Intracorporeal impedance and leak monitoring device

• US 7,899,508 B2
• Filed: 03/10/2005
• Issued: 03/01/2011
• Est. Priority Date: 03/11/2004
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: DeArmond, Daniel T.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US11/077,178
• Publication Number:
  US 20050240093A1
• Time in Patent Office: 2,182 Days
• Field of Search: 424/551, 600/350, 600/372, 600/483, 604/524, 606/8, 607/40, 607/124, 607/133
• US Class Current: 600/327
• CPC Class Codes: A61B 5/02042 Determining blood loss or bleeding, e.g. during a surgical procedure
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant

Abstract

The system and method may measure and monitor physiological changes in a body. In some embodiments, the system and method may measure the impedance at a site in the body. In some embodiments, the system and method identify, quantify, and localize leaks from a site following surgery. In an embodiment, the system includes a flexible conduit with one or more sensors. A flexible conduit shape may be selected to facilitate monitoring of physiological changes in a body and/or detection of leaks at a desired site. In an embodiment, contrast solution may be ingested by, injected in, and/or delivered to a patient. If a leak is present at a site, salt contrast solution may leak from a site and be detected by sensors in a flexible conduit.

Claims

1. A leak monitoring system comprising:

a flexible conduit, wherein the flexible conduit is, during use, positioned inside of an opening in a human body, and wherein the flexible conduit comprises one or more channels;

one or more sensors disposed in or on, or connected to, the flexible conduit, wherein at least one of the sensors, during use, senses impedance changes caused by one or more fluids, introduced into the body part, leaking from the body part and contacting the one or more impedance sensors; and

an electrical conduit connected to provide electrical signals from one or more of the impedance sensors to a measurement determining unit, wherein the measurement determining unit determines, during use, the impedance change due to the presence of at least one fluid leaking from the body part;

wherein fluid leaking from the body part flows through one or more channels in the flexible conduit.

2. The system of claim 1, wherein the measurement determining unit determines the presence of a leak when an impedance decrease is detected in one or more of the impedance sensors.

3. The system of claim 1, wherein the flexible conduit is positionable proximate a hollow organ, and wherein at least one sensor directly measures impedance_changes proximate of the hollow organ.

4. The system of claim 1, wherein at least one channel comprises a groove.

5. The system of claim 1, wherein at least one channel is corrugated.

6. The system of claim 1, wherein a portion of a cross sectional area of the flexible conduit is convex.

12. The system of claim 1, wherein at least one sensor is in substantially direct contact with the body part.

13. The system of claim 1, wherein the system is capable of being positioned in an opening in the body proximate to an esophagus.

14. The system of claim 1, wherein the system is capable of being positioned in an opening in the body proximate to a lung.

15. The system of claim 1, wherein the system is capable of being positioned in an opening in the body proximate to a portion of a gastrointestinal tract.

16. The system of claim 1, wherein the system is capable of being positioned in an opening in the body proximate to a stomach.

19. The system of claim 1, wherein body part is a body part subjected to a surgical procedure, and wherein flexible conduit is positionable proximate to the body part such that fluids leaking from the body part, as a result of the surgery, are sensed by one or more of the sensors.

20. The system of claim 1, wherein the body part is the stomach, and wherein the flexible conduit is positionable proximate to the stomach such that fluids leaking from the stomach are sensed by one or more of the sensors.

7. A method of detecting leaks in a body part comprising:

inserting a flexible conduit in an opening in the body, wherein the flexible conduit comprises two or more sensors disposed in or on, or connected to, the flexible conduit, wherein at least one of the sensors, during use, senses impedance changes proximate to the body part, and wherein the flexible conduit further comprises one or more channels wherein fluid leaking from the body part flows through one or more channels in the flexible conduit;

positioning the flexible conduit in the body proximate to a body part such that the two or more sensors are proximate the body part;

introducing a fluid into the body, wherein the fluid comprises one or more ions; and

monitoring the status of the two or more sensors after the fluid is introduced into the body, wherein a change in the impedance of one or more of the impedance sensors indicates the presence of a leak from the body part.

8. The method of claim 7, wherein introducing the fluid comprises:

allowing a patient to ingest the fluid;

allowing the fluid to flow through the body; and

wherein monitoring the status of the two or more sensors comprises allowing sufficient time for the fluid to pass to the body part before determining if a leak from the body part is present.

9. The method of claim 7, wherein the fluid is a saline solution.

10. The method of claim 7, further comprising:

transmitting the change in the impedance of one or more of the impedance sensors to a measurement detection unit;

comparing the change in the impedance of one or more of the impedance sensors to a base line value of the impedance proximate to the body part; and

producing a signal when the change in the impedance of one or more of the impedance sensors deviates greater than a selected range from the base line value.

17. The method of claim 7, wherein at least one of the sensors, during use, senses ion concentration changes proximate to the body part, the method further comprising:

allowing a patient to ingest the fluid; and

allowing the fluid to flow through the body;

wherein monitoring the status of the two or more sensors comprises allowing sufficient time for the fluid to pass to the body part before determining if a leak from the body part is present.

18. The method of claim 17, wherein the fluid is a solution containing dissolved ions, said dissolved ions being of a type and/or concentration out of physiological norms.

21. The method of claim 7, wherein the flexible conduit is positioned proximate to a portion of a gastrointestinal tract.

22. The method of claim 7, wherein the flexible conduit is positioned proximate to a portion of a gastrointestinal tract after a surgical procedure, wherein monitoring the status of two or more sensors comprises monitoring leakage of the fluid from the gastrointestinal portion.

11. A leak monitoring system comprising:

a flexible conduit, wherein the flexible conduit is, during use, positioned inside of an opening in a human body, and wherein the flexible conduit comprises one or more channels;

one or more sensors disposed in, or on, or connected to, the flexible conduit, wherein at least one of the sensors, during use, senses ion concentration changes caused by one or more fluids, introduced into the body part, leaking from the body part and contacting the ion concentration sensor, and wherein ions measured by the ion concentration sensor comprise fluoride, bromide, carbonate, bicarbonate, potassium, copper, lead, silver, gold, sulfide, nitrate, ammonium, iodide, or calcium; and

an electrical conduit connected to provide electrical signals from one or more of the ion concentration sensors to a measurement determining unit, wherein the measurement determining unit determines, during use, ion concentration changes due to the presence of at least one fluid leaking from the body part;

wherein fluid leaking from the body part flows through one or more channels in the flexible conduit.