Devices, systems, and methods to measure parallel tissue conductance, luminal cross-sectional areas, fluid velocity, and/or determine plaque vulnerability using temperature

• US 9,351,661 B2
• Filed: 04/22/2014
• Issued: 05/31/2016
• 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): SZMAL, BRIAN SCOTT
• Application Number:
  US14/258,920
• Publication Number:
  US 20140222129A1
• Time in Patent Office: 770 Days
• Field of Search: 600/547, 600/549, 600/505, 600/526, 600/587, 600/481, 600/486, 600/454, 600/561, 600/485, 600/490, 600/506, 600/593, 606/192, 606/194, 606/198, 128/898, 424/439, 607/72, 623/1.11
• US Class Current: 1/1
• 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 at least partially positioned within a luminal organ at a first location to obtain a first fluid temperature measurement;

detecting a temperature change at the first location using the detection device, the temperature change indicative of an injection of a bolus of a solution having a known conductivity into the luminal organ; and

measuring multiple output conductances using at least two impedance electrodes of the detection device prior to dilution of the bolus at the first location at least until a threshold temperature is reached.

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

calculating a parallel tissue conductance at the first location based in part upon the temperature change, at least one output conductance of the multiple output conductances, and the conductivity of the injected solution.

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

calculating a cross-sectional area of the luminal organ at the first location based in part upon at least one output conductance of the multiple output conductances;

selecting an appropriately-sized stent based upon the cross-sectional area; and

implanting the stent into the luminal organ at the first location.

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

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

C. of the first fluid temperature measurement.

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

obtaining a native conductance of fluid present within the luminal organ prior to injection of the bolus.

8. 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.

9. The method of claim 1, wherein the detection device comprises an inflatable balloon along a longitudinal axis of the detection device.

10. The method of claim 9, further comprising the step of:

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

11. The method of claim 9, 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.

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

an elongated body having a longitudinal axis extending from a proximal end to a distal end;

at least two electrodes located on the elongated body, the at least two electrodes configured to obtain conductance data within a luminal organ in the presence of a fluid; and

a thermistor positioned along the longitudinal axis proximal to the at least two electrodes, the thermistor configured to obtain temperature data within the luminal organ;

wherein the device is configured so that when a bolus of a solution having a known conductivity is injected into the luminal organ, a temperature change at a first location indicative of the bolus of the injected solution can be detected using the device prior to any dilution of the bolus at the first location, multiple output conductances in connection with the injected solution based upon the detected temperature change can be measured using the device prior to any dilution of the bolus and at least until the temperature within the luminal organ reaches a threshold temperature, and a parallel conductance at the first location based in part upon at least one output conductance of the multiple output conductances and the conductivity of the injected solution can be calculated.

13. The device of claim 12, 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.

14. The device of claim 13, 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.

15. The device of claim 12, configured to provide conductance data from the at least one electrode to a data acquisition and processing system capable of calculating a parallel tissue conductance and/or a cross-sectional area of the luminal organ based in part upon the conductance data and a known conductivity of a solution injected into the luminal organ.

16. The device of claim 12, wherein the elongated body is selected from the group consisting of a wire and a catheter.

17. The device of claim 12, 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.

18. The device of claim 12, 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.

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

a device, comprising;

an elongated body having a longitudinal axis extending from a proximal end to a distal end;

a detector located on the elongated body and configured to obtain conductance data within a luminal organ in the presence of a fluid; and

a thermistor positioned along the longitudinal axis proximal to at least one electrode of at least two electrodes of the detector, the thermistor configured to obtain temperature data within the luminal organ; 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 an injection of a bolus of a solution having a known conductivity, and (b) obtaining conductance data comprising multiple conductances from the detector while receiving the temperature data.

20. The system of claim 19, 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 output conductance of the multiple conductances and the known conductivity of the solution.