DEVICE AND METHOD FOR CLEANING NASAL CAVITIES

Abstract

A device for cleaning nasal membranes comprising a head that is inserted into a nostril. Fluid is pumped from a reservoir onto the nasal membrane. The head rotates to remove debris from the membrane. The sprayed fluid and debris is suctioned through inlets into a suction chamber.

Claims

1. A nasal membrane cleaning device for cleaning a nasal membrane comprising: (a) a body (b) a rotatable head attached to the body, the head including a plurality of fluid outlets through which fluid is expelled during use, wherein the head is formed of a deformable and resilient material; (c) a pump; (d) a fluid reservoir in communication with the pump such that, when the pump is activated, fluid contained in the fluid reservoir is expelled from the outlets located on the head for delivery onto the nasal membrane of a user; and (e) a power source for powering the rotation of the head and the pumping of fluid from the fluid reservoir to the fluid outlets such that fluid from the fluid reservoir can be sprayed from the outlets onto a user's nasal membrane while the head rotates.

2. The nasal membrane cleaning device of claim 1, further comprising a suction chamber for receiving expelled fluid and debris collected after fluid is expelled through the outlets, and a fluid inlet adjacent the head, the fluid inlet in fluid communication with the suction chamber, wherein the device is adapted such that expelled fluid and debris removed from a user's nasal membrane are suctioned into the suction chamber during use.

3. A method of using the device of claim 1 having fluid in said reservoir to clean the nasal cavity of a user, comprising the steps of: (a) introducing the head of the device into one nostril; (b) activating the pump so that the fluid is expelled from the fluid outlets while the head rotates so that it rubs against the nasal membrane, thereby cleaning the nasal membrane of debris without damaging the nasal membrane; and (c) suctioning the fluid sprayed out of the outlets and the debris removed from the nasal membrane into the suction chamber.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a perspective view of an embodiment with a cap in place.

[0026] FIG. 2 is a perspective view of an embodiment with the cap shown in see-through.

[0027] FIG. 3 is an overall schematic diagram of an embodiment of the present invention.

[0028] FIG. 3A is a blow-out view of the rotation means.

[0029] FIG. 4 is a perspective view of an embodiment of a head with a cover in relation to the rotation means.

[0030] FIG. 5 is diagram of certain actions of the invention.

[0031] FIG. 6 is a depiction of the device in use.

DETAILED DESCRIPTION OF THE INVENTION

[0032] FIGS. 1 and 2 depict a nasal membrane cleaning device according to an embodiment of the invention. The cleaning device comprises a body 1, a head 2, and a neck 3 connecting the head to the body. A removable cap 4 covers the head and/on neck when not in use.

[0033] As depicted in FIG. 3, disposed in the housing of the body 1 is a processor 10 connected to a power source 5. The body 1 is water resistant shell 40 with a neck 3 for connecting the head. The neck typically extends from a first end of the body. The power source 5 (recharger, batteries or electric cord) is located at the opposite end of the body. The shell 40 is preferably made of a durable material, such as injection molded plastic, silicone, other polymers and/or metals.

[0034] The body 1 comprises means to access the interior of the shell 40, such as but not limited to a hinged door 20, screw compartment, snap in place component and the like.

[0035] Referring to FIG. 3, The fluid dispensing system includes a fluid reservoir 80 in communication with a pump 70 powered by a motor 150. In an embodiment, the fluid reservoir 80 has a capacity of about 10 ml to about 500 ml, preferably, about 100 to about 400 ml. The fluid reservoir 80 may include a moveable floor to aid in dispensing the fluid. The fluid reservoir 80 many include more than one compartment to mix separate solutions together to provide the desired fluid. When the pump 70 is activated, fluid is pumped from the fluid reservoir 80 through a conduit network 16 and delivered to outlets 12 in the head. The circuitry within the device (not shown) is programmed such that when a sensor (not shown) within the reservoir determines that the fluid is depleted, in addition to alerting the user via a control panel 200, the device is automatically shut off. When fluid is depleted from the fluid reservoir, the reservoir may be re-filled and/or replaced.

[0036] As the fluid is sprayed from the outlets, the discharged fluid is suctioned back into the device via inlets 15 positioned near the outlets. The suction inlets 15 are arranged around the neck below the head to collect the fluid sprayed on the nasal membranes. Discharged fluid is collected by suction inlets 15 via action of a wet vacuum pump 60 powered by a motor 150 and delivered to a suction chamber 100 for containment, handling and disposal. The inlets 15 may also include screens or apertures that prevent large materials from clogging the waste collection. In operation, waste travels through the inlets 15 by virtue of the force of the vacuum pump 60 through channels 17, 17a and is then deposited within the suction chamber 100. The inlets may comprise restrictions that increase the suction produced by operation of the wet vacuum pump 60 to enhance the suction of sprayed solution. While FIG. 3 depicts two channels 17, 17a, any configuration that pumps fluid from a first container and returns fluid to a second container is applicable.

[0037] Discharged solution, which is collected by suction inlets 15 via action of a wet vacuum pump 60, is delivered to a suction chamber 100 for containment, handling and disposal. All of the waste material collected by the device is stored within the suction chamber 100. An indicator located on a control panel 200 of the device alerts a user when the suction chamber 100 is full. The circuitry within the device (not shown) is programmed such that when a sensor (not shown) within the suction chamber 100 determines that the suction chamber 100 is full, in addition to alerting the user, the device is automatically shut off.

[0038] To discard the contents of a full suction chamber 100, a user presses a button (not shown) located on the shell control panel 200. The suction chamber 100 is removed/slides out from the device and can be emptied, cleaned and replaced. In another embodiment, the suction chamber 100 is disposable and discarded, and a new suction chamber 100 is then placed in the device.

[0039] Referring to FIG. 4, in an embodiment, the head 2 is disposable and formed of a soft, low-density open cell foam, such that the head 2 is easily deformable and provides outlets 12 for the solution. The head 2 has a textured outer surface, such as is characteristic for a soft open cell foam product. The head 2 may be constructed of a variety of materials that provide deformability and resiliency. The head has a lower hardness than the membrane to avoid abrasion. It is preferred that the head be formed from a foam-like material, such as polyurethane foam, particulate-filled polymers, as well as various natural and synthetic sponge materials. It is preferred that the foam-like material has a low density. The head may be a hollow sphere with opening for outlets 12. The head preferably has a generally smooth surface with no protrusions or embedded particulates/fillers that could scratch the membrane. The head is resistant to chemicals.

[0040] The head is preferably long enough to access the area to be cleaned, yet short enough to fit within the nasal cavity. The head cross-sectional profile creates convergent and divergent flows as it moves over the membranes such that effective shear stress is generated to clean the membranes. The head profile is preferably circular or elliptical shaped. Circular geometry may also be useful to facilitate the conditions of convergent and divergent flow field as the head moves/rotates within the nasal cavity.

[0041] In an embodiment, the head is designed for ease of insertion into the nasal opening. In an embodiment, the angle between the head and the nasal membrane is about 180 degrees. The gap between the head and the nasal membrane is preferably small to position of head so that the rotating head touches a side of the nasal cavity when moved slightly by the operator. Flexibility of the head is low so that the head is approximately parallel to the surface to be cleaned such that a small and uniform narrow gap/distance is maintained during the motion of the head. Distortion or wobbling of the head is achieved by materials selection and by the thickness of the head. In an embodiment, the distal end of the head is thinner than the remainder of the head to increase its flexibility.

[0042] Head shape increases turbulence to sweep contaminants from the nasal membranes and create flow fields onto the membrane and back into the inlets. In an embodiment, the head is shaped to provide a uniform and minimal gap within the nares in a vertical direction. The distal end of the head is rounded to facilitate insertion and prevent membrane scratching.

[0043] In an embodiment, the head 2 is a multiuse head. In an embodiment depicted in FIG. 4, the head is formed from a rubberized plastic and includes a disposable cover 22. The disposable cover slips over the head 2 and is secured using connectors, such as hook and loop material, snaps, or an elastic material forming a band elastic. In an embodiment, the cover 22 is an elasticized generally U-shaped material that firmly grips the head without the use of adhesive. The cover 22 may be formed of a pair of sheets, forming a front and a back having an interconnection. In an embodiment, the cover 22 is formed of a spun-lace non-woven sheet. The cover may be single-layer, multiple-layer, with or without reinforcement scrim, textured, and/or untreated or pretreated with a variety of materials. The cover outer surface may be tufted, flocked, or frayed to provide additional cleaning abilities. As will be clear to those of skill in the art, the outer surfaces of the covers may be configured in a variety of ways, and may have a variety of textures or treatments.

[0044] The head and/or the cover may be coated, incorporate a controlled release substance or otherwise surface treated. Some non-exclusive coatings examples include biocides, wetting agents, lubricants, and the like.

[0045] In an embodiment, the head is a generally spherical or oblong shape and comprises outlets 12 to spray solution from the head. The head may also take various other forms, provided the head fits within the nares and contacts or nearly contacts the nasal membranes. In an embodiment, the outlets are openings formed in the foam in the head. In an embodiment, the outlets are nozzles. Having the cover and/or head disposable is provided so that the cover or head is used once and disposed of when soiled. A new cover/head is then placed on the head/body. The head cover has a tensile strength, tear strength, and hardness tear strength sufficient to avoid breaking apart during use.

[0046] In an embodiment, the head 2 is releasably connected to the neck 3 via a connector 21. The connector is a hollow, hard plastic piece that extends from the head. In an embodiment, the connector has flat external sides. In an embodiment, the connector forms a fluid conduit to the outlets 12. In an embodiment where the head is a hollow sphere, the connector provides solution to the sphere, where it is then forced through the outlets 12 by the force of the pump 70. The connector and or the neck may be straight or on an angle. The neck should have some flexibility to avoid trauma to the nasal membrane; however, the connector has to be rigid enough to avoid excessive vibrations and to maintain contact with the membrane.

[0047] As shown in FIG. 3A and FIG. 4, the connector 21 inserts into a rotor 23 located in the neck 3. The connector 21 can be attached to, and detached from, the rotor 23 by insertion. Preferably, the connector 21 is a quick connect coupling that connects to the rotor 23. For example, there can be a quick connect on the connector, the rotor, or both. Examples of couplings include threads, a chuck, a friction sleeve, a non-circular profile to resist rotation, and the like. The rotor is a gear that is turned by a gear mechanism 210 powered by a motor 150 in the body of the device. In an embodiment, the connector 21 also maintains the position of the head relative to the surface to be cleaned. The rotor has a circular ring of gear teeth 28a-n that engage with the gear mechanism 210. An O-ring 26 is positioned above the rotor so that when the head 2 is attached to the neck 3, it forms a seal.

[0048] The pressure asserted on the fluid as it exits the outlets is about 0.5 psi to about 30 psi, preferably about 3-10 psi. Fluid flow rate is about 10 ml/s to about 60 ml/s, preferably about 20 ml/s to about 40 ml/s. If a greater number of outlets is provided, a greater flow rate would be required to maintain the optimum velocity. Pulse frequency is about 0.5 Hz to about 50 Hz, preferably from about 5 Hz to about 25 Hz. Delivery pulse duty cycle may be from about 10% to 100%, preferably from about 40% to about 60%. Where the cycle is 100% a continuous flow of fluid is produced. Delivery pulse volume is about 0.1 ml to about 5 ml, preferably from about 0.5 ml to about 2 ml.

[0049] The rotational speed of the head is about 1,000 rpm to 15,000 rpm, preferably from about 5000-9000 rpm. The device has the ability to rotate the head in either direction around a vertical axis. The speed of the motor is matched to the velocity of gear, which is transferred to the head. The rotational speed is low enough so as to avoid damage to the head or the membranes, but high enough to gently abrade the nasal membrane.

[0050] In operation, the user removes the removable cap 4 and switches the device on using the control button 300 located on the body 1 of the device. The control panel 200 is connected to the circuitry within the device for making various electrical operations, such as direction of rotation speed of rotation, spray velocity, pulsation rate, warming of the solution and the like, available to the user. Switching the device on activates the motor 150 causing the pumps to activate and activating the gear to turn the head. The pump 70 forces the fluid from the fluid reservoir 80 to the head and through the outlets 12. In an embodiment, the outlets spray enough fluid on to the nasal membrane to ensure flow around the head, and preferably in sufficient volume to also dislodged contaminants.

[0051] The rotation of the head gently rubs the nasal membrane to remove debris. The fluid with debris is returned to the device through the suction inlets 15 by the action of the wet vacuum pump 60 and stored in the suction chamber 100. Vacuum duty cycle is about 10% to 100%, preferably from about 50% to 100%. Fluid delivery to vacuum ratio is about 1:1 with a small amount of spray not recovered by the inlets.

[0052] During operation, the user places the head slightly inside the nostril. When cleaning the membranes, a user actuates a control button 300 to produce a solution spray through outlets 12 in order to cover the membrane with solution. Cover 22 or the head 2 gently brushes the surface to dislodge debris. The head 2 is configured and moving in a direction whereby the spray passes over the membrane first, the cover 22/head 2 loosens debris, and the spray is collected by the inlets 15. Debris is removed. The trajectory angle of the spray varies as the head rotates to position the sprayed solution near the inlets. In an embodiment, the head rotates in the nasal cavity a small distance from the membrane. In an embodiment, the exterior of the inlets help position the head in the cavity. The exterior structure of the inlets positions the device within the nares at the nostril opening to steady the head against sudden movement.

[0053] To diminish sprayed fluid from leaking from the nares, the neck comprises a splash guard 50. The splash guard fills the opening of the nares and deflects fluid and contaminants from the nasal membrane into the inlets. the splash guard is relatively flexible for comfort to the user.

[0054] The user then inserts the head into the second nostril and repeats the cleaning. The disposable head cover may be replaced in between cleaning each nostril. After completion, the device is shut off, the suction chamber 100 removed, cleaned and replaced, and the fluid reservoir 80 refilled or replaced. The wet vacuum pump 60 operates to collect most of the contaminated fluid from the nares. The contaminated fluid collected in the suction chamber 100 is contained to prevent exposure of the contaminated fluid to the environment.

[0055] In an embodiment, the fluid is a sterile saline. In an embodiment, the fluid is a sterile buffered hypertonic saline solution. In an embodiment, the fluid comprises purified water, sodium chloride, disodium hydrogen phosphate, and potassium dihydrogen phosphate. The pH of the fluid is from about 5 to about 7, preferably, about 5.5 to about 6.5.

[0056] The foregoing description of the invention has been presented for purposes of illustration and description. It is intended neither to be exhaustive nor to limit the invention to the precise form disclosed. Many alternatives, modifications, and variations will be apparent to those skilled in the art. For example, the terms: cleaning and rotation are not meant to limit the overall invention. Such terms can include modifications or combination with other methods, such as air, vibrations, heat and the like. While surface cleaning is a major application of this invention, other surface modifications such as coating (with a drug or medication) and disinfection are possible. Accordingly, this invention is intended to embrace all alternatives, modifications, and variations that fall within the spirit and broad scope of the claims.