Device and method for cleaning nasal cavities
09884147 ยท 2018-02-06
Inventors
Cpc classification
A61M1/774
HUMAN NECESSITIES
A61M1/63
HUMAN NECESSITIES
A61M1/85
HUMAN NECESSITIES
A61M31/00
HUMAN NECESSITIES
A61B17/24
HUMAN NECESSITIES
A61M11/006
HUMAN NECESSITIES
A61M3/0283
HUMAN NECESSITIES
International classification
A61H33/00
HUMAN NECESSITIES
Abstract
A device for cleaning nasal membranes comprising a head that is inserted into a nostril. Fluid is pumped from a reservoir stored in a body of the device onto the membrane. The head rotates to remove debris from the membrane. A vacuum pump suctions the sprayed fluid and the debris into inlets and stores the used fluid in a chamber in the body.
Claims
1. A nasal membrane cleaning device for cleaning a nasal membrane comprising: a body, a rotating head and a neck connecting the head to the body; the head including a plurality of outlets through which fluid is sprayed during use of the device, the head having a smooth surface without protrusions or embedded particulates or fillers that could scratch the nasal membrane during use; the body housing a motor, a pump, a vacuum pump, a fluid reservoir and a suction chamber, wherein the motor is adapted for powering the pump, and the pump is in communication with said fluid reservoir such that, when the pump is activated, the fluid contained in the reservoir is forced through a conduit network to said outlets for delivery onto the nasal membrane of a user; and the neck including a splash guard and fluid inlets located below the head and in communication with the vacuum pump and the suction chamber, wherein the splash guard is configured to deflect the fluid into the inlets; the head further comprising a hollow connector that comprises part of the conduit network through which the fluid is delivered from the reservoir to the outlets; the cleaning device configured such that the head is insertable into a user's nasal opening, with the head adapted for powered rotation about a vertical axis to rub a user's nasal membrane to remove debris located at the nasal membrane, without damaging the nasal membrane, while the fluid from the fluid reservoir is sprayed from said outlets onto the user's nasal membrane and thereafter the fluid along with the debris removed from the user's nasal membrane is suctioned through said inlets into the device and into the suction chamber.
2. A method of using the device of claim 1 having the fluid in said reservoir to clean the nasal cavity of a user, comprising the steps of: introducing the head of the device into one nostril such that said splash guard fills the opening of the nostril; powering on the device so that the pump delivers the fluid from the reservoir through the neck to the head and through the outlets, while the head rotates so that it rubs against the nasal membrane, thereby cleaning the nasal membrane of the debris without damaging the nasal membrane; and suctioning the fluid sprayed out of the outlets and the debris removed from the nasal membrane into the suction chamber where it is stored.
3. The method of claim 2 wherein the fluid in the reservoir comprises a sterile saline solution.
4. The method of claim 2 wherein the fluid in the reservoir comprises purified water, sodium chloride, disodium hydrogen phosphate, and potassium dihydrogen phosphate.
5. The method of claim 2 wherein the fluid in the reservoir has a pH from about 5 to about 7.
6. The method of claim 2, further comprising the steps of: prior to cleaning the nasal cavity, inserting a disposable collection unit inside the device and covering the head of the device with a disposable cover; and after cleaning the nasal cavity, removing the collection unit containing the fluid and the debris cleaned from the nasal membrane.
7. The cleaning device of claim 1 wherein the head comprises a shape that provides a uniform gap and a minimal gap between the nasal membrane and an exterior of the head.
8. The cleaning device of claim 1 wherein the head further comprises a disposable cover.
9. The cleaning device of claim 8 wherein the disposable cover comprises a coating selected from the group consisting of a biocide, a wetting agent, and a lubricant.
10. The cleaning device of claim 1 wherein the outlets spray the fluid from the reservoir onto the nasal membrane from multiple points about the head.
11. The cleaning device of claim 1 wherein the head is rotatable at a speed sufficient to generate a mechanical stress to remove the debris from the nasal membrane.
12. The cleaning device of claim 1, further comprising a rotor, wherein said connector engages with the rotor for causing the head to rotate.
13. A nasal membrane cleaning device, comprising: a body housing a pump, a fluid reservoir for containing fluid to be discharged from the device onto a user's nasal membrane, and a suction chamber for receiving used fluid and debris collected after discharge from the device; a head adapted for insertion into a user's nostril and powered rotation therein, said head mounted above said body and including a plurality of outlets in fluid communication with said fluid reservoir, wherein the head is formed of a deformable and resilient material that provides said plurality of outlets; a power source for powering the rotation of said head and the pumping of the fluid from said fluid reservoir to said outlets such that the fluid from said fluid reservoir can be sprayed from said outlets onto a user's nasal membrane while the head rotates; and fluid inlets arranged below and external to said head, said inlets in fluid communication with said suction chamber; wherein the cleaning device is configured such that the head is insertable into a user's nasal opening, and thereafter the head caused to rotate about a vertical axis to rub a user's nasal membrane to remove the debris located on the nasal membrane, without damaging the nasal membrane, while the fluid from the fluid reservoir is sprayed from said outlets onto the user's nasal membrane and thereafter the fluid along with the debris removed from the user's nasal membrane is suctioned into the device through said inlets and into the suction chamber.
14. The nasal cleaning device of claim 13, further comprising a splash guard configured to deflect the discharged fluid into the inlets, said splash guard arranged in spaced-apart relationship with said head such that the discharged fluid is directed to the inlets between the splash guard and the head.
15. A method of using the device of claim 13 having the fluid in said reservoir to clean the nasal cavity of a user, comprising the steps of: introducing the head of the device into one nostril; activating the device so that the pump delivers the fluid from the reservoir to the head and through the outlets, while the head rotates so that it rubs against the nasal membrane so as to clean the debris from the nasal membrane without damaging the nasal membrane, and the fluid sprayed out of the outlets and the debris removed from the nasal membrane is suctioned into the suction chamber.
16. The nasal membrane cleaning device of claim 13, wherein said head is formed of a low-density, open-cell foam.
17. The nasal membrane cleaning device of claim 13, wherein the head further comprises a disposable cover.
18. A nasal membrane cleaning device, comprising: a body housing a fluid reservoir for containing fluid to be discharged from the device onto a user's nasal membrane, and a suction chamber for receiving used fluid and debris collected after discharge from the device; a head adapted for insertion into a user's nostril and powered rotation therein, said head mounted above said body and including a plurality of outlets in fluid communication with said fluid reservoir, the head having a smooth surface without protrusions or embedded particulates or fillers that could scratch the nasal membrane during use; a power source for powering the rotation of said head and the pumping of the fluid from said fluid reservoir to said outlets such that the fluid from said fluid reservoir can be sprayed from said outlets onto a user's nasal membrane while the head rotates; fluid inlets arranged adjacent and external to said head, said inlets in fluid communication with said suction chamber; and a splash guard configured to deflect the discharged fluid into the inlets, said splash guard arranged in spaced-apart relationship with said head such that the discharged fluid is directed to the inlets between the splash guard and the head; wherein the cleaning device is configured such that the head is insertable into a user's nasal opening, and thereafter the head caused to rotate about a vertical axis to rub a user's nasal membrane to remove debris located on the nasal membrane, without damaging the nasal membrane, while the fluid from the fluid reservoir is sprayed from said outlets onto the user's nasal membrane and thereafter the fluid sprayed from said outlets along with the debris removed from the user's nasal membrane is suctioned through said inlets into the device and into the suction chamber.
19. A method of using the device of claim 18 having the fluid in said reservoir to clean the nasal cavity of a user, comprising the steps of: introducing the head of the device into one nostril; activating the device so that the pump delivers the fluid from the reservoir to the head and through the outlets, while the head rotates so that it rubs against the nasal membrane so as to clean the debris from the nasal membrane without damaging the nasal membrane, and the fluid sprayed out of the outlets and the debris removed from the nasal membrane is suctioned into the suction chamber.
20. The nasal membrane cleaning device of claim 18, wherein the head further comprises a disposable cover.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
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(9) As depicted in
(10) 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.
(11) Referring to
(12) 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
(13) 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.
(14) 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.
(15) Referring to
(16) 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.
(17) 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.
(18) 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.
(19) In an embodiment, the head 2 is a multiuse head. In an embodiment depicted in
(20) 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.
(21) 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.
(22) 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.
(23) As shown in
(24) 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 are 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.
(25) 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.
(26) In operation, the user removed 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.
(27) 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.
(28) 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.
(29) 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.
(30) 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.
(31) 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.
(32) The foregoing description of the invention has been presented for purposes of illustration and description. It is neither intended 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.