System for nasal irrigation

TECHNICAL FIELD

The embodiments described below generally relate to methods and devices for irrigating and rinsing the nasal cavity and anatomical openings thereof.

BACKGROUND OF THE INVENTION

Nasal and sinus disease and sinus-related syndromes and symptoms are a common clinical problem with considerable patient morbidity, substantial direct costs and a significant negative impact on the quality of life of those affected. The three main categories of affected groups are: 1) individuals with acute and chronic rhinosinusitis; 2) individuals with acute upper respiratory infections; 3) individuals suffering from allergic rhinitis; and 4) individuals with chronic snoring problems. These four categories reach millions of people who suffer from nasal congestion daily.

The Centers for Disease Control and Prevention estimated the number of chronic rhinosinusitis cases in the United States at 35 million in 1994, a prevalence of approximately 13.5%, or about 40.5 million Americans adjusted for population numbers in the United States. 2007. Rhinosinusitis was the fifth most common diagnosis for which antibiotics were prescribed from 1985 to 1992. In 1996 rhinitis was the cause of approximately 26.7 million office and emergency room visits, resulting in $ 5.8 billion in direct costs.

Allergic rhinitis has been reported to affect approximately 17% of the general population in the United States (and, in selected pediatric populations, may be present in up to 42%). This is equivalent to an estimate of over 60

Petition 870180165291, 12/19/2018, p. 5/9

2/16 million Americans.

Problems with snoring currently affect about 90 _t million adult Americans, 37 million on a regular basis.

·> 5 The combined number of those suffering from rhinosinusitis, allergic rhinitis and snoring problems equals a high estimate of 190 million Americans and a low estimate of 128 million Americans, not counting double-counting individuals who may be in 10 two or more categories. Adopting the conservative assumption of over 40% doubling results in an estimated 75 million Americans suffering from adverse sinus symptoms who should benefit from effective therapy to alleviate those symptoms.

Washing the nasal cavities and sinus cavities with lightly salted water to remove encrusted mucus, irritants and external particles for the purpose of improving airflow and relieving nasal congestion has been widely practiced in many cultures for literally 20 thousand years. More recently, and particularly since about 1990, a significant number of re-evaluated clinical trials have been conducted at leading American and European medical schools and research centers to test whether anecdotal statements of nasal disease symptom relief * 25 as a result of nasal irrigation are well-founded and undergo scientific examination.

Several clinical studies have shown that regular use of nasal irrigation is an effective therapy for alleviating the symptoms of chronic and acute rhinosinusitis, including 30 statistically significant findings of reduced nasal congestion, increased nasal airflow, reduced physician visits, prescription for medicines for reduced sinus and quality of life

3/16 improved. Other clinical studies indicate that regular nasal irrigation is a beneficial therapy for the treatment of allergy-related nasal symptoms. Other unpublished clinical studies are currently underway, - 5 testing whether nasal irrigation is an effective preventive therapy in the common cold and snoring.

These studies indicate that nasal irrigation is a clinically proven method for treating the symptoms of sinus-related diseases by exposing the nasal cavity to a tidal volume of saline. Although the exact mechanism with which the effectiveness of nasal irrigation is obtained is not yet well understood by the medical and scientific research community, it is likely to be multifaceted and includes several physiological effects that may individually or jointly result in improved mucosal capacity. by reducing the pathological effects of inflammatory mediators and other causes of allergic rhinitis, asthma and other chronic mucosal reactions, as follows. First, it rinses the entire interior of the nasal cavity, 20 removing fouling that may obstruct the multiple ostium that connects the sinus cavities to the nasal cavity, thereby allowing the sinus cavities to flow properly into the nasal cavity and making the sinus cavities sinus a breeding site much less attractive to bacterial colonization. Secondly, it decreases mucus viscosity in the nasal cavity, thereby reducing the formation of fouling inside. Third, it leaves a small saline effluent on the inner surface of the nasal cavity, including the openings of the 30 sinus cavities and sometimes the sinus cavities themselves. This is beneficial because the saline has an inherent antiseptic quality that prevents the growth of bacteria. Fourth, the exposure of the nasal shells, the

4/16 vascular tissue that warms and humidifies nose-inspired air before it reaches the lungs, the saline solution reduces the size of the lungs, thereby reducing nasal congestion. Fifth, it favors mucociliary clearance as a result of the increased ciliary beat frequency, which improves the ability of the mucosa to perform its natural flow function. Sixth, the saline solution can remove airborne bacteria, viral particles, irritants, and other outer particles that cause infections and allergies.

There are three methods by which the nasal cavity can be irrigated: gravity, pressure and suction.

Gravity-based devices allow saline to flow into the nasal cavity, for example, by introducing the tip of a teapot-like nozzle into one nostril and then pouring saline into it. Saline then flows around the posterior margin of the nasal septum and into the user's other nostril. An example of a gravity-based device is the Neti potentiometer.

However, the uncomfortable physical position required to perform such a rinse is difficult for many people, and the effluent flowing free from the nasal passage is dirty, so substantial cleaning procedures are required.

Pressure-based devices pump saline into the nasal cavity again by introducing saline into one nostril, forcing it under pressure around the posterior margin of the nasal septum and allowing it to flow into the other nostril. . This can be done, for example, by placing the nozzle of a plastic tube 30 or flexible saline vial in one nostril and squeezing it, thereby injecting saline into one nostril through the nasal cavity and to the other nostril. Although this avoids any physical discomfort necessary to

To achieve the forced flow of gravity, dirt problems and the inconvenience of subsequent cleaning remain. In addition, the varying pressures imparted by a clamping tube can cause unwanted, painful, and even uncomfortable pressures throughout the nasal passage, and particularly at the eustachian tube ostium. Thus, some acquired skill is required for proper use.

Earlier devices generally do not use suction. The most common method by which suction is used 10 to perform nasal irrigation is as simple as the user putting some lightly salty water into his palm and aspirating it with his nostrils.

There is currently no practical device that provides the user with the ability to perform nasal irrigation 15 using the three methods presented in a single device.

There is currently no practical device that gives the user the ability to perform nasal irrigation with a combination of gravity and pressure, gravity 20 and suction, or pressure and suction in a single device, nor is there a device that provides a powered mechanism by any of the previous three combinations.

There is currently no practical device that provides the user with the ability to perform nasal irrigation * 25 using suction only.

A convenient portable device is required that can safely irrigate the nasal cavity with a smooth, controlled supply that removes the irrigation element from the nasal cavity under the influence of a gently fed suction 30 which safely collects effluent facilitates rapid and easy elimination, and is readily adaptable to a wide variety of nasal dimensions.

6/16

BRIEF DESCRIPTION OF THE INVENTION

A nasal irrigation device for therapeutic irrigation of a user's nasal cavity is presented. The device includes a saline source, an effluent receptacle, a nasal interface, a vacuum source, fluid passages, and a switch and valve assembly. The nasal interface attaches a user's nostrils to the device to dispense the saline by gravity from the source to the nasal cavity. The saline source 10 communicates with the effluent receptacle through the fluid passage, nasal interface and nasal cavity of the device user. The switch and valve assembly controls the vacuum source and saline flow through the fluid passage. It should be understood that in addition to the above saline, alternative irrigation elements may also be incorporated for use with the device.

Also disclosed is a method for irrigating a nasal cavity including sealing a user's nostrils with a portable device that includes an associated fluid passage in communication with a saline source and a saline effluent receptacle. The passage, source and receptacle are integrally mounted on the portable device. A relative vacuum is applied to the effluent receptacle with a powered suction source also included in the portable device. Saline is released from the source into the passageway and nasal cavity, whereby a flow of saline through the nostrils and around a posterior margin of a user's nasal septum irrigates the nasal cavity.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is a perspective view of one embodiment of the exposed nasal irrigation device;

Figure 2 is a side top view of the embodiment of Figure 1;

Figure 3 is a perspective sectional view showing an upper wall removed for a clearer view of the elements housed in the embodiment of Figure 1;

Figure 4 is a partial cross-sectional view of the side top view of Figure 2, wherein an outer side wall is removed, again to show the inner elements;

Figure 5 is a top plan view of the device corresponding to Figure 3, wherein the top wall is also removed to similarly illustrate the internal components;

Figure 6 is a partial view of the internal components 15 of the device, in which all outer walls have been removed;

Figure 7 is a view similar to Figure 6 of an alternate embodiment, wherein a vacuum source such as an electric pump assembly is missing;

Figure 8 is a perspective view of another alternative embodiment, wherein a grip is arranged below a nasal interface in front of an effluent receptacle;

Figure 9 is another alternative embodiment, in ^k25 whereas both the saline source and the effluent receptacle are disposed relatively below the nasal interface;

Figure 10 is a perspective view of another alternative embodiment including a mug type configuration including a side handle;

Figure 11 is an elevated side view of the embodiment of Figure 10 which particularly illustrates a non-evident rear view of Figure 10;

Figure 12 is a partial cross-sectional view of the embodiment of Figure particularly illustrating the internal components; and Figure 13 is a flow chart illustrating the steps of an embodiment for practicing the nasal irrigation method.

DETAILED DESCRIPTION OF THE FIGURES

The figures show a portable, preferably easily portable, nasal irrigation device or instrument that features a more convenient, cleaner, more pleasant and more effective therapy for nasal cavity and sinus ostium irrigation. Device 10 consists primarily of three components, an irrigation element source vial 12, which contains, for example, saline, a receptacle vial 14 for receiving effluent saline, and a controller 16 for controlling communication. fluid from the first vial through the nasal cavity to the second vial as will be further explained below. Vials 12, 14 may be of any variety of shapes and may be attached to the controller in various ways, such as with a threaded neck, a pressure adjustment, a bayonet holder, or the like. A typical size will accommodate from 6 to 10 ounces of fluid. It should be provided that the first flask 12, being emptied as a result of being used, may subsequently be used as the second flask 14, which, after being filled with effluent due to use, may then be discarded. Therefore, the provision of a single vial provides both the first saline source vial at one time, and then the effluent receptacle 14 at a next time. Also within the intended scope of the present embodiment is the fact that the vials may be refilled or reusable, or may even be compartments

9/16 devices within controller 16 that can be charged or emptied upon completion of an irrigation therapy. In Figure 3, vial 12 'does not have an upper wall, so it has its open end for refilling. While saline is mentioned herein as an exemplary irrigation element, embodiments lend themselves to including alternative irrigation elements of a variety of saline mixtures, including flavourants or medicaments.

Controller 16 includes a grip portion and a housing 22. The grip portion 20 is intended to function as a gun-type stock that includes a trigger 24 and a support base 26 having a flat bottom wall 28 to permit that the entire assembly 10 stand on a flat surface such as a bathroom vanity or kitchen counter top when not in use. The base 26 also includes an arcuate cutout 30 in a shape that corresponds to the contour of the effluent vial 14 for ease of support and positioning of the vial 14 relative to controller 16. The handle assembly 20 is configured to accommodate both a right-hand grip buttock and a left-hand grip stock as trigger 24 and the ergonomic handle configuration must be -25 neutral in terms of which hand to use. The housing 22 includes a top cap 34 which includes an opening for the source vial 36 through which the saline source vial extends, and a nasal interface 38 is arranged to engage the nostrils 32 of a user's nose with a good seal to form an integral fluid passage between the source bottle 12 and the effluent bottle 14 through the user's nasal cavity. The nasal interface consists of a first and a second nozzle 40, 42, which are also called

10/16 nasal cushions, which can swivel or pivot as needed to form a cushion seal against the nostrils, depending on the user's personal anatomy. A positive seal between a user's nasal cushions and nostrils is essential to the successful operation of the device with respect to its therapeutic function as well as its distinctive qualities of convenience, cleanliness and order.

Therefore, the pads 40, 42 are specially configured to facilitate such sealing. In operation, flow from the nasal cavity is prevented as long as the coupling seal between interface 38 and the nostrils is maintained.

It can be seen that the nasal cushions have a truncated elliptical configuration in a flat view and a slightly flattened conical configuration in the cross section. The opening of the cushion is slightly spaced from the center of the cushion to provide a longer sealing surface to engage the outer edges of the nostrils rather than the inner edges, which are limited by the nose columella. Cushions 40, 42 may alternatively comprise common nozzles which are easily removed and replaced for proper rinsing or for securing a personal set of nozzles that correspond to distinct individual users. Adjustment to accommodate different nose sizes is effected by rotating the support swing gears 56 or other generally known mechanical devices.

The overall configuration of a nasal interface is designed to obtain a positive, fluid-tight seal by gently but vigorously pushing the nozzles 40, 42 against a user's nostrils 32.

With particular reference to Figures 3-6, it can be seen that the housing also includes a lower housing wall 44 for supporting the fluid passageways forming the fluid passageway and a pump assembly 60.

11/16 to direct the saline from the first vial 12 to the second vial 14. The first vial is mounted to the controller so that the saline can be communicated to a saline supply conduit 46 and a conduit - 5 of pressure relief from the supply bottle 48 (Figure

6). The supply duct passes through the trigger 24 which may corrugate the duct or otherwise interrupt fluid flow through the duct as with a valve (not shown). Conduit 46 is normally closed by corrugation 10 and will only communicate vial fluid to a nasal interface when the user activates trigger 24. Supply conduit 46 communicates directly with the first nozzle so that the saline can be directed to the user's left nostril (as shown), passes through the nasal cavity and then is received at the second nozzle 42 for direct communication to the patient. effluent flask 14 through effluent conduit 50. Effluent flask 14 is mounted to the effluent flask holder 52. The size and configuration of the conduits is not particularly limited as long as they allow immediate fluid flow. The sizes from 3/16 to

5/16 inches proved to be efficient. Minimizing the sharpness of the conduit angle terms and the appropriate volume metric achieves the desired irrigation therapy. Effluent conduit 50 terminates in a 25 effluent vial holder 52 which provides air-tight and fluid-proof seal between effluent vial 14, conduit 50, and vacuum source conduit 54.

It is a feature of the embodiments that the vacuum pump assembly 60 is a relative vacuum source within device 10 to further facilitate irrigation therapy by enhancing flow with a suction force that extracts the saline irrigation element. nasal cavity besides inducing the severity of the flow of the

12/16 source 12. A vacuum source is believed to be a boosting force in relation to a user's health and therapeutic experience, unlike pressure pump-based devices, which introduce saline - 5 into the cavity and develop high pressure regions therein.

Therefore, the vacuum pump 60 communicates the relative vacuum or negative pressure to the effluent vial through the vacuum conduit 54, thereby facilitating the extraction of saline from the nasal cavity and to the second nasal cushion 10 42. Pressure relief 64 is arranged to limit the maximum amount of vacuum to no more than approximately 5.5 inches of mercury. Pressure relief valve 62 likewise allows air to replace saline flowing out of supply bottle 12.

Electrical power is supplied to the pump 60 by a battery source 68 located at the base of the handle 26. The battery source may comprise replaceable or rechargeable batteries, or may alternatively comprise a wired power source 20 for irrigation devices which may be be continuously employed in professional medical care.

With particular reference to Figure 4, trigger 24 operates not only to release saline flow to supply line 46, but also to couple a switch 70 to be closed to supply electrical power to pump 60 from the source. battery life 68.

In operation, device 10 is disposed adjacent to the nostrils in the manner shown in Figure 2, whether portable or supported on a surface by moving the user's head to the intended coupling position. The user will pull trigger 24, which will have several effects at the same time. It can be seen that the first bottle

13/16 is disposed relative to the nasal cavity such that the saline solution is above the nasal cavity. Opening the saline supply conduit 46 allows the saline fluid to flow to the first nozzle 5 simply by gravity, and likewise to the nasal cavity, in the remaining fluid passages, by gravity. The exclusive use of the force of gravity is indeed a particular achievement as will be discussed below. However, extraction of fluid from the nasal cavity through activated suction 10 significantly enhances the wash, massage and rinse elements that are critical to effective nasal irrigation. In addition, the use of triggered suction virtually eliminates the risk of pressure application that can cause pain and potentially damaging the ostium in the fallopian tube.

Eustachian in the nasal cavity. Since the flow is all downhill, a relatively small amount of vacuum is required to achieve the desired effect of extracting saline around the posterior margin of the nasal septum and expelling effluent from the nostrils. A miniature pump that generates vacuum in the range of 3 to 5 pounds per square inch is sufficient for the purpose of properly depressurizing the effluent bottle. However, an alternative embodiment (Figure 12) may readily include a multi-speed pump source for varying pressure based on different trigger positions.

With particular reference to Figure 7, an alternate embodiment of a fluid passageway 82 is missing in which pump assembly 60 and battery assembly 68 are missing. Saline should pass through nasal cavity 30 through supply conduit 46 and for effluent conduit 50 to flow into the effluent receptacle merely by gravitational induction, since both the nasal interface 38 and effluent receptacle 14 (not

14/16 shown) are arranged downhill from the supply bottle 12. Although the flow does not exhibit the intensified flushing action of the triggered flow of the embodiment of Figure 1, the embodiment of Figure 7 still provides therapeutic cavity irrigation. nasal. Relief valves 64, 62 function more as vents than as pressure regulators in this embodiment.

With particular attention to Figure 8, an alternative embodiment 90 is shown wherein the grip 92 is disposed directly below the nasal interface 94 and in front of the receptacle vial 14, and includes a thumb switch 95 that operates to release the flow of saline solution and to provide electrical power to the pump. Although the internal conduits comprising the fluid passage in this embodiment 90 are slightly different in order to accommodate the alternative positions of the vial 14, the effective operation is the same and confers the advantage of not having to run a hand around the vial 14 to holding the handle 20 as in the embodiment of Figure 1.

0 With particular reference to Figure 9, another alternative embodiment shown is similar to the embodiment of Figure 8, except that the supply bottle 12 is now disposed below the housing 98 and adjacent to the effluent receptacle bottle 14. In this embodiment, a Since the supply bottle 12 is disposed below interface 100, only gravity cannot induce a saline solution from bottle 12 to interface 100. Therefore, vial 12 must be pressurized in some way to propel the saline through the supply duct 102. In this case the pump assembly (not shown) pumps air into vial 12 through the pressure duct 104 of opposite way to pumping air out of the effluent receptacle bottle 12 to obtain the relative vacuum

Desired 15/16 of the same. Alternatively, the pump assembly could comprise a first pump (not shown) for pressurizing the supply bottle 12, and a second pump (not shown) for producing the relative vacuum in the effluent receptacle 14 similar to the pump 60 .

With particular reference to Figures 10-12, an alternate embodiment is shown with a mug-like configuration 72 including a side grip 74 and a thumb-controlled trigger 76 (nasal interface not shown). A supply bottle 78 is received on a support base 80 while effluent bottle 81 has a removable compartment 82. Trigger 76 controls a two-speed switch 77 for variable flow.

With particular reference to Figure 13, the method for practicing nasal irrigation is detailed. The method comprises sealing a user's nostrils with a fluid passageway of the device 10 including the supply and effluent conduits. When the user turns on the device by pulling the trigger 24, a relative vacuum is applied 108 to the effluent receptacle 14 while saline is released from the supply bottle 12 to flow to the nasal interface 38 and the nasal cavity and specifically around the posterior margin of a nasal septum, and finally to the effluent vial. Flow is induced by gravity as a result of positioning the supply bottle 12 above interface 38 and receptacle bottle 14 and the resulting suction from the relative vacuum in the effluent bottle 14.

The liquid supply should at least comprise an integrated saline solution to prevent cavity irritation. It has been found that a mixture comprising several fragrances or flavors can intensify the

16/16 such as eucalyptus, chamomile, mint or others. It has also been found that buffering saline with sodium bicarbonate may intensify the experiment. It has also been found that the use of hypertonic saline may intensify the experience. Alternative irrigation elements may also be used, as well as mixtures with medicaments such as antibiotics, steroids or analgesics that are especially suitable for clearing the nasal cavity as rinses, unlike absorbents.