Devices, systems, and methods for determining vein geometric and compliance profiles for venous stenting

• US 10,034,623 B2
• Filed: 04/16/2015
• Issued: 07/31/2018
• Est. Priority Date: 04/16/2014
• Status: Active Grant

• Current Assignee: 3DT Holdings LLC
• Original Assignee: 3DT Holdings LLC
• Inventors: Kassab, Ghassan S.
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US14/688,624
• Publication Number:
  US 20150297110A1
• Time in Patent Office: 1,202 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• 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 5/1077 Measuring of profiles
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00

Abstract

Devices, systems, and methods for determining vein geometric and compliance profiles for venous stenting. In one device embodiment, the device comprises an elongated body configured to fit within a mammalian luminal organ, a balloon coupled to the elongated body capable of and configured for inflation and deflation within the mammalian luminal organ, at least two excitation electrodes positioned along the elongated body within the balloon, and a plurality of at least three detection electrodes positioned in between at least two of the at least two excitation electrodes, wherein a first pair of two adjacent detection electrodes of the at least three detection electrodes can detect an electric field generated by the at least two excitation electrodes and obtain a first conductance measurement within the balloon, and a second pair of two adjacent detection electrodes can detect the electric field and obtain a second conductance measurement within the balloon.

Claims

1. A device, comprising:

an elongated body configured to fit within a mammalian luminal organ;

a balloon coupled to the elongated body, the balloon capable of and configured for inflation and deflation within the mammalian luminal organ;

at least two excitation electrodes positioned along the elongated body within the balloon;

a plurality of at least three detection electrodes positioned in between at least two of the at least two excitation electrodes; and

a temperature sensor positioned within the balloon;

wherein when the elongated body is at least partially inserted into the mammalian luminal organ, wherein when an unheated fluid is introduced into the balloon, and wherein when at least two of the at least two excitation electrodes generate an electric field, a first pair of two adjacent detection electrodes of the at least three detection electrodes can detect the electric field and obtain a first conductance measurement within the balloon, and a second pair of two adjacent detection electrodes of the at least three detection electrodes can detect the electric field and obtain a second conductance measurement within the balloon, the first conductance measurement and the second conductance measurement indicative of different locations within the balloon; and

wherein the device is configured to obtain pressure data in addition to the first conductance measurement and the second conductance measurement, wherein dimensional data from the first conductance measurement or the second conductance measurement along with the pressure data provide compliance data at one or more locations within the mammalian luminal organ.

2. The device of claim 1, wherein the unheated fluid within the balloon is at room temperature.

3. The device of claim 1, wherein a plurality of conductance measurements in addition to the first conductance measurement and the second conductance measurement can be obtained within the balloon using at least two of the at least three detection electrodes.

4. The device of claim 3, wherein the plurality of conductance measurements are indicative of various stages of balloon inflation.

5. The device of claim 2, further comprising:

at least one additional element in communication with an inner lumen of the balloon, the at least one additional element comprising a pressure sensor.

6. The device of claim 1, wherein the device is configured to obtain a plurality of conductance measurements, used to determine a plurality of cross-sectional areas, along a length of the balloon at various inflation pressures, the plurality of conductance measurements used to generate a profile of the balloon, corresponding to dimensions of the mammalian luminal organ.

7. The device of claim 1, further defining a suction/infusion port defined within the elongated body and in communication with a lumen defined within the elongated body.

8. The device of claim 1, forming at least part of an impedance system, the impedance system further comprising a data acquisition and processing system.

9. The device of claim 8, wherein the data acquisition and processing system is configured to display the first conductance measurement and the second conductance measurement in real time.

10. The device of claim 1, wherein the plurality of at least three detection electrodes comprises a plurality of at least seven detection electrodes forming six consecutive adjacent pairs of detection electrodes.

11. The device of claim 1, wherein the plurality of at least three detection electrodes comprises a plurality of at least seventeen detection electrodes forming sixteen consecutive adjacent pairs of detection electrodes.

12. A method, comprising the steps of:

inserting at least part of a device into a mammalian luminal organ, the device comprising;

an elongated body configured to fit within the mammalian luminal organ,

a balloon coupled to the elongated body, the balloon capable of and configured for inflation and deflation within the mammalian luminal organ,

at least two excitation electrodes positioned along the elongated body within the balloon,

a plurality of at least three detection electrodes positioned in between at least two of the at least two excitation electrodes, and

a temperature sensor within the balloon;

inflating the balloon with an unheated fluid within the mammalian luminal organ so that the balloon contacts the mammalian luminal organ;

obtaining a first conductance measurement within the balloon by exciting an electric field using the at least two excitation electrodes and detecting the electric field using a first pair of two adjacent detection electrodes; and

obtaining a second conductance measurement within the balloon by detecting the electric field using a second pair of two adjacent detection electrodes different from the first pair of two adjacent detection electrodes, the first conductance measurement and the second conductance measurement indicative of different locations within the balloon.

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

generating a profile of the mammalian luminal organ based upon the first conductance measurement and the second conductance measurement.

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

selecting an appropriately sized stent based upon the profile; and

placing the appropriately-sized stent within the mammalian luminal organ.

15. The method of claim 13, wherein the profile indicates a lesion or other vascular abnormality within the mammalian luminal organ, and wherein the placing step is performed to place the appropriately-sized stent within the mammalian luminal organ at the lesion or other vascular abnormality.

16. The method of claim 14, wherein the mammalian luminal organ is a vein, and wherein the stent is ultimately placed within the vein.

17. The method of claim 12, wherein the method is performed to identify portions of/the mammalian luminal organ that are relatively more or less compliant than other portions of the mammalian luminal organ.

18. The method of claim 12, wherein at least one of the steps of obtaining a first conductance measurement and obtaining a second conductance measurement is performed in connection with obtaining at least one pressure measurement and/or at least one temperature measurement within the balloon.

19. A method of treating a luminal organ disease, comprising the steps of:

inserting at least part of a device into a mammalian luminal organ, the device comprising;

an elongated body configured to fit within the mammalian luminal organ,

a balloon coupled to the elongated body, the balloon capable of and configured for inflation and deflation within the mammalian luminal organ,

at least two excitation electrodes positioned along the elongated body within the balloon,

a plurality of at least five detection electrodes positioned in between at least two of the at least two excitation electrodes, and

a temperature sensor within the balloon;

inflating the balloon with an unheated fluid within the mammalian luminal organ at a lesion or other vascular abnormality so that the balloon contacts the mammalian luminal organ;

obtaining at least four conductance measurements within the balloon by exciting an electric field using the at least two excitation electrodes and detecting the electric field using a first pair of two adjacent detection electrodes, a second pair of two adjacent detection electrodes, a third pair of two adjacent detection electrodes, and a fourth pair of two adjacent detection electrodes, each of the four conductance measurements indicative of different locations within the balloon;

generating a profile of the mammalian luminal organ based upon the at least four conductance measurements, the profile identifying a location of the lesion or other vascular abnormality relative to the balloon and a size of the lesion relative to other portions of the mammalian luminal organ;

identifying an appropriately-sized stent based upon the size of the lesion or other vascular abnormality; and

placing the stent within the mammalian luminal organ at the location of the lesion or other vascular abnormality identified by the profile.

20. The method of claim 19, wherein the step of obtaining at least four conductance measurements is performed in connection with obtaining at least one pressure measurement and/or at least one temperature measurement of the unheated fluid within the balloon.