Devices, systems, and methods to obtain conductance and temperature data

• US 10,213,129 B2
• Filed: 05/31/2016
• Issued: 02/26/2019
• Est. Priority Date: 02/05/2010
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): Cerioni, Daniel L
• Application Number:
  US15/168,723
• Publication Number:
  US 20160270689A1
• Time in Patent Office: 1,001 Days
• Field of Search: 600547
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/028 by thermo-dilution
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: G01K 13/20 Clinical contact thermometers for use with humans or animals

Abstract

Devices, systems, and methods to measure parallel tissue conductance, luminal cross-sectional areas, fluid velocity, and/or determine plaque vulnerability using temperature. In at least one embodiment of a method to obtain parallel tissue conductance, the method comprises the steps of inserting at least part of a detection device into a luminal organ, applying current thereto, obtaining a native temperature measurement, injecting a solution of a known conductivity into the luminal organ, detecting a temperature change indicative of the fluid within the luminal organ, measuring an output conductance, and calculating a parallel tissue conductance based upon the output conductance and the conductivity of the injected solution.

Claims

1. A method to obtain conductance data within a luminal organ, the method comprising the steps of:

operating a detection device having an elongate body with a plurality of electrodes and a thermistor disposed thereon, wherein at least one of the electrodes is located distal to the thermistor, and wherein the elongate body of the detection device is at least partially positioned within the luminal organ to detect a temperature change using the thermistor from a first temperature to a temperature indicative of an injection of a bolus of a solution having a known conductivity;

obtaining multiple conductance measurements using at least one of the plurality of the electrodes located along the elongate body of the detection device prior to dilution of the bolus until a threshold temperature is reached;

calculating a dimension of the luminal organ based in part upon at least one conductance measurement of the multiple conductance measurements; and

selecting an appropriately-sized stent based upon the calculated dimension.

2. The method of claim 1, further comprising the step of:

calculating a parallel tissue conductance based in part upon the temperature change, at least one conductance measurement of the multiple conductance measurements, and the conductivity of the injected solution.

3. The method of claim 1, further comprising the step of:

implanting the appropriately-sized stent into the luminal organ.

4. The method of claim 1, wherein the first temperature is a measurement of blood obtained using the thermistor of the detection device.

5. The method of claim 1, wherein the temperature change is based upon a temperature measurement at least 5°

C. lower than the first temperature.

6. The method of claim 1, wherein the threshold temperature is within 2°

C. of the first temperature.

7. The method of claim 1, further comprising the step of:

calibrating the detection device using at least one phantom immersed in a solution bath of the same solution injected into the luminal organ, wherein the solution within the solution bath is at a known temperature.

8. The method of claim 1, wherein the detection device further comprises an inflatable balloon along a longitudinal axis of the detection device, and the method further comprising the step of:

inflating the balloon to breakup materials causing a stenosis within the luminal organ.

9. The method of claim 1, wherein the detection device further comprises an inflatable balloon along a longitudinal axis of the detection device, wherein the detection device further comprises a stent located over the balloon, the stent capable of being distended to a desired lumen size and implanted into the luminal organ, and the method further comprising the step of:

implanting the stent into the luminal organ.

10. A detection device configured to obtain conductance data within a luminal organ, comprising:

an elongated body having a thermistor located thereon, the thermistor configured to detect a temperature change within the luminal organ from a first temperature to a temperature indicative of an injection of a bolus of a solution having a known conductivity; and

at least two electrodes along the elongated body wherein at least one of the at least two electrodes is/are located distal to the thermistor, the at least two electrodes configured to obtain multiple conductance measurements within the luminal organ in connection with the injected solution and based upon the detected temperature change prior to dilution of the bolus and until a threshold temperature is reached;

wherein the device is configured for use in connection with a method to obtain the conductance data within the luminal organ, the method comprising the steps of;

operating the detection device at least partially positioned within the luminal organ to detect the temperature change using the thermistor of the detection device from the first temperature to the temperature indicative of the injection of the bolus of the solution having the known conductivity; and

obtaining multiple conductance measurements using the at least two electrodes of the detection device prior to dilution of the bolus at least until the threshold temperature is reached;

calculating a dimension of the luminal organ based in part upon at least one conductance measurement of the multiple conductance measurements; and

selecting an appropriately-sized stent based upon the calculated dimension.

11. The device of claim 10, configured so that a parallel conductance can be calculated based in part upon the temperature change obtained by the thermistor, at least one conductance measurement of the multiple conductance measurements obtained by the at least two electrodes, and the conductivity of the injected solution.

12. The device of claim 10, wherein the at least two electrodes comprises at least two detection electrodes, and wherein the device further comprises at least two excitation electrodes, wherein two of the at least two detection electrodes are positioned in between two of the at least two excitation electrodes.

13. The device of claim 12, wherein at least one excitation electrode is/are in communication with a current source capable of supplying electrical current to the at least one excitation electrode.

14. The device of claim 10, wherein the elongated body is selected from the group consisting of a wire and a catheter.

15. The device of claim 10, wherein the device defines a lumen therethrough and further comprises a suction/infusion port located proximal to the at least one electrode, wherein the suction/infusion port is in communication with the lumen, thereby enabling injection of a solution into a luminal organ through the suction/infusion port.

16. The device of claim 10, wherein at least one of the at least two electrodes and the thermistor share an electrical wire connection capable of providing current to the at least one of the at least one electrodes and the thermistor.

17. A system configured to obtain conductance data within a luminal organ, comprising:

a detection device, comprising;

an elongated body having a thermistor located thereon, the thermistor configured to detect temperature data including a temperature change within the luminal organ from a first temperature to a temperature indicative of an injection of a bolus of a solution having a known conductivity; and

at least two electrodes along the elongated body wherein at least one of the at least two electrodes is/are located distal to the thermistor, the at least two electrodes configured to obtain multiple conductance measurements within the luminal organ in connection with the injected solution and based upon the detected temperature change prior to dilution of the bolus and until a threshold temperature is reached; and

a data acquisition and processing system operably coupled to the device and capable of (a) receiving the temperature data from the thermistor in connection with the injection of the bolus, and (b) obtaining the multiple conductance measurements from the at least two electrodes while receiving the temperature data;

wherein the device is configured for use in connection with a method to obtain the conductance data within the luminal organ, the method comprising the steps of;

operating the detection device at least partially positioned within the luminal organ to detect the temperature change using the thermistor of the detection device from the first temperature to the temperature indicative of the injection of the bolus of the solution having the known conductivity; and

obtaining multiple conductance measurements using the at least two electrodes of the detection device prior to dilution of the bolus at least until the threshold temperature is reached;

calculating a dimension of the luminal organ based in part upon at least one conductance measurement of the multiple conductance measurements; and

selecting an appropriately-sized stent based upon the calculated dimension.

18. The system of claim 17, wherein the elongated body is selected from the group consisting of a wire and a catheter, and wherein the data acquisition and processing system is further operable to calculate a parallel tissue conductance based in part upon at least one conductance measurement of the multiple conductance measurements and the known conductivity of the solution.