The present invention in general is related to systems and methods for washing body cavity. More particularly, the present invention is related to an apparatus for discharging a fluid to the nasal cavity of a user.
Nasal cleansing involves washing out nasal and sinus passages with a suitable solution. The solution is made to circulate in and out of the sinus cavities, coming back out from the mouth or from the opposite side of the user's nose. This is believed to be helpful in maintaining nasal hygiene, limiting sinus infection and in relieving symptoms and signs of rhinitis. Also, in pre and post-operative periods, nasal irrigation can be used to flush out bacteria, clots, and normal crusts.
Nasal irrigation is now widely recognized as a treatment for chronic rhinosinusitis and during the postoperative period. Topical sinus irrigations play a critical role in the management of sinonasal disease, and the improvement in irrigant penetration into the sinuses postoperatively greatly contributes to the success of endoscopic sinus surgery. High-volume irrigation delivery is more effective for achieving distribution to the sinuses that other topical delivery methods such as nasal sprays, nebulizers or atomizers. The improvement of sinus irrigation penetration thus increasingly becomes an important outcome of endoscopic sinus surgery.
Powered nasal irrigation systems that may include a suctioning option are not generally available for home use. Devices such as squeeze bottle, gravity feed neti pots, collapsible deformable bulbs etc., are commercially available for home use. Also, available for home use are devices that use a motorized pump or other electromechanical means to provide a fluid flow for nasal irrigation. Many of these devices require the user's head to be tilted to one side during use. This is not always convenient or comfortable for the user. For users with certain medical conditions, leaning of the head to irrigate the nasal passage may not be possible at all. The problem may get aggravated if the flow and pressure of the fluid are not controlled and splashing or overflow of the fluid occurs. Also, the conventional bottles or containers used for nasal irrigation are not ergonomically convenient for the users. Variability related to the overall shape of the nose, presence of cartilaginous components and skin thickness makes use of conventional nasal irrigation devices even more challenging.
Accordingly, systems and methods that overcome the above-mentioned disadvantages associated with conventional nasal irrigation devices, such as providing better sinus penetration and coverage of the nasal cavity, and that account for different nasal configurations, are desirable and an object of the present disclosure.
The following presents a simplified summary in order to provide a basic understanding of some aspects of the present disclosure. This summary is not an extensive overview, and it is not intended to identify key/critical elements or to delineate the scope thereof. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is presented later.
The present disclosure is directed to a nasal irrigation device having an adjustable nozzle. In certain embodiments the nasal irrigation device of the present disclosure comprises a container having a storage space for a nasal rinsing solution, a dispenser and an adapter. The container having a large opening is capable of holding adequate quantity of the nasal rinsing solution and also facilitates mixing of the solution. The adapter on one side surrounds the mouth of the container and holds the dispenser on the other side. A ball-and-socket kind of coupling between a socket disposed on the adapter and a substantially spherical mounting end of the dispenser enables rotation of the dispenser with respect to a longitudinal axis of the container in an assembled condition. The socket has a tube extension which defines a fluid passageway between the container and the dispenser. The coupling allows flow of fluid through the fluid passageway from the container to the nozzle end at any inclined position of the dispenser within an allowable range of angle of inclination. An angle limiter projecting inwardly to the socket from the top end of the tube extension prevents the dispenser from being tilted to a degree wherein the mounting end may block the fluid passageway.
A user may keep his/her head in a vertical position, put the nozzle tip in the nostril and tilt the container to hold it at any desired angle. A gentle squeeze of the resilient sidewall of the container propels the nasal rinsing solution through the nozzle end to the nasal passage of the user.
The present disclosure also provides a nasal irrigation device comprising: a) a container comprising a top end, a bottom end, a bottom surface, an upper portion and a lower portion, the top end defining a neck portion comprising an inner surface and an outer surface; b) an inner cap comprising an inner surface, an outer surface, a top end and a bottom end, the inner cap comprising a sealing ring proximal to the top end of the inner cap; c) a nozzle comprising an opening, a top portion, a middle portion and a bottom portion, the nozzle defining a passageway therethrough, the top portion of the nozzle defining a tip and the middle portion of the nozzle defining a ball joint, the nozzle engaging with the sealing ring of the inner cap; and d) a tube having a top end and a bottom end, the top end of the tube engaging with the bottom portion of the nozzle and the bottom end of the tube extending within the container from the top end of the container toward the bottom end of the container; wherein the angle of the nozzle is adjustable relative to the container when the nasal irrigation device is assembled.
In certain embodiments the outer surface of the neck portion comprises a first fitting and the inner surface of the inner cap comprises a second fitting, wherein the first fitting and the second fitting are designed to releasably engage with each other. In some embodiments the first fitting and the second fitting are threadably engaged when the nasal irrigation device is assembled. In other embodiments the first fitting and the second fitting form a snap fit connection when the nasal irrigation device is assembled. In further embodiments the inner surface of the neck portion comprises a third fitting and the outer surface of the inner cap comprises a fourth fitting, wherein the third fitting and the fourth fitting are designed to releasably engage with each other. In yet further embodiments the third fitting and the fourth fitting are threadably engaged when the nasal irrigation device is assembled. In still further embodiments the third fitting and the fourth fitting form a snap fit connection when the nasal irrigation device is assembled.
In some embodiments the nozzle is adjustable relative to the container when the nasal irrigation device is assembled based on a rotational position of the ball joint relative to the sealing ring of the inner cap. In various embodiments the opening has a stellate shape. In additional embodiments the nasal irrigation device further comprises an outer cap comprising a top end, a bottom end, an outer surface and an inner surface, the inner surface proximal to the bottom end of said outer cap designed to engage with the outer surface of the inner cap. In yet other embodiments the nasal irrigation device further comprises a time management strip attached to the bottom surface of the container.
In particular embodiments the container is comprised of a flexible polymer. In some embodiments the polymer comprises zinc or silver. In other embodiments the polymer comprises low-density polyethylene (LDPE). In further embodiments the tip of the nozzle is designed to fit within a nostril of a patient. In certain embodiments the tip of the nozzle has a semicircular shape. In additional embodiments the tip is comprised of rubber or a thermoplastic elastomer. In yet other embodiments the tip is comprised of a material that reduces the risk of at least one of nasal bleeding or septum perforation when the tip is inserted into a nostril. In some embodiments the tip is in the shape of a reverse taper. In particular embodiments the reverse taper shape provides for improved nasal fitting at the nostril level. In certain embodiments the middle portion of the nozzle is comprised of plastic. In some embodiments the middle portion of the nozzle comprises acrylonitrile butadiene styrene (ABS).
In additional embodiments the container further comprises a liquid, and wherein the nozzle is capable of varying the amount of the liquid passing through the nozzle. In some embodiments the liquid is a saline solution. In certain embodiments the container further comprises a flexible sidewall. In other embodiments the container further comprises a liquid, and wherein the nozzle is configured to create a turbulent stream of liquid exiting the nozzle when the sidewall is squeezed. In yet other embodiments the container further comprises a liquid, and wherein the nozzle is configured to create a level of turbulence in a stream of liquid exiting the nozzle when the sidewall is squeezed, such that the turbulent stream of liquid is directed toward and sufficient to enter and flush at least a substantial portion of a sinus passage.
In further embodiments the tip of the nozzle defines a stellate shaped opening. In yet further embodiments the tip of the nozzle defines an opening that increases surface area dispersion and intranasal turbulence. In additional embodiments the surface area dispersion and intranasal turbulence are sufficient to generate a flooding mechanism for irrigation of a sinus cavity. In some embodiments the upper portion of the container is angled relative to the lower portion of the container. In other embodiments the inner cap comprises ABS. In yet other embodiments the sealing ring comprises a thermoplastic elastomer.
In certain embodiments wherein upon engagement of the ball joint with the sealing ring the nozzle comprises multidirectional positioning capabilities. In some embodiments the nozzle is positioned to irrigate in at least one of a superior or inferior arrangement.
It is, therefore, an object of the present disclosure to provide an apparatus that enables adjustment of the nozzle in different angles. Another object of the present disclosure is to provide an ergonomically enhanced nasal irrigation device. Yet another object of the present disclosure is to provide an efficient nasal irrigation device. Another object of the present disclosure is to provide a nasal irrigation device that enables easy introduction of solution to nasal passage of a user. Yet another object of the present disclosure is to provide a device for effective irrigation of solution to all the desired parts of the nasal passage. Another object of the present disclosure is to provide a cost effective method for enabling a user to get his/her nasal passage irrigated while keeping his/her head in an upright position.
All of the figures depict preferred embodiments, although other embodiments are contemplated, and the present disclosure is not limited to the embodiments shown.
To provide an overall understanding of the disclosure, certain illustrative embodiments and examples will now be described. However, it will be understood by one of ordinary skill in the art that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the disclosure. The compositions, apparatuses, systems and/or methods described herein may be adapted and modified as is appropriate for the application being addressed and that those described herein may be employed in other suitable applications, and that such other additions and modifications will not depart from the scope hereof.
In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. However, it will be understood by those skilled in the art that the present disclosure may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the present disclosure.
Reference to
The concave shape of the sidewall 202 provides a comfortable gripping location and contour for a user to hold the container 102. The resilient, flexible nature of the bottle material makes it convenient for the user to squeeze the container 102, particularly in the narrowed waist middle section 203, toward the longitudinal axis 200 to dispense a liquid stored in the storage space 204. The container 102 quickly rebounds to its original, non-squeezed shape immediately upon release of the squeeze pressure.
The adapter 104 is configured to connect the dispenser 106 rotatably or pivotally to the container 102 while allowing fluid communication between the two. As shown in
A top end 268 of the tube extension 218 opens into the socket cavity 304 and a distally opposite tube bottom end 269 of it opens into the storage space 204 when the adapter 104 is attached to the mouth 206 of the container 102 thereby forming a fluid passageway 220 between the storage space 204 and the socket cavity 304. An angle limiter 270 is disposed over the top end 268 of the tube extension 218 that projects inwardly into the spherical socket cavity 304. In some embodiments, an elongated tube 224 is affixed to the tube extension 218 so that the distal end 228 of the elongated tube 224 can reach the bottom of the storage space 204.
With continuing reference to
As illustrated in
The mounting end 234 has a spherical region defined by the outer wall 235 that is dimensioned to conform to at least a portion of the inner wall of the socket cavity 304 so that adequate sealing can be provided between the mounting end 234 and the socket cavity 304 against any leakage of fluid even when the mounting end 234 rotates within the socket cavity 304. The mounting end 234 has a truncated bottom face 264 disposed substantially perpendicular to the axis of the nozzle channel 238. As illustrated in
The angle limiter 270 restricts the angle by which the dispenser 106 can incline/pivot with respect to the longitudinal axis 200 so that the spherical region of the mounting end 234 never blocks the top end 268 of the tube extension 218 when the dispenser 106 is rotated within the socket cavity 304. The area of cross-section of the nozzle channel 238 inside the mounting end 234 is dimensioned to be greater than an area of cross-section of the top end 268 of the tube extension 218 such that the angle limiter 270 is surrounded by at least a portion of the nozzle channel 238 in an assembled condition of the device 100.
For use, the storage space 204 of the container 102 is filled with a nasal rinsing solution after unscrewing the adapter 104 from the mouth 206 of the container 102. A large opening 302 of the mouth 206 facilitates pouring of the solution to the container 102. The adapter 104 holding the dispenser 106 is then screwed back onto the mouth 206. As the dispenser 106 is rotatable within a wide range of allowable angles of inclination, the user is not required to tilt his/her head to get his/her nasal passage irrigated. Instead, the user can keep his/her head substantially vertical and tilt the dispenser 106 at a desired angle so that the nozzle tip 242 sealingly makes contact with the entrance of the nasal passage 604. The user may hold the container vertically or tilt it to any angle while maintaining the user's head at a vertical position and the nozzle tip 242 still engaged with the entrance of the nasal passage 604. To inject the solution to the nasal passage 604, the user may apply pressure and squeeze the container 102 with his/her hand 602. The pressure difference thus created will force the solution out of the container 102 through the dispenser 106 into the nasal passage 604. As the mounting end 234 of the dispenser 106 and the socket cavity 304 form an airtight/watertight seal, no leakage of fluid occurs even when the dispenser 106 or the container 102 is rotated/pivoted with respect to each other. Since, the angle of the dispenser 106 is changed as required, better irrigation can be achieved in all the sections of the nasal cavity including the frontal sinuses.
The sealing ring 705 is dimensioned to conform to at least a portion of the nozzle 706 so that adequate sealing can be provided between the inner cap 704 and the container 701 against any leakage of fluid even when the nozzle 706 rotates within the inner cap 704. The tube 709 is configured to connect the nozzle 706 rotatably or pivotally to the container 701 while allowing fluid communication between the two. The tube 709 removably attaches the nozzle 706 to the container 701. In some embodiments the tube 709 can reach the bottom of the container 701.
For use, the container 701 is filled with a nasal rinsing solution after unscrewing the inner cap 704 from the container 701. A large opening of the container 701 facilitates pouring of the solution to the container 701. The inner cap 704 holding the nozzle 706 is then screwed back onto the container 701. As the nasal irrigation device 700 is rotatable within a wide range of allowable angles of inclination, the user is not required to tilt his/her head to get his/her nasal passage irrigated. Instead, the user can keep his/her head substantially vertical and tilt the nasal irrigation device 700 at a desired angle so that the nozzle tip 707 sealingly makes contact with the entrance of the nasal passage of the user. The user may hold the container vertically or tilt it to any angle while maintaining the user's head at a vertical position and the nozzle tip 707 still engaged with the entrance of the nasal passage. To inject the solution to the nasal passage, the user may apply pressure and squeeze the container 701 with his/her hand. The pressure difference thus created will force the solution out of the container 701 through the nozzle 706 into the nasal passage. As the inner cap 704 and the container 701 form an airtight/watertight seal, no leakage of fluid occurs even when the nozzle 706 or the container 701 is rotated/pivoted with respect to each other. Since, the angle of the nozzle 706 is changed as required, better irrigation can be achieved in all the sections of the nasal cavity including the frontal sinuses.
The material configuring the nasal irrigation device and component parts thereof is not limited, and may comprise any suitable material.
All references, including any patents or patent applications cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinence of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents form part of the common general knowledge in the art.
It is acknowledged that the term ‘comprise’ may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term ‘comprise’ shall have an inclusive meaning—i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements. This rationale will also be used when the term ‘comprised’ or ‘comprising’ is used in relation to one or more steps in a method or process.
Features or functionality described with respect to certain example embodiments may be combined and sub-combined in and/or with various other example embodiments. Also, different features and/or elements of example embodiments, as disclosed herein, may be combined and sub-combined in a similar manner as well. Further, some example embodiments, whether individually and/or collectively, may be components of a larger system, wherein other procedures may take precedence over and/or otherwise modify their application. Additionally, a number of steps may be required before, after, and/or concurrently with example embodiments, as disclosed herein. Note that any and/or all methods and/or processes, at least as disclosed herein, can be at least partially performed via at least one entity or actor in any manner.
As used herein, a term “about” or “substantially” refers to a +/−10% variation from a nominal value/term. Such variation is always included in any given value/term provided herein, whether or not such variation is specifically referred thereto.
Any component described herein can include a material suitable for a medical use. The material can be, flexible, elastic, or resilient. The material can be suitable to be disinfected, sterilized, or sanitized, which can be with a hot steam, an autoclave, or others. For example, the material can include plastic, metal, rubber, shape memory, fabric, foam, or others.
The device and system of the present disclosure has been described with specific reference to certain drawings and various embodiments, but may, however, be embodied in many different forms and should not be construed as necessarily being limited to only embodiments disclosed herein. Rather, these embodiments are provided so that this disclosure is thorough and complete, and fully conveys various concepts of this disclosure to skilled artisans.
Note that various terminology used herein can imply direct or indirect, full or partial, temporary or permanent, action or inaction. For example, when an element is referred to as being “on,” “connected” or “coupled” to another element, then the element can be directly on, connected or coupled to the other element or intervening elements can be present, including indirect or direct variants. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present.
Likewise, as used herein, a term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless specified otherwise, or clear from context, “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then “X employs A or B” is satisfied under any of the foregoing instances.
As used in the specification and claims, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “material” may include a plurality of materials unless the context clearly dictates otherwise. As used in the specification and claims, singular names or types referenced include variations within the family of said name unless the context clearly dictates otherwise. For example, a term “a” or “an” shall mean “one or more,” even though a phrase “one or more” is also used herein.
Certain terminology is used in the following description for convenience only and is not limiting. The words “lower,” “upper,” “bottom,” “top,” “front,” “back,” “left,” “right” and “sides” designate directions in the drawings to which reference is made, but are not limiting with respect to the orientation in which the various parts of the nasal irrigation device or any assembly of them may be used.
Moreover, terms “comprises,” “includes” or “comprising,” “including” when used in this specification, specify a presence of stated features, integers, steps, operations, elements, or components, but do not preclude a presence and/or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Furthermore, when this disclosure states that something is “based on” something else, then such statement refers to a basis which may be based on one or more other things as well. In other words, unless expressly indicated otherwise, as used herein “based on” inclusively means “based at least in part on” or “based at least partially on.”
Additionally, although terms first, second, and others can be used herein to describe various elements, components, regions, layers, or sections, these elements, components, regions, layers, or sections should not necessarily be limited by such terms. Rather, these terms are used to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section. As such, a first element, component, region, layer, or section discussed herein could be termed a second element, component, region, layer, or section without departing from this disclosure.
Also, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in an art to which this disclosure belongs. As such, terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in a context of a relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
In addition, features described with respect to certain example embodiments may be combined in or with various other example embodiments in any permutational or combinatory manner. Different features or elements of example embodiments, as disclosed herein, may be combined in a similar manner. The term “combination”, “combinatory,” or “combinations thereof” as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof” is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context.
Although preferred embodiments have been depicted and described in detail herein, skilled artisans know that various modifications, additions, substitutions and the like can be made without departing from spirit of this disclosure. As such, these are considered to be within the scope of the disclosure, as defined in the following claims.
This patent application claims the benefit of U.S. Provisional Patent Application 63/302,031 filed 22 Jan. 2022; which is incorporated herein by reference for all purposes.
Number | Date | Country | |
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63302031 | Jan 2022 | US |