A handheld device for cerumen removal

Abstract

A portable handheld device for cerumen removal from an ear canal, comprising an elongate body having a first compartment 101 comprising a first reservoir 115 for a cleaning solution, and a delivery me

Description

Field of the Invention

[0001] The present invention relates to a handheld device and method for cerumen removal. Background to the Invention

[0002] Ear wax or cerumen impaction in the ear canal currently affects approximately five percent of the population, with both the paediatric and geriatric population more significantly impacted. Ear wax impaction results in hearing loss, blocked sensation, itchiness, pain and infection. Currently approximately 12 million people in the United States of America present annually to clinicians for problematic cerumen impaction. 8 million cerumen removal procedures are carried out in the USA annually. To date, at home treatment options include ear wax drops and mechanical devices. Ear wax drops for example are used to soften the ear wax and are often used as a prelude to syringing.

[0003] While inexpensive, they are usually not very effective. The mechanical devices are inserted into the ear canal and configured for twisting or rotating to extract the ear wax. Spiral silicon ear cleaners have poor efficacy. Cotton buds are also routinely used for ear wax removal. However, rather than removing ear wax, they tend to cause further impaction. Ear candles are also often proposed as a solution however their efficacy is questionable. In clinical settings, syringing, micro-suction and ear irrigation devices are the preferred solutions. Syringing for example has reasonable efficacy but requires at least one visit to the physician. Syringing can be uncomfortable for the patient and there is an inherent risk of trauma to the ear canal or ear drum. The collection of the waste material can also be a messy procedure.

[0004] EP 3 478 233 B1 provides for an over-ear earpiece, sized and dimensioned to be worn over human ears. A cleaning agent reservoir is provided to hold cleaning agents, and a discharge collection reservoir is provided to collect discharge fluids. A cannula is provided which is inserted into the ear. The cannula has two separate ports, one which outputs the irrigation fluid under pressure, and a second port for collection of the discharge through the application of negative pressure. This is an automated cleaning device and saves time for the physician but is overly complicated and expensive to produce. The complex pathways from the cleaning agent reservoir to the cannula output and similarly from the discharge collection port to the discharge collection reservoir is complex and difficult to clean.

[0005] It is therefore desirable to have a simple, cost effective and easily used device to allow a user to irrigate the ear canal safely and outside a clinical environment. Summary of the Invention

[0006] In a first aspect, the present invention provides a portable handheld device for cerumen removal from an ear canal, comprising an elongate body having a first compartment comprising a first reservoir for a cleaning solution and a delivery means for expelling the cleaning solution and a second compartment comprising a second reservoir for collecting waste material; and a nozzle comprising a single aperture in fluid communication with the delivery means for expelling the cleaning solution and with the second reservoir for collecting waste material.

[0007] The portable handheld device allows for a simplified and safe self-administrable treatment which obviates against the need for a physician visit. A single nozzle for both the delivery of the cleaning solution and the collection of debris reduces the inconvenience of traditional mechanisms for irrigation of the ear canal and the collection of the associated debris. The reduced complexity of a single nozzle allows for ease of cleaning and ease of manufacture.

[0008] The first compartment and second compartment may be detachably coupled. This facilitates the removal of the second compartment so that the waste debris can be removed completely from the second compartment. This further aids in the cleaning of the second compartment.

[0009] The elongate body may extend between a first end of the elongate body and a second end of the elongate body and wherein the nozzle is positioned proximal to the first end.

[0010] A handgrip region may be provided between the nozzle and the second end.

[0011] The first compartment may comprise an inlet for receiving the cleaning solution.

[0012] This allows the device to be reusable. It also allows differing cleaning solutions to be used depending on the requirement of the user.

[0013] The delivery means may comprise a discharge port for expelling the cleaning solution and a pump for pumping the cleaning solution from the first reservoir to the discharge port.

[0014] The portable handheld device may further comprise means for activating and deactivating the pumping mechanism. This increases the control for the end user.

[0015] The discharge port may comprise a one-way valve. This ensures no cross contamination of the waste product and the cleaning solution. It should be noted that the discharge port does not occlude the nozzle.

[0016] The portable handheld device may further comprise a power supply.

[0017] The power supply may be rechargeable.

[0018] The second compartment comprises an outlet for removing the waste material.

[0019] This allows the user to remove waste product and clean the second compartment.

[0020] The second compartment may include or incorporate the nozzle.

[0021] The portable handheld device may further comprise a heating mechanism for heating the cleaning solution.

[0022] A second aspect of the present invention provides a docking station for a portable handheld device, comprising a dock for receiving and supporting the portable handheld device.

[0023] The docking station may further comprise a power transfer system for recharging a rechargeable power supply of the portable handheld device.

[0024] The docking station may further comprise a connector for connecting the power transfer system to an external power supply.

[0025] The docking station may further comprise a chamber for storing a container of liquid, such as cleaning solution or the like.

[0026] The docking station may further comprise means for heating a cleaning solution.

[0027] A further aspect of the present invention includes a system for cerumen removal comprising a portable handheld device according to the first aspect and further comprising a docking station for the portable handheld device according to the second aspect. Brief Description of the Drawings

[0028] Embodiments of the invention will be described, by way of example only, with reference to the accompanying drawings in which:

[0029] Figure 1 is an isometric view of a portable handheld device in accordance with an aspect of the present invention.

[0030] Figure 2 is a cross-section of a portable handheld device with a slanted nozzle region in accordance with an embodiment of the present invention.

[0031] Figure 3 is an isometric view of a nozzle section of a portable handheld device in accordance with an aspect of the present invention.

[0032] Figure 4 is an isometric view of a second compartment in accordance with the present invention.

[0033] Figure 5 is an isometric view of a first compartment in accordance with the present invention.

[0034] Figure 6 is a cross section of the portable handheld device in accordance with the present invention.

[0035] Figure 7 is a cross section of the portable handheld device showing fluid flow in accordance with the present invention.

[0036] Figure 8 is a system incorporating a dock and a portable handheld device in accordance with the present invention. Detailed Description of the Drawings

[0037] The portable handheld device 100 of the present invention comprises an elongate body comprising a first compartment 101 and a second compartment 102. The first 101 and second compartment 102 may be formed as a single unit or may be detachable coupled. The portable handheld device body has an elongate body extending between a first end 106 and a second end 107. The first and second end are substantially cube shaped or square shaped. In one configuration rounded corners are provided on the substantially cube shaped end pieces. Alternatively, the end pieces may be circular or substantially circular, or domed. The elongate body extends between the first and second ends. The elongate body in Figure 1 is substantially cuboidal, however, it may equally be substantially cylindrical.

[0038] A nozzle 103 is positioned proximal the first end, 106 (upper end as shown in Figure 1) of the elongate body of the portable handheld device. This is described herein as the nozzle section 108. The distance between the first end and the second end is a height h.

[0039] The nozzle is positioned in the nozzle section 108. Extending from the nozzle section towards the second end 107, there is provided a handgrip region 105 facilitating the user of the portable handheld device to hold the portable handheld device in their hand.

[0040] This handgrip region 105 may include a guide for guiding the end user to the correct holding position. For example, the handgrip region or a portion thereof may be indented or stippled or be coated in a tactile coating. The guide may be located on the external surface of the second compartment or on both the external surface of the second compartment and the first compartment.

[0041] In an alternative configuration to that shown in Figure 1, the nozzle section 108 may be located proximal the second end 107, with the handgrip region 105 located towards the first end 106.

[0042] While the portable handheld device is described as an elongate body, the nozzle section 108 may be angled with respect to the handgrip region 105. The nozzle region may be slanted with respect to the vertical axis. The nozzle region in one configuration is at an angle x with respect to the vertical. The portable handheld device is therefore profiled for close engagement with the ear and neck of the user when in use.

[0043] The nozzle 103 as shown in Figure 1 is formed as part of the second compartment. The nozzle 103 in this configuration is integral to the second part. Alternatively, the nozzle 103 may be separate to the second compartment and formed separately therefrom. The tip 113 of the nozzle may be indented. This allows for the placement of a rubber or silastic tip 113. Such a tip 113 allows a snug fit against the ear canal preventing leakage and allowing for a comfortable and ergonomic fit. The tip 113 pieces may be of different sizes allowing for varying ear canal sizes, varying users and are further readily replaceable for ease of cleaning.

[0044] The first 101 and second 102 compartments and the nozzle 103 may be formed using three-dimensional printing or plastic extrusion mechanisms to form either a single unit, or separate components that are detachably coupled. The first component and second compartment may snap fit, slide-ably engage, magnetically adhere or otherwise attach. The nozzle may be formed integral to the second compartment 102 or may be separately formed and screw fit, snap fit, push fit or otherwise engage with the second compartment 102.

[0045] The nozzle 103 is substantially frustoconical. A first end 112 of the frustoconical nozzle is located proximal the portable handheld device body or proximal the second compartment 102. A second end 111 of the frustoconical nozzle is located distal the portable handheld device body. The diameter of the second end is smaller than the diameter of the first end. The frustoconical nozzle tapers from the first end to the second end 111. In a configuration as shown in Figure 2, a discontinuity is provided at the second end of the nozzle. This discontinuity / indentation at 111 provides an installation point or guide for a rubber or silastic tip 113. Such a tip 113 allows a snug fit against the ear canal preventing leakage and allowing for a comfortable and ergonomic fit. The tip 113 pieces may be of different sizes allowing for varying ear canal sizes, varying users and are further readily replaceable for ease of cleaning.

[0046] The height of the frustoconical nozzle between the first end and the second end is such that the second end of the frustoconical nozzle when applied to the ear does not contact the ear drum of the user. The nozzle has an aperture 104 at the second end 111. The diameter of the nozzle aperture 104 exceeds the diameter of the opening of the ear canal to ensure that there is no impingement against the ear drum.

[0047] The frustoconical nozzle ensures that a secure fit between the outer wall of the ear canal and the first end of the frustoconical nozzle. The frustoconical nozzle is a rigid structure. For example, the frustoconical nozzle may be formed from rigid rubber or plastic material or the like. The frustoconical nozzle may have a tactile finish such that a comfortable engagement with the ear of the user is provided for. A rubber seal, or washer may be provided on the second end proximal the aperture such that a seal is formed with the ear to ensure that the waste material is collected by the nozzle rather than leaking from the ear. The tip 113 of the frustoconical nozzle adjacent the second end 112 may be formed from an alternative material to the remainder of the nozzle. For example, the tip 113 of the frustoconical nozzle 113 may be a rubberised or silicon seal. A discontinuity in the outer surface of the frustoconical nozzle or indentation at 111 provides an installation point or guide for a rubber, plastic, or silastic tip 113 or seal. Such a tip 113 allows a snug fit against the ear canal preventing leakage and allowing for a comfortable and ergonomic fit. The tips or seals may be of different sizes allowing for varying ear canal sizes, varying users and are further readily replaceable for ease of cleaning. The tips or seals further ensures a smooth linear flow through the nozzle aperture 104 to the second reservoir. The removable tips or seals may be of different sizes allowing for varying ear canal sizes suitable for different users. The removable tips or seals may also allow for ease of cleaning and improved hygiene.

[0048] The first compartment 101 in one configuration as shown in Figure 4 comprises an elongate body extending between the first end 106 and the second end 107. The portable handheld device sits or stands on the second end 107, for example, when not in use. The first compartment comprises a reservoir 115. The reservoir is for holding the cleaning solution. A viewing window 117 is provided. This allows a view of the contents of the reservoir. This viewing window 117 is optional. In the configuration shown in Figure 4, the reservoir is adjacent the second end 107 of the elongate body. The second end of the first compartment may comprise an additional compartment 118. This additional compartment may be formed integral to the second end. The additional compartment may contain a battery, or power source or a charging couple for a power source. The first compartment further comprises a rail or engagement means 114 for engaging a second compartment. The rail 114 is positioned on along the rim or edge of the second compartment and facilitates a slidable engagement with the first compartment. A further clip 114b may also be provided to facilitate a snap fit engagement with the second compartment of the portable handheld device.

[0049] Proximal the first end of the first compartment a delivery means 109 is provided. The delivery means 109 may be an outlet port in fluid communication with the liquid in the reservoir. When the second compartment 102 is engaged with the first compartment, the delivery means 109 aligns with the nozzle such that the cleaning fluid is dispensed or delivered through the delivery means to the nozzle. The cleaning fluid is then dispensed through the single aperture in the nozzle. The delivery means is positioned such that it does not impede or block flow of waste material or effluent back into the aperture and to the waste reservoir. The delivery means does not occlude the nozzle. The delivery means may be maintained at a distance from the nozzle or adjacent the nozzle. The delivery means is separate to the nozzle. By maintaining a separate delivery means and dispensing tube and nozzle, this obviates the need for a delivery tube in the nozzle which could block the delivery tube or impede flow of solid material back through the nozzle.

[0050] The second compartment 119 as shown for example in Figure 5 comprises a nozzle 103. The nozzle has an aperture 104. The nozzle 103 is substantially frustoconical. A first end 112 of the frustoconical nozzle is located proximal the portable handheld device body or proximal the second compartment 102. A second end 111 of the frustoconical nozzle is located distal the portable handheld device body. The diameter of the second end is smaller than the diameter of the first end. The frustoconical nozzle tapers from the first end to the second end 111. In a configuration as shown in Figure 2, a discontinuity in the outer surface of the nozzle or indentation is provided at the second end of the nozzle. This provides an installation point or guide for a rubber, plastic, or silastic tip 113 or seal. Such a tip 113 or seal allows a snug fit against the ear canal preventing leakage and allowing for a comfortable and ergonomic fit. The tips or seals may be of different sizes allowing for varying ear canal sizes, varying users and are further readily replaceable for ease of cleaning. The tips or seals further ensures a smooth linear flow through the nozzle aperture 104 to the second reservoir. The removable tips or seals may be of different sizes allowing for varying ear canal sizes suitable for different users. The removable tips or seals may also allow for ease of cleaning and improved hygiene.

[0051] The height of the frustoconical nozzle between the first end and the second end is such that the second end of the frustoconical nozzle when inserted into the ear does not contact the ear drum of the user. The diameter of the aperture 104 exceeds the diameter of the external ear canal rather than extending into the ear canal thus ensuring that the tip 113 of the nozzle cannot contact the ear drum. This arrangement prevents a situation where a nozzle inserted into the canal would block the cerumen / effluent / waste material washing out of the ear canal.

[0052] The frustoconical nozzle ensures that a secure fit between the outer wall of the ear canal and the first end of the frustoconical nozzle. The frustoconical nozzle may be formed from rubber or plastic and have a tactile finish such that a comfortable engagement with the ear of the user is provided for. A rubber seal, or washer or tip 113 may be provided on the first end such that a seal is formed with the ear to ensure that the waste material is collected by the nozzle rather than leaking from the ear. The tip 113 adjacent the second end 112 may be formed from an alternative material to the remainder of the nozzle. For example, the tip 113 of the frustoconical nozzle 113 may be a rubberised or silicon or plastic seal.

[0053] The second compartment comprises a rail 119 which cooperates with the rail 114 of the first compartment to ensure a secure engagement. The second compartment 102 may slidably engage or snap fit with the first compartment. A magnetic coupling may also be used to provide engagement between the first compartment and the second compartment 102. A magnetic coupling allows for the first and second compartment to be easily disarticulated and relocated. When the second compartment is engaged with the first compartment the delivery means 109 aligns with the nozzle 103 such that the cleaning fluid is dispensed through the nozzle aperture 104.

[0054] The nozzle is positioned in the nozzle section. Extending longitudinally away from the nozzle section, there is provided a handgrip region 105 facilitating the user of the portable handheld device to hold the portable handheld device in their hand.

[0055] This handgrip region 105 may include a guide for guiding the end user to the correct holding position. For example, the handgrip region or a portion thereof may be indented or stippled or be coated in a tactile coating. The guide may be located on the external surface of the second compartment or on both the external surface of the second compartment and the first compartment.

[0056] The first compartment as shown in Figure 4 and the second compartment as shown in Figure 5 detachably engage to form the elongate body of the portable handheld device. In the configuration shown in Figure 6, the first compartment 101 and the second compartment 102 are detachably engaged to form an elongate body extending between a first end 106 and a second end 107. A battery compartment or charging unit 118 is provided at the second end of the elongate body. This battery compartment or charging unit 118 is separated from the reservoir of the first compartment by a dividing wall. The second end 107 comprises a cover plate 126 for accessing a battery compartment or charging unit 118. The cover plate 126 may be removable. The battery compartment may comprise a power source 120 including for example one or more batteries 120, rechargeable or otherwise or alternative power source. The power source 120 is configured to power a pumping mechanism. Alternatively, this compartment may include battery charger for charging a battery in an alternative location in either the first or second compartment. The pumping mechanism 200 pumps the cleaning solution underpressure through a siphon tube 123. For example, the pumping mechanism may lie adjacent the rechargeable battery. The siphon tube 123 is located in the reservoir 115 of the first compartment 101.

[0057] When the cleaning solution is pumped from the reservoir 115 through the siphon tube it is then expelled through the delivery means under pressure. A stream of cleaning solution is dispensed through the delivery means through the nozzle 103.

[0058] The second compartment comprises a second reservoir 124 for collecting waste material returned through the nozzle aperture 104. The delivery means 109 preferably includes a one-way valve, ensuring that the waste material does not return to the first compartment reservoir.

[0059] The engagement of the first and second compartments as shown in Figure 6 provides a handheld elongate and portable solution for the cerumen removal from an ear canal.

[0060] A viewing window 121 is provided. This allows the amount of cleaning solution in the reservoir to be easily observed. An inlet port 122 is provided to allow additional cleaning solution to be added to the reservoir 115. The inlet port may be a one-way valve.

[0061] A power button 110 is provided on the first compartment. When the power button is pressed, the power supply 120 is switched on. This in turn provides power to activate the pump. Control electronics may be housed in the proximal end of the first compartment 101. In one configuration the control electronics provides control for the pump, in terms of power, duty cycle, pump flow pulsation, as well as gradually increasing or decreasing the speed of the pump during dispensing to control fluid flow.

[0062] The reservoir 115 may comprise heating means (not shown) for heating the cleaning solution contained in the reservoir. This heating means may also maintain the temperature of a warmed cleaning solution introduced into the reservoir 115. The power supply 120 may be configured to provide power to this heating element. Control electronics may also be provided to monitor the temperature of the liquid in the reservoir 115. These control electronics may be provided to control the temperature of the liquid in the reservoir. One or more additional controls may be provided on the external surface of the first compartment. These controls allow the user of the device to select or control the temperature of the liquid. One or more displays may be provided on the external surface of the first or second compartment to provide information to the user of the device such as the liquid level in the cleaning solution reservoir 115, and / or the waste product reservoir in the second compartment These displays may be graphic user interfaces such as LED or LCD displays. The one or more displays may display the temperature of the liquid in the reservoir.

[0063] When the pumping mechanism is activated, the cleaning solution in the reservoir 115 is drawn through the siphon tube 123. The siphon tube extends from the pumping mechanism into the reservoir. The cleaning solution under the pumping action is drawn through the tube and into the pumping mechanism. The pumping mechanism then expels the cleaning solution through the delivery means 108. The alignment of the first compartment and the second compartment results in an alignment of the delivery means and the nozzle 103. When inserted in the ear canal, the cleaning solution is expelled from the nozzle as shown by the direction of the arrows in Figure 7. The cleaning solution circulates in the ear canal and returns through the aperture 104 carrying with it the ear wax or cerumen as waste material. The waste material (cleaning solution and ear wax) is then returned to the reservoir 124 of the second compartment 102. The waste material is not pumped or suctioned to the reservoir. Rather it returns to the reservoir under the action of gravity. To remove the waste material, the second compartment is detached from the first compartment. The second compartment can then be cleaned or rinsed for subsequent usage.

[0064] A docking station 128 for the handheld device is provided. The docking station provides a first compartment 130a for storing and / or charging the handheld device, a second compartment 130b for storing a bottle or container of cleaning solution and a third compartment 130c for storing an additional bottle or container for storing additional cleaning solution or the like. While shown as three compartments, it will be appreciated that the docking station may include only a single compartment for docking the portable handheld device. It will equally be appreciated that any number of additional compartments may be provided.

[0065] The docking station 128 may facilitate recharging of the power supply of the portable handheld device. For example, a rechargeable battery or power supply of the portable handheld device may be capacitively or inductively recharged when the portable handheld device of the present invention is mounted in the first compartment 130a. A power supply may be connected to a connector of the docking station for transferring power to the rechargeable battery or power supply. An indicator light 129 may be provided to indicate when the device is charging / charged and ready to use. When the handheld device is docked in the docking station in the first compartment 130a, power is transferred to the power unit in the battery or power compartment 118. Where a charging unit is located in the power compartment, this charging unit transfers power to the battery.

[0066] Additionally, the docking station may be configured to heat the cleaning fluid in the second or third compartment, such that warmed heating solution may be provided to the handheld device. The dock may be configured to heat the cleaning solution to 37 degrees Celsius.

[0067] While described herein as suitable for cerumen removal from an ear canal, it will be appreciated that this device could alternatively be used for the removal of nasal mucus.

[0068] The words “comprises / comprising” and the words “having / including” when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

[0069] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 08 10 25

Claims

1. A portable handheld ear canal cerumen removal device (100) forcerumen removal from an ear canal, comprising:an elongate body havinga first compartment (101) comprising a first reservoir for a cleaning solution and a delivery means (109) for expelling the cleaning solution and a second compartment (102) comprisinga second reservoir for collecting waste material, wherein the first compartment (101) and second compartment (102) are detachably coupled;and where the second compartment (102) comprises a frustoconical nozzle (103) extending laterally therefrom for insertion into the ear, the nozzle comprisinga single aperture (104) in fluid communication with the delivery means for expelling the cleaningsolution as a stream of cleaning solution through the nozzle (103) and with the second reservoir for collecting waste material.

2. The portable handheld ear canal cerumen removal device of claim 1 wherein the elongate body extends between a first end of the elongate body (106) and a second end (107) of the elongate body and wherein the nozzle is positioned proximal to the first end.

3. The portable handheld ear canal cerumen removal device according to claim 2, wherein a handgrip region is located between the nozzle and the second end.

4. The portable handheld ear canal cerumen removal device of claim 1 wherein the first compartment comprises an inlet for receiving the cleaning solution.

5. The portable handheld ear canal cerumen removal device according to any previous claim wherein the delivery means (109) comprises a discharge portfor expelling the cleaning solution and a pump for pumping the cleaning solution from the first reservoir to the discharge port.

6. The portable handheld ear canal cerumen removal device according to claim 5 further comprising means for activating and deactivating the pumping mechanism.

7. The portable handheld ear canal cerumen removal device according to claim 5 wherein the discharge port comprises a one-way valve.

8. The portable handheld ear canal cerumen removal device according to any previous claim further comprising a power supply.

9. The portable handheld ear canal cerumen removal device according to claim 8 wherein the power supply is rechargeable.

10. The portable handheld ear canal cerumen removal device according to any previous claim wherein the second compartment comprises an outlet for removing the waste material.

11. The portable handheld ear canal cerumen removal device according to any previous claim further comprising a heating mechanism for heating the cleaning solution.

12. The portable handheld ear canal cerumen removal device according to any previous claim further comprising a cleaning solution, wherein the cleaning solution comprises a mixture of saline, surfactant cleaning solution, hydrogen peroxide and water.

13. A ear canal cerumen removal system comprising a handheld ear canal cerumen removal device according to any of claims 1 to 12 and a docking station for docking the portable handheld ear canal cerumen removal device, the docking station comprising a dock for receiving and supporting the portable handheld ear canal cerumen removal device.

14. The system according to claim 13 wherein the docking station further comprises a power transfer system for recharging a rechargeable power supply of the portable handheld ear canal cerumen removal device.

15. The system according to claim 14 wherein the docking station further comprises a connector for connecting the power transfer system to an external power supply.

16. The system according to any of claims 13 to 15, wherein the docking station further comprises a chamber for storing and / or heating a container of liquid, such as cleaning solution or the like.LDCM

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