Single injection methods for obtaining conductance measurements within luminal organs using impedance devices

• US 10,034,618 B2
• Filed: 06/30/2015
• Issued: 07/31/2018
• Est. Priority Date: 10/27/2011
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S., Svendsen, Mark, Browder, John
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/755,405
• Publication Number:
  US 20150297112A1
• Time in Patent Office: 1,127 Days
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• 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 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence

Abstract

Single injection methods for obtaining conductance measurements within luminal organs using impedance devices. In at least one method embodiment, the method is performed by introducing at least part of an impedance device into a mammalian luminal organ, the impedance device comprising an elongated body and a detector positioned along the elongated body, obtaining conductance measurements indicative of a fluid native to the mammalian luminal organ and indicative of a fluid injection while the detector is present within and outside of the lumen of the outer sheath, and calculating a size parameter of the mammalian luminal organ based in part upon some of the obtained conductance measurements.

Claims

1. A method for obtaining one or more conductance measurements using an impedance device, the method comprising the steps of:

introducing at least part of an impedance device into a mammalian luminal organ, the impedance device comprising an elongated body and a detector positioned along the elongated body and calibrated based on a conductivity of a first solution so that the conductivity of the first solution is known;

obtaining a first conductance measurement using the detector, the first conductance measurement indicative of a fluid native to the mammalian luminal organ;

obtaining a second conductance measurement using the detector, the second conductance measurement indicative of a first injection of the first solution through a lumen of an outer sheath surrounding at least part of the impedance device; and

calculating a size parameter of the mammalian luminal organ based in part upon the first conductance measurement, the second conductance measurement, and a known distance between detection electrodes of the detector;

wherein the first conductance measurement and the second conductance measurement are obtained when the outer sheath does not surround the detector.

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

obtaining a third conductance measurement using the detector while the detector is surrounded by the outer sheath, the third conductance measurement indicative of the fluid native to the mammalian luminal organ present within the lumen of the outer sheath.

3. The method of claim 2, wherein the step of obtaining the third conductance measurement is performed while an aperture defined within the outer sheath is opened to allow the fluid native to the mammalian luminal organ to flow within the lumen of the outer sheath.

4. The method of claim 2, wherein the step of obtaining the third conductance measurement is performed while the fluid native to the mammalian luminal organ is pulled into the lumen of the outer sheath using suction.

5. The method of claim 2, wherein the step of calculating the size parameter of the mammalian luminal organ is further based in part upon the conductivity of the fluid native to the mammalian luminal organ determined in part from the first conductance measurement and/or the third conductance measurement.

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

obtaining a fourth conductance measurement using the detector while the detector is surrounded by the outer sheath, the fourth conductance measurement indicative of an additional injection of the first solution through the lumen of the outer sheath.

7. The method of claim 6, wherein the step of obtaining the fourth conductance measurement is performed when a desired temperature local to the detector is achieved, the desired temperature indicative of the additional injection of the first solution.

8. The method of claim 7, wherein the desired temperature is determined using a temperature sensor coupled to the impedance device at or near the detector.

9. The method of claim 6, wherein the step of obtaining the fourth conductance measurement is performed when a threshold conductance is achieved, the threshold conductance indicative of a conductance sufficiently different from the third conductance measurement.

10. The method of claim 1, wherein the step of introducing the at least part of the impedance device is performed using access through a patient'"'"'s femoral artery and advancement to a location of interest within the mammalian luminal organ.

11. The method of claim 1, wherein the impedance device is calibrated by operating the device within a plurality of phantoms of known sizes in the presence of the first solution to determine the conductivity of the first solution.

12. The method of claim 6, wherein the step of calculating a size parameter is performed using the conductivity of the fluid native to the mammalian luminal organ which is further determined from the fourth conductance measurement and the conductivity of the first solution.

13. The method of claim 12, wherein the step of calculating a size parameter is performed using the conductivity of the fluid native to the mammalian luminal organ which is further determined using a known inner cross-sectional area of the outer sheath.

14. The method of claim 1, wherein the step of obtaining the second conductance measurement is performed when a desired temperature local to the detector is achieved, the desired temperature indicative of the first injection of the first solution.

15. The method of claim 1, wherein the introducing step is performed by introducing an impedance device selected from the group consisting of an impedance catheter and an impedance wire into the mammalian luminal organ, wherein the impedance device is at least partially surrounded by the outer sheath selected from the group consisting of catheter and a non-catheter sheath.

16. The method of claim 6, wherein the step of introducing is performed by introducing the at least part of the impedance device into the mammalian luminal organ at a stenosis, and wherein the method further comprises the steps of:

moving the at least part of the impedance device to a second location within the mammalian luminal organ;

obtaining a fifth conductance measurement using the detector, the fifth conductance measurement indicative of the fluid native to the mammalian luminal organ at the second location;

obtaining a sixth conductance measurement using the detector, the sixth conductance measurement indicative of a third injection of the first solution through the lumen of the outer sheath; and

calculating a second size parameter of the mammalian luminal organ at the second location based in part upon the fifth conductance measurement and the sixth conductance measurement;

wherein the first conductance measurement and the second conductance measurement are indicative of one of a stenotic lesion or a non-stenotic region, and wherein the fifth conductance measurement and the sixth conductance measurement are indicative of the other of the stenotic lesion or the non-stenotic region.

17. A method for obtaining one or more conductance measurements using an impedance device, the method comprising the step of:

calculating a size parameter within a mammalian luminal organ using a first conductance measurement indicative of a fluid native to the mammalian luminal organ and obtained using an impedance device having a detector calibrated based on a conductivity of a first solution so that the conductivity of the first solution is known, a second conductance measurement indicative of a first injection of the first solution through a lumen of an outer sheath surrounding at least part of the impedance device, and a distance between electrodes of the impedance device, wherein the first conductance measurement and the second conductance measurement are obtained when the outer sheath does not surround the detector.

18. A method for obtaining one or more conductance measurements using an impedance device, the method comprising the step of:

calculating a size parameter within a mammalian luminal organ using a first conductance measurement indicative of a fluid native to the mammalian luminal organ and obtained using an impedance device selected from the group consisting of an impedance catheter and an impedance wire and having a detector calibrated based on a conductivity of a first solution so that the conductivity of the first solution is known, a second conductance measurement indicative of a first injection of the first solution through a lumen of an outer sheath surrounding at least part of the impedance device and obtained when a threshold/desired parameter is achieved, and a distance between electrodes of the impedance device, wherein the first conductance measurement and the second conductance measurement are obtained when the outer sheath does not surround the detector.

19. The method of claim 18, wherein the threshold/desired parameter comprises a desired temperature local to the detector indicative of the first injection of the first solution.

20. The method of claim 18, wherein the threshold/desired parameter comprises a threshold conductance indicative of a conductance sufficiently different from the first conductance measurement.