Abstract:
An otoscope provides an extremely narrow tip holding an electronic camera sized to allow the space of the ear canal to be shared between the otoscope and a tool such as a curette for removing foreign objects. The tip may be flexible for increased patient comfort when using a compact tip design.

Description:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     CROSS REFERENCE TO RELATED APPLICATION 
     BACKGROUND OF THE INVENTION 
     The present invention relates to an otoscope for inspection of the ear and in particular to an otoscope providing improved ear canal access during inspection or during the use of additional medical instruments inserted into the car canal. 
     An otoscope is a medical device allowing a healthcare professional to inspect the ear canal and tympanic membrane (eardrum). A simple otoscope provides for a hollow funnel-shaped speculum whose small end is inserted into the ear canal. The funnel shape of the speculum stabilizes the otoscope against the ear canal wall and may limit the depth of insertion of the speculum. Modern otoscopes include an internal source of illumination directed down the speculum axis from a contained battery-operated lamp and may provide a magnifying lens supported outside the ear and aligned with the axis of the speculum to provide an enlarged image of the ear structure being viewed. 
     Recently otoscopes have been developed that include a digital camera fitting within the speculum to permit the documentation of a diagnosis by image capture. 
     SUMMARY OF THE INVENTION 
     The present invention provides an otoscope that allows improved inspection of the ear, for example, by being able to pass beyond or image to the side of minor accumulations of earwax, and which allows improved access to other medical instruments into the ear canal while the otoscope is being used, such as a curette used for the removal of earwax or foreign bodies. In this regard, the present invention may mount a digital camera on a narrow diameter, flexible support having a diameter significantly smaller than that of the ear canal. The otoscope housing provides openings that allow axial access through the otoscope body along side of the camera support when the camera support is within the ear canal. By making the camera support flexible, discomfort that may be associated with a narrow probe against the ear canal is significantly reduced. 
     In one embodiment, the invention may provide an otoscope having a housing with a head portion and a grip portion, the latter of which may be grasped by the hand of a healthcare professional when the head portion is in an inspection position adjacent to an outer ear of an average patient. An elongate probe element holding an electronic camera is supported by the head portion so that a distal end of the probe element may extend along an axis into the ear canal, the probe element being sized to be inserted into ear canal for inspection of the ear canal without blocking the ear canal to access by other instruments within the ear canal and passing by the probe element as so inserted. 
     It is thus a feature of at least one embodiment of the invention to redesign the otoscope probe so as to open a channel between the probe and the walls of the ear canal for improved imaging and access. 
     The probe element may include a distal portion having a maximum outside diameter less than an average diameter of the patient&#39;s ear canal for a length of at least one-half the length of the patient&#39;s ear canal. 
     It is thus a feature of at least one embodiment of the invention to provide a probe that can provide clearance for a second medical instrument (such as a curette) for substantially the entire length of the probe within the ear canal. 
     The distal portion of the probe element may be flexible to bend with contact against the ear canal. 
     It is thus a feature of at least one embodiment of the invention to permit the use of a small diameter probe without increased discomfort to the patient. 
     The probe element may provide a substantially rigid proximal portion providing less flexibility than the distal portion comprising at least one-third a length of the probe element. 
     It is thus a feature of at least one embodiment of the invention to permit a high degree of flexibility at the tip for comfort while preserving alignment of the probe over the necessary probe length. 
     The distal portion may be a flexible member extending slidably and coaxially through the substantially rigid proximal portion. 
     It is thus a feature of at least one embodiment of the invention to provide a probe that may be extended or retracted with respect to the housing for improved positioning after the otoscope is stabilized against the patient by the healthcare professional. 
     The probe element may include a breakaway electrical connector connecting flexible conductors within the probe element to circuitry within the housing, the breakaway electrical conductor providing a reversible separation of connector portions at a predetermined oblique force. 
     It is thus a feature of at least one embodiment of the invention to reduce the risk of damage of a slender probe during clinical use. 
     The head portion of the otoscope may include at least one passageway extending substantially parallel to the axis to a side of the axis allowing insertion of tools through the head portion into the ear canal when the probe portion is within the ear canal. 
     It is thus a feature of at least one embodiment of the invention to provide axial access to the ear canal through the otoscope when the probe is in place in the ear. 
     The head portion of the otoscope may support the probe element through a rotating coupling allowing rotation of the probe element about the axis with respect to the head portion. 
     It is thus a feature of at least one embodiment of the invention to provide a method for orienting images acquired by the camera with respect to the housing body, for example, for later viewing when those images are exported to an external device, such orientation adhering to a consistent standard. 
     The grip portion may extend substantially perpendicular to the axis of the probe. 
     It is thus a feature of at least one embodiment of the invention to provide an otoscope having a proven form factor familiar to healthcare professionals. 
     The head portion of the otoscope may include an electronic display communicating with the camera portion for displaying an image from the camera. 
     It is thus a feature of at least one embodiment of the invention to provide convenient real-time imaging of the ear in a manner that mimics a conventional otoscope both with respect placement of the display on the housing and the orientation of the display to be viewed along the normal line of sight from the healthcare professional to the structure of the ear. 
     The display may be displaceably mounted on the housing to be movable from covering the passageway used for instruments to uncovering the passageway. 
     It is thus a feature of at least one embodiment of the invention to provide a compact configuration for the otoscope that nevertheless allows axial access through the otoscope to the ear canal. 
     The housing may hold a battery communicating electrical power to the camera. 
     It is thus a feature of at least one embodiment of the invention to provide a handheld, portable, and compact device for regular clinical use. 
     These particular objects and advantages may apply to only some embodiments falling within the claims and thus do not define the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an otoscope constructed according to the present invention providing a housing presenting on a front side an electronic display and on a rear side having a probe element extending away from the electronic display for insertion into the ear canal; 
         FIG. 2  is a fragmentary, side elevational view of the otoscope of  FIG. 1  in place in the ear canal in an inspection position, shown in cross-section, in use for observing removal of earwax using a curette positioned adjacent to the probe element in the ear canal; 
         FIG. 3  is a rear fragmentary elevational view of the otoscope of  FIG. 1  aligned with a side elevational cross-section taken along line  3 - 3  of  FIG. 1  showing access ports for a curette or the like through the otoscope housing adjacent to the probe; 
         FIG. 4  is an aligned rear and side cross-sectional fragment of the tip of the probe element of  FIG. 3  showing the camera element surrounded by LEDs as held in a flexible tube; 
         FIG. 5  is an exploded view of a magnetic coupling for holding the probe element to the otoscope housing in one embodiment; 
         FIG. 6  is a fragmentary cross-sectional view similar to  FIG. 3  showing an alternative embodiment of the otoscope allowing extension of the probe element with respect to the housing of the otoscope; 
         FIG. 7  is a simplified block diagram of the electronics of the otoscope of  FIG. 1 ; and 
         FIG. 8  is a side elevational view of multiple probe elements that may comprise a kit. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to  FIG. 1 , an otoscope  10  of the present invention may provide a housing  12  having a head portion  14  and a grip portion  16 . The grip portion  16  is sized to be grasped by the hand of a healthcare professional in the manner of conventional otoscope with the grip portion  16  extending generally upward from the healthcare professional&#39;s hand to the head portion  14 . 
     A front surface of the head portion  14  may provide for an electronic display  18 , for example, being a backlit three-color liquid display of a type known in the art. A probe element  20  may extend on a rear face of the head portion  14  opposite the display  18  along an axis  22  normal to the surface of the display  18 . The probe element  20  may include a generally conical sheath  24  constructed of a relatively rigid thermoplastic material such as polypropylene. The conical sheath  24  may taper inward as one moves away from the head portion  14  to a distally located tip portion  26  of substantially constant diameter and constructed of a relatively flexible material such as a silicone or polyvinyl chloride material. A distal end of the tip portion  26  provides an outwardly facing camera  27  as will be discussed below. Generally the camera  27  provides an image that may be displayed on display  18 . 
     A front side of the housing  12 , at an upper end of the grip portion  16 , may provide for power button  28  that may control the power to the otoscope  10 , to be discussed below. In one embodiment, an extension control knob  30 , also to be discussed below, may extend from a rear side of the grip portion  16  to be manipulated by the hand of the healthcare professional holding the grip portion  16 . Portions of the outer periphery of a probe rotation knob  32  may extend from the right and left sides of the head portion  14  allowing rotation of the probe element  20  about the axis  22  with respect to the housing  12  as will also be discussed below. 
     Referring now to  FIG. 2 , as is generally understood in the art, the outer ear  33  of a human patient  34  includes the pinna  37  providing a sound collecting structure. The pinna  37  surrounds an ear canal  36  leading to and terminating at the tympanic membrane or eardrum  38 . A length  44  of the car canal  36  in an average adult human is approximately 2.5 centimeters and the ear canal  36  has an average diameter of approximately 0.7 centimeters. 
     The tip portion  26  of probe element  20  of the present invention is intended to fit within the ear canal  36  to a depth so as to be able to fully image the ear canal and eardrum  38 . In this regard the tip portion  26  may be sized, in one embodiment, to extend at least one centimeter into the ear canal  36  or preferably at least half the distance of the ear canal  36 . More generally the tip portion  26  will be sized to extend substantially the full distance of the ear canal  36 . 
     It is intended that the tip portion  26  be sized to allow imaging of the eardrum  38  past minor obstructions such as normally present earwax  42 . The diameter of the tip portion  26  and its length are selected to allow passage within the ear canal  36  by medical instruments  40  such as a curette for removing obstructing bodies such as earwax  42  while tip portion  26  is in place for imaging. That is to permit instruments  40  to extend to the side and pass the end of the tip portion  26 . In this regard, the diameter of the tip portion  26  may be less than half an average diameter of the ear canal  36  and maybe less than four millimeters and preferably smaller than 2.5 millimeters. 
     Referring now to  FIG. 3 , in one embodiment, the tip portion  26  has a length that extends rearwardly coaxially through the sheath  24  to an electrical connector assembly  46  communicating between the probe element  20  and the head portion  14  of the otoscope  10 . In this way the sheath  24  may provide rigidity to the tubing of the tip portion  26  over part of its length. The connector assembly  46  may be supported by radially extending struts  48  holding the connector assembly  46  centered within and spaced away from the inner walls of a cylindrical support tube  50  that may communicate and rotate with knob  32 . Rotation knob  32  thereby allows the support tube  50  to rotate with respect to the head portion  14  rotating the probe element  20  and tip portion  26  about axis  22 . 
     This rotation allows the grip portion  16  to be angled from vertical with respect axis  22  while ensuring that an image to be generated (to be discussed below) remains intuitively aligned in the display  18  with images taken at a normal orientation with the grip portion  16  substantially vertical. In this way, captured images (as will be discussed below) may be properly interpreted without knowledge of the orientation of the grip portion  16  in a particular instance. 
     The struts  48  also provide for passageways  54  generally parallel to axis  22  along the side of the probe element  20  through the head portion  14  from the front face to the rear face. When these passageways  54  are to be used, the display  18  may slide upward on the head portion  14  so as to remain visible to the healthcare professional, in close proximity to the instrument  40 , yet removed from obstruction of the instrument  40 . When access to the passageways  54  is not required, the display  18  may slide downward over the passageways  54  to give the otoscope  10  a more compact form factor. The sheath  24  is designed to be narrower than a typical speculum to minimize interference within instrument  40  used in this regard both with respect to its distal end which is generally sized not to block the ear canal  36  and its proximal end so that the instrument  40  need not be angled so severely as to be out of alignment with the ear canal  36 . 
     Referring now to  FIG. 4 , the tip portion  26  may be constructed of a flexible tube  56  that may support coaxially within the tube  56  signal and power conductors  58  leading to an integrated circuit camera  27  at the distal end of the tip portion  26 . Camera  27  may be a three-color charge coupled device (CCD) of the type generally known in the art and may be supported on a substrate  62  sealed to the tube  56  by a transparent lens or encapsulation material  64 . White light LEDs  66  may be attached to the substrate  62  around the camera  27  to provide a light ring of localized illumination for imaging of the ear structure. Image signals and power to the LEDs  66  are provided through the flexible conductors  58  to other circuitry of the otoscope  10 . By placing the camera at the distal end of the tip portion  26 , stiffening optical structures such as fiber optics may be avoided and a wide field of view may be obtained from a small diameter device without complex optics. 
     Referring momentarily to  FIG. 3 , as noted above, the present invention provides a tip portion  26  that is more flexible than the sheath  24  and more flexible than a typical otoscope speculum. Generally the flexibility of the tip portion  26  is intended to improve the comfort to the patient and reduce risk of damage to structure of the outer ear  33  caused by a small diameter probe. When the head portion  14  is stabilized, a perpendicular force  68  applied to the distal end of the tip portion  26  of 100 grams will cause a deflection  69  of no less than one millimeter. In contrast, a similar force applied to the end of the sheath  24  will provide a corresponding deflection at the end of the sheath  24  of much less than one millimeter. 
     Referring now to  FIG. 5 , the breakaway connector assembly  46  may provide for a first connector half  70 , for example, having a cylindrical form as shown with a circular periphery received by a second connector half  72 . The connector half  70  may provide keys  74  allowing it to attach to second connector half  72  only in a predetermined rotational orientation about axis  22 . The keys  74  engage with corresponding key slots (not shown) in only one rotated position. 
     Connector halves  70  and  72  may be mechanically releasably retained in connection, for example, by a snap fitting, magnetic attraction or the like to be released upon receiving an oblique force  75  generally perpendicular to axis  22  that might otherwise damage the sheath  24  and/or tip portion  26 , for example, if the otoscope  10  is dropped or the probe element  20  is struck against a surface inadvertently. A rear face of the connector half  70  may provide for electrical contacts  76  mating with corresponding electrical contacts  80  in the connector half  70  to provide for electrical continuity when the two are engaged. 
     Referring now to  FIG. 6 , the coaxial construction of the tip portion  26  with respect to the sheath  24 , allows an embodiment in which the tip portion  26  may be extended or retracted as indicated by arrow  82  along axis  22  through the hollow sheath  24 . In this embodiment, the tube  56  of the tip portion  26  may slidably extend through the sheath  24  to be received within a collar  84  extending rearward from an attachment between the sheath  24  and the struts  48  (which may be a continuous structure without the breakaway connector assembly  46 ). The collar  84  may include key surfaces preventing its rotation with respect to the sheath  24  and may be surrounded, coaxially, by compression spring  86  urging the tip portion  26  in a forward retraction direction toward display  18 . A toggle arm  88  may restrain upward motion of the collar  84  connecting between the exposed end of the collar  84 , via a pivot  92 , and a retractor wire  94  extending vertically downward into the grip portion  16 . The retractor wire  94  is received by a threaded bar  98  fixed against rotation with respect to the housing  12  by a sliding keyway  100 . Knob  30  provides a threaded bore engaging the threads of the threaded bar  98 . Rotation of the knob  30  may thus be used to retract or extend the retractor wire  94  and thus retracting or extending the tip portion  26  within the sheath  24 . This mechanism allows the healthcare professional to stabilize the housing  12  against the patient, for example, using the gripping hand as a stabilizing spacer between the patient&#39;s head and the housing  12 , and then to adjust the tip portion  26  into or out of the ear canal  36  as necessary. 
     Referring now to  FIG. 7 , the otoscope  10  may incorporate an electronic controller  102  such as a microcontroller being in essence an electronic computer and I/O circuitry. The controller  102  will provide a processor  104  communicating with a memory  106  permitting non-transient storage of a program  108 . Generally the program  108  will provide for the receipt of signals from the camera  27  and the display on display  18  of images from the camera. The program  108  may perform normal image processing, for example, exposure control, contrast adjustment, color balance and the like. The program  108  through the controller  102  may also control the illumination of the LEDs  66  as part of the exposure control process. 
     In some embodiments, the otoscope  10  may include an accelerometer  110  communicating with the microcontroller  120  to provide a signal indicating orientation of the grip portion  16  as may deviate from vertical. The signal may be used to rotate the image displayed on the display  18  instead of using knob  32  as described above to rotate the probe element  20 , or may provide for a marker on the image denoting upward position. 
     The controller  102  may also communicate either through a wireless transceiver  112  or an electrical connector  114  with other devices such as a computer printer or the like so that images may be captured or transmitted as required by the camera  27 . 
     The power button  28  may communicate with the controller  102  to put it into a low power sleep state, disabling the display  18 , camera  27  and LEDs  66 . The otoscope circuitry described above may be powered by a battery  109  contained in the housing  12 . 
     Referring now to  FIG. 8 , it will be appreciated that in the embodiment of  FIG. 3 , that multiple probe elements  20   a  and  20   b  may be provided for use in different applications, for example, for inspection of nasal cavities, the mouth, or throat, by simply changing a relative length of the probe element  20 , and hence the distance it may pass through the ear or other cavity, and/or may change the relative length of the tip portion  26  or sheath  24  alone. 
     Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “bottom” and “side”, describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. 
     When introducing elements or features of the present disclosure and the exemplary embodiments, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed. 
     References to “a controller” and “a processor” can be understood to include one or more microprocessors that can communicate in a stand-alone and/or a distributed environment(s), and can thus be configured to communicate via wired or wireless communications with other processors, where such one or more processor can be configured to operate on one or more processor-controlled devices that can be similar or different devices. Furthermore, references to memory, unless otherwise specified, can include one or more processor-readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network. 
     “Diameter” as used herein should not be understood to require a cylindrical or circular element but to simply describe a diameter of a circumscribing cylinder closely conforming to the element. 
     It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein and the claims should be understood to include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims. All of the publications described herein, including patents and non-patent publications are hereby incorporated herein by reference in their entireties.