Systems, devices, and methods for mapping organ profiles

• US 10,413,211 B2
• Filed: 08/26/2013
• Issued: 09/17/2019
• 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): Weare, Meredith
• Application Number:
  US14/010,202
• Publication Number:
  US 20140066738A1
• Time in Patent Office: 2,213 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• 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 5/6853 with a balloon

Abstract

Devices, systems, and methods for the localization of body lumen junctions and other intraluminal structure are disclosed. Various embodiments permit clinicians to identify and locate lesions and/or anatomical structures within a lumen and accurately place leads and/or devices within a lumen, through determining the intralumen conductance and/or cross-sectional area at a plurality of locations within the body lumen.

Claims

1. A system comprising:

a device having a proximal end and a distal end, the distal end of the device configured for placement into a body lumen, the device comprising an electrode located between the proximal and distal ends of the device, the electrode to detect conductance data at a plurality of locations within the body lumen, the conductance data determined at each of the plurality of locations when the electrode is immersed in a fluid within the body lumen; and

a computer operably connected to the electrode of the device, the computer including;

a processor to collect conductance data from the device and to determine a profile of the body lumen based upon the conductance data, and

a computational program stored on the computer and executed by the processor, the computational program configured to;

(1) detect a first spike and a second spike in the conductance data obtained at the plurality of locations,

(2) responsive to determining the first spike is greater than a predefined threshold limit, eliminate the first spike from the conductance data to generate a first modified conductance data,

(3) determine whether the second spike is due to a bifurcation,

(4) apply a smoothing algorithm to the first modified conductance data to eliminate the second spike in the first modified conductance data to generate a second conductance data if the second spike is determined to be due to the bifurcation, and

(5) generate a lumen profile based on the second conductance data.

2. The system of claim 1, wherein the smoothing algorithm includes one of linear interpolation or cubic spline interpolation.

3. A system for determining a location within a body lumen, the system comprising:

a device having a proximal end and a distal end, the distal end of the device configured for placement into the body lumen, the device comprising an electrode located between the proximal and distal ends of the device, the electrode to detect conductance data at a plurality of locations within the body lumen, the conductance data determined at each of the plurality of locations when the electrode is immersed in a fluid within the body lumen; and

a computer operably connected to the electrode, the computer including;

a processor to obtain conductance data from the device at a plurality of locations within the body lumen when the electrode is immersed in a fluid within the body lumen; and

a computational program that, upon execution by the processor, causes operations capable of detecting a target location in the body lumen based upon the conductance data obtained at the plurality of locations, and configured to;

(1) detect a first spike and a second spike in the conductance data,

(2) responsive to determining the first spike is greater than a predefined threshold limit, eliminate the first spike from the conductance data to generate a first modified conductance data,

(3) determine whether the second spike is due to a bifurcation,

(4) apply a smoothing algorithm to the first modified conductance data to eliminate the second spike to generate a second conductance data if it is determined to be due to the bifurcation, and

(5) generate a lumen profile based on the second conductance data.

4. The system of claim 3, further comprising a display to depict a profile of the conductance data.

5. The system of claim 3, wherein the device is selected from the group consisting of an impedance catheter and an impedance wire.

6. The system of claim 3, wherein the body lumen comprises an aortic lumen.

7. The system of claim 3, wherein the body lumen comprises a lumen of a coronary artery.

8. The system of claim 3, wherein the fluid comprises blood.

9. The system of claim 3, wherein the computational program is configured to detect a gradient.

10. The system of claim 3, wherein the smoothing algorithm comprises one of linear interpolation or cubic spline interpolation.

11. The system of claim 3, wherein execution of the computational program causes performance of further operations including detecting a conductance value of the conductance data that exceeds the predefined threshold limit.

12. A method for determining a location within a body lumen, the method comprising:

inserting a distal end of a device into the body lumen, the device including an electrode located on the device, and a processor operably connected to the electrode;

detecting, by the electrode, conductance data at a plurality of locations within the body lumen, the conductance data determined at each of the plurality of locations when the electrode is immersed in a fluid within the body lumen;

obtaining the conductance data from the device;

determining, by a computational program, a target location in the body lumen based upon the conductance data obtained at the plurality of locations;

detecting a first spike and a second spike in the conductance data;

responsive to determining the first spike is greater than a predefined threshold limit, eliminating the first spike from the conductance data to generate a first modified conductance data;

determining, by the computational program, whether the second spike is due to a bifurcation;

applying a smoothing algorithm to the first modified conductance data to eliminate the second spike in the first modified conductance data to generate a second conductance data if the second spike is determined to be due to the bifurcation; and

generating a lumen profile based on the second conductance data.

13. The method of claim 12, wherein the conductance data at each of the plurality of locations includes a value, further comprising displaying relative values of the conductance data compared between the plurality of locations within the body lumen.

14. The method of claim 13, wherein the value is a cross-sectional area value, and wherein the displayed conductance data represents a profile of relative cross-sectional area values compared between the plurality of locations within the body lumen.

15. The method of claim 14, further comprising monitoring the profile to determine an anatomical structure of the body lumen.

16. The method of claim 12, wherein the body lumen comprises at least a portion of an atrium, a coronary sinus, an aorta, a pulmonary vein-atrial junction, a blood vessel, a biliary tract, or an esophagus.

17. The method of claim 12, wherein the plurality of locations are chosen to create a conductance profile to locate the target location.

18. The method of claim 17, wherein a target destination is determined based on a relative increase in the conductance profile compared between the plurality of locations within the body lumen.

19. The method of claim 12, wherein the smoothing algorithm includes one of linear interpolation or cubic spline interpolation.