Background

This invention relates to devices for removal of excess nitric oxide (NO) as a therapeutic method from paranasal sinuses of a patient and to induce sympathetic tone by using warmed air blowing to the facial skin .In the world , more than 20% people suffer from migraine head ache which is suggested with strong scientific evidences to be caused by sinorhinological nitric oxides (s NO) .Moreover it has been proposed that this s NO is contributes to cause neurological and psychiatric disorders as well as respiratory illness( 1,2,3) .These have been introduced by many authors reveling the comorbidity between migraine and those disorders and other such as cardio vascular ,endocrine disorders etc. . Many factors contribute to cause pranasal hypoxia to induce more production of s NOwhen there is hypoxia due to nasal and ostial inflammation or odema is treated by means of antihistamines, antibiotics, decongestants, diuretics and pain relievers. Many of these drugs would work more effectively in relieving symptoms if they could be directly applied to all of the affected areas. In addition anatomical anomalies causing hypoxia has been treated by standardized nasal and pranasal surgery .Moreover migraine and other illnesses comorbid with migraine has been treaded medically and modification of life pattern and avoiding migraine triggers .On the other hand reliving stress and breathing exercises practiced in yoga medication has been observed to reduce frequency and severity of migraine and the other disorders .The responsible molecule for migraine which has been recently proposed on strong scientific evidences that paranasal and nasal nitric oxide (s NO) ,cause for migraine as well as many neuro psychiatric disorders.Existence of this type of pathology in human been is named as Sinus Hypoxic Nitric Oxide Phenomenon (SHNOP). It is practically very important to reduce NO level in the nasal cavity by remove intranasal air or supplying adequate oxygen into the nasal cavity .E.g. when people want to reduce sleepiness during important events or occasions such as during driving, studding , listing lectures , security services and machinery works .This drowsiness or sleepiness mainly could be due to excess NO production or absorption of NO by congested or inflamed nasal or sinus mucosa that will be reduced by heat therapy ,ventilation of blocked side of one or both nasal cavity where there is nasal blocked / or sinus ostia blocked ,Then there is a suborbital pain or tenderness over sub orbital area or scalp or unilateral head ache . In sinusitis there is same tenderness with rhinorrhea ,fever .post nasal drips it will not be treated with this device .

However, the portable devices or methods has not been designed or introduced to utilize in the management of the migraine or its relate or comorbid respiratory ,neurological and psychiatric illness .Some device used in the intranasal ventilation had not been claimed for the therapy for migraine or other neuropsychiatric illness regarding removable of excess nitric oxide or reduce s NO by reducing hypoxia . However Some inventers talked about ventilating paranasal area to increase availability of nitric oxide so that it reduces respiratory infections and while their deficiency relates to respiratory health .thus far to ventilate nasal and para nasal area. However methods and device havenot been introduced to remove or reduce excess absorption of nitric oxide . Moreover they had not talk about excess NO .

A current delivery system of the device has a nob or hole to introduce a tub of a pressurized canister (MDI) that ejects the medicine, oxygen or water vapor into the nostrils in short bursts, or streams of atomized liquid in an aqueous nasal spray. The efficacy of medicine administered in this manner is already established . In cases of severe congestion or nasal polyps, Some devices have been made so that the medicine proceeds beyond the nostril .That has been introduced to delivery system alternatives to better deliver more of the medicine to the nasal cavity and paranasal sinuses and of the sufferers of upper respiratory track diseases.

Nasal nebulizers are currently used for effectively delivering antibiotics and some other purposes . But this new device is used for mainly remove and reduce NO absorption in the nasal and paranasal sinuses through air blow out from nasal cavity or blow in to nasal cavity intermittently .The concentration of sNO may sometimes reach more than 20-30 parts per million (ppm) in the healthy sinuses [4-6]. The US Occupational Safety and Health administration has set a limit of NO exposer time to 25ppm when breathed for 8h/day in the work place. It has been identified that the therapeutic beneficial level is around 1000 ppb(lppm) concentration of NO. Excess amount of s NO is harmfuland cause tissue damage and inflammation(07). In addition hypoxic conditions in the nasal and pranasal sinuses cause reduce defense against to micro bacteria ,new vessel formation ,increase vascular permeability ,and hyper responsive ness(8).It has been observed that NO increased 15-fold during humming compared with quiet exhalation(09).On this back ground ventilation done by this new device is aim to reduce this inflammation and reduce the risk of excesses s NO .Moreover this device helps to overcome of the hypoxia induce pathological sequences .Interestingly this device could be used to ventilatenasal cavity when patients are suffering from migraine and its comorbid Illnesses too. On the other hand this could be used for keeping awake during driving period .studying , listing to lectures , security services and machinery works. Hot air released by the device would help to activate sympathetic nerve activity and reduce parasympathetic activity in migraine pathology .This effect will also reduce migraine pathology and reduce hypoxic environment to para nasal sinuses improving oxygenation act there are prior art publications concerning the delivery of breathing gases, where oscillations are imparted to the inhaled gas in order to internally massage the lungs to loosen mucus (see e.g. GB 2 196 858), and to vibrate the cilia in the lungs (see e.g. U.S. 4,054,134; U.S. 4,226,233). Other patents have focused on improving breathing and expectoration (see e.g. U.S. 5,569,122) and in particular to improve peripheral ventilation in patients having disturbed ventilation, for example patients suffering from chronic bronchitis, asthma etc. (see e.g. U.S. 5,018,517).Another important document appears to have addressed the issue of the upper airways and the sinuses, that has been described by Lundberg Jon, Weitzberg Eddie [ WO2003105937 Al ] .They have introduced solution for many practical problems such as improving the gas exchange in remote and/or difficultly accessible parts of the upper airways, in particular the paranasal sinuses wherein said device comprises means for generating and/or maintaining an oscillating airflow or a vibration .

None of these documents appears to have addressed the issue of the medical problems of inflammations and excess nitric oxide in the nasal cavity and para nasal sinuses and its wash out mechanism or its impotence .On the other hand Lundberg Jon, Weitzberg Eddie has considered for treating a condition of the upper airways of a human in their clams . But they did not clam to give attention to the suppression of neuropsychiatric or respiratory diseases using their device by removing excesses NO .Further features and associated advantages of the present invention will be evident from the description, examples, figure and attached claims, incorporated herein by reference.

Many practical problems remains to be solved, .One problem to this device is how to improve the gas exchange in remote and/or difficultly accessible parts of the upper airways, in particular the paranasal sinuses it can be assisted by introducing a probeor mechanical way of breathing .For instance closed the more ventilating nasal orifice by patients thumb and ask to take deep breath and try to exhale through partially or completely closed nasal orifice .Then the nasal part of the air suction hole of the device is introduced to that nostril and allow to be forced suction .This would help to remove excess NO of the para nasal cavities that are patent .If theostia of the cavity blocked or partially blocked , another mechanism can be used by this device for blocked nasal cavity or Ostia .This problem is partly helped by using heater part of the device to increase temperature in the palms .soles and peri oral and nasal aria. Other simpleway is to be used a nasal decongestion drugs before used the device . Some other problems and their solution and the associated advantages of the invention will be evident from the description and examples.

[01]S.M. RathnasiriBandara.Paranasal Sinus Nitric Oxide and Migraine(Medical Hypnosis :www.jouernla elsievr.com(Medical hypotheses, 80(2013),329-340). [02.]S.M. RathnasiriBandara. Migraine and psychiatric disorder explained by Sinus hypoxic nitric oxide theory .Medical Hypnosis :www.jouernla elsievr.com (Medical hypotheses Volume 82 (2014) Issue 3

[03].M. S.M. RathnasiriBandara.Migraine,etal.Migraine and neurological disorders disorder explained by Sinus hypoxic nitric oxide theory. J NeurolDisord 2014, 2:5[04].Lundberg JON, Farkas-Szallasi T, Weitzberg E, et al. (1995) High nitric oxide production in human paranasal sinuses. Nature Med 1 :370-373

[05]. Lundberg JO. Nitric oxide and paranasal sinuses.Anat Rec (Hoboken)

2008;291(11): 149-84.

[06]. Lundberg JON, Farkas-Szallasi T, Weitzberg E, et al. High nitric oxide production in human paranasal sinuses. Medicine 1 1995;1:370-3.

(07). Ichinose M, Sugiura H, Yamagata S, Koarai S, Shirato K. Increase in reactive nitrogen species production in chronic obstructivepulmonary disease airways. Am J RespirCrit Care Med 2000; 162: 701-706.

(8) .Holger K. Eltzschig, and Peter Carmeliet, .Hypoxia and Inflammation.NEngl J Med 2011; 364:656-665February 17.

(09) .Weitzberg El, Lundberg JO. Humming greatly increases nasal nitric oxide. Am J RespirCrit Care Med. 2002 Jul 15; 166(2): 144-5.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram showing the inner arrangement of battery , fan, fan motor ,housing according to the invention.

FIG. 2 is a diagram of housing with air hole , two switches, canister hanger and ,proximal nob for canister tube or drug delivery tube ,outer opening in a device according to the invention. .

FIG. 3 is a diagram of two probes for deep ventilation according to the invention.

FIG. 4 is a diagram of a pressurized canister (MDI) that ejects the medicine into the nostrils in short bursts, or streams of atomized liquid in an aqueous nasal spray, connected to the outer opening of the nob useful in oxygen ventilation or drug delivery according to the invention. FIG. 5 is a diagram of inner aspect of the housing containing a coil consisting with electric circuit connected to switch and the power supplier orbattery . .

FIG. 6 is a diagram of the distal part of the ventilator tube hold on ventilator tube and prons holder. Side view of man wearing the probe and its holder .

FIG. 7.is a diagram of the ventilator tube and connected to the device .

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, the novel device of the present invention is illustrated and generally indicated as 7 in FIGS. 1-7. Turning now to FIG. 1 and 2 having inner covering part and outer covering . The inner covering part includes at least two inner openings [9, 8] ,air holes[7] ,fan[4 ],fan motor [2] ,battery[l] or energy supplier, outer covering part includes canister holder clips[14 A ] ,fan switch[5], heater coil switch [6]in a housing according to the invention

The entire housing will be formed from a single aluminum or plastic material or housing that can tolerate the high thermal condition in the apparatus and outlet of the device cone shaped and outer hole or two holes is smaller so that it can be inserted into nostril or it can be fixed to the nasal probes [figure -03]. The outer covering has canister holder clips that can hold nasal spray canister or ventilator tubs or drug containers .lower portion of the out let has a nob[6]that is also a hole to which canister tube or drugs delivery tub can be inserted , a hallow track inside the nob direct towards the outer hole so that the air or contents can be released at the surface of the outer opening[9,18] .The fan [4] can blow forwarders to blow air towards out let area and backwards so that air sucked out from the nasal cavity . It can be planed so that one end is as sucker and other end is as a blower [ figure 8] .Fan has 8000- 10000 rpm so that it can act normal nasal deep exhalation and inhalation air flow rate and strength or that is adequate to suck air out to the device determinants required . It needs to nearly equal like when one does normal air blow while one nostril is closed .Rechargeable battery has strengthen to supply energy to the motor [2] to rotate the fan at that needs in the invention .If necessary additional current supply( AN or DC current can be added ) is attached to the circuits that connect to the battery e.g. heat the coil[19] or repetitive use the device .The air holes [7] has designed to supply adequate air flow to the fan when it works at its highest velocity . Turning to FIG. 3,] The two probes can be used when normal ventilation is in adequate . The proximal ends of the probes [10,12] has been designed to fix to the device out let [9]. The distal end of the probe [11] has a curve so that it can close its ventilation sites to the Ostia of the sinuses .The other proximal end [13] has designed to less resistant or without damage to the inner tissue of the nasal cavity .

Finally, turning to FIGS. 04, One alternate embodiment of the present invention is shown in the figure .it is the form of one attachment of oxygen canister[14B] to the device .The canister is a smaller size so that it can be attached to the device .The canisters air releasing nob [15] can be used to release air to the device outlet end through ventilator tube [16] which is connected to the device nob [8,17] .Then the air flow through hollow groove[18] to end in the out let of the device [9] .

Finally, turning to FIG. 05. Another alternate embodiment of the present invention is shown as small coil heater [19] at the distal outlet end of the device .Warm air can be applied to peri oral ,facial skin ,and at the openings of the nostril .The heat range is adjusted at therapeutic level which is the not beyond the normal body temperature .But it can vary within the range of nor harm to skin and nasal mucosal tissue. This heater can be used for keep awaken during sleepinessf e.g. driving ,reading or studying etc]. This might help to send stimuli to the brain or increased sympathetic neuron impulse which leads to increase Ostia patency and then device can remove excess NO easily and ventilate the sinuses to increase oxygen in the sinuses . This mechanism will be helped by nasal decongestion However this warmer does not need when normal air ventilations is functioning and no other symptoms like sleepiness ,yawning., congestion of nose .

FIG. 6 and 7 . The six figure is side view of head of a man wearing a nasal prons [21] and its holder[24] . The sevenfigure is a diagram of the distal part of the ventilator tube[23] ,and its holder , ventilator tube [23] and small nasal prone [22] is connected to main ear holder [25]. This nasal ventilator tube is connected by long tube to out let [9]of the device through a connecter [27] . A small Oxygen canister is connected to the device and is kept on to deliver oxygen through the ventilator tube comprising 20— 90% oxygen therapy for short period(5-10 ) mints or canister sending level . Air blowing towards nostril can be adjusted if it needs to increase flowing rate .The ventilator tube and the prone holder [25] is fixed to the ear like head microphone used by a singer. This type of holder is designed to be adjusted when operator needs .e.g. Driver can move the nasal prone holder fully up or down when he reduces his sleepiness during driving .and he can get the nasal prone to nostril when he gets sleepiness again. Finally, turning.FIG. 8.The eight figure is a form of housing and bilateral opening .one end act as an air sucker and other end act as a blowing normal air and heat air .Figure show side view of the head of a man using the device

Condition to improve and method of use

NOanalyzer or NO sensor and apparatus to detect nasal air flow rate can be used and attached to the device .This is not added here because of high cost .Therefore it needs to get basic knowledge of high para nasal NO conditions or illnesses , symptoms or sings of medical illness caused or related with high para nasal NO(before the device is used ) .The proposed device is preferably suitable for the treatment and a clue to diagnosis of diseases of the neuropsychiatric illness , such as, migraine, vertigo ,narcolepsy , sleepiness psychological stress( e.g. . laziness, lethargy, fear , )and impulse or impulsive moods( e.g. anger, sorrow , for abusing or to do harm to self or others ),and improving respiratory and neurological health. In addition The device with oxygen therapy canister or well aeration into the cavities is used to increase wound healing after intra nasal or sinus surgery or other wound as well as reduce odema or inflammation induced by hypoxia

It should not be used to remove NO by blow out intranasal air when there is NO

concentration low conditions such as sinusitis or any other conditions having low s NO pathology .However repeatedly aeration of blocked nasal cavity with additional oxygen supply with a pressurized oxygen canister will reduce inflammation and edema .This intern helps to improve nasal and paranasal healthiness. Oxygen should be used after sucked out of para nasal gas or s NO

Other important knowledge to use this with user self or assistant examination .A important physical examination is to check your nostril air ventilation by your own 2 nd and 3 d finger (dorsal aspect ) or otherperson's assistance .More blocked side or if both blocked side of nasal holes to air should be ventilated .Other method to examine is to be examined more tendenceside or to be induced pain when suborbital area is compressed by thumb . This side isto be ventilated first .If sleepiness is more oxygen supply should be added .In addition other side must be ventilated because of less significant of the examination with the pathology .

The frequency of ventilation is limited to 5-15 per one occasion .The maximum of air velocity is equal as at the velocity of deep nasal exhalation and inspiration of healthy human beings .It is decided with clinical improvement . 2-10 minutes interval should be kept before next round .As this device is mainly for normal people or patients with mentioned symptoms oxygen can be delivered at its desirable or adjustable level .It is because aim is to reduce intra sinus excess NO production . However if the recovery of symptoms is not felt medical advice should be taken as it may be due to other pathology or more severe form of the illness. SUMMARY OF INVENTION

In this regard, the present invention provides for a novel construction for nasal ventilator that provides air blow in and out of the nostrils .An addition one feature of this device is to add hot air blow out method .When one gets drowsiness or head ache or nasal congestion this device can be used to ventilate nasal cavity .

The battery or current supply and motor and axial fan keeps the air flow in and out for the need of short duration .The heat coil is used when it is essential to use .

It is an important feature of the present invention that the additional nob for insert canister tube or drug delivery tube is provided as close to the terminal end of the contact lower part of the end of the device out let area without interfering with the necessary direct air flow .. The nob valve is preferably formed as a flap of the same material from which the device is formed which is for insertion of canister tube . Placing the canister in this device location provides several important advantages over the prior art. First, in this location, oxygen or any other aerosol or gas form medicine can be added easily and same events and reduce preventing any back flow of air because it is placed in a portion of the lumen out let in a cannel or grove that tapers outwardly. When the device is used in long ventilator tube. This effect may be enhanced by further providing additional flow pressure towards the nostril. When the device can be put in a bag or pocket.

Furthermorethe adjustable small nasal prone and adjustableventilator tub holder is another advantage of this device because it can be used as normal healthy looking appearance rather than wearing ventilator tube either side of face and easy to manipulate and transportable size.

The second is advantage provided by adding nasal probes (2.5cm ) which is necessary to be ventilated more deeper nasal cavity .One probe has a 15 o angelat its distal end . This can be manipulated towards lateral side of the inner nasal cavity to suck out air or blow air at the area of medial meatus of the that side of the maxillary sinus Other probe(3.5cm) can used to suck out or remove air deeper area of the nasal cavity including sphenoid sinus .This can be self-inserted after training when there is no major obstructions or abnormality in the nasal cavity

In this manner, the ventilator construction insures prevention of production of unnecessary or absorption of extra NO and reduce or prevention of hypoxia induce inflammation . Another advantage of the present invention is that when employed withheat coil construction, which is located at outlet side of the inner aspect of device. In this manner, hot air through small out let to small aria may be provided if desired to allow warming through the device as it has been previously unknown in the art. With the prior art devices of this type, the only way to drug or water vapor or facilitate air for other purposes but they are not to remove NO or reduce inflammation or supply heat for particular area for mention purposes- In addition they are not potable and large ventilators.

Accordingly, one of the objects of the present invention is the provision of a novel oxygen ventilator construction that provides protection against the inflammation and excess NO production .

Yet a further object of the present invention is the provision of anattached oxygen canister that provide oxygen directly to nostril or while one can used ventilator tube holder mechanism for the attachment of accessories such as nasal small prone.

Finally, since the machinery and additional parts of the present invention is located in a small housing or portable device it is more likely to use among the many people or patients when they are in many discomfort conditions or events.

Other objects, features and advantages of the invention shall become apparent as the description thereof proceeds when considered in connection with the accompanying illustrative drawings.