CA2792024A1 - Portable high frequency air pulse delivery device - Google Patents

Abstract

A portable air pulse delivery device includes a housing and an air compressor having a motor disposed in the housing. The motor is operable at speeds between 1200 and 4800 rpm. The air compressor includes an air inlet and an air outlet. An untethered power source is disposed in the housing and is operably connected to the motor. An intake filter is disposed in the housing and is in fluid communication with the air inlet of the air compressor. An outlet port is coupled to the air outlet of the air compressor and is in communication with an exterior of the housing. A mouthpiece includes an inlet coupled to the outlet port and an outlet having a gas exit port. The air compressor is operative to produce an average gas flow rate of between about 2-3 L/min at the gas exit port at a pulsation frequency of between about 20 Hz to 80 Hz. A method for delivering air pulses to a mouth of a user is also provided.

Description

PORTABLE HIGH FREQUENCY AIR PULSE DELIVERY DEVICE

[0001] This application claims the benefit of U.S. Provisional Application No.
61/310,590, filed March 4, 2010, the entire disclosure of which is hereby incorporated herein by reference.

TECHNICAL FIELD

[0002] The present invention relates generally to an air pulse delivery device used to administer a stimulus to a human or animal to elicit and/or facilitate a desired physiological response and in particular, to a portable air pulse delivery device connected to a mouthpiece for delivering a substance to a human or animal to initiate, evoke and/or facilitate swallowing or other sensorimotor behaviors, and a method for the use thereof.

BACKGROUND

[0003] Dysphagia is a condition in which a person has difficulty swallowing, characterized by impaired transport of saliva, drink, and food from mouth to stomach. Dysphagia results from disease, or damage, to the neural and/or aerodigestive tract structures that produce swallowing. Often, dysphagia presents in stroke patients, patients with other acute neurological conditions, patients having Parkinson's disease or other neurodegenerative diseases, cerebral palsy or chronic obstructive pulmonary disease (COPD) and/or in response to various cancer treatments, wherein the patient has difficulty in, and/or experiences pain with, swallowing. Likewise, other patients may exhibit various swallowing, speech, salivary and/or oral sensory impairments. Dysphagia compounds these health problems via resultant complications, most commonly aspiration pneumonia secondary to entry of saliva or food into the lungs, dehydration and malnutrition. As such, some deaths attributed to stroke, may actually be caused by dysphagia and the resulting complication of pneumonia. These complications may CONFIRMATION COPY

also lead to extended hospital stays, emergency room visits, re-admissions, long-term institutional care and need for expensive respiratory and nutritional support.

[0004] In response, various techniques and treatments have been developed to induce or stimulate swallowing, which can provide various therapeutic benefits to the patient or user. For example, various devices and methods for inducing swallowing in a patient include delivering one or more gas pulses to a predetermined area of the mouth and/or throat. Often, however, such devices are incapable of producing a train of pulses at desired frequencies, operate at relatively high pressures, require various inputs related to pressure, duration and frequency and/or are not portable. Other devices apply electrical stimulation to the neck overlying the laryngeal muscles.

SUMMARY

[0005] The present invention is defined by the following claims, and nothing in this section should be considered to be a limitation on those claims.

[0006] In a first aspect, one embodiment of a portable air pulse delivery device includes a housing and an air compressor having a motor disposed in the housing.
The motor is operable at speeds between 1200 and 4800 rpm. The air compressor includes an air inlet and an air outlet. An untethered power source is disposed in the housing and is operably connected to the motor. An intake filter is disposed in the housing and is in fluid communication with the air inlet of the air compressor.
An outlet port is coupled to the air outlet of the air compressor and is in communication with an exterior of the housing. A mouthpiece includes an inlet coupled to the outlet port and an outlet having a gas exit port. The air compressor is operative to produce an average gas flow rate of between about 2-3 L/min at the gas exit port at a pulsation frequency of between about 20 Hz to 80 Hz.

[0007] In another aspect, a method for delivering air pulses to a mouth of a user includes providing an untethered portable air pulse delivery device having a housing and a mouthpiece connected to the housing and inserting the mouthpiece into the mouth of the user. The method further includes actuating a power switch on the housing and thereby automatically switching a compressor motor located in the housing on and off for a predetermined sequence of predetermined time periods. The motor is operated at a speed of between 1200 and 4800 rpm when switched on and produces an average gas flow rate of air of between about 2-3 L/min at a gas exit port at a pulsation frequency of between about 20 Hz to 801 ii.

[0008] The various aspects and embodiments provide significant advantages relative to the prior known devices. In particular, the delivery device is capable of producing a train of pulses at frequencies of 20-80 Hz, which is in the range of optimal muscle stimulation for inducing swallowing. At the same time, the device provides air pulses at low pressure, which avoids various risks associated with electrical stimulation, for example with patients with implanted pacemakers and/or potential risks and damage associated with high-pressure systems. The system has also been optimized in one embodiment, such that it does not require any input from the user. Rather, the user simply switches the device on, with a predetermined sequence of air train pulses being administered at a predetermined frequency, duration and pressure. The system then automatically powers down without any input from the user. In this way, the device is not susceptible to tampering or misuse, and does not require excessive training or knowledge about alternative inputs for duration, pressure or frequency. As such, it is particularly well suited for use outside of the patient care system, including for example use in the home, office or everyday environments.

[0009] The system also has been designed to be truly portable, such that various embodiments can fit in the pocket, e.g., shirt, of the user and/or be secured around the neck of the user with a lanyard, or secured to clothing articles with a clip or hook and loop (e.g., Velcro) fastener, e.g., on a strap, or be secured to other structures such as a rail or hook. Due to the small size and untethered power source, the user can undergo treatment while going about their day-to-day activities, untethered and hands free.

[0010] The foregoing paragraphs have been provided by way of general introduction, and are not intended to limit the scope of the following claims.
The various preferred embodiments, together with further advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Figure 1 is a front perspective view of one embodiment of a portable air pulse delivery device.

[0012] Figure 2 is a rear perspective view of the portable air pulse delivery device shown in FIG. 1.

[0013] Figure 3 is a rear perspective view of the portable air pulse delivery device shown in FIG. I with the battery cover removed.

[0014] Figure 4 is a front interior view of the portable air pulse delivery device shown in FIG. 1.

[0015] Figure 5 is an enlarged, partial view of the power switch take along line 5 of FIG. 4.

[0016] Figure 6 is an enlarged, partial interior view of the filter housing shown in FIG. 4.

[0017] Figure 7 is circuit diagram of the logic for the circuitry used to control and supply power to the compressor motor used in the embodiment of FIG. 1..

[0018] Figure 8 is a plan view of one embodiment of a mouthpiece.

[0019] Figure 9 is a front view of the mouthpiece of FIG. 8 applied to a user.

[0020] Figure 10 is a partial perspective view of one embodiment of a mouthpiece disposed in the mouth of the user.

(0021] FIGURE 11 is a front perspective view of another embodiment of a portable air pulse delivery device.

[0022] Figure 12 is a rear perspective view of the portable air pulse delivery device shown in FIG. 11.

[0023] Figure 13 is a perspective view of a carrier structure.

[0024] Figure 14 is a front interior view of the portable air pulse delivery device shown in FIG. I I with the front cover removed.

[0025] Figure 15 is a rear interior view of the portable air pulse delivery device shown in FIG. 11 showing the printed circuit board.

[0026] Figure 16 is circuit diagram of the logic for the circuitry used to control and supply power to the compressor motor of the embodiment shown in FIG. 11.

[0027] FIG. 17 is an exploded perspective view of alternative embodiment of a portable air pulse delivery device.

DETAILED DESCRIPTION OF THE DRAWINGS

[0028] The terms "top," "bottom," "upwardly" and "downwardly" are intended to indicate directions when viewing the device from the perspective of the user.
The term "lateral," as used herein, means situated on, directed toward or running from side-to-side, for example and without limitation from one side of the user's mouth to the other. It should be understood that the term "plurality," as used herein, means two or more. The term "longitudinal," as used herein means of or relating to length or the lengthwise direction. The term "coupled" means connected to or engaged with whether directly or indirectly, for example with an intervening member, and does not require the engagement to be fixed or permanent, although it may be fixed or permanent, and includes both mechanical and electrical connection. It should be understood that the term "substance"
as used in this specification includes without limitation a fluid, such as a gas, liquid or combination thereof (including, without limitation, an aerosolized liquid), and/or a powder, including, without limitation, particles entrained in any fluid, or combinations thereof.

(0029] As disclosed herein, a method and apparatus are provided for delivering or applying a train of air pulses to the mouth or neck of the user, whether human or animal, for the purpose of(l) initiating, evoking or facilitating swallowing, speech production, salivation, or an oral or oropharyngeal sensorimotor behaviour in a subject, (2) increasing lubrication of the oral cavity, oropharynx, and pharynx in a subject, (3) decreasing oral or oropharyngeal or pharyngeal discomfort in a subject, (4) contracting muscles of the lips, mouth, buccal area, tongue, jaw, soft palate, pharynx, larynx, any of which could result in muscle strengthening with WO 2011/107860 PCT/IB2011/0(10443 repeated use of the oral appliance; (5) moving the lips, mouth, buccal area, tongue, jaw, soft palate, pharynx, larynx, including elevation of the larynx, including pre-swallow oral transport movements and pre-swallow chewing-like movements;
and/or (6) creating sensations from the oral cavity or oropharynx that include somatic, thermal or gustatory sensations.

[0030] One embodiment of the portable air pulse delivery device provides a means of delivering a sequence of distinct air-pulse trains, or aerosol-pulse trains to the oral cavity, oropharynx, or pharynx of a person, where a train is defined as a series of at least one pulse. The individual air-pulse trains may vary in terms of the following pulse parameters: pulse duration, pulse amplitude, pulse frequency, and train duration. In one embodiment, the air-pulse trains, individually and in the aggregate, are presented within a predetermined sequence.

[0031] Referring to FIGS. 1-7, 11-15 and 17, portable air pulse delivery devices 120, 220, 420 are shown. The term "portable" as used herein means capable -of being operated free of any tethered power source, and capable of being transported by hand, free of any carriage device such as a wheeled caddy. The term "hands-free" refers to a device that can be coupled or secured to the body of the user or adjacent support structure such that the device does not need to be held or retained by the user.

[0032] Referring to FIGS. 1-4, 11-15 and 17, the delivery device includes a housing 122, 222, 422 formed in one embodiment by front and rear housing components 124, 126, 224, 226, 424, 426 that are secured to each other, for example by snap fit, fasteners, adhesives, tabs, and similar fastening components, alone or in combination. The housing has a front 128, rear 130, top 132, bottom 134 and opposite side walls 136. Of course, it should be understood that the housing can be configured in other shapes and forms, and is not limited to the disclosed rectangular parallelpiped shape. The housing is made of a durable material with a reasonable degree of impact resistance, for example ABS. The housing is relatively small, such that it may be disposed in the pocket 140, e.g., shirt or pant, of a user, or otherwise supported by or on the user in a hands-free configuration, for example by way of a lanyard 142 or clip, as shown in FIG.
9. In various embodiments, the overall volume of the housing may be less than about 1000 cm', less than about 600 cm3, or less than about 200 cm3. For example, in one embodiment, shown in FIGS. 1-4, the housing has dimensions of 146 mm x 75 mm x 46 mm, or a volume of about 500 cm'. In another embodiment, the housing has dimensions of 100 mm x 35 mm x 55 mm, or a volume of about 193 cm3. In the embodiment shown in FIGS. 11-15, the housing has dimensions of 135mm x 81mm x46 mm, or a volume of about 503 cm3. In another embodiment, the housing has dimensions of 141 mm x 80 mm x 46 mm, and weighing about 350g. Due to the compact nature of the device, the mass of the entire device, including the housing, and a compressor 160, controller 170, 270 and batteries 180, 280 disposed therein, may be less than about 600g, preferably less than about 400 g, and in one embodiment as low as 300 g.

[0033] In one embodiment as shown in FIG. 17, by incorporating a brushless motor and eliminating the batteries, the housing has dimensions of 70 mm x 70 mm x 45 mm, or a volume of about 221 cm3, and weighs about 215g.
Alternatively, using a motor with brushes, which may reduce the cost of the device, the housing has dimensions of 90mm x 90mm x 47 mm, and a weight of' about 285g.

[0034] As shown in FIGS. 1, 12 and 17, an air intake port 144, 244, 444 is positioned in one of the side walls 136 or rear cover 226 of the housing respectively. An air filter 146 is disposed in the housing adjacent the intake port such that air entering the intake port passes through the air filter.
Preferably, the air filter is capable of removing air-borne particles greater than 50 m. In one embodiment, the air filter may be configured as a removable module 145, as shown in FIG. 6, with the module received in a socket forming a filter housing.
Under normal operating conditions, daily use of the air pulse delivery device may warrant yearly replacement of the air filter. The air filter medium is preferably made of a material satisfying USP Class VI requirements, including for example and without limitation Sefar Medifab monofilament polyamide, Nylon 6-6. The filter may incorporate a scented element, which adds a flavor to the air drawn through the filter. For the incorporation of flavours (scents) into the air filter, a WO 2011/107860 PC'T/1B20111000443 low-melting point material is preferred so as to minimize degradation of the flavouring elements, including for example a low-density polyethylene.
Beneficial scents may include lemon and mint. Various long lasting (100 hours or more) food-grade (USP Class VI) flavor impregnated polymers (e.g., PolyFlav''M
material available from Schulman, Inc.) can be configured as a perforated plug element. In other embodiments, flavor coatings are provided on the filter mesh, which is capable of creating the desired scent(s) for shorter durations.

[0035] Referring to FIGS. 1-5, 11-15, a power button 148 and an air outlet port 150 are positioned on the top of the housing. Of course, it should be understood that the air intake port 144, air outlet port 150 and power button 148 can be positioned anywhere on the housing as deemed most suitable. The housing also includes a loop 152 or opening, which can be connected to the lanyard 142. The lanyard 142 may be disposed around a neck of the user such that they can use the device hands-free. The device also can be configured with a clip, which may releasably engage a belt of the user, or other clothing elements such as pocket, edge, etc.. The lanyard and clip are referred to as a hands-free retention component. Similarly, a hook and loop, or Velcro fastener, e.g., on a strap, may be attached to the retainer attachment 152, and the Velcro fastener strap may then be used for the hands-free support of the device on the user (e.g., a belt), or a bed rail, chair arm or other convenient rail, hook or nearby support structure.

[0036] Referring to FIGS. 2 and 3, a removable panel 154 is releasably secured to and forms a portion of the rear of the housing. For example, a resilient tab 155 may releasably engage the housing. A power source 180 is disposed in a cavity behind the panel. In one embodiment, the power source is configured as a pair of 9V batteries. When installed, the batteries engage corresponding pairs of battery contacts 182. It should be understood that a single battery may suffice, and that the batteries can be configured in different sizes, for example in a range of 12 to 24 V, and further may be disposable or rechargeable. A plurality of pads 156, e.g., rubber, are disposed on the rear of the housing, including the cover 154, so as to provide shock absorption as well as provide the housing with an anti-slip interface to prevent sliding along a surface.

[0037] __Referring to the embodiment of FIGS. 11-16, fixed, rechargeable batteries 280 may be incorporated and connected with battery connectors 281.
One suitable embodiment uses a pair of 9Vdc NiMH rechargeable batteries. In this embodiment, a removable panel providing access to the batteries may be eliminated. A battery charger may also be used to power the system while it is recharging the batteries, with the charger coupled to a DC input 283 as shown in FIG. 1 I and 17. The batteries may be removed or retained in situ for recharging.
Alternatively, the enclosed compressor system and its control circuitry may be enclosed in a smaller casing (without batteries) as shown in FIG. 17, and instead powered by a 115 Vac-powered transformer that provides the requisite dc voltage to drive the motor and control circuitry. As shown in FIG. 17 a power button and underlying switch 482 are located on top of the device. Referring to FIGS.
11-16, an output jack 281 provides a I We signal that may be used for synchronizing the period of air pulsations with complementary recordings from swallowing transducers, throat microphones, and respiratory transducers.
Referring to FIGS. 13 and 14, a carrier structure 290 is disposed in and secured to the housing, for example with a plurality of fasteners. The carrier structure 290 includes a plate structure 300 that holds the batteries 280 in place, as well as provides a mounting component, configured as a pair of lugs 306, for the printed circuit board 270, and a mounting component 304 including a series or ports 292, 294, 296, 298 for the power button 148, battery power indicator 271, configured as an LED light, signal output 281 and mouthpiece connector 150. The battery power indicator 271 provides an indication when the rechargeable batteries 270 are low on power. The mounting component 304 is flush with and is received in an opening defined by end portions of the front and rear covers as shown in FIG.
11.

[0038] Referring to FIGS. 4 and 14-15, the compressor 160 includes a motor 162 and pump 164, which are disposed in the housing. The compressor has an air inlet 166 to the pump. The air inlet 166 is connected to and in fluid communication with the air intake filter, for example with a conduit 168 (not shown in FIGS. 14 and 15). The compressor further includes an air outlet 172 connected to and in fluid communication with the outlet port 150, for example with a conduit 174 (not shown in FIGS. 14 and 15). The interior conduits 168, 174 are USP Class VI (ISO 10993-1), and may be made for example and without limitation from silicone rubber, PVC or polyurethane. In one embodiment, these materials do not include any DEHP plasticizers. The compressor 160 is configured to provide time-controlled, low-pressure, air pulses at frequencies in the range of 20 to 80 Hz. For example, the motor 162 may be operable to run at speeds of between about 1,200 and about 4,800 rpm, which correlates to the desired frequencies without the need for a gear system. For example, in one embodiment, the motor is operated by the controller at a speed of about 2,400 rpm when switched on.

[0039] The pump 164 is coupled to the motor 162. One suitable pump is a diaphragm pump, which is configured with a diaphragm piston, and which may have a suitable displacement of about 1 mL. One exemplary pump is the Hargraves BTC diaphragm pump, available from Hargraves Technology Corp., Mooresville, North Carolina. In such a pump, air may be delivered without contacting any moving parts of the pump. The parts of the pump in contact with the air may be made of Vetra (liquid crystal polymer), while the diaphragm may be made of EPDM (ethylene-propylene-diene-monomer). The pump may also be configured as an electro-magnetically driven pump. The portions of the pump in contact with the respired air are biocompatible and do not introduce adverse scents into the air circulated therethrough.

[0040] The mouthpiece 2 is sized and configured such that an air flow rate of about 2-3 L/min (measured at standard temperature and pressure (STP)) is achieved. For example, when operating at 2,400 rpm (40 Hz pulsations), a pump 164 with a displacement of about I mL can provide an average 2.5 L/min flow rate in a 1 in long mouthpiece tube having a 1.5 mm internal diameter. In such a system, air exiting the mouthpiece has kinetic energy at ambient pressure.
Testing has shown that with an average flow rate of 2.5 L/min, the resultant kinetically produced pressure on a surface at 1-8 mm from the exit port of the mouthpiece is in the range of 1.5 - 2 mmHg. In various preferred embodiments, the pressure is less than about 2.25 mmHg.

[0041] Referring to FIGS. 4, 5, 7, 15, 16 and 17, the controller 170, 270, 470 is disposed in the housing and is coupled to the power source 180 and power switch 182. In one embodiment, the controller is configured as a control circuit incorporated on a circuit board. Referring to FIGS. 7 and 16, the control circuit is arranged and configured to cycle the compressor motor 162 and pump 164 on and off in a predetermined sequence of time periods. It should be understood that other arrangements of hardware and software may also be suitable. For example, the controller may include a processor running software. The device may be configured with an input/output for the processor, such that the motor speed, duration of the ON/OFF periods and overall time of operation can be changed.

[0042] Preferably, the burst of pulsating air-pulses should not substantially interfere with the normal cycle of breathing. For example, a normal adult may breathe 15 times per minute with 3 seconds of inspiration. Therefore, in one embodiment, the controller 170, 270 energizes the motor 162 for X seconds ON
and Y seconds OFF (X:Y). In one embodiment for rehabilitation of dysphagic patients, the predetermined X:Y sequence is repeated for a predetermined time period, e.g., 20 minutes, with the treatment being repeated every day, for example three times.

[0043] The air pulse trains are delivered to the oropharynx via the mouthpiece 2, which has an input end releasably connected to the outlet port with a quick lock connector 18 (see e.g., FIGS. 8 and 9). In one embodiment, shown in FIG. 10, portions 38 of the mouthpiece sit within the buccal cavity, between the teeth and cheek. In this embodiment, there is no mouthpiece material between the upper and lower teeth, such that the patient is able to maintain his/her upper and lower teeth 114, 116 in occlusion. This is preferable since kinematic studies of swallowing have shown that the upper and lower teeth are positioned along the occlusal plane during the pharyngeal stage of swallowing. The mouthpiece appears to have a relatively small impact on the resting position of the subject's mouth, tongue, oropharynx, and face. For example, the tongue in rest position II

does not make contact with the mouthpiece. Because the mouthpiece is thin, the subject is able to achieve closure of the lips. The mouthpiece does not come in contact with pooled saliva in the sublingual region or along the lingual surfaces of the teeth. Being positioned within the upper or lower buccal region, the mouthpiece potentially allows the patient to ingest and swallow food and drink while the mouthpiece is in place.

[0044] In one embodiment, shown in FIGS. 8 and 9, the mouthpiece 2 is configured as an oral cannula. The oral cannula may include a pair of flexible tubes 4, 6 configured to be positioned on opposite sides of the face of a user. Of course, it should be understood that the oral cannula may include only a single tube disposed on one side of the user's face. The oral cannula may also be configured with two tubes, but with gas being delivered through only one of the tubes in some desired treatment modalities. The flexible tubes 4, 6 may be made of thermoformed tubing, which can be formed into a particular shape and configuration, but which has some flexibility and ability to conform to the face and mouth of the user. In one suitable embodiment, the flexible tube is made of polyurethane, polyethylene, PVC, other suitable and biocompatible materials, and/or combinations thereof. The tubes may have a 1/8th inch outer diameter and a 1/16`h inch inner diameter forming a lumen. Of course, other size tubes may also be suitable, and the cross-sectional shape may be circular, or configured in other geometrical shapes. The tubes may be clear or transparent, translucent, coloured or opaque, and/or various combinations thereof, with the visual characteristics varying along the length of the tube for example so as to provide one or more windows. Each tube may also be formed with a plurality of lumens, or channels, to allow for additional features such as light, sensors, fluid delivery, etc., including for example and without limitation the delivery of an aerosolized liquid. In such embodiments, the lumens may run parallel to each other, and include for example and without limitation a first inner lumen and a second exterior lumen formed around the inner lumen, or alternatively two or more lumens running side by side.
Of course, the plurality may include more than two lumens.

[0045] In one embodiment, a wire may run along a length of at least a portion of the flexible tubing 4, 6. The wire provides further shape memory to the flexible tubing. The wire may be co-extruded with the tube, or may be connected to the tubing by molding, welding, adhesives and the like, or combinations thereof.
The tubing may also be shaped by over-molding with another polymer, or by molded, curved sections that are subsequently attached to the straight portions of tubing.

[0046] Referring to FIGS. 8 and 9, the flexible tube 4, 6 may be made of, impregnated with, or coated with a flavored material, including without limitation fruit (e.g., lemon), menthol or mint flavors, which may be pleasing to the user and which may facilitate swallowing. The tube may also be made of, impregnated with, or coated with, an antistatic material, or alternatively a conductive material.
Antistatic materials have a surface resistivity of between about I OE 10 ohm/sq and about l OE 12 ohm/sq. Static dissipative materials have a surface resistivity of between about 10E6 ohm/sq. and about I OE 12 ohm/sq. Conductive materials have a surface resistivity of between about IOEI ohm/sq and about 10E6 ohm/sq.
Metals typically have a surface resistivity of between about I OE-1 to about I

ohm/sq. Surface resistivity as set forth herein is measured pursuant to ASTM
test D257. The tubing may also be made of, or coated with, an antibacterial material.
For example, silver impregnation may provide antibacterial properties.

[0047] Each flexible tube 4, 6 includes an inlet portion 10, which is preferably elongated and may extend from the neck region to the ear of the user. The inlet portion has an inlet end portion 12 connected to an adapter (e.g., Y adapter) 14, with the adapter having a feed tube 16 connected to an opposite end thereof, A
slideable connector 20, configured in one embodiment as a sleeve, is disposed over and slidably receives the inlet portions 10 of the tubes. The connector may be moved back and forth along a portion of the lengths of the inlet portions 10 of the tubes so as to lengthen the end portion 12, and thereby secure the tubes under the chin of the user, or to shorten the end portion 12, and thereby loosen the tubes for comfort or removal.

[0048] As explained above, the feed tube 16 is configured to connect to the outlet port, which supplies air, for example and without limitation by way of the WO 2011/107860 PCTIIB2011ro00443 quick connect 18 having a releasable component, such as a detent. Various exemplary mouthpieces and control systems are shown and disclosed in US Pub.
No. 2006/0282010A1, entitled Oral Device, and U.S. Patent Application No.
12/424,191, filed April 15, 2009 and entitled Swallowing Air Pulse Therapy Mouthpiece and Methods for the Use Thereof, the entire disclosures of which are hereby incorporated herein by reference.

[0049] Referring to FIGS. 8 and 9, the pair of tubes 4, 6 are a mirror image of each other, or can be folded one onto the other, along a longitudinal axis 24.
The various portions of the tubes may be formed or positioned within a plane, although during use, the tubes 4, 6 conform to the face 28 of the user and are self supported on the face and in the mouth 30, meaning the user and/or care giver are not required to hold or position the tubes with their hands, lips, tongue, teeth and/or other devices.

[0050] The tubes 4, 6 each have a curved portion 32 forming an ear loop connected to the inlet portion 10. In one embodiment, the ear loop 32 may be encapsulated, or covered with a padding material 40, such as foam, which provides greater comfort to the user. Of course, it should be understood that other portions of the tube, such as the portion 42 running along the face of the user, may also be covered or secured to an interfacing material, such as a padding, to improve comfort.

[0051] Another curved portion 34 forms a lip bend. The curved portion 34 is connected to the curved portion 32 with an elongated portion 42 that runs along the face or cheek of the user. The curved portion 34 has a curvature that is less than the curvature of the curved portion 32, meaning in this embodiment, the radius of the curved portion 32 is greater than the radius of the second curved portion 34. In one suitable embodiment, the curvature of the curved portion 34 has an inner radius of about .25 inches. It should be understood that the curvatures may be other than semi-circular, such as quarter circular, and may for example be curvilinear, or polygonal (i.e., formed from a plurality of discrete linear segments).
The term "curvature" refers to the tube having a first portion defining a first vector and a second portion defining a second vector, wherein the vectors are co-planar but not the same (meaning they may have different angles or orientations (e.g., parallel but directed in opposite directions)). It should be understood that a curved portion may have multiple curvatures, for example having a curvature in one plane and another curvature in another plane. For example, the curved portion 34, or lip bend, has a plurality of curvatures, including a first curvature in a plane, and a second curvature of a portion thereof as the curved portion 34 transitions to an outlet portion 36 having a curvature in a plane substantially perpendicular to the plane. It should be understood that the curvatures may be formed in multiple planes not perpendicular or parallel to each other. The curved portions 32, 34 open in opposite first and second directions 50, 52.

[0052] The outlet portion 42 extends from the curved portion 32 and terminates in an end portion 38 having a gas exit port 54. The outlet portion 42 has a curvature defined by first and second vectors 44, 46 forming angles (3 of 30 relative to the plane 26. In one embodiment, the length (L1) of the outlet portion is about 1.6 inches ( .2 inches), or 1.760 inches ( .2 inches) from the inner surface of the curved portion 32 to the terminal end of the end portion 38, with the end portion extending below the first plane. The end portion 38 may also be formed as a curved portion.

[0053] The outlet portion 36, as shown in FIGS. 10, is curved such that it extends into the user's mouth 30 and is disposed between the side of a row of upper teeth 114 of the user (preferably above the gum line) and the interior surface of the user's cheek. Of course, it should be understood that the configuration and shape can be altered to accommodate placement in a similar location along the side of the lower teeth or even along the occlusal plane. The end portion 38, or curved portion, may be directed laterally inwardly at a targeted region of the rear of the user's mouth 30 and throat. The end portion is configured with the gas exit port 54. In this way, no portion of the tube is disposed between the user's upper and lower teeth, or between the user's tongue and palate (roof of the mouth).
As such, the tube does not interfere with normal speech, eating, drinking swallowing, etc., e.g., enabling the tongue to elevate and move a bolus rearwardly as it contacts the palate, and the tube does not have to be held in place over or between the user's teeth. In one embodiment, each of the inlet portions, ear loop, lip bend and outlet portion may be integrally formed from a single piece of tubing.
[0064] In operation, the user or care giver disposes a portion of the mouthpiece, e.g., the flexible tube, and in particular the outlet portions 38, 408, 410, between an outer side surface of a row of teeth 114, 116 (upper or lower) and an inner surface of a cheek. In one embodiment, tubes are disposed on opposite sides of the mouth. The tubes are positioned such that the exit ports 54 are positioned in a rear region of the mouth and wherein no portion of the flexible tube is disposed between the upper and lower teeth of the user such that the upper and lower teeth can be closed against each other, or between the tongue and palate of the user, such that the tongue is free to touch the palate. The ear loops 32 are disposed around the ears 100 of the user, with the mouth/lip bend being positioned around/over the lip 102 and the outlet portion of the tube being positioned along the side of the teeth as just described. The position of the connector 20 can then be adjusted to further secure the cannula to the user. It should be understood that the disclosed mouthpiece is exemplary, and that other mouthpieces may also work with the air pulse delivery device.
[0055] In any of the embodiments, the mouthpiece feed tube 16 is connected to the outlet port of the housing 122. To ensure that the correctly sized tubing is utilized with the miniature compressor, the connection between the mouthpiece and housing may be customized so as to allow for mating of a particular configuration. Alternatively, a radio frequency identification, or RFID tag, can be employed to ensure a proper combination of mouthpiece and portable pulsed air supply device, with the system only being actuatable with the proper RFID. The system may alternatively incorporate a memory chip and direct electrical connection.
[0056] Once the device is properly configured, and the mouthpiece 2 installed, the power button 148 is pushed, which moves the power switch 182 to an ON
position, with a green LED light being illuminated and the controller 170 receiving an input. The LED light may be disposed in the button 148, or at another location on the housing. After about I second, the automated sequence of air-pulsing is commenced, with pulsating air delivered to the rear of the subject's mouth through the mouthpiece port 54. No adjustments are required by the person being treated or the caregiver to control the frequency, duration or pressure of the pulsations. The air pulses will continue for 2-3 seconds (or some other desired time period) before the compressor 160 stops. After a second predetermined time period, e.g., 17 or 20 seconds or some other desired and controlled time period, the compressor recommences the air pulses for another predetermined time period, e.g., 2-3 seconds. This predetermined X:Y sequence, e.g., 2-3 seconds ON and or 20 seconds OFF, continues for a predetermined time period, e.g., 20 minutes, unless manually switched off before then. Further use of the device requires.the unit to be switched off and then switched on again. Alternatively, the device is configured to automatically switch off, with the LED light no longer displaying power indicia. Using a pair of two 9 V batteries as the power source 180, the device is capable of providing twelve 20 minute treatments, or about 4 hours of operation. The device is configured such that a red LED light 271 will illuminate when the batteries require replacement or recharging.
[0057] In another embodiment, the delivery device 120 is connected to an external applicator of pulses. In particular, a cup of about 18 mm inside diameter and 4 mm depth is held by hand or with a strap against the neck 190 of the user.
The cup is shaped and configured to prevent the cup from being filled by the skin of the user. The device is then operated to provide air pulses to the outer skin of the neck, so as to evoke swallowing in the same manner as that achieved by more complex electro-mechanical systems.
[0058] Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes may he made in form and detail without departing from the spirit and scope of the invention. As such, it is intended that the foregoing detailed description be regarded as illustrative rather than limiting and that it is the appended claims, including all equivalents thereof, which are intended to define the scope of the invention.

Claims (25)

1. A portable air pulse delivery device comprising:
a housing;
an air compressor comprising a motor disposed in said housing, said motor operable at speeds between 1200 and 4800 rpm, said air compressor comprising an air inlet and an air outlet;
an untethered power source disposed in said housing and operably connected to said motor;
an intake filter disposed in said housing, said intake filter in fluid communication with said air inlet of said air compressor;
an outlet port coupled to said air outlet of said air compressor and communicating with an exterior of said housing; and a mouthpiece comprising an inlet coupled to said outlet port and an outlet comprising a gas exit port, wherein said air compressor is operative to produce an average gas flow rate of between about 2-3 L/min at said gas exit port at a pulsation frequency of between about 20 Hz to 80 Hz.

2. The portable air pulse delivery device of claim 1 wherein said mouthpiece is releasably coupled to said outlet port.

3. The portable air pulse delivery device of claim 1 further comprising a hands free support coupled to said housing.

4. The portable air pulse delivery device of claim 1 wherein said housing has a volume of less than about 1000 cm3.

5. The portable air pulse delivery device of claim 1 wherein said housing has a volume of less than about 600 cm3.

6. The portable air pulse delivery device of claim 1 wherein said housing has a volume of less than about 200 cm3.

7. The portable air pulse delivery device of claim 1 further comprising controller operably coupled to said motor so as to cycle said motor on and off in a predetermined sequence of time periods.

8. The portable air pulse delivery device of claim 1 wherein said untethered power source comprises at least one 9V battery.

9. The portable air pulse delivery device of claim 1 wherein said filter comprises a scented element.

10. The portable air pulse delivery device of claim 3, wherein said hands free support is a lanyard.

11. The portable air pulse delivery device of claim 3, wherein said hands free support is a hook and loop strap.

12. The portable air pulse delivery device of claim 1 further comprising an output delivering a signal when said air compressor is operative.

13. A portable air pulse delivery device comprising:
a housing;
an air compressor comprising a motor disposed in said housing, said motor operable at speeds between 1200 and 4800 rpm, said air compressor comprising an air inlet and an air outlet;
a power source disposed in said housing and operably connected to said motor;

an intake filter disposed in said housing, said intake filter in fluid communication with said air inlet of said air compressor;
an outlet port coupled to said air outlet of said air compressor and communicating with an exterior of said housing;
a mouthpiece comprising an inlet coupled to said outlet port and an outlet comprising a gas exit port, and a controller that controls said compressor to produce a gas flow at said gas exit port at a predetermined frequency, duration and pressure.

14. The portable air pulse delivery device of claim 1, wherein said frequency, duration and pressure of said gas flow at said gas exit port minimizes interference with the breathing cycle while providing a stimulus to evoke a sensorimotor behavior.

15. A method for delivering air pulses to a mouth of a user comprising:
providing an untethered portable air pulse delivery device comprising a housing and a mouthpiece connected to said housing, said mouthpiece having a gas exit port;
inserting said mouthpiece into the mouth of the user wherein said gas exit port is disposed in the mouth of the user;
actuating a power switch on said housing;
automatically turning a compressor motor located in said housing on and off for a predetermined sequence of predetermined time periods and actuating a pump with said compressor motor;
operating said motor at a speed of between 1200 and 4800 rpm when turned on; and producing an average gas flow rate of air with said pump between about 2-3 L/min at said gas exit port at a pulsation frequency of between about 20 Hz to 80 Hz when said motor is turned on.

16. The method of claim 15 wherein said compressor motor is automatically turned off a final time after said predetermined sequence without intervention by the user.

17. The method of claim 16 further comprising coupling said device to the user such that said device is retained by the user hands-free.

18. The method of claim 17 wherein said coupling said device to the user comprises disposing said housing in a pocket of an article of clothing.

19. The method of claim 18 wherein said coupling said device to the user comprises disposing a lanyard connected to said housing about a neck of the user.

20. The method of claim 15 wherein said producing said average gas flow rate of air comprises producing air pulses at said gas exit port at a pressure less than 2.25 mmHg.

21. The method of claim 15 further comprising filtering air entering said pump driven by said compressor motor.

22. The method of claim 21 wherein said filtering said air comprises adding a scent to said air with a scent element.

23. The method of claim 15 further comprising releasably connecting said mouthpiece to said housing.

24. The method of claim 15 further comprising powering said compressor motor with an untethered power source disposed in said housing.

25. The method of claim 15 further comprising delivering an output signal while operating said motor.