COMPLETE UPPER RESPIRATORY TRACT CLEANSING SYSTEM AND ITS USE

Abstract

The present invention discloses a four-way complete cleansing system for the entire upper respiratory tract (upper airway) and the process of how to use this advanced system to perform a complete cleansing of the upper airway of a human. The device is equipped with two one-way valves and at least two exchangeable tips for an effective upper airway cleansing. The composition of the cleansing solution comprises a chemical compound or an herb extract or the combination having at least one of the cleansing activities against viruses, bacteria, fungi, inflammatory factors, allergens, and promoting membrane healing or immunomodulating, for the treatment and prevention of a respiratory tract disease of a human. The present invention also provides a process for cleansing the hard-to-reach upper respiratory tract, such as sinus, of a mammal to reduce the load of the pathogen, to reduce the amount of inflammatory mediators, to heal pathological changes, and collectively to treat a disease of a mammal, such as nasal allergy or the common cold. This invention also provides a new method of treating a variety of human respiratory tract diseases without adverse effects.

Claims

1. A complete upper respiratory tact cleansing system comprising: 1) a squeezable-pump irrigator with the anti-backilow function; 2) a sodium chloride based biocompatible liquid for the entire upper respiratory tract; 3) an connector on the cap of the bottle to fit-in at least two exchangeable tips; 4) two or more lips for cleansing the different pails of the upper respiratory tract; 5) a cap for holding the connector for seating the exchangeable hp and for sealing the squeezable bottle; 6) one pair of the air valve and liquid valve in the correct opposite flow directions to maintain continual positive pressure within the squeezable bottle; 7) a tube for transferring liquid from the bottle to the liquid valve.

2. The complete upper respiratory tract cleansing system in accordance with claim 1, wherein the squeezable-pump irrigator holds at least 20 ml of the solution.

3. The complete upper respiratory tract cleansing system in accordance with claim 1, wherein the tips are for cleansing sinonasal cavity, throat and oral cavity of a mammal.

4. The complete upper respiratory tract cleansing system in accordance with claim wherein the connector on the cap of the irrigator is to fit-in the tips for cleansing sinonasal cavity, throat and oral cavity of a mammal.

5. A biocompatible liquid for the entire upper respiratory tract comprising: 1) sodium chloride in water at least 0.6% weight/weight; 2) sodium bicarbonate in water at least 0.001% weight/weight; 3) sodium citrate in water at least 0.00001% weight/weight; 4) citric add in water at least 0.00001% weight/weight; 5) a plant extract in water at least 0.00001% weight/weight; 6) a moisturizing agent in water at least 0.000001% weight/weight; 7) an anti-inflammatory agent in water at least 0.000001% weight/weight. 8) An anti-allengic agent in water at least 0.000001% weight/weight.

6. The biocompatible liquid for the entire upper respiratory tract in accordance with claim 5 wherein the plant extract is Aloe vera extract.

7. The biocompatible liquid for the entire upper respiratory tract, in accordance with claim 5, wherein the moisturizing agent is glycerin.

8. The bicompatible liquid for the entire upper respiratory tract in accordance with claim 5, wherein the anti-inflammation agent is eucalyptol.

9. The biocompatible liquid for the entire upper respiratory tract in accordance with claim 5, wherein the anti-allergic agent is the extract of Centipede minima.

10. The process of using an upper respiratory tract cleansing system comprising: 1) selecting a hand-pump irrigator which can be used to supply the cleansing solution continually; 2) filling the hand-pump irrigator with a biocompatible solution for the entire upper respiratory tract; 3) pumping the solution run from the left nostril to the right nostril and out of the body; 4) pumping the solution run from the right nostril to the left nostril and out of the body; 5) pumping the solution to fulfill the left nasal canal then sniff slightly to let the solution run through the throat and out of the mouth; 6) pumping the solution to fulfill the right nasal canal then sniff slightly to let the solution run through the throat and out of the mouth.

11. The process of using an upper respiratory tract cleansing system in accordance with claim 10, wherein the steps 3) and 4) as specified above can be omitted when the user has a significant nasal congestion The user can directly perform the upper respiratory tract cleansing following steps 5) and 6) as specified in claim 10.

12. A method for reducing a respiratory tract disease comprising: 1) selecting a hand-pump irrigator which can be used to supply the cleansing solution continually; 2) filling the hand-pump irrigator with a biocompatible solution for the entire upper respiratory tract; 3) performing a complete upper respiratory tract cleansing to remove any of the pathogen entered into the upper respiratory tract, and/or to remove an allergic agent, and/or to remove an inflammatory factor generated by the body, and/or to remove an excessive mucus from the upper respiratory tract.

13. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said pathogen is a virus, or a bacterium, or a fungus, or a pollen particle, or an environment pollutant.

14. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is the common cold.

15. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is influenza.

16. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is nasal allergy.

17. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is asthma.

18. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is post nasal drip.

19. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is sinusitis.

20. The method for reducing a respiratory tract disease in accordance with claim 12, wherein said respiratory tract disease is a bacterial infection of the upper respiratory tract, such as sinusitis caused by Staphylococats aureus.

Description

DESCRIPTION OF THE DRAWINGS

[0020] That and other objects of the present invention will be apparent to those skilled in the art from the following description of the invention. The invention is described with reference to the following figures:

[0021] FIG. 1 is a drawing of the 4-way upper respiratory tract cleansing device. It is a hand-squeezable pump bottle to deliver a liquid into the entire upper airway. The squeezable bottle 1 varies in the liquid holding capacity, from 20 to 500 ml. The liquid is transferred through a thin tube 2 inside of the bottle to the one-directional liquid valve 5 and then is forced to flow to one of the three exchangeable tips, throat wash tip 7, nostril fitting tip 8, oral cleansing tip 9 via the connector 6. The throat wash tip 7 has two ends. The lower end at the label 7 has an out-diameter which fits into the inner diameter of the Connector 6 to form a tight connection. The other end of the throat wash tip at the label 10 is a smooth semi-ball shape with multiple small holes. When the cleansing solution pumped to run out through these many holes, the liquid can rinse and cleanse the throat effectively and still relatively comfortable. The nostril fitting tip 8 can be tightly connected into Connector 6. The other end of the nostril fitting is a semi-ball like with a central hale. The diameter of the central hole can vary from 2 to 6 millimeters. The oral wash tip 9 can be tightly connected to Connector 6. The other end of the oral wash tip 12 is a thin-sharp and smooth structure to allow the liquid flow into the oral cavity, particularly the spaces between the teeth, with strong wash strength. Combinational use of the three exchangeable tips can effectively cleanse the entire upper airway, including nostril, sinuses, nasopharynx, oropharynx, throat, and mouth.

[0022] Cap 3 is to seal the bottle to form a pump. Air-valve 4 is to let air enter into the bottle to balance the negative pressure after the bottle is being squeezed then released. When the user releases the bottle after forcing the liquid flow into a human body space, air will enter into the bottle through one-directional air valve 4 while no liquid can flow back into the bottle because the one-way liquid valve 5 stops the liquid back flow. The air valve 5 is to keep the bottle with positive pressure. There will be no negative pressure build up when the liquid is repeatedly forced flow out. Valves 4 and 5 can be made as two parts or can be constructed as one part.

[0023] FIG. 2 shows the process of the 4-way upper airway cleansing.

[0024] The first way (or Direction 1): the user is to pump the solution to enter into the left nostril, continually flow into the left side of sinuses, run through nasopharynx, finally flow out of the right nostril.

[0025] The second way (or Direction 2): the user is to pump the solution to enter into the right nostril, continually flow into the right side of sinuses, run through nasopharynx, finally flow out of the left nostril.

[0026] The third way (or Direction 3): the user is to pump the solution to enter into the left nostril, continually flow into left side of sinuses, then the user is instructed to sniff/inhale gently. The continually pump-supplied solution will run through nasopharynx to oropharynx, then run down to throat and end in mouth. The user then spit the wash solution to a sink.

[0027] The fourth way (or Direction 4): the user is to pump the solution to enter into the right nostril, continually flow into the right side of sinuses, then the user is instructed to sniff/inhale gently. The continually pump-supplied solution will run through nasopharynx to oropharynx, run down to throat and end in mouth. The user then spit the wash solution to a sink.

[0028] To further cleansing throat and oral cavity, the user can switch the throat wash tip and then the oral wash tip to rinse the throat and oral cavities to remove viruses or any harmful materials from the throat and the oral cavity.

[0029] It is further disclosed that the 4-way upper airway cleansing system has the following features: 1) the cleansing device is connected with any of the three tips. Any of these tips can be made with different size to be suitable for the different users; 2) said the 4-way upper airway cleansing system is in the dosed position nominally and opens to deliver a solution into the targeted parts of the upper airway upon hand-pumping; 3) said the 4-way upper airway cleansing system has a control means for quantitatively delivering a solution into the specific part of the upper airway; 4) said nostril fitting tip is a one-fit-all object to prevent leakage of the solution from nose openings; 5) said throat wash tip is to spray the solution to the throat and other parts of the oral cavity; 6) said oral tip is to spray the solution into any hard-to-reach space in the oral cavity, such as the space between the teeth; 7) said throat wash tip, nostril fitting tip, and oral wash tip are exchangeable at the Connector 6 on the top of the cap; 8) said throat wash tip is curved or straight to be suitable for any users; 9) said oral wash tip is curved or straight to be suitable for any users; 10) said squeeze bottle is powered or triggered by a human hand; 11) said the 4-way cleansing system disallows liquid back-flow; 12) said 4-way cleansing system can be made with any safe materials; 13) said 4-way cleansing system has a liquid-valve mean to ensure one-directional liquid flow; 14) said 4-way cleansing system has an air-valve mean to maintain a positive pressure within the squeeze bottle;. 15) said 4-way cleansing system can be used for cleaning both upper airway and oral cavity; 16) said 4-way cleansing system is a device to be used to administer a functional liquid to upper airway and oral cavity to reduce the load of pathogenic microbes without causing drug resistance; 17) said 4-way cleansing system is to be used to administer a functional liquid to upper airway and oral cavity to reduce the content of inflammatory agents without disturbing the body's immune function; 18) said 4-way cleansing system is to be used to administer a functional liquid to upper airway and oral cavity in treating respiratory diseases without causing adverse events; 19) said 4-way cleansing system is to be used to administer a functional liquid to upper airway and oral cavity to treat other human diseases without causing the time of a medical professional.

[0030] Description of the Composition of the Biocompatible Solution

[0031] These and other composition of the present invention will be apparent to those skilled in the art from the following description of the invention. The invention is described with reference to the following composition:

[0032] A biocompatible solution for the entire upper airway is very important for the safety and effectiveness of the complete cleansing. A company introduced the wrong rinsing solutions containing detergents at a too high concentration into nasal cavities and caused loss of sense of smell for many users. The solution invented herein is an aqueous solution, an improved normal saline. It is known that the most common isotonic solution for nasal irrigation is a normal saline solution, which contains 9 g of sodium chloride in 1 liter of water (0.9% by weight). This isotonic salt solution, based on the observation obtained from clinical researches, however, can cause dryness of the nasal cavity and it is not optimal to use for a long time. The newly invented solution can contain 9 g of sodium chloride in 1 liter of water, but includes a buffer system and other protective factors. The optimal buffer system is formed by using citric acid and sodium citrate in a correct proportion, such as in a 1:1 ratio to maintain the pH of solution around 7.4. The concentration of sodium chloride can be slightly higher that 9 g/liter, up to 18 g/liter. Sodium bicarbonate has been widely used in a number of nasal irrigation solutions. This ingredient can be used to make a basic formula. The safe ingredient glycerin, a moisturizing agent, is included in the invented formulation. Aloe vera extra, another natural moisturizing agent, is also included. The biocompatible solution may also contain an appropriate amount of an anti-attachment agent, such as carbohydrates which prevent or reduce the attachment of microbial pathogens to the nasopharyngeal and oropharyngeal cavities. The solution may also contain anti-allergy agents, such as eucalyptus oil/eucalyptol. The solution may also contain corticosteroids, antibiotics, antihistamines, and/or mucolytic agents. The solution may also contain a suitable decongestant such as phenylephrine hydrochloride. The temperature of the solution, when administered, is typically about 20 to 40 degree C. and more preferably about 30 to 37 degree C.

[0033] Centipeda minima is a herb and has been safely used in the traditional Chinese medicine for the treatment of rhinitis, sinusitis, relieving pain, and reducing nasal swelling. New scientific study shows that the extract of this herb has antioxidant and anti-inflammatory activity, which supports previous observation made during the oral use for relieving inflammation and pain. It is better to use this herb extract locally in the upper airway, not necessarily to let the whole body to have the exposure to this herb. The current invented biocompatible solution is to include the extract from Centipeda minima to treat the upper respiratory tract disorder locally.

[0034] Description of the Four-Way Cleansing Process

[0035] These and other objects of the present invention will be apparent to those skilled in the art from the following description of the invention.

[0036] This invention teaches a new process of the 4-way complete upper airway cleansing. To have a complete upper airway cleansing to remove any harmful substances out of the upper respiratory tract, the user needs to use a hand-pump irrigator with the dual valve anti-backwash function to supply the solution continually. After performs this 4-way cleansing procedure, one can completely cleanse nasal cavity, sinuses, nasopharynx, oropharynx, throat and mouth. Here are the four steps:

[0037] Step 1: Pump the cleansing solution run from the left to right nostril. Gently pump the solution into the left nostril, flow pass through nasopharynx, then flow out of the right nostril. One can use about ¼ of the solution (about 60 ml if the bottle holds 240 ml) in the bottle to complete this step. At this time, one can gently blow her/his nose to get rid of the, excessive mucus and leftover liquid. This is mainly to cleanse the left nasal passage, left side sinuses, nasopharynx, and finally, the right side of the nasal passage.

[0038] Step 2: Pump the cleansing solution run from the right to the left nostril. Gently pump about 60 ml of solution from the right nostril, let it flow pass nasopharynx, then flow out from the left nostril. One can then gently blow the nose. This is mainly to cleanse the right nasal passage, right side sinuses, nasopharynx from the other direction, and finally, the left side of the nasal passage.

[0039] Step 3. Pump the cleansing solution run from the left nostril to throat-mouth. Gently pump about 60 ml of solution into the left side of the nostril. When that side of the nasal cavity is full of the liquid, the user is to gently sniff/inhale the liquid through the nose while continually pumping so the solution will run through oropharynx, throat, and enter into the mouth. Spit the solution to sink. This will cleanse the left nasal passage, left sinuses, nasopharynx, and then the left side of the oropharynx, throat and mouth.

[0040] Step 4: Pump the cleansing solution run from the right nostril to throat-mouth. Gently pump the last 60 ml of solution into the right nostril; when the right side nasal cavity is full, gently sniff/inhale the liquid through the nose while continually pumping so the solution runs through oropharynx, throat, and enters the mouth. Spit the solution to a sink. This will cleanse the right nasal passage, right sinuses, nasopharynx, oropharynx, throat and mouth.

[0041] After completing the 4-steps of cleansing, one will feel much fresher of the upper respiratory tract. These harmful substances on the surface of the upper respiratory tract will be largely rinse away.

[0042] It is not necessary to follow these 4 steps exactly in the order taught herein. Any user can start any one of the 4 steps as the first step or mix any order. When the user has a complete nasal congestion, one can perform Steps 3 and 4 to remove these inflammatory mucus, help drain these sinuses and re-open the nasal cavity. For this purpose, neti pot or these bottles with a functional anti-backflow mechanism will become useless when the nasal cavity is completely blocked.

[0043] After performing the above procedure, the user can replace the nostril fitting tip with a throat cleansing tip. Using the remaining liquid in the bottle or freshly made liquid, one can further cleanse the throat area to further remove any pathogens, mucus and inflammatory materials.

[0044] Finally, the user can replace the throat cleansing tip with an oral cleansing tip. Using the remaining liquid in the bottle or freshly made liquid, one can further cleanse the mouth to further remove any pathogens, mucus and inflammatory materials.

[0045] Description of the Invention of the Method of Use

[0046] The present invention further provides a method of treating the common respiratory disorders in a human by effectively removing a variety of pathogens, such as viruses, bacteria, fungi, allergens, environment pollutions, as well as the body produced inflammatory factors, from the upper respiratory tad. After the pathogen is removed from the upper respiratory tract, the body can heal itself. For example, rhinovirus is the cause of the common cold in the upper respiratory tract. The replication of the rhinoviruses triggers the body's immune system to launch an attack against these viruses. The end result of the fight is the inflammation in the upper respiratory tract. When the patient is performing the 4-way complete cleansing procedure to remove these rhinoviruses, the immune system will stop the attack The disease will then disappear.

[0047] The present invention further provides a method of preventing common respiratory disorders in a human by effectively removing a variety of pathogens, such as viruses, bacteria, fungi, allergens, environment pollutions, as well as the body produced inflammatory factors, from the upper respiratory tract If the pathogen is removed from the upper respiratory tract before it can cause a disease. Therefore, the disease can be prevented. For example, one individual inhaled infectious aerosols containing the influenza virus during a social gathering. She knows dearly she had a dose contact with a friend who coughed nearby, and she has a high chance to be infected. After leaving that social gathering, she can use the 4-way complete cleansing system to remove any inhaled influenza viruses. Because influenza viruses take time to enter into the epithelium cells to cause infection, timely performing a complete cleansing of the upper respiratory tract, these inhaled influenza viruses will be removed before entering into the cells, hence, the infection can be prevented.

[0048] The following examples further illustrate the present invention but, of course, should not be construed as in any way limiting its scope.

EXAMPLE 1

[0049] This example illustrates the efficacy of the 4-way complete cleansing system in treating the common cold. Two groups of the patients with the clinically diagnosed common old were randomly divided into the Treatment or Control groups. In the

[0050] Control group, all 8 patients were treated with the currently available medicines for cough and cold. There was no anti-viral drug available. In the Treatment group, these 8 patients were instructed to perform a complete upper airway cleansing, three times a day, using the hand-pump cleansing system. The majority of the patients in the Treatment group recovered 2 or 3 days after starting the upper airway cleansing. The average of duration of the common cold was 3 days. In the Control group, the duration of the cold varied from 7 to 14 days. This dearly demonstrates that the 4-way cleansing procedure with a hand-pump is very effective in treating the common cold.

EXAMPLE 2

[0051] This example illustrates the procedure of performing the complete upper airway cleansing can remove common viruses from the upper respiratory tract. A group of 8 patients were tested to have a positive infection by influenza virus A. They were instructed to perform a complete cleansing of their upper respiratory tract, three times a day, using a hand-pump cleansing system. Three days late, all patients were tested again for influenza viruses. The test result dearly showed that no more viruses could be detected after the three days of performing an effective upper respiratory tract cleansing. These patients recovered within 5 days after the initial infection, which was much faster than the typical influenza virus infection of 10 or more days.

EXAMPLE 3

[0052] This example illustrates the efficacy of using the present invention to remove inflammatory mediators from upper airway cavities of 8 patients with viral infection. The patients with a current viral infection were observed by a physician specialized in Ear, Nose and Throat on Day 1 office visit. All of them had inflammation signs, such as intranasal edema and membrane redness. On Day 4, the same ENT did another observation. Almost all patients had no more inflammation signs. These inflammation signs, such as intranasal edema and membrane redness, were gone. Patients have no more nasal congestion.

INDUSTRIAL APPLICABILITY

[0053] Through the easy use of the 4-way complete upper airway cleansing system, the general population now has a simple, safe, easy and inexpensive method that can be used to remove many kinds of pathogens from the upper respiratory tract to treat and prevent a variety of the common human diseases. This system can also be used to remove inflammatory agents generated by the human body in response to viral infection or reacted towards an allergen. Timely remove infectious particles from the upper respiratory tract will reduce pathogenic microorganism loads and thereby reduce the spread of infection to others, and reduce the opportunity for the disease causing agents to reach his or her lower respiratory tract. The significant advantage of using this new system is that there will be less chance to develop multiple-drug resistance, which is a big public threat in light of many deaths caused by those super bugs. This system also helps the patient to remove harmful inflammation mediators from the upper respiratory tract without using those anti-inflammatory drugs. Hence, those drug's adverse effects and disturbance of immunity can be avoided. The medical community and the general population will greatly benefit from using the new system, and from performing the complete cleansing process and the method disclosed herein. The medical community now has a simple and reliable method to let the patient to remove these pathogens from the upper respiratory tract to treat those disorders.

[0054] Those skilled in the art will appreciate that changes and modifications of the upper airway cleansing system can be made, as well as the 4-way cleansing process and the methods of use disclosed herein without departing from the spirit and scope of the present invention as set forth as defined by the following claims.

REFERENCE

[0055]

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