Disclosure of Invention
The present invention addresses the technical problems described above by combining mechanical measurement fluid dispenser or sensor technology (e.g., bluetooth or RFID) with hardware and software features that detect the time and amount of fluid dispensing operations and communicate that information to the user's smartphone application or software, which then optionally and preferably communicates that information to the user's doctor, pharmacy, retailer, manufacturer, or other interested party that requires compliance, monitoring, and repurchase functions at the user's option.
According to various embodiments of the present invention, mechanical or sensor-based measurement fluid dispensers of the type described are disclosed, for example, in U.S. patent nos. 8,123,073, 7,419,322, 8,387,833, 10,259,645, and/or U.S. patent application No. 15/941,893, the disclosures of which are incorporated herein by reference in their entirety.
According to further embodiments of the present invention, a sensor or mechanical measurement fluid dispenser may include a chip or other sensor configured to detect a physical change caused by pressing an actuator of the dispenser. For example, the sensor may be a pressure sensor, or a flow sensor, a timer, or some combination thereof. The sensor may be any single sensor or combination of sensors that provide information about the amount of fluid dispensed upon activation of the actuator of the dispenser. Thus, the sensor may be located inside or below the actuator itself, somewhere in the fluid channel/passage, or in the dispenser box housing.
According to a further embodiment, the mechanical measuring dispenser may comprise an adjustable dosing mechanism according to which a user may adjust the amount of dose. According to yet another feature of the present embodiment, one or more sensors may be provided to determine the adjustment status of the adjustable dose feature. According to one embodiment, the sensor determining the adjustment state of the adjustable dose mechanism may be separate from, and optionally in addition to, the sensor detecting and/or measuring the amount of dose upon actuation of the dose actuator.
According to a further embodiment, the measuring and dosing device can be reused, according to which it can be detached from the first fluid bag and attached to a second fluid bag with a just supplied fluid when the first fluid bag is empty.
According to a further embodiment, the fluid bag may comprise a smart label and/or an RFID tag. According to aspects of these embodiments, a user may scan a smart label or RFID tag with a smart phone application that will then cause information about the fluid to be displayed to the user. Such information may include how to administer the fluid by using a mechanical measuring dispenser or a bag dispenser, how to use an application to remind the user to take the fluid, track compliance, the location of the reorder, automatically reorder, or identify the location where the fluid is available, how to use an application to track the dosage and time information delivered and/or deliver such information to interested parties based on the user's preferences and choices.
Thus, the present invention provides a reliable and verifiable way for a user of a fluid to be automatically reminded to take a dose, for the user to determine that the proper dose is being taken, and for a doctor, pharmacy, retailer, manufacturer, or other person who needs compliance, monitoring, and reordering functions to reliably track and record usage.
Drawings
The following description of preferred embodiments of the invention refers to the accompanying drawings, in which:
FIG. 1 is an exploded perspective view of an adjustable fluid dosing dispenser according to an embodiment of the present invention.
FIG. 1b is an alternative illustration of the embodiment shown in FIG. 1 a.
FIG. 1c is a perspective view of an adjustable fluid dosing dispenser dosing collar having an alternative slot design.
Fig. 1d is a bottom perspective view of the dosing dial/button.
Fig. 2 is a bottom perspective view of the dosing/control collar shown in fig. 1 a.
Fig. 3 is a cross-sectional view of the dosing/control collar shown in fig. 1 a.
Fig. 4 is a perspective view of a dosing/control collar according to a further alternative embodiment of the present invention.
Fig. 5a is a perspective view of an assembled adjustable fluid dosing dispenser according to an embodiment of the present invention in a closed/locked position.
Fig. 5b is an alternative illustration of the embodiment shown in fig. 5 a.
FIG. 6a is a perspective view of an adjustable fluid dosing dispenser according to another embodiment.
FIG. 6b is a side view of the adjustable fluid dosing dispenser according to the embodiment of FIG. 6 a.
Fig. 6c is a side cross-sectional view of an adjustable fluid dosing dispenser according to the embodiment of fig. 6a and 6 b.
FIG. 7a is a perspective view of an adjustable fluid dosing dispenser according to an embodiment of the present invention approaching a mating opening on a flexible fluid container.
Fig. 7b is an alternative illustration of the embodiment shown in fig. 7 a.
Fig. 8a is a perspective view of an adjustable fluid dosing dispenser attached to a surface of a flexible fluid container according to an embodiment of the present invention.
Fig. 8b is an alternative illustration of the embodiment shown in fig. 8 a.
Detailed Description
The present invention is a device for dispensing fluid from a bag that can be set to different discrete and repeatable/equal dispensing amounts depending on the amount of fluid that a user needs to dispense for various applications and uses. The device may also be set to an "off" or "closed" position to prevent accidental dispensing of fluid when not in use. The device is preferably configured to be affixed to an outer surface of a fluid container, which is preferably a flexible bag or pouch. According to various embodiments, at least one surface of the fluid container or a sufficient portion of the fluid container is flexible such that the container is foldable when fluid is removed therefrom. In the case where the fluid container is not made entirely of flexible material, the dispensing device is preferably attached to a portion of the container that is flexible and said portion is foldable when dispensing fluid from the container.
The device also includes one or more sensors configured to record, store and/or transmit one or more physical properties of the device, particularly when the dispensing device is actuated in order to dispense fluid and/or when the device is adjusted to a particular dose.
Fig. 1a to 1c show an embodiment of the device comprising a dosing/control collar, a flexible dosing dome and a combination dose setting dial and dose delivery button. The flexible dosing dome and the dosing/control collar form a pump or dosing chamber when assembled. The dosing/control collar is preferably cylindrical with concentric inner and outer annular shafts/posts rising from a common base and defining a narrow passage therebetween. The outer portion of the outer annular shaft may have a flange extending away from the center of the shaft. The inner shaft also has a plurality of horizontal and vertical dosing and rotation channels or slots that receive and interact with corresponding nubs on the outer surface of the dose dial/button. According to an alternative embodiment, the dosing and rotation channel may be located on the shaft of the dose dial/button and the nubs may be located on the outer surface of the inner annular shaft. The horizontal slot is a rotational slot and may have a plurality of relief positions so that a user may tactilely feel the progress of the dial as it rotates. The vertical channels are dosing slots and have different depths (measured from the horizontal slot to the bottom of the vertical slot) corresponding to different dispensed amounts. According to a preferred embodiment, each vertical slot on the inner annular shaft is paired with a second vertical slot spaced on the inner annular shaft by the same depth, and each nub on the dose dial/button is paired with a second nub spaced on the dose dial/button at a position corresponding to the position of the second vertical shaft. When the dial/button is rotated so that a nub on the exterior of the dial/button is aligned with the vertical slot, the button can be pressed to dispense fluid. The limit of depression limits the amount dispensed and the depth of the vertical slot limits the extent to which the button can be depressed because when a nub hits the bottom of the vertical slot, the dial/button is prevented from further depression in order not to damage the nub, the slot/channel, or both.
According to one embodiment, there is at least one vertical slot or set of vertical slots for a "full" dose and at least one second vertical slot or set of vertical slots for a "half" or "partial" dose. According to other embodiments, there may be third and fourth vertical slots or groups of vertical slots for other fractional doses, e.g., 3/4 dose, 2/3 dose, 1/3 dose, and 1/4 dose.
The dosing/control collar also has the following: a through opening on the bottom surface to accommodate incoming fluid, a fluid inlet valve (represented in fig. 3 as a flexible flap configured to be positioned over the through opening), a fluid outlet on the outer surface of the dosing/control collar, and a fluid delivery channel between the fluid inlet and the fluid outlet.
According to a further alternative embodiment shown in fig. 4, the dosing/control collar may have separate dosing and return slots. According to this embodiment, the dosing slot may have a downward facing tooth or prong that prevents the nub from traveling upward, thus requiring full depression before the dial/button returns to the set position. Since the nubs cannot travel up in the dosing slot, a separate return slot is provided adjacent to the dosing slot, the two being connected by a horizontal slot. The return slot preferably has upward teeth or prongs to prevent the nubs from traveling downward in the return slot.
The dose setting dial/dose delivery button is preferably made of a relatively rigid plastic with a rigid bottom part that snaps into a channel formed between the inner and outer annular shaft parts of the base (dosing/control collar).
The dose setting dial/dose delivery button and the dosing/control collar are preferably made of a rigid plastic material. Nubs molded or otherwise formed on the interior surface of the dial/button are placed inside slots formed on the inner shaft. When the user presses the dial/button, the dial/button forces the flexible dosing dome downwards to evacuate the internal volume of the dome via the fluid outlet; when the dial/button is released, the flexible dosing dome returns to its original shape, forcing the dial/button upwards and drawing fluid into the interior of the dome under vacuum.
The flexible dosing dome is preferably made of a shape memory elastic material which returns to its original shape after deformation.
Fig. 5a and 5b show the assembly of these three parts into an adjustable fluid dispensing device according to the invention, wherein the flexible dosing dome is sealed to a seat within the inner post of the dosing/control collar and the bottom part of the dose setting dial/dose delivery button snaps into the channel between the inner and outer shaft part above the flexible dosing dome. The upper part of the dial/button protrudes above the top of the dosing/control collar. According to a preferred embodiment, the perimeter of the upper part of the dial/button has been molded or printed with indicia (e.g. "Open", "Closed" and "FULL" and "HALF") to indicate the rotational position of the dial corresponding to various functions or dispensed amounts. Each of these indicia corresponds to a nub/slot combination that permits no-press, full-press, half-press, or other partial-press to dispense a corresponding amount of fluid. Likewise, the outer surface of the outer shaft part of the collar preferably has printed or molded other indicia indicating the location on the collar that must be aligned with the appropriate indicia on the dial/button in order to achieve the desired function. In the configuration shown in fig. 5a and 5b, the dial/button is in the fully depressed position and rotated counterclockwise so that a nub on the inner surface of the dial/button is located in the bottom horizontal slot, locking the dial/button into the closed position. According to a preferred embodiment, the bottom horizontal slot is slightly downwardly inclined before leveling to slightly pull the dial/button down when it is rotated into the closed position, see fig. 1c, causing the bottom surface of the dial/button to exert pressure on the fluid delivery channel, squeezing it closed. As shown in fig. 5a and 5b, the mark on the collar is aligned with the "< Open" mark on the button, indicating that to dispense fluid, the dial/button must be rotated clockwise until the nub is aligned with the "FULL" vertical slot. If the user wishes to dispense only half of the dose, the dial/button must be rotated clockwise again until the nub is aligned with the corresponding shorter/shallower vertical channel/slot.
Fig. 6a, 6b and 6c show alternative designs of the adjustable fluid dispensing device according to the invention. Instead of the nub and slot interaction of the devices shown in fig. 1 a-1 d, 2, 4, 5a and 5b, the embodiments of fig. 6a, 6b and 6c contain a central screw that can be turned by the top dial portion of the continuous dose adjustment device. As the screw turns, the maximum depression of the button is increased or decreased as the screw moves the button toward or away from the dosing/control collar. As with the embodiments of fig. 1a to 1d, 2, 4, 5a and 5b, a sensor or other smart chip may be arranged to detect rotation, and hence the amount of dose.
Fig. 7a and 7b show an adjustable metering device of the present invention about to be connected to a flexible fluid container, preferably a bag or pouch. According to a preferred embodiment, the fluid container is collapsible as fluid is dispensed therefrom, and is preferably free of air. According to one embodiment, the bottom of the adjustable metering device has an adhesive that allows the adjustable metering device to make a secure, sealed connection with the fluid container. According to a further embodiment, the adhesive may be covered by a thin pull-off film before use to protect and preserve the adhesive until the device is attached to the fluid container. According to various alternative embodiments, the bottom of the adjustable metering device may be heat welded to the fluid container, sonic welded to the fluid container, or sealed to the fluid container in any other known method. According to a further embodiment, the fluid container may have reinforced areas and/or treated surfaces corresponding to the shape and size of the device to facilitate a secure and safe connection and to prevent the container from breaking or tearing if a force or load is applied to the device after it is attached to the fluid container.
Fig. 8a and 8b show an adjustable metering device of the present invention connected to a flexible fluid container. The device may be operated to dispense fluid regardless of the orientation of the device in space, although gravity or other forces may be present in addition to pressing the dial/button.
The application will provide instructional material regarding the fluid being dispensed.
Compliance is measured by the actual pressure on the button and the number of pushes. The time and date of capture. When the fluid in the bag is nearly exhausted, the reorder can be performed.
The smartphone application automatically tracks dose size and time using mechanical or sensor technology.
The data may be shared with a doctor, pharmacy, retailer, manufacturer, or other person who obtains user-permitted compliance, monitoring, and reordering functions. Sensor and application technology allows the reorder options to be identified using GPS technology or online ordering applications.
According to embodiments, the fluid may have any viscosity.
According to another embodiment, RFID, sensor sticker, bluetooth and other sensor technologies are used.
The user will download the application. The application will obtain sensor signals from the sensor technology and prompt for teaching and compliance participation.
The application will automatically capture the dosage, time to take the medication, next medication prompt, and alert when the fluid is nearly exhausted, requiring a reorder.
From the first day on, this can be done using off-the-shelf sensor technology.
When the dose expires, the application will sound an alarm.
The pressure sensor in the "button" sends a signal to dispense fluid and how much. 1TOUCH dispense technique indicates dose.
The patient may provide rights through the application to share with a doctor, pharmacy, retailer, manufacturer, or other person who requires compliance, monitoring, and reordering functions.
Sensor technology provides automatic tracking to ensure ease of use. GPS enables the opportunity for real-time reorder and retail functions.