WO2017085549A2 - Guided endotracheal intubation system - Google Patents
Guided endotracheal intubation system Download PDFInfo
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- WO2017085549A2 WO2017085549A2 PCT/IB2016/001743 IB2016001743W WO2017085549A2 WO 2017085549 A2 WO2017085549 A2 WO 2017085549A2 IB 2016001743 W IB2016001743 W IB 2016001743W WO 2017085549 A2 WO2017085549 A2 WO 2017085549A2
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- visible light
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
- A61B1/0661—Endoscope light sources
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00002—Operational features of endoscopes
- A61B1/00004—Operational features of endoscopes characterised by electronic signal processing
- A61B1/00009—Operational features of endoscopes characterised by electronic signal processing of image signals during a use of endoscope
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
- A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
- A61M2205/3313—Optical measuring means used specific wavelengths
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/587—Lighting arrangements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8206—Internal energy supply devices battery-operated
Definitions
- Some embodiments relate to the field of endotracheal intubation, especially using external illumination to assist in the positioning of the endotracheal tube in the trachea of a subject.
- the present invention provides a system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
- the system further comprises an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
- an optical sensing system comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows
- the system further a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- the dermal patch is configured to provide the frequency- modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
- the apparent sensed illumination intensity is adjusted to the pre-determined value by the user.
- the apparent sensed illumination intensity is adjusted to the pre-determined value by the control system.
- the processing of the image data further comprises phase manipulation of the image data, wherein the phase manipulation is configured to discriminate between the illumination of the subject's trachea by the frequency modulated light output and illumination of the subject's trachea from other sources.
- the dermal patch comprises at least one battery, at least one light emitter, and a circuit for powering the at least one light emitter.
- the dermal patch further comprises a skin contact sensor configured to activate the light source when the light source contacts the subject's neck.
- the dermal patch further comprises a potentiometer configured to vary the maximum intensity of the light output.
- the dermal patch further comprises a power switch.
- the at least one light emitter is a light emitting diode.
- the frequency-modulated light output has a wavelength within the range of from 0.4 micrometers to 1.4 micrometers.
- the dermal patch further comprises an adhesive element, for application to the neck of the subject in the region of the subject's larynx.
- the dermal patch further comprises a strap, for application to the neck of the subject in the region of the subject's larynx.
- the dermal patch is disposable.
- the image data is received by the system at a frequency at least 2 times greater than the frequency-modulated light output.
- the frequency-modulated light output is in the frequency range of 0.5 Hz to 60 Hz.
- the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- the dermal patch comprises at least one battery, at least one light emitter configured to emit visible light, at least one light emitter configured to emit non- visible light, and a circuit for powering the at least one light emitter configured to emit visible light and the at least one light emitter configured to emit non-visible light.
- the circuit is configured to power either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non- visible light, not both.
- the at least one light emitter configured to emit visible light is a light emitting diode.
- the at least one light emitter configured to emit visible light emits red light.
- the at least one light emitter configured to emit visible light emits green light.
- the at least one light emitter configured to emit visible light emits blue light.
- the at least one light emitter configured to emit visible light emits yellow light.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 750 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength of 625 nm.
- the at least one light emitter configured to emit non-visible light is a light emitting diode.
- the at least one light emitter configured to emit non-visible light emits near infra-red light.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1400 nm.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength of 850 nm.
- the frequency -modulated light output of the at least one light emitter configured to emit visible light is the same as the frequency-modulated light output of the at least one light emitter configured to emit non-visible light.
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value
- the present invention provides a method for performing guided tracheal intubation on a subject, using a system according to some embodiments of the present invention, comprising:
- the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea
- the method further comprises processing the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- Fig. l shows schematically a conventional endotracheal procedure being performed on a subject.
- FIG. 2 is a schematic view of a prior art sensing system for tracheal intubation, making use of an externally applied illumination source.
- FIG. 3 schematically shows the system architecture of the prior art intubation system shown in Fig. 2.
- Fig. 4A illustrates schematically a novel intubation illumination system of the present disclosure according to some embodiments
- Fig. 4B is a schematic drawing of an exemplary disposable illumination patch for use in the system of Fig. 4A according to some embodiments of the invention.
- FIG. 5 schematically shows the system architecture of the intubation system of
- FIG. 4A according to some embodiments of the invention.
- Figs. 6A-6G illustrate the use of phase sensitive detection techniques on received modulation pulse trains for a method of viewing endoscopic intubation and for controlling the displayed image intensity, using the system of Fig. 4 according to some embodiments of the invention.
- Figs. 7A-7E illustrate an alternative method to that of Figs. 6A-6G, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system according to some embodiments of the invention.
- FIG. 8 is a schematic drawing of an exemplary disposable illumination patch further configured with a skin sensor according to some embodiments of the invention.
- FIG. 9 is a schematic drawing of an exemplary disposable illumination patch further configured with a power switch according to some embodiments of the invention.
- Fig. 10 is a schematic drawing of an exemplary disposable illumination patch further configured with a potentiometer according to some embodiments of the invention.
- Fig. 11 is a representation of the modulation of the output of the at least one light emitter according to some embodiments of the present invention.
- Fig. 12 is a schematic drawing of an exemplary disposable illumination patch further configured with an indicator LED according to some embodiments of the invention.
- Fig. 13 is a schematic drawing of an exemplary disposable illumination patch further configured with an external power supply according to some embodiments of the invention.
- FIGs. 14 A-D are schematic drawings of exemplary disposable illumination patches according to some embodiments of the invention.
- the present invention provides systems for the simple yet accurate viewing, guidance and execution of endotracheal intubation.
- the system utilizes light source comprising a dermal patch configured to provide a frequency modulated light output, and configured to be applied externally to the neck of a subject, over the subject's larynx.
- the endotracheal tube contains within its lumen, an optical sensing system, having a camera and a light source at the distal end, configured to provide data, in the form of images of the subject's trachea at the location of the distal end of the endotracheal tube.
- Fig. 1 illustrates schematically a conventional endotracheal procedure being performed on a subject 10.
- the trachea 11 is shown in its location in front of the esophagus 12, and an endotracheal intubation tube 13 has been successfully inserted past the epiglottis 14 and past the vocal chords 15 which are located at the junction of the trachea 11 and the esophagus 12, into the trachea.
- the problem of successfully negotiating the junction of the trachea and the esophagus is clear from Fig. 1.
- the attending personnel manipulate the intubation tube into its correct position in the trachea by endoscopically viewing the progress of the distal tip of the intubation tube using illumination conveyed internally down the intubation tube assembly.
- FIG. 2 is a schematic view of a prior art sensing system for tracheal intubation.
- an energy source 21 which is conveniently an optical source, conveys illumination down a light guide 22 to the external region 23 of the subject's throat, and the light passing through the tissue of the subject's throat illuminates the trachea far more strongly than the esophagus.
- An endoscopic intubation tube 24 provides an image of the junction region, which is viewed in the display and processing, and steering system 25. Because of the increased illumination in the trachea, the display signal processing software can determine the position of the entrance to the trachea, and can selectively enable the intubation tube to be directed into the trachea.
- the prior art system described has a light intensity auto-gaining feature, in which a feedback loop is established between the level of light detected by the endoscopic intubation tube sensor electronic circuitry, and the light level applied from the light source unit to the outside of the subject's throat.
- the electronic circuitry 25 and the light source unit 21 must be electronically linked, as shown by the electronic communication cable connection 26 in Fig. 2.
- a further need for controlled adjustment of the illumination level in such a system is because of the change in sensed illumination as the intubation tube is moved down the subject's throat.
- the externally emitted illumination should be changed to compensate for changes in the optical transmission through the neck cartilage and tissue to the viewing lens of the endoscope, as it moves down the throat.
- FIG. 3 schematically shows the system architecture of the prior art intubation system of the type shown in Fig. 2.
- the externally applied light source 30 delivers its illumination through the subject's tissues, as indicated by the arrow 31, to the region of the trachea/esophagus bifurcation.
- the endoscopic detector 32 of the endotracheal intubation tube images the inside of the subject's throat, and conveys these images, which could be in the form of a video stream, to the electronic display and processing system 33, which can include display and signal processing hardware and software, for outputting such a video stream to a display unit 34 for view by the user 35.
- this electronic unit can include a user interface 36, by means of which the user can control the display function by inputting 37 commands back to the electronic system.
- the electronic system 33 After processing the received image intensities, and any user inputs from, the user interface, the electronic system 33, is programmed to send a feedback signal 38 to the light source 30, in order to control the level of the external illumination applied to the subject's throat.
- the system is thus complex, requiring the use of its own dedicated sensing and illumination units, connected electronically so that they will operate correctly together.
- the present invention provides a system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
- the system further comprises an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
- an optical sensing system comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows
- the system further a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- the present invention provides system for performing guided tracheal intubation on a subject, comprising: a.
- a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea;
- an optical sensing system comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency -modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea; and c.
- control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a predetermined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
- the present invention provides system for performing guided tracheal intubation on a subject, comprising: a. a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea; and b.
- an optical sensing system comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency -modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
- the system further comprises a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
- the trachea may not be detectable.
- the image data may contain light from both the trachea and the esophagus, and/or light that may be reflected or scattered from the surrounding tissues, thereby causing anatomical identification errors.
- One of ordinary skill in the art may readily determine the pre-determined level of the apparent sensed illumination intensity.
- the image data may be processed as the distal end of the endotracheal tube advances down the subject's trachea toward the subject's larynx, to compensate to changes in the intensity of the frequency modulated light detected by the camera on the distal end of the endotracheal tube.
- the changes in the intensity of the frequency modulated light may be due to, for example, the distance of the distal end of the endotracheal tube from the light source configured to provide a frequency-modulated light output.
- frequency -modulated light output refers to the periodic variation of the intensity of the light output from the light source from a first value to a second value, wherein the periodic variation has a given fixed time interval or frequency.
- the frequency of the periodic variation of the intensity of the light output from the light source is in the range of 0.5 Hz to 60 Hz.
- the frequency of the periodic variation of the intensity of the light output from the light source is in the range of 2 Hz to 4 Hz.
- the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- Fig. 4A illustrates schematically an exemplary implementation of the novel intubation illumination system of the present disclosure according to some embodiments.
- the present system differs from that shown in the above mentioned prior art, in that the illumination is supplied by a stand-alone light source unit 40, which can be in the form of a dermal patch, applied adhesively to the external throat region of the subject opposite the trachea/esophagus bifurcation, such that the frequency modulated illumination 44 emitted by the dermal patch, is directed internally towards the subject's airway.
- a stand-alone light source unit 40 which can be in the form of a dermal patch, applied adhesively to the external throat region of the subject opposite the trachea/esophagus bifurcation, such that the frequency modulated illumination 44 emitted by the dermal patch, is directed internally towards the subject's airway.
- autonomous or “stand alone” refers to a dermal patch comprising a light source that is configured to operate without input from any other component of the system of the present invention, wherein a dermal patch comprising a light source is configured to provide the frequency-modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
- the dermal patch is configured to provide the frequency- modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
- the dermal patch can be held in position either by an adhesive sticky pad, or by means of a strap, or by any other means which will hold the dermal patch in position on the subject's throat.
- the dermal patch can be simply constructed, containing in its simplest implementation, no more than a battery, one or more LED's, and a power supply for providing the current for the LED's. Because of this simple and low cost structure in the embodiment shown, the dermal patch can be manufactured to be disposable, such that its use becomes extremely simple.
- the dermal patch may be applied to the subject's throat, and once the intubation has been completed, it can be removed and discarded.
- a battery of low capacity may be used, capable of supplying power to the light source only for the duration of one intubation procedure, or somewhat more for safety considerations.
- the illumination patch is adapted to emit a constant level of average light output, and can thus be completely independent of any input signals from other electronic control units.
- the wavelength of the illumination 44 emitted by the light source 40 can conveniently be in the range of the visible to near infra-red, which is a range which has good transmission through the tissues of the subject's neck, and to which silicon photo -detector arrays, whether CCD or CMOS, have good sensitivity. Such Si camera arrays are preferable because of their low cost and wide availability.
- the VIS-NIR wavelengths most typically used for implementing the systems of the present disclosure range from approximately 0.4 to 1.4 ⁇ , though wavelengths outside of this range may also be possible.
- Fig. 4B is a schematic drawing of one embodiment of a disposable illumination patch 40, showing the battery 41, electronic circuitry 42 for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes 43, emitting their illumination 44.
- the disposable illumination patch 40 of Fig. 4B is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects.
- the imaging module in order for the system to be able to handle the different internally collected levels of airway illumination that could arise from application of an external illumination source having a fixed intensity output level, the imaging module must be able to process and display the internal view of the subject's glottal region at an intensity that can be comfortably viewed by the medical personnel administering the intubation, or readily used by any automatic guidance procedures that require a processable image for implementation of the procedure. Therefore, the imaging module should have a system by which the level of light of the imaged frames of the subject's airways can be controlled.
- the imaging module should operate completely independently from the dermal patch, and have no connection thereto.
- the dermal patch is constructed to emit modulated illumination, at a predetermined frequency modulation
- the detection system is adapted to detect the frequency modulated light penetrating to the subject's airway, and to adjust the level of the output image for display and processing by phase manipulation and/or gating of the received modulated signal.
- the apparent sensed illumination intensity is adjusted to the pre-determined value by the user.
- the apparent sensed illumination intensity is adjusted to the pre-determined value by the control system.
- the processing of the image data further comprises phase manipulation of the image data, wherein the phase manipulation is configured to discriminate between the illumination of the subject's trachea by the frequency modulated light output and illumination of the subject's trachea from other sources.
- Fig. 5 schematically shows the system architecture of the intubation system according to certain embodiments of the present invention, displayed in a similar manner to that shown in Fig. 3 for prior art systems.
- the externally applied light source 50 is a battery powered light source, which can conveniently be disposable after use.
- the light output 51 is modulated, passes into the subject's glottal region, and is imaged by a detector unit 52, which transfers the video stream to the electronic display and processing system 53.
- the system differs from that shown in Fig. 3, in that there is no feedback or connection from the electronic display and processing system 53 to the externally applied light source 50.
- adjustment 58 of the displayed light intensity is generated either by an auto-gain feedback system within the electronic display and processing system 53, or by user preferences 56, applied by the user 55 as he/she views the images of the intubation on the display 54 as the intubation proceeds. Adjustment of the apparent illumination level, as seen as the displayed light intensity, is achieved entirely within the processing system 53, as indicated by the arrow 58. The user can thus control the intensity of that part of the image arising from the externally applied illumination during the intubation procedure to the level desired for maximum clarity, without communicating either physically or wirelessly with the external battery powered passive light source, which remains completely independent of the detection, control and display electronic units.
- the applied external light source 50 transmits a predetermined frequency modulated light output in order to be able to perform the intensity manipulation of the displayed images, and is completely independent and unconnected to the electronic display and processing system 53. This is one of the features that enables the external light source 50 to be made as a low-cost and disposable item.
- the dermal patch is further configured to vary the intensity of illumination.
- the dermal patch is further configured to vary the intensity of illumination via a potentiometer.
- the detection and image processing system may function by applying known image processing techniques to separate those parts of the images of the video frames arising from the modulated illumination coming from the external source, from those parts of the images of the video frames arising from illumination coming from the endotracheal tube illumination system, such as, for example, a light source incorporated in the distal end of the optical sensing system. By this means it becomes possible to control the comparative level of these two illumination components, and in particular to maintain the modulated illumination emerging from the trachea at a level which enables ready identification of the trachea. In addition to providing the user with a simpler and more readily controllable image display for use in manually guided intubation procedures, this technique may also enable possible automatic guidance of the endotracheal tube into the trachea, with minimal or no user assistance.
- FFT Fast Fourier transform
- Such an algorithm requires knowledge of the modulation frequency of the externally applied illumination source, but since the standard video frame rates are low, typically no more than a few tens of Hz, modulation frequencies of between 0.5 Hz and 60 Hz can be typically used in this situation.
- the bandwidth of any FFT algorithm can therefore readily accommodate such a low frequency, and the predetermined modulation frequency can be closely tracked.
- the FFT algorithm is sufficiently fast to enable signal processing to the performed in real-time on each frame of the video stream.
- Eulerian video magnification can be used as another method of delineating the time varying components of the sensed illumination arising from the externally applied light from the constant or slowly varying background illumination from inside the subject's throat regions.
- Another method based on phase manipulation is to subtract images generated when the externally modulated light source is at its maximal or ON intensity from the images generated when the externally modulated light source is at its minimal or OFF intensity state.
- Figs. 6A to 6G and to Figs. 7A to 7E are time based graphs of the sensed illumination, I, displayed by the endoscopic viewing system, as a function of elapsed time, t.
- the graphs of 6A-6G and 7A-7E are drawn using square-wave pulse modulation, since it is simpler to expound the procedure thus, but it is to be understood that any form of modulation, such as sinusoidal modulation, can equally well be used.
- the modulation period of the external illumination generated by the throat patch is given by T, and the detected illumination intensity from the internal illumination, is designated by the letter i, while that arising from the external illumination is designated by the letter e.
- the time graphs illustrate two different ways of controlling the imaged intensity, either for display to the user or for use as an input to any other control feature such as automatic guidance, without the need for any connection, physical or wireless to the throat patch in order to change the apparent illumination level emitted from the throat patch, as displayed or analyzed by the system.
- FIG. 6 A shows the combined output of the internal and external illumination detected by the image sensor.
- the total illumination is composed of the modulated external illumination e riding on top of the constant internal illumination i.
- this sampling process can be performed either by means of a sampling gate implemented in the imaging hardware, or by means of a virtual sampling gate implemented by the image processing algorithms operating on the imaging data.
- Fig. 6D shows the time trace of the periodic sampling gate of Fig. 6B, but this time with the sampling gate in anti -phase with the external modulated illumination.
- the resulting signal output is shown in Fig. 6E, where it is seen that since the sampling gate is OFF during the ON periods of the external illumination, the external illumination is completely suppressed, and only the internal illumination, i, is displayed.
- the phase of the sampling gate relative to the phase of the external modulation illumination, it is possible to adjust the level of the external illumination sensed by the display system.
- the sampling gate is temporally positioned, such that it is 90° out of phase with the externally applied modulation illumination, and the result is intermediate between full suppression and full display of the external illumination, as shown in Fig. 6G.
- phase sensitive detection mode it is necessary for the display system to be able to synchronize to the phase of the external modulation illumination, which, being generated in a completely independent unit, cannot be measured by direct electronic connection to the source modulation driver.
- Such synchronization can be achieved by simply varying the phase delay ⁇ of the sampling gate, while observing the total intensity of the video stream images detected. When the total intensity is at a maximum, which is a sign that the sampling gate timing is exactly in phase with the external modulation.
- Figs. 7 A to 7E illustrate an alternative method of controlling the displayed image intensity, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system. This method operates by use of video frame manipulation, including addition or subtraction of frame sequences.
- Fig. 7A is equivalent to Fig. 6A, and shows the combined output of the internal and external illumination detected by the image sensor system.
- Fig. 7B is equivalent to Fig.
- Fig. 7C is equivalent to Fig. 6E, and shows the display outputted for anti-phase detection of the illumination, which corresponds to the internal illumination, i, only.
- the image video frame streams can now be time manipulated by the system algorithm, in order to achieve the desired output.
- Fig. 7D the internal illumination signal of Fig. 7C has been shifted by 180°, so that it is now in the same phase as the in-phase detected illumination shown in Fig. 6B. If the signal train of Fig. 7D is now subtracted from that of Fig. 7B, the resulting output shown in Fig. 7E is a video train, representing the external illumination only.
- phase shift applied to the video train of Fig. 7D before subtraction from that of Fig. 7B, it becomes possible to vary the comparative percentages of the internal and external illumination shown in the displayed images.
- attenuation can be applied to either the internal video data stream, as represented by Fig. 7D, or the external video data stream, as represented by Fig. 7E, in order to achieve the optimum illumination combination for the intubation procedure. If an auto gain feature is provided in the display control, then any of these attenuation or phase adjustments can be performed automatically, to provide a loop closing illumination level.
- the intubation illumination system of the present disclosure includes a battery powered, stand-alone light source unit, which can most conveniently be in the form of a dermal patch, applied adhesively to the external throat region of the subject opposite the trachea/esophagus bifurcation, such that the illumination 4 emitted by the dermal patch, is directed internally towards the subject's airway.
- the illumination patch can be held in position either by an adhesive sticky pad, or by means of a strap, or by any other means which will hold the source in position on the subject's throat.
- the dermal patch can be simply constructed, containing in its simplest implementation, at least one battery, at least one light emitter configured to emit visible light, at least one light emitter configured to emit non-visible light, and a circuit for powering the at least one light emitter configured to emit visible light and the at least one light emitter configured to emit non-visible light.
- the dermal patch can be manufactured to be disposable, such that its use becomes extremely simple.
- the dermal patch may be applied to the subject's throat, and once the intubation has been completed, it can be removed and discarded.
- a battery of low capacity may be used, capable of supplying power to the light source only for the duration of one intubation procedure, or somewhat more for safety considerations.
- the circuit is configured to power either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non-visible light, not both.
- the at least one light emitter configured to emit visible light is a light emitting diode.
- the at least one light emitter configured to emit visible light emits red light. [000109] In some embodiments, the at least one light emitter configured to emit visible light emits green light.
- the at least one light emitter configured to emit visible light emits blue light.
- the at least one light emitter configured to emit visible light emits yellow light.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 750 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 400 nm to 750 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 450 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 450 nm to 495 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 495 nm to 570 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 570 nm to 590 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 590 nm to 620 nm.
- the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 620 nm to 750 nm. [000120] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength of 625 nm.
- the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 0.5 Hz to 60 Hz.
- the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 2 Hz to 4 Hz.
- the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- the at least one light emitter configured to emit non-visible light is a light emitting diode.
- the at least one light emitter configured to emit non-visible light emits near infra-red light.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1400 nm.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1200 nm.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1000 nm.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 850 nm.
- the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 800 nm. [000131] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength of 850 nm.
- the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 0.5 Hz to 60 Hz.
- the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 2 Hz to 4 Hz.
- the modulated illumination output of the at least one light emitter configured to emit non-visible light is a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- the modulation frequency of the at least one light emitter configured to emit visible light is the same as the modulation frequency of the at least one light emitter configured to emit non-visible light.
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value
- the light emitted from the at least one light emitter configured to emit visible light and the light emitted from the at least one light emitter configured to emit non-visible light is a range which has good transmission through the tissues of the subject's neck, and to which silicon photo -detector arrays, whether CCD or CMOS, have good sensitivity.
- Such Si camera arrays are preferable because of their low cost and wide availability.
- the at least one light emitter configured to emit visible light comprises at least one light emitter configured to emit visible light comprises at least one LED.
- the at least one light emitter configured to emit visible light comprises four or more LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises four LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises three LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises two LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises one LED.
- the at least one light emitter configured to emit non-visible light comprises at least one light emitter configured to emit non-visible light comprises at least one LED.
- the at least one light emitter configured to emit non-visible light comprises four or more LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises four LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises three LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises two LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises one LED.
- the imaging module In order for the system to be able to handle the different internally collected levels of airway illumination that could arise from application of an external illumination source, the imaging module must be able to process and display the internal view of the subject's glottal region at an intensity that can be comfortably viewed by the medical personnel administering the intubation, or readily used by any automatic guidance procedures that require a processable image for implementation of the procedure. Therefore, the imaging module should have a system by which the level of light of the imaged frames of the subject's airways can be controlled. However, in order not to depart from the primary concept of the use of a disposable low-cost dermal patch, the imaging module should operate completely independently from the dermal patch, and have no connection thereto.
- the dermal patch is constructed to emit modulated illumination, at a predetermined modulation rate
- the detection system is adapted to detect the modulated illumination penetrating to the subject's airway, and to adjust the level of the output image for display and processing by phase manipulation and/or gating of the received modulated signal.
- the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 0.5 Hz to 60 Hz.
- the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 2 Hz to 4 Hz.
- the modulated illumination output of the at least one light emitter configured to emit visible light is a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 0.5 Hz to 60 Hz.
- the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 2 Hz to 4 Hz.
- the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
- the modulation frequency of the at least one light emitter configured to emit visible light is the same as the modulation frequency of the at least one light emitter configured to emit non-visible light.
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value
- the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value
- adjustment of the displayed light intensity is generated either by an auto-gain feedback system within the electronic display and processing system, or by user preferences, applied by the user as he/she views the images of the intubation on the display 54 as the intubation proceeds. Adjustment of the apparent illumination level, as seen as the displayed light intensity, is achieved entirely within the processing system. The user can thus control the intensity of that part of the image arising from the externally applied illumination during the intubation procedure to the level desired for maximum clarity, without communicating either physically or wirelessly with the external battery powered passive light source, which remains completely independent of the detection, control and display electronic units.
- the applied external light source transmits a predetermined and fixed light level, which is modulated in order to be able to perform the intensity manipulation of the displayed images, and is completely independent and unconnected to the electronic display and processing system. This is one of the features that enables the external light source to be made as a low-cost and disposable item.
- the detection and image processing system may function by applying known image processing techniques to separate those parts of the images of the video frames arising from the modulated illumination coming from either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non- visible light, or both, from those parts of the images of the video frames arising from the internally applied illumination coming from the endotracheal tube illumination system.
- this technique may also enable possible automatic guidance of the endotracheal tube into the trachea, with minimal or no user assistance.
- FFT Fast Fourier Transform
- One such common image processing technique uses a Fast Fourier Transform (FFT) algorithm to extract any components of the original images detected at the modulation frequency, and to create from these components, a separate image of the modulated illumination, which can then be used as emphasized features overlaid on the conventional for the imaged frames detected by the endotracheal tube video display system.
- FFT Fast Fourier Transform
- Such an algorithm requires knowledge of the modulation frequency of the externally applied illumination source, but since the standard video frame rates are low, typically no more than a few tens of Hz, modulation frequencies of between 0.5 Hz and 60 Hz can be typically used in this situation.
- the bandwidth of any FFT algorithm can therefore readily accommodate such a low frequency, and the predetermined modulation frequency can be closely tracked.
- the FFT algorithm is sufficiently fast to enable signal processing to the performed in real-time on each frame of the video stream.
- Eulerian video magnification can be used as another method of delineating the time varying components of the sensed illumination arising from the externally applied light from the constant or slowly varying background illumination from inside the subject's throat regions.
- Figs. 6A to 6G illustrate a method based on phase sensitive detection techniques.
- the display system In order to implement such a phase sensitive detection mode, it is necessary for the display system to be able to synchronize to the phase of the external modulation illumination from either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non-visible light, or both, which, being generated in a completely independent unit, cannot be measured by direct electronic connection to the source modulation driver.
- Such synchronization can be achieved by simply varying the phase delay ⁇ of the sampling gate, while observing the total intensity of the video stream images detected. When the total intensity is at a maximum, which is a sign that the sampling gate timing is exactly in phase with the external modulation.
- Another method based on phase manipulation is to subtract images generated when the externally modulated light source is at its maximal or ON intensity from the images generated when the externally modulated light source is at its minimal or OFF intensity state.
- FIG. 7 A to 7E illustrate an alternative method of controlling the displayed image intensity, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system.
- the intubation guidance system described herein it is possible readily to implement an automatic intubating system, using the enhanced image of the modulated illumination emitted from the position of the trachea as the target for the endotracheal tube.
- the image is processed in order to isolate or increase the modulated light originated from the external source, and to separate it from the "background" noise which did not originate from the modulated external source.
- the processing of the image can be done by using the system and algorithms described hereinabove, or by any other methods.
- the area in the image where the received intensity of the modulated light is maximal can be calculated in order to define the preferred direction for the automatic guidance and movement of a mechanical or robotic conduit that carries the intubation tube towards the trachea.
- the tip of the conduit is guided to automatically turn towards the maximum modulated light intensity as calculated by the software, whereas the movement of tip or of the entire conduit forward or backward within the subject's throat may be performed manually by the user.
- Fig. 8 is a schematic drawing of another embodiment of a disposable illumination patch, showing the battery, electronic circuitry for generating the modulated drive current for the illumination source, an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor.
- the disposable illumination patch of Fig. 8 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects.
- Fig. 9 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor.
- the disposable illumination patch of Fig. 9 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
- Fig. 10 is a schematic drawing of another embodiment of a disposable illumination patch, showing a potentiometer to vary the intensity of illumination, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor.
- the disposable illumination patch of Fig. 10 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
- Fig. 12 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, an indicator LED, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination.
- the indicator LED is configured to indicate that the power to the illumination patch is "on”.
- the indicator LED is configured to indicate that the state of charge in the battery is acceptable for use.
- the indicator LED is configured to indicate that the state of charge of the battery is low.
- the dermal patch 12 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
- Fig. 13 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, an indicator LED, an external power supply, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination.
- the disposable illumination patch of Fig. 13 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile.
- the dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
- Figs. 14A-D are schematic drawings of embodiments of illumination patches, depicting various configurations of disposable and reusable components.
- the battery is in the reusable part of the illumination patch.
- the battery is in the disposable part of the illumination patch.
- the power supply is external to the illumination patch.
- the present invention provides a method for performing guided tracheal intubation on a subject, using a system according to some embodiments of the present invention, comprising:
- the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
- the method further comprises processing the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
- distinguishing the subject's esophagus from the subject's trachea allows the user to correctly position an endotracheal tube.
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Abstract
The present invention provides a system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
Description
GUIDED ENDOTRACHEAL INTUBATION SYSTEM
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional Patent Application Serial Nos.
62/257,470, filed on November 19, 2015, and 62/341,872, filed on May 26, 2016, the entire contents of which are incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] Some embodiments relate to the field of endotracheal intubation, especially using external illumination to assist in the positioning of the endotracheal tube in the trachea of a subject.
SUMMARY
[0003] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.
[0004] Among those benefits and improvements that have been disclosed, other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying figures. Detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely illustrative of the invention that may be embodied in various forms. In addition, each of the examples given in connection with the various embodiments of the invention which are intended to be illustrative, and not restrictive.
[0005] Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases "in one embodiment" and "in some embodiments" as used herein do not necessarily refer to the same
embodiment^ s), though it may. Furthermore, the phrases "in another embodiment" and "in some other embodiments" as used herein do not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments of the invention may be readily combined, without departing from the scope or spirit of the invention.
[0006] In addition, as used herein, the term "or" is an inclusive "or" operator, and is equivalent to the term "and/or," unless the context clearly dictates otherwise. The term "based on" is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of "a," "an," and "the" include plural references. The meaning of "in" includes "in" and "on."
[0007] In one embodiment, the present invention provides a system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
[0008] In one embodiment, the system further comprises an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
[0009] In one embodiment, the system further a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
[00010] In one embodiment, the dermal patch is configured to provide the frequency- modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
[00011] In one embodiment, the apparent sensed illumination intensity is adjusted to the pre-determined value by the user.
[00012] In one embodiment, the apparent sensed illumination intensity is adjusted to the pre-determined value by the control system.
[00013] In one embodiment, the processing of the image data further comprises phase manipulation of the image data, wherein the phase manipulation is configured to discriminate between the illumination of the subject's trachea by the frequency modulated light output and illumination of the subject's trachea from other sources.
[00014] In one embodiment, the dermal patch comprises at least one battery, at least one light emitter, and a circuit for powering the at least one light emitter.
[00015] In one embodiment, the dermal patch further comprises a skin contact sensor configured to activate the light source when the light source contacts the subject's neck.
[00016] In one embodiment, the dermal patch further comprises a potentiometer configured to vary the maximum intensity of the light output.
[00017] In one embodiment, the dermal patch further comprises a power switch.
[00018] In one embodiment, the at least one light emitter is a light emitting diode.
[00019] In one embodiment, the frequency-modulated light output has a wavelength within the range of from 0.4 micrometers to 1.4 micrometers.
[00020] In one embodiment, the dermal patch further comprises an adhesive element, for application to the neck of the subject in the region of the subject's larynx.
[00021] In one embodiment, the dermal patch further comprises a strap, for application to the neck of the subject in the region of the subject's larynx.
[00022] In one embodiment, the dermal patch is disposable.
[00023] In one embodiment, the image data is received by the system at a frequency at least 2 times greater than the frequency-modulated light output.
[00024] In one embodiment, the frequency-modulated light output is in the frequency range of 0.5 Hz to 60 Hz.
[00025] In one embodiment, the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[00026] In one embodiment, the dermal patch comprises at least one battery, at least one light emitter configured to emit visible light, at least one light emitter configured to emit non- visible light, and a circuit for powering the at least one light emitter configured to emit visible light and the at least one light emitter configured to emit non-visible light.
[00027] In one embodiment, the circuit is configured to power either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non- visible light, not both.
[00028] In one embodiment, the at least one light emitter configured to emit visible light is a light emitting diode.
[00029] In one embodiment, the at least one light emitter configured to emit visible light emits red light.
[00030] In one embodiment, the at least one light emitter configured to emit visible light emits green light.
[00031] In one embodiment, the at least one light emitter configured to emit visible light emits blue light.
[00032] In one embodiment, the at least one light emitter configured to emit visible light emits yellow light.
[00033] In one embodiment, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 750 nm.
[00034] In one embodiment, the at least one light emitter configured to emit visible light emits light having a wavelength of 625 nm.
[00035] In one embodiment, the at least one light emitter configured to emit non-visible light is a light emitting diode.
[00036] In one embodiment, the at least one light emitter configured to emit non-visible light emits near infra-red light.
[00037] In one embodiment, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1400 nm.
[00038] In one embodiment, the at least one light emitter configured to emit non-visible light emits light having a wavelength of 850 nm.
[00039] In one embodiment, the frequency -modulated light output of the at least one light emitter configured to emit visible light is the same as the frequency-modulated light output of the at least one light emitter configured to emit non-visible light.
[00040] In one embodiment, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value.
[00041] In one embodiment, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value.
[00042] In one embodiment, the present invention provides a method for performing guided tracheal intubation on a subject, using a system according to some embodiments of the present invention, comprising:
a. externally illuminating the neck of the subject in the region of the subject's larynx; and
b. receiving a stream of image data from the camera located at the distal end of the endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck,
wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and
wherein the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea
[00043] In one embodiment, the method further comprises processing the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
[00044] The figures constitute a part of this specification and include illustrative embodiments of the present invention and illustrate various objects and features thereof. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. In addition, any measurements, specifications and the like shown in the figures are intended to be illustrative, and not restrictive. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention. The figures are listed below.
BRIEF DESCRIPTION OF THE FIGURES
[00045] Fig. l shows schematically a conventional endotracheal procedure being performed on a subject.
[00046] Fig. 2 is a schematic view of a prior art sensing system for tracheal intubation, making use of an externally applied illumination source.
[00047] Fig. 3 schematically shows the system architecture of the prior art intubation system shown in Fig. 2.
[00048] Fig. 4A illustrates schematically a novel intubation illumination system of the present disclosure according to some embodiments, while Fig. 4B is a schematic drawing of an exemplary disposable illumination patch for use in the system of Fig. 4A according to some embodiments of the invention.
[00049] Figs. 5 schematically shows the system architecture of the intubation system of
Fig. 4A according to some embodiments of the invention.
[00050] Figs. 6A-6G illustrate the use of phase sensitive detection techniques on received modulation pulse trains for a method of viewing endoscopic intubation and for controlling the displayed image intensity, using the system of Fig. 4 according to some embodiments of the invention.
[00051] Figs. 7A-7E illustrate an alternative method to that of Figs. 6A-6G, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system according to some embodiments of the invention.
[00052] Fig. 8 is a schematic drawing of an exemplary disposable illumination patch further configured with a skin sensor according to some embodiments of the invention.
[00053] Fig. 9 is a schematic drawing of an exemplary disposable illumination patch further configured with a power switch according to some embodiments of the invention.
[00054] Fig. 10 is a schematic drawing of an exemplary disposable illumination patch further configured with a potentiometer according to some embodiments of the invention.
[00055] Fig. 11 is a representation of the modulation of the output of the at least one light emitter according to some embodiments of the present invention.
[00056] Fig. 12 is a schematic drawing of an exemplary disposable illumination patch further configured with an indicator LED according to some embodiments of the invention.
[00057] Fig. 13 is a schematic drawing of an exemplary disposable illumination patch further configured with an external power supply according to some embodiments of the invention.
[00058] Figs. 14 A-D are schematic drawings of exemplary disposable illumination patches according to some embodiments of the invention.
DESCRIPTION
[00059] In some embodiments, the present invention provides systems for the simple yet accurate viewing, guidance and execution of endotracheal intubation. In some embodiments, the system utilizes light source comprising a dermal patch configured to provide a frequency modulated light output, and configured to be applied externally to the neck of a subject, over the subject's larynx.
[00060] Without intending to be limited to any particular theory, during intubation, a flexible endotracheal tube is inserted into the subject's trachea. During the intubation, accidental misplacement of the distal end of the endotracheal tube is to be avoided. In some embodiments, the endotracheal tube contains within its lumen, an optical sensing system, having a camera and a light source at the distal end, configured to provide data, in the form of images of the subject's trachea at the location of the distal end of the endotracheal tube.
[00061] By way of illustration, reference is now made to Fig. 1, which illustrates schematically a conventional endotracheal procedure being performed on a subject 10. The trachea 11 is shown in its location in front of the esophagus 12, and an endotracheal intubation tube 13 has been successfully inserted past the epiglottis 14 and past the vocal chords 15 which are located at the junction of the trachea 11 and the esophagus 12, into the trachea. The problem of successfully negotiating the junction of the trachea and the esophagus is clear from Fig. 1. In
commonly used procedures, the attending personnel manipulate the intubation tube into its correct position in the trachea by endoscopically viewing the progress of the distal tip of the intubation tube using illumination conveyed internally down the intubation tube assembly.
[00062] Reference is now made to Fig. 2, which is a schematic view of a prior art sensing system for tracheal intubation. In this system, an energy source 21, which is conveniently an optical source, conveys illumination down a light guide 22 to the external region 23 of the subject's throat, and the light passing through the tissue of the subject's throat illuminates the trachea far more strongly than the esophagus. An endoscopic intubation tube 24 provides an image of the junction region, which is viewed in the display and processing, and steering system 25. Because of the increased illumination in the trachea, the display signal processing software can determine the position of the entrance to the trachea, and can selectively enable the intubation tube to be directed into the trachea.
[00063] However, as in all such tracheal imaging systems, there exists the problem that the illumination sensed internally within the subject's throat region, can vary considerably because any cross-sectional population of subjects will have a variety of neck sizes and skin colors. These will range from the small, thin, baby's neck, which has very little light absorption ability and therefore will have a very high intra-airway intensity level, to the thick neck of, for instance, an overweight, adult subject, where the illumination penetrating to the larynx region and hence to the image sensor, will be substantially lower. The illuminating device and power level used for the baby would be almost useless for performing the procedure on the large adult subject. In order to overcome this problem, the prior art system described has a light intensity auto-gaining feature, in which a feedback loop is established between the level of light detected by the endoscopic intubation tube sensor electronic circuitry, and the light level applied from the
light source unit to the outside of the subject's throat. The electronic circuitry 25 and the light source unit 21 must be electronically linked, as shown by the electronic communication cable connection 26 in Fig. 2.
[00064] A further need for controlled adjustment of the illumination level in such a system is because of the change in sensed illumination as the intubation tube is moved down the subject's throat. Without intending to be limited to any particular theory, in order to maintain a reasonable level of sensed illumination from the externally located source, and also in order to effectively discriminate the sensed illumination from the external source from any illumination internally provided by the illumination system of the intubation tube endoscope, the externally emitted illumination should be changed to compensate for changes in the optical transmission through the neck cartilage and tissue to the viewing lens of the endoscope, as it moves down the throat.
[00065] Reference is now made to Fig. 3, which schematically shows the system architecture of the prior art intubation system of the type shown in Fig. 2. The externally applied light source 30 delivers its illumination through the subject's tissues, as indicated by the arrow 31, to the region of the trachea/esophagus bifurcation. The endoscopic detector 32 of the endotracheal intubation tube images the inside of the subject's throat, and conveys these images, which could be in the form of a video stream, to the electronic display and processing system 33, which can include display and signal processing hardware and software, for outputting such a video stream to a display unit 34 for view by the user 35. In addition, this electronic unit can include a user interface 36, by means of which the user can control the display function by inputting 37 commands back to the electronic system. After processing the received image intensities, and any user inputs from, the user interface, the electronic system 33, is programmed
to send a feedback signal 38 to the light source 30, in order to control the level of the external illumination applied to the subject's throat. The system is thus complex, requiring the use of its own dedicated sensing and illumination units, connected electronically so that they will operate correctly together.
[00066] In some embodiments, the present invention provides a system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
[00067] In some embodiments, the system further comprises an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
[00068] In some embodiments, the system further a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
[00069] In some embodiments, the present invention provides system for performing guided tracheal intubation on a subject, comprising: a. a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea; b. an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency -modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea; and c. a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a predetermined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
[00070] In some embodiments, the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
[00071] In some embodiments, the present invention provides system for performing guided tracheal intubation on a subject, comprising: a. a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein
the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea; and b. an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency -modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
[00072] In some embodiments, the system further comprises a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
[00073] In some embodiments, the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
[00074] Without intending to be limited to any particular theory, if the apparent sensed illumination intensity is below the pre-determined level, the trachea may not be detectable. Furthermore, if the apparent sensed illumination intensity is above the pre-determined level, the image data may contain light from both the trachea and the esophagus, and/or light that may be reflected or scattered from the surrounding tissues, thereby causing anatomical identification errors. One of ordinary skill in the art may readily determine the pre-determined level of the apparent sensed illumination intensity.
[00075] Without intending to be limited to any particular theory, the image data may be processed as the distal end of the endotracheal tube advances down the subject's trachea toward the subject's larynx, to compensate to changes in the intensity of the frequency modulated light detected by the camera on the distal end of the endotracheal tube. The changes in the intensity of the frequency modulated light may be due to, for example, the distance of the distal end of the endotracheal tube from the light source configured to provide a frequency-modulated light output.
[00076] As used herein, the term "frequency -modulated light output" refers to the periodic variation of the intensity of the light output from the light source from a first value to a second value, wherein the periodic variation has a given fixed time interval or frequency.
[00077] In some embodiments, the frequency of the periodic variation of the intensity of the light output from the light source is in the range of 0.5 Hz to 60 Hz.
[00078] In some embodiments, the frequency of the periodic variation of the intensity of the light output from the light source is in the range of 2 Hz to 4 Hz.
[00079] In some embodiments, the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[00080] Reference is now made to Fig. 4A, which illustrates schematically an exemplary implementation of the novel intubation illumination system of the present disclosure according to some embodiments. In some embodiments, the present system differs from that shown in the above mentioned prior art, in that the illumination is supplied by a stand-alone light source unit 40, which can be in the form of a dermal patch, applied adhesively to the external throat region
of the subject opposite the trachea/esophagus bifurcation, such that the frequency modulated illumination 44 emitted by the dermal patch, is directed internally towards the subject's airway.
[00081] As used herein, the term "autonomous" or "stand alone" refers to a dermal patch comprising a light source that is configured to operate without input from any other component of the system of the present invention, wherein a dermal patch comprising a light source is configured to provide the frequency-modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
[00082] In some embodiments, the dermal patch is configured to provide the frequency- modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
[00083] In some embodiments, the dermal patch can be held in position either by an adhesive sticky pad, or by means of a strap, or by any other means which will hold the dermal patch in position on the subject's throat. In some embodiments, the dermal patch can be simply constructed, containing in its simplest implementation, no more than a battery, one or more LED's, and a power supply for providing the current for the LED's. Because of this simple and low cost structure in the embodiment shown, the dermal patch can be manufactured to be disposable, such that its use becomes extremely simple.
[00084] The dermal patch may be applied to the subject's throat, and once the intubation has been completed, it can be removed and discarded. For such a disposable illumination patch, a battery of low capacity may be used, capable of supplying power to the light source only for the duration of one intubation procedure, or somewhat more for safety considerations. The illumination patch is adapted to emit a constant level of average light output, and can thus be completely independent of any input signals from other electronic control units. The wavelength
of the illumination 44 emitted by the light source 40 can conveniently be in the range of the visible to near infra-red, which is a range which has good transmission through the tissues of the subject's neck, and to which silicon photo -detector arrays, whether CCD or CMOS, have good sensitivity. Such Si camera arrays are preferable because of their low cost and wide availability. The VIS-NIR wavelengths most typically used for implementing the systems of the present disclosure, range from approximately 0.4 to 1.4 μπι, though wavelengths outside of this range may also be possible.
[00085] Fig. 4B is a schematic drawing of one embodiment of a disposable illumination patch 40, showing the battery 41, electronic circuitry 42 for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes 43, emitting their illumination 44. Although for the purposes of showing its internal construction, the disposable illumination patch 40 of Fig. 4B is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects.
[00086] However, regardless of suitability of the size of the dermal patch used, in order for the system to be able to handle the different internally collected levels of airway illumination that could arise from application of an external illumination source having a fixed intensity output level, the imaging module must be able to process and display the internal view of the subject's glottal region at an intensity that can be comfortably viewed by the medical personnel administering the intubation, or readily used by any automatic guidance procedures that require a processable image for implementation of the procedure. Therefore, the imaging module should
have a system by which the level of light of the imaged frames of the subject's airways can be controlled. However, in order not to depart from the primary concept of the use of a disposable low-cost dermal patch, the imaging module should operate completely independently from the dermal patch, and have no connection thereto. In order to achieve this, in an exemplary implementation of such an intensity control system, the dermal patch is constructed to emit modulated illumination, at a predetermined frequency modulation, and the detection system is adapted to detect the frequency modulated light penetrating to the subject's airway, and to adjust the level of the output image for display and processing by phase manipulation and/or gating of the received modulated signal.
[00087] In some embodiments, the apparent sensed illumination intensity is adjusted to the pre-determined value by the user.
[00088] In some embodiments, the apparent sensed illumination intensity is adjusted to the pre-determined value by the control system.
[00089] In some embodiments, the processing of the image data further comprises phase manipulation of the image data, wherein the phase manipulation is configured to discriminate between the illumination of the subject's trachea by the frequency modulated light output and illumination of the subject's trachea from other sources.
[00090] Reference is now made to Fig. 5, which schematically shows the system architecture of the intubation system according to certain embodiments of the present invention, displayed in a similar manner to that shown in Fig. 3 for prior art systems. The externally applied light source 50 is a battery powered light source, which can conveniently be disposable after use. The light output 51 is modulated, passes into the subject's glottal region, and is imaged by a detector unit 52, which transfers the video stream to the electronic display and processing
system 53. The system differs from that shown in Fig. 3, in that there is no feedback or connection from the electronic display and processing system 53 to the externally applied light source 50. In the embodiment shown, adjustment 58 of the displayed light intensity is generated either by an auto-gain feedback system within the electronic display and processing system 53, or by user preferences 56, applied by the user 55 as he/she views the images of the intubation on the display 54 as the intubation proceeds. Adjustment of the apparent illumination level, as seen as the displayed light intensity, is achieved entirely within the processing system 53, as indicated by the arrow 58. The user can thus control the intensity of that part of the image arising from the externally applied illumination during the intubation procedure to the level desired for maximum clarity, without communicating either physically or wirelessly with the external battery powered passive light source, which remains completely independent of the detection, control and display electronic units.
[00091] An important difference from the prior art systems is that in the system of the present disclosure, the applied external light source 50 transmits a predetermined frequency modulated light output in order to be able to perform the intensity manipulation of the displayed images, and is completely independent and unconnected to the electronic display and processing system 53. This is one of the features that enables the external light source 50 to be made as a low-cost and disposable item.
[00092] However, in some embodiments, the dermal patch is further configured to vary the intensity of illumination.
[00093] In some embodiments, the dermal patch is further configured to vary the intensity of illumination via a potentiometer.
[00094] In some embodiments, the detection and image processing system may function by applying known image processing techniques to separate those parts of the images of the video frames arising from the modulated illumination coming from the external source, from those parts of the images of the video frames arising from illumination coming from the endotracheal tube illumination system, such as, for example, a light source incorporated in the distal end of the optical sensing system. By this means it becomes possible to control the comparative level of these two illumination components, and in particular to maintain the modulated illumination emerging from the trachea at a level which enables ready identification of the trachea. In addition to providing the user with a simpler and more readily controllable image display for use in manually guided intubation procedures, this technique may also enable possible automatic guidance of the endotracheal tube into the trachea, with minimal or no user assistance.
[00095] One such common image processing technique uses a Fast Fourier Transform
(FFT) algorithm to extract any components of the original images detected at the modulation frequency, and to create from these components, a separate image of the modulated illumination, which can then be used as emphasized features overlaid on the conventional for the imaged frames detected by the endotracheal tube video display system. Such an algorithm requires knowledge of the modulation frequency of the externally applied illumination source, but since the standard video frame rates are low, typically no more than a few tens of Hz, modulation frequencies of between 0.5 Hz and 60 Hz can be typically used in this situation. The bandwidth of any FFT algorithm can therefore readily accommodate such a low frequency, and the predetermined modulation frequency can be closely tracked. Furthermore, the FFT algorithm is
sufficiently fast to enable signal processing to the performed in real-time on each frame of the video stream.
[00096] Eulerian video magnification can be used as another method of delineating the time varying components of the sensed illumination arising from the externally applied light from the constant or slowly varying background illumination from inside the subject's throat regions.
[00097] Other possible methods of processing the image data are based on identifying the phase of the modulation in the images and to separate the image into its two component parts— one that is in-phase with the external light source, where light originated from the external light source will be seen with maximal intensity, and one which is out-of-phase with the external light source, where light originated from the external light source will be seen with minimal intensity or will not be seen at all.
[00098] Another method based on phase manipulation, is to subtract images generated when the externally modulated light source is at its maximal or ON intensity from the images generated when the externally modulated light source is at its minimal or OFF intensity state.
[00099] In order to illustrate how these latter two image processing methods operate, reference is now made respectively to Figs. 6A to 6G and to Figs. 7A to 7E, which are time based graphs of the sensed illumination, I, displayed by the endoscopic viewing system, as a function of elapsed time, t. The graphs of 6A-6G and 7A-7E are drawn using square-wave pulse modulation, since it is simpler to expound the procedure thus, but it is to be understood that any form of modulation, such as sinusoidal modulation, can equally well be used. The modulation period of the external illumination generated by the throat patch is given by T, and the detected illumination intensity from the internal illumination, is designated by the letter i, while that
arising from the external illumination is designated by the letter e. The time graphs illustrate two different ways of controlling the imaged intensity, either for display to the user or for use as an input to any other control feature such as automatic guidance, without the need for any connection, physical or wireless to the throat patch in order to change the apparent illumination level emitted from the throat patch, as displayed or analyzed by the system.
[000100] Reference is first made to Figs. 6A to 6G, which illustrate a method based on phase sensitive detection techniques. Fig. 6 A shows the combined output of the internal and external illumination detected by the image sensor. The total illumination is composed of the modulated external illumination e riding on top of the constant internal illumination i. Fig. 6B shows the time trace of a periodic sampling gate applied to the detected illumination of Fig. 6 A, the gate temporal profile having the same frequency f = 1/T as the external modulated illumination, and being in phase with it. It is to be understood that this sampling process can be performed either by means of a sampling gate implemented in the imaging hardware, or by means of a virtual sampling gate implemented by the image processing algorithms operating on the imaging data. Additionally, although according to the Nyquist sampling theory, in order to accurately detect an unknown modulated light signal, it is necessary to sample it at a frequency at least twice the modulation frequency, if the modulation frequency is known, either by knowledge of the predetermined characteristics of the external illumination source, or if not, by a preliminary calibration step (which does then need to use the Nyquist criterion), this requirement is unnecessary, and only the gating mechanism for selection of the sampled signals at the modulation frequency is considered to explain this method. The method by which phase synchronization is achieved, when the external modulation is free-running and has no electronic connection with the display system, is described hereinbelow. The resulting signal output from
the sampling profile shown in Fig. 6B is shown in Fig. 6C, where a signal is shown representing the total illumination i+e, and in phase with the external modulation of the dermal patch.
[000101] Reference is now made to Fig. 6D, which shows the time trace of the periodic sampling gate of Fig. 6B, but this time with the sampling gate in anti -phase with the external modulated illumination. The resulting signal output is shown in Fig. 6E, where it is seen that since the sampling gate is OFF during the ON periods of the external illumination, the external illumination is completely suppressed, and only the internal illumination, i, is displayed. Thus, by adjusting the phase of the sampling gate relative to the phase of the external modulation illumination, it is possible to adjust the level of the external illumination sensed by the display system. Thus, for instance, in Fig. 6F, the sampling gate is temporally positioned, such that it is 90° out of phase with the externally applied modulation illumination, and the result is intermediate between full suppression and full display of the external illumination, as shown in Fig. 6G.
[000102] In order to implement such a phase sensitive detection mode, it is necessary for the display system to be able to synchronize to the phase of the external modulation illumination, which, being generated in a completely independent unit, cannot be measured by direct electronic connection to the source modulation driver. Such synchronization can be achieved by simply varying the phase delay τ of the sampling gate, while observing the total intensity of the video stream images detected. When the total intensity is at a maximum, which is a sign that the sampling gate timing is exactly in phase with the external modulation.
[000103] One of the disadvantages of the phase sensitive detection method shown in Figs. 6A to 6G is that it is impossible to eliminate the effect of the internally generated illumination from the endoscopic source, though of course it is possible to reduce the level of that
illumination if necessary. Reference is therefore now made to Figs. 7 A to 7E, which illustrate an alternative method of controlling the displayed image intensity, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system. This method operates by use of video frame manipulation, including addition or subtraction of frame sequences. Fig. 7A is equivalent to Fig. 6A, and shows the combined output of the internal and external illumination detected by the image sensor system. Fig. 7B is equivalent to Fig. 6C, and shows the displayed output for in-phase detection of the illumination. Fig. 7C is equivalent to Fig. 6E, and shows the display outputted for anti-phase detection of the illumination, which corresponds to the internal illumination, i, only. The image video frame streams can now be time manipulated by the system algorithm, in order to achieve the desired output. Thus, in Fig. 7D, the internal illumination signal of Fig. 7C has been shifted by 180°, so that it is now in the same phase as the in-phase detected illumination shown in Fig. 6B. If the signal train of Fig. 7D is now subtracted from that of Fig. 7B, the resulting output shown in Fig. 7E is a video train, representing the external illumination only. By varying the phase shift applied to the video train of Fig. 7D, before subtraction from that of Fig. 7B, it becomes possible to vary the comparative percentages of the internal and external illumination shown in the displayed images. Alternatively, attenuation can be applied to either the internal video data stream, as represented by Fig. 7D, or the external video data stream, as represented by Fig. 7E, in order to achieve the optimum illumination combination for the intubation procedure. If an auto gain feature is provided in the display control, then any of these attenuation or phase adjustments can be performed automatically, to provide a loop closing illumination level.
[000104] In some embodiments, the intubation illumination system of the present disclosure according to some embodiments includes a battery powered, stand-alone light source
unit, which can most conveniently be in the form of a dermal patch, applied adhesively to the external throat region of the subject opposite the trachea/esophagus bifurcation, such that the illumination 4 emitted by the dermal patch, is directed internally towards the subject's airway. The illumination patch can be held in position either by an adhesive sticky pad, or by means of a strap, or by any other means which will hold the source in position on the subject's throat. The dermal patch can be simply constructed, containing in its simplest implementation, at least one battery, at least one light emitter configured to emit visible light, at least one light emitter configured to emit non-visible light, and a circuit for powering the at least one light emitter configured to emit visible light and the at least one light emitter configured to emit non-visible light.
[000105] Because of this simple and low cost structure in the embodiment shown, the dermal patch can be manufactured to be disposable, such that its use becomes extremely simple. The dermal patch may be applied to the subject's throat, and once the intubation has been completed, it can be removed and discarded. For such a disposable illumination patch, a battery of low capacity may be used, capable of supplying power to the light source only for the duration of one intubation procedure, or somewhat more for safety considerations.
[000106] In some embodiments, the circuit is configured to power either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non-visible light, not both.
[000107] In some embodiments, the at least one light emitter configured to emit visible light is a light emitting diode.
[000108] In some embodiments, the at least one light emitter configured to emit visible light emits red light.
[000109] In some embodiments, the at least one light emitter configured to emit visible light emits green light.
[000110] In some embodiments, the at least one light emitter configured to emit visible light emits blue light.
[000111] In some embodiments, the at least one light emitter configured to emit visible light emits yellow light.
[000112] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 750 nm.
[000113] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 400 nm to 750 nm.
[000114] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 450 nm.
[000115] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 450 nm to 495 nm.
[000116] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 495 nm to 570 nm.
[000117] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 570 nm to 590 nm.
[000118] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 590 nm to 620 nm.
[000119] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 620 nm to 750 nm.
[000120] In some embodiments, the at least one light emitter configured to emit visible light emits light having a wavelength of 625 nm.
[000121] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 0.5 Hz to 60 Hz.
[000122] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 2 Hz to 4 Hz.
[000123] In some embodiments, the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[000124] In some embodiments, the at least one light emitter configured to emit non-visible light is a light emitting diode.
[000125] In some embodiments, the at least one light emitter configured to emit non-visible light emits near infra-red light.
[000126] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1400 nm.
[000127] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1200 nm.
[000128] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 1000 nm.
[000129] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 850 nm.
[000130] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength within the range from 750 nm to 800 nm.
[000131] In some embodiments, the at least one light emitter configured to emit non-visible light emits light having a wavelength of 850 nm.
[000132] In some embodiments, the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 0.5 Hz to 60 Hz.
[000133] In some embodiments, the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 2 Hz to 4 Hz.
[000134] In some embodiments, the modulated illumination output of the at least one light emitter configured to emit non-visible light is a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[000135] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is the same as the modulation frequency of the at least one light emitter configured to emit non-visible light.
[000136] In some embodiments, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value.
[000137] In some embodiments, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value.
[000138] In some embodiments, the light emitted from the at least one light emitter configured to emit visible light and the light emitted from the at least one light emitter configured to emit non-visible light is a range which has good transmission through the tissues of
the subject's neck, and to which silicon photo -detector arrays, whether CCD or CMOS, have good sensitivity. Such Si camera arrays are preferable because of their low cost and wide availability.
[000139] In some embodiments, the at least one light emitter configured to emit visible light comprises at least one light emitter configured to emit visible light comprises at least one LED.
[000140] In some embodiments, the at least one light emitter configured to emit visible light comprises four or more LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises four LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises three LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises two LEDs. In some embodiments, the at least one light emitter configured to emit visible light comprises one LED.
[000141] In some embodiments, the at least one light emitter configured to emit non-visible light comprises at least one light emitter configured to emit non-visible light comprises at least one LED.
[000142] In some embodiments, the at least one light emitter configured to emit non-visible light comprises four or more LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises four LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises three LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises two LEDs. In some embodiments, the at least one light emitter configured to emit non-visible light comprises one LED.
[000143] In order for the system to be able to handle the different internally collected levels of airway illumination that could arise from application of an external illumination source, the imaging module must be able to process and display the internal view of the subject's glottal region at an intensity that can be comfortably viewed by the medical personnel administering the intubation, or readily used by any automatic guidance procedures that require a processable image for implementation of the procedure. Therefore, the imaging module should have a system by which the level of light of the imaged frames of the subject's airways can be controlled. However, in order not to depart from the primary concept of the use of a disposable low-cost dermal patch, the imaging module should operate completely independently from the dermal patch, and have no connection thereto. In order to achieve this, in an exemplary implementation of such an intensity control system, the dermal patch is constructed to emit modulated illumination, at a predetermined modulation rate, and the detection system is adapted to detect the modulated illumination penetrating to the subject's airway, and to adjust the level of the output image for display and processing by phase manipulation and/or gating of the received modulated signal.
[000144] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 0.5 Hz to 60 Hz.
[000145] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is in the range of 2 Hz to 4 Hz.
[000146] In some embodiments, the modulated illumination output of the at least one light emitter configured to emit visible light is a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[000147] In some embodiments, the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 0.5 Hz to 60 Hz.
[000148] In some embodiments, the modulation frequency of the at least one light emitter configured to emit non-visible light is in the range of 2 Hz to 4 Hz.
[000149] In some embodiments, the intensity of the frequency-modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
[000150] In some embodiments, the modulation frequency of the at least one light emitter configured to emit visible light is the same as the modulation frequency of the at least one light emitter configured to emit non-visible light.
[000151] In some embodiments, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value.
[000152] In some embodiments, when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value.
[000153] In some embodiments, adjustment of the displayed light intensity is generated either by an auto-gain feedback system within the electronic display and processing system, or by user preferences, applied by the user as he/she views the images of the intubation on the display 54 as the intubation proceeds. Adjustment of the apparent illumination level, as seen as the displayed light intensity, is achieved entirely within the processing system. The user can thus
control the intensity of that part of the image arising from the externally applied illumination during the intubation procedure to the level desired for maximum clarity, without communicating either physically or wirelessly with the external battery powered passive light source, which remains completely independent of the detection, control and display electronic units.
[000154] An important difference from the prior art systems is that in the system of the present disclosure, the applied external light source transmits a predetermined and fixed light level, which is modulated in order to be able to perform the intensity manipulation of the displayed images, and is completely independent and unconnected to the electronic display and processing system. This is one of the features that enables the external light source to be made as a low-cost and disposable item.
[000155] In some embodiments, the detection and image processing system may function by applying known image processing techniques to separate those parts of the images of the video frames arising from the modulated illumination coming from either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non- visible light, or both, from those parts of the images of the video frames arising from the internally applied illumination coming from the endotracheal tube illumination system. By this means it becomes possible to control the comparative level of these two illumination components, and in particular to maintain the modulated illumination emerging from the trachea at a level which enables ready identification of the trachea. In addition to providing the user with a simpler and more readily controllable image display for use in manually guided intubation procedures, this technique may also enable possible automatic guidance of the endotracheal tube into the trachea, with minimal or no user assistance.
[000156] One such common image processing technique uses a Fast Fourier Transform (FFT) algorithm to extract any components of the original images detected at the modulation frequency, and to create from these components, a separate image of the modulated illumination, which can then be used as emphasized features overlaid on the conventional for the imaged frames detected by the endotracheal tube video display system. Such an algorithm requires knowledge of the modulation frequency of the externally applied illumination source, but since the standard video frame rates are low, typically no more than a few tens of Hz, modulation frequencies of between 0.5 Hz and 60 Hz can be typically used in this situation. The bandwidth of any FFT algorithm can therefore readily accommodate such a low frequency, and the predetermined modulation frequency can be closely tracked. Furthermore, the FFT algorithm is sufficiently fast to enable signal processing to the performed in real-time on each frame of the video stream.
[000157] Eulerian video magnification can be used as another method of delineating the time varying components of the sensed illumination arising from the externally applied light from the constant or slowly varying background illumination from inside the subject's throat regions.
[000158] Reference is first made to Figs. 6A to 6G, which illustrate a method based on phase sensitive detection techniques. In order to implement such a phase sensitive detection mode, it is necessary for the display system to be able to synchronize to the phase of the external modulation illumination from either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non-visible light, or both, which, being generated in a completely independent unit, cannot be measured by direct electronic connection to the source modulation driver. Such synchronization can be achieved by simply varying the
phase delay τ of the sampling gate, while observing the total intensity of the video stream images detected. When the total intensity is at a maximum, which is a sign that the sampling gate timing is exactly in phase with the external modulation.
[000159] Other possible methods of processing the image data are based on identifying the phase of the modulation in the images and to separate the image into its two component parts— one that is in-phase with the external light source, where light originated from the external light source will be seen with maximal intensity, and one which is out-of-phase with the external light source, where light originated from the external light source will be seen with minimal intensity or will not be seen at all.
[000160] Another method based on phase manipulation, is to subtract images generated when the externally modulated light source is at its maximal or ON intensity from the images generated when the externally modulated light source is at its minimal or OFF intensity state.
[000161] Reference is therefore now made to Figs. 7 A to 7E, which illustrate an alternative method of controlling the displayed image intensity, in such a manner that the external intensity can be rendered to be the major or even the only component shown in the display system.
[000162] Using the intubation guidance system described herein, it is possible readily to implement an automatic intubating system, using the enhanced image of the modulated illumination emitted from the position of the trachea as the target for the endotracheal tube. In such a system, the image is processed in order to isolate or increase the modulated light originated from the external source, and to separate it from the "background" noise which did not originate from the modulated external source. The processing of the image can be done by using the system and algorithms described hereinabove, or by any other methods. In addition, the area in the image where the received intensity of the modulated light is maximal, can be calculated in
order to define the preferred direction for the automatic guidance and movement of a mechanical or robotic conduit that carries the intubation tube towards the trachea. In one possible implementation, the tip of the conduit is guided to automatically turn towards the maximum modulated light intensity as calculated by the software, whereas the movement of tip or of the entire conduit forward or backward within the subject's throat may be performed manually by the user.
[000163] Fig. 8 is a schematic drawing of another embodiment of a disposable illumination patch, showing the battery, electronic circuitry for generating the modulated drive current for the illumination source, an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor. Although for the purposes of showing its internal construction, the disposable illumination patch of Fig. 8 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects.
[000164] Fig. 9 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor. Although for the purposes of showing its internal construction, the disposable illumination patch of Fig. 9 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and
output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
[000165] Fig. 10 is a schematic drawing of another embodiment of a disposable illumination patch, showing a potentiometer to vary the intensity of illumination, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination, and a skin sensor. Although for the purposes of showing its internal construction, the disposable illumination patch of Fig. 10 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
[000166] Fig. 12 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, an indicator LED, the battery, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination. In some embodiments, the indicator LED is configured to indicate that the power to the illumination patch is "on". In some embodiments, the indicator LED is configured to indicate that the state of charge in the battery is acceptable for use. In some embodiments, the indicator LED is configured to indicate that the state of charge of the battery is low. Although for the purposes of showing its internal construction, the disposable illumination patch of Fig. 12 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material,
so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
[000167] Fig. 13 is a schematic drawing of another embodiment of a disposable illumination patch, showing a power switch, an indicator LED, an external power supply, electronic circuitry for generating the modulated drive current for the illumination source, and an illumination source, in this case shown as arrays of light emitting diodes, emitting their illumination. Although for the purposes of showing its internal construction, the disposable illumination patch of Fig. 13 is shown as a planar unit, it is to be understood that it is most conveniently constructed of a flexible material, so that it can conform to the profile of the subject's neck region to which it is applied, and be wrapped around that profile. The dermal patches may also be supplied in a range of sizes and output power, to more readily match the physical size and physiology of different subjects. Additionally, the dermal patch may also contain a skin sensor.
[000168] Figs. 14A-D are schematic drawings of embodiments of illumination patches, depicting various configurations of disposable and reusable components. In embodiments shown in Fig. 14 B, the battery is in the reusable part of the illumination patch. In embodiments shown in Fig. 14 C, the battery is in the disposable part of the illumination patch. In embodiments shown in Fig. D, the power supply is external to the illumination patch.
[000169] According to a further embodiment, motion of the tip or of the entire conduit forward or backward can also be automatically controlled by the system, so that the endotracheal the tube can be automatically located within the trachea.
[000170] In some embodiments, the present invention provides a method for performing guided tracheal intubation on a subject, using a system according to some embodiments of the present invention, comprising:
a. externally illuminating the neck of the subject in the region of the subject's larynx; and
b. receiving a stream of image data from the camera located at the distal end of the endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck,
wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
[000171] In some embodiments, the method further comprises processing the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea. In some embodiments, distinguishing the subject's esophagus from the subject's trachea allows the user to correctly position an endotracheal tube.
[000172] It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and sub combinations of various features described
hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.
[000173] Publications cited throughout this document are hereby incorporated by reference in their entirety. Although the various aspects of the presently disclosed embodiments have been illustrated above by reference to examples and preferred embodiments, it will be appreciated that the scope of the presently disclosed embodiments are defined not by the foregoing description but by the following claims properly construed under principles of patent law.
[000174] In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the presently disclosed embodiments. To the extent that section headings are used, they should not be construed as necessarily limiting.
Claims
1. A system, wherein the system is a dermal patch comprising a light source configured to provide a frequency-modulated light output, wherein the dermal patch is configured to be externally applied to the neck of the subject over the subject's larynx, wherein the frequency modulated light output is configured to penetrate the tissue of the subject's neck and illuminate the subject's trachea.
2. The system of claim 1, further comprising an optical sensing system, comprising a camera configured to receive a stream of image data from a distal end of an endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck, wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the frequency-modulated light output allows a user to correctly position an endotracheal tube in the subject's trachea.
3. The system of claim 2, further comprising a control system configured to receive the image data, process the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a pre-determined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
4. The system of claim 1, wherein the dermal patch is configured to provide the frequency- modulated light output once the dermal patch is activated by the user, and operate without any further input until the dermal patch is deactivated.
5. The system of claim 3, wherein the apparent sensed illumination intensity is adjusted to the pre-determined value by the user.
6. The system of claim 3, wherein the apparent sensed illumination intensity is adjusted to the pre-determined value by the control system.
7. The system of claim 3, wherein the processing of the image data further comprises phase manipulation of the image data, wherein the phase manipulation is configured to discriminate between the illumination of the subject's trachea by the frequency modulated light output and illumination of the subject's trachea from other sources.
8. The system of claim 1, wherein the dermal patch comprises at least one battery, at least one light emitter, and a circuit for powering the at least one light emitter.
9. The system of claim 8, wherein the dermal patch further comprises a skin contact sensor configured to activate the light source when the light source contacts the subject's neck.
10. The system of claim 8, wherein the dermal patch further comprises a potentiometer configured to vary the maximum intensity of the light output.
11. The system of claim 8, wherein the dermal patch further comprises a power switch.
12. The system of claim 8, wherein the at least one light emitter is a light emitting diode.
13. The system of claim 1, wherein the frequency-modulated light output has a wavelength within the range of from 0.4 micrometers to 1.4 micrometers.
14. The system of claim 8, wherein the dermal patch further comprises an adhesive element, for application to the neck of the subject in the region of the subject's larynx.
15. The system of claim 8, wherein the dermal patch further comprises a strap, for application to the neck of the subject in the region of the subject's larynx.
16. The system of claim 8, wherein the dermal patch is disposable.
17. The system of claim 2, wherein the image data is received by the system at a frequency at least 2 times greater than the frequency-modulated light output.
18. The system of claim 1, wherein the frequency-modulated light output is in the frequency range of 0.5 Hz to 60 Hz.
19. The system of claim 1, wherein the intensity of the frequency -modulated light output follows a profile selected from the group consisting of a square wave, a triangular wave, a sinusoidal wave, or any combination thereof.
20. The system of claim 1, wherein the dermal patch comprises at least one battery, at least one light emitter configured to emit visible light, at least one light emitter configured to emit non-visible light, and a circuit for powering the at least one light emitter configured to emit visible light and the at least one light emitter configured to emit non-visible light.
21. The system of claim 20, wherein the circuit is configured to power either the at least one light emitter configured to emit visible light, or the at least one light emitter configured to emit non-visible light, not both.
22. The system of claim 20, wherein the at least one light emitter configured to emit visible light is a light emitting diode.
23. The system of claim 20, wherein the at least one light emitter configured to emit visible light emits red light.
24. The system of claim 20, wherein the at least one light emitter configured to emit visible light emits green light.
25. The system of claim 20, wherein the at least one light emitter configured to emit visible light emits blue light.
26. The system of claim 20, wherein the at least one light emitter configured to emit visible light emits yellow light.
27. The system of claim 20, wherein the at least one light emitter configured to emit visible light emits light having a wavelength within the range from 380 nm to 750 nm.
28. The system of claim 27, wherein the at least one light emitter configured to emit visible light emits light having a wavelength of 625 nm.
29. The system of claim 20, wherein the at least one light emitter configured to emit non- visible light is a light emitting diode.
30. The system of claim 29, wherein the at least one light emitter configured to emit non- visible light emits near infra-red light.
31. The system of claim 29, wherein the at least one light emitter configured to emit non- visible light emits light having a wavelength within the range from 750 nm to 1400 nm.
32. The system of claim 31, wherein the at least one light emitter configured to emit non- visible light emits light having a wavelength of 850 nm.
33. The system of claim 20, wherein the frequency-modulated light output of the at least one light emitter configured to emit visible light is the same as the frequency-modulated light output of the at least one light emitter configured to emit non-visible light.
34. The system of claim 33, wherein when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a maximum value, the amplitude of the light emitted from the at least one light emitter configured to emit non-visible light is at a minimum value.
35. The system of claim 33, wherein when the amplitude of the light emitted from the at least one light emitter configured to emit visible light is at a minimum value, the amplitude of
the light emitted from the at least one light emitter configured to emit non-visible light is at a maximum value.
36. A method for performing guided tracheal intubation on a subject, using the system of claim 1, comprising:
a. externally illuminating the neck of the subject in the region of the subject's larynx; and
b. receiving a stream of image data from the camera located at the distal end of the endotracheal placement device within the throat of the subject, wherein the image data comprises the intensity of the frequency modulated light output that has penetrated the tissue of the subject's neck,
wherein the frequency modulation allows a user to identify the light output from the light source externally applied to the neck of the subject, and wherein the identification of the light output from the light source externally applied to the neck of the subject allows a user to correctly position an endotracheal tube in the subject's trachea.
37. The method of claim 36, further comprising processing the image data, and, based on the processing, generate an image having an apparent sensed illumination intensity of a predetermined value, wherein the pre-determined value is an optimal intensity for a user to distinguish the subject's esophagus from the subject's trachea.
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US5560351A (en) * | 1994-10-07 | 1996-10-01 | University Of Florida | Transtracheal energy application and sensing system for intubation: method and apparatus |
US7131990B2 (en) * | 2002-10-07 | 2006-11-07 | Natus Medical Inc. | Phototherapy system and device |
US8954134B2 (en) * | 2005-09-13 | 2015-02-10 | Children's Medical Center Corporation | Light-guided transluminal catheter |
DE102006008990B4 (en) * | 2006-02-23 | 2008-05-21 | Atmos Medizintechnik Gmbh & Co. Kg | Method and arrangement for generating a signal corresponding to the opening state of the vocal folds of the larynx |
KR20120024495A (en) * | 2010-09-03 | 2012-03-14 | 주식회사 세라젬메디시스 | Lighting device for skin |
US8747306B1 (en) * | 2011-07-28 | 2014-06-10 | Patricia Ramos | Endotracheal intubation assistance device and method of use |
US20150164310A1 (en) * | 2012-07-13 | 2015-06-18 | The Henry M. Jackson Foundation For The Advancement Of Military Medicine, Inc. | Infrared illuminated airway management devices and kits and methods for using the same |
TR201808083T4 (en) * | 2013-05-16 | 2018-06-21 | Hadasit Med Res Service | Guided endotracheal intubation system. |
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