Otoscopy devices

Abstract

An otoscopy device 10 comprises a base speculum 11 and a second speculum 20 attached to the base speculum. The base speculum may have a groove 18 or recess formed in an outer surface through which the

Description

This invention relates to otoscopy devices. Otoscopy is a key clinical skill in the assessment of hearing loss. In addition, in the treatment of hearing loss, ears often need to be de-obstructed of wax, foreign bodies etc. In known clinical procedures such as microsuction, instrumentation is often employed. As well as wax, there are many other ear, nose and throat (ENT) procedures that are done including Grommet insertion, tympanic membrane injections and antibiotic / steroid injections. Current technologies in video otoscopy and mechanical otoscopy use a single speculum with a viewing device e.g. mechanical otoscope, ear microscope and speculum, Loupe glasses and specula. Ear specula are very commonly used clinical aids and are often cone shaped and made from a plastic or metal design. They have key functions of straightening an ear canal and infection control measure. In such devices such as a mechanical otoscope, a disposable speculum may have an inner groove in the inner side to it can be attached to a base head unit. The base head unit often is constructed with an attachment means for the speculum, a viewing lens and a lighting system. The base head unit it is designed to be not disposable due to the complexity of construction ; a disposable speculum is designed for such purpose between patient use. In particular the specula attachment means is typically made of solid metal and designed for long term use We proposed in PCT publication WO2018 / 197870 a new embodiment of ear specula which allows the attachment of a camera system and configured to allow the passage of instruments to do outer ear procedures. This is fundamentally an improvement on the otoscope described above which is an enclosed system for viewing only. However, the anatomy of the ear canal can be twisted / tortuous / narrow and though ear specula are used to straighten ear canal in patients with long canals and bends, the tip of the speculum can be insufficiently long enough to overcome a bend. This can lead to an incomplete / partial view of the ear canal and tympanic membrane. The only way to get around this is to use force to get around the bend or using an deep-ear speculum less video otoscope or even endoscope to view beyond the bend. None of these are convenient, and many are unpleasant to a patient. In ear procedures such as aural microsuction using a microscope or Loupe Glasses, a single speculum is often held in the ear in the non-dominant hand of the practitioner and typically a single surgical instrument held in the dominant hand to do the procedure. The practitioner’s hands are fully pre-occupied without being able to do anything else. Lighting is provided externally e.g. via a headset and the human eye is use view the outer ear canal. Our earlier application WO2018 / 197870 described a new embodiment to allow the attachment of a light and using a digital camera system in lieu of a headset etc. According to a first aspect of the invention, we provide an otoscopy device comprising a base speculum and a second speculum attached to the base speculum. Thus, this allows for viewing and operating further down the ear canal, especially where the ear canal is twisty or tortuous or narrow. Typically, the base speculum may have an outer surface in which is formed a groove or recess through which the second speculum is attached to the base speculum. The second speculum may be a screw or push fit on the base speculum and / or the groove. This allows for a secure fit between the two components and avoids insecure fitting in use, specula getting detached and even falling out of ears during use, clinical manoeuvres to keep the speculum in place which may hurt the patient and poor alignment of a central optical axis. Currently disposable specula do not have any outer groove on their surface, for example when stacked in clinic for storage they are all loose fit to be easily removable. Alternatively, there may be an intermediary device which connects the base speculum to the second speculum. The intermediary device may have an outer surface which carries a groove or recess through which the second speculum is attached to the intermediary device. The intermediary device may be attached to the base speculum by, for example, glue, adhesive or suction-fit. Such an intermediary device is useful, as it allows the second speculum to be a prior art, mass-produced speculum, thus reducing manufacturing costs. The base speculum and the second speculum typically will have a common optical or central axis. The base speculum may have a distal end, and may have a proximal end. The second speculum may have a distal end, and may have a proximal end. Typically, the distal end of each of the base and second specula have a greater diameter than the distal end. It may be possible to pass at least one instrument through a central passage of the base speculum and a central passage of the second speculum. Typically, it will be possible to operate the instrument from the distal end of the base speculum, the instrument passing through the base and second specula and operating in a region adjacent to the proximal end of the second speculum. Typically, it may be possible to view the region from the distal end of the base speculum whilst operating the instrument. The device may include the instrument, passing through the central passage of the base speculum and the central passage of the second speculum. The proximal end of the base speculum may have a diameter that is greater than a diameter of the proximal end of the second speculum. Having a wider base speculum allows greater amount of light to be shown through the base specula and so improve illumination. Whilst prior art otoscopy imaging systems have a fixed-focus optical system, the otoscopy device may comprise a variable focus system, arranged so that it provides a focal point that can be chosen or varied and which is outside a volume of, or beyond, the second speculum. A fixed focus system would most likely point the centre of focus inside the 2nd specula making it optically unusable or near the tip making clinical use difficult since viewing at a distance beyond this would be blurry and not high value. The variable focus system may also have a zoom function. The base and / or second specula may be circular in cross section. Alternatively, they may be non-circular, such as oval or square shaped, or have different length walls. These specula will allow greater flexibility for different ear canals such as narrower or twisted ear canals the longer side is sometimes used to overcome undulations in the outer ear canal. Therefore, the specula discussed above can be screwed on or positioned / rotated around in view of an individual’s anatomy to overcome any bends or narrow diameters. The device may be provided with a third speculum attached to the second speculum. The device may be provided with a fourth speculum attached to the third speculum. According to a second aspect of the invention, there is provided an otoscopy device, comprising a base speculum, a camera attachment by means of which the device can be attached to a camera, and a strut joining the base speculum to the camera attachment, in which the strut has a physical hole or space through which at least one instrument can pass so as to pass through the base speculum. Preferably, the physical hole or space may allow the passage of two, or at least two instruments. This allows simultaneous use of two, or more, instruments. Combination of instruments include surgical tools such as a Zollner sucker (typically held with the dominant hand); a liquid spray delivery system (e.g. olive oil / cerumenolytic / water), extra lighting, a wire flexible endoscope that could be threaded to the tip of a distal part of the speculum, to allow greater field of view since camera at tip of the speculum, a fluid sucker device to take samples of fluid from a leaking ear drum for example and tissue forceps used in human tissue biopsy. The instruments may also be selected from the group comprising devices that detect or emit visible or non visible radiation that is not visible / not perceptible to the naked human eye (e.g. infra-red / ultraviolet / blue light etc), LIDAR, acoustic instruments (e.g. Ultrasound). There may be a first instrument and a second instrument, and the device may comprise a remote instruction device for the second instrument, such as a foot pedal. The remote instruction device could control, for example, a level, power or presence of suction due to the second instrument or the spray of water or oil by the second instrument. The device, and in particular the strut, may comprise a device for tensioning part of the ear of a subject, typically the pinna / ear-lobe. This can act to straighten the ear canal during a procedure to allow better access of instruments, and reduce the need for the user to do so manually. There may be a plurality - 2, 3, 4 or more - additional physical holes or spaces through which instruments can pass. For example, the additional physical holes or spaces could house additional light, suction or forceps. The device may comprise a second speculum attached to the base speculum. As such, the device may form the device of the first aspect of the invention, and may have any of the optional features of the first aspect. There may be two, or more, instruments passing through the physical hole or space. The strut may also act as an attachment means for devices that may use the physical hole or space as a means of better secure attachments or provide the sole attachment means of any instruments. There now follows, by way of example only, description of embodiments of the invention, described with reference to the accompanying drawings, in which: Figure la shows a side elevation of an otoscopy device in accordance with a first embodiment of the invention, without the second speculum; Figure lb shows a side elevation of the otoscopy device of Figure la, including the second speculum; Figure 1c shows a side elevation of the otoscopy device of Figure la, showing the central axis; Figure Id shows a side elevation of the otoscopy device of Figure la, showing the use of an instrument through the otoscopy device; Figure 2a shows a front elevation of an intermediary device in accordance with a second embodiment of the invention; Figure 2b shows a rear elevation of the intermediary device of Figure 2a; Figure 2c shows a side elevation of an otoscopy device using the intermediary device of Figure 2a; Figure 2d shows a front elevation of an alternative intermediary device in accordance with a third embodiment of the invention; Figure 2E shows a 2nd ear speculum of a Rosen variation. Figure 2F shows a side view of the second speculum with a friction or adhesive fit attaching onto the base speculum. Figure 3a shows a rear perspective view of an otoscopy device in accordance with a fourth embodiment of the invention; Figure 3b shows a plan view of the otoscopy device of Figure 3a; Figure 3c shows a rear perspective view of the otoscopy device of Figure 3a, including the use of two instruments; Figure 3d shows a side elevation of the otoscopy device of Figure 3a, including the use of two instruments; Figure 3e shows a side elevation of an otoscopy device in accordance with a fifth embodiment of the invention; Figure 3f shows a perspective view of an otoscopy device in accordance with a sixth embodiment of the invention; Figure 3g shows a side elevation of an otoscopy device in accordance with a seventh embodiment of the invention; and Figure 3h shows a rear perspective view of the otoscopy device of Figure 3g. Figures la to Id show an otoscopy device 10 comprising a base speculum 11 and how a 2nd speculum 20 can attach. Figure la shows an external view of the base speculum 11 which has been modified to have an external groove 18 on the outer surface. Figure IB shows the additional 2nd speculum 20 attaching onto the base speculum 11. The 2nd speculum 20 on the internal surface has a screw mechanism that can attach and detach from the base speculum 11. Figure IC shows that the base 11 and 2nd 20 specula being aligned to have a common optical axis 30 in particular a common central optical axis. Figure ID shows that when the device is in use with instruments 40 able to pass through the base 11 and 2nd specula 20 to reach the outer side 23. Figure IB also demonstrates that the gross / overall shape of the speculum has changed with respect to our earlier application. Essentially in this configuration, it makes patient contact part (the proximal end 23 of 2nd speculum 20) longer and overcome the aforementioned issues with long twisty and small canals. As written before, there is no restriction on the number of specula that can be attached on. The end diameter entering the ear canal maybe smaller, equal or even larger than the base speculum. With the device of WO2018197870, variable focus device can be used to look beyond the 2nd speculum 20. This would be housed in the camera mount 16, which is separated from the base speculum 11 by a strut 18. The strut 18 has an aperture 24 through which the instrument 40 can pass, such that it passes through the distal end 12 of base speculum 11, through the proximal end 13 of base speculum 11 (which is nested within the distal end 22 of the 2nd speculum 20) and out through the proximal end 23 of the 2nd speculum 20. This, the instrument 40 can operate in the region 50 past the proximal end 23, being operated from the other end of the device, whilst a camera attached to mount 16 can use the variable focus device to focus in the region 50. Figures 2a to 2d shows the accessory that can be added to a base speculum that acts as an intermediary for the added speculum. Figure 2A in the particular the cross-hatched area 58 shows suction fit material (e.g. rubber) that can be attached to the outer surface of a base speculum 11. There is a groove 63 on the outside that is the attachment means for the 2nd speculum 20. Figure 2B shows a 3rd oblique view of the intermediary and Figure 2C shows a planar view of the base speculum 11, intermediary device 72 and a 2nd speculum 20 attached. Figure 2C area 73 highlights the suction fit. Figure 2D shows a different embodiment with instead of a suction fit is screw fit 83 that goes on external surface of the base speculum and is a screw fit that attaches to the internal surface of the 2nd speculum 20. In Figure 2E show a second speculum of the Rosen variety. A Rosen speculum has a full thickness split along the wall of the speculum, which may provide better access for instruments going through the slit rather than proximal hole of the base speculum. The intermediary device base speculum would also have a corresponding slit so the two slits of the base and second speculum align. The second speculum would attach to the base specula also of a Rosen Variety (truncated for diagrammatic purposes) however it would also have a central cut out that would align to 104. This allows the passing of instruments through the cut out. Though we have suggested that the 104 and 94 should align, there may be reasons where partial or no alignment is preferred. Instruments may be passed through the base specula or the 2nd specula through the side wall cut-out depending on access needs, It maybe disadvantageous to just have the 2nd specula with the cut out since it would be closer to the patients’ ear and may be in the ear canal so the cut out would be completely covered and off-limits. A more practical example (not shown) is the base specula with the central cutout and the base specula enclosed since the cut out is more likely to be out and clear the patients head and so instruments can be inserted A further embodiment may include channels along the outer surface of the ear specula. Channels are partial cutouts of the external surface of a specula (unlike full thickness cutouts like Rosen specula) with the function of allowing instruments that can be passed along the channel wall but not interfering with direct vision of the user / camera. In this case, 104 can represent a channel and likewise the base speculum may have a channel that may or may not align with the second speculum. Having a long channel of both base and 2nd speculum may be advantageous since ease of access is greater being further away from the ear. In Figure 2F, 304 represents a friction or adhesive grip (collectively known as Grip) that on the inner side of the 2nd speculum. When attached, the Grip acts a secure connection between the 2 specula. Though not shown, there may be a friction on wall 301 meaning there could be one or two grips. The adhesive can be delivered as a liquid, adhesive pad + / - covering just before use. The length of the Grip should be short enough that when the otoscope is constructed the Grips do not block view which maybe partial length of 301 and 304 but may include full length. The outer surface of the base speculum (204) may also be constructed with an area of friction grip material or even the whole base specula. We also disclose an embodiment where the internal surface of the second speculum is constructed so that the external surface of the base speculum can “push fit” and be locked without need for any modification of the external surface. In such an embodiment the internal surface of the second speculum has a mechanism (e.g. layer of material on the internal surface with a receiving slit / cut-out in it that may go full 360 degrees or any angle less than 360) and the external surface of the base specula can push fit in for a secure attachment. Figures 3a to 3h demonstrate the aperture 404 that has functional use in the strut of base speculum 401. Figure 3 A show a side profile of the device, comprising abase speculum 401, a strut 408 joined to the base speculum 401 and a camera mount 406. In the strut 408 there is an aperture. Figure 3B shows plan view of the aperture 404. Figure 3C shows that flexible instruments 520, 540 can be passed through the aperture 504 that includes a lighting, liquid sprayer, additional cameras or radiation emitting devices, sensors to detect such radiation or specified radiation, suction machine. Figure 3D shows how 2 instruments 520, 540 can be used at the same time. 544 represents the hand part of the forceps where fingers are inserted to the forceps. Figure 3E shows an example of how device holding the speculum 601 can be controlled. In this example - a bottle with fluid 666 (e.g. water / olive oil spray) is connected to the body of handheld portion / handle 606 of the device. If someone was to hold the device at a handle 606, they would be able to squeeze a bottle with one hand and simultaneously with the right hand control the forceps 640. A liquid could be controlled by another part of the body e.g. foot and a foot pedal. Though not shown is equally possible to have a fluid collection system taking fluid out of the ear canal. Thus Figure 3E shows how an advance in ear procedures with the ability to do 2 instruments at the same time rather than the status quo of today of single instrument. Figure 3F shows an embodiment on a device using the aperture 704 which can be used to create tension the ear lobe to straighten the canal. In this demonstration, a spring like mechanism 744 can be inserted through the aperture 704 which causes a minimally obstructive view. The spring-loaded device maybe given enough tension to pull the ear pinna back to straighten an ear canal. In this case the spring loaded device 744 maybe attached to the strut or be separate to it or may attach onto the strut directly. In Figures 3a to 3f, we suggest an aperture that is constructed in a vertical plane, however this application does not limit itself to that. An aperture can be created in a horizonal plane and such a horizonal plane maybe advantageous since it would be create an obstructive view for the camera. Figures 3g and 3h shows an aperture 804 in the horizonal plane. However, the angle of the aperture 804 could be at any angle e.g. diagonally. We also envisage embodiments where the strut has an aperture on a base speculum and additional 2nd / 3rd speculum (not limited) are attached on to base speculum. There could be any number of apertures that can be in the strut and indeed there may be a plurality of apertures. There now follows the text of our original application, which is included as an integral part of this application: Device Improvements Applicant: Audelation Ltd Background: Otoscopy is a key clinical skill in the assessment of hearing loss. In addition, in the treatment of hearing loss - ears often need to be de-obstructed of wax, foreign bodies etc. Known clinical procedures such as microsuction, instrumentation is often employed to do this. As well as wax - there are many other ENT procedures that are done including Grommet insertion, tympanic membrane injections and antibiotic / steroid injections. Current technologies in video otoscopy, mechanical otoscopy use a single speculum on with viewing device e.g. mechanical otoscope, ear microscope and speculum, Loupe glasses and specula. Ear specula are very commonly used clinical aids - are often cone shaped and made from a plastic or metal design. They have key functions of straightening an ear canal and infection control measure In such devices such as mechanical otoscope, the disposable speculum may have an inner groove in the INNER side to it can be attached to a base head unit. The base head unit often is constructed with an attachment means for the speculum, a viewing lens and a lighting system, it is designed to be NOT disposable due to the complexity of construction and a disposable speculum is designed for such purpose between patient use. Audelation in 2017 (WO2018197870) filed a granted patent (through the former name GWMV) described a new type of embodiment of ear specula which allows the attachment of a camera system and configured to allow the passage of instruments to do outer ear procedures. This is fundamentally an improvement on the otoscope described above which is an enclosed system for viewing only. However, the anatomy of the ear canal can be twisted / tortuous and though ear specula are used to straighten ear canal - in patients with long canals and bends — the tip of the speculum is not long enough to overcome a bend, this can lead to an incomplete / partial view of the ear canal and tympanic membrane. The only way to get around this use force to get around the bend OR using an deep-ear speculum-less video otoscope or even endoscope to view beyond the bend. In ear procedures such as a aural microsuction - a single speculum is often held in the ear in the non-dominant hand and typically a single surgical instrument held in the dominant hand to do the procedure The hands are fully pre-occupied to be able to do anything else. Lighting is provide externally e.g. via a headset and the human eye is use view the outer ear canal. Audelation’s WO2018197870 described a new embodiment to allow the attachment of a light and using a digital camera system in lieu of a headset etc. What we describe in this application is improvements in speculum design to allow 1. Innovation for “tricky ear canals” - typically ear canals that are narrow, twisty i.e. multiple that need manipulation and 2. A novel idea for TWO (but can also include a plurality) complimentary instruments to be used at the same time in a procedure. Having two complimentary instruments / functions could increase the efficiency of ENT procedural work. We describe improvements to the Audelation 2017 filed patent specula design . Summary of Invention: One possible issue with specula design is the length of the specula and that it can be difficult to go past the 2nd bend of the outer ear canal. Not going beyond the 2nd canal means that some of the tympanic membrane is obstructed. This can be easily solved with a single speculum with a redesign by additionally designing a new speculum with a longer tapered end for example. However, that adds cost to a manufacturer company since additional tooling / materials is needed to make a longer speculum. Figure 1 describes an embodiment of a speculum where the outer surface of a speculum has a groove or recess. The purpose of the recess is to allow the attachment of a second speculum to the groove to provide in totally a new form for ear examination service where the end point. Like how specula are attached to traditional otoscopes, this can include screw fit or push fit. The specula ideally have a common optical axis and optimally have a common central axis. Using the specula as a “base / proximal disposable specula” of the 2017 patent (WO2018197870) instruments can be still be passed around the camera and both the base / proximal specula AND distal specula into the ear canal Therefore procedures such ear microsuction or ear instrumentation are still possible. The benefits to wax microsuction / ear surgical procedures that a great range of ear canal anatomy and idiosyncratic features to be accommodated rather by a singular speculum. The groove does not just allow for single brand of specula but can include multiple brands of specula. It is envisaged that that the “base specula” maybe of greater end diameter than the 2nd specula but is not restricted to this. Having a wider base specula allows greater amount of light to be shown through the base specula and so improve illumination. One reason the inventor has thought this embodiment doesn’t exist yet is that most otoscopes are traditionally designed with a single fixed focus lens (magnifying / non magnifying) with a viewer’s eye looks through to look at ear canal structures. By adding additional specula - you would distort optics in that the end focal point may could within the volume of the 2nd specula. This makes suboptimal viewing since the ear canal and structures (areas of interest) will not be in focus leading to poor quality examinations. You would reach a vicious cycle situation that you need a 2nd specula to view beyond a tight angle in the ear canal however you would need to remove the 2nd specula since the fixed focus lens only permits an optical focus within the volume of the 2nd specula. To overcome this, application WO2018197870 and device incorporates a variable focus feature in that the clinician can choose the focal length and so avoid / mitigate by always having the focal point outside the volume of the 2nd specula. The variable focus also allows focus beyond the 2nd specula. We also disclose in WO2018197870 a “zoom” feature and having a device that can do variable focus and zoom is preferable with a 2nd specula add on. Another embodiment (Figure 2) of the use of an intermediary device that can be attached to the outer rim of the specula by suction fit or glue / adhesive. One configuration could be a “ring” configuration, One outer surface of the intermediary contains a groove that allows the attachment of a distal specula on top of the proximal specula. The inner surface could be glue / adhesive / suction-fit (not limited to this) the clinician would push the ring onto the outer surface on the base specula and it would be designed to be a certain length away from distal specula whole. Once secured, the clinician can attach a 2nd speculum to the device with a screw fit. An additional benefit to Figure 1 and Figure 2 would that it could remove the necessity of re-tooling a specula design which would need to incorporate a groove in the new design. It could use commonly used specula , today produced in the millions quantity and low pricing. Ear specula are traditionally stackable for storage purposes — in that they ae placed non—secured / unsecured on top of each other - like stackable cups. However if you were to use such a unsecured configuration to extend a speculum functional length - the structure is unstable and the speculum can shift on top of each other which would cause an obstructive view, mal-alignment of optical axis and even fall off during operative use. You would also need to hold the distal specula while inserting into the ear Therefore, the advantage of having a new securing mechanism is to prevent such slippage and create stability of structure and optical view and easier to insert in the ear. If one was so minded using an “unsecured” system as described in the past paragraph -a speculum embodiment where the outer layer of one and inner layer of another can be adhesive to each other so that they could be “glued” . This is a new innovation since specula of today are made of a non-sticky / non-adhesive plastic material. With the WO2018197870 disclosed specula; instruments can be passed past the camera and down two specula to go past the 2nd opening of the 2nd specula to perform wax deconstructions or outer ear surgical procedures. A new additional speculum attachment is also disclosed. Typically speculum are circular shaped and equal shape and equal wall length. The WO2018197870 application device because it is held in the non-dominant hand during use , which is typically the left hand, has led to development where the speculum is circular in nature at the end point and walls of equal length. However, this application also includes specula shapes and sizes that included specula have that oval / square / other shaped end points and also have walls that longer than other. These specula will allow greater flexibility for different ear canals such as narrower or twisted ear canals the longer side is sometimes used to overcome undulations in the outer ear canal. Therefore, the specula discussed above can be screwed on or positioned / rotated around in view of an individual’s anatomy to overcome any bends Though we disclose 2 specula construction (base specula and additional specula)- it is not limited to just 2 and can be 3 or 4 specula. Therefore, the attached specula may all be designed out with outer grooves to attach further specula to create a “chain” of securely attached specula. We also mention a specific embodiment with a Rosen design ear specula. Rosen ear specula are designed to have open channel / hole that runs in a line wall of the specula -however the channel is both embodies the outer and inner wall of the specula. The channel can run along the entire length or a partial length of the specula. The attaching speculum may have a extension / insert that fits into the channel of the base speculum and can be attached by tight fit / adhesive / locking mechanism (temporary / permanent) which allows the attachment of a 2nd speculum. The “insert” forms a continuous and ideally non obstructive to the optical view through the specula so ideally will be flush with the outer ear speculum or minimally / insignificantly obstructive. Additionally, there may be an adhesive component between the inner surface of the second speculum and the outer surface of the base speculum strengthening the connection between the two specula. During microsuction ear procedures - the speculum must be held in a hand (typically non dominant hand) and the surgical instrument is held in the dominant hand. Together a surgical procedure such as aural microsuction can be performed. However that means that each hand is preoccupied with a device / object. Therefore, a wax de-obstruction procedure only can have 1 single operative hand (the one holding the tool) and so only one single instrument procedure. Compared to an operation in a operating theatre, the two hands of a surgeon are used to hold two different surgical tools e.g. one hand holding dissection scissors and the other hand holding tissue / toothed forceps. We want to expand with an innovation to replicate what goes on with the surgeons’ hand in an operating theatre to aural microsuction that allows at least 2 surgical instruments to be used alongside the inserted speculum. In WO2018197870, with reference to 5B we describe an embodiment of a speculum that has a “strut”. The strut is this meaning, provides a physical gap between the conical shape of the speculum and camera attachment. However the strut in 5B is a construct made of a solid material. In this application - we suggest an innovative modification to this strut. We propose that within the strut can be a physical hole / space. The purpose of this hole / space is the allow the passage of instruments through the strut hole so that the instrument can be threaded along the conical portion of the speculum. By doing so -allows the intended purpose - as stated before - to allow 2 instruments to be used at the same time during aural microsuction. The strut acts as a support mechanism for the 2nd function for microsuction. Combination of tools include surgical tool such as a Zollner sucker held with dominant hand and liquid spray (e.g. olive oil / cerumenolytic / water not limited to this), extra lighting, a wire flexible endoscope that can be threaded to the tip of the distal part of the speculum — to allow greater field of view since camera at tip of the speculum. It may also include devices that detect or emit non visible radiation that is not visible to the naked human eye (e.g. infra-red / ultraviolet / blue light etc), LIDAR, acoustic instruments (e.g. Ultrasound) , The 2nd function / device could be controlled by a foot pedal or other remote “instruction” giving device such suction control, a water or oil spray to spray water, a suction to be turned on / off or variable suction power, For example with the spray - you could have liquid storage device attached that can be held in the palm of the non-dominant hand or attached to a handle of the device. For suction, the microsuction The strut hole and / or whole strut can be used as a supporting mechanism for attaching a device pull in a direction to strengthen the canal. Typical clinical behaviour is the pulling an ear lobe upwards and laterally to straighten the canal for adults and in children, to pull an ear lobe downwards and laterally. A clinician typically has to use the same non dominant hand We describe a device that can be use to temporarily attached through the strut hole or encompassing / attached the strut can be placed where the distal end can be placed in the pinna (e.g. concha) to create tension to straighten the ear canal. The device may also have spring / spring like mechanism to increase or decrease tension and a mechanism of control on the earlobe. In the above we describe a single opening in the strut, however the application is not limited to just a single but can be 2 / 3 / 4 or any number so that a plurality of instruments (>2) can be used at the same time. One such arrangement could be an additional light, suction and forceps. Detailed Description of Figures Figure 1 shows the base speculum and how a 2nd speculum can attach. Figure 1A shows external view the base speculum analogous to figure 5B in WO2018197870 however has been modified to have an external groove on the outer surface. Not shown is a camera attachment element. Figure IB shows the additional 2nd speculum attaching onto the base speculum. The 2nd speculum on the internal surface has a screw mechanism that can attach and detach from the base speculum. Figure IC shows that the speculum being aligned to have a common optical axis in particular a common central optical axis (dotted red line). Figure ID shows that when the device is in use with instruments able to pass through the base and 2nd specula to reach the outer side. Figure IB also demonstrates that the gross / overall shape of the speculum has changed. Essentially in this configuration, it makes patient contact part longer and overcome the aforementioned issues with long twisty and small canals. As written before, there is no restriction on the number of specula that can be attached on. The end diameter entering the ear canal maybe smaller, equal or even larger than the base speculum. With the device of WO2018197870, variable focus can be used to look beyond the 2nd speculum. Figure 2 shows the accessory that can be added to a base speculum that acts as an intermediary for the added speculum. Figure 2A in the particular the red criss-cross area shows the suction fit material (e.g. rubber) that can be attached to the outer surface of a base speculum. There is a groove on the outside that is the attachment means for the 2nd speculum. Figure 2B shows a 3rd oblique view of the intermediary and Figure 2C shows a planar view of the base / intermediary and a 2nd speculum attached. Figure 2C red area highlights the suction fit. Figure 2D shows a different embodiment with instead of a suction fit is screw fit that goes on external surface of the base speculum and 2nd screw fit that attaches to the internal surface of the 2nd speculum. Figure 3 demonstrate the aperture that has functional use in the strut of base speculum. Figure 3A show a side profile of the aperture (shown in red) and Figure 3B shows a oblique / 3D view of the aperture. Figure 3C shows that a flexible instrument can be passed through the aperture that includes a lighting, liquid sprayer, additional cameras or radiation emitting devices, sensors to detect such radiation or specified radiation, suction machine. Figure 3D shows how 2 instruments can be used at the same time. Figure 3E shows an example of how device holding the speculum can be controlled. In this example - a bottle with fluid (e.g. water / olive oil spray) is connected to the body of handheld portion / handle of the device. If someone was to hold the device at a handle - they would be able to squeeze a bottle with one hand and simultaneously with the right hand - control the forceps (blue). A liquid could be controlled by another part of the body e.g. foot and a foot pedal. Thus Figure 3E shows how an advance in ear procedures with the ability to do x2 instruments at the same time. Finally Figure 3F shows an embodiment on a device using the aperture which can be used to create tension the ear lobe to straighten the canal. In this demonstration, a spring like mechanism can be inserted through the aperture which causes a minimally obstructive view. The spring-loaded device maybe given enough tension to pull the ear pinna back to straighten an ear canal. In this case the spring loaded device maybe attached to the strut OR be separate to it. In Figure 3, we suggest an aperture that is constructed in a vertical plane, however this application does not limit itself to that. An aperture can be created in a horizonal plane and such a horizonal plane maybe advantageous since it would be create an obstructive view for the camera. Figure 3G shows an aperture in the horizonal plane in a 2D and oblique view (3H) However, we do not wish to limit ourselves to just those 2 planes, and claim embodiments can be at any angle e.g. diagonally. 5 We also envisage embodiments where you can have strut aperture on a base speculum and additional 2nd / 3rd speculum (not limited) attached on to base speculum. We also do not restrict on the number of apertures that can be in the strut and may be a plurality of apertures. 10

Claims

1. An otoscopy device comprising a base speculum and a second speculum attached to the base speculum.

2. The otoscopy device of claim 1, in which the base speculum has an outer surface in which is formed a groove or recess through which the second speculum is attached to the base speculum.

3. The otoscopy device of claim 1, in which there is an intermediary device which connects the base speculum to the second speculum.

4. The otoscopy device of claim 3, in which the intermediary device has an outer surface which carries a groove or recess through which the second speculum is attached to the intermediary device and the intermediary device is attached to the base speculum.

5. The otoscopy device of claim 4, in which the intermediary device is attached to the base speculum by glue, adhesive or suction-fit.

6. The otoscopy device of any preceding claim, in which the base speculum and the second speculum have a common optical or central axis.

7. The otoscopy device of any preceding claim, in which the base speculum has a distal end and a proximal end; the second speculum has a distal end and a proximal end,8. The otoscopy device of claim 7. in which the proximal end of the base speculum has a diameter that is greater than a diameter of the proximal end of the second speculum.

9. The otoscopy device of claim 7 or claim 8, in which it is possible to pass at least one instrument through a central passage of the base speculum and a central passage of the second speculum and to operate the instrument from the distal end of the base speculum, the instrument passing through the base and second specula and operating in a region adjacent to the proximal end of the second speculum.

10. The otoscopy device of claim 9, in which it is possible to view the region from the distal end of the base speculum whilst operating the instrument.

11. The otoscopy device of claim 9 or claim 10, including the instrument, passing through the central passage of the base speculum and the central passage of the second speculum.

12. The otoscopy device of any preceding claim, comprising a variable focus system, arranged so that it provides a focal point that can chosen or varied and which is outside a volume of, or beyond, the second speculum.

13. The otoscopy device of claim 12, in which the variable focus system has a zoom function.

14. The otoscopy device of any preceding claim, in which the base and / or second specula are non-circular, such as oval or square shaped, or have different length walls.

15. The otoscopy device of claim 14, in which the device is provided with a third speculum attached to the second speculum and optionally a fourth speculum attached to the third speculum.

16. An otoscopy device in accordance with any preceding claim, in which at least one of the first and base specula is a Rosen speculum having a slit in an outer wall thereof where at least one instrument can be passed through the slit.

17. An otoscopy device in accordance with any preceding claim, in which at least one of the first and base specula has at least one channel in but not through an outer wall thereof where at least one instrument can be passed through the channel.

18. An otoscopy device, comprising a base speculum, a camera attachment by means of which the device can be attached to a camera, and a strut joining the base speculum to the camera attachment, in which the strut has a physical hole or space through which at least one instrument can pass so as to pass through the base speculum.

19. The otoscopy device of claim 18, in which the physical hole or space allows the passage of two, or at least two instruments.

20. The otoscopy device of claim 19, in which there are a first instrument and a second instrument, and the device comprises a remote instruction device for the second instrument, such as a foot pedal.

21. The otoscopy device of any of claims 18 to 20, in which the device, and in particular the strut, comprises a device for tensioning part of the ear of a subject, typically the pinna.

22. The otoscopy device of any of claims 18 to 21, in which there are a plurality of additional physical holes or spaces through which instruments can pass.

23. The otoscopy device of any of claims 18 to 22, comprising a second speculum attached to the base speculum.

24. The otoscopy device of claim 23, also falling within any of claims 1 to 17.

25. The otoscopy device of any of claims 18 to 24, in which there are two, or more,instruments passing through the physical hole or space.A

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