Sino-Nasal Rinse Delivery Device with Agitation, Flow-Control and Integrated Medication Management System
20200001060 ยท 2020-01-02
Assignee
Inventors
Cpc classification
A61J1/1481
HUMAN NECESSITIES
A61M3/0233
HUMAN NECESSITIES
A61M3/0245
HUMAN NECESSITIES
A61H2201/105
HUMAN NECESSITIES
A61M31/00
HUMAN NECESSITIES
International classification
Abstract
A device, a system and a method are provided to accurately apply a medically beneficial substance directly to a laterally or superiorly located paranasal sinus cavity. When the device is assembled with a solution in a reservoir, and inverted such that the reservoir is above an input apparatus and a housing, weight of the solution pushes down on a diaphragm creating a negative pressure on the diaphragm, which prevents air from entering the reservoir and prevents a liquid from flowing out of the reservoir. Applying a positive pressure to a bottom of the diaphragm causes the diaphragm to open and allows air to flow into the reservoir. When a user creates the positive pressure by exhaling air into the device the act of exhaling causes the user's choana to close. Thereby any solution introduced into the user's sino-nasal cavity will remain contained within the user's sino-nasal cavity increasing effectiveness of treatment and decreasing user discomfort including gagging, choking, and inner ear disturbance. When the positive pressure on the bottom of the diaphragm is removed, the flow of the liquid from the reservoir stops.
Claims
1. A device for delivering a solution to a sino-nasal cavity of a user, the device comprising: a reservoir container; a housing adapted to connect to the reservoir container wherein the housing has a nose tube and a grinding chamber with a filter in the housing and a plurality of grinding teeth extending perpendicular to the filter; an input apparatus adapted to connect to the housing wherein the input apparatus has a mouth piece connected to a tube and the tube is connected to a L-connector on the input apparatus; and, a mortar with a first end and a second end.
2. (canceled)
3. The device for delivering a solution to the sino-nasal cavity of a user of claim 1 wherein the mouth piece is removably attached to a first terminal end of the tube and a diaphragm is interposed at the L-connector on the input apparatus.
4. The device for delivering a solution to the sino-nasal cavity of a user of claim 1 further comprising a mortar having a first end with a recess containing a plurality of grinding teeth and a second end with a plurality of tines configured to align with the plurality of holes in the filter.
5. The device for delivering a solution to the sino-nasal cavity of a user of claim 4 wherein the mortar further comprises a removable cap that frictionally engages the mortar and covers the tines of the second end of the mortar.
6. The device for delivering a solution to the sino-nasal cavity of a user of claim 1 further comprising a tip with directional flow that is removably attached to a distal end of the nose tube.
7. A device for delivering a solution to a sino-nasal cavity of a user, the device comprising: a reservoir container adapted to removably engage a housing wherein the housing has a nose piece with a nasal tip adapted to removably attach to a terminal end of the nose piece; an input apparatus with a tube that connects a mouth piece to a L-connector on the input apparatus wherein the mouth piece is adapted to removably connect to the housing; a mortar with a first end with a plurality of grinding teeth and a second end with a plurality of tines.
8. The device for delivering a solution to the sino-nasal cavity of a user of claim 7 wherein the tube has a first terminal end with the mouth piece removably attached and the L-connector on the input apparatus with a diaphragm interposed between the L-connector and the bottom of the input apparatus.
9. The device for delivering a solution to the sino-nasal cavity of a user of claim 8 wherein the diaphragm permits air flow into the reservoir container when a positive pressure exists in the tube.
10. The device for delivering a solution to the sino-nasal cavity of a user of claim 8 wherein the diaphragm prevents gravity flow of the solution from the reservoir container when a positive pressure does not exist in the tube.
11. The device for delivering a solution to the sino-nasal cavity of a user of claim 7 further comprising a nasal tip extension with directional flow adapted to removably engage the terminal end of the nose piece or the nasal tip.
12. The device for delivering a solution to the sino-nasal cavity of a user of claim 7 wherein the housing has a grinding chamber with a filter comprising a plurality of holes in the housing.
13. The device for delivering a solution to the sino-nasal cavity of a user of claim 7 further comprising a mortar with a first end with a plurality of grinding teeth and a second end with a plurality of tines.
14. The device for delivering a solution to the sino-nasal cavity of a user of claim 8 wherein the plurality of tines of the second terminal end of the mortar are configured to match a plurality of holes in a filter.
15. The device for delivering a solution to the sino-nasal cavity of a user of claim 7 wherein the nasal tip is selected from the group consisting of: a nasal tip to accommodate nasal opening sizes of children; a nasal tip to accommodate the nasal opening sizes of adults; and, a nasal tip to accommodate the nasal opening sizes of larger adults.
16. A device for delivering a solution to a sino-nasal cavity of a user, the device comprising: a reservoir container adapted to removably engage a housing wherein the housing has a nose piece with a nasal tip adapted to removably attach to a terminal end of the nose piece; the housing further comprising a grinding chamber with a filter in the housing consisting of a plurality of holes in the housing and a plurality of grinding teeth extending perpendicular to the filter; and, an input apparatus with a tube with a mouth piece at a first terminal end of the tube and a diaphragm at a second terminal end of the tube that connects to a L-connector on the input apparatus.
17. The device for delivering a solution to the sino-nasal cavity of a user of claim 16 wherein the diaphragm has a first closed position that prevents gravity flow of a solution in the reservoir container when a positive pressure does not exists in the tube and a second open position that permits air flow into the reservoir container when the positive pressure exist in the tube.
18. The device for delivering a solution to the sino-nasal cavity of a user of claim 16 further comprising a nasal tip extension with directional flow adapted to removably engage the terminal end of the nose tube or the nasal tip.
19. The device for delivering a solution to the sino-nasal cavity of a user of claim 16 further comprising a mortar with a first terminal end with a plurality of grinding teeth and a second terminal end with a plurality of tines.
20. The device for delivering a solution to the sino-nasal cavity of a user of claim 19 wherein the plurality of tines of the second terminal end of the mortar are configured to match the plurality of holes in the filter.
21. An input device for use with a sino-nasal treatment device comprising: an input apparatus with a tube having a first terminal end and a second terminal end that is connected to the input apparatus wherein a diaphragm is interposed at the second terminal end of the tube; the diaphragm has a top side proximate the input apparatus and a bottom side proximate the tube; wherein the diaphragm has a first closed position that prevents flow through the tube when pressure is asserted on the top side of the diaphragm and a second open position that permits flow through the tube when pressure is asserted on the bottom side of the diaphragm.
Description
DESCRIPTION OF THE DRAWINGS
[0022] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure may be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.
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DETAILED DESCRIPTION
[0041] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[0042] While the disclosed subject matter is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. To the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.
[0043] The term solution as used herein means a liquid; water; a pharmaceutically acceptable buffer solution, preferably consisting of a saline solution and more preferably still a sterile saline solution; and, a solution with a therapeutically effective concentration of a pharmaceutical. The pharmaceutical compound portion of the solution may be a salt, solid, liquid, or a gas (including a vapor). The pharmaceutical compound may be selected form any of the biopharmaceutical classes of the Biopharmaceutical Classification System (BCS) where Class 1 has high permeability and high solubility to Class 4 which has low permeability to low solubility. The solution containing a pharmaceutical compound may be an unsaturated solution, a saturated solution, a supersaturated solution, a mixture of two or more substances that are not chemically combined, a homogenous solution, a heterogenous solution, a suspension, or an emulsion.
[0044] The use of including, comprising, or having and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.
[0045] As the terms are used herein with respect to ranges of measurements (such as those described above), about and approximately may be used interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement, but that may differ by a reasonably small amount such as will be understood, and readily ascertained, by individuals having ordinary skill in the relevant arts to be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like.
[0046] Although the term block may be used herein to connote different elements illustratively employed, the term should not be interpreted as implying any requirement of, or particular order among or between, various steps disclosed herein unless and except when explicitly referring to the order of individual steps. Additionally, a set or group of items (e.g. inputs, algorithms, data values, etc.) may include one or more items, and, similarly, a subset or subgroup of items may include one or more items.
[0047] The term means as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C. Section 112(f). Accordingly, a claim incorporating the term means shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials or acts and the equivalents thereof shall include all those described in the summary of the invention, brief description of the drawings, detailed description, abstract, and claims themselves.
Sino-Nasal Irrigation Device
[0048] Referring to
[0049] The reservoir container (110) in the preferred embodiment has a hollow interior cavity adapted to contain an solution and has a base (112). The reservoir container (110) has a curved sidewall (115) that extends substantially perpendicular to the base (112) to the open top (117) of the reservoir container (110) thereby defining the hollow interior cavity. The reservoir container (110) is adapted to removably engage the housing (120). In the preferred embodiment the reservoir container (110) has male threads (118) to threadingly mate with the housing (120). The reservoir container (110) may be of any shape or size including a round bulbous shape, a square or a rectangle.
[0050] The housing (120) is removable attachable to the reservoir container (110). In the preferred embodiment the housing (120) has female threads (124) to threadably mate with the reservoir container (110). The top of the housing (122) has a grinding chamber (125) and a nose piece aperture (140). The grinding chamber (125) has a sidewall (128) that is preferably curved and extending substantially perpendicular to the top of the housing (122). The grinding chamber (125) has a filter (135) at the base that is integrated into the housing top (122) consisting of a plurality of holes (138) that will allow ground material of a defined size and water or a solution to pass through the filter (135). The plurality of holes (138) may be of uniform size or varying size. In the preferred embodiment the plurality of holes (138) are of varying size ranging from .sup.th of an inch in diameter to 3/16.sup.th of an inch in diameter.
[0051] In an alternative preferred embodiment other substances including powders, liquids, gaseous and vapors may be introduced into the reservoir container (110) through the filter integrated into the grinding chamber (135) or by bypassing the grinding chamber (125) and introduced directly into the solution in the reservoir container (110). In an alternative preferred embodiment a vapor pod (not shown) may be removably attached to the air tube (180) so that when a user exhales into the mouth piece (185) on the input apparatus (170) air and vapor from the vapor pod creates a positive pressure in the air tube (180) and air and vapor passes through the diaphragm (190) and into the reservoir container (110) where the vapor mixes with and dissolves into the solution. The introduction of air and vapor into the reservoir container (110) displacing the solution held in the reservoir container (110) out the nose tube (150) through the nasal tip (160).
[0052] The grinding chamber (125) also has a plurality of grinding teeth (130) that extend substantially perpendicular to the filter (135). The plurality of grinding teeth (130) may be of either uniform size and shape or varied size and shape. In the preferred embodiment the plurality of grinding teeth (130) consist of a plurality of cured grinding teeth (131) spaced equal distantly in a circular pattern in the grinding chamber (125) and a plurality of wedge shaped grinding teeth (132) located within the circular pattern formed by the curved grinding teeth (131).
[0053] The nose tube (150) is attached to the nose piece aperture (140) in the housing top (122). In the preferred embodiment the nose piece aperture (140) is a curve-linear oval shape. The nose tube (150) is preferably substantially rigid and curved such that when the sino-nasal device (100) is inverted the mouth piece (185) is proximate a user's mouth then the distal end of the nose tube (150) is proximate a user's nose bench. The nose tube (150) has a removable nasal tip (160) at the distal end of the nose tube (150). The nasal tip (160) frictionally engages the nose tube (150) and thus is adjustable and may be positioned in a preferable location for each user. The nasal tip (160) may be removed from the nose tube (150) for cleaning or replacement. The nasal tip (160) has various sizes and shapes (160a-160c) to accommodate the customary nasal opening sizes of children (160a), adults (160b), and larger adults (160c).
[0054] An alternative preferred embodiment may include a nasal tip for directional flow (167) that frictionally engage the nose tube (150) or the nasal tip aperture opening (165) to provide for a more controlled and direction application of medicine and/or solution to a surgical site, wound, or by user preference. The nasal tip for directional flow (167) is preferably flexible with a blunt terminal end (168) with a plurality of aperture openings (169) proximate to the terminal end that are preferably 2 to 4 mm in length and more preferably 1 to 2 mm in length. The plurality of aperture openings (169) are preferably oval, but may also be substantially circular or substantially square in order to provide a desired flow rate of solution in a preferred direction. The nasal tip for directional flow (167) are preferably 1 to 4 cm length, and more preferably 1 to 2 cm length. The exposed length of nasal tip for directional flow (167) may also be controlled by how far the nasal tip for directional flow (167) is inserted on the nose tube (150), or alternatively, into the tip aperture opening (165) in order to maximize the delivery of medicine and/or solution to a surgical site, wound, or by preference of a user.
[0055] The input apparatus (170) is removably attached to the grinding chamber (125) on the housing (120). In the preferred embodiment the input apparatus (170) has a hollow interior cavity (177) that is threaded to connect to the exterior of the grinding chamber sidewall (128). When the input apparatus (170) is attached to the grinding chamber (125) the mouth piece (185) of the input device (170) should align with the nasal tip (160) of the housing (120) when assembled and closed. The input apparatus (170) is comprised of a mouth piece (185) that is frictionally attached to an air tube (180) so that the location of the mouth piece (185) may be configured in a preferred way for each user. The air tube (180) is also connected to the L-connector (175) of the input apparatus (170). In the preferred embodiment the air tube (180) connects in the center of the top of the L-connector (175) which is attached to the input apparatus (170). A diaphragm (190) is interposed at the terminal end of the air tube (180) where the air tube (180) connects to the input apparatus (170).
[0056] When the sino-nasal irrigation device is assembled with a solution in the reservoir container, the diaphragm (190) permits air into the reservoir container (110) when a positive pressure exists in the air tube (180) by allowing air to pass through the diaphragm (190). When a positive pressure does not exist in the air tube (180), then the diaphragm (190) prevents the flow of an solution in the reservoir container (110) from flowing pass the diaphragm (190) and out the input apparatus (170).
[0057] The mortar (200) has a first distal end (205) with a recess (210) containing a plurality of grinding teeth (205) and a second distal end (207) with a plurality of tines (prongs) (225) that are covered by a frictionally engaged cap (220). In the preferred embodiment the plurality of grinding teeth (215) in the recess (210) in the first distal end (205) consist of a plurality of curved grinding teeth (215) spaced equal distantly in a circular pattern in the recess (210) and a square pike grinding tooth (210) in the center of the recess (210). The second distal end (207) has a plurality of tines (225) that may be sized or of variable sizes. In the preferred embodiment, the size and placement of the tines (225) matches the aperture size and pattern of the plurality of holes (138) in the filter integrated into the bottom of the grinding chamber (135) to facility the cleaning of the grinding chamber (135) by dislodging any material caught in the integrated filter (135) by pushing the tines (225) into underside of the integrated filter (135) in the housing top (122).
[0058] Referring to
[0059] The base station (700) contains a logic engine that permits a user to input the desired temperature a user wants the solution in the reservoir container (610) warmed to. The temperature probe (730) takes a temperature reading, and then compares that temperature reading to the input temperature. If the temperature reading is below the input temperature, then the logic engine provides power to the base station heating sources (720) in order to raise the temperature of the solution to the input temperature. Once the solution reaches the input temperature, the logic engine may reduce power to the base station heating source (720) or turn the base station heating source off. The logic engine will continue to measure the temperature of the solution through the temperature probe (730) and apply heat as needed to maintain temperature. The temperature probe (730) is preferably a thermistor, thermocouple or similar temperature measuring probe. The base station heating source (720) is preferably resistive heating coils but may be any known heating source known to one of ordinary skill in the art.
[0060] The alternative preferred embodiment may also have indirect stirring means such as a magnetic stirrer consisting of one or more magnets in the base station and at least one magnet in the reservoir container that may be used to stir the solution to aid the dissolution of difficult to dissolve chemical compounds into solution.
[0061] The alternative preferred embodiment may also include an ultra-violate (UV) light source proximately located adjacent to the reservoir container (610) that will sterilize the water in the reservoir container (610).
Method of Using the Sino-Nasal Irrigation Device
[0062] The sino-nasal irrigation device (100) may be used by filling the reservoir container (110) with the desired amount of water. Preferably, and recommended, sterile water is used. Alternatively, denatured water may be used. The housing (120) is then removably engaged on the reservoir container (110).
[0063] Optionally, if a user wants to use an aqueous saline solution, then the user may place capsule(s) containing the equivalent of 2.4 grains of sodium chloride (NaCl) per 10 ounces of water into the grinding chamber (125) on the housing (120). Then, while firming holding the reservoir container (110), the user engages the first distal end (205) of the mortar (200) with the grinding chamber (125) containing the capsule to grind the capsule and its contents to sufficiently fine size to pass through the filter integrated into the bottom of the grinding chamber (135). Preferably, grinding of a capsule is achieved by twisting the mortar (200) in the grinding chamber (125) while applying downward pressure. Thereby allowing the ground capsule to form an solution in reservoir container (110). If the plurality of holes (138) in the filter (135) have become occluded with remnants of the capsule, then the plurality of holes (138) should be cleared by removing the housing (120) from the reservoir container (110) and pushing the tines (225) on the second distal end of the mortar (207) through plurality of holes from the underside of the integrated filer (135) in the housing top (122) to dislodge any material occluding the filter holes (135). The housing (120) is then removably engaged on the reservoir container (110). In an alternative preferred embodiment other substances including powders, liquids, gaseous and vapors may be introduced into the reservoir container (110) through the filter integrated into the grinding chamber (135) or by bypassing the grinding chamber (125) and directly into the substance into the reservoir container (110), thereby creating an solution.
[0064] The input apparatus (170) may then be removably engaged on the housing (120). The mouth piece (185) of the input apparatus (170) is aligned with the nasal tip (160) on the housing (120). The sino-nasal irrigation device (100) is then ready for treatment application.
[0065] The sino-nasal irrigation device (100) is then inverted such that the reservoir container (110) is above the input apparatus (170) and the housing (120), the weight of the solution in the reservoir container (110) pushes down on the diaphragm (190) creating a negative pressure on the diaphragm (190). The weight of the solution on the diaphragm (190) prevents air from entering the reservoir container (110) and thus prevents liquid from the reservoir container (110) from flowing out through the nose tube (150). Applying a positive pressure to the bottom of the diaphragm (190) causes the diaphragm to open and allows air to flow into the reservoir container (110). The air flowing into the reservoir container (110) causes turbulence in the solution held in the reservoir container resulting in the mixing of the air and solution. The air flowing into the reservoir container also allows the liquid in the reservoir container (110) to flow out of the reservoir (110) through the nose tube (150) and into a user's nasal cavity. When the positive pressure on the bottom of the diaphragm (190) is removed, the flow of liquid from the reservoir container (110) stops.
[0066] When a user, blows or exhales against resistance, the user's soft palate/uvula elevates and contacts the posterior wall of the oro/nasopharynx, thereby closing the choana. This normal physiologic process effectively creates temporary anatomic isolation of the nasal cavity from the oral cavity, distal airway and glottis/proximal trachea. As such, any fluid that is introduced into the user's sino-nasal cavity, as described herein, will remain contained within a user's sino-nasal cavity, being directed out the contralateral sino-nasal cavity, and not travel into the user's distal airway, glottis/superior trachea.
[0067] In an alternative preferred embodiment, a user blows or exhales against resistance to close the choana by blowing into the mouth piece (185) on the input apparatus (170), but the tube (180) is partially constrained allowing only a fraction of the air exhaled by the user to reach the reservoir container (110), or is fully constrained such that none of the air exhaled by the user reaches the reservoir container (110). When a positive pressure is detected in the tube (180) due to a user exhaling then a small pump (not shown) is activated to pump solution from the reservoir container (110) out the nose tube (150). When the positive pressure is removed, the pump is deactivated and the flow ceases. This alternative preferred embodiment may be used by those with compromised respiratory systems due to illness or other infirmity.
[0068] Referring to
[0069] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Summary for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. For example, the device(s) described in the present disclosure may be used in conjunction with other medical devices. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, which each claim standing on its own as a separate preferred embodiment of the disclosure.
[0070] Moreover, though the general description of the invention has included detailed description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of this disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. The intent is to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, inter-changeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.