Patent Publication Number: US-2006020171-A1

Title: Intubation and imaging device and system

Description:
FIELD OF THE INVENTION  
      The present invention relates to the field of medical devices, more specifically to an endotracheal intubation tool having integrated visualization and to a method for its use.  
     BACKGROUND OF THE INVENTION  
      Endotracheal intubation is a common medical procedure often directed at opening a closed larynx by inserting a laryngoscope through the larynx followed by the insertion of an endotracheal tube, which enables air supply to the patient. Endotracheal intubation is a typically life saving procedure performed in emergency cases. Thus, the ability to intubate a patient rapidly is highly important.  
      In many patients, intubation may be particularly difficult to perform due to morphological anomalies, such as a large tongue, excessive soft tissue, or tracheal displacement. These morphological anomalies may make it difficult to visualize the posterior pharyngeal area, larynx and cords, and may cause difficulties in intubation. In medical emergency situations, an attempt to intubate such persons may be difficult, time consuming, and may meet with failure. Other situations may make intubation and/or the associated viewing difficult.  
      To overcome this problem intubation devices have been developed which include, for example, illumination and visualizing components for illuminating and visualizing the pharynx, larynx, trachea and associated structures, during intubation.  
      The illumination and visualization is typically performed by using fiber optics both for illuminating and for viewing. Optical fibers are typically connected by, for example, wires or a bus to a power supply source and to an illumination source, both typically located outside a patient&#39;s body. Optical fibers and wires may take up space within an intubation tool, and also may restrict the free movement and ability to maneuver the intubation tool. Further, in some devices an external power source may be required.  
     SUMMARY  
      Some embodiments of the present invention include endotracheal intubation tools such as laryngoscopes, and may include for example an imaging unit, which allows typically continuous in vivo visualization during insertion, and possibly during use, of the laryngoscope. Endotracheal intubation may be a life saving procedure performed in emergency situations, such as in the case of an obstructed airway. Thus, the procedure, according to embodiments of the invention may be performed in the field, outside of a medical center or hospital. Embodiments of the present invention may have the benefit of performing endotracheal intubation procedures while enabling the viewing of inner cavities, lumens, organs, etc. of the patient in-vivo, while in the field. Other embodiments may allow for treatment in other settings, such as a hospital.  
      Embodiments of the present invention provide a device, system and method allowing for effective intubation through the use of an intubation device or tool with an improved imaging system..  
      In one embodiment the invention provides an intubation tool that includes a handle; a blade; and at least one imaging unit. The handle and blade are typically releasably interlockable or attachable to each other. Typically, there is a passageway or channel through the handle and blade. The tool may include, for example, a bivalve element, typically used for forming the passage. The imaging unit typically includes an image sensor and an illumination source. According to one embodiment both image sensor and illumination source are situated behind an optical window. According to some embodiments the intubation tool may include a transmitter, typically for transmitting signals, such as image data. The intubation tool may also include a power source for powering components of the imaging unit.  
      According to one embodiment the intubation tool is connected to the blade, typically to a distal end of the blade, although other positions are possible.  
      A system for intubation, according to embodiments of the invention may include an intubation tool, which includes a handle; a blade; at least one imaging unit; and a transmitter; and a receiving unit for receiving signals transmitted from the transmitter. The system may include a processing unit for, for example, processing received signals and a display. According to one embodiment image data is displayed on the display.  
      In some embodiments, an intubation tool or device may have visualization capabilities that may take up less space within the tool or device, and may not restrict the free movement and ability to maneuver the intubation tool. In some embodiments, the imaging unit may be, for example, self contained, autonomous and/or single use. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
      The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:  
       FIG. 1  is a schematic illustration of an intubation system in accordance with an embodiment of the invention;  
       FIG. 2  is a schematic illustration of an intubation system in accordance with another embodiment of the invention; and  
       FIGS. 3A-3B  are schematic illustrations of an imaging unit in accordance with embodiments of the invention.  
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      In the following description, various aspects of the present invention will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the present invention. However, it will also be apparent to one skilled in the art that the present invention may be practiced without the specific details presented herein. Furthermore, well known features may be omitted or simplified in order not to obscure the present invention.  
      Reference is now made to  FIG. 1 , which is a schematic illustration of an intubation system  10  in accordance with an embodiment of the invention. The intubation system  10  typically includes a laryngoscope  20 , an imaging unit  30  attached to or included as part of laryngoscope  20  and a receiving unit  50 . receiving unit  50 , which, according to one embodiment includes a receiver  52 , a processor  54  and a screen or display  56 , receives signals, for example image data, from imaging unit  30  and processes the signals, for example, to form an image. According to one embodiment imaging unit  30  is located at the distal end  21  of the laryngoscope  20 . In alternate embodiments imaging unit  30  may be located at any other suitable site on the laryngoscope  20 .  
      In some embodiments, the imaging unit may be, for example, self contained, autonomous and/or single use. For example, the imaging unit may be a self contained or encapsulated unit which can operate without external power and without a tether or cable required to send images to a viewer. In other embodiments, power may be provided by, for example, an external source, but without a wire or cable; for example, via magnetic waves.  
      In one embodiment laryngoscope  20  is a two piece laryngoscope that includes a blade  22  and a handle  24 . According to one embodiment handle  24  is attached to the proximal end  23  of blade  22 . In other embodiments, other devices or tools may be used having other configurations; for example a blade and handle may not be separate pieces.  
      In one embodiment blade  22  is a curved structure attached to the handle  24  at a convenient angle to be place over a patient&#39;s tongue, for example, as described in U.S. Pat. No. 4,982,729 to Wu, incorporated herein by reference in its entirety. For example, in one embodiment the axis of the handle and the axis of the blade are at an angle of about 100 degrees to 120 degrees. Other suitable angles may be used. In such an embodiment, the laryngoscope may include, for example, an integral handle  24  and blade  22 . The blade  22  may optionally include a bivalve element  28  that is, for example, releasably attachable to the blade  22  and/or the handle  24  to form a passageway for, for example, threading an endotracheal tube to the distal end of the blade  22 .  
      The handle  24  may be attached to the blade  22  at an angle so that the blade  22  may enter the upper oral cavity with minimal maneuvering of the patient&#39;s head and neck. According to one embodiment the blade  22  may be laterally curved to form a groove running the length of the blade  22  and opening toward the convex portion of the blade  22 . The laryngoscope may include a bivalve element (e.g.,  28 ) shaped to correspond with the shape of the blade  22 , including a longitudinal groove opening toward the concave side of the curved portion. In such a case the groove in the blade  22  may connect with a groove in the bivalve element when they are positioned together to form a passageway from the handle  24  to the distal end  21  of the blade  22 . The bivalve element  28  may be releasably attachable to the proximal end  23  of the blade  22  as well as being releasably attachable to the handle  24 . The passageway formed between the blade  22  and the bivalve element  28  may be large enough in diameter to hold, for example, an endotracheal tube.  
      According to one embodiment the two parts of the laryngoscope  20  may be assembled, for example, in bivalve fashion before insertion into the patient&#39;s mouth. The interconnected bivalve elements may be disconnected within the patient&#39;s throat after an endotracheal tube has been inserted into the patient&#39;s trachea and intubation has been effected, typically so that the laryngoscope can be removed from the patient in two pieces leaving the endotracheal tube in place. In one embodiment the blade may include a substantially straight section attached to the handle, with an arced mid-portion, and a straight or substantially straight distal portion. Other blades may be used, having other components and configurations, having other functionalities and uses, and in alternate embodiments a blade need not be used. Other tools may be used.  
      Laryngoscope  20  may be a single use laryngoscope. Alternatively, the handle  24  may be a multi use piece and the blade  22  may be a single use piece. Alternatively, laryngoscope  20  may be a multi use laryngoscope.  
      In other embodiments laryngoscope  20  may be of any suitable kind including, for example, a multi piece laryngoscope, a laryngoscope including a tube for air passage or for insertion of tools, a laryngoscope having a straight blade, a curved blade, various shapes of handles, or other equipment, etc. The device, system and method of the present invention may be used with suitable endotracheal tools other than a laryngoscope  20 .  
      Imaging unit  30  typically captures in-vivo images. According to some embodiments other in vivo sensing units (e.g., pressure sensor, blood detector, temperature sensor etc.) may be included in an imaging unit, which may facilitate correct and easy insertion. According to one embodiment imaging unit  30  may be a single use unit that may be attached to a single use laryngoscope or to the single use blade  22  of a laryngoscope, or to another structure having a single use blade. By utilizing single use parts the need to sterilize the device in between uses may be avoided. Alternatively, a single use imaging unit  30  may be attached to a multi use laryngoscope such that only imaging unit  30  may be changed between uses. Alternatively, a multi use imaging unit  30  may be attached to a multi use laryngoscope.  
      The attachment of imaging unit  30  to laryngoscope  20  may be achieved for example, by gluing, soldering, clamping or other mechanical attachment or by other suitable methods. Imaging unit  30 , or a shell or covering for imaging unit  30 , may be integral with laryngoscope  20  or another tool Imaging unit  30  may be a wireless imaging unit. A wireless imaging unit may enable comfortable and flexible use of laryngoscope  20 . Furthermore, the wireless imaging unit may enable free maneuvering of the laryngoscope during the procedure while simultaneously viewing the images captured by wireless imaging unit  30 . Free maneuvering is desirable, especially in use with patients having morphological anomalies.  
      In one embodiment wireless imaging unit  30  may be a one piece unit, that may be, for example autonomous. One piece unit  30  may be located near or at the distal end  21  of blade  22  to enable imaging of a patient at the site of treatment or operation. In alternate embodiments imaging unit  30  may be located at any other point on the system  10 , or at another place in the patient suitable for enabling in-vivo imaging.  
      In alternate embodiments, imaging unit  30  may include multiple parts which may be, for example, separately located along the overall tool, or may, for example, be a wired imaging unit connected by, for example, wires or a bus to a power supply system and/or to receiving unit  50 .  
      The receiving unit  50  may receive signals from one piece imaging unit  30  or from multi piece imaging unit (e.g.,  32  in  FIG. 2 ) and may process the signals by processor  54  to an output (e.g., image output) displayed on a screen  56 . The signals may be received by receiver  52  through, for example, wireless communication between one piece unit  30  or multi piece unit  32  and receiver  52 . In one embodiment, the receiving unit  50  may be part of a portable computer. This may enable, for example, viewing of in-vivo images in field conditions without having wires complicate the procedure.  
      Processor  54  typically is or includes a computer that processes the received signals to create an image. Screen  56  is typically a screen such as a computer monitor that enables presenting a view of the images. Receiver  52  may be connected to processor  54  by, for example, wires or a bus. Alternatively, receiver  52  may be incorporated in processor  54  or in a unit incorporating processor  54 . Display unit  50  may have other structures or components.  
      A reception and display system used with the system and method of the present invention may (with possible modifications) be similar to those, or may use components and methods similar to those, described in U.S. Pat. No. 5,604,531 to Iddan et al. and/or in International Application publication number WO 01/65995 entitled “A Device And System For In Vivo Imaging”, published on 13 Sep., 2001, each of which are assigned to the common assignee of the present application, and each of which are incorporated herein by reference in their entirety.  
      In use, receiving unit  50  is typically located outside the patient body while the one piece imaging unit  30  is typically located in-vivo. In the case of a multi piece imaging unit, a first imaging piece may be located in-vivo and a second transmitting and/or power supplying piece may be located outside the patient body, for example, in the handle, or attached to the patient.  
      Reference is now made to  FIG. 2 , which is a schematic illustration of an intubation system  11  in accordance with an embodiment of the invention where the imaging unit may be a multi piece unit. Laryngoscope  20  includes a multi piece unit  32  According to one embodiment multi piece unit  32  includes an imaging unit  34 , a transmitter  37  and a power supplying unit  36  (e.g., batteries, a power receiving unit, or another suitable power supply). The communication between imaging unit  34  and transmitter  37  and/or power supplying unit  36  may be conducted via, for example, a wire or set of wires  35  progressing, for-example, along the internal side of blade  22  and handle  24 . The wire(s)  35 , the imaging unit  34 , and transmitter  37  and/or power supply unit  36  may be located differently. Imaging unit  34  is typically located near or at the distal end  21  of blade  22  to enable in-vivo imaging, for example, at the site of operation or treatment. It may be attached, for example, at the inner side of the distal end  21  of blade  22 . The attachment of imaging unit  34 , wire(s)  35  and transmitter  37  and power supplying unit  36  to laryngoscope  20  may be achieved for example, by gluing, soldering, clamping or other mechanical methods, or by other methods; various components may be integral with laryngoscope  20  or other parts of the tool. According to some embodiments the multi piece unit  32  may enable further miniaturizing of the piece attached to blade  22 .  
      Multi piece imaging unit  32  may transmit, typically through transmitter  37  or otherwise send signals to receiving unit  50  ( FIG. 1 ) where the signals are received by receiver  52  and typically processed by processor  54  to produce an image that can be viewed on screen  56 .  
      In alternate embodiments multi piece unit  32  may be an imaging unit connected by, for example, wires or a bus to a power supply system and/or to receiving unit  50 .  
      The operation of laryngoscope  20  may be assisted by viewing in vivo images captured by one piece unit  30  or multi piece unit  32 . Organs or structures at the site of the operation may be imaged and viewed simultaneously via receiving unit  50 , in real time, during operation of laryngoscope  20 .  
      Reference in now made to  FIG. 3A , which is an illustration of an in-vivo imaging unit according to an embodiment of the invention. One piece unit  30  typically includes an image sensor  44  (such as, for example, a CMOS or CCD camera, or another imager) and an illumination source  46  (such as, for example, white LEDs, or another illumination source). The components of one piece unit  30  may be used in other embodiments discussed herein. Optionally, image sensor  44  and illumination source  46  may both be situated behind a dome or other shaped optical window  41 . According to one embodiment the one piece unit  30  further includes a transmitter  43 , optionally with an antenna  45 , that transmits signals from the image sensor  44  to the receiving unit  50 , either wirelessly, for example by using radio waves (e.g., “RF”), or through a wire connection. The wireless transmission of signals from the image sensor  44  to receiver  52  may be effected using, for example, various digital or analog modulation techniques. For example, transmission of a digital image over a radio channel may use an FSK (Frequency Shift Keying) modulation technique. Other transmission techniques may be used.  
      One piece unit  30  may include a power supply  47  (such as, for example, one or more silver oxide batteries, rechargeable batteries, etc.), for supplying the electric power required for the operation of the one piece unit  30 . Other imaging units, and other power supplies, may be used.  
      Image sensor  44  may be, for example, a CCD or an active or passive CMOS imaging chip and may generate digital or analog signals. In one embodiment, image sensor  44  is a single chip imager such as or similar to the CMOS image sensor (“Camera on Chip”) designed by Photobit Inc. of Calif., USA, with integrated active pixel and post pixel circuitry. Typically, the one piece unit  30  also includes an optical system (such as lenses, mirrors etc.).  
      In some embodiments, the imaging unit and its use, and other imaging systems described herein, may be similar to embodiments disclosed in U.S. Pat. No. 5,604,531 and/or International Application publication number WO 01/65995. A device, system and method of embodiments of the present invention may be used with other imagers, image processing systems, and imaging systems, having different structures and components.  
      It will be appreciated that a plurality of imaging cameras may be used in the device, system and method of the invention. Each imaging camera may include its own optical system and either one or more illumination sources, in accordance with specific requirements of the device or system.  
      Typically both image sensor  44  and illumination sources  46  are low power components such that they may be powered by one or more batteries and thus may not require wire connection to an external power supply system. Other imaging or lighting systems may be used, and power by wire may be used.  
      Reference is now made to  FIG. 3B , which is an illustration of a multi piece unit  32  according to one embodiment of the invention. Multi piece unit  32  includes, for example, a first, imaging piece  34  situated, for example, at the distal end of blade  22 . Multi piece unit  32  may include a second piece  36  including, for example, transmitting and power supply capabilities and situated at a remote location, for example, in the handle  24 . According to other embodiments transmitting capabilities and power supply capabilities may be included in separate units. Other connection points for the first and second piece are possible. The first and second pieces  34  and  36  may be connected through, for example, wire(s)  35 . In alternative embodiments piece  34  and piece  36  communicate completely or partially wirelessly, such as by microwave, infrared (IR) or radio waves (RF); other wireless communication methods may be used. Furthermore, other communications methods, such as fiber optic, may be used.  
      The first, imaging, piece  34  typically includes imager  44  (for example a CMOS camera) and at least one illumination source  46  (for example white LEDs) both situated behind a typically dome or other shaped optical window  41 . The second piece  36  typically provides transmitting and power supply functionality, and includes a power supply  47  (e.g. one or more batteries), a transmitter  43  and an antenna  45  that transmits signals from the imager  44  to an external receiving system (for example display unit  50  in  FIG. 1 ). Such an arrangement may allow miniaturizing of the first piece of imaging unit  32  located at the distal end of blade  22 . The components may be divided between more than two pieces.  
      In another embodiment the power supply  47 , which may convey energy to the imaging unit  30  either wirelessly or through a wired connection, may be situated outside a patient&#39;s body.  
      It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Alternate embodiments are contemplated which fall within the scope of the invention.