Patent Description:
The invention relates generally to an oral hydration system and more specifically to an oral hydration system that incorporates a pumping mechanism that provides variable flow rates for hydration and can be reversibly mounted to a variety of structures.

Hydration is essential for humans to survive and operate at optimal levels. For many reasons such as physical exertion, limited mobility and other health factors people can have a hard time staying adequately hydrated. In the healthcare settings dehydration is a constant concern and problem. For severe dehydration and patient immobility, intravenous hydration is generally provided, but due to possible infection and patient discomfort it is desirable to avoid if possible but at least transition to oral hydration as soon as possible. Dehydration increases the frequency and severity of many common health issues ranging from diabetes and heart disease to pressure ulcers and urinary tract infections to name just a few. People who are older or have suffered from stroke or dementia, have a reduced desire to drink and are particularly vulnerable to dehydration. Furthermore, dehydration has been shown to increase the length of patient stay in hospitals as well an increased mortality rate. Therefore, there remains a great need in the healthcare industry for safer and easier access to oral hydration to promote better health and outcomes for patients and reduce unnecessary spending.

In the medical field a basic pitcher, cup and a straw are generally provided for the patient. A cup and straw however require sufficient mobility and coordination from the patient, often leading to accidental spills and a reduced desire to drink adequate amounts of liquid. In addition, even mobile patients often do not have the energy and motivation required to frequently sit up and reach for their cup and pitcher. To address these deficiencies the patient must rely on help from a caregiver or nurse to fill the cup and even assist them with drinking. The patient is then dependent on the caregiver who is often very busy with other patients. This leads to inadequate hydration for the patient and increased workload for the caregiver. It is also difficult to keep an accurate record of the amount of liquid consumed. In addition a cup and pitcher are exposed to environmental contaminants and therefore there is risk of contaminating the fluid.

Many attempts have been made to improve oral hydration in the healthcare setting yet there remain deficiencies in the designs, there remains concerns related to ease of use for the patient and caregiver, and they can be costly. Previous hydration mounting systems are overly mechanical and very limiting in their adaptation to a variety of structures. Squeeze bulbs with a one-way valve have been utilized to move fluids through a tube for many different reasons. However, squeeze bulbs are hand operated, which can be difficult for a patient to operate. In addition, fluid transfer can be difficult to regulate since squeezing the bulbs often transfers large volumes of fluid. Additionally prior squeeze bulb configurations do not provide the added options for the user to bite down on the mouthpiece to inject fluid or simply draw fluid by sucking. Furthermore, prior squeeze bulbs are not molded as a single piece with a mouthpiece valve and require additional components therein that could become dislodged and become a choking hazard. Thus, adaptation of such systems provides challenges in that they do not provide for the variety of functional needs required by different user groups.

<CIT>, entitled, "Patient Hydration System", describes a patient hydration system having a bladder, flexible tube, safety guard handle, and a mouthpiece. The patient can either draw liquid through the flexible tube and mouthpiece, or the bladder can be hung from an IV tree to utilize gravity for delivering liquid to the mouthpiece. Liquid flow is regulated using a bite-valve, where biting opens the valve to permit flow of liquids, and when the bite is released the flow stops. While biting the valve can stop and start the flow of fluid, the rate of flow is dictated largely by the gravitational force exerted on the fluid. Thus, when the valve is open a patient may receive too much liquid too fast creating a choking hazard. Additionally this system is not convenient to disconnect the supply tube and reservoir to refill.

<CIT>, entitled, "Hydration System" describes a patient hydration system with a fluid reservoir connected by a tube and terminating at a valved mouthpiece. Liquid is transferred through the tubing using gravity or suction. The flow of fluid can be regulated using a bite valve or a hand valve biased in the closed position. A removable holder and safety ring is coupled to the tube to facilitate gripping and sanitation with a very similar design to <CIT>. A mouthpiece is described as being of sufficient size to stay in the user's mouth to fit behind the lips or teeth of the subject. A supply tube with a bendable quality is described as attaching to a reservoir.

<CIT>, entitled, "Medical Patient Oral Hydration System" describes an oral hydration system including a hydration water bladder with a holster and rotatable semi rigid boom. A supply tube connects to the reservoir and terminates in a backflow prevention bite valve. This system is overly complicated and limited in its ability to mount to a variety of structures. Additionally, a user must provide enough suction to initially prime a supply tube.

<CIT>, entitled, "Drinking Device for Handicapped Persons" describes a reusable hydration system with a fluid source and bendable tube with a mouthpiece that can be positioned near the users mouth for easy access. A mounting bracket and plate support the fluid bottle and provide means for it to be hung from and IV tree. A one-way valve is utilized to maintain fluid in the supply tube.

Hydration systems are also used in outdoor sporting goods; however, their designs suffer from similar deficiencies as the above medical devices. They frequently operate using a bite valve together with suction to deliver liquid from a reservoir. When the user releases pressure on the mouthpiece the valve closes preventing liquid from leaking out. However, for people exercising or on the move, it is often difficult to use a hand to grab the mouthpiece and forego much needed breathing to suck on the mouthpiece to receive fluids.

Another example is <CIT>, entitled, "Hydration pack", which includes a hydration pack for outdoor use, which includes a hydration bladder for holding water, a pump for drawing water into the hydration bladder, and a bite valve. Here, the pump pressurizes the hydration bladder.

Therefore, there remains a need for an improved hydration system that safely and conveniently delivers liquids to individuals or patients in need of hydration.

The invention addresses the above deficiencies and provides related benefits. In particular, it is an object of the invention to provide a more efficient and safe method for an individual to maintain proper hydration. In particular when mobility of the individual or strength is lessened.

The invention is claimed as set out in independent claim <NUM>. Accordingly, an oral hydration system is claimed that delivers fluid to a person in need of hydration at variable flow rates, the system comprising a fluid reservoir optionally comprising a lid; a supply tube fluidly coupled to the reservoir at its distal end; and a mouthpiece pump fluidly coupled to a proximal end of the supply tube, wherein the pump is molded as a single piece and reversibly deformable along its entire length, the pump comprising a first opening at its distal end for attachment to the supply tube, the pump or supply tube further comprising a one-way distal valve and at a proximal end of the pump the mouthpiece with a proximal bite valve that seals against leaking fluid until deformed by a user by biting or hand compression of the pump, wherein the proximal bite valve of the mouthpiece sufficiently seals to prevent air induction when under a vacuum force during pump decompression.

In some embodiments, the oral hydration system includes a fluid reservoir with a bendable mount configured to reversibly mount the oral hydration system to a structure by bending the mount around the structure.

The mount improves user access to the hydration system by permitting the mounting of the hydration system to a variety of structures. In the medical industry the mount is particularly useful for bed rails. In some embodiments, mount is co-molded or bonded to the reservoir. However, in other embodiments the mount is releasably attached to reservoir.

In embodiments where the reservoir includes a lid, the mount can be formed of a shape memory material and joined to the lid. In some embodiments, the mount is co-molded or bonded to the lid. In other embodiments the mount is releasably attached to the lid.

The supply tube is generally bendable or flexible and can be formed any suitable tubing material used in the corresponding art, such as polysiloxanes (silicone) and other polymers used in the medical device industry. Preferably the supply tube is a medical grade tubing. In some embodiments the supply tube has a bendable guidewire that maintains a bent shape that can be adjustably bent to a variety of orientations and released to maintain the orientations. The guidewire permits movement of the supply tube while permitting the supply tube to stay in a desired position upon release. In further embodiments, the guidewire is configured for reversible connection to a brush sized to brush the interior of the mouthpiece and/or supply tube. In some embodiments, the supply tube is reversibly attached to the reservoir, optionally at a lid, a bendable handle forming part of the reservoir, and/or the mount. Attachment may be by way of magnetic attraction between complementary magnets mounted to the corresponding structures.

In a related embodiment, the hydration system includes a fluid reservoir having a means for reversibly mounting the hydration system to a structure; a supply tube fluidly coupled to the reservoir at its distal end; a reversibly compressible chamber fluidly coupled to the supply tube; a mouthpiece proximate to or at a proximal end of the collapsible chamber; and at least two valves that, together with the chamber, regulate the flow of fluid through the hydration system, wherein a distal valve is poisoned at a distal end of the chamber or along the supply tube and closes in response to compression of the chamber to reduce backflow of fluid into the reservoir during compression, and a proximal valve is positioned at the mouthpiece and biased in a closed position for regulating the delivery of fluid out of the mouthpiece and prevent air induction upon decompression of the chamber.

The means for mounting the hydration system can be any suitable structure, which includes the bendable mount, two or more mounts, a hook, a detachable loop, or others.

The compressible chamber, together with the valves provides a pumping mechanism to deliver fluid from the reservoir and out from the mouthpiece. In some embodiments, the chamber is configured as a bellows with alternating folds to direct compression of the chamber longitudinally. In other embodiments the chamber is configured to compress radially. The chamber can be configured as a single chamber or can have two or more sub-chambers, which may further retain different volumes of fluid.

The distal valve can be biased in an open position, such that it temporarily closes only when applying a sufficient fluidic pressure distally from a compressing chamber, thereby preventing or reduce backflow while pumping the chamber to deliver fluid from the mouthpiece. In a preferred embodiment, the distal valve is biased closed and opens in response to a vacuum force induced by decompression of a compressed chamber.

The proximal valve is biased closed and opens in response to a positive force applied by sufficient compressing or pumping the compressible chamber or by applying a vacuum force by sucking from the proximal end. The proximal valve is a bite valve configured to open when biting the mouthpiece. In still further embodiments, the proximal valve is a bite valve that can also be opened by applying sufficient compression or pumping force to the chamber.

In still further embodiments the hydration system can include a third valve positioned between the distal and proximal valves, optionally at the proximal region of the compressible chamber. In some embodiments the third valve is biased in a closed position and is selectively opened during compression of the chamber to deliver fluid proximally. In some embodiments the distal valve and third valve are each biased in a closed position, such that compression of the chamber selectively opens the third valve, and release of the chamber selectively closes the third valve and opens the distal valve to refill the chamber under vacuum.

The hydration system may also be equipped with an inline flow rate control valve positioned distal to the distal valve that regulates a maximum rate of flow independent of compression. In further embodiments, the flow rate control valve has an adjustable selector to select or index the maximum rate of flow through the flow rate valve. The flow rate control valve regulates the time needed for the chamber and mouthpiece to refill with fluid. This provides a user with an initial bolus of fluid and a delay for chamber refilling, thus preventing overconsumption of fluids. Selection of indexing may be by way of a twist valve that opens when twisting the selector in a first direction and closes when twisting in an opposing direction.

The hydration system can also include a safety ring positioned around the mouthpiece to limit entry of the hydration system into a user's mouth that is to receive hydration.

The mouthpiece is generally formed consistent with insertion into the mouth of an individual requiring hydration. The mouthpiece is typically nonrigid and can be formed of pliable polymer, high density foam, silicone, pva, eva, or other suitable materials. The mouthpiece can be integral with the chamber and the chamber reversibly connected to the supply tube, thereby permitting disconnection and reconnection. Such connection can be by way of barbed fittings, luer locks, complementary threads, friction fit or other suitable connection approaches.

In another related aspect, a fluid reservoir with lid is provided, where the reservoir includes a coated bendable mount that maintains a bent shape under pressure exerted by the reservoir when filled with an aqueous solution, wherein a force needs to bend the bendable mount is about three to four times the force exerted by the reservoir in the filled state.

Relatedly, a fluid reservoir with lid is also provided, which includes a bendable guidewire that maintains a bent shape without applying a continuous bending force, a supply tube fluidly connected to the reservoir and an adapter configured to accept the guidewire and the supply tube, thereby providing an adjusting mechanism for the supply tube.

In yet another related aspect, a method for hydration is provided, which includes providing one of the embodied hydration systems filled with a hydrating fluid; and opening the proximal valve to deliver fluid to an individual in need of hydration. In some embodiments the proximal valve is a bite valve that is biased closed, and thus the step of opening the proximal valve includes biting the bite valve. In some embodiments the distal valve remains closed while the proximal valve is open. In some embodiments the chamber is compressed or pumped to increase flow of fluid through the opened proximal valve. In some embodiments sufficient compression or pumping opens the proximal valve whether or not undergoing biting. In embodiments where the hydration system has a third valve positioned between the distal and proximal valves, optionally at the proximal region of the compressible chamber, wherein third valve is biased in a closed position, the method can also include opening the third valve by compressing the chamber. Refilling the chamber under vacuum can be by way of releasing a compressed chamber to open the distal valve by vacuum.

The invention can be better understood with reference to the following drawings, which are part of the specification and represent embodiments The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. And, in the drawings, like reference numerals designate corresponding parts throughout the several views.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this invention belongs. If a definition set forth in this document is contrary to or otherwise inconsistent with a well-accepted definition set forth in the art, the definition set forth in this document prevails over a contradictory definition.

The term "proximal" and "proximate" as used herein refers to a position which is nearest to the patient receiving hydration through the mouthpiece. The mouthpiece is proximate to the supply tube, which is proximate to the reservoir since fluid travels from the reservoir, through the supply tube and into the mouthpiece. The term "at a proximal end" as used herein refers to the half or portion closest to the patient.

The term "distal" as used herein refers to a position which is farthest from to the patient receiving hydration through the mouthpiece. The reservoir is distal to the supply line, which is distal to the mouthpiece.

The term "fluidly coupled" or "fluidly connected" as used herein refers to the joining of two structures, each having a lumen through which a fluid may pass. A variety of complementary structures are known in the art to fluidly couple lumens. Among these include luer locks, complementary mating structures, or friction fit connection.

Among the improvements of the oral hydration systems herein, include an improved pumping mechanism, which results in a variable delivery rate under precise control. In particular, the hydration system permits a caregiver to initially prime a supply of liquid which can be later selectively delivered aggressively or passively as needed by a patient even when in a weakened state.

Although the invention has particular benefit for those in the medical industry, such as for the treatment of hydration in human patients, adaptations of the invention are also envisioned for use with sports, gym workout, outdoor activities, and driving when access to hydration is desired.

As depicted collectively in <FIG>, an exemplary hydration system <NUM> provides a fluid reservoir <NUM>; a supply tube <NUM> fluidly coupled to the reservoir <NUM> at its distal end 14a; a reversibly compressible chamber <NUM> fluidly coupled to the supply tube <NUM>; a mouthpiece <NUM> proximate to and forming a proximal end of the collapsible chamber <NUM>; and at least two valves 20a, 20b that regulate the flow of fluid through the hydration system <NUM>, wherein a distal valve 20a is positioned at a distal end 14a of the chamber <NUM> or along the supply tube <NUM> and closes in response to compression of the chamber <NUM> to reduce backflow of fluid into the reservoir <NUM> during compression, and a proximal valve 20b is positioned generally at the mouth piece <NUM> for regulating the delivery of fluid out of the mouthpiece <NUM>, wherein the proximal valve <NUM> is biased closed to prevent leakage and configured to selectively open when the chamber <NUM> is sufficiently compressed. Preferably, the hydration system <NUM> also includes a mount <NUM> for reversibly mounting the hydration system <NUM> to a structure <NUM>.

Also as shown in <FIG>, a variation of the hydration system <NUM> provides a fluid reservoir <NUM> having a bendable mount <NUM> configured to reversibly mount the oral hydration system <NUM> to a structure <NUM> by bending the mount <NUM> around the structure <NUM>; a supply tube <NUM> fluidly coupled to the reservoir <NUM> at its distal end 14a; and a compressible chamber <NUM> configured as a squeeze bulb with integral mouthpiece <NUM> fluidly coupled to a proximal end 14b of the supply tube <NUM>, wherein the sequence bulb mouthpiece is molded as a single piece with a proximal face containing a proximal valve 20b that seals the mouthpiece until deformed by the user.

The reservoir <NUM> provides a housing for maintaining a supply of liquid and therefore may be adapted from other hydration systems or may be improved as demonstrated herein. Examples of suitable reservoirs <NUM> include, but are not limited to a bottle, a cup, a glass, a pitcher, a box, or a bag. The reservoir <NUM> can be either rigid or flexible and can be constructed from any suitable material such as glass, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), poly(vinyl chloride) (PVC), polypropylene, polystyrene, and other opaque or transparent polymers. To this end, the reservoir <NUM> can be either disposable or reusable depending on the materials used. The reservoir <NUM> is insulated or has an insulating sleeve, which can be reversibly removable. The reservoir includes a mechanism for temperature change and adjustment. The skilled artisan will appreciate that the reservoir can have volume measurement and time of day indicia and/or can be made of a material or textured so that it can be written on using pens or markers used in the medical field, such as ballpoint pens, felt tip pens, and others.

In medical applications, it may be desirable to have the reservoir <NUM> prefilled with liquid; however, the reservoir <NUM> is fillable or refillable by an outside source. In furtherance of the above, the reservoir <NUM> can be pre-filled and refillable after use. A refillable reservoir <NUM> should have at least one opening large enough to be filled with hydrating liquid, which may include one or more of water, electrolyte liquid, juice, melting ice, thickened liquids, bowel prep, vitamins, medicaments, soft foods, or any other suitable oral liquids. A refillable reservoir <NUM> also provides a convenient mode to administer one or more therapeutic or analytes in that doses may be adjusted depending on volume.

<FIG> depicts the oral hydration system <NUM> with reservoir <NUM> having a removable lid <NUM>, which itself has an aperture <NUM> capable of receiving the supply tube <NUM> there through and recessed channels <NUM> that provide one or more guides for guiding or releasably holding the supply tube <NUM>. Another embodiment is depicted in <FIG>, where a reservoir <NUM> has a self-supporting opening <NUM>, which provides sufficient rigidity to maintain the integrity of the reservoir <NUM> when mounted to a structure <NUM>.

Thus reservoir <NUM> may be open (as shown in <FIG>); partially open (as indicated in <FIG> due to the gap around the supply tube <NUM>; or sealed fluid tight seal to prevent contaminants from entering the reservoir <NUM>. Furthermore, reservoirs <NUM> can be include a suitable lid <NUM> or complementary mating structures (e.g. a ZIPLOC seal). The reservoir <NUM> is configured as a collapsible bag and thus collapses as fluid is removed; however, if a rigid or semi rigid reservoir <NUM> is utilized a one way air vent or other suitable fenestrations or gas permeable barriers can be provided to promote better fluid flow.

As shown in <FIG>, the reservoir <NUM> can be configured to mount to a variety of structures <NUM> using a suitable mount <NUM>. Among the structures <NUM> include an IV pole, a bed, wheelchair, sitting chair, or a walker when the oral hydration system is for medical use. Exemplary mounts <NUM> can include a reinforced aperture, a hook, a clip, a bendable rod or other hanging structure. The mount <NUM> is formed as a bendable rod with a polymer coating, such as silicone, that can hook (as shown in <FIG>) and/or wrap around a structure <NUM> (as shown in <FIG>). A bendable mount <NUM> is formed from a bendable metal or metal alloy coated in a vinyl or silicone. As shown in <FIG>, in some embodiments, the mount <NUM> is hooked at one end for hooking to a reservoir <NUM>, is configured for wrapping around a structure <NUM> to support the reservoir <NUM>, and booms outward to provide a support for the supply tube <NUM>. The supply tube <NUM> is shown supportively connected to the mount <NUM> by clips <NUM>. The hooked end of the mount <NUM> can be pre-formed and more rigid than the remaining portion of the mount <NUM>, but this is not a requirement. In any event, the bendable mount <NUM> should maintain a sufficiently bent shape under pressure exerted by the reservoir <NUM> when filled with an aqueous solutions so that the mount <NUM> does not release the reservoir <NUM>. A force need to bend the bendable mount <NUM> is about three or four times the force exerted by the reservoir <NUM> in the filled state.

In <FIG> and <FIG>, the mount <NUM> is co-molded or bonded to the reservoir <NUM>; whereas in <FIG>, the mount <NUM> is releasably attached to reservoir <NUM>. In still other variations are provided in <FIG>, where the mount <NUM> is affixed to a receptacle <NUM> or wrapped around a contoured region <NUM> to hold the reservoir <NUM>. Alternatively, or in addition the reservoir <NUM> can be configured to stand upright by forming a suitable base.

The supply tube <NUM> supplies fluid, such as hydrating liquid, from the reservoir <NUM> to a reversibly compressible chamber <NUM> via a pumping mechanism. The supply tube <NUM> can be attached permanently to the reservoir <NUM> in that it does not disconnect and reconnect. Alternatively, the tube <NUM> can be releasably mated to the reservoir <NUM> through surface modification, such as barbs, complementary connectors or friction fit. Suitable connectors can be selected from any that are known in the art to which the invention belongs, such as luer locks, bayonet, or tongue and groove connectors. If using a releasable supply tube connection, a leak proof disconnect system can also be utilized akin to a bayonet or septum/Huber needle configuration known in the medical device arts. Alternatively, as shown in <FIG>, the supply tube <NUM> can merely feed through an aperture <NUM> of the lid <NUM> to access the internal fluid of the reservoir <NUM>. Thus, the supply tube <NUM> can be fluidly coupled to the reservoir <NUM> to access liquid from the bottom, the sides, corners, or from the top of the reservoir <NUM>.

The length of the supply tube <NUM> can vary depending on the position of the oral hydration system <NUM> in relation to the individual in need of hydration. Accordingly, the hydration system <NUM> includes further notable advantages. For example, the hydration system <NUM> can include means for attaching the supply tube to the reservoir <NUM> and/or to the mount <NUM>. These means for attachment <NUM> can be formed integral with the reservoir <NUM> or mount <NUM> or attach separately. Examples of suitable means for attachment <NUM> include a hook, hook and loop (VELCRO), a strap, and a stick on. However, a particularly useful example is shown in <FIG>, where the supply tube <NUM> and reservoir <NUM> and/or lid <NUM> have magnets <NUM> that attach to one another to provide a holding mechanism for the supply tube <NUM>. In another particularly useful example, <FIG> depict clips <NUM>, slidably positioned along the mount <NUM>, that reversibly clip the supply tube <NUM>, thereby permitting the mount <NUM> to act as a boom for adjusting the position of the supply tube <NUM>.

The supply tube <NUM> can be semi-rigid and bendable or can be made semi-rigid and bendable using a suitably formed guidewire <NUM> so that the supply tube <NUM> can be suspended and directionally boomed toward the user. This improves patient access to the supply tube <NUM>, prevents the user from pulling the supply tube <NUM> and reservoir <NUM> too far, and prevents the user from rolling or sitting on the chamber <NUM> or mouthpiece <NUM>. An elevated and boomed supply tube <NUM> also minimizes contact with other surfaces and possible contamination. Such a guidewire <NUM> can be made from any materials that provide enough rigidity to support the supply tube <NUM> such that it may be temporarily bent and directed or boomed toward the mouth of the user then moved away as desired. Preferably, the supply tube <NUM> is formed from a bendable polysiloxane (silicone) or other suitable medical grade bendable polymer to permit bending and preferably the guidewire <NUM> is formed from a bendable metal alloy. This configuration maintains a bent shape when releasing the bending force thereby providing a supply tube <NUM> that can be adjustably bent and released for positioning in a variety of orientations. The bendable guidewire <NUM> may be permanently connected to the supply tube <NUM> or temporarily connected to the supply tube <NUM>, such as by slidable insertion or movement. Still further, as shown in <FIG>, the oral hydration system <NUM> may include a brush <NUM> adapted for reversible connection to either end of the guidewire <NUM> and sized to brush the interior of the mouthpiece <NUM>, chamber <NUM> and/or supply tube <NUM>.

The supply tube <NUM> terminates proximally at the distal end of a reversibly compressible chamber <NUM>, which itself is fluidly coupled to at least two valves 20a, 20b to form a pumping mechanism. The artisan will appreciate the volume of the compressible chamber <NUM> can vary but when used in medical situations it is usually at least <NUM> but less than <NUM>, more typically the volume is about <NUM> to <NUM>. The chamber <NUM> is embodied as a squeeze bulb formed from a polymer, such as a polysiloxane (silicone) that is elastic and contoured to form a mouthpiece <NUM>, such that the chamber <NUM> deforms when squeezing and returns to its original form when squeezing pressure is released. The chamber <NUM> can compress longitudinally and/or radially. For instance, longitudinal compression can be achieved by incorporating a bellows configuration having alternating folds and squeezing to induce further folding. A bellows configuration provides an advantage in that the actuating the pumping mechanism is primarily by longitudinal compression, which may prevent leakage during accidentally applied radial forces. A radial compressible chamber <NUM> can be by way of molding the chamber <NUM> using a pliable plastic or rubber so that it can be squeezed akin to a squeeze bulb. Further, in configurations where radial compression is desired, the chamber <NUM> can be made of a same material across the entire chamber <NUM> or may be made with materials that more easily compress about its mid-region, thereby providing relatively stiffer ends and a relatively softer mid region to further direct pumping or compression at the mid-region.

As will follow, the chamber <NUM> is formed of two sub-chambers 42a, 42b, such as a smaller proximal sub-chamber 42b and a larger distal sub-chamber 42a. This two sub-chamber 42a, 42b configuration provides additional advantages in that a slow or low volume delivery approach can be employed from the proximal sub-chamber 42b without affecting the larger distal sub-chamber 42a. This approach permits a smaller aliquot of fluid to be easily delivered without spilling by patients with significant impairment.

As shown in <FIG>, the pumping mechanism is formed using at least two valves 20a, 20b, referred to as a distal valve 20a and proximal valve 20b, but preferably includes a third valve 20c between the distal and proximal valves 20a, 20b. The valves 20a-c can be permanently molded or connected to the chamber <NUM>, mouthpiece <NUM> or supply tube <NUM>. Further, a reservoir valve 20e may be positioned within the supply tube <NUM> and within the reservoir <NUM>. The chamber <NUM> can be reinforced at sections having the valves 20a-c to encourage compression at regions between the valves 20a-c. In particular, the chamber <NUM> can be reinforced at valve regions by increasing the thickness of the chamber <NUM> at those regions or increasing polymer crosslinking at those regions. Alternatively, molding the valves 20a-c within the chamber <NUM> would itself increased the rigidity due to the supporting material surrounding the valve 20a-c. The chamber <NUM> can be molded with the mouthpiece <NUM> as one unit or as separate pieces then fused or reversibly attached. The mouthpiece <NUM> may have a slidable cover <NUM>, such as a soft or high density foam or silicone.

The distal end of the chamber <NUM> (also referred to herein as "an inlet side") is fluidly coupled to the supply tube <NUM>; whereas the proximal end of the chamber <NUM> (also referred to as "an outlet side") terminates at or with the mouthpiece <NUM>. The chamber <NUM> is preferably integral with the mouthpiece <NUM>.

Fluidly connected to the distal or inlet side of the chamber <NUM> is preferably the distal valve 20a. The distal valve 20a may be any suitable valve such as a diaphragm valve, duck bill valve, a ball valve, a flap valve, a louver valve, or any other valve that closes to block or interfere with the flow of fluid distally during compression of the chamber and permits the flow of fluid proximally to refill the chamber by vacuum during release of a compressed chamber. Compressing the chamber <NUM> closes the distal valve 20a to forcibly direct liquid proximally from the chamber <NUM> and decompressing a compressed chamber <NUM> opens the distal valve 20a to draw liquid into the chamber <NUM> from the supply line <NUM> or reservoir <NUM>.

Fluidly connected to the proximal or outlet side of the chamber <NUM> or mouthpiece <NUM> is a proximal valve 20b. The proximal valve 20b is biased closed and substantially compressing the chamber <NUM> opens the proximal valve to eject liquid proximally from the oral hydration system <NUM>. Decompressing a compressed chamber <NUM> closes the proximal valve 20b to form a vacuum that draws liquid into the chamber <NUM> from the supply line <NUM>.

With reference to <FIG>, the following is an advantageous configuration that delivers fluid using two different mechanisms, each with a different delivery volume and rate. Beginning with <FIG>, the compressible chamber <NUM> includes a distal valve 20a positioned distally, a proximal valve 20b positioned proximally and a third valve 20c positioned between the distal and proximal valves 20a, 20b. Furthermore, the proximal and third valves 20a, 20c define a proximal sub-chamber 42b having a comparatively small volume and the distal and third valves 20a, 20c define a distal sub-chamber 42a have a comparatively larger volume.

Turning to <FIG>, substantial radial compression of the compressible chamber <NUM> opens the third valve 20c, which is biased closed, to deliver fluid housed in the distal sub-chamber 42a proximally into the proximal sub-chamber 42b and then proximally out of the proximal valve 42b. The distal valve 42a, which is biased closed, remains closed.

<FIG> depicts the decompression of the compressible chamber <NUM>. In particular, release of the compressed chamber <NUM> induces its expansion and a corresponding vacuum force, which closes the third valve 20c, thereby permitting the proximal valve 20b to return to its biased closed state. The vacuum force opens the distal valve 20a and the resulting vacuum induced through the supply tube <NUM> draws more fluid into the distal sub-chamber 42a for refilling.

As shown in <FIG>, the smaller proximal chamber 42b can itself be actuated separately to release a smaller volume of fluid, such as for a sip. In <FIG>, the proximal sub-chamber 42b is compressed and fluid is expelled from the smaller sub-chamber 42b through the proximal valve 20b. Compressing the proximal sub-chamber 42b can be accomplished by the individual by simply biting the mouthpiece region between the proximal and third valves 20b, 20c. The proximal valve 20b is a bite valve and the third valve 20c is a one way valve, such as a flap valve, configured to flow proximally and prevent or minimize the amount of air entering the chamber <NUM> distally.

<FIG> demonstrates the mechanics upon release of the smaller proximal sub-chamber 42b. In particular, releasing the compressing force from the smaller sub-chamber 42b causes its expansion and closure of the proximal valve 20b. Closing the proximal valve 20b induces a vacuum force which opens the third valve 20c to refill the proximal sub-chamber 42b. In some instances the vacuum force is sufficiently strong to also open the distal valve 20a to further refill the emptying distal sub-chamber 42a. Once the vacuum forces are within the tolerances of the biasing forces of the third and distal valves 20c, 20a, they subsequently close.

Accordingly, among the advantages of the hydration system <NUM> is the selective delivery of liquid using different approaches, each configured to deliver liquid in different amounts or at different delivery forces. In a first approach, outlined in <FIG>, the compressible chamber <NUM> is compressed to forcibly inject a greater volume of liquid into the mouth of the user in need of hydration.

Where the chamber <NUM> is provided as a bellows configuration with alternating folds (not shown), a user may push the chamber <NUM> proximally toward their mouth for longitudinal compression along the folds to forcibly eject liquid. In either variation, when a user squeezes the chamber <NUM> with their fingers, hand, mouth or teeth, the distal valve 20a at the inlet side of the chamber <NUM> remains closed, which directs liquid flow proximally towards the subject in need of hydration. When the user releases pressure from the chamber <NUM> it decompresses to about its original volume, which closes the proximal valve 20b and creates a vacuum that opens the distal valve 20a, which pulls liquid from the supply tube <NUM> into the chamber <NUM>, thereby refilling the chamber <NUM>. Once the vacuum pressure is reduced, the distal valve 20a is permitted to return to its biasing closed state. A benefit of this first approach is that the pumping can be performed either by a subject in need of hydration or a caretaker in instances where the subject is too weak. In addition, by closing the distal valve 20a after refilling the chamber <NUM>, the distal valve 20a helps maintain liquid in the chamber <NUM> by preventing backflow into the supply tube <NUM>.

In the second approach outlined in <FIG>, the user opens the proximal valve 20b by compression of the proximal sub-chamber 42b. This approach permits the user to receive the liquid at a slow rate and added suction permits opening of the distal valve 20a to receive more liquid from the supply tube <NUM>. A benefit of this approach is that the user can receive the liquid generally at a slower rate or volume than compressing the distal chamber 42a.

In some embodiments the distal sub-chamber 42a and proximal sub-chamber 42b incorporate a same compressing mechanism to inducing pumping; however, in other embodiments each incorporates a different compressing mechanism to induce pumping. For instance, both the distal sub-chamber 42a and proximal sub-chamber 42b can be configured to compress radially to pump fluid. In other embodiments, the distal sub-chamber 42a can be configured to compress primarily radially, while the proximal sub-chamber 42b can be configured as a bellows that compresses primarily longitudinally. In still other embodiments the distal sub-chamber 42a can be configured to compress primarily longitudinally via bellows, while the proximal sub-chamber 42b can be configured to compresses primarily radially.

Referring back to <FIG> collectively, the hydration system <NUM> includes still further advantages. As shown in <FIG>, in some embodiments, a safety ring <NUM> is attached to the supply tube <NUM>, mouthpiece <NUM>, or pump chamber <NUM> to prevent a patient from inserting the hydration system <NUM> too far and possibly choking. The safety ring <NUM> can be permanently attached or temporarily attached and removable. The safety ring <NUM> can be provided with openings so that if a patient inserts the safety ring into their mouth airflow will be maintained. The safety ring <NUM> can be connected to the supply tube <NUM> on the proximal side of the pump chamber <NUM> or between the mouthpiece <NUM> and chamber <NUM>.

As depicted in <FIG>, an additional flow rate control valve 20d can be added to the supply tube <NUM> or inlet side of the chamber <NUM> to function as a flow restrictor slowing the refill rate of the chamber <NUM> and the amount of liquid the user can intake over time. This flow rate control valve <NUM> can provide a fixed amount of liquid flow. The flow rate control valve <NUM> can also be adjustable and indexed to allow the caregiver and user to set a relative setting and expected flow rate as well provide a complete shutoff. In some embodiments the flow rate control valve <NUM> has an adjustable selector to select the maximum rate of flow through the flow rate valve <NUM>. Selection may be by way of a twist valve that opens when twisting the selector in a first direction and closes when twisting in an opposing direction. The flow rate control valve <NUM> can also be added anywhere along the supply tube <NUM> as well as a part of the reservoir <NUM> itself and can take any suitable form as known in the intravenous infusion arts.

As depicted in <FIG>, a reservoir valve 20e may be place in the supply line <NUM> to ensure the supply line remains primed.

In view of the above, the oral hydration system <NUM> can be used to maintain hydration or to treat dehydration in a subject by providing any of the above described hydration systems <NUM>, filled with a hydrating fluid; and opening the proximal valve 20b to deliver fluid to an individual in need of hydration. The method includes opening the proximal valve 20b by biting the bite valve. Biting deforms the valve 20b for opening or can pressurize a proximal sub-chamber 42b to forcibly eject the fluid. In each configuration, the distal valve 20a remains closed while the proximal valve 20b is open.

In embodiments where the hydration system <NUM> includes a third valve 20c positioned between the distal and proximal valves 20a, 20b, the method also includes opening the third valve 20c by the compression of the chamber <NUM>. Furthermore, closing the proximal valve 20b and third valve 20c and releaseing the chamber <NUM> to open the distal valve 20b refills the chamber under vacuum.

Claim 1:
An oral hydration system (<NUM>) that delivers fluid to a person in need of hydration at variable flow rates, the system comprising:
a) a fluid reservoir (<NUM>), optionally comprising a lid (<NUM>);
b) a supply tube (<NUM>) fluidly coupled at its distal end (14a) to the reservoir (<NUM>);
and
c) a mouthpiece (<NUM>) pump (<NUM>, 42a, 42b) fluidly coupled to a proximal end (14b) of the supply tube (<NUM>), wherein the pump (<NUM>, 42a, 42b) is molded as a single piece and reversibly deformable along its entire length, the pump (<NUM>, 42a, 42b) comprising a first opening at its distal end (14a) for attachment to the supply tube (<NUM>),
characterized in that the pump (<NUM>, 42a, 42b) or supply tube (<NUM>) further comprises a one-way distal valve (20a) and at a proximal end of the pump is the mouthpiece (<NUM>) with a proximal bite valve (20b) that seals against leaking fluid until deformed by a user by biting or hand compression of the pump, and that the proximal bite valve (20b) of the mouthpiece (<NUM>) sufficiently seals to prevent air induction when under a vacuum force during pump decompression.