TRANSESOPHAGEAL OR TRANSTRACHEAL CARDIAC MONITORING BY OPTICAL SPECTROSCOPY

• US 20160220117A1
• Filed: 10/29/2015
• Published: 08/04/2016
• Est. Priority Date: 10/29/2014
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaufman, Chris, Herken, Ulrich, Silver, Annemarie, Freeman, Gary A.
• Granted Patent: US 10,206,581 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• 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 7/023 for introduction into the body, e.g. into the oesophagus oesophageal ECG probes A61B5/285

Abstract

Devices, systems and methods useable for useable for monitoring a physiological variable in a target tissue or body fluid located within the thorax of a subject by optical spectroscopy.

Claims

1. A system useable for monitoring a physiological variable in a target tissue or body fluid located within the thorax of a subject by optical spectroscopy, said system comprising:

an elongate body configured for insertion into the esophagus, trachea or bronchus of the subject;

an optical spectroscopy system which is useable for measuring the physiological variable located on or in the elongate body, said optical spectroscopy system comprising i) an emitter for emitting light in the wavelength range of 200-2500 nm through the wall of the esophagus and into a target tissue or body fluid located in the heart, chamber of the heart or intrathoracic blood vessel and ii) a detector for detecting light that has been emitted from the emitter after said light has undergone dispersion and/or reflection by the target tissue or body fluid; and

a processing device which receives signals from the detector, said processing device being programmed to use signals received from the detector to estimate at least one physiological variable within the target tissue or body fluid.

2. A system according to claim 1 wherein said at least one physiological variable comprises a variable selected from the group consisting of:

temperature, oxygen tension, oxygen saturation, partial pressure of oxygen, partial pressure of carbon dioxide, hemoglobin concentration, water concentration, hematocrit, glucose concentration and presence of a biomarker.

3. A system according to claim 1 wherein the processing device a) receives spectral information from the detector, b) compares that spectral information to a set of spectra determined from a model for light attenuation in the sample to identify a member of the set of spectra that corresponds to the measured spectral information;

c) corrects the identified member of the set of spectra using a set of spectral correction factors determined from the set of spectra; and

d) uses the corrected identified member of the set of spectra as input to a calibration equation to determine a value associated with the particular physiological variable being measured.

4. A system according to claim 1 wherein the emitter is configured to emit near-infrared light having a wavelength in the range of 600-660 nm.

5. A system according to claim 1 wherein the emitter is configured to emit near-infrared light having a wavelength in the range of 200-400 nm.

6. A system according to claim 1 wherein the emitter is configured to emit near-infrared light having a wavelength in the range of 400-600 nm.

7. A system according to claim 1 wherein the emitter is configured to emit near-infrared light having a wavelength in the range of 600-2500 nm.

8. A system according to claim 1 wherein the emitter comprises at least one light emitting diode.

9. A system according to claim 1 further comprising a locator apparatus on or in the elongate body, said locator apparatus being useable to locate a desired position for the emitter and detector relative to the target tissue or body fluid, wherein the elongate body is longitudinally and rotationally moveable within the esophagus or trachea to cause the emitter and detector to be positioned at said desired location.

10. A system according to claim 9 wherein the locator apparatus is selected from:

microphones, stethoscopes, other sound detectors, electrical impulse detectors, electrocardiographic signal detectors, pressure sensors, pressure wave form sensors and detectors which detect user-generated location signals.

11. A system according to claim 9 wherein the locator apparatus is mounted on or in the elongate body in fixed spatial relation to at least the detector such that, when the locator apparatus has become aligned with a predetermined target, at least the detector will be positioned to receive light that has been emitted from the emitter after said light has undergone dispersion and/or reflection by the target tissue or body fluid.

12. A system according to claim 9 wherein the elongate body comprises a first elongate member which has the emitter and detector mounted thereon or therein and a second elongate member which has the locator apparatus mounted thereon or therein, wherein the second elongate member is moveable within the esophagus or trachea until the locator apparatus has located the desired position for the emitter and detector and, thereafter, the first elongate member is moveable to an operative position relative to the locator apparatus, said operative position causing the emitter and detector to be positioned at said desired location.

13. A system according to claim 12 wherein the first elongate member comprises a tube having a lumen and the second elongate member is insertable into and moveable within the lumen of the first elongate member.

14. A system according to claim 12 wherein the locator apparatus further comprises a position marker which is useable to facilitate maneuvering the second elongate apparatus to a position where the infrared spectroscopy system is operatively aligned with the then-current position of the locator apparatus.

15. A system according to claim 14 wherein the position marker comprises a signal emitter on either the locator apparatus or the second elongate apparatus and a signal receiver on the other, the signal receiver being operative to receive a signal from the signal emitter.

16. A system according to claim 15 wherein the signal receiver provides an indication of when the near infrared spectroscopy system is operatively aligned with the then-current position of the locator apparatus.

17. A system according to claim 9 wherein the processing device compares signals sensed by the locator apparatus to one or more reference signals, each reference signal being associated with a different tissue or body fluid within the subject'"'"'s thorax.

18. A system according to claim 17 wherein said reference signals are associated with one or more tissues or body fluids selected from;

myocardial tissue, blood within the left ventricle, blood within the right ventricle, blood within the right atrium, blood within the pulmonary artery, blood within a pulmonary vein and blood within the aorta.

19. A system according to claim 17 further comprising a user interface whereby a user may select a target reference signal from a plurality of stored reference signals and wherein the processing device is programmed to then compares signals received from the locator apparatus to the selected target reference signal.

20. A system according to claim 19 further comprising a notification apparatus which issues a notification to the user when the signal received from the locator apparatus matches the selected target signal, thereby indicating that the locator apparatus is currently in an operative position relative to the target tissue or body fluid.

21. A system according to claim 9 wherein the locator apparatus has a plurality of zones, each of said zones being programmed to compare signal received from the locator apparatus with a different reference signal, wherein each reference signal is associated with a different tissue or body fluid within the thorax of the subject.

22. A system according to claim 21 further comprising a user interface by which a user may select a particular zone that is programmed with a reference signal that is associated with a target tissue or body fluid to be monitored.

23. A system according to claim 22 further comprising a notification apparatus which issues a notification to the user when the the selected zone is receiving a sensed signal that matches the target signal for which that zone is programmed so as to indicate that the locator apparatus is operatively positioned relative to the desired target location.

24. A system according to claim 1 wherein the detector measures incident photonic intensity at more than one wavelength or more than one wavelength range.

25. A system according to claim 24 wherein the detector comprises a spectroscopic bench capable of generating spectrographic curves for analysis.

26. A system according to claim 1 wherein the detector comprises an optical element that focuses incident light into an optically conductive pathway that runs along the elongate body to the processing device or other apparatus.

27. A system according to claim 12 wherein the detector comprises a sensing element located at a distal end of the first elongate member.

28. A system according to claim 1 wherein the detector comprises a reuseable sensing element that is attachable to and detachable from the elongate body.

29. A system according to claim 12 further comprising apparatus for measuring the a rotational, transverse or longitudinal position of the first elongate member relative to the position of the second elongate member.

30. A system according to claim 29 wherein the apparatus for measuring determines the rotational orientation of the first elongate member relative to the rotational orientation of the second elongate member.

31. A system according to claim 29 wherein the apparatus for measuring determines the insertion depth of the first elongate member relative to the insertion depth of the second elongate member.

32. A system according to claim 29 wherein the apparatus for measuring comprises optical encoding system.

33. A system according to claim 29 wherein the apparatus for measuring comprises a linear resistive encoder.

34. A system according to claim 29 wherein the apparatus for measuring comprises an inertial sensor system.

35. A system according to claim 29 wherein the apparatus for measuring comprises a magnetometer device.

36. A system according to claim 1 further comprising a signaling device positionable on the exterior surface of the subject'"'"'s chest at a location having a known spatial relationship to an intrathoracic location from which it is desired to measure the physiological variable and wherein the detector or other apparatus on the elongate body is adapted to sense a signal from the signaling device thereby providing information whereby a user may maneuver the elongate body to a position and rotational orientation suitable for measuring the physiological variable from the intended intrathoracic location.

37. A system according to claim 36 wherein the signaling device comprises a vibrating device, piezoelectric transducer, percussive device, acoustical device, speaker, magnetic field producing device, an electromagnetic coil, an electromagnetic coil adapted to generate a narrow field beam, a Helmholtz double-coil or an electromagnetic coil which incorporates a ferrous metal or other magnetic flux concentrating element.

38. A system according to claim 36 wherein the signaling device is positionable on the subject'"'"'s chest directly above the Apex Beat Location.

39-77. -77. (canceled)