Impedance devices for obtaining conductance measurements within luminal organs

• US 8,886,301 B2
• Filed: 10/27/2011
• Issued: 11/11/2014
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/282,906
• Publication Number:
  US 20120053441A1
• Time in Patent Office: 1,111 Days
• Field of Search: 600/547
• 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 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• 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 5/6851 Guide wires
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

Impedance devices for obtaining conductance measurements within luminal organs. In at least one embodiment of an impedance device of the present disclosure, the device, comprises an elongated body and an detector positioned upon the elongated body, the detector comprising at least five electrodes and configured to obtain one or more conductance measurements generated using a first arrangement of four of the at least five electrodes and further configured to obtain one or more fluid velocity measurements using a second arrangement of four of the at least five electrodes when the elongated body is positioned within a fluid environment of a mammalian luminal organ, wherein the first arrangement is different from the second arrangement.

Claims

1. An impedance device, comprising:

an elongated body; and

a detector positioned upon the elongated body, the detector comprising at least five electrodes and configured to obtain one or more conductance measurements generated using a first arrangement of four of the at least five electrodes and further configured to obtain one or more fluid velocity measurements using a second arrangement of four of the at least five electrodes when the elongated body is positioned within a fluid environment of a mammalian luminal organ, wherein the first arrangement is different from the second arrangement.

2. The impedance device of claim 1, wherein the elongated body is selected from the group consisting of a wire and a catheter.

3. The impedance device of claim 1, wherein at least three electrodes of the at least five electrodes are capable of excitation to generate an electric field when a current source capable of supplying electrical current to the at least three electrodes is operably coupled thereto, and wherein at least two electrodes of the at least five electrodes are capable of obtaining one or more luminal organ measurements selected from the group consisting of the one or more conductance measurements and the one or more fluid velocity measurements.

4. The impedance device of claim 3, wherein when the at least two electrodes are operably connected to a data acquisition and processing system, the data acquisition and processing system is capable of receiving the one or more luminal organ measurements and calculating a cross-sectional area of the luminal organ based in part upon the one or more luminal organ measurements and a known distance between the at least two electrodes.

5. The impedance device of claim 1, wherein the at least five electrodes comprise five electrodes comprising:

a most distal electrode,

an electrode immediately adjacent to the most distal electrode,

a most proximal electrode,

an electrode immediately adjacent to the most proximal electrode, and

a central electrode positioned between the electrode immediately adjacent to the most distal electrode and the electrode immediately adjacent to the most proximal electrode.

6. The impedance device of claim 5, wherein the first arrangement of electrodes comprises the most distal electrode, the electrode immediately adjacent to the most distal electrode, the central electrode, and the electrode immediately adjacent to the most proximal electrode, wherein the most distal electrode and the electrode immediately adjacent to the most proximal electrode are capable of excitation to generate an electric field, and wherein the electrode immediately adjacent to the most distal electrode and the central electrode are configured to obtain the one or more conductance measurements within the electric field.

7. The impedance device of claim 6, wherein one or more cross-sectional areas can be calculated based in part upon the one or more conductance measurements and a known distance between the electrode immediately adjacent to the most distal electrode and the central electrode.

8. The impedance device of claim 6, wherein the most proximal electrode is configured to detect an indicator and the device is configured such that when the elongated body is positioned within a fluid environment of a mammalian luminal organ and the most proximal electrode detects the indicator, the first arrangement of electrodes are activated to obtain the one or more conductance measurements within the electric field.

9. The impedance device of claim 5, wherein the second arrangement of electrodes comprises the most distal electrode, the electrode immediately adjacent to the most distal electrode, the central electrode, and the most proximal electrode, wherein the most distal electrode and the most proximal electrode are capable of excitation to generate an electric field, wherein the most distal electrode and the electrode immediately adjacent to the most distal electrode comprise a first fluid velocity detection electrode pair, and wherein the central electrode and the most proximal electrode comprise a second fluid velocity detection pair.

10. The impedance device of claim 9, wherein when the elongated body is positioned within the fluid environment and wherein the fluid environment comprises an indicator, movement of the indicator past the first fluid velocity detection electrode pair and the second fluid velocity detection electrode pair allows the first fluid velocity detection electrode pair and the second fluid velocity detection electrode pair to obtain the one or more fluid velocity measurements.

11. The impedance device of claim 5, wherein the most distal electrode is spaced at 4 mm from the an electrode immediately adjacent to the most distal electrode, wherein the electrode immediately adjacent to the most distal electrode is spaced at 1 mm from the central electrode, wherein the central electrode is spaced at 4 mm from the electrode immediately adjacent to the most proximal electrode, and wherein the electrode immediately adjacent to the most proximal electrode is spaced at 8 mm from the most proximal electrode.

12. The impedance device of claim 5, wherein the most distal electrode is spaced at 3 mm from the an electrode immediately adjacent to the most distal electrode, wherein the electrode immediately adjacent to the most distal electrode is spaced at 3 mm from the central electrode, and wherein the central electrode is spaced at 6 mm from the electrode immediately adjacent to the most proximal electrode.

13. The impedance device of claim 1, wherein the at least five electrodes comprise eight electrodes comprising:

a most distal electrode,

an electrode immediately adjacent to the most distal electrode,

a most proximal electrode,

an electrode immediately adjacent to the most proximal electrode,

a central distal electrode,

a central proximal electrode,

an electrode immediately adjacent to and distal to the central distal electrode, and

an electrode immediately adjacent to and proximal to the central proximal electrode.

14. The impedance device of claim 13, wherein the most distal electrode and the central distal electrode are capable of excitation to generate a distal electric field, wherein the electrode immediately adjacent to and distal to the central distal electrode and the electrode immediately adjacent to and proximal to the central proximal electrode are capable of excitation to generate a central electric field, wherein the central proximal electrode and the most proximal electrode are capable of excitation to generate a proximal electric field, wherein the one or more conductance measurements can be obtained within each of the distal electric field, the central electric field, and the proximal electric field, and wherein one or more cross-sectional areas can be calculated based in part upon the one or more conductance measurements and known distances between the electrodes used to generate the distal electric field, the central electric field, and the proximal electric field.

15. The impedance device of claim 13, wherein the second arrangement of electrodes comprises the most distal electrode, the central distal electrode, the central proximal electrode, and the most proximal electrode, wherein the most distal electrode and the central distal electrode comprise a first fluid velocity detection electrode pair, and wherein the central proximal electrode and the most proximal electrode comprise a second fluid velocity detection pair.

16. The impedance device of claim 15, wherein the device is configured such that when the elongated body is positioned within the fluid environment and wherein the fluid environment comprises an indicator, movement of the indicator past the first fluid velocity detection electrode pair and the second fluid velocity detection electrode pair allows the first fluid velocity detection electrode pair and the second fluid velocity detection electrode pair to obtain the one or more fluid velocity measurements.

17. The impedance device of claim 13, wherein the most distal electrode is spaced at 3 mm from the electrode immediately adjacent to the most distal electrode, wherein the electrode immediately adjacent to the most distal electrode is spaced at 2 mm from the electrode immediately adjacent to and distal to the central distal electrode, wherein the electrode immediately adjacent to and distal to the central distal electrode is spaced at 6 mm from the central distal electrode, wherein the central distal electrode is spaced at 2 mm from the central proximal electrode, wherein the central proximal electrode is spaced at 6 mm from the electrode immediately adjacent to and proximal to the central proximal electrode, wherein the electrode immediately adjacent to and proximal to the central proximal electrode is spaced at 2 mm from the electrode immediately adjacent to the most proximal electrode, and wherein the electrode immediately adjacent to the most proximal electrode is spaced at 3 mm from the most proximal electrode.

18. The impedance device of claim 1, further comprising:

an inflatable balloon positioned along the longitudinal axis of the elongated body located proximal to the detector, wherein the inflatable balloon is in communication with a lumen defined within the elongated body.

19. The impedance device of claim 18, further comprising:

a tetrapolar detector positioned upon the elongated body within the balloon, the tetrapolar detector comprising two excitation electrodes and two detection electrodes operable to obtain one or more balloon cross-sectional areas.

20. A method for using an impedance device to obtain a luminal cross-sectional area measurement and a fluid velocity measurement, comprising the steps of:

introducing at least part of an impedance device into a luminal organ at a first location, the impedance device comprising;

an elongated body, and

a detector positioned upon the elongated body, the detector comprising;

a most distal electrode,

an electrode immediately adjacent to the most distal electrode,

a most proximal electrode,

an electrode immediately adjacent to the most proximal electrode, and

a central electrode positioned between the electrode immediately adjacent to the most distal electrode and the electrode immediately adjacent to the most proximal electrode;

applying current to the impedance device using a current source; and

obtaining, in either order,

(a) one or more conductance measurements by exciting the most distal electrode and the electrode immediately adjacent to the most proximal electrode to generate an electric field and detecting using the electrode immediately adjacent to the most distal electrode and the central electrode within the electric field, wherein one or more cross-sectional areas can be calculated based in part upon the one or more conductance measurements and a known distance between the electrode immediately adjacent to the most distal electrode and the central electrode, and

(b) one or more fluid velocity measurements by exciting the most distal electrode and the most proximal electrode are capable of excitation to generate an electric field, wherein the most distal electrode and the electrode immediately adjacent to the most distal electrode comprise a first fluid velocity detection electrode pair, wherein the central electrode and the most proximal electrode comprise a second fluid velocity detection pair, and wherein the first fluid velocity detection electrode pair and the second fluid velocity detection electrode pair are operable obtain the one or more fluid velocity measurements by detecting an indicator positioned within the luminal organ.

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

implanting a stent within the luminal organ using an inflatable balloon coupled to the impedance device, wherein the stent is positioned upon the inflatable balloon prior to implantation within the luminal organ.