JP5891180B2 - Portable high frequency air pulse feeder - Google Patents

Description

(Related application)
This application claims priority from US patent application Ser. No. 61 / 310,590, filed Mar. 4, 2010. The entire disclosure of the US patent application is hereby incorporated herein by reference.

  This application relates generally to an air pulse delivery device for managing stimuli to a human or animal to elicit and / or assist a desired physiological response, and in particular, to deliver a substance to a human or animal to swallow or otherwise The present invention relates to a portable air pulse delivery device that is coupled to a mouthpiece to initiate, evoke and / or facilitate sensorimotor phenomena and methods of use thereof.

  A dysphagia is a state of difficulty in swallowing, characterized by the failure of normal delivery of saliva, beverages and food from the mouth to the stomach. Dysphagia is caused by a disease or injury to the nerve structures that cause swallowing and / or airway gastrointestinal structures. Dysphagia is in response to stroke patients, patients with other acute neurological abnormalities, Parkinson's disease or other neurodegenerative diseases, cerebral palsy or chronic obstructive pulmonary disease (COPD), and / or various cancer treatments Often present, this disorder makes patients difficult to swallow and / or suffers from swallowing. Similarly, other patients may present with various dysphagia, speech problems, saliva and / or oral sensory disturbances. Dysphagia exacerbates health problems due to concomitant complications, most commonly saliva or food entering the lungs, dehydration, and pneumonia due to secondary aspiration for malnutrition. Thus, some deaths attributed to seizures are actually caused by the resulting complications of dysphagia and pneumonia. These complications also lead to long-term hospitalization, emergency room visits, readmissions, long-term institutional care, and costly respiratory and nutritional support.

  In response, various techniques and treatment methods have been developed to induce or stimulate swallowing, which can confer 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 in the mouth and / or throat. However, such instruments are unable to form pulse trains at the desired frequency, operate at relatively high pressures, often require various inputs regarding pressure, duration, and frequency and / or are not portable. . Other devices apply electrical stimulation to the neck covering the laryngeal muscles.

  The invention is defined by the claims, and nothing in this section should be taken as a limitation on the claims.

  In a first aspect, one embodiment of a portable air pulse delivery device includes a housing and an air compressor including a motor provided in the housing. The motor can operate at a rotational speed of 1200 to 4800 rpm. The air compressor includes an air inlet and an air outlet. A cableless power source (a power source not connected by a wire) is disposed in the housing, and the power source is operatively connected to the motor. A suction filter is provided in the housing and is in fluid communication with the air inlet of the air compressor. An outlet port is connected to the air outlet of the air compressor, and the outlet port communicates with the outside of the housing. The mouthpiece has an inlet coupled to the outlet port and an outlet having a gas outlet port. The air compressor operates to produce an average gas flow rate of about 2-3 liters / minute at a pulsation frequency of about 20 Hz to 80 Hz at the gas outlet port.

  In another aspect, a method of delivering an air pulse into a user's mouth provides a cableless portable air pulse delivery device that includes a housing and a mouthpiece coupled to the housing. And inserting the mouthpiece into a user's mouth. The method further includes turning on a power switch on the housing to automatically switch the compressor motor disposed in the housing on and off at a predetermined time-case at predetermined time intervals. The compressor motor operates at a rotational speed of 1200-4800 rpm when switched on and produces an average gas flow rate of about 2-3 liters / minute of air at the gas outlet port at a pulsation frequency of about 20 Hz to 80 Hz. .

  The various features and embodiments provide significant advantages over previously known devices. In particular, the delivery device can generate a train of pulses at a frequency of 20-80 Hz that falls within the optimal muscle stimulation range for inducing swallowing. At the same time, the device provides a low-pressure air pulse, which can be associated with various risks associated with electrical stimulation and / or potential risks and damage associated with high-pressure systems, for example, in a patient with an implanted pacemaker. Avoid. The device has also been optimized in one embodiment to require no input from the user. Rather, the user simply turns on the instrument with a predetermined sequence of air pulse trains administered at a predetermined frequency, duration, and pressure. The system is then automatically turned off without any input from the user. In this way, the instrument does not allow for unauthorized use or misuse, and does not require excessive training or knowledge of alternative inputs for duration, pressure, or frequency. Accordingly, the device is particularly suitable for use outside of a patient care facility including, for example, use in a home, office, or everyday environment.

  The device is also designed to be truly portable so that the various embodiments can fit within a user's pocket, such as a shirt, and / or be secured to the user's neck by a strap or, for example, a clip on the strap Or it may be secured to the garment by hook and loop (eg, Velcro) fasteners or to other securing members such as rails or hooks. The small size and the cable-free power supply allow the user to receive treatment in a hands-free state, not in a state where the user is connected to the electric wire when walking around in daily life operation.

  The above clause is provided as a general introduction and is not intended to limit the scope of the claims. Various preferred embodiments, along with further advantages, will be better understood by reference to the following detailed description taken in conjunction with the drawings.

FIG. 1 is a front perspective view of one embodiment of a portable air pulse delivery device.

FIG. 2 is a rear perspective view of the portable air pulse delivery device shown in FIG.

FIG. 3 is a rear perspective view of the portable air pulse delivery device shown in FIG. 1 with the battery cover removed.

4 is a front view of the portable air pulse delivery device shown in FIG.

FIG. 5 is an enlarged partial view of the power switch along line 5 of FIG.

FIG. 6 is an enlarged partial internal view of the filter housing shown in FIG.

FIG. 7 is a logic circuit diagram of the circuitry used to control and provide power to the compressor motor used in the embodiment of FIG.

FIG. 8 is a plan view of an embodiment of the mouthpiece.

FIG. 9 is a front view of the mouthpiece of FIG. 8 applied to a user.

FIG. 10 is a partial perspective view of one embodiment of a mouthpiece positioned in a user's mouth.

FIG. 11 is a front perspective view of another embodiment of a portable air pulse delivery device.

12 is a rear perspective view of the portable air pulse delivery device shown in FIG.

FIG. 13 is a perspective view of the support structure.

14 is a front internal view of the portable air pulse delivery device shown in FIG. 11 with the front cover removed.

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

FIG. 16 is a logic circuit diagram for the circuit used to control and provide power to the compressor motor of the embodiment shown in FIG.

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

  The terms “top”, “bottom”, “upper”, and “lower” are intended to refer to the orientation of the instrument when viewed in the user's field of view. As used herein, the term “transverse direction” means, for example, that it is arranged, directed, or extended from side to side, and from one side of the user's mouth. There is no limit to one side. It should be understood that the term “plurality” as used herein means two or more. As used herein, the term “longitudinal” has a length or longitudinal meaning or meaning. The term “coupled” means that it is coupled or engaged regardless of whether it is direct or indirect, for example by an intervening member, Although it may be a permanent attachment, it need not be fixed, i.e. a permanent attachment, and includes both mechanical coupling and electrical connection. As used herein, the term “substance” includes, but is not limited to, a fluid such as a gas, a liquid, or a combination thereof (including but not limited to an aerosolized liquid), and It should be understood that it includes / but is not limited to a powder comprising particles entrained in a fluid, or a combination thereof.

  The methods and apparatus disclosed herein are provided for delivering or applying a train of air pulses into a user's mouth or neck, whether human or animal, and (1) subject Initiating, stimulating, or assisting in swallowing, speech, salivation, or sensory-motor phenomena of the oral cavity or oropharynx, (2) increasing the lubricity of the subject's oral cavity, oropharynx, and pharynx (3) reducing the subject's oral cavity or oropharynx or pharyngeal discomfort; (4) lip, mouth, cheek area, tongue, jaw, soft palate, which can result in muscle strengthening through repeated use of oral appliances; Contraction of muscle strength in the pharynx and larynx, (5) lip, mouth, cheek area, tongue, jaw, soft palate, pharynx, larynx, including oral passage movement before swallowing and laryngeal lift including chewing movement before swallowing And / or (6) somatosensory, warm Sensation, or the sensation including taste, be formed into oral or oropharynx is an object.

  One embodiment of the portable air pulse delivery device provides a means for delivering individual air-pulse trains or successive aerosol pulse trains into the human palate, oropharynx, or pharynx. Here, a column is defined as a series of at least one pulse. Individual air-pulse trains may vary in parameters such as pulse duration, pulse amplitude, pulse frequency, and train duration. In one embodiment, the air-pulse trains are provided individually and generally in a predetermined order.

  1-7, 11-15, and 17, portable air pulse delivery devices 120, 220, 420 are shown. As used herein, the term “portable” means that it can operate without a cabled power supply and that it can be carried by hand without a carrier such as a wheeled carrier. . The term “hands free” refers to a device that can be coupled or secured to the user's body or to an adjacent support structure so that the device does not need to be held or held by the user.

1-4, 11-15, and 17, the delivery device includes housings 122, 222, 422, which in some embodiments are front and rear housing components 124. , 126, 224, 226, 424, 426, these components can be formed by, for example, snap fittings, fasteners, adhesives, tabs, and similar mounting components, alone or in combination. Are connected to each other. The housing includes a front surface 128, a rear surface 130, a top surface 132, a bottom surface 134, and opposing side walls 136. Of course, the housing can be formed in other shapes and forms and is not limited to the rectangular parallelepiped shape disclosed herein. The housing is made of a durable material with moderate impact resistance, such as ABS. The housing is relatively small so that it can be placed, for example, in a user's shirt or pant pocket 140 or otherwise hands-free, for example by a strap 142 or clip, as shown in FIG. Supported by or on the user. The total volume of the housing, in various embodiments, less than about 1,000 cm ^3, less than about 600 cm ^3, or is less than about 200 cm ^3. For example, in one embodiment shown in FIGS. 1-4, the housing has dimensions of 146 mm × 75 mm × 46 mm, ie a volume of about 500 cm ³ . In another embodiment, the housing is dimensioned for 100 mm × 35 mm × 55 mm, i.e. a volume of about 193 cm ^3. In the embodiment shown in FIGS. 11-15, the housing has dimensions of 135 mm × 81 mm × 46 mm and a volume of about 503 cm ³ . In another embodiment, the housing measures 141 mm × 80 mm × 46 mm and weighs about 350 g. Due to the compactness of the instrument, the overall mass of the instrument, including the housing and the compressor 160, controllers 170, 270, and batteries 180, 280 provided in the housing, is less than about 600 g, and in one embodiment as much as 300 g. It becomes light.

In one embodiment shown in FIG. 17, by incorporating a brushless motor and eliminating the battery, the housing is 70 mm × 70 mm × 45 mm or about 221 cm ³ in volume and weighs about 215 g. . Alternatively, if a brushed motor is used that can reduce the cost of the instrument, the dimensions of the housing are 90 mm × 90 mm × 47 mm and weigh about 285 g.

  As shown in FIGS. 1, 12, and 17, the air suction ports 144, 244, 444 are each disposed on one of the housing side wall 136 or the rear cover 226. An air filter 146 is disposed in the housing adjacent to the suction port so that air entering the suction port passes through the air filter. The air filter is preferably capable of removing airborne particles larger than 50 μm. In one embodiment, the filter is formed as a removable module 145 as shown in FIG. 6, in which case the module is housed in a socket forming a filter housing. ing. If the air pulse delivery device is used daily under normal operating conditions, the air filter guarantees annual replacement. The air filter medium is preferably made of a material that meets the requirements of USP Class VI, such as, but not limited to, Separ Medifab® monofilament polyamide, 6-6 nylon. is there. The filter may incorporate a fragrance that adds scent to the air drawn through the filter. Regarding the incorporation of flavor (fragrance) in the air filter, a low melting point material is preferred in order to minimize the deterioration of the fragrance, and examples of such a material include low density polyethylene. Beneficial fragrances include lemon and mint scents. Various long-lasting (more than 100 hours) food grade (USP Class VI) aroma impregnated polymers (eg, PolyFlav® material available from Schulman, Inc.) can be formed as a perforated plug member. In other embodiments, a fragrance coating is applied on the filter mesh, which can produce the desired scent over a relatively short period of time.

  1-5 and 11-15, a power button 148 and an air outlet port 150 are disposed on the top surface of the housing. Of course, it should be understood that the air inlet port 144, the air outlet port 150, and the power button 148 can be located anywhere on the housing as deemed most appropriate. The housing also includes a loop or hole 152 into which the strap 142 can be coupled. By hanging the hanging strap 142 around the user's neck, the device can be used in a hands-free manner. The device can also create a clip that can be removably engaged with other structural elements of the garment, such as the user's belt or pocket, rim, and the like. Similarly, a hook and loop or velcro fastener, for example on a strap, is attached to the retainer attachment 152, and then the velcro fastener strap is used on the user (eg, belt) or bed rail, chair arm, or The device can be supported hands-free on other common rails, hooks, or nearby support structures.

  2 and 3, a removable panel 154 is removably attached to the rear surface of the housing to form a portion of the rear surface of the housing. For example, the elastic tab 155 is releasably engaged with the housing. A power supply 180 is disposed in the space behind the panel. In one embodiment, the power source is composed of a pair of 9V batteries. When installed, the battery engages with a corresponding pair of battery contacts 182. It should be understood that a single battery may be sufficient, and the battery may be formed in various sizes, for example in the range of 12-24V, and may be disposable or rechargeable. A plurality of pads 156, such as rubber, are disposed on the rear surface of the housing including the cover 154, and an anti-slip contact surface is imparted to the housing to provide shock absorption and prevent slipping on the surface.

  Referring to the embodiment of FIGS. 11-16, a fixed rechargeable battery 280 is incorporated and connected to the battery connector 281. One suitable embodiment uses a pair of 9Vdc NiMH rechargeable batteries. In this embodiment, the removable panel providing access to the battery may be omitted. A battery charger may be used to power the device while the battery is being recharged, in which case the charger is a DC as shown in FIGS. Connected to input 283. The battery may be removed or held on site for recharging. Alternatively, the hermetically sealed compressor device and its control circuit are sealed in a relatively small case (without battery) as shown in FIG. 17, which instead is a motor and control. Power is supplied by a 115Vac power transformer that provides the requisite dc voltage to drive the circuit. As shown in FIG. 17, the power button 148 and the switch 482 located below it are located on the top of the instrument. Referring to FIGS. 11-16, the output jack 281 provides a 1 Vdc signal, which is used to synchronize the air pulsation period with the complementary recordings from the swallowing transducer, throat pad microphone and respiration transducer. used. Referring to FIGS. 13 and 14, a bracket structure 290 is disposed within and secured to the housing, such as by a plurality of attachment members. The bracket structure 290 includes a plate structure 300 that holds the battery 280 in place and includes mounting components 304 that are formed as a pair of securing protrusions 306 for the printed circuit board 270. The mounting component 304 is provided with a series of holes 292, 294, 296, 298 for a power button 148, a battery output indicator 271 formed as an LED light, a signal output 281 and a mouthpiece connector 150. It has. The battery output indicator 271 provides an indication when the output of the rechargeable battery 270 is low. As shown in FIG. 11, the mounting component 304 is housed in the hole on the same surface as the hole formed by the ends of the front cover and the rear cover.

  4 and 14-15, the compressor 140 includes a motor 162 and a pump 164, which are disposed within the housing. The compressor includes an air inlet 166 to the pump. The air inlet 166 is in fluid communication with, for example, a conduit 168 (not shown in FIGS. 14 and 15) via a suction filter. The compressor further includes an air outlet 172 that is connected to and in fluid communication with the outlet port 150, for example, via a conduit 174 (not shown in FIGS. 14 and 15). Yes. Inner conduits 168, 174 are of USP Class VI (ISO 10993-1) and are made of, for example, but not limited to, silicone rubber, PVC, or polyurethane. In one embodiment, these materials do not include a DEHP plasticizer. The compressor 160 is configured to supply a time-controlled low-pressure air pulse at a frequency in the range of 20 to 80 Hz. For example, the motor 162 can be operated to rotate at a rotational speed of about 1,200-4,800 rpm, thereby corresponding to the desired frequency without the need for a gearing. For example, in one embodiment, the motor is actuated by the controller at a rotational speed of about 2,400 rpm when switched on.

  Pump 164 is coupled to motor 162. One suitable pump is a diaphragm pump, which is constituted by a diaphragm piston and has a suitable displacement of about 1 milliliter. One exemplary pump is Hargraves Technology Corp., located in Mooresville, North Carolina. Hargraves BTC diaphragm pump available from In such a pump, air is pumped without contacting any moving parts of the pump. The parts of the pump in contact with air can be made by Vectra (liquid crystal polymer), while the diaphragm can be made by EPDM (ethylene propylene diene monomer). The pump may also be made as an electromagnetically driven pump. The portion of the pump that is in contact with the breathed air is biocompatible and does not introduce unintentional scent into the air circulating through it.

  The mouthpiece 2 is sized and structured to provide an air flow rate of about 2-3 liters / minute (measured at standard temperature and pressure (STP)). For example, when operating at 2,400 rpm (40 Hz pulsation), a pump 164 having a displacement of about 1 milliliter has an average of 2.5 liters per minute in a mouthpiece tube having an inner diameter of 1.5 mm and a length of 1 m. A flow rate of minutes can be provided. In such a device, the air leaving the mouthpiece has kinetic energy at atmospheric pressure. Test that the pressure generated by the motion finally obtained at the surface 1-8 mm from the mouthpiece outlet port at a flow rate of 2.5 liters / min is in the range of 1.5-2 mmHg. Indicated by. In various preferred embodiments, the pressure is less than about 2.25 mmHg.

  Referring to FIGS. 4, 5, 7, 15, 16, and 17, controllers 170, 270, and 470 are disposed in the housing and connected to a power source 180 and a power switch 182. In one embodiment, the controller is formed as a control circuit incorporated on a circuit board. Referring to FIGS. 7 and 16, the control circuit is arranged and configured to circulate the compressor motor 162 and pump 164 between on and off in a predetermined time interval sequence. It should be appreciated that other arrangements of hardware and software are also appropriate. For example, the controller includes a processor that operates software. The instrument is structured to be able to change the motor speed, the duration of the on / off period, and the overall duration of operation.

  The burst of pulsating air pulses preferably does not substantially interfere with the normal breathing cycle. For example, a normal adult breathes 15 times per minute, and the inspiration is 3 seconds. Accordingly, in one embodiment, the controllers 170, 270 apply a voltage to the motor 162 such that it is on for X seconds and off for Y seconds (X: Y). In one embodiment for rehabilitation of a dysphagic patient, a predetermined X: Y sequence is repeated for a predetermined time, eg, 20 minutes, where the treatment is repeated, eg, 3 times daily.

  The train of air pulses is fed into the pharynx through the mouthpiece 2, which also includes an input end that is removably coupled to the outlet port by a quick lock connector 18 (eg, (See FIGS. 8 and 9). In one embodiment shown in FIG. 10, the mouthpiece portion 38 is placed in the oral vestibule between the teeth and cheeks. In this embodiment, there is no mouthpiece material between the upper and lower teeth so that the patient can keep their upper teeth 114 and lower teeth 116 occluded. . This is preferred because it indicates that the upper and lower teeth are positioned along the occlusal surface during pharyngeal swallowing. The mouthpiece apparently has a relatively small effect on the subject's resting mouth, tongue, oropharynx, and face positions. For example, a tongue in a resting position does not contact the mouthpiece. Since the mouthpiece is thin, the subject can close the lips together. The mouthpiece does not come into contact with saliva accumulated in the sublingual area or along the lingual side of the tooth. Since the mouthpiece is positioned in the upper cheek or lower cheek region, it is essentially possible for the patient to receive and chew and drink while the mouthpiece is in place.

  In one embodiment shown in FIGS. 8 and 9, the mouthpiece 2 is made as an oral cannula. The oral cannula includes a pair of flexible tubes 4 and 6, and these flexible tubes are arranged on both sides of the user's face. Of course, it should also be appreciated that the oral cannula may include a single tube located on one side of the user's face. The oral cannula may also be constituted by two tubes, but in some desired treatments, gas is pumped through only one of the tubes. The flexible tubes 4, 6 may be made by thermoformed tubes, which are molded into a special shape and structure, but with some flexibility and to fit the user's face and mouth. It has a function. In one suitable embodiment, the flexible tube is made of polyurethane, polyethylene, PVC, other suitable biocompatible materials, and / or combinations thereof. The tube has an outer diameter of 1/8 inch (3.18 millimeters) and an inner diameter of 1/16 inch (1.59 millimeters) forming a lumen. Of course, other sizes of tubes are also suitable, and the cross-sectional shape may be circular or other geometric shapes. The tube can be transparent or clear, translucent, colored or opaque, and / or combinations thereof, in which case, for example, one or more With different optical characteristics along the length of the tube to provide a window. Each tube also includes a plurality of lumens or grooves that allow additional features such as, but not limited to, aerosolized liquid delivery, such as light, sensor, fluid delivery, etc. May also be formed. In such embodiments, the lumens include a first inner lumen and a second outer lumen formed about the inner lumen, such as, but not limited to, extending parallel to each other. Alternatively, two or more lumens extending in parallel may be provided. Of course, the plurality of lumens include two or more lumens.

  In one embodiment, the wire may extend along the length of at least a portion of the flexible tubes 4, 6. The wire imparts shape memory to the flexible tube. The wire may be coextruded with the tube, or may be coupled to the tube by molding, welding, bonding, etc., or a combination thereof. The tube may also be shaped by overmolding another polymer, or may be shaped by a plurality of curved sections formed that are attached sequentially to a straight portion of the tube.

  Referring to FIGS. 8 and 9, the flexible tubes 4, 6 are fragrances that include, but are not limited to, a fruit (eg lemon) or menthol or mint scent that is pleasant to the user and assists in swallowing. Made by the agent, impregnated with the fragrance or coated. The tube may also be made of, impregnated with, or coated with an antistatic material or alternatively a conductive material. The antistatic material has a surface resistance of about 10E10 ohm / square to about 10E12 ohm / square. The static dissipative material has a surface resistance of about 10E6 ohm / square to about 10E12 ohm / square. The conductive material has a surface resistance of about 10E1 ohm / square to about 10E6 ohm / square. The metal typically has a surface resistance of about 10E1 ohm / square to about 10E5 ohm / square. The surface resistance described here is measured according to ASTM test D257. The tube may also be made of or coated with an antimicrobial material. For example, antibacterial properties are imparted by impregnating silver.

  Each of the flexible tubes 4 and 6 includes an inlet portion 10, which is preferably elongated and extends from the user's neck to the ear. The inlet portion includes an inlet end 12 that is connected to an adapter (eg, a Y-type adapter) 14 that includes a feed tube 16 that is connected to the opposite end thereof. In one embodiment, a slidable connector 20 formed as a sleeve is disposed on the outer periphery of the inlet portion 10 of the tube and houses the inlet portion in a slidable form. The connector 20 moves back and forth along a portion of the length of the inlet portion 10 of the tube to extend the end 12 to secure the tube under the user's chin or shorten the end 12. The tube can be loosened for goodness or removal.

  As explained above, the feed tube 16 is structured to be connected to an outlet port, which outlet port includes a releasable part such as, but not limited to, a detent. Air is supplied through 18. U.S. Patent Application Publication No. 2006/0282010 A1 entitled Oral Device and Swallowing Air Pulse Therapeutic Medicine and Methods for the Use Therapeutic Therapeutic Therapeutic Therapeutic Treatment Various exemplary mouthpieces and control devices are shown and disclosed in U.S. patent application Ser. No. 12 / 424,191, entitled, and its method of use. These publications are hereby incorporated by reference in their entirety by reference thereto.

  Referring to FIGS. 8 and 9, the pair of tubes 4 and 6 are mirror images of each other, that is, one can be folded over the region along the longitudinal axis 24. While the various portions of the tube are formed or positioned in a plane, in use, the tubes 4, 6 will conform to the user's face 28 and are themselves on the face and in the mouth 30. This means that the user and / or caregiver does not need to hold or position the tube with his hand, lips, tongue, teeth, and / or other appliances.

  Each of the tubes 4, 6 includes a curved portion 32 that forms an ear loop coupled to the inlet portion 10. In one embodiment, the ear loop 32 is protected or covered by a pad material 40, such as a foam material, which provides greater comfort to the user. Of course, other portions of the tube, such as the portion 42 extending along the user's face, may also be covered or secured with an intervening material such as a pad to improve comfort.

  Another curved portion 34 forms a lip curved portion. The curved portion 34 is coupled to the curved portion 32 by an elongated portion 42 extending along the user's face or cheek. The curved portion 34 is smaller than the curvature of the curved portion 32, which means that in this embodiment the radius of the curved portion 32 is larger than the radius of the second curved portion 34. In one suitable embodiment, the curvature of the curved portion 34 is about 0.25 inches (6.35 millimeters). The curved portion may be other than a semicircle, such as a quadrant, for example, it may be curved or polygonal (ie formed by a plurality of separate straight line segments) You should understand. The term “curvature” is a tube having a first part defining a first vector and a second part defining a second vector, the vectors being coplanar. Refers to tubes that are inside but not the same (these are at different angles or orientations (eg, parallel but oriented in the opposite direction)). It should be appreciated that the curved portion has multiple curves, for example, having one curve in one plane and another curve in another plane. For example, the curved portion 34 or lip curved portion has a first curvature in one plane and the outlet portion 36 has a curvature in a plane substantially perpendicular to said plane. A plurality of curves having a second curve in a part thereof when moving to. It should be understood that these curves can be formed in multiple planes that are neither perpendicular nor parallel to one another. The curved portions 32 and 34 open in first and second directions 50 and 52 which are opposite to each other.

  The outlet portion 42 terminates at an end 38 that extends from the curved portion 32 and includes a gas outlet portion 54. Outlet portion 42 has a curvature defined by first and second vectors 44, 46 that form an angle β of 30 ° with respect to surface 26. In one embodiment, the length of the outlet portion (L1) is about 1.6 inches (± 0.2 inches) (40.64 millimeters (± 5) from the curved portion 32 to the end of the end 38. 0.08 millimeters)) or 1.760 inches (± 0.2 inches) (44.7 millimeters (± 5.08 millimeters)), with the end extending below the first surface. Yes. The end 38 may also be formed as a curved portion.

  The exit portion 36 shown in FIG. 10 extends into the user's mouth 30 and is located between the side of the user's upper tooth row (preferably above the gingival line) and the inner surface of the user's cheek. So that it is curved. Of course, it should be understood that the structure and shape can be varied to accommodate placement at similar locations along the side or occlusal surface of the lower tooth. The end 38 or bend is oriented transversely inward in the targeted area behind the user's mouth 30 and throat. A gas outlet port 54 is formed at the end. In this way, no part of the tube is placed between the user's upper and lower teeth or between the user's tongue and palate (mouth lid part). Therefore, the tube does not interfere with normal conversation, eating, drinking, swallowing, etc., for example, when the bolus touches the palate, the tongue is lifted and the bolus can be moved backward, and The tube need not be held in place on or between the user's teeth. In one embodiment, the inlet portion, the ear loop, the lip bend, and the outlet portion are each integrally formed by a single piece of tubing.

  In operation, the user or caregiver can attach a portion of the mouthpiece, such as the flexible tube and in particular the exit ports 38, 408, 410, to the outer side of the (upper or lower) dentition 114, 116 and the inner side of the cheek. Place between. In one embodiment, these tubes are placed on both sides of the mouth. These tubes have an exit port 54 positioned in the posterior area of the mouth, in which case no part of the flexible tube is placed between the user's upper and lower teeth, so that The upper and lower teeth can be relatively closed, or no part of the flexible tube is placed between the user's tongue and the palate, so that the tongue is free to the palate Can touch. The ear loop 32 is placed around the user's ear 100 and in this state the mouth / lip curvature is positioned around / above the lip 102 and the outlet portion of the tube is along the side of the tooth as described above. Is positioned. The position of the connector 20 can then be adjusted to further secure the cannula to the user. It should be understood that the mouthpiece disclosed herein is exemplary and that other mouthpieces can also be used with the air pulse delivery device.

  In any of these embodiments, the mouthpiece delivery tube 16 is coupled to the outlet port of the housing 122. In order for the correct size tube to be used with a small compressor, the coupling between the mouthpiece and the housing can be customized to allow special structural engagement. Alternatively, radio frequency identification or RFID tags can be used to ensure the proper combination of mouthpiece and portable air pulse delivery device, and in this state the device can only be activated by proper RFID. Can be able to. The device may alternatively incorporate a memory chip and direct electrical connection.

  When the device is properly made and the mouthpiece 2 is loaded, when the power button 148 is pressed, the power switch 182 moves to the ON position, the green LED light is lit, and the controller 170 receives the input signal. . The LED light is provided in the button 148 or at another location on the housing. After about 1 second, an automated sequence of air-pulses is initiated and pulsating air is pumped back into the subject's mouth via port 54 of the mouthpiece. No adjustment by the person being treated or the caregiver is required to control the frequency, duration, or pressure of the pulsation. The air pulse lasts 2-3 seconds (or some other desired time) before the compressor 160 stops. After a second predetermined time (eg, 17 seconds or 20 seconds or some other desired and controlled time), the compressor resumes the air pulse for another predetermined time, eg, 2-3 seconds. This predetermined X: Y sequence, such as 2-3 seconds on and 17 seconds or 20 seconds off, continues for a predetermined time, eg, 20 minutes, unless it is manually turned off before that. To use the instrument further, the unit needs to be switched off and then switched on again. Alternatively, the instrument automatically switches off and in this state the LED light no longer displays a power indication. By using a pair of two 9V batteries as the power source 180, the instrument can provide twelve or 20 minutes of treatment for 20 minutes of treatment. The appliance is configured to turn on the LED light 271 when the battery needs to be converted or recharged.

  In another embodiment, the delivery device 120 is connected to an external pulse application device. In particular, a cup having an inner diameter of about 18 mm and a depth of 4 mm is held on the user's neck 190 by hand or strap. The cup is shaped and structured to avoid the user's skin filling the cup. The instrument is then actuated to apply an air pulse to the skin outside the neck to stimulate swallowing in the same manner as is done by more complex electro-mechanical devices.

  Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. Therefore, the above detailed description is intended to be considered illustrative rather than limiting, and it is the claims, including all equivalents, that are intended to define the scope of the invention. is there.

2 mouthpiece, 4 flexible tube,
6 flexible tube, 10 inlet part,
12 inlet end, 14 adapter,
16 Feeding tube, 18 Quick connector,
20 slidable connector, 24 longitudinal axis,
28 faces, 30 mouths,
32 curved portion, 34 second curved portion,
36 exit part, 38 mouthpiece part,
40 pad material, 42 elongated portion,
50 first direction, 52 second direction,
54 gas outlet part, 100 ears,
102 lips, teeth on 114,
116 lower teeth, 120 portable air pulse delivery device,
122 housing, 124 housing components,
126 housing components, 128 front face,
130 rear surface, 132 top surface,
134 bottom, 136 side walls,
140 pockets, 142 straps,
144 Air suction port,
145 removable filter module,
146 Air filter, 148 Power button,
150 air outlet port, 152 holes,
154 panels, 155 elastic tabs,
156 pads, 160 compressors,
162 motor, 164 pump,
166 air outlet, 168 conduit,
170 controller, 172 air outlet,
174 conduit, 180 battery,
182 battery contacts, 190 necks,
220 air pulse delivery device, 222 housing,
224 housing components,
226 Housing component, rear cover,
244 air suction port, 270 printed circuit board,
271 battery output indicator, 280 battery,
281 signal output, battery connector, 283 DC input,
290 bracket structure, 292 holes,
294 holes, 296 holes,
298 holes, 300 plate structure,
304 mounting components, 306 locking projections,
420 air pulse delivery device, 424 housing component,
426 housing component, 444 air inlet port,
470 controller, 482 switch

Claims (13)

A mouthpiece having an outlet for supplying air pulses to a user's mouth or oropharynx or pharynx to the aroused to initiate an inlet and swallowing receiving air pulse or readily portable for feeding the air pulse An air pulse feeder,
A housing;
An air compressor provided in the housing, wherein the air compressor includes a motor capable of operating at a rotational speed of 1200 to 4800 rpm, an air inlet, and an air outlet;
A cableless power supply provided in the housing and connected in an operable manner to the motor;
A suction filter provided in the housing and in fluid communication with the air inlet of the air compressor;
An outlet port coupled to the air outlet of the air compressor and communicating with the exterior of the housing, the outlet port fluidly connected to the inlet of the mouthpiece ;
With
The air compressor does not interfere with the user's normal breathing cycle at the outlet with a plurality of air pulse trains with a predetermined pulsation frequency between about 20 Hz and 80 Hz at an average gas flow rate of about 2-3 liters / minute To be provided in a predetermined time interval sequence,
A portable air pulse feeder characterized by that.   The portable air pulse delivery device of claim 1, wherein the mouthpiece is removably coupled to the outlet port.   The portable air pulse delivery device of claim 1, further comprising a hands-free support member coupled to the housing. Portable air pulse delivery device of claim 1 in which the volume of the housing is being in the range of from about 193 cm ³ ~ about 1000 cm ^3, characterized in that. The portable air pulse delivery device of claim 1, wherein the housing has a volume in the range of about 193 cm ³ to about 600 cm ³ . Portable air pulse delivery device of claim 1 in which the volume of the housing is in the range of from about 193 cm ³ ~ about 200 cm ^3, it is characterized.   The portable air pulse of claim 1, further comprising a controller operably coupled to the motor and configured to cycle the motor on and off in a predetermined time interval sequence. Feeding equipment.   The portable air pulse delivery device of claim 1, wherein the cableless power source comprises at least one 9V battery.   The portable air pulse delivery device according to claim 1, wherein the filter includes a scented member.   The portable air pulse delivery device according to claim 3, wherein the hands-free support member is a strap.   The portable air pulse delivery device according to claim 3, wherein the hands-free support member is a hook-and-loop type strap.   The portable air pulse delivery device of claim 1, further comprising an output for sending a signal when the air compressor is operating. The portable air pulse delivery device of claim 1, wherein the plurality of air pulse trains comprise an aerosolized liquid.

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