Patent ID: 12220107

DETAILED DESCRIPTION

Referring firstly toFIGS.1ato1dof the accompanying drawings, an otoscope10according to the present invention is shown. The otoscope comprises a digital camera20, an ear speculum30and an attachment means40for attaching the camera to the speculum.

The speculum defines a first end32with a circular first opening, and a second end36with a circular second opening. The first opening and the second opening are substantially parallel. The first opening defines a larger diameter than the second opening. The center of the first opening and the center of the second opening define a central axis. A curved side wall extends between the first opening and the second opening. The speculum is hollow and funnel-shaped.

The speculum shown in this non-limiting example is a commercially available speculum in which the diameter of the first opening is 43 mm and the diameter of the second opening is 35 mm.

The attachment means40is attached to the first end32of the speculum. The attachment means40comprises an attachment portion and a portion to receive the camera. The attachment portion comprises a ring45that is configured to fit within the first end of the speculum, i.e. within the first opening. The ring45press fits within the first end32of the speculum.

The portion to receive the camera is of unitary construction, therefore formed as one piece, with the attachment portion. The camera is movable within the portion to receive the camera. InFIG.1aandFIG.1c, the camera is shown in a first position in which the camera view is along the central axis of the speculum and it can view a region beyond the second opening. InFIG.1bandFIG.1d, the camera is shown in a second position in which it does not extend across the first opening at all. The portion to receive the camera is configured to allow the camera to be displaced from the first position in a plane that is perpendicular to the central axis or parallel to the plane of the first opening to the second position. The displacement is by means of the camera being slidably received by the portion to receive the camera such that it can slide between the first and second positions. The size, shape and configuration of the portion to receive the camera allows the movement and position of the camera to be controlled by pressure applied by the fingers of the clinician.

This displacement in particular reduces the risk of the camera being contaminated with earwax on an instrument as it is removed from the speculum.

The camera views a region beyond the second opening by viewing along the central axis from a position substantially in the plane of the first opening. The camera is positioned 10 mm or less outside of the plane of the first opening. The camera is connected to a viewing device, such as a tablet (not shown) by a cable28.

A user of the otoscope shown inFIG.1could hold the otoscope by its speculum or attachment means, for example.FIG.1shows that no handle is present in this embodiment of the invention.

The otoscope is configured to allow an instrument to reach through the first opening and the second opening of the speculum such that the instrument can be operated by a user from beyond the first opening to operate in the region beyond the second opening.

FIGS.2ato2dof the accompanying drawings shows an otoscope10according to the present invention. The otoscope comprises a camera20, a speculum30and an attachment means40.

The speculum is similar to that shown inFIG.1, and the attachment means40attaches to the first end of the speculum30by means of the attachment portion in the form of ring45as described in relation toFIG.1. The attachment means also comprises a portion to receive the camera (not visible). InFIG.2aandFIG.2c, the camera is shown in a first position in which the camera view is along the central axis of the speculum such that it can view a region beyond the second opening. InFIG.2bandFIG.2d, the camera is shown in a second position in which it does not extend fully across the first opening. The portion that receives the camera is pivotally secured to the attachment means such that the camera can rotate or pivot between the first position and the second position.

The camera views a region beyond the second opening by viewing along the central axis from a position substantially in the plane of the first opening. The camera is positioned 10 mm or less outside of the plane of the first opening. The camera is connected to a viewing device, such as a tablet (not shown) by a cable28.

Although not shown the portion to receive the camera can envelope the camera or have a portion that envelopes the camera. The portion to receive the camera can be or comprise a rectangular housing or “tower”. The tower is preferably made a transparent material especially at the edge/face that directly faces the first end32of the speculum so that the light reflection back to the camera is unimpeded and the illumination system from any LED's is also unimpeded. The tower may have optical properties that allow the focusing of the illumination or the camera or both. The tower may also hold electronics to drive the individual components such as the camera.FIGS.1ato1dandFIGS.3ato3cshow different orientations for the electronics.

FIGS.3ato3cof the accompanying drawings shows an otoscope10according to the present invention. The otoscope comprises a camera20, an ear speculum30and an attachment means40.

The speculum defines a first end32with a projection34. The projection extends from the first end approximately half way along the length of the speculum. The first end32has a first opening that is mostly circular, except for the projection34where the circumference of the first opening is expanded. The speculum also defines a second end36with a circular second opening.

The first opening and the second opening are substantially parallel. The first opening defines a larger diameter than the second opening. The centre of the first opening and the centre of the second opening define a central axis. A curved side wall extends between the first opening and the second opening. The speculum is hollow and funnel-shaped.

The attachment means comprises an attachment portion42for attachment to the first end of the speculum. The attachment portion42is adapted fit around a part of the first end of the speculum. The attachment portion42is configured to engage with ribs38on the external surface of the first end of the speculum, the ribs being elongate and parallel to the central axis. The attachment portion is arc shaped, the arc extends approximately 180° or more around the central axis of the speculum.

The attachment means further comprises an extension44extending from the attachment portion away from the speculum and being parallel to the plane of the arc of the attachment portion. The extension44comprises a hinge or pivot to attach to the portion46to receive the camera.

The portion to receive the camera is attached to the attachment portion through the hinge or pivot of portion44. InFIG.3aandFIG.3b, the camera is shown in a first position in which the camera view is along the central axis of the speculum such that it can view a region beyond the second opening. InFIG.3c, the camera is shown in a second position in which it does not extend across the first opening at all. The portion that receives the camera is secured to the attachment means by a hinge so that the camera can move between the first and second positions by a hinged movement. In this way, the otoscope is configured to allow the camera to be displaced from the detection position in a plane defined by the central axis or in a plane perpendicular to the first opening.

The camera of the otoscope shown inFIG.3communicates with a viewing device that is connected to the camera wirelessly. For example, the connection may be by Bluetooth or WiFi.

A further aspect of the embodiment inFIG.3is a mechanism that allows the speculum to be rotated while keeping the camera in a static position. This mechanism works through movable communication between the attachment portion42and ribs38on the outer surface of the speculum around the first opening. This sometimes may be necessary for the clinician to allow a better fit to an individual's curvature of their ear canal but keep the camera in a static position so stopping the camera picture from being rotated.

We also disclose a new type of ear speculum—where there is a bulge/protrusion/channel/tunnel that allows greater movement of surgical instruments and allows a greater distance of clearance away from the camera attachment means. Based on a clinician's dexterity—the speculum can be rotated so that the bulge/protrusion/channel/tunnel is same laterality of the hand that is using the medical instruments.

FIGS.4ato4dof the accompanying drawings shows an otoscope10according to the present invention. The otoscope also comprises an ear speculum30. The plane of the second opening of the speculum is at an angle of about 30° from the angle of the plane of the first opening.

The otoscope comprises a camera20that extends beyond the plane of the first opening, into the speculum, by a distance of about 10-15 mm.

The otoscope comprises a handle50that is integral with or contains the camera. In use, a clinician will hold the handle. A cable to attach a viewing device to the camera extends from the handle.

The otoscope also comprises an attachment means40. The attachment means comprises an attachment portion in the form of a ring45that fits within the first end of the speculum.

The portion that receives the camera is fixed to or unitary with the attachment portion. The portion that receives the camera comprises an elongate mount47that extends radially from the attachment portion towards the centre of the first opening and a tubular portion48extending therefrom perpendicular to the elongate mount in which the camera can be press fit. As such as the ways to move the camera relative to the speculum are to either detach the camera or detach the speculum from the attachment means. The camera detects along the central axis to allow the best possible view of the ear canal for the clinician.

FIG.4bshows a cross-section through the speculum and attachment means. The line A-A shows the central axis of the speculum. It can be seen that, in use, the attachment means will align the camera to detect along the central axis of the speculum. This gives the best possible view of the ear canal for the clinician.

FIG.5is the side profile a new type of ear specula, which has an extension to receive a micro digital camera system.FIG.5ashows a camera system at the mouth of the speculum and is flush to the same vertical axis specula mouth. Annotation1refers to the tip of the speculum that enters the patient first. Annotation2refers to built in recess that holds the camera, lighting parts. Annotation4refers to wires of the camera.FIG.5crefers to the structure of annotation2, which has openings+/−focusing lenses that allow a light source e.g. a white LED source (but not limited to that) and opening for the camera. The camera portion ends at central point of the ear specula to allow co-axial views of the tympanic membrane.FIG.5bshows an alternative embodiment of this speculum. In this embodiment there is an additional horizontal strut (annotation3) that places the camera structure away from the mouth. The reason for this is that being further away from the mouth of the camera may mean the camera is not contaminated by wax and other ear canal debris.

The strut would be of a short length so that the camera view would not be obscured by hand.

In all embodiments, the camera is attached by wire to a high definition display such as a tablet and the wire transmits the electronic signals from the camera to the tablet. We envisage the tablet, power electronics and power management systems will be in portable stand, which can be based by the patient and then a swivel arms which connects the tablet and the stand can be provide rotation of the display depending if the practitioner is performing a procedure in the left or right ear.

Software within the display and will manipulate the image to provide clear natural colour image. Software and the camera can be manipulated for zoom functions of the product. Software can also perform real-time/live or historical data analysis to inform the clinical user of normal and abnormal pathology.

We do not wish to limit our electronic transmission to just wires, but this can be done without wires with WiFi or Bluetooth technologies but not limited to just those technologies.

FIG.5dshows a possible embodiment of the ear speculum is to have an opening that leads to a tunnel (annotation7) along the inner side of the speculum—which acts as a port for a flexible microcamera. The tunnel would protect the microcamera from any debris and dirt and would have at the end, a clear covering which may also act as a focusing lens (annotation8). The end of the tunnel can end at the tip of the speculum or just before. The reason to add such a port is that a flexible camera at the end of the tip increases the field of view an otoscope can be used as a screening tool.

FIG.6is view of the camera from the opening side.FIG.6is a view of the camera from the first opening side. In the preferred embodiment, the camera and lighting system only take a small proportion of the total surface area of the south. In this figure, the camera is at a 6 o'clock position however in this position instruments would find the passage of instruments to be obstructive. Because aural microsuction (AM) is an ambidextrous procedure, we envisage that the camera can be held at 8 o'clock and 4 o'clock positions. In these positions, it allows para-central insertion of instruments. When the camera is in these positions, software and hardware can re-orientate the image to the user. These positions are for example and are not limiting on possible positions.

Though the speculum can be simply rotated in the hand to these positions, an alternative embodiment is to have within the outer ring of the ear speculum the camera system along an inner track, which can be rotated. This would also allow for the camera to be fixed in position.

Avoiding Wax Contamination

InFIGS.7a-cwe describe mechanisms to move the camera out of the way when surgical instruments are removed. There is a risk that when instruments are removed with wax and other ear debris, on the extraction of these instruments—the wax and debris can contaminate and cover the camera system. There also may be a mechanism (e.g. ratchet) that allows the camera to be retracted nearer and further to the specula end tip as required.

FIG.7a: An alternative embodiment of a mechanism to avoid earwax contamination on the camera system is to have a mechanism that allows the camera to be moved downwards such as using a spring loaded mechanism. During AM, specula are held in the hand with the thumb, index and middle finger. In this embodiment preserves this natural hold of the specula, since the index finger can rest on the camera system. When a large piece of wax cerumen or debris is removed, it's envisaged that the finger can press down on the camera system to push it out of the way and avoid wax contamination with the camera. When the camera is needed, the mechanism can be released to allow restoration of the camera to the neutral position. It's also envisaged that camera when it's pressed down goes into a recess as part of the speculum or as in built on the camera attachment mechanism or part of the camera setup.

FIG.7eshows a possible mechanism and embodiment of moving the camera out of the way. In this embodiment the camera holding element is on a track. The camera and the holding element can be moved along the track with the use of finger. There is also be a form of locking mechanism that keeps the camera in the position and the locking mechanism is disengaged when the camera is required to be move along the track. The track is intended to be along the horizontal axis in parallel to how the speculum is inserted into the ear.

FIG.7bshows another possible embodiment of an avoidance mechanism. In this mechanism the camera can be moved out of position by having the camera rotate on an axis. Again the camera would be locked in position but the use of a finger or electronic/mechanical button would allow the camera to swing out of the way. The camera would have predominantly two axis's could rotate, inFIG.7bthe camera in a vertical motion so the camera can be “flipped down” inFIG.7c, the motion is horizontal. FinallyFIG.3Drepresents a camera mounted on a spherical/ball structure which allows 360 multidirectional movement. We also anticipate a combination of mechanisms may also be available as well.

In addition—it is an ambition of the embodiment that if necessary the tower and parts of the speculum can be cleaned with an anti-infective anti smear wipe/spray especially areas that may obscure the camera part.

Though in this application we describe aural microsuction as the primary purpose, there are many other possible specula that our camera system can be fitted with for example with nasal specula, which would allow direct visualization of the anterior part of the nose in the management of nose bleeds.

FIG.8describes an embodiment with a handle (annotation14); which has the electronics and batteries. Annotation13is display integrated into the embodiment. The display would pick up signals from the camera system (annotation2). Within the handle may be buttons that activate mechanisms described inFIG.7about removing the camera out of the way.

FIG.9describes a construction that a single ring and camera. The purpose of this system is that it would allow the digital camera system to be retrofitted into any ear specula and by allowing the hand to hold specula, creates a digital otoscope system.

FIG.10describes an embodiment using a smartphone/portable device, which the portable device camera is located with a gap between the specula and the mobile device to allow the passage of instruments. Previous smartphone otoscopes all have enclosed systems which do not allow the passage of instruments.

Because of the limitations of the digital systems, compared to ear microscopes, we also envisage that the speculum can be made of a transparent material; which can aid in the “anatomical mapping” that AM practitioners do. This would allow a greater field of view that endoscope systems allow.

One of the limitations of digital systems is that with single cameras only allow 2D planar view. We would also describe a system where a plurality of cameras may be present, and by having a plurality allows a 3D dimensional view of the outer ear canal.

Other functions include:A chip system on the specula so that when the camera attaches; there is an automatic recognition of which specula is being used and software will be at the right settings.Within the walls of the specula—with space permitting there can be channels which allow the passage of instruments (rather than through the speculum) such as water channels, pneumatic air.