Patent Application
20230072482
A portion of the disclosure of this patent document contains material which is subject to copyright protection. This patent document may show and/or describe matter which is or may become trade dress of the owner. The copyright and trade dress owner has no objection to the facsimile reproduction by anyone of the patent disclosure as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright and trade dress rights whatsoever.
The present invention relates to a speculum and an otoscope.
The ears of humans and other animals can require examination and/or treatment from time to time, or when the patient is afflicted with a particular disease. It is especially common for patients to require removal of earwax, which is also known as cerumen, using techniques such as aural microsuction.
As well as being useful in the restoration of a patient's hearing and for general aural health, the removal of earwax is necessary in audiological assessments, and in the fitting and maintenance of hearing aids. The removal of wax or foreign bodies from the ear of a patient is the most common outpatient appointment in the world.
The overall process of removing wax or a foreign body from a patient's ear is typically composed of two procedures: ear canal inspection (otoscopy); and removal of the wax or foreign body using microsuction and/or tools, such as wax hooks and/or Jobson Horne Probes. The classical technique is for the clinician to hold a speculum, which is typically a lightweight plastic cone, in their non-dominant hand and uses the instruments listed above and inserts the tools through the centre of the speculum to remove the contents of outer ear canals such as wax.
Examination and treatment of the outer ear canal can be performed by a variety of devices, such as microscopes, loupe glasses, rigid endoscopes and conventional otoscopes. Tympa Health Technologies Limited of London, United Kingdom, have proposed a smartphone-based system using a smartphone with a camera; a similar smartphone-based system is described in WO2019/116024. We ourselves have proposed camera-based solutions in our earlier PCT application published as WO2018/197870; we refer to that application below as “our earlier application” and the device described therein as “our earlier device”. However, each of these types of device can be improved.
Ear microscopes are typically preferred for the removal of wax or a foreign body from a patient's ear. These devices allow for direct vision of the ear canal. Ear microscopes are typically freestanding. However, ear microscopes are large and not portable, occupying a lot of clinic space. Ear microscopes are also considerably expensive. In addition, ear microscopes do not allow the patient to move position during examination and/or treatment, and a microscope can require frequent readjustment during an examination or treatment to keep the desired area in view.
Loupe glasses are glasses with small, magnifying lenses that are very portable and allow visualisation of the ear canal. Loupe glasses suffer from the fact that they need to be bespoke for each clinician, to fit their eye dimensions and prescription. In addition, loupe glasses provide a fixed focus, magnification and viewpoint, meaning that the clinician has to move their head to produce different views. This requirement for movement can make clinicians nauseous. Loupe glasses commonly require illumination and are therefore used with headwear and a large battery pack to provide a light source. A clinician using loupe glasses must manoeuvre around the patient to keep the area of examination and/or treatment in view.
Rigid endoscopes and conventional otoscopes offer visualisation of the ear canal but restrict or even prevent the access of instruments required to perform treatments such as aural microsuction.
In particular, rigid endoscopes require a lighting source to be present within the ear canal. Such lighting sources typically generate heat, which puts the patient at risk of receiving burns. Furthermore, in use the endoscope extends into the ear canal, restricting the movement of instruments and providing an increased risk of ear drum perforation. The insertion of rigid endoscopes into the ear canal also means that they require sterilisation after each use to prevent cross-contamination between patients.
Conventional otoscopes are frequently used to physically examine the outer ear canal. Otoscopes typically comprise a handle and viewing system, wherein the viewing system holds a light source and a tip. Otoscopes are usually used with disposable ear specula to cover the tip and prevent cross-contamination between patients. However, having a speculum attached to, for example screwed on to, and covering the tip prevents the passage of instruments into the ear canal to perform treatments, such as earwax removal.
As referred to above, our earlier device described in WO2018/197870 describes a digital camera system that allows direct visualization of the outer ear canal and tympanic membrane/eardrum through an ear speculum and allows simultaneous passage of instruments through the outer and inner ring of the speculum to perform procedures such as microsuction and ear procedures. Our earlier device is attached either by wire or wireless connections to a display such as a computer tablet or computer. Lighting can be provided at the end of the speculum furthest from the patient, shining into the ear.
The inventor has realised that the lack of portability of ear microscopes prevents these devices being used outside of the clinic. This presents a particular issue because patients must be referred to a specialist that has the required equipment. Furthermore, the lack of portability of the equipment means that treatment cannot easily be performed on patients that are immobile.
In addition improved visualisation of the outer ear canal and ear drum whilst also allowing access for instruments that are required to be inserted in to the outer ear canal is an aim of this invention.
Therefore, the inventor has determined a need for an otoscope that is portable to enable clinicians to perform procedures such as earwax removal outside of the clinic and that allows visualisation of the outer ear canal and ear drum without preventing, and ideally without unduly restricting, access of instruments.
The present invention provides, in a first aspect, a speculum for use in an otoscope, wherein:
Preferably, each coupling point is at the first end of the speculum; this allows the light source to be as far from the patient (who will be at the second end in use) as possible.
One of the issues with our earlier device is related to the use of a lighting structure where there are a ring of LEDs at the proximal end of the speculum from the patient, there being insufficient room to provide the LEDs to the distal end. Having a ring of LEDs at a distance from the patient can mean however that light is lost from the point from illumination on the light source to the tip of the speculum and beyond.
By illuminating from the tip (having transmitted the light from elsewhere) means
The light transmitting portion may comprise a transparent material typically covered in a cladding material. As such, the light transmitting portion may act as a light pipe. The cladding material may act to guide the light within the transparent material and may have a reflective inner surface in contact with the transparent material. Alternatively, the cladding material and the transparent material may have refractive indices such that total internal reflection of the light from the light source occurs at a junction between the transparent material and the cladding material (as occurs in a fibre optic cable). The cladding material may block transmission of light through itself.
The light transmitting portion may have a first cross-sectional area at at least one coupling point, and a second cross-sectional area at the second end, with the second cross-sectional area being smaller than the first cross-sectional area. As such, this may act to concentrate the light passed through the light transmitting portion.
The speculum may comprise at least one light sensor arranged to determine where light is being emitted from the second end, and a control circuit coupled to each light sensor, the control circuit being arranged to modulate the brightness of the light emitted by the light source in response to light levels detected by each light sensor.
The light sensor may comprise a digital camera arranged to capture images through the passageway through the body of the speculum. As such, the control circuit may be arranged so as to analyse images captured by the digital camera and to determine illumination levels of at least one, if not a plurality, of regions of those images.
Where the light source comprises a plurality of light generating elements, the control circuit may be arranged so as to dim or extinguish any light generating element to a region where each light sensor indicates no light is being emitted (so as to reduce or cease transmitting to an area of the second end which is blocked in some way), and optionally to increase the brightness of light generating element transmitting to a region which each light sensor indicates light is being transmitted (so as to accommodate for the blockage). Typically, the control circuit will disregard any short term (e.g. less than a predetermined period, such as 1 s, 0.5 s, 0.1 s) change in the light levels indicated by each light sensor, so that temporary blockages (such as hairs moving past the end of the speculum) do not affect the illumination.
The speculum may be provided with a housing. The housing may house at least one of the light source, the control circuit and at least part of a digital camera. If the digital camera is provided in the housing, the speculum can by itself function as an otoscope.
The digital camera may comprise an image sensor and image processing circuitry. The housing may be formed of first and second parts pivotably mounted with respect to each other. The first part may house the image sensor, and so may be provided with a viewing window to view the passageway through the body of the speculum. The second part may house the image processing circuitry. There may be a flexible connection connecting the image sensor and the image processing circuitry, which may comprise at least one wire.
According to a second aspect of the invention, we provide an otoscope, comprising a digital camera, a speculum in accordance with the first aspect of the invention and an attachment means for attaching the camera to the speculum, and wherein the attachment means is for attaching to the first end of the speculum.
According to a third aspect of the invention, we provide a speculum for use in an otoscope, wherein the speculum comprises a body having a passageway therethrough, defining a first end with a first opening, and a second end with a second opening; and a housing at least part of a digital camera;
The first part may be provided with a viewing window to view the passageway through the body of the speculum. There may be a flexible connection connecting the image sensor and the image processing circuitry, which may comprise at least one wire.
There follows a description of embodiments of the invention, described with reference to the accompanying drawings, in which:
In a first embodiment of the invention, an otoscope with a speculum 1D is shown in
The LEDs are positioned so the light is directed to a bridge 1C joining the protrusion to the speculum 1D. The speculum bridge 1C is made of a material that can conduct light (e.g. a transparent plastic). The conducted light then is directed to the cone of the speculum 1D. The speculum is again constructed of a material that conducts light (e.g. a transparent plastic). It is envisioned that light concentrates at the tip of the speculum—to create what we call the “light emitting tip” (LET) 1F. The speculum defines an internal bore through which a user can observe, and narrows both internally and externally from the end at which it is connected to the bridge to the light emitting tip 1F.
The LEDS can be powered by electronics (and a power source such as a battery) from within the tower and can be controlled for dimming/brightening.
So that light is not emitted during the transfer to the tip, the speculum 1D can be manufactured so that it is spray painted black or another dark colour on its surface 1E. We make specific reference to the tip 1F, which is devoid of any black paint or material. By being devoid of material, the light is then “focused” to the tip of the speculum and so projects into the ear canal (when the ear speculum is inserted). The paint free tip 1F can be manufactured by having a cover that is inserted into distal end of the speculum that may cover the tip and a certain length from the tip to keep that part of the speculum tip pain free.
The cone part of the speculum can be constructed also from a combination of nonconductive and conductive material that is either mixed or proportion of the circumference of the material. By doing it this way, can reduce the cost of the speculum.
When LEDs are powerful enough, only part of the distal circle of the speculum may be illuminated that can be powerful enough provide full illumination of the ear
It is envisioned the colour the LED is primarily white and cold in temperature however a combination of different coloured LED to combine to form a white light or other desired light is also described including as ultra-violent bandwidth or infrared or anywhere else on the electromagnetic spectrum. In particular having infrared sensors in a body cavity with no natural illumination may improve image quality.
The ear canal is not a straight structure and has many undulations and curves, ear hair, wax and debris. Because of the tip of the speculum has the light emitting element or tip “LET”, it can be envisioned that part of the light emitting element can be partially blocked. We describe a system where the light emitting diodes also have a sensor or plurality of illumination detecting sensors built in that detect if a part of the light emitting element is blocked. A simple algorithm can be that system can calculate how much light is being emitted, make deductions for any light lost during the flow of light to the light emitting tip and compare how much light comes back and making corrections to provide better illumination. We also describe the system that can compensate for when light emitting tip is blocked by or a combination of:
There may be a light control for the light source arranged to vary a brightness of the light output from the light source. The light control may vary the brightness over at least three discrete levels, or continuously over a range of light levels. The light control may be manually activated and/or may be automatic based upon ambient light levels and the output of the light sensor.
While we describe a system with primarily light sensors and illumination, there is no restriction in the use of other sensors, energy emitting devices (e.g. speakers). One such example is the combination with supplementary camera sensors which with the main camera can form 3D images. A further example is the use of the speaker (or other sound emitting device) to emit sounds for use in audiometry testing.
In a second embodiment of the invention shown in
The lighting from 2A is alignment with the bridge 2C connecting to the speculum 2D. The lighting from 2A can be a single LED or a multitude of LEDs. The lighting system is in direct line of the bridge which conducts light (through a transparent medium) to the speculum. There may be a layer between the lighting system and the bridge that helps to focus or intensify the light down the bridge.
The LEDs can be powered by electronics from the tower and can be controlled for dimming/brightening purposes.
A third embodiment of the invention is shown in
This embodiment of the camera can avoid the use of reflective mirrors. The aperture of the camera can be smaller as a result which results in a smaller tower 3A.
One of the advantages of a flex-camera system is that it is a mirror-less/minimum mirrors but not necessarily lens-less system. Having a mirror system means there must be alignment of the mirrors. In our previous device, one embodiment has a mirror system to get image to the camera. However, having housing for the mirror system creates some physical restrictions on the device. One way of holding our previous device is to hold it like a pencil, where in the non-dominant hand the edge of the speculum is held with fingers and thumb for control. However the housing for the mirror system can get in the way for some hands—making it uncomfortable to use.
Having a mirror-less/minimum mirror system allows for a housing that can adapt the size of the user's hands.
We also describe a dynamic/intelligent illumination/video system as similarly described in
In this dynamic learning system features include:
Other features of the devices of the preceding embodiments include:
We propose various embodiments of the improved device that may have all or part of the features proposed above.
There now follows the text of our previous application, which describes further aspects and embodiments of the invention.
In April 2017, the company filed an application for a new way of visualising the outer ear canal and performing outer ear procedures. This shall be called and referenced as Device GWMV. Device-GWMV describes digital camera system that allows direct visualization of the outer ear canal and tympanic membrane/eardrum through an ear speculum and allows the passage of instruments through the outer and inner ring of the speculum to perform procedures such as microsuction and ear procedures. The Device-GWMV is attached either by wire or wireless connections to a display such as a computer tablet or computer.
The inventor has realised that the portability of ear microscopes prevents these devices being used outside of the clinic. This presents a particular issue because patients must be referred to a specialist that has the required equipment. Furthermore, the lack of portability of the equipment means that treatment cannot easily be performed on patients that are immobile.
In addition improved visualisation of the outer ear canal and ear drum whilst also allowing access for instruments that are required to be inserted in to the outer ear canal is an aim of this invention.
Therefore, the inventor has determined a need for an otoscope that is portable to enable clinicians to perform procedures such as earwax removal outside of the clinic and that allows visualisation of the outer ear canal and ear drum without preventing, and ideally without unduly restricting, access of instruments.
One of the issues of Device-GWMV is that the current embodiments as described has a lighting structure where there is a ring of LED's around an aperture on the tower. Having a ring of LEDs can mean however that light is lost from the point from illumination on the light source to the tip of the speculum and beyond.
We propose a new way of improving the illumination and the optics of the Device-GWMV by using light-pipe technology to transmit light to the tip of the ear speculum. By having the illumination at the tip of the speculum means
The present invention provides, in a first aspect, an otoscope comprising a digital camera, a speculum and an attachment means for attaching the camera to the speculum, wherein:
The inventor has devised a portable otoscope that is capable of use in a multitude of different scenarios. The otoscope allows visualisation of the outer ear canal and ear drum without preventing, and ideally without unduly restricting, access of instruments. The otoscope of the present invention is simply and low cost.
The present invention is directed to improving the construction of otoscopes and its primary function is to allow digital viewing of the outer canal and ear drum. The inventor proposes the use of a handle-less otoscope. We describe in the present invention integration with a digital camera and ear speculum and a novel mechanism to avoid wax and debris contamination. Typically otoscopes require the construction of a handle to be able to hold a speculum—however in this invention the inventor describes how an otoscopy can be performed by holding the speculum alone.
In one embodiment the camera is configured to be displaced from the detection position. Such displacement may aid the access and/or removal of the instrument. In particular, such displacement may help to prevent contaminated instruments from contaminating parts of the otoscope that are not disposable, such as the camera.
The otoscope of the present invention may suitably be used in the process of removing earwax or debris from the outer ear canal.
Accordingly, in a second aspect, the present invention provides a method of using an otoscope according to the first aspect.
According to a third aspect, the present invention provides a method of diagnosing the human or animal with a disease or condition, the method comprising providing an otoscope according to the first aspect and using the otoscope in the process of diagnosing the human or animal body with a disease or condition.
According to a fourth aspect, the present invention provides a method of treating the human or animal body, the method comprising providing an otoscope according to the first aspect and using the otoscope in the process of treating the human or animal body.
In this embodiment; 1A refers to the camera tower and protrusion (1B) that sticks out. The protrusion forms a curved shape that may be circular but not restricted to that shape which contains an LED or row of LEDs that provide illumination. The speculum has been redesigned to allow a cover over the lights.
The LEDs are positioned so the light is directed to the bridge 1C of the speculum. The speculum bridge is made of a material that can conduct light. The conducted light then is directed to the cone of the speculum 1D. The speculum is again constructed of a material that conducts light. It is envisioned that light concentrates at the tip of the speculum—to create what we call the “light emitting tip” (LET)
The LEDS can be powered by electronics from the tower and can be controlled by a for dimming/brightening.
So that light is not emitted during the transfer to the tip, the speculum can be manufactured so that it is spray painted black or another dark colour (1E). We make specific reference to the tip 1F, which is devoid of any black paint or material. By being devoid of material, the light is then “focused” to the tip of the speculum and so projects into the ear canal (when the ear speculum is inserted). The paint free tip can be manufactured by having a cover that is inserted into distal end of the speculum that may cover the tip and a certain length from the tip to keep that part of the speculum tip pain free.
The cone part of the speculum can be constructed also from a combination of nonconductive and conductive material that is either mixed or proportion of the circumference of the material. By doing it this way, can reduce the cost of the speculum.
When LEDs are powerful enough, only part of the distal circle of the speculum may be illuminated that can be powerful enough provide full illumination of the ear
It is envisioned the colour the LED is primarily white and cold in temperature however a combination of different coloured LED to combine to form a white light or other desired light is also described including as ultra-violent bandwidth or infrared or anywhere else on the electromagnetic spectrum. In particular having infrared sensors in a body cavity with no natural illumination may improve image quality.
The ear canal is not a straight structure and has many undulations and curves, ear hair, wax and debris. Because of the tip of the speculum has the light emitting element “LET”, it can be envisioned that part of the light emitting element can be partially blocked. We describe a system where the light emitting diodes also have a sensor or plurality of illumination detecting sensors built in that detect if a part of the light emitting element is blocked. A simple algorithm can be that system can calculate how much light is being emitted, make deductions for any light lost during the flow of light to the light emitting tip and compare how much light comes back and making corrections to provide better illumination. We also describe the system that can compensate for when light emitting tip is blocked by or a combination of:
While we describe a system with primarily light sensors and illumination, there is no restriction in the use of other sensors, energy emitting devices (e.g. speakers). One such example is the combination with supplementary camera sensors which with the main camera can form 3D images.
In this embodiment the lighting source is in the tower and not in the protrusion outline in
The lighting from 2A is alignment with the bridge of the speculum. The lighting from 2A can be a single LED or a multitude of LEDs. The lighting system is in direct line of the bridge which conducts light to the speculum. There may be a layer between the lighting system and the bridge that helps to focus or intensify the light down the bridge.
The LEDS can be powered by electronics from the tower and can be controlled by a for dimming/brightening purposes.
A classical camera sensor is attached and wired to an electronics board. However, there are electronics boards where the camera sensor can be off mainboard and be positioned at the apertures.
This embodiment of the camera means that it can avoid any reflective mirrors. The aperture of the camera can be smaller as a result which results in a smaller tower.
One of the advantages of a flex-camera system is that it's a mirror-less/minimum mirrors but not necessarily lens-less system. Having a mirror system means there must be alignment of the mirrors. In the Device-GWMV system one embodiment has a mirror system to get image to the camera. However, having housing for the mirror system creates some physical restrictions on the device. One way of holding the Device-GWMV is to hold it like a pencil, where in the non-dominant hand the edge of the speculum is held with fingers and thumb for control. However the housing for the mirror system can get in the way for some hands -making it uncomfortable to use.
Having a mirror-less/minimum mirror system allows mechanism to be developed, allows a housing that can adapt the size of the user's hands. We describe a hinge like mechanism along the housing to accommodate the size of the users hands. (
We would also like to describe a dynamic/intelligent illumination/video system as similarly described in
In this dynamic learning system features include:
Other features of the improved new device include:
We propose various embodiments of the improved device that may have all or part of the features proposed above.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2001741.4 | Feb 2020 | GB | national |
This patent claims priority from International PCT Patent Application No. PCT/GB2021/050305, filed Feb. 10, 2021, entitled, “SPECULUM AND OTOSCOPE”, which claims priority to United Kingdom Patent Application No. 2001741.4, filed Feb. 10, 2020, all of which are incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/GB2021/050305 | 2/10/2021 | WO |
