Systems and methods for determining vessel compliance

• US 8,099,161 B2
• Filed: 04/18/2009
• Issued: 01/17/2012
• 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:
  US12/426,225
• Publication Number:
  US 20090216133A1
• Time in Patent Office: 1,004 Days
• Field of Search: 600/547, 600/506, 600/505, 600/526, 600/587, 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 vessel compliance, 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;

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, each of the two or more fluid injections having a known conductivity;

calculating a first vessel parameter of the site based on at least two of the two or more conductance values and the conductivities of at least two of the two or more fluid injections;

calculating a second vessel parameter of the site based on at least two of the two or more conductance values and the conductivities of at least two of the two or more fluid injections;

calculating a change in vessel parameter based upon the first vessel parameter and the second vessel parameter;

calculating vessel compliance based upon the relationship between the change in vessel parameter and a change in pressure during a cardiac cycle; and

calculating an index of compliance based in part upon a difference between the first vessel parameter and the second vessel parameter divided by the first vessel parameter.

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

determining the extent of vessel disease based upon the calculated vessel compliance.

3. The method of claim 2, wherein the extent of vessel disease is determined to be relatively low if the calculated vessel compliance is relatively high.

4. The method of claim 2, wherein the extent of vessel disease is determined to be relatively high if the calculated vessel compliance is relatively low.

5. The method of claim 2, wherein the extent of vessel disease is determined to include vessel calcification if the calculated vessel compliance is zero.

6. The method of claim 2, 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.

7. 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 vessel compliance.

8. The method of claim 1, wherein the change in pressure during a cardiac cycle has a constant value for a patient.

9. The method of claim 1, wherein the first vessel parameter and the second vessel parameter each comprise a vessel diameter, and wherein the change in vessel parameter comprises a change in vessel diameter.

10. The method of claim 1, wherein the first vessel parameter and the second vessel parameter each comprise a vessel cross-sectional area, and wherein the change in vessel parameter comprises a change in vessel cross-sectional area.

11. The method of claim 1, wherein the first vessel parameter comprises a first vessel systolic diameter, wherein the second vessel parameter comprises a second vessel diastolic diameter, and wherein the first vessel systolic diameter and the second vessel diastolic diameter are representative of a single vessel.

12. The method of claim 1, wherein the first vessel parameter comprises a first vessel systolic cross-sectional area, wherein the second vessel parameter comprises a second vessel diastolic cross-sectional area, and wherein the first vessel systolic cross-sectional area and the second vessel diastolic cross-sectional area are representative of a single vessel.

13. 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.

14. 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.

15. The method of claim 14, 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.

16. The method of claim 15, 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.

17. 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.

18. A method for determining vessel compliance, the method comprising the steps of:

introducing a device into a site within a vessel, the device comprising a pair of excitation electrodes and a pair of detection electrodes positioned therebetween;

operating the device to obtain two or more conductance values;

calculating a change in cross-sectional area based in part upon the two or more conductance values;

calculating vessel compliance based upon the relationship between the change in cross-sectional area and a change in pressure during a cardiac cycle; and

calculating an index of compliance based in part upon a difference between the first vessel parameter and the second vessel parameter divided by the first vessel parameter.

19. A system for determining vessel compliance, 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 vessel compliance based upon;

a. a calculated change in vessel parameter based upon a calculated first vessel parameter and a calculated second vessel parameter, the calculated first vessel parameter and a calculated second vessel parameter calculated based upon the conductance data acquired from the device; and

b. a calculated relationship between the calculated change in vessel parameter and a change in pressure during a cardiac cycle;

wherein the data acquisition and processing system is further operable to calculate an index of compliance based in part upon a difference between the first vessel parameter and the second vessel parameter divided by the first vessel parameter.