System and method for measuring cross-sectional areas and pressure gradients in luminal organs

• US 7,454,244 B2
• Filed: 02/19/2004
• Issued: 11/18/2008
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: Electro-Cat, LLC
• Original Assignee: Electro-Cat, LLC
• Inventors: Kassab, Ghassan S., Gregersen, Hans, Movahed, Mohamed Reza
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/782,149
• Publication Number:
  US 20040230131A1
• Time in Patent Office: 1,734 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
• US Class Current: 600/547
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 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
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

The invention comprises a system, catheter and method for measuring the cross-sectional areas and pressure gradients in any hollow organ, such as, for example, blood vessels. One embodiment of such a system includes: an impedance catheter capable of being introduced into a targeted site; a solution delivery source; a constant current source; a balloon inflation control device; and a data acquisition and processing system that receives conductance and/or pressure gradient data from the catheter and calculates the cross-sectional area of the targeted site. In one embodiment, the catheter has an inflatable balloon along its longitudinal axis, thereby enabling the breakup of any materials causing stenosis at the targeted site and/or distention and delivery of an optional stent into the targeted site.

Claims

1. A method for measuring the instantaneous cross-sectional area of a targeted treatment site, comprising:

introducing an impedance catheter into a treatment site;

providing constant electrical current flow to the treatment site through the catheter;

injecting a known volume of a first solution of a first compound having a first conductivity into the treatment site;

measuring a first conductance value at the treatment site;

injecting a second solution of a second compound having a second conductivity into the treatment site, wherein the second solution has a second volume and wherein the second conductivity does not equal the first conductivity;

measuring a second conductance value at the treatment site;

calculating the instantaneous cross-sectional area of the treatment site based on the first and second conductance values and the conductivities of the first and second solutions.

2. The method of claim 1, wherein the treatment site comprises a body lumen.

3. The method of claim 2, wherein the body lumen comprises a blood vessel.

4. The method of claim 2, wherein the body lumen comprises a biliary tract.

5. The method of claim 2, wherein the body lumen comprises the esophagus.

6. The method of claim 5, wherein the step of injecting a first solution of a first compound comprises the step of administering said first solution to a patient orally.

7. The method of claim 5, wherein the step of injecting a second solution of a second compound comprises the step of administering said second solution to a patient orally.

8. The method of claim 1, wherein the first compound is NaCl.

9. The method of claim 1, wherein the second compound is NaCl.

10. The method of claim 1, wherein the catheter comprises an inflatable balloon along the longitudinal axis of the catheter.

11. The method of claim 10, further comprising the step of inflating the balloon to breakup any materials causing stenosis at the treatment site.

12. The method of claim 10, wherein the catheter further comprises a stent located over the balloon, said stent capable of being distended to the desired lumen size and implanted into the treatment site.

13. The method of claim 12, further comprising the steps of:

distended the stent by inflating the underlying balloon; and

releasing and implanting the stent into the treatment site.

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

selecting an appropriately-sized stent based on the cross-section area value of the treatment site; and

implanting the stent into the treatment site.

15. The method of claim 1, wherein the catheter comprising a pressure transducer.

16. The method of claim 15, further comprising the steps of:

measuring a first pressure gradient value from the pressure transducer near the treatment site; and

calculating the cross-sectional area of the treatment site based in part on the first gradient pressure value.

17. The method of claim 1, wherein the step of injecting the first solution further includes injecting the first solution local to the treatment site.

18. The method of claim 1, wherein the step of injecting the second solution further includes injecting the second solution local to the treatment site.

19. The method of claim 1, wherein the step of injecting the first solution temporarily substantially displaced the blood at the treatment site.

20. The method of claim 1, wherein the step of injecting the second solution temporarily substantially displaces the blood at the treatment site.

21. The method of claim 1, further including the step of heating the first solution to body temperature prior to injection.

22. The method of claim 1, further including the step of heating the first and second solutions to a common temperature prior to injection.

23. The method of claim 1, wherein the second volume is equal to the first volume.

24. A method for measuring the cross-sectional area of a targeted treatment site, comprising:

introducing an impedance catheter into a treatment site;

providing constant electrical current flow to the treatment site through the catheter;

injecting a known volume of a first solution of a first compound having a first conductivity into the treatment site;

measuring a first conductance value at the treatment site;

injecting a second solution of a second compound having a second conductivity into the treatment site, wherein the second solution has a second volume and wherein the second conductivity does not equal the first conductivity;

measuring a second conductance value at the treatment site;

calculating the cross-sectional area of the treatment site based on the first and second conductance values and the conductivities of the first and second solutions; and

selecting the catheter to be introduced into the treatment site based on the measurement of a first conductance and a first current density at the treatment site.

25. The method of claim 24, further comprising the step of calculating a first nodal voltage and a first electrical field based on the first conductance and the first current density.

26. The method of claim 25, further comprising the steps of:

applying finite element analysis to the first nodal voltage and first electrical field values;

determining the appropriate catheter dimensions for minimizing nonparallel electrical field lines at the treatment site; and

selecting an appropriately-sized catheter for introduction into the treatment site.

27. The method of claim 26, wherein the step of finite element analysis is performed using a finite element software package.

28. A method for measuring the cross-sectional area of a targeted treatment site, comprising:

introducing an impedance catheter into a treatment site;

providing constant electrical current flow to the treatment site through the catheter;

injecting a known volume of a first solution of a first compound having a first conductivity into the treatment site;

measuring a first conductance value at the treatment site;

injecting a second solution of a second compound having a second conductivity into the treatment site, wherein the second solution has a second volume and wherein the second conductivity does not equal the first conductivity;

measuring a second conductance value at the treatment site;

calculating the cross-sectional area of the treatment site based on the first and second conductance values and the conductivities of the first and second solutions;

selecting an appropriately-sized stent based on the cross-sectional area value of the treatment site;

implanting the stent into the treatment site;

inflating with a fluid a balloon attached to the catheter;

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

measuring the conductance of the fluid inside the balloon; and

calculating the cross-sectional area of the balloon lumen.