Methods for generating luminal organ profiles using impedance

• US 9,445,743 B2
• Filed: 08/26/2013
• Issued: 09/20/2016
• Est. Priority Date: 02/21/2003
• Status: Expired due to Term

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US14/010,139
• Publication Number:
  US 20130338468A1
• Time in Patent Office: 1,121 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: 1/1
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 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 5/6853 with a balloon
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• 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
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Methods to generate luminal organ profiles using impedance. One embodiment of such a method comprises the steps of introducing an impedance device having at least two detection electrodes positioned in between at least two excitation electrodes into a treatment site of a luminal organ at a first position, measuring a first treatment site conductance at the first position using the impedance device and at least two injections of solutions having different conductivities, moving the impedance device to a second position in the luminal organ, measuring a second treatment site conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities, calculating a first position cross-sectional area using the first treatment site conductance and a second position cross-sectional area using the second treatment site conductance, and constructing a profile of the treatment site.

Claims

1. A method of creating a cross-sectional area profile of a targeted treatment site, the method comprising the steps of:

introducing an impedance device having at least two detection electrodes positioned equidistant between at least two excitation electrodes into a treatment site of a luminal organ at a first position, wherein a distance between the at least two detection electrodes and the at least two excitation electrodes is based on a vessel diameter;

measuring a first conductance at the first position using the impedance device and at least two injections of solutions having different conductivities;

moving the impedance device to a second position in the luminal organ;

measuring a second conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities;

calculating a first position cross-sectional area using the first conductance and a second position cross-sectional area using the second conductance; and

constructing the cross-sectional profile of the targeted treatment site based in part on the calculated first position cross-sectional area and the calculated second position cross-sectional area.

2. The method according to claim 1, wherein the at least two detection electrodes comprises a first detection electrode and a second detection electrode, wherein the at least two injections of solutions comprises a first solution and a second solution, and wherein the different condictivities are measured by the first and second electrodes.

3. The method according to claim 1, wherein a first solution of the at least two injections of solutions has a first concentration, and wherein a second solution of the at least two injections of solutions has a second concentration different from the first concentration.

4. The method according to claim 3, wherein the first solution and the second solution comprise a NaCl solution.

5. The method according to claim 4, wherein the first solution comprises 0.5% NaCl and the second solution comprises 1.5% NaCl.

6. The method according to claim 1, further comprising providing an electrical current flow with the at least two excitation electrodes.

7. The method according to claim 1, wherein the impedance device includes an inflatable balloon positioned along a longitudinal axis thereof.

8. The method according to claim 7, wherein the impedance device includes a stent distendable to a desired size and implantable into the targeted treatment site, the stent positioned over the inflatable balloon.

9. The method according to claim 1, wherein the impedance device includes a pressure transducer.

10. The method according to claim 9, further comprising measuring a first pressure gradient with the pressure transducer at at least one of the first treatment site or the second treatment site, wherein constructing the profile of the treatment site is based in part on the first pressure gradient.

11. The method according to claim 1, wherein at least one of the at least two injections of solutions is heated to an internal body temperature of a body surrounding the treatment site prior to injection of the at least one of the at least two injections of solutions.

12. The method according to claim 1, wherein the impedance device includes an infusion port, and wherein injection of the at least two injections of solutions is through the infusion port.

13. The method according to claim 1, wherein a first detection electrode of the at least two detection electrodes is spaced 1 mm apart from a second detection electrode of the at least two detection electrodes.

14. A method of creating a cross-sectional area profile of a targeted treatment site, the method comprising the steps of:

introducing an impedance device into a treatment site of a luminal organ at a first position, the impedance device comprising;

at least two detection electrodes positioned between at least two excitation electrodes;

a first pressure sensor proximal to a most proximal excitation electrode; and

a second pressure sensor distal to a most distal excitation electrode;

measuring a first conductance at the first position using the impedance device and at least two injections of solutions having different conductivities;

moving the impedance device to a second position in the luminal organ;

measuring a second conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities;

measuring a first pressure gradient with the first pressure sensor and a second pressure gradient with the second pressure sensor;

calculating a first position cross-sectional area using the first conductance and a second position cross-sectional area using the second conductance; and

constructing the cross-sectional profile of the targeted treatment site based in part on (i) the calculated first position cross-sectional area, (ii) the calculated second position cross-sectional area, (iii) the first pressure gradient, and (iv) the second pressure gradient.

15. The method according to claim 14, wherein the first pressure sensor and the second pressure sensor provide simultaneous pressure gradient recordings.

16. The method according to claim 14, wherein the at least two detection electrodes comprises a first detection electrode and a second detection electrode, wherein the at least two injections of solutions comprises a first solution and a second solution, and wherein the conductivity of both the first solution and the second solution are measured by the first and second electrodes.

17. The method according to claim 14, wherein a first solution of the at least two injections of solutions has a first concentration, and a second solution of the at least two injections of solutions has a second concentration different from the first concentration.

18. The method according to claim 17, wherein the first solution and the second solution comprise a NaCl solution.

19. The method according to claim 14, further comprising providing an electrical current flow with the at least two excitation electrodes.

20. A method of creating a cross-sectional area profile of a targeted treatment site, the method comprising the steps of:

introducing an impedance device having at least two detection electrodes positioned equidistant between at least two excitation electrodes into a treatment site of a luminal organ at a first position, wherein a first detection electrode of the at least two detection electrodes is spaced 1 mm apart from a second detection electrode of the at least two detection electrodes;

measuring a first conductance at the first position using the impedance device and at least two injections of solutions having different conductivities;

moving the impedance device to a second position in the luminal organ;

measuring a second conductance at the second position using the impedance device and the at least two injections of solutions having different conductivities;

calculating a first position cross-sectional area using the first conductance and a second position cross-sectional area using the second conductance; and

constructing the cross-sectional profile of the targeted treatment site based in part on the calculated first cross-sectional area and the calculated second position cross-sectional area.

21. The method according to claim 20, wherein the at least two injections of solutions comprises a first solution and a second solution, and wherein the conductivity of both the first solution and the second solution are measured by the first and second electrodes.

22. The method according to claim 20, wherein a first solution of the at least two injections of solutions has a first concentration, and wherein a second solution of the at least two injections of solutions has a second concentration different from the first concentration.

23. The method according to claim 22, wherein the first solution and the second solution comprise a NaCl solution.

24. The method according to claim 23, wherein the first solution comprises 0.5% NaCl and the second solution comprises 1.5% NaCl.

25. The method according to claim 20, further comprising providing an electrical current flow with the at least two excitation electrodes.

26. The method according to claim 20, wherein the impedance device includes an inflatable balloon positioned along a longitudinal axis thereof.

27. The method according to claim 26, wherein the impedance device includes a stent distendable to a desired size and implantable into the targeted treatment site, the stent positioned over the inflatable balloon.

28. The method according to claim 20, wherein the impedance device includes a pressure transducer.

29. The method according to claim 28, further comprising measuring a first pressure gradient with the pressure transducer at at least one of the first treatment site or the second treatment site, wherein constructing the profile of the treatment site is based in part on the first pressure gradient.

30. The method according to claim 20, wherein at least one of the at least two injections of solutions is heated to an internal body temperature of a body surrounding the treatment site prior to injection of the at least one of the at least two injections of solutions.

31. The method according to claim 20, wherein the impedance device includes an infusion port, and wherein injection of the at least two injections of solutions is through the infusion port.

32. The method according to claim 20, wherein a distance between the at least two detection electrodes and the at least two excitation electrodes is based on a vessel diameter.