measurement values of at least two of the plurality of temperature sensors.