Oximeter probes and methods for the invasive use thereof

• US 5,715,816 A
• Filed: 10/20/1995
• Issued: 02/10/1998
• Est. Priority Date: 12/06/1993
• Status: Expired due to Fees

• Current Assignee: Dolphin Medical, Inc. (OSI Systems Incorporated)
• Original Assignee: Sensor Devices, Inc. (Mars Incorporated)
• Inventors: Mainiero, Louis M., Gorski, Stephen H., Young, Robert L.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/546,246
• Time in Patent Office: 844 Days
• Field of Search: 128/632, 128/633, 128/634, 128/637, 128/664, 128/665, 128/666, 128/667, 128/207.15, 128/204.23, 128/205.23, 128/200.26, 604/93, 604/264, 356/39, 356/40, 356/41
• US Class Current: 600/323
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6855 with a distal curved tip
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 7/023 for introduction into the body, e.g. into the oesophagus oesophageal ECG probes A61B5/285
• CPC Class Codes: A61M 2205/3368 Temperature

Abstract

A probe useful for invasively monitoring the oxygen saturation level of blood in the tissue walls of an anatomical cavity generally comprises a chassis with an electrical connector extending from the proximal end of the chassis and terminating at a plug configured for connection to a pulse oximeter box. The probe further includes an optics assembly configured to generate and transmit electrical signals that are indicative of the dynamic oxygen saturation level of blood in the wall tissue. The probe further includes a deployment device attached to the chassis for biasing the optics assembly into the tissue wall of the anatomical canal and stabilizing the probe within the canal. Further, the oximetry sensing assembly may be configured as part of an esophageal stethoscope having other sensing devices, for example, a temperature sensor, a pacing assembly, and an acoustic monitor.

Claims

1. A probe useful for invasively monitoring at best the oxygen saturation level of blood in at least one tissue wall of an esophagus, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from said proximal end of said chassis and terminating at a plug configured for connection to a pulse oximeter box;

an optics assembly configured to generate and transmit electrical signals to said oximeter box, said signals being indicative of the dynamic oxygen saturation level of blood in the wall tissue; and

a deployment device attached to said chassis and configured to carry said optics assembly;

wherein said deployment device is configured to stabilize the probe in the esophagus and limit movement of the probe within the esophagus.

2. The probe of claim 1, wherein the deployment device is configured to reside in the crico-pharyngeal muscle region of the esophagus.

3. The probe of claim 1, further comprising a temperature measuring device connected to said chassis for measuring a temperature of a subject.

4. The probe of claim 1, further comprising a pacing assembly connected to said chassis for measuring heart pacing of a subject.

5. The probe of claim 1, further comprising an acoustic monitor connected to said chassis for monitoring sounds within the anatomical cavity of a subject.

6. A probe useful for invasively monitoring at least the oxygen saturation level of blood in a region of an anatomical cavity, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from said proximal end of said chassis and terminating at a plug configured for connection to a pulse oximeter box;

an optics assembly configured to generate and transmit electrical signals to said oximeter box, said signals being indicative of the dynamic oxygen saturation level of blood in a cavity wall tissue; and

a deployment device attached to said chassis and configured to carry said optics assembly, said deployment device comprising;

means for causing a muscle in the region of the anatomical cavity to dilate allowing said deployment device to pass into the region including the muscle;

means for securing said deployment device in the muscle region when the muscle constricts, so that movement of the probe is inhibited; and

means for biasing said optics assembly against tissue of the anatomical cavity.

7. The probe of claim 6 wherein said deployment device has a circumferentially symmetrical hour-glass configuration.

8. A probe useful for invasively monitoring at least the oxygen saturation level of blood in at least one tissue wall of a rectal canal, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from said proximal end of said chassis and terminating at a plug configured for connection to a pulse oximeter box;

an optics assembly configured to generate and transmit electrical signals to said oximeter box, said signals being indicative of the dynamic oxygen saturation level of blood in the wall tissue; and

a deployment device attached to said chassis and configured to carry said optics assembly, and wherein said deployment device is configured to stabilize the probe in the rectal canal and limit movement of the probe within the rectal canal.

9. The probe of claim 8, wherein the deployment device is configured to reside in the sphincter muscle region of the rectal canal.

10. The probe of claim 8, wherein said deployment device comprises:

a first lobe having a crest and a substantially smooth outer surface;

a first segment having a leading edge and a generally sloped outer surface terminating at said crest of said first lobe; and

a second segment having a trailing edge and a generally sloped outer surface terminating at the crest of said first lobe.

11. The probe of claim 10 wherein the leading edge of said first segment causes a muscle in the rectal canal to dilate allowing said deployment device to pass into a region including the muscle, and wherein the muscle then constricts around said second segment between said first lobe and said trailing edge such that movement of the probe is inhibited and said optics assembly carried by said deployment device is biased into a tissue of the rectal canal.

12. The probe of claim 10, wherein said deployment device is connected to a handle, said handle configured to aid in the insertion of said deployment device into the rectal canal.

13. The probe of claim 10, wherein the leading edge of said second segment further comprises a temperature measuring device.

14. The probe of claim 10, wherein said optics assembly is located near the outer surface of said first lobe and comprises an emitter assembly and a detector assembly, and wherein the emitter assembly is parallel to and in close proximity to the detector assembly, each said emitter assembly and detector assembly being directed perpendicular to a center axis of the deployment device toward the outer surface of said first lobe.

15. A probe useful for invasively monitoring at least the oxygen saturation level of blood in a region of an anatomical cavity, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from said proximal end of said chassis and terminating at a plug configured for connection to a pulse oximeter box;

an optics assembly configured to generate and transmit electrical signals to said oximeter box, said signals being indicative of the dynamic oxygen saturation level of blood in a cavity wall tissue; and

a deployment device attached to said chassis and configured to carry said optics assembly, said deployment device comprising;

a first lobe and a second lobe, each lobe having a crest and a substantially smooth outer surface; and

a first segment having a substantially smooth, hyperboloid shaped outer surface extending from the crest of said first lobe to the crest of said second lobe interconnecting said first lobe with said second lobe, wherein the outer surface of said first segment further comprises a first slope adjacent to said first lobe and a second slope adjacent to said second lobe.

16. The probe of claim 15 wherein said deployment device further comprises:

a second segment having a leading edge and a substantially smooth sloped outer surface terminating at said first lobe; and

a third segment having a trailing edge and a substantially smooth sloped outer surface terminating at said second lobe.

17. The probe of claim 16, wherein the leading edge of said second segment is configured to cause a muscle in the region of the anatomical cavity to dilate allowing said deployment device to pass into the region including the muscle, and wherein said first segment is configured such that the muscle then constricts around said first segment between said first lobe and said second lobe such that movement of the probe is inhibited and said optics assembly carried by said deployment device is biased against a tissue of the anatomical cavity.

18. The probe of claim 17, wherein said optics assembly is configured for reflective oximetry measurements, said optics assembly comprising an emitter assembly and a detector assembly mounted in spaced relation near the surface of said first segment on the first slope adjacent to said first lobe, such that when the muscle constricts around said first segment, the emitter assembly and the detector assembly are biased against the muscle so that during operation, a signal from the emitter assembly passes into the muscle, reflects off and through the muscle tissue back into the detector assembly, thereby obtaining a reflective oximetry reading.

19. The probe of claim 17, wherein said optics assembly is configured for transmissive oximetry readings, the optics assembly comprising an emitter assembly and a detector assembly, the emitter assembly being mounted near the surface of said first segment on the first slope adjacent to said first lobe and the detector assembly is mounted near the surface of said first segment on the second slope adjacent to said second lobe, such that when the muscle constricts around said first segment, the emitter assembly and the detector assembly are biased against the muscle so that during operation, a signal from the emitter assembly passes through the muscle tissue to the detector assembly, thereby obtaining a transmissive oximetry reading.

20. The probe of claim 15, wherein said deployment device is made of a soft polyvinyl chloride having a durometer in the range of 15 to 60.

21. The probe of claim 15, wherein said deployment device comprises optically non-reflective and non-transmissive material.

22. A probe configured for insertion into an anatomical cavity for invasively monitoring bodily functions of a patient, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from the proximal end of said chassis and configured for connection to a monitoring device; and

a deployment device attached to said chassis and configured to carry an optics assembly, wherein said deployment device is configured to limit movement of the probe within the anatomical cavity and enable measurement by said optics assembly of a dynamic oxygen saturation level of blood in tissue of at least one tissue wall of the anatomical cavity, said optics assembly configured to generate and transmit electrical signals indicative of the dynamic oxygen saturation level of the blood in the tissue to the monitoring device.

23. The probe of claim 22, further comprising:

a temperature measuring device attached to the distal end of said chassis, wherein said temperature measuring device is configured to generate and transmit electrical signals to the monitoring device, the signals being indicative of a temperature of the patient;

an acoustic monitoring device positioned in spaced relation between said temperature measuring device and said deployment device, said acoustic monitoring device configured to receive sounds within the anatomical cavity and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the received sounds; and

a pacing assembly positioned in spaced relation between said temperature measuring device and said acoustic monitoring device, said pacing assembly configured to monitor heart pacing of the patient and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the heart pacing.

24. The probe of claim 23, wherein said pacing assembly comprises an atrial pacing/recording electrode and a ventricular pacing/recording electrode.

25. The probe of claim 24, wherein the atrial pacing/recording electrode is rotated clockwise on the chassis with respect to the ventricular pacing/recording electrode in the range of 30 degrees to 60 degrees.

26. A probe useful for invasively monitoring at least the oxygen saturation level of blood in a region of an anatomical cavity, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from the proximal end of the chassis and terminating at a plug configured for connection to a pulse oximeter box;

an optics assembly configured to generate and transmit electrical signals to the pulse oximeter box, the signals being indicative of a dynamic oxygen saturation level of blood in a cavity wall tissue;

a deployment device attached to the chassis, wherein the optics assembly is carried by the deployment device having a circumferentially symmetrical hour-glass configuration.

27. A method for invasively monitoring the oxygen saturation level of blood in a muscle region of an anatomical canal, comprising the steps of:

providing a probe having a chassis, an electrical connector and an optics assembly comprising an emitter and a detector, said optics assembly being carried on a deployment device having first, second and third segments and first and second lobes said optics assembly being carried on the second segment;

inserting a distal end of said probe into the canal;

guiding said probe into the muscle region of the canal until the first segment of the deployment device engages the muscle;

inserting the deployment device of said probe further into the muscle region until the second segment of the deployment device passes the muscle region such that the deployment device is substantially secured in the muscle region, and the optics assembly is biased against the muscle;

configuring an optical path between the emitter and the detector of the optics assembly, such that an oximetry signal passes through the blood perfused muscle from the emitter to the detector; and

evaluating the signals received by the detector to monitor the oxygen saturation level of the blood.

28. The method of claim 27 further comprising the steps of:

inserting the deployment device of the probe further into the muscle region until said third segment passes the muscle region;

reversing the direction of the probe such that the third segment backs up through the muscle region securing the deployment device in the muscle region, such that the optics assembly contained in the second segment of the deployment device is biased against the muscle tissue.

29. A multi-parameter probe configured for insertion into an anatomical cavity for invasively monitoring bodily functions of a patient, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from the proximal end of said chassis and configured for connection to a monitoring device;

an optics assembly configured to generate and transmit electrical signals to the monitoring device, the signals being indicative of a dynamic oxygen saturation level of blood in a cavity wall tissue;

a deployment device attached to said chassis and configured to carry said optics assembly, said deployment device having a circumferentially symmetrical hour-glass configuration;

a temperature measuring device attached to the distal end of said chassis, wherein said temperature measuring device is configured to generate and transmit electrical signals to the monitoring device, the signals being indicative of a temperature of the patient;

an acoustic monitoring device positioned in spaced relation between said temperature measuring device and said deployment device, said acoustic monitoring device configured to receive sounds within the anatomical cavity and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the received sounds; and

a pacing assembly positioned in spaced relation between said temperature measuring device and said acoustic monitoring device, said pacing assembly configured to monitor heart pacing of the patient and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the heart pacing.

30. A multi-parameter probe configured for insertion into an anatomical cavity for invasively monitoring bodily functions of a patient, the probe comprising:

a chassis having a proximal end and a distal end;

an electrical connector extending from the proximal end of said chassis and configured for connection to a monitoring device;

an optics assembly configured to generate and transmit electrical signals to the monitoring device, the signals being indicative of a dynamic oxygen saturation level of blood in a cavity wall tissue;

a deployment device attached to said chassis and configured to carry said optics assembly, said deployment device, comprising;

a first lobe and a second lobe, each lobe having a crest and a substantially smooth outer surface; and

a first segment having a substantially smooth, hyperboloid shaped outer surface extending from the crest of the first lobe to the crest of the second lobe interconnecting the first lobe with the second lobe, wherein the outer surface of said first segment further comprises a first slope adjacent to the first lobe and a second slope adjacent to the second lobe;

a temperature measuring device attached to the distal end of said chassis, wherein said temperature measuring device is configured to generate and transmit electrical signals to the monitoring device, the signals being indicative of a temperature of the patient;

an acoustic monitoring device positioned in spaced relation between said temperature measuring device and said deployment device, said acoustic monitoring device configured to receive sounds within the anatomical cavity and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the received sounds; and

a pacing assembly positioned in spaced relation between said temperature measuring device and said acoustic monitoring device, said pacing assembly configured to monitor heart pacing of the patient and to generate and transmit electrical signals to the monitoring device, the signals being indicative of the heart pacing.

31. The probe of claim 30 wherein said deployment device further comprises:

a second segment having a leading edge and a substantially smooth sloped outer surface terminating at the first lobe; and

a third segment having a trailing edge and a substantially smooth sloped outer surface terminating at the second lobe.

32. The probe of claim 31, wherein the leading edge of said second segment is configured to cause a muscle in the region of the anatomical cavity to dilate allowing said deployment device to pass into the region including the muscle, and wherein said first segment is configured such that the muscle then constricts around said first segment between said first lobe and said second lobe such that movement of the probe is inhibited and said optics assembly carried by said deployment device is biased against a tissue of the anatomical cavity.

33. The probe of claim 32, wherein said optics assembly is configured for reflective oximetry measurements, said optics assembly comprising an emitter assembly and a detector assembly mounted in spaced relation near the surface of said first segment on the first slope adjacent to said first lobe, such that when the muscle constricts around said first segment, the emitter assembly and the detector assembly are biased against the muscle so that during operation, a signal from the emitter assembly passes into the muscle, reflects off and through the muscle tissue back into the detector assembly, thereby obtaining a reflective oximetry reading.

34. The probe of claim 32, wherein said optics assembly is configured for transmissive oximetry readings, said optics assembly comprising an emitter assembly and a detector assembly, the emitter assembly being mounted near the surface of said first segment on the first slope adjacent to said first lobe and the detector assembly is mounted near the surface of said first segment on the second slope adjacent to said second lobe, such that when the muscle constricts around said first segment, the emitter assembly and the detector assembly are biased against the muscle so that during operation, a signal from the emitter assembly passes through the muscle tissue to the detector assembly, thereby obtaining a transmissive oximetry reading.