AU2017100347A4 - Apparatus for Inducing Pressure Changes - Google Patents

Abstract

Abstract An apparatus for inducing a change of air pressure in a person's external ear canal. The apparatus includes: 5 - an elastically resilient bellows including a hollow central cavity, - a longitudinally-rigid tube extending from said bellows, the tube having: - a proximal end at said bellows, - a tip at its distal end, and - its hollow core in communication with said cavity, and 10 - mounted on said tip, a soft resilient earpiece, of a size suitable for sealing around the outer portion of said ear canal, and having a bore therethrough in communication with said hollow core. The bellows has a maximum displaceable volume of air of no greater than 6 ml when depressed by a user's fingers. 1aa 26a 7e FIG. 4

Description

1 2017100347 24 Mar 2017

Apparatus for Inducing Pressure Changes Background and Summary of the Invention 5 This invention concerns a portable apparatus that is useful for the treatment and/or alleviation of symptoms of various ear disorders by inducing changes of air pressure into the ear.

During descent in an aircraft, a person’s ear drum is pushed in due to increasing 10 pressure in the aircraft cabin. Swallowing is the usual mode of relieving the discomfort this may cause. But swallowing alone often fails to allow the eardrum to assume its normal position. In this situation, relief may be obtained by applying a negative pressure to the ear, in conjunction with swallowing. The applied negative pressure induces the eardrum back to its normal position and the swallowing 15 momentarily opens the Eustachian tube, allowing air into the middle ear, so equalizing the pressures as desired. The apparatus of the present invention provides a device which can induce the negative pressure in a person’s ear in order to achieve such relief. 20 During ascent in an aircraft, air in the middle ear expands and usually escapes passively through the Eustachian tube without causing undue discomfort. Although only rarely would any external intervention be necessary, the present invention provides a device which can induce a positive pressure in a person’s ear in order to achieve relief. 25

Meniere’s disease is a disorder of the inner ear. It has been shown that applying appropriate positive pressure pulses to the round window of the inner ear has a positive effect on Meniere’s disease. While the present invention provides a device which can induce appropriate positive pressure pulses in a person’s ear to have a 30 positive effect on the symptoms of Meniere’s disease, it is only applicable where the person concerned has an open ear drum such as from a paracentesis procedure or the insertion of a middle ear ventilation tube. 2 2017100347 24 Mar 2017

The present invention provides a device that is simple to operate, inexpensive, and can induce either positive or negative changes in pressure to the ear canal. 5 Accordingly, in one aspect the invention provides an apparatus for inducing a change of air pressure in a person’s external ear canal, said apparatus including: - an elastically resilient bellows including a hollow central cavity, - a longitudinally-rigid tube extending from said bellows, the tube having: - a proximal end at said bellows, 10 - a tip at its distal end, and - its hollow core in communication with said cavity, and - mounted on said tip, a soft resilient earpiece, of a size suitable for sealing around the outer portion of said ear canal, and having a bore therethrough in communication with said hollow core, 15 wherein said bellows has a maximum displaceable volume of air of no greater than 6 ml when depressed by a user’s fingers.

Preferably said longitudinally-rigid tube is formed integrally with said bellows. Preferably said tube is formed of the same material as said bellows. Preferably said 20 elastically resilient bellows and said rigid tube together take the general form of a small conventionally-shaped toothpaste tube which has an elongated narrow outlet.

Preferably said earpiece is removeable from said tip. Preferably said tip locates into said bore. Preferably said bore is stepped so as to prevent said tip from protruding 25 fully through said earpiece. Preferably said tube is substantially straight.

Preferably the maximum displaceable volume of air from the bellows is no greater than 5 ml, and more preferably in the range 3 to 4 ml. 30 In another aspect the invention provides a kit of parts for apparatus for inducing a change of air pressure in a person’s ear canal, said kit of parts comprising: a body portion comprising: 2017100347 24 Mar 2017 3 a resilient bellows, including a hollow central cavity, - a longitudinally-rigid tube extending from said bellows, the tube having: a proximal end at said bellows, a tip at its distal end, and 5 - its hollow core in communication with said cavity, and - a selection of soft resilient earpieces of a size suitable for sealing around the outer portion in said ear canal and adapted to releasably fit onto said tip, wherein said bellows has a maximum displaceable volume of air of 6 ml when depressed by a user’s fingers. 10

Brief Description of the Drawings

In order that the invention may be more fully understood there will now be described, by way of example only, preferred embodiments and other elements of the invention 15 with reference to the accompanying drawings where:

Figure 1 is a perspective view of an air-pulsing apparatus according to a first embodiment of the present invention;

Figure 2 is a plan view of the apparatus in Figure 1;

Figure 3 is a side view of the apparatus in Figure 1; 20 Figure 4 is a plan view of a first component of the apparatus in Figure 1;

Figure 5 is a perspective view of a second component of the apparatus in Figure 1;

Figure 6 is a perspective view of an apparatus according to a second embodiment of the invention. 25

Description of Examples of the Invention

Referring to Figures 1 to 5, the apparatus 10 shown therein comprises a device having a body portion 12 (the entirety of Figure 4) and an earpiece portion 14 (the entirely of 30 Figure 5). 4 2017100347 24 Mar 2017

The body 12 has the general shape of a small conventionally-shaped toothpaste tube which has an elongated narrow outlet. The body 12 has a flexible bellows portion 15 and an elongated tube portion 18 extending from the bellows portion. A rounded shoulder portion 20 connects the bellows 15 to the tube 18. 5

The body 12 is formed as an integral plastic moulding which is first moulded as a stepped cylindrical tube and then has its wide end sealed shut by heated clamping to form a flat seal 22 straight across the base 24 of the body 12. The bellows portion 15 accordingly has a generally circular cross-section at its proximal end 16, and a 10 generally linear cross-section at its distal end 17.

The body 12 is 10cm long, the base 24 is 3cm wide, and the tube portion 18 is 5cm long. 15 The wall thickness of the bellows portion 15 is much thinner than the wall thickness of the tube portion 18. The bellows can be readily squeezed by the fingers of a user.

The rounded shoulder portion 20 of the body provides a support to the shape of the bellows 15 so that, when the depressed bellows is released, it promptly returns to its 20 original position thereby sucking air into the bellows. The bellows is accordingly elastically resilient.

The elongated tube portion 18 of the device has a wall thickness substantially greater than the wall thickness of the bellows portion 15, and even greater than that of the 25 shoulder portion 20, to the extent that the tube 18 is longitudinally rigid, although it can be laterally bent to a limited degree. The tube portion 18 is gently tapered inwards towards its distal end 32.

The earpiece 14 is made of a soft rubbery material and has a generally cylindrical 30 main body portion 25 and flexible mushroom shaped head 26 with a waved perimeter 28 which provides for a sealing engagement with ear canal entrances of different sizes and shapes. It is desirable for proper use of the apparatus that the head 26 provides a 2017100347 24 Mar 2017 5 good generally airtight seal with the patient’s ear canal. Different sized earpieces may be provided with the device in order to optimize the sealing in a variety of people, including children, having different sized ear canals. 5 The earpiece 14 has an axial bore 30 throughout its length. The portion of the bore 30 within the main body portion 25 of the earpiece frictionally engages with the distal end 32 of the tube portion 18. When the end 32 is pushed into the earpiece 14, they are held together by friction. The distal end 32 of the tube does not protrude from the head 26 of the earpiece. To reduce the chance of such protrusion, the bore 30 in the 10 earpiece may be stepped to provide a stop for the end 32 part-way through the bore.

The earpiece 14 is readily separated from the body 12 for replacement or cleaning and this allows the device to be used by different people while maintaining hygiene. The apparatus may be provided as a single use personal item with a single body portion 15 and a single rubber earpiece. Alternatively it may be provided as a kit of parts comprising one body portion and multiple earpieces in order to provide an improved level of hygiene for multiple use or when used by a plurality of different persons. The multiple earpieces in the kit may vary in size to provide for use by persons of different sizes. 20

When finger pressure is applied to squeeze the bellows 15, the volume of the air chamber defined by the bellows and the neck is reduced and air flows from the earpiece 14 resulting in a pressure increase in the user’s ear cavity. The user may elect to only partially depress the bellows in order to elevate ear pressure by a smaller 25 amount. A rapid squeeze results in a sharp pressure pulse while a slower squeeze results in a gentler pressure increase.

Users wishing to induce a negative pressure pulse in their ear canal first squeeze the bellows, then seal the earpiece 14 into their ear and quickly release the squeeze. The 30 elastic bellows returns to its expanded configuration, sucking air in through the tube 18 and so inducing the desired negative pressure in the ear canal. 6 2017100347 24 Mar 2017

While the pressures induced should be sufficient for the retardant to be effective, in order to avoid damaging an ear, it is important that safe negative and positive pressures, and pulse severity, cannot be exceeded due to use of the device. In particular, the positive pressures induced should be in the range 200 to 600mm water 5 and preferably in the range 400 to 500mm water, and the negative pressures induced should not exceed 600mm water and preferably be in the range 500 to 600mm water. This is achieved by constructing the bellows portion to have a maximum volumetric displacement which is deemed safe. 10 The maximum volume of air that may be expelled from, or drawn into, the device is controlled by the volume of the bellows portion 15 and the nature of its construction. Consideration should be given to the feature that around the shoulder portion 40, the bellows portion is much stiffer to compress than closer to the base portion 24 due to a thicker wall and its curved surface. The bellows portion should be sized and shaped 15 such that the maximum volumetric displacement is no greater than 6 ml. The maximum volumetric displacement from apparatus 10 in a single squeeze is between 3 and 4 ml.

The device 40 shown in Figure 6 is identical to that shown in Figure 1 except that the 20 sealed end 42 of the bellows 46 is achieved by making the sealed end 42 curved in order to remove the sharp comers 34 present in the embodiment of Figure 1. This is an advantage when the device is carried in a pocket as it does not catch on the pocket material or prick uncomfortably into the hand of a user. 25 Users of the device to treat Meniere’s disease need to have a ruptured ear drum or a tympanostomy tube fitted so that equal pressures are achieved either side of the ear drum. Therefore the volume into which the device operates includes the middle ear connected cavities. The device will produce safe pressure levels regardless of whether the user has an intact ear drum or not. 30

Whilst the above description includes the preferred embodiments of the invention, it is to be understood that many variations, alterations, modifications and/or additions 2017100347 24 Mar 2017 7 may be introduced into the constructions and arrangements of parts previously described without departing from the essential features or the spirit or ambit of the invention. For example, although the neck portions described in the two embodiments are straight, the other embodiments of the invention envisage a curved 5 neck.

It will be also understood that where the word “comprise”, and variations such as “comprises” and “comprising”, are used in this specification, unless the context requires otherwise such use is intended to imply the inclusion of a stated feature or 10 features but is not to be taken as excluding the presence of other feature or features.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that such prior art forms part of the common general knowledge in Australia. 15

Claims (11)

1. Claims

   1. Apparatus for inducing a change of air pressure in a person’s external ear canal, said apparatus including: - an elastically resilient bellows including a hollow central cavity, - a longitudinally-rigid tube extending from said bellows, the tube having: - a proximal end at said bellows, - a tip at its distal end, and - its hollow core in communication with said cavity, and - mounted on said tip, a soft resilient earpiece, of a size suitable for sealing around the outer portion of said ear canal, and having a bore therethrough in communication with said hollow core, wherein said bellows has a maximum displaceable volume of air of no greater than 6 ml when depressed by a user’s fingers.
2. 2. Apparatus according to claim 1 wherein said longitudinally-rigid tube is formed integrally with said bellows.
3. 3. Apparatus according to claim 2 wherein said tube is formed of the same material as said bellows.
4. 4. Apparatus according to claim 3 wherein said elastically resilient bellows and said rigid tube together take the general form of a small conventionally-shaped toothpaste tube which has an elongated narrow outlet.
5. 5. Apparatus according to any one of claims 1 to 4 wherein said earpiece is removeable from said tip.
6. 6. Apparatus according to claim 5 wherein said tip locates into said bore.
7. 7. Apparatus according to claim 6 wherein said bore is stepped so as to prevent said tip from protruding fully through said earpiece.
8. 8. Apparatus according to any one of the previous claims wherein said tube is substantially straight.
9. 9. Apparatus according to any one of the previous claims wherein said maximum displaceable volume of air from the bellows is no greater than 5 ml.
10. 10. Apparatus according to claim 9 wherein said maximum displaceable volume of air from the bellows is in the range 3 to 4 ml.
11. 11. A kit of parts for apparatus for inducing a change of air pressure in a person’s ear canal, said kit of parts comprising: - a body portion comprising: - a resilient bellows, including a hollow central cavity, - a longitudinally-rigid tube extending from said bellows, the tube having: - a proximal end at said bellows, - a tip at its distal end, and - its hollow core in communication with said cavity, and - a selection of soft resilient earpieces of a size suitable for sealing around the outer portion in said ear canal and adapted to releasably fit onto said tip, wherein said bellows has a maximum displaceable volume of air of no greater than 6 ml when depressed by a user’s fingers.