CN111565622A

CN111565622A - Otoscope provided with low-obstruction electronic display

Info

Publication number: CN111565622A
Application number: CN201880084374.2A
Authority: CN
Inventors: 格雷格·雷贝拉; 詹姆斯·贝尔比; 阿齐塔·哈姆达尼; 卡梅伦·洛珀
Original assignee: Wisconsin Alumni Research Foundation
Current assignee: Wisconsin Alumni Research Foundation
Priority date: 2017-12-28
Filing date: 2018-12-21
Publication date: 2020-08-21
Anticipated expiration: 2038-12-21
Also published as: CN111565622B; WO2019133496A2; EP3731729A4; AU201813729S; WO2019133496A3; CA3085355A1; EP3731729A2; AU201813731S

Abstract

An otoscope is provided with a circular display to allow a compact housing such that simultaneous viewing of the display and the patient's ear is improved, thereby improving positioning and stabilization of the otoscope. The recorded image may be rotationally corrected and the non-image data displayed on the screen may be rotationally corrected by using an inclinometer.

Description

Otoscope provided with low-obstruction electronic display

Cross Reference to Related Applications

This application claims the benefit of 15/856,865, a U.S. non-provisional application filed 2017, 12, month 28, which is a continuation-in-part application of U.S. application 14/749,945 filed 2015, 6, month 25, both of which are incorporated herein by reference.

Background

The present invention relates to otoscopes for examining the ear and in particular to otoscopes employing electronic cameras insertable into the ear canal.

Otoscopes are medical devices that allow a healthcare professional to examine the ear canal and tympanic membrane (eardrum). A simple otoscope is provided with a hollow funnel speculum, the small end of which is inserted into the ear canal. The purpose of the funnel shape of the speculum is to provide a visual path to the tympanic membrane and to assist in controlling the depth of insertion of the speculum. Modern otoscopes include an internal illumination source directed downwardly along the axis of the speculum from an included battery-operated lamp, and may be provided with a magnifying lens supported outside the ear and aligned with the axis of the speculum to provide a magnified image of the ear structure being viewed. More recently, otoscopes have incorporated digital cameras with displays directly on the otoscope to view the camera images. Examples of such otoscopes are found in U.S. patent 9,326,668, which is incorporated herein by reference.

The use of an otoscope requires the clinician to carefully note the position of the otoscope throughout the examination. The clinician must use one hand to not only hold the otoscope but also to stabilize the otoscope relative to the patient's head while the other hand manipulates the outer ear to maximize the "straightness" of the external ear canal. Once the visual axis is properly aligned, a single user is able to view and evaluate the features of the tympanic membrane.

The use of otoscopes, particularly with respect to infants, requires the healthcare professional to continuously focus on the placement and positioning of the otoscope by observing the outer ear of the infant and sometimes using one hand to not only hold the otoscope but also to hold the otoscope steady relative to the infant's head while the other hand manipulates the outer ear to maximize the "straightness" of the external auditory canal. Desirably, the camera display for the otoscope is mounted on the otoscope itself to minimize the need for the healthcare professional to shift the line of sight from the otoscope and patient to view the required clinical information. However, in such a case, if the healthcare professional wants to view the display simultaneously during the positioning and fixing operation, the necessary display size required to provide adequate readability and resolution often obstructs the healthcare professional's view of the patient. This can be particularly problematic when, for example, the otoscope is rotated using a handle that is oriented laterally rather than vertically to improve fixation or access to the patient.

Disclosure of Invention

The present inventors have realised that by using a matching circular display directly aligned with the visual axis of the camera tip, the ability of the display to be obscured over a range of different otoscope orientations can be significantly minimised, improving the ability to view both the display and the patient's outer ear simultaneously, since the region of interest of the image acquired by the otoscope is circular over a large range. The net effect is to allow the clinician greater flexibility and maximize comfort during otoscopy.

In various embodiments, the invention may also provide a disposable cleaning sheath (speculum) for an otoscope of this type having a tip-mounted camera and a light source. Such tip-mounted cameras and light sources pose a significant risk of occluded internal reflections when covered by a window. By providing the speculum with a window that can be pulled against the light source and camera, this intentionally created occluded internal reflection can be reduced or eliminated while providing a clean barrier between the otoscope and the patient.

In various embodiments, the present invention may provide a structure that allows an otoscope to fit into a commonly available otoscope base. This adaptation allows the use of a locking collar that replaces the varistor system used in conventional incandescent otoscopes, thereby allowing the inventive otoscope of the present invention to be easily adapted to a conventional examination room.

In various embodiments, the present invention can provide voice commands to the otoscope camera to obtain a "snapshot," thereby eliminating the need for a manual operation button that could cause a healthcare professional to inadvertently reposition the otoscope while the image is being acquired.

In particular, then, in one embodiment, the invention provides an otoscope having a housing adapted to be supported by a hand of a healthcare professional. An elongate probe element having a proximal end supported by the housing is provided with a distal end which may extend along an axis into the ear canal. The distal end of the elongated probe may support an electronic camera for viewing into the ear canal in communication with a circular electronic display that displays an otoscope image from the camera and is spaced along the axis from and centered along the axis.

It is therefore a feature of at least one embodiment of the invention to realize the benefits of electronic displays, including magnification, image stabilization, and brightness and contrast adjustment, while maintaining the ability of the viewing healthcare professional to fully view the outer ear to aid in the alignment and stabilization of the otoscope. Particularly where the otoscope is used with a handle that is rotated from a vertical position, a circular display maximizes the useful display area while minimizing the obstruction of the display.

The display may be circumscribed by a cone having a tip at the distal end of the probe and a cone angle of less than 45 degrees, and/or may have a diameter extending less than three inches from the axis at all angles about the axis.

It is therefore a feature of at least one embodiment of the invention to optimize the trade-off between display readability and minimizing display obstruction.

The processor may execute a stored program for displaying non-image data in a peripheral ring around the image.

It is therefore a feature of at least one embodiment of the invention to allow for the simultaneous display of image and non-image data on a single display to minimize the need for a healthcare professional to move his or her line of sight away from the display and patient, while locating the data in locations of the image that have a priori lower clinical importance.

The non-image data may include a curved bar display with an angular extent indicative of the data.

It is therefore a feature of the present invention to provide an intuitive compact graphic that works well on the periphery of a circular display.

The circular electronic display may be provided with a touch screen for sensing touches on a surface of the circular electronic display, wherein the arc-shaped bar displays a video sequence representing images captured by the electronic camera, and wherein touches displayed along the arc-shaped bar select images from the video sequence for display.

It is therefore a feature of at least one embodiment of the invention to provide an extremely compact method of indexing through a video sequence that allows a healthcare professional to capture the best images from the video sequence, for example, when imaging a restless or underage patient.

The display may indicate the left ear or the right ear being imaged as linked to the image.

It is therefore a feature of at least one embodiment of the invention to ensure that the recorded image clearly indicates which ear is being imaged in the image recording.

The otoscope may further include an electronic inclinometer for changing an orientation of at least one of the displayed non-image data and the recorded image data according to the inferred gravity vector.

It is therefore a feature of at least one embodiment of the invention to maximize the readability of non-image data during use of the otoscope and to maximize the interpretability of image data for review at a later time by clearly indicating the orientation of the data.

The housing may be provided with: a display portion holding an electronic display and an elongated probe; and a handle portion extending away from the axis to be held by a healthcare professional, and the display portion may be mechanically and electrically removably attached to the handle portion by means of a twist-lock coupling.

It is therefore a feature of at least one embodiment of the invention to integrate favorably with existing examination room equipment intended for conventional otoscopes having twist-lock couplings.

The handle portion may be provided with a varistor controlling power transmitted to the display portion, and the handle portion may be provided with a collar fitted on the varistor to prevent movement of the varistor.

It is therefore a feature of at least one embodiment of the invention to disable a varistor located on a conventional otoscope to prevent inadvertent reduction of power during use of the otoscope.

The collar portion may include a varistor engagement surface that rotates the varistor to the full power position with rotation of the twist lock coupling for engagement.

It is therefore a feature of at least one embodiment of the invention to raise the full power position of the rheostat when the otoscope is assembled onto a pre-existing conventional handle.

The invention may also provide a speculum for an otoscope having an in-ear camera, the speculum being provided with a replaceable tubular sheath dimensioned to fit within the ear canal and to receive an elongate probe element therein, the distal end of the tubular sheath being provided with a transparent window shield allowing imaging therethrough, and the proximal end of the tubular sheath providing a connection with the housing, thereby creating a resilient bias of the window against the distal end of the probe element.

Accordingly, at least one embodiment of the invention features a protective cover that allows the use of a window layer to prevent cross-contamination of the camera with the patient without image degradation due to the close proximity of the intense light source and the camera in the narrow tip of the probe.

In one embodiment, the distal end of the tubular sleeve may be covered by an elastic sleeve, and the proximal end of the tubular sheath may stretch the elastic sleeve over the electronic camera to provide a transparent cover through which the camera may be imaged.

It is therefore a feature of at least one embodiment of the invention to provide close abutment of the window with respect to the camera and light source (to minimize internal reflection and optimize image quality) while providing a low aberration window that is easily manufactured, formed in part by a stretching process.

The present invention may additionally or alternatively provide a speculum having a tubular sheath sized to fit within an ear canal to receive an elongate otoscopic probe element therein, wherein the distal end of the tubular sleeve provides a means of extending axially beyond the distal end of the probe element to engage a target within the ear within the field of view of the camera. In this way, cerumen and foreign bodies can be safely removed under direct visualization.

It is therefore a feature of at least one embodiment of the invention to provide a disposable scraper appliance incorporated into a disposable speculum and positioned close to a camera to improve positioning and handling.

The appliance element may be malleable to form into a curved portion relative to the axis after manufacture and to maintain the curvature.

It is therefore a feature of at least one embodiment of the invention to provide an extremely versatile appliance that can be modified as needed by a healthcare professional for a particular situation and better nested for efficient transport.

The appliance element may be provided with a scoop communicating with a channel connectable to a vacuum source.

It is therefore a feature of at least one embodiment of the invention to provide a suction appliance positioned in close proximity to a camera for precise control of the suction appliance.

The otoscope may provide a processor that operates in a first mode in which dynamic images indicative of views from the electronic camera are provided on the display and in a second mode triggered by sound of the user received by the microphone to capture on the display static images indicative of views from the electronic camera at the time of a voice command.

It is therefore a feature of at least one embodiment of the invention to allow images to be captured without disturbing the orientation of the otoscope as may occur during activation of a physical button or touch screen by a user's hand.

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.

Drawings

FIG. 1 is a perspective view of an otoscope constructed in accordance with the present invention, provided with a housing presenting an electronic display on a front side and having a camera on a rear side located on a probe element extending away from the electronic display for insertion into the ear canal and covered by a disposable speculum;

FIG. 2 is a front cross-sectional view through the probe element and the disposable speculum showing the mechanism for retracting the probe element and the camera when the speculum is removed and extending the probe element and the camera when the speculum is in place;

FIG. 3 is a detailed partial view of FIG. 2 with the camera element fully extended showing radial and axial illumination of the ear canal, for example, to better address diffuse illumination of the ear structure;

FIG. 4 is a side view of the speculum mounted on the probe element showing the flexibility of the combined assembly;

FIG. 5 is a detailed cross-sectional view of the distal end of FIG. 4 showing radial teeth on the speculum to assist in removing foreign objects from the ear canal and showing the lens protector incorporated into the disposable speculum;

FIG. 6 is a simplified block diagram of the electronics of the otoscope of FIG. 1;

FIG. 7 is a view similar to FIG. 2 showing an alternative otoscope design providing a circular display and improved visualization of the outer ear when the health care professional views the display, and also showing a detachable powered handle;

FIG. 8 is a side partial view of the embodiment of FIG. 7 showing a replaceable cleaning speculum partially mounted on the otoscope and having a resilient window material at the distal end of the speculum;

FIG. 9 is a side cross-section in the vertical plane of the distal end of the cleaning speculum of FIG. 8, showing the elastic material stretched to provide a tight, elastically biased window against the distal end of the probe;

FIG. 10 is a side cross-sectional view through the distal end of the probe showing the positioning of the camera and the peripheral separate fiber optic light source such that internal reflections are minimized when coupled with the spring biased front window of the interchangeable speculum;

FIG. 11 is a perspective view of an alternative speculum having an axially extending scraper;

fig. 12 is a side perspective view along a vertical plane of the distal end of the speculum of fig. 11, showing a laminated soft metal element providing an extensible and reshapeable scraper;

FIG. 13 is an exploded view showing an alternative speculum having a vacuum scoop for communicating with a corresponding port on an otoscope;

figure 14 is a sectional view along a vertical plane through the speculum and assembled otoscope of figure 13;

figure 15 is a perspective view of an alternative design of the speculum providing an inflatable collar for removing obstructions from the ear canal;

FIG. 16 is a cross-section along a vertical plane through the speculum and otoscope of FIG. 15, showing an internal air channel for inflating the collar;

FIG. 17 is a view similar to FIG. 7, showing the addition of a valve pump button and valve release button and pump mode button that allow a small amount of stored pressurized air or relative vacuum to be generated within the housing of the otoscope;

FIG. 18 is a schematic view of the pump system of FIG. 17, showing a system to provide high or low pressure air to the reservoir that is releasable upon generation;

FIG. 19 is a partial cross-section through the housing of FIG. 1 showing the engagement of the detachable handle to the display portion using a collar extending over the upper end of the handle to prevent accidental operation of the rheostat of the handle and to provide activation of the rheostat after the collar is installed;

FIG. 20 is a rear view of the otoscope of FIG. 1 showing the addition of non-image data on an image displayed on the display and showing a detachable adapter for implementing the collar arrangement of FIG. 19;

FIG. 21 is an embodiment showing a spring-loaded collar extending outward to protect the probe when the speculum is removed; and

FIG. 22 is a partial cross-sectional view of the probe element of FIG. 7, which allows for snap-in interchangeability of the probe element in the event of damage and which allows for damage to be mitigated by dislodging the probe element.

Detailed Description

First embodiment

Referring now to FIG. 1, an otoscope 10 of the present invention may be provided with a housing 12, the housing 12 having a head portion 14 and a removable grip portion 16. Grip portion 16 is sized to be held by a hand of a healthcare professional in the manner of a conventional otoscope, wherein grip portion 16 extends generally upwardly from the hand of the healthcare professional to head portion 14.

The front surface of the head portion 14 may be provided with an electronic touch screen display 18, such as a backlit three-color Liquid Crystal Display (LCD) having a touch surface and a decoder, of the type known in the art. An elongate probe assembly 20 may extend from the rear surface of head portion 14 in a direction away from display screen 18 along an axis 22 orthogonal to the surface of display 18. Probe assembly 20 may include a generally conical speculum 24, the generally conical speculum 24 being at least partially constructed of a transparent thermoplastic material to provide light guiding characteristics as will be described below.

As is generally understood, the outer ear 33 of a human patient includes a pinna 37 that provides a sound collection structure. The pinna 37 surrounds the ear canal 36, with the ear canal 36 opening to and terminating at the tympanic membrane or eardrum 38. The ear canal 36 of a typical adult is about 2.5 centimeters in length, and the average diameter of the ear canal 36 is about 0.7 centimeters.

Referring now additionally to fig. 2, specula 24 may taper inwardly as one moves away from head portion 14 toward a distally located distal tip 26. Speculum 24 is provided with a central bore holding an extendable barrel probe 28, which barrel probe 28 has a forward facing electronic camera 30 on the distal tip of the barrel probe 28 for acquiring a multi-pixel, three-color image in a field of view directed along axis 22. The electronic camera 30 may be, for example, a self-contained Charge Coupled Device (CCD) camera such as is commercially available and provides, for example, a 1.4mm diagonal and a measurement area of 62,500 pixels.

The proximal end of the barrel probe 28 is supported by a spring-loaded slide 32, which spring-loaded slide 32 is movable along the axis 22 relative to the structure of the housing 12 which is typically limited to translational movement. A helical compression spring 34 may extend between an inwardly extending flange 39 on the housing 12 and a rearward radially outwardly extending flange 41 on the slider 32 to bias the slider 32 in the retraction direction to withdraw the camera 30 within the protective sleeve 35. The sleeve 35 is fixed relative to the housing 12 and surrounds the camera 30 for protection when the camera 30 is fully retracted.

The proximal end of the tapered speculum 24 may be provided with a collar 40, which collar 40 has an internal thread that may engage the outwardly extending pin 42 of the slider 32. Clockwise rotation (proximally facing) of collar 40 pulls pin 42 forward toward distal tip 26 of speculum 24 while simultaneously pulling speculum 24 onto housing 12. The forward movement of the pin 42 moves the slider 32 forward against the force of the spring 34, thereby extending the camera 30 to a position proximate the distal tip 26. Thus, the vulnerable camera 30 is only exposed when the protective speculum 24 is in place. A stop feature (not shown) on the housing 12 may lock the collar 40 against movement or, alternatively, friction provided by the force between the internal threads and the pin 42 may be used for the same purpose.

Referring now additionally to FIG. 3, all or a portion of the speculum 24 may be constructed of a transparent material such that the light emitting diode 44 mounted on the structure of the housing 12 may project light 52 into the proximal portion of the conical speculum 24. From this proximal portion, light 52 may be conducted by internal reflection to the distal tip 26 of the cone-shaped speculum 24 in the manner of a light pipe. The light emitting diode 44 is retained when attached to the structure of the housing 12 with the cone speculum 24 removed, and the light emitting diode 44 may be oriented to face a feature on the cone speculum 24 that facilitates coupling of light 52 from the LED 44 into the cone speculum 24, such as an optical plane perpendicular to the direction of light propagation. In an alternative embodiment, the light emitting diode 44 may be coupled to an optical fiber within the speculum 24.

In one embodiment, the LED 44 may, for example, provide a combination of red, green, and blue elements such that the hue of projected light 52 from the LED 44 may be controlled to emphasize certain ear structures. At distal tip 26, a portion of light 52a exits in a direction parallel to axis 22; however, some of the light 52b in distal region 46 in front of distal tip 26 of speculum 24 may be coupled out of speculum 24 through diffusing asperities 48 on the outer surface of speculum 24 to provide light 52b that emanates in a radial direction from speculum 24 to illuminate the walls of ear canal 36. The light 52b provides diffuse multi-angle illumination of the ear structure in the ear canal by reflection and scattering between the outer surface of the speculum 24 and the walls of the ear canal 36 and by internal conduction to the tissues of the ear canal 36, thereby providing improved viewing of the ear structure by more uniform illumination and illumination occurring at multiple angles. In one embodiment, region 46 may have a length of five millimeters along axis 22, and in some embodiments 1.5 centimeters.

Referring now to FIG. 4, diameter 31 of distal tip 26, measured in a plane perpendicular to axis 22, may be less than two millimeters, and diameter 31 of distal region 46 of speculum 24, which distal region 46 extends at least five millimeters and in one embodiment one centimeter from distal tip 26 along axis 22, may be less than five millimeters and in some embodiments may be less than three millimeters to be substantially less than ear canal 36. The speculum 24 surrounding the camera 30 is intended to be sized to allow imaging of the eardrum 38 over smaller obstacles, such as normally present cerumen, and to allow passage within the ear canal 36 with a medical instrument, such as a curette, while the probe assembly 20 is in place for imaging in order to remove obstacles, such as cerumen, i.e., to allow the instrument to extend to the side and over the end of the distal tip 26.

Still referring to FIG. 4, as mentioned above, the present invention provides a distal tip 26 that is more flexible than typical otoscopes. Generally, the flexibility of the distal tip 26 is intended to improve comfort for the patient and reduce the risk of damage to the structure of the outer ear 33 caused by small diameter probes. When head portion 14 is stabilized, a 100 gram vertical force 68 applied to the distal end of distal tip 26 will cause a deflection 69 of no less than one millimeter. In contrast, a similar force applied to the end of an atypical speculum would provide a corresponding deflection at the end of the speculum of much less than one millimeter. It should be understood that this flexibility may be provided by: constructing barrel probe 28 and tapered speculum 24 from a flexible material, or mounting barrel probe 28 and tapered speculum 24 to housing 12 via a flexible or compliant mount that allows barrel probe 28 and tapered speculum 24 to invert in response to an applied lateral force, or coating a cylindrical, tapered sheath with an elastomeric material, or a combination of these methods.

Referring now to fig. 5, distal tip 26 of speculum 24 may be enclosed by an optically transparent, low distortion window 50, which window 50 allows images to be detected through window 50 while preventing contamination of camera 30 and while also providing a clean shield between camera 30 and the patient. The outer surface of speculum 24 proximate distal tip 26 may include rearwardly angled bristles or teeth 53, which rearwardly angled bristles or teeth 53 may serve the purpose of using speculum 24 itself to assist in removing debris and material from ear canal 36. These teeth 53 can be formed at the same time as the material of the speculum 24 to be optically transparent and thus to pass the illumination. Alternatively, the teeth 53 may be overmolded with a flexible resilient material, such as silicone rubber, thereby also serving to reduce pressure between the distal tip 26 and the ear canal 36 through a cushioning operation.

Barrel probe 28 may be constructed of a relatively flexible material, such as a silicone or polyvinyl chloride material, and barrel probe 28 may be tubular to provide a passage for electrical conductors 54 that communicate pixel image data from camera 30.

Referring now to FIG. 6, the otoscope 10 may include an electronic controller 102, such as a microcontroller that is essentially an electronic computer and I/O circuitry, for example. The controller 102 will set up a processor 104 that communicates with a memory 106 that allows non-transient storage of programs 108. Typically, the program 108 will effect reception of signals from the camera 30 in order to present images from the camera 30 on the display 18 and will effect transmission of these images to an accessory device, such as a PACS apparatus. Program 108 may perform normal image processing such as exposure control, contrast adjustment, color balance, motion stabilization, image rotation, 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 addition, the memory 106 may hold, for example, a bar code decoder program 111 that allows the otoscope 10 to also be used to read data from the bar code 117 to identify a particular image to a particular patient's document and to transmit bar code data with the image in a protocol for associating the bar code data with the image.

The controller 102 can also communicate with other devices, such as via a wireless transceiver 112 or an electrical connector 114, to allow image data and barcode data to be transmitted to a remote electronic medical record server.

The power button 113 may communicate with the controller 102 to place the electronic circuitry in a low power sleep state to disable the display 18, the camera 30, and the LEDs 66.

The program 108 in the standby mode may cycle through different colors or display a particular color (e.g., pink) on the LEDs 44 to enhance the appeal of the otoscope 10 to pediatric patients who may be afraid of medical devices. The otoscope circuitry described above may be powered by a battery 109 contained in a grip that may be removably connected to the housing 12 by an electrical and mechanical connector 115. Alternatively, the electrical and mechanical connector 115 may allow the otoscope 10 to be attached to a handle unit attached to a wall transformer or the like as commonly understood in the art, such as used in many examination rooms.

A sleeve detector switch 120 may also be provided to detect whether the speculum 24 is in place prior to activation of the otoscope 10 to prevent use of the otoscope 10 without the protective speculum 24.

The controller 102 may also communicate with a microphone 105 exposed through a microphone grill 110 as shown in fig. 7, for example. In this regard, the controller 102 may, for example, provide a simple voice recognition feature, allowing a healthcare professional to take a snapshot using the otoscope 10, for example, by speaking a keyword such as "snapshot". An exemplary speech recognition core suitable for use with the present invention is Texas instruments C5535 or C5534 equipment commercially available from Texas instruments Corporation.

A MEMs-type inclinometer 107, for example in the form of a triaxial accelerometer or accelerometer/gyroscope or similar device, may be used to detect the rotational orientation of the housing 12 about the axis 22, which will be used to provide rotational correction of the image, as will be discussed below.

As will be discussed in more detail below, the controller 102 may receive data from the camera 30 and provide image processing such as contrast and brightness adjustment, image stabilization and magnification, and the controller 102 may display images on the touch screen display 18 along with other important non-image data based on battery power, video sequences, etc. while using stored programs to communicate with the various components discussed above. Camera 30 may take a conventional sequence of images in a video stream to be stored in memory 106 or may store or mark selected snapshot images under user control, as will be discussed below.

It will be appreciated that the speculum 24 is for example constructed to be relatively low-cost and thus disposable, that the speculum 24 may for example be manufactured by injection moulding, and that in this respect, for example, a variety of different sleeve types may be provided having different tooth designs for different purposes including other medical examinations of the nose or the like.

Second embodiment

Referring now to FIG. 7, display 18 may have a circular shape with a diameter of about 1.5 inches and less than two inches, and desirably less than 2.5 inches. The display 18 may be centered on the axis 22 by having the viewing surface perpendicular to the axis 22 such that the display 18 is opposed by a straight cone 133, the top of the straight cone 133 being at the distal end of the barrel probe 28 and the base of the straight cone 133 being perpendicular to the axis 22. The opposing cones 133 may have a vertex angle 23 of less than 60 degrees and desirably less than 45 degrees to provide improved ability to visualize the display 18 and the outer ear 33 (shown in fig. 1) around the housing 12 by a healthcare professional.

The grip portion 16 may include a downwardly extending grip collar 124 connecting the head portion 14 with a removable power handle 126, the power handle 126 may fit within the collar 124 and be locked to the housing 12 by making a quarter turn of the power handle 126. In this regard, the powered handle may have upwardly extending electrical and mechanical connectors 128 that are received by corresponding connectors within the collar 124. Surrounding the connector 128 is a rheostat operator 130, rotation of which rheostat operator 130 varies the voltage transmitted by the handle 126 to the rest of the head portion 14. The locking button 132 may protrude upward from an edge of the varistor operator 130 to be depressed before the varistor operator 130 may be rotated from the open position to increase the power of the connector 128 from zero voltage to the operating voltage. The handle 126 may be provided with an internal rechargeable battery or may be connected to a wall transformer or the like by a cable (not shown) extending from the bottom of the handle 126 that is connected to the handle 126.

Referring now additionally to fig. 8, removable speculum 24 may be fitted over probe 28, and probe 28 is attached to head portion 14 of housing 12 by making a quarter turn at the twist lock interface between cylindrical mounting boss 134 and tubular speculum collar 136 on housing 12. As is understood in the art, such a quarter turn of collar 136 allows speculum 24 to be slidably mounted on probe 28 and into engagement with mounting boss 134, collar 136 having radially inwardly extending teeth that are received in corresponding peripheral helical grooves 137 around the exterior of cylindrical boss 134. The helical groove 137 is coiled approximately 90 degrees away from the distal end of the probe 28 and then returned a short distance in the opposite direction to provide a stop point. As will be discussed below, locking is provided due to a resilient bias tending to push locking collar 136 away from housing 12, depending on interference between speculum 24 and housing 12 or interference between probe 28 and speculum 24.

In general, the body of speculum 24 may be in the form of a hollow horn tapering downwardly toward distal tip 26 and constructed of a rigid thermoplastic integrally molded to collar 136, for example. The rigid material allows speculum 24 to slide easily over probe 28 without the resistance that might be expected if the material were elastomeric, for example. Transparent elastomeric material 138 may be overmolded to speculum 24 to hermetically seal distal tip 26 of probe 28 from contamination by the environment of the ear and from contamination by distal tip 26 of probe 28.

Referring now to fig. 9, the length of speculum 24 is set such that: the distal end of the probe 28 presses outwardly on the elastic material 138 when the locking collar 136 is fully installed on the barrel boss 134, stretching the elastic material 138 and thinning the elastic material 138 to improve the transparency of the elastic material 138 and reduce optical aberrations through the elastic material 138 by virtue of the natural balancing properties of the stretching of the elastic material. During the stretching process, the elastic material 138 remains adhered to the end of the speculum 24, thereby maintaining a clean separation between the ear and the probe 28. The resilience of the resilient material 138 provides a resilient bias to promote a locking engagement between the collar 136 and the boss 134, and the resilience of the resilient material 138 also pulls the resilient material 138 into a window 140 closely against the end of the probe 28 to reduce internal reflections.

Referring now to FIG. 10, the outer wall of the probe 28 may be formed by an outer tube 143 that holds a second coaxial tube 142. Located within the second coaxial tube 142 is the camera 30 oriented to face along the axis 22. The second coaxial tube 142 serves to block light transmitted by the optical fiber 144 from propagating laterally to the camera 30, the position of the optical fiber 144 preferably being aligned with the axis 22 between the tube 142 and the outer tube 143 of the probe 28. Both the optical fiber 144 and the camera 30 may be embedded in an optically transparent epoxy material 139 and have a rearward conductor 141 for the camera electrical signal. The window 140 of elastomeric material 138 is pulled against the ends of these

tubes

143 and 142, eliminating such gaps: in the case where the window 140 is loosely spaced from the ends of the

tubes

142 and 143, this gap will allow internal reflections from the optical fiber 144 to the camera 30 that reflect from the inner surface of the window 140, such as would obscure the camera 30. A similar effect can be obtained without the inner tube 142 by placing the fiber or camera 30 directly at the edge of the tube 143 so that there is no gap where optical internal reflection can occur. In this case, the optical fiber 144 may communicate with the LED 44 as a set of colored LEDs or one or more high intensity white LEDs.

In an alternative embodiment (not shown), window 140 may be constructed of a rigid material, for example using a thermoforming process or an injection molding process, to separately form speculum 24 and window 140 or to form speculum 24 and window 140 as assembled components, such that window 140 is still pulled against the end of tube 142 to prevent light reflections between the bright light source and camera 30 due to the presence of window 140. By controlling the strong internal reflections, the present invention allows full coverage of the probe to reduce cross-contamination.

Referring now to fig. 11 and 12, in an alternative embodiment, speculum 24 may have a scraper 146 at distal tip 26 of speculum 24, which scraper 146 extends parallel to axis 22 from a side wall of speculum 24 at the periphery around the circular aperture in speculum 24 that exposes the distal end of probe 28. In a preferred embodiment, the scraper 146 may extend 1/8 inches to 1/2 inches, for example, from the end of the probe 28. The scraper 146 may, for example, be pre-curved toward the axis 22 or away from the axis 22, or in a preferred embodiment the scraper 146 may be parallel to the axis 22 for general use and for improved transport in which the specula 24 are nested. In the latter case, the scraper 146 may include a separate ductile metal layer 148 or a ductile metal layer 148 laminated to a flexible thermoplastic layer 150, allowing a curvature to be formed in the scraper 146 by the particular application of a simple bending process on the scraper 146 by a healthcare professional, wherein the ductile metal layer 148 maintains the curvature after bending. Generally, curvature is possible within the field of view 153 (about 50 degrees) of the camera 30 within the probe 28, allowing visualization of the use of the scraper 146 during use.

Referring now to fig. 13 and 14, in an alternative embodiment, speculum 24 may have a scoop 152 at distal tip 26 of speculum 24, which scoop 152 extends parallel to axis 22 like scraper 146 of fig. 11 from a side wall of speculum 24 at a periphery around a circular opening in speculum 24 that exposes the distal end of probe 28. Scoop 152 may be positioned to the side of the distal end of probe 28 to extend beyond the distal end of probe 28 and face inwardly over the front of probe 28. Scoop 152 may communicate via an internal channel 154 within speculum 24 that may connect to an air port 156 in the front face of boss 134, port 156 leading to a vacuum source via conduit 160, allowing speculum 24 to be used to aspirate debris and the like through scoop 152. In this case, collar 136 may support an O-ring 162 on the interior face of collar 136 that provides a seal against the forward face of boss 134 to prevent air from leaking past the proximal end of the sheath and the sheath's interface with boss 134. As will be discussed below, the vacuum source connected to conduit 160 may be an external vacuum line or an internal vacuum pump system connected to housing 12 as will be discussed.

Referring now to fig. 15 and 16, in yet another alternative embodiment, speculum 24 may have a small annular balloon 164 coaxial with axis 22 at distal tip 26 of speculum 24, which small annular balloon 164 may be inflated and deflated to extend radially from speculum 24 or to collapse relative to speculum 24. This inflation and deflation may be via a channel 154 in speculum 24 leading to port 156. In this case, the conduit 160 provides a source of pressurized air or a release of pressurized air for inflation and deflation operations. The balloon 164 may be constructed of an elastomeric material 138 that is otherwise also used for the windows 140 formed simultaneously during the dipping process. In this regard, balloon 164 may be inflated once speculum 24 is in place, such as taught in U.S. patent 6,152,940, incorporated herein by reference, for removing debris or cerumen from the ear, but with the following modifications, in contrast to the cited references: the annular shape of balloon 164 allows for continuous visualization through window 140. As described below, the conduit 160 may be provided with an external source of pressurized gas or may be operated by an internal pressure reservoir.

The features of these embodiments may be combined, for example, adding a clean window to either of the embodiments of fig. 11 and 13.

Referring now to fig. 17 and 18, the housing 12 may be modified to provide a pump button 166, a release button 168, and a valve direction knob 170, the pump button 166, the release button 168, and the valve direction knob 170 allowing the use of a pump 176 actuated by the pump button 166 to pressurize or evacuate an internal reservoir 172 within the housing 12. Once reservoir 172 is filled, the vacuum or pressure may be released by valve button 168 controlling a valve 178 in communication with scoop 152 or balloon 164 discussed above via speculum 24. An input check valve 180 located on the inlet side of the pump 76 and an output check valve 182 located on the outlet side of the pump 176 may be rotated simultaneously in two different directions to either cause the pump 176 to evacuate the reservoir 172 or to increase the pressure in the reservoir 172. By pre-pumping the reservoir 172, the healthcare professional can easily apply vacuum or pressure during use of the otoscope 10 with little damage to the housing 12.

Referring now to fig. 7 and 19, the collar 124 of the head portion 14 of the housing 12 may be fitted over the handle 126 and in particular over the varistor operator 130 and varistor operator button 132 to prevent accidental movement of these components during use of the otoscope 10. During installation of the collar 124 on the end of the handle 126, an inner collar flange 184 extending radially inward on the varistor operator 130 and having resilient gripping material 186 on its lower surface may engage the upper surface of the varistor operator 130 and the varistor operator button 132 to press the button 132 downward to release the varistor operator for movement. Twisting the handle 188 to engage the connector 128 with the mating connector 190 retained in the head portion 14 will rotate the varistor operator 130 relative to the handle 126 to rotate the varistor to its highest voltage position and retain the varistor therein during use of the otoscope 10.

The

connectors

128 and 190 may work with standard otoscope handles 126 using, for example, a connector system as taught by U.S. patents 3,071,747, 1,516,133, and 2,469,857, which are incorporated by reference herein. As noted, the interconnection of connector 190 and connector 128 provides both a mechanical connection between handle 126 and housing 12 and an electrical connection to terminal 192 of connector 190, which provides power to a system, shown for example as battery 109 in fig. 6, where connector 190 and connector 128 provide connector system 115.

Referring now to fig. 20, the collar 124, flange 184, resilient gripping material 186 and connector 190 may alternatively be placed in a detachable adapter 194, which detachable adapter 194 may be removably attached to the remainder of the head portion 14 such that the adapter 194 may be pre-installed on the handle 126 and on a separate arbitrary connector system for mechanically and electrically connecting the adapter 194 with the remainder of the head portion 14 and the grip portion 16.

Still referring to fig. 20, the circular display 18 may be, for example, a touch screen LCD or organic LED display, such as to minimize visual impairment when the display 18 is viewed by healthcare personnel — the display 18 is displaying an area of interest such as a clinical image 200 that may depict portions of the tympanic membrane and ear canal. The peripheral region of display 18 may, for example, provide non-image data of arc bar display 202, thereby providing arc bands extending at different angles around the center of display 18 to indicate the magnitude and/or range of various parameters. In one embodiment, the arc length of the bar display 202 may represent the length of a video sequence of images acquired by the camera 30. Moving finger 204 around the arc of bar display 202 allows a particular still image to be selected from the video sequence for viewing in a video browsing operation. The bar display 202 may also indicate various parameters, such as battery level, by the length of the bar display 202. Alternatively, the arc length of the bar display 202 may indicate a range of battery charge states (0 to 100 percent), and the labeled arrow 205 moving around the periphery may indicate the battery charge within that range. In general, the present invention contemplates that this peripheral region may be used for display purposes without interfering with the display of the clinical image 200.

The center area of the circular display 18 may also provide touch sensitivity, for example, to allow touch to trigger a snapshot of a given video when video recording is not enabled. A touch to the right of the display 18 may display non-image data of a right marker 206, the right marker 206 indicating on the display 18 (and recorded in the stored image): the specific episode image is an image of the right ear. A corresponding touch on the left side of the display 18 may provide a similar (but not shown) left marker. By positioning this data around the periphery of the display 18, less important areas of the clinical image 200 are covered, while allowing the healthcare practitioner to simultaneously view important areas of the clinical image 200 as well as non-image data without shifting his or her gaze.

The accelerometer or inclinometer 107 discussed with respect to fig. 16, for example, may be used to infer the orientation of the handle element at 18 or at 18' to rotate the displayed non-image data, such as the arced bar display 202 or the side marker 206, into such a way that the displayed elements maintain a standard orientation with respect to gravity and the user during use of the otoscope 10. During normal use, the displayed clinical image 200 always maintains the same orientation as the image structure in the ear; however, the recorded images may be adjusted at the time of storage by: the image is rotated using the orientation derived from inclinometer 107 so that the image is displayed in the same orientation as when otoscope 10 is held in the normal position (usually pointing downwards) of grip portion 16. In this manner, the image viewed by an individual who does not know the actual orientation of otoscope 10 during image acquisition provides a standard orientation, thereby eliminating ambiguity. Thus, using inclinometer 107 to rotate images prior to storage allows greater flexibility in obtaining images without having to worry that the recording orientation of these images is uncertain. Alternatively, inclinometer 107 may be used to position arrow markers (non-image data) in the image to indicate an upward direction.

Referring now to fig. 21, in one embodiment, a protective tubular sheath 210 may extend from housing 12 around probe 28 when speculum 24 is removed or changed. The sheath 210 may bypass the exterior of the boss 134 to be received within an interior pocket 212 within the housing. Sheath 210 may be biased outwardly toward the extended position when a helical compression spring 214 captured in pocket 212 is urged. The extension of sheath 210 prevents damage to probe 28 when speculum 24 is removed, for example if otoscope 10 is to be dropped. Contact between collar 136 and the distal end of sheath 210 when speculum 24 is attached presses sheath 210 back into housing 12 and into a remote position.

Referring now to fig. 22, the space between the inner surface of speculum 24 (not shown in fig. 21) and probe 28 may contain one or more compliant ribs 216 or similar overmolded plastic supports having a generally flared profile. These ribs 216 provide additional support and protection to the probe 28 and eliminate the visual impression that the probe 28 is a needle, such as may be painful for pediatric patients. For additional strength, the ribs 216 may be integrally molded with the boss 134. The boss 134 may, for example, be separable from the structure of the housing 12 such that the plug end 218 on the boss 134 is removably retained in a socket 222 fixed to the housing 12, for example, by a snap element 220. The receptacle 222 may support an electrical connector 224 that mates with a similar connector 226 supported by the plug end 218. The receptacle 222 may also support one or more high power LEDs 227 in alignment with the optical fiber 144 when the plug end 218 is inserted into the receptacle 222. In this manner, the probe 28 may be easily replaced when the probe 28 is damaged or a different style or length of probe 28 may be installed. The amount of force required to remove the plug end 218 from the receptacle 222 can be set to allow these components to separate when the otoscope 10 is dropped to minimize damage. In one embodiment, the inclinometer 107 may be accelerometer based and detect free fall of the otoscope 10 (by near zero measured acceleration) and employ an electronic actuator (not shown) to release the connection, thereby further minimizing damage.

The boss 134 may also include an LED to simplify replacement of the LED by requiring only an electrical connection to the remainder of the otoscope. The boss 134 may have a threaded attachment of the boss 134 itself or may be held in place by a threaded collar or the like.

Certain terminology is used herein for reference purposes only and is therefore 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. The terms "front," "back," "rear," "bottom," and "side" describe the orientation of portions of the components within a consistent but arbitrary frame of reference which is made clear by reference to the text and the figures in which the components being discussed are described. Such terms 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 the specifically identified elements or features. It should also 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 should also be understood that additional or alternative steps may be employed.

References to "controller" and "processor" may be understood to include one or more microprocessors that may communicate in stand-alone and/or distributed environments, and thus may be configured to communicate with other processors via wired or wireless communication, where such one or more processors may be configured to operate on one or more processor-controlled apparatuses that may be similar or different devices. Further, unless otherwise noted, references to memory may include one or more processor-readable and accessible memory elements and/or components that may be internal to the processor-controlled device, external to the processor-controlled device, and accessible via a wired or wireless network.

As used herein, "diameter" should not be construed to require a cylindrical or circular element, but merely describe the diameter of a circumscribed cylinder that closely conforms to the element.

It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein, and that the claims be construed 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 claims. All publications, including patent and non-patent publications, described herein are incorporated by reference in their entirety.

Claims

1. An otoscope comprising:

a housing adapted to be supported by a hand of a healthcare professional, wherein the housing is in an inspection position adjacent to an outer ear of a patient;

an elongate probe element, a proximal end of the elongate probe element supported by the housing such that a distal end of the elongate probe element is extendable along an axis into an ear canal;

an electronic camera supported by a distal end of the elongated probe element for viewing into the ear canal of the outer ear when the distal end of the probe element is positioned in the ear canal; and

a circular electronic display in communication with the electronic camera and displaying an otoscope image from the electronic camera, and the circular electronic display is spaced apart from the distal end of the elongate probe along the axis and centered along the axis.

2. The otoscope according to claim 1, wherein the display is circumscribed by a cone having a tip at the distal end of the probe and a cone angle of less than 45 degrees.

3. The otoscope according to claim 1, wherein said display extends less than three inches from said axis at all angles about said axis.

4. The otoscope as recited in claim 1, further comprising a processor executing a stored program for displaying non-image data in a peripheral ring around said image.

5. The otoscope according to claim 4, wherein said non-image data comprises a curved bar display, an angular extent of said curved bar display indicating data.

6. The otoscope according to claim 5, wherein the circular electronic display provides a touch screen for sensing touches on a surface of the circular electronic display, wherein the arc-shaped bar displays a video sequence representing images acquired from the electronic camera, and wherein touches displayed along the arc-shaped bar select images from the video sequence for display.

7. The otoscope as recited in claim 4, further comprising a display indicating a left ear or a right ear recorded as linked with the image.

8. The otoscope according to claim 4, further comprising an electronic inclinometer for changing at least one of an orientation of the non-image data and an orientation of the recorded image on the circular electronic display according to an inferred gravity vector.

9. Otoscope according to claim 1, wherein the housing is provided with: a display portion holding the electronic display and the elongate probe; and a handle portion extending away from the axis for retention by a healthcare professional; and wherein the display portion is mechanically and electrically detachably attachable to the handle portion by means of a twist-lock coupling.

10. The otoscope according to claim 9, wherein the handle portion is provided with a varistor controlling the power transmitted to the display portion, and wherein the handle portion is provided with a collar fitted over the varistor to prevent movement of the varistor.

11. The otoscope as recited in claim 10, wherein the collar portion includes a varistor engagement surface that rotates the varistor to a full power position through rotation for engagement of the twist lock coupling.

12. The otoscope as recited in claim 10, wherein the display portion includes a removable adapter portion that removably receives the handle portion.

13. The otoscope according to claim 12, wherein the handle portion is attached to the display portion with a twist-lock coupling.

14. An otoscope comprising:

an electronic camera supported by the distal end of the elongated probe element for viewing into the ear canal of the outer ear when the distal end of the probe element is positioned in the ear canal;

a set of light sources supported by the distal end of the elongated probe element for illuminating the ear canal when the distal end of the probe element is positioned in the ear canal;

a replaceable tubular sheath sized to fit within the ear canal and receive the elongate probe element therein, a distal end of the tubular sheath being provided with a transparent window covering through which imaging is permitted, and a proximal end of the tubular sheath providing a connection with the housing that provides a resilient bias of the window against the distal end of the probe element;

wherein a proximal end of the light source and a proximal end of the electronic camera are configured to eliminate a path between the light source and the electronic camera for internal reflections from the window when the window is pulled relative to the distal end of the probe element.

15. The otoscope as recited in claim 14, wherein the transparent window is an elastic sleeve, and attachment to the housing stretches the elastic sleeve over the electronic camera to provide the camera with a transparent cover through which images are allowed to be imaged.

16. A disposable speculum for an otoscope of the type having:

wherein a proximal end of the light source and a proximal end of the electronic camera are configured to eliminate a path between the light source and the electronic camera for internal reflection from the window when the window is pulled against the distal end of the probe element, the disposable speculum comprising:

a replaceable sheath provided with a substantially inelastic sidewall sized to fit within the ear canal and receive the elongate probe element therein, a distal end of the tubular sheath being provided with a transparent window covering allowing imaging therethrough, and a proximal end of the tubular sheath providing a connection with the housing providing a resilient bias of the replaceable tubular sheath to pull the window against the distal end of the probe element.

17. A disposable speculum for an otoscope, comprising:

a tubular sheath sized to fit within an ear canal and to receive an elongate probe element within the tubular sheath, a distal end of the probe element supporting an electronic camera, wherein a distal end of the tubular sleeve is covered by an elastic sleeve, and wherein a proximal end of the tubular sheath is adapted to engage the otoscope to stretch the elastic sleeve over the electronic camera to provide a transparent cover over the camera that allows imaging therethrough.

18. A disposable speculum for an otoscope, comprising:

a tubular sheath sized to fit within an ear canal and to receive an elongate otoscopic probe element within the tubular sheath, a distal end of the probe element supporting an electronic camera, wherein a distal end of the tubular sleeve provides a means for engaging a target within the ear within the field of view of the camera that extends axially beyond the distal end of the probe element.

19. The disposable speculum for the otoscope according to claim 18, wherein the instrument element is malleable to form a curved portion relative to the axis of the tubular sheath and maintain that curvature.

20. The disposable speculum for otoscopy according to claim 18, wherein the utensil element is provided with a scoop in communication with a channel connectable to a vacuum source.

21. An otoscope comprising:

a housing adapted to be supported by a hand of a healthcare professional with the housing in an inspection position adjacent to an outer ear of a patient;

a microphone;

an electronic display; and

a processor executing a program stored in a non-transitory medium and in communication with the electronic camera, the microphone, and the electronic display to operate in a first mode in which a dynamic image indicating a view from the electronic camera is provided on the display and a second mode in which a trigger is triggered by a user's voice received by the microphone to capture a static image on the display indicating the view from the electronic camera at the time of the trigger.

22. An otoscope for medical examination of an ear, comprising:

an electronic camera;

an elongate probe sized for insertion into an ear canal, the elongate probe supporting the electronic camera at a distal end facing outwardly from the elongate probe along an imaging axis, and a first releasable electrical connector half disposed at a proximal end of the elongate probe; and

an otoscope body housing comprising a handle extending away from the imaging axis and dimensioned to be grasped by a human hand, the otoscope body housing further provided with a second releasable electrical connector half for receiving the first releasable electrical connector half;

wherein the first and second releasable electrical connector halves are releasably connected such that: physically separating and electrically disconnecting the otoscope body housing from the elongated probe when a predetermined force is applied.

23. The otoscope as recited in claim 22, wherein said otoscope body housing supports a light emitting diode aligned with an optical fiber extending along said elongated probe when a proximal end of said elongated probe is received by said otoscope body housing.

24. The otoscope according to claim 22, wherein said predetermined force required to separate said elongated probe from said otoscope body housing is set to allow separation when said otoscope is dropped without damaging said electronic camera.

25. The otoscope of claim 22, further comprising an accelerometer that detects free fall of the otoscope and an electronic actuator configured to release the elongated probe from the otoscope body housing when free fall is detected.

26. An otoscope as claimed in claim 22, wherein said first and second releasable electrical connectors are snap-fit elements adapted to be released without an appliance.