Apparatus and method for continuous monitoring of tissue gas composition and pH using recirculating gas tonometry

• US 5,957,839 A
• Filed: 02/19/1998
• Issued: 09/28/1999
• Est. Priority Date: 02/16/1995
• Status: Expired due to Fees

• Current Assignee: Wayne State University
• Original Assignee: Wayne State University
• Inventors: Kruse, James Alexander, Guzman, Jorge Alberto
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/026,360
• Time in Patent Office: 586 Days
• Field of Search: 600/309-312, 600/316, 600/322-23, 600/325-28, 600/345-48, 600/353, 600/360-64, 600/473, 600/476, 600/350, 600/365, 600/366
• US Class Current: 600/309
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

A tonometry catheter apparatus comprises an elongate, flexible, multilumen tube having a proximal end to be positioned outside the human body and a distal end to be positioned within a portion of the human body. Provided at the distal end are an ingress lumen through which gas may enter the tube, and an egress lumen through which gas may exit the tube. A hollow connecting member links the ingress lumen and the egress lumen to define a sampling circuit through which the gas may continuously recirculate. In one embodiment, the distal end of the tube is provided with a distensible, gas-permeable vessel in communication with the ingress and egress lumens. In an alternative embodiment, an extracorporeal gas-permeable membrane links the sampling circuit to a separate, gas-containing analyzing circuit. In each embodiment, a pump is provided for propelling gas through the circuits, and a sensor continuously quantifies the level of gas within the circuits.

Claims

1. A tonometry catheter apparatus comprising:

an elongate flexible tube having a proximal extracorporeal end and a distal intracorporeal end;

the distal end of the tube having

a distensible, inflatable, gas-permeable tonometry vessel, the vessel and the distal end defining therebetween a space which is filled with a gas,

an egress orifice in communication with the space, through which gas may enter the vessel,

an egress lumen with a distal end and a proximal end, the distal end being in communication with the egress orifice,

an ingress orifice in communication with the space, through which the gas may exit the vessel, and

an ingress lumen with a distal end and a proximal end, the distal end being in communication with the ingress orifice,

wherein the diameter of the ingress orifice is larger than the diameter of the egress orifice so as to prevent overdistention of the vessel;

the proximal end of the tube having

a propeller for propelling gas into the vessel, the propeller being selected from a group consisting of a peristaltic pump, a roller pump, an impeller pump, a blower, a fan, a circulator, and their equivalents,

a quantifier for continuously quantifying the level of gas exiting the vessel, and

a hollow connecting member linking the propeller and the quantifier to define with the vessel, the ingress lumen, and the egress lumen a closed circuit through which the gas may continuously recirculate, thereby resulting in a substantially error-free, stable reading of gas composition within the circuit.

2. The tonometry catheter apparatus of claim 1, wherein the diameter of the ingress lumen is larger than the diameter of the egress lumen so as to prevent overdistension of the vessel.

3. The tonometry catheter apparatus of claim 1, further comprising a device for injecting gas into the circuit or aspirating gas from the circuit.

4. The tonometry catheter apparatus of claim 3, wherein the device is actuated automatically to maintain an optimal level of pressure within the circuit.

5. A tonometry catheter apparatus comprising:

an elongate flexible tube having a proximal extracorporeal end and a distal intracorporeal end;

the distal end of the tube having

a distensible, inflatable, gas-permeable tonometry vessel, the vessel and the distal end defining therebetween a space which is filled with a gas,

an egress orifice in communication with the space, through which gas may enter the vessel,

an egress lumen with a distal end and a proximal end, the distal end being in communication with the egress orifice,

an ingress orifice in communication with the space, through which the gas may exit the vessel, and

an ingress lumen with a distal end and a proximal end, the distal end being in communication with the ingress orifice,

the proximal end of the tube having

a propeller for propelling gas into the vessel, the propeller being selected from a group consisting of a peristaltic pump, a roller pump, an impeller pump, a blower, a fan, a circulator, and their equivalents,

a quantifier for continuously quantifying the level of CO₂ gas exiting the vessel, and

a hollow connecting member linking the propeller and quantifier to define with the vessel, the ingress lumen, and the egress lumen a closed circuit through which the gas may continuously recirculate, thereby resulting in a substantially error-free, stable reading of gas composition within the circuit;

wherein the gas contained within the circuit comprises a mixture of a nontoxic gas and a physiologic concentration of CO₂ gas prior to placement of the vessel within the body of a patient so as to facilitate equilibration with the gas concentration adjacent the vessel.

6. The tonometry catheter apparatus of claim 5, wherein the nontoxic gas includes helium.

7. The tonometry catheter apparatus of claim 5, further comprising a device for injecting gas into the circuit or aspirating gas from the circuit.

8. The tonometry catheter apparatus of claim 7, wherein the device is actuated automatically to maintain an optimal level of pressure within the circuit.

9. A tonometry catheter apparatus comprising:

a sampling circuit and an analyzing circuit through which fluid may continuously recirculate;

the sampling circuit having

a proximal end and a distal end, the distal end of the sampling circuit in communication with a space which is filled with a fluid to be sampled,

an ingress lumen in communication with the space, through which fluid may exit the space and enter the sampling circuit, and

an egress lumen in communication with the space, through which the fluid may exit the sampling circuit and enter the space;

the analyzing circuit having a sensor for quantifying the level of fluid within the space;

wherein a segment of the sampling circuit and a segment of the analyzing circuit share a common interface which permits gaseous diffusion between the sampling circuit and the analyzing circuit.

10. The tonometry catheter apparatus of claim 9, further including an ingress orifice in communication with the ingress lumen and an egress orifice in communication with the egress lumen.

11. The tonometry catheter apparatus of claim 10, wherein the egress orifice is spaced apart from and upstream of the ingress orifice, so as to minimize the shunting of gas directly between the egress orifice and the ingress orifice thereby enhancing gas mixing.

12. The tonometry catheter apparatus of claim 10, wherein the ingress orifice is spaced apart from and upstream of the egress orifice, so as to minimize the shunting of gas directly between the ingress orifice and the egress orifice thereby enhancing gas mixing.

13. The tonometry catheter apparatus of claim 10, wherein the diameter of the ingress orifice is larger than the diameter of the egress orifice, so as to prevent the overdistention of a hollow organ into which the catheter is placed.

14. The tonometry catheter apparatus of claim 9, wherein the diameter of the ingress lumen is larger than the diameter of the egress lumen, so as to prevent the overdistension of a hollow organ into which the catheter is placed.

15. The tonometry catheter apparatus of claim 9, wherein the sensor quantifies the level of CO₂ gas within the space.

16. The tonometry catheter apparatus of claim 9, wherein the sensor provides real time trending information of the gas level in a tissue or organ of interest.

17. The tonometry catheter apparatus of claim 9, further including a device for displaying one or more variables indicative of physiological condition of the patient.

18. The tonometry catheter apparatus of claim 9, wherein the segment of the sampling circuit and the segment of the analyzing circuit sharing the common interface are parallel.

19. The tonometry catheter apparatus of claim 9, wherein the segment of the sampling circuit and the segment of the analyzing circuit sharing the common interface are coaxial.

20. The tonometry catheter apparatus of claim 9, further comprising at least one propeller for propelling gas through the sampling and analyzing circuits.

21. The tonometry catheter apparatus of claim 20, wherein the at least one propeller is selected from a group consisting of a peristaltic pump, roller pump, diaphragm pump, impeller pump, blower, compressor, fan, circulator, and other types of pumps.

22. The tonometry catheter apparatus of claim 9, further including a pressure sensor in communication with the sampling circuit for quantifying pressure in the sampling circuit.

23. The tonometry catheter apparatus of claim 9, further including one or more pressure relief valves in communication with the sampling circuit to regulate pressure within the sampling circuit.

24. The tonometry catheter apparatus of claim 9, further including a pressure sensor in communication with the analyzing circuit for quantifying pressure in the analyzing circuit.

25. The tonometry catheter apparatus of claim 9, further comprising one or more safety pressure relief lumens, each having a distal end and a proximal end, each distal end opening into a plurality of orifices, which may be proximate to the distal tip thereof along the tonometry catheter near its distal tip, none of the orifices communicating with the ingress lumen or with the egress lumen.

26. The tonometry catheter apparatus of claim 25, further including a pressure sensor in communication with the one or more safety pressure relief lumens for quantifying pressure in the safety pressure relief lumens and detecting undesirable or hazardous increases in pressure within a body cavity of a human subject in whom the catheter has been inserted.

27. The tonometry catheter apparatus of claim 25, further including one or more pressure relief valves in communication with the one or more safety pressure relief lumens to regulate pressure within the safety pressure relief lumens in the event of malfunction that could otherwise lead to an undesirable and hazardous progressive accumulation of gas within a body cavity of a human subject in whom the catheter has been inserted.

28. The tonometry catheter apparatus of claim 9, wherein gas contained within the analyzing circuit comprises ambient air prior to placement of the catheter within the body of a patient, and after equilibration the gas comprises a mixture having a composition approximating that of body tissues adjacent the catheter.

29. The tonometry catheter apparatus of claim 9, wherein gas contained within the analyzing circuit comprises a mixture of a nontoxic gas and a physiologic concentration of CO₂ gas prior to placement of the catheter within the body of a patient so as to facilitate equilibration, and after equilibration the gas comprises a mixture having a composition approximating that of body tissues adjacent the catheter.

30. The tonometry catheter apparatus of claim 29, wherein the nontoxic gas includes helium.

31. The tonometry catheter apparatus of claim 9, further comprising a device for injecting gas into the analyzing circuit and aspirating gas from the analyzing circuit.

32. The tonometry catheter apparatus of claim 31, wherein the device is actuated automatically to maintain an optimal level of pressure within the analyzing circuit.

33. The tonometry catheter apparatus of claim 9, wherein fluid flow within the sampling circuit occurs in a direction opposite to fluid flow within the analyzing circuit.

34. A method for indirect monitoring of organ or tissue gas composition comprising:

providing a catheter having an elongate flexible tube, the tube having a distal end and a proximal end;

introducing the catheter into an organ of interest so that the tube distal end is disposed at a desired sampling site;

positioning the tube distal end at the sampling site for a length of time sufficient to allow fluid at the sampling site to enter an ingress orifice provided within the tube;

circulating the fluid within a sampling circuit defined by the ingress orifice, an egress orifice, and a first hollow member connecting the ingress and egress orifices;

allowing gas to diffuse out the sampling circuit into a second hollow member which is filled with a gas and defines a closed analyzing circuit via a common, gas-permeable interface disposed therebetween; and

analyzing gas within the analyzing circuit to determine the gas composition of the organ into which the catheter was placed.

35. The method of claim 34, wherein introducing the catheter into an organ of interest includes inserting the catheter by a transnasal, transoral, transrectal, surgical, or other route of placement into some portion of the gastrointestinal tract, which includes the esophagus, stomach, duodenum, small intestines, jejunum, ileum, colon or large intestine, or rectum, or other organ of interest of the body.

36. The method of claim 34, wherein analyzing gas within the analyzing circuit includes continuously monitoring the level, percentage, proportion, or partial pressure of the gas.

37. The method of claim 36, wherein continuously monitoring the gas includes continuously monitoring the level, percentage, proportion, or partial pressure of CO₂ gas.

38. The method of claim 37, further including determining the intracellular pH of the organ or tissue at or near the sampling site on a continuous basis from the level of CO₂ gas and a measure or estimate of body bicarbonate concentration or total CO₂ content of the blood, serum, plasma, or tissue.

39. The method of claim 34, further comprising allowing entry of the bicarbonate ion concentration of the blood, serum, plasma, or tissue into the electronic portion of the system.

40. The method of claim 34, further comprising displaying and/or recording the measured and/or derived values on a continuous basis.

41. The method of claim 34, further comprising triggering an audible or visual alarm when a malfunction in the system is sensed, or when the measured or derived values are above or below pre-selected critical values.