Systems and methods for determining phasic cardiac cycle measurements

• US 8,185,194 B2
• Filed: 04/17/2009
• Issued: 05/22/2012
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: DTherapeutics LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US12/426,033
• Publication Number:
  US 20090204029A1
• Time in Patent Office: 1,131 Days
• Field of Search: 600/547, 600/506, 600/505, 600/526, 600/481, 600/486, 600/454, 600/561, 606/192, 606/194, 606/198, 128/898, 424/439, 623/1.11, 623/1.15, 623/23.7
• US Class Current: 600/547
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• 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 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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

Abstract

The disclosure of the present application provides for systems and methods for determining a phasic change in a vessel and vessel compliance. In at least one exemplary method for determining a phasic change in a vessel, the method comprises the steps of introducing a device into a site within a vessel, operating the device in connection with two or more fluid injections in the vessel to obtain two or more conductance values, calculating a parallel conductance value and a total conductance value, and calculating a phasic change in at least one vessel parameter based in part upon the calculated parallel conductance value and the calculated total conductance value. In an exemplary method for determining vessel compliance, the method comprises, in part, the steps of calculating a first vessel parameter and a second vessel parameter based on at least two conductance values, calculating a change in vessel parameter based upon the first and second vessel parameters, and calculating vessel compliance based upon the relationship between the change in vessel parameter and a change in pressure during a cardiac cycle.

Claims

1. A method for determining a phasic change in a vessel, the method comprising the steps of:

introducing a device into a site within a vessel, the device comprising;

a pair of excitation electrodes positioned along a portion of the device; and

a pair of detection electrodes positioned along a portion of the device, the pair of detection electrodes comprising two detection electrodes having a known distance from one another, the pair of detection electrodes physically positioned in between the pair of excitation electrodes along a portion of the device;

operating the device in connection with two or more fluid injections in the vessel at or near the site to obtain two or more conductance values;

calculating at least one parallel conductance value and at least one total conductance value at or near the site based upon at least two of the two or more conductance values; and

calculating a phasic change in the at least one vessel parameter based upon the known distance of the two detection electrodes from one another, the calculated at least one parallel conductance value, and the calculated at least one total conductance value.

2. The method of claim 1, wherein the at least one vessel parameter comprises at least one vessel diameter.

3. The method of claim 1, wherein the at least one vessel parameter comprises at least one vessel cross-sectional area.

4. The method of claim 1, wherein the step of calculating a phasic change in the at least one vessel parameter is further based upon a mean conductivity of a fluid present within the vessel.

5. The method of claim 4, wherein the fluid present within the vessel comprises blood.

6. The method of claim 1, wherein the step of calculating a phasic change in the at least one vessel parameter considers a constant representing a mean conductivity of a fluid present within the vessel.

7. The method of claim 6, wherein the constant may vary by no more than 10%.

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

determining the extent of vessel disease based upon the calculated phasic change in the at least one vessel parameter.

9. The method of claim 8, wherein the extent of vessel disease is determined to be relatively low if the calculated phasic change in the at least one vessel parameter is relatively high.

10. The method of claim 8, wherein the extent of vessel disease is determined to be relatively high if the calculated phasic change in the at least one vessel parameter is relatively low.

11. The method of claim 8, wherein the extent of vessel disease is determined to include vessel calcification if the calculated phasic change in the at least one vessel parameter is zero.

12. The method of claim 8, wherein the extent of vessel disease includes a vessel disease selected from the group consisting of atherosclerosis, vessel calcification, degenerative calcific disease, congenital heart disease, rheumatic disease, and coronary artery disease.

13. The method of claim 1, wherein the calculated at least one parallel conductance value used in the step of calculating a phasic change in the at least one vessel parameter is a mean parallel conductance value.

14. The method of claim 1, wherein the site comprises a site selected from the group consisting of a body lumen, a body vessel, a biliary tract, and an esophagus.

15. The method of claim 1, further comprising the step of providing electrical current flow for a period of time to the site through the device.

16. The method of claim 1, wherein the device comprises a device selected from the group consisting of an impedance catheter, a guide catheter, a guide wire, and a pressure wire.

17. The method of claim 1, wherein the device further comprises an inflatable balloon positioned along a portion of the device, and wherein the method further comprises the step of inflating the balloon to breakup materials causing stenosis at the site.

18. The method of claim 17, wherein the device further comprises a stent positioned over the balloon, the stent capable of being distended to a desired size and implanted into the site, and wherein the method further comprises the steps of:

distending the stent by inflating the balloon; and

releasing and implanting the stent into the site.

19. The method of claim 18, wherein the balloon is inflated using a fluid, and wherein the method further comprises the steps of:

providing electrical current to the fluid filling the balloon at various degrees of balloon distension;

measuring a conductance of the fluid inside the balloon; and

calculating a cross-sectional area of the balloon lumen.

20. The method of claim 1, wherein the device further comprises a stent positioned along a portion of the device, the stent capable of being distended to a desired size and implanted into the site.

21. The method of claim 20, further comprising the steps of:

positioning the stent at or near the site;

distending the stent; and

releasing and implanting the stent into the site.

22. The method of claim 1, wherein the two or more conductance values are retrieved by a data acquisition and processing system operably connected to the device, and wherein the data acquisition and processing system is operable to calculate a phasic change in the at least one vessel parameter.

23. The method of claim 1, wherein the device comprises at least one suction/infusion port in communication with at least one lumen of the device, whereby the two or more fluid injections occur via the at least one suction/infusion port.

24. The method of claim 1, wherein the device comprises a catheter having a lumen, a proximal end, and a distal end, and wherein the pair of excitation electrodes and the pair of detection electrodes are positioned along a portion of the device at or near the distal end of the device.

25. The method of claim 24, wherein the pair of excitation electrodes and the pair of detection electrodes have insulated electrical wire connections that run through the lumen and proximal end of the catheter.

26. The method of claim 1, wherein the calculated phasic change is indicative of a phasic change throughout a cardiac cycle.

27. A method for determining a phasic change in a vessel, the method comprising the steps of:

introducing a device into a site within a vessel, the device comprising;

a catheter having a lumen, a proximal end, and a distal end;

a pair of excitation electrodes positioned along a portion of the device at or near the distal end of the device; and

a pair of detection electrodes positioned along a portion of the device at or near the distal end of the device, the pair of detection electrodes comprising two detection electrodes having a known distance from one another, the pair of detection electrodes physically positioned in between the pair of excitation electrodes along a portion of the device;

operating the device in connection with two or more fluid injections in the vessel at or near the site to obtain two or more conductance values, wherein the two or more conductance values are retrieved by a data acquisition and processing system operably connected to the device;

calculating at least one parallel conductance value and at least one total conductance value at or near the site based upon at least two of the two or more conductance values;

calculating a phasic change in the at least one vessel parameter using the data acquisition and processing system based upon the known distance of the two detection electrodes from one another, the calculated at least one parallel conductance value, and the calculated at least one total conductance value; and

determining the extent of vessel disease based upon the calculated phasic change in the at least one vessel parameter, wherein the extent of vessel disease is determined to be relatively low if the calculated phasic change in the at least one vessel parameter is relatively high, and wherein the extent of vessel disease is determined to be relatively high if the calculated phasic change in the at least one vessel parameter is relatively low.

28. A system for determining a phasic change in a vessel, the system comprising:

a device capable of acquiring conductance data, the device comprising;

a pair of excitation electrodes positioned along a portion of the device; and

a pair of detection electrodes positioned along a portion of the device, the pair of detection electrodes comprising two detection electrodes having a known distance from one another, the pair of detection electrodes physically positioned in between the pair of excitation electrodes along a portion of the device;

an injection source for injecting one or more solutions through the device to a target site;

a current source for providing current to the device; and

a data acquisition and processing system that receives conductance data from the device, wherein the data acquisition and processing system is operable to calculate a phasic change in the at least one vessel parameter based upon;

a. the known distance of the two detection electrodes from one another; and

b. a calculated at least one parallel conductance value and a calculated at least one total conductance value, each value calculated based upon the conductance data acquired from the device.