WO2021096769A1

WO2021096769A1 - Multi-enclosure specimen collector and therapeutic agent dispensing systems and devices

Info

Publication number: WO2021096769A1
Application number: PCT/US2020/059325
Authority: WO
Inventors: Nikolaos Chronis; Helen Julia BURGESS; Eric M. Harding; Nishant JALGAONKAR; Jacob CIEPLY
Original assignee: The Regents Of The University Of Michigan
Priority date: 2019-11-13
Filing date: 2020-11-06
Publication date: 2021-05-20

Abstract

The present invention relates to systems, devices, kits, and methods employing multienclosure dispensing devices and systems (e.g., for home use) that control when a user can remove a specimen collector (SC) or therapeutic agent (TA) from one of the enclosures, and is able to detect when a utilized SC is returned to a chamber. In certain embodiments, a data recording component (DRC) records if/or when an SC or TA is removed from each enclosure, and records when a utilized SC is returned to an enclosure.

Description

MULTI-ENCLOSURE SPECIMEN COLLECTOR AND THERAPEUTIC AGENT DISPENSING SYSTEMS AND DEVICES

The present application claims priority to U.S. Provisional application serial number 62/934,919, filed November 13, 2019, which is herein incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to systems, devices, kits, and methods employing multi enclosure dispensing devices and systems (e.g., for home use) that control when a user can remove a specimen collector (SC) or therapeutic agent (TA) from one of the enclosures, and is able to detect when a utilized SC is returned to a chamber. In certain embodiments, a data recording component (DRC) records if/or when an SC or TA is removed from each enclosure, and records when a utilized SC is returned to an enclosure.

BACKGROUND

When clinical or research trials are conducted, it is important to have precise information of when a sample was collected or a dose was taken, as this data impacts the interpretation of the results of the trial. Attempts by the pharmaceutical industry to have samples self-collected from patients have met with poor results due to errors in documenting dates and times. Self-collected samples, if they could be done at home and properly dated and timed, could expand clinical trials to additional patients groups and reduce the cost to perform a clinical trial.

SUMMARY OF THE INVENTION

In some embodiments, provided herein are system or devices compnsing: a dispensing device comprising: i) a pluralit of enclosures, wherein each enclosure comprises a compartment comprising an opening, wherein the compartment is configured to contain at least one specimen collector (SC) and/or at least one therapeutic agent (TA), ii) a motor, iii) a cover operably attached to the motor and moveable by the motor between a plurality of positions, wherein each of the plurality of positions allows one, and only one, of the plurality of enclosures to be accessible by a human hand via the opening while all other of the enclosures are blocked from human hand access, and wherein the plurality of positions are sufficient such that each of the plurality of enclosures is accessible by a human hand in one of the plurality of positions; iv) a motor control component operably linked to, and activates, the motor to move the cover between the plurality of positions, and v) at least one presence sensor configured to sense the presence or absence of the at least one SC and/or TA before and after each enclosure has been accessible by a human hand. In certain embodiments, the systems and devices further comprise: a data recording component (DRC) that is either part of the dispensing device or is part of a separate electronic device (SED), and is operably linked to the at least one presence sensor, wherein the DRC, based on the at least one presence sensor, is configured to record: i) if and/or when the at least one SC and/or TA is removed from each of the enclosures, and ii) in the instance when at least one of the SC's is removed, if and/or when the SC is returned to each of the enclosures.

In certain embodiments, provides herein are systems comprising: a) a dispensing device comprising: i) a plurality of enclosures (e.g., 2 .. 5 ... 10 ... 15 or more), wherein each enclosure comprises a compartment comprising an opening, wherein the compartment is configured to contain at least one specimen collector (SC) and/or at least one therapeutic agent (TA), ii) a motor, iii) a cover operably attached to the motor and moveable by the motor between a plurality of positions, wherein each of the plurality of positions allows one, and only one, of the plurality of enclosures to be accessible by a human hand via the opening while all other of the enclosures are blocked from human hand access, and wherein the plurality of positions are sufficient such that each of the plurality' of enclosures is accessible by a human hand in one of the plurality of positions; iv) a motor control component operably linked to, and activates, the motor to move the cover between the plurality of positions, and v) at least one presence sensor configured to sense the presence or absence of the at least one SC and/or TA before and after each enclosure has been accessible by a human hand; and b) a data recording component (DRC) that is either part of the dispensing device or is part of a separate electronic device (SED), and is operably linked to the at least one presence sensor, wherein the DRC, based on the at least one presence sensor, is configured to record: i) if and/or when the at least one SC and/or TA is removed from each of the enclosures, and ii) in the instance when at least one of the SC's is removed, if and/or when the SC is returned to each of the enclosures.

In some embodiments, provided herein are methods comprising: a) employing the systems or devices described herein by retrieving said SC or TA through said opening when said one enclosure is accessible; and b) performing at least one of the following: i) collecting a biological specimen with said retrieved SC to generate a utilized SC and returning said utilized SC to said enclosure prior to it being in-accessible, and/or ii) ingesting or injecting said TA. In certain embodiments, the person performing steps a) and b) are performed by a user. In other embodiments, the person performing steps a) and b) is not a user. In some embodiments, the motor control component moves the cover between the plurality of positions based on a schedule. In certain embodiments, the methods further comprising c) repeating steps a) and b) until all, or a subset, of the pluralit of enclosures have been made accessible according to the schedule.

In additional embodiments, the motor control component moves the cover between the plurality of positions based on a schedule. In further embodiments, the schedule comprises: A) a pre-determined schedule, B) a user input schedule, C) a combination of the pre-determined schedule and the user input schedule, D) a regular schedule, or E) irregular schedule. In further embodiments, the motor control component moves the cover between the plurality of positions based on: A) input by a user into tje motor control component, and/or B) a SC or TA being removed from one or more enclosures; and/or C) a SC placed in one or more enclosures (e.g., a user returning a used SC to the enclosure it came from, where its presence is sensed by a presence sensor).

In other embodiments, the systems further comprise a specimen collector (SC) in at least some, or all, of the enclosures. In some embodiments, the systems further comprise a therapeutic agent (TA) in at least some, or all, of the enclosures. In other embodiments, the cover comprises a generally circular and flat surface with a notch opening therein that, when over an opening in one of the enclosures, allows a human hand to retrieve a specimen collector or therapeutic agent therefrom. In other embodiments, wherein, for the enclosures that are blocked, the cover is close enough to the opening in each of the enclosures, but does not touch the opening in each of the enclosures, such that a human hand cannot reach into the blocked enclosures. In particular embodiments, wherein, for the enclosures that are blocked, the cover is mated to the opening in each of the blocked enclosures.

In other embodiments, the motor prevents the cover from being moved, without breaking the cover or the motor, in each of the plurality of positions. In some embodiments, the at least one presence sensor comprises a plurality of presence sensors, such that each of the enclosures has their own presence sensor. In certain embodiments, the at least one presence sensor is positioned such that it interrogates the enclosure that is not blocked.

In some embodiments, the dispensing device further comprises: v) a user interaction and/or display component, wherein the user interaction and/or display component provides at least one of the following: A) an audio or visual signal to the user that one of the enclosures is accessible, or will accessible in a set period of time; B) a wireless signal to the SED indicating that one of the enclosures is accessible, or will be accessible in a set period of time; C) an audio or visual signal to the user providing instructions of actions to take prior to one of the enclosures being accessible; and D) a wireless signal to the SED providing instructions to take prior to one of the enclosures being accessible.

In particular embodiments, the systems further comprise the SED, wherein the SED comprises an app that provides at least one of the following: A) an audio, visual, or vibrating signal to the user that one of the enclosures is accessible, or will be accessible in a set period of time; and B) an audio or visual signal to the user providing instructions prior to one of the enclosures being accessible. In other embodiments, the audio signal is an alarm and/or wherein the visual signal is a countdown timer based on the set period of time. In additional embodiments, wherein: A) the user interaction and/or display component comprises a graphical user interface and/or display screen, or B) wherein the dispensing device comprises at least one display screen present on the cover. In particular embodiments, the instruction are selected from the group consisting of: brush teeth, do not brush teeth, eat food, do not eat food, rinse out mouth, do not rinse out mouth, exercise, do not exercise, take a therapeutic, do not take a therapeutic, how the SC should be used once retrieved, how the TA should be used once retrieved, to take one's temperature, urinate, do not urinate, defecate, do not defecate, and to w eigh themselves.

In other embodiments, the dispensing device further comprises at least one or a plurality of temperature sensors, wherein at least one of the temperature sensors is present in, or near, at least one, or each, of the enclosures. In some embodiments, the DRC is operably linked to the plurality of temperature sensors, and wherein the DRC, based on the temperature sensors, is configured to record the temperature of the plurality of enclosures. In certain embodiments, the dispensing device comprises at least one light intensity measurement component. In other embodiments, the SC comprises at least one of the following: a saliva collection device, a urine collection device, a semen collection device, a blood spot collection device, a blood sample collection device, a stool sample collection device, a cheek swab collection device, an exhaled breath collection device, a tear collection device, a mucus collection device, a vaginal discharge collection device, a vaginal swab collection device, and a hair sample collection device.

In particular embodiments, the TA is selected from the group consisting of: a pharmaceutical agent, a suppository, a cream, a probiotic, a prebiotic, a supplement, and an antibiotic. In some embodiments, the dispensing device or the SED further comprises a start control, wherein the start control is configured such that when it is activated, the schedule is initiated. In additional embodiments, the SED comprises a smartphone, tablet computer, notebook computer, or desktop computer, and wherein the SED is operably linked to the at least one presence sensor via a wireless connection.

In further embodiments, the motor control component is configured to activate the motor to move the cover according to the schedule such that some, or all, of the plurality of enclosures are accessible at some point during the schedule. In some embodiments, the motor control component, based on the schedule, allows one of the enclosures to be accessible for every incremental period of time until all of the plurality of enclosures have been accessible. In additional embodiments, the incremental period of time is about 5 minutes, or about 10 minutes, or about 20 minutes, or about 30 minutes, or about 1 hour or about 12 hours.

In certain embodiments, the dispensing device is configured to be stored: at room temperature, in a refrigerator, or in a freezer. In other embodiments, the systems and devices further compnse at least one, or a plurality of, cooling components, wherein at least one of the cooling components is present in the dispensing device, or in each of the enclosures. In other embodiments, the dispensing device further comprises a power cord configured to plug into a power source. In certain embodiments, the dispensing device further comprises a battery power source.

In other embodiments, the dispensing device is shaped and sized to be transmitted through a postal service or package delivery service. In further embodiments, the systems further comprise a packaging component (e.g., box or reinforced large envelope), wherein the packaging component is configured to enclose the dispensing device such that is may be transmitted through a postal service or package delivery service.

In particular embodiments, the dispensing device further comprises a graphical user interface that allows all of the enclosures to be unlocked. In additional embodiments, the plurality of enclosures each have a generally pie slice shape or generally tubular shape. In other embodiments, the plurality of enclosures comprises at least 5 ... 10 ... 20 ... 36 ... or 50 enclosures. In additional embodiments, each of the enclosures contains one, and only one, of the SCs or the TAs. In certain embodiments, the motor control component comprise a realtime clock.

In certain embodiments, the motor control component comprises non-transitory computer memory comprising one or more computer programs, wherein the one or more computer programs comprises instructions for implementing the schedule. In other embodiments, the DRC comprises: A) non-transitory computer memory; or B) non-transitory computer memory comprising one or more computer programs, wherein the one or more computer programs comprises instructions for recording if and/or when the at least one SC and/or TA is removed from each of the enclosures. In further embodiments, the one or more computer programs further comprises instructions for recording if and/or when the SC is returned to each of the enclosures. In some embodiments, the SED is part of the dispensing device.

In some embodiments, provided herein are systems comprising: a) a plurality of specimen collectors (SCs) and/or therapeutic agents (TAs); b) a dispensing device comprising: i) a plurality of enclosures, wherein each enclosure comprises: A) a compartment comprising an opening, wherein the compartment contains at least one of the SCs and/or TAs, B) a lock mechanism, and C) a lid mated with the compartment to cover the opening to prevent a user from accessing the at least one SC and/or TA, wherein the lid is locked to the compartment via engagement of the lock mechanism; iii) a plurality of presence sensors, wherein at least one of the presence sensors is located in each of the enclosures and is configured to sense the presence or absence of the at least one SC and/or TA; and iv) an electronic lock/unlock component operably connected to the lock mechanism for each of the enclosures, wherein the electronic lock/unlock component is, based on a predetermined schedule (e.g., programmed in by an administrator), configured to: A) unlock one, and only one, of the enclosures by disengaging the lock mechanism such that a user is able to retrieve the at least one SC and/or TA through the opening; B) after a period of time, relock the one, and only one, enclosure by re-engaging the lock mechanism; and C) repeat A) and B) until all (or a subset of all) of the plurality of enclosures have been unlocked and relocked according to the predetermined schedule; and c) a data recording component (DRC) (e.g., comprising a circuit board and data storage component) that is either part of the dispensing device or is part of a separate electronic device (SED), and is operably linked (e.g., via wires or wireless connection such as Bluetooth) to the plurality of presence sensors, wherein the DRC, based on the presence sensors, is configured to record: i) if and/or when the at least one SC and/or TA is removed from each of the enclosures, and ii) in the instance when at least one of the SC's is removed, if and/or when the SC is returned to each of the enclosures.

In certain embodiments, provided herein are devices and systems: a) a dispensing device comprising: i) a plurality of enclosures, wherein each enclosure comprises: A) a compartment comprising an opening, wherein the compartment is configured to house at least one specimen collectors (SCs) and/or therapeutic agents (TAs), B) a lock mechanism, and C) a lid (e.g., a hinged lid) mated with the compartment to cover the opening to prevent a user from accessing the at least one SC and/or TA, wherein the lid is locked to the compartment via engagement of the lock mechanism; ii) a plurality of presence sensors, wherein at least one of the presence sensors is located in each of the enclosures and is configured to sense the presence or absence of the at least one SC and/or TA; iii) an electronic lock/unlock component operably connected to the lock mechanism for each of the enclosures, wherein the electronic lock/unlock component is, based on a predetermined schedule, configured to: A) unlock one, and only one, of the enclosures by disengaging the lock mechanism such that a user is able to retrieve the at least one SC and/or TA through the opening; B) after a period of time, relock the one, and only one, enclosure by re-engaging the lock mechanism; and C) repeat i) and ii) until all (or a subset) of the plurality of enclosures have been unlocked and relocked according to the predetermined schedule; and b) a data recording component (DRC) that is either part of the dispensing device or is part of a separate electronic device (SED), and is operably linked to the plurality of presence sensors, and wherein the DRC, based on the presence sensors, is configured to record: i) if and/or when the at least one SC and/or TA is removed from each of the enclosures, and ii) in the instance when at least one of the SC's is removed, if and/or when the SC is returned to each of the enclosures. In certain embodiments, the systems and devices comprises a light intensity measurement component.

In other embodiments, the light intensity from the light intensity measurement component is recorded (e.g., at particular times) by the DRC.

In some embodiments, provided herein are methods comprising: a) employing the systems and devices described herein by retrieving the SC or TA through the opening when the enclosure is unlocked in part iv) A) of Claim 1 (e.g., by first moving the lid of one of the enclosures); and b) performing at least one of the following: i) collecting a biological specimen from a subject with the retrieved SC to generate a utilized SC and returning the utilized SC to the enclosure prior to it being locked, and/or ii) administering the TA to the subject. In certain embodiments, the person performing steps a) and b) is the subject themselves (e.g., the steps are performed in the user's home). In other embodiments, the person performing steps a) and b) is not the subject (e.g., a nurse or home healthcare provider). In particular embodiments, the methods further comprise: repeating steps a) and b) until all (or a subset) of the plurality of enclosures have been unlocked and relocked according to the predetermined schedule.

In particular embodiments, the dispensing device further comprises: vi) a user interaction and/or display component, wherein the user interaction and/or display component provides at least one of the following: A) an audio or visual signal to the user that one of the enclosures will be unlocked in a set period of time; B) a wireless signal to the SED indicating that one of the enclosures will be unlocked in a set penod of time; C) an audio or visual signal to the user providing instructions to take prior to one of the enclosures being unlocked; and D) a wireless signal to the SED providing instructions prior to one of the enclosures being unlocked. In certain embodiments, wherein the SED comprises an app that provides at least one of the following: A) an audio, visual, or vibrating signal to the user that one of the enclosures will be unlocked in a set period of time; and B) an audio or visual signal to the user providing instructions prior to one of the enclosures being unlocked. In further embodiments, the audio signal is an alarm and/or wherein the visual signal is a countdown timer based on the set period of time. In certain embodiments, when the clock reaches zero and enclosure is unlocked.

In some embodiments, the user interaction and/or display component comprises a graphical user interface and/or display screen, or a collection of labeled buhons and/or knobs. In certain embodiments, the dispensing device comprises at least one display screen present on at least one, or all of said lids (e.g., to provide instructions and alerts regarding the contents of a particular compartment).

In additional embodiments, the instruction are selected from the group consisting of: brush teeth, do not brush teeth, eat food, do not eat food, rinse out mouth, do not rinse out mouth, exercise, do not exercise, take a therapeutic, do not take a therapeutic, how the SC should be used once retrieved, how the TA should be used once retrieved, to take one's temperature, urinate, do not urinate, defecate, do not defecate, and to weigh themselves. In certain embodiments, the methods further comprise reviewing the instructions. In particular embodiments, the methods further comprise: before step a), an action selected from the group consisting of: brushing teeth, not brushing teeth, eating food, not eating food, rinsing out mouth, not rinsing out mouth, exercising, not exercising, taking a therapeutic, not taking a therapeutic, taking one's own temperature, urinating, not urinating, defecating, not defecating, and weighing yourself.

In further embodiments, the dispensing device further comprises at least one or a plurality of temperature sensors, wherein at least one of the temperature sensors is present in at least one, or in each, of the enclosures and is configured to detect the temperature of the enclosure and/or the temperature of the enclosed SC or TA. In other embodiments, the DRC is operably linked (e.g., via wires or wireless connection such as Bluetooth) to the plurality of temperature sensors, and wherein the DRC, based on the temperature sensors, is configured to record the temperature of the plurality of enclosures at multiple time points before, during, and/or after the predetermined schedule. In other embodiments, the dispensing device comprises at least one temperature sensor. In additional embodiments, the DRC is operably linked to the at least one temperature sensor, and wherein the DRC, based on the at least one temperature sensor, is configured to record the temperature of the dispensing device at multiple time points before, during, and/or after the predetermined schedule. In other embodiments, the methods further comprise placing the dispensing device in a refrigerator or freezer.

In some embodiments, the plurality of specimen collectors (SCs) and/or therapeutic agents (TAs) is a plurality of SCs. In additional embodiments, the plurality of specimen collectors (SCs) and/or therapeutic agents (TAs) is a plurality of TAs. In certain embodiments, the plurality of SCs comprise a plurality of saliva collection devices (e.g., SALIVETTE brand). In additional embodiments, the plurality of SCs comprise a plurality of: urine collection devices, semen collection devices, blood spot collection device, blood sample collection devices, stool sample collection devices, cheek swab collection devices, exhaled breath collection devices, tear collection devices, mucus collection devices, vaginal discharge collection devices, vaginal swab collection devices, and hair sample collection devices. In further embodiments, the plurality of TAs are selected from the group consisting of: a pharmaceutical agent, a suppository, a cream, a probiotic, a prebiotic, a supplement, and an antibiotic (e.g., any of which is being studied as part of a clinical trial).

In some embodiments, the dispensing device further comprises a start control (e.g., push in button, knob, switch, etc.), wherein the start control is configured such that when it is activated, the predetermined schedule is initiated, and wherein the method further comprises activating the start control. In certain embodiments, the lock mechanism comprises: i) a first lock component that is attached to or integral with the compartment, and ii) a second lock component that is attached to or integral with the lid. In other embodiments, A) the first lock component is selected from the group consisting of: a pin, an opening, a bolt, a bolt hole, a screw, and a screw hole, and/or B) the second lock component is selected from the group consisting of: a pin, an opening, a bolt, a bolt hole, a screw, and a screw hole. In further embodiments, the SED comprises a smartphone, tablet computer, notebook computer, or desktop computer, and wherein the SED is operably linked to the plurality of presence sensors via a wireless connection.

In certain embodiments, the electronic lock/unlock component, based on the pre determined schedule, unlocks and relocks one of the enclosures once a day until all of the plurality of enclosures have been unlocked and relocked. In some embodiments, the electronic lock/unlock component receives a signal from the SED or other electronic device that causes it to lock and/or unlock enclosures. In certain embodiments, the pre-determined schedule is programmed into the SED or other electronic device. In certain embodiments, the pre-determined schedule is programmed into the electronic lock/unlock component. In further embodiments, the electronic lock/unlock component, based on the pre-determined schedule, unlocks and relocks one of the enclosures every 1 ... 3 ... 6 ... 9 ... or 12 hours until all of the plurality of enclosures have been unlocked and relocked. In further embodiments, the period of time is about 5 minutes, or about 10 minutes, or about 20 minutes, or about 30 minutes, or about 1 hour.

In certain embodiments, the dispensing device is configured to be stored: at room temperature, in a refrigerator, or in a freezer. In some embodiments, the dispensing device further comprises a plurality of cooling components, wherein at least one of the cooling components is present in the device, in at least one enclosure, or in each of the enclosures. In certain embodiments, the methods further comprise placing the dispensing device in the refrigerator or freezer.

In some embodiments, the dispensing device further comprises a power cord configured to plug into a power source. In other embodiments, the dispensing device further comprises a battery power source.

In certain embodiments, the dispensing device is configured to be transmitted through a postal service or package delivery service. In certain embodiments, the methods further comprise: delivering the dispensing device to: a post office, packaging delivery service, or postal drop box, or packing delivery service drop box. In other embodiments, the methods further comprise: delivering the dispensing device to a hospital, clinic, or laboratory. In additional embodiments, the methods comprise downloading data from the dispensing device and/or the SED (e.g., at a healthcare facility). In some embodiments, the methods further comprise wrapping the dispensing device in a packaging component, wherein the packaging component is configured to enclose the dispensing device such that is may be transmitted through a postal service or package delivery service.

In further embodiments, the dispensing device further comprises a graphical user interface that allows all of the enclosures to be unlocked (e.g., by an administrator at a healthcare facility). In other embodiments, the dispensing device has a generally circular shape and the plurality of enclosures have a generally pie slice shape. In further embodiments, the dispensing device has a general square, linear, or rectangular shape.

In certain embodiments, the plurality of enclosures comprises at least 5 ... 10 ... 20 ... 36 ... or 50 ... 100 ... or 200 enclosures. In certain embodiments, each of the enclosures contains one, and only one, of the SCs or the TAs. In other embodiments, the electronic lock/unlock component and/or the DRC and/or SED comprises a real-time clock. In further embodiments, electronic lock/unlock component and/or SED comprises non-transitory computer memory comprising one or more computer programs, wherein the one or more computer programs comprises instructions for the predetermined schedule. In further embodiments, DRC comprises non-transitory computer memory comprising one or more computer programs, wherein the one or more computer programs comprises instructions for recording if and/or when the at least one SC and/or TA is removed from each of the enclosures. In further embodiments, the one or more computer programs further comprises instmctions for recording if and/or when the SC is returned to each of the enclosures. In additional embodiments, the SED is part of the dispensing device.

BRIEF DESCRIPTION OF THE FIGURE

Figure 1 shows an exemplary round dispensing device with multiple compartments. Some of the compartments are shown with a specimen collector (e.g., saliva specimen collector). A number of the lids of the compartments are shown with visual displays.

Figure 2 shows an exemplary dispensing device, with: i) 13 tubular enclosures and 1 tubular spacer (e.g., used as a place where all the SC or TA containing samples are locked, or itself contains a spare SC or TA in case something happens necessitating this); ii) a circular cover with a notch, where the cover prevents access to the tubular enclosures except where the notch is over an enclosure; iii) a plurality of presence sensors to monitor the contents of enclosures; iv) a case to generally house the rest of the components; v) a display to provide information to a user (e.g., subject of clinical trial or technician setting up the device); vi) a motor to move the cover to different positions based on a schedule; vii) a data storage component to record information (e.g., when contents of enclosures removed and/or replaced, or the temperature of enclosures); and viii) a circuit board (e.g., a plurality of circuit boards, to provide electronic instructions to the motor).

DETAILED DESCRIPTION OF THE INVENTION

Provided herein, in certain embodiments, are home-based sample collection systems, and devices (e.g., for collecting blood, saliva, urine, semen, stool, or other biological sample). Such systems and devices allow proper collection of such samples, consistent with research standards, at pre-set time points. In certain embodiments, such systems and devices control when a user has access to a sample collection device or therapeutic by unlocking and relocking at specific times. In other embodiments, a cover prevents access to all of the enclosures except one at a time. In certain embodiments, the systems and devices is automated, electronically controlled, and is a battery powered unit. In particular embodiments, the dispensing device has a rotating disc composed of a plurality of compartments (e.g., 5 ... 10, 11, 12, 13, 14, 15, ... 20 ... 36 ... 50), where one compartment is accessible by the user at any time (see, e.g., Figure 1). In some embodiments, compartments containing the therapeutic or sample/specimen collection device (e.g., SALIVETTE, such as one SALIVETTE in each compartment), are used to store and collect the collection before and after use.

An exemplary dispensing device is shown in Figure 2. As shown in this figure, the exemplary dispensing device has 13 tubular enclosures and 1 tubular spacer (e.g., used as a place where all the SC or TA containing samples are locked, or itself contains a spare SC or TA in case something happens necessitating this). In other embodiments, the enclosures have a different shape, such as square, rectangle, or other shape. Figure 2 shows the cover as a circular rotating cover with a notch, where the rotating cover prevents access to the tubular enclosures except where the notch is over an enclosure. In other embodiments, the cover has a rectangular or other shape (e.g., a belt or solid article), and has an internal cut-out that allows access to a single enclosure at a time. In such embodiments, the belt or solid rectangular cover can move around (e.g. for a belt) or back and forth (e.g., for a solid rectangular cover). Figure 2 shows a plurality of presence sensors to monitor the contents of enclosures. Figure 2 also shows a case to generally house the rest of the components of the device. Figure 2 also shows a display to provide information to a user (e.g., subject of clinical trial or technician setting up the device). Such information can include instructions on how to take a sample, when to take it, etc. Figure 2 shows a motor to move the cover to different positions based on a schedule. Figure 2 also shows a data storage component to record information (e.g., when contents of enclosures removed and/or replaced, or the temperature of enclosures). Figure 2 also shows a circuit board (e.g., to provide electronic instmctions to the motor).

In an exemplary embodiment, the general operation of the dispensing systems and devices are as follows. First, the user (e.g., patient or medical care giver) initiates specimen collecting protocol (e.g., for collecting clinical trial information and/or for diagnosing or treating the user) by pressing a start button the dispensing device. Next, a visual display (e.g., on the lid of the first chamber to be unlocked or made accessible, or a general display screen, or smart phone) provides instructions regarding what phase of the collection process the user is in (e.g., it’s time for the user to brush their teeth, rinse their mouth, provide a saliva sample, or take a break, etc.). It is noted that the duration of each step can be adjusted to meet the needs of the specific clinical trial experiment or treatment or collection protocol.

It is further noted that the phase labels and instructions can also be adjusted per experiment or treatment/collection needs. Next, during the sample collection (and/or therapeutic agent dispensing) process, only one compartment (the proper compartment for the desired protocol) is unlocked or otherwise made accessible to allow the user or medical personal to take out the specimen collection device (e.g., a collection device designed to collect blood, saliva, urine, semen, stool, etc.) or therapeutic agent (e.g., a biological or small molecule in clinical testing) from the compartment. Once out of the compartment, the user or medical personal, can employ the specimen collector and provide the desired sample or take the therapeutic. For the specimen collector, the user or medical personal places the specimen collector back into the chamber that is unlocked or accessible before the timer automatically locks the compartment. There is a real time clock and sensors, for detecting the removal and insertion of the specimen collector device from their individual compartments, to measure and record the time the collector is being used by the user. Not only are the sample collection devices (or therapeutic agent) locked (or inaccessible) in their compartments until the user is supposed to access them, but the device also electronically records that the user properly uses the device so the researcher can verify proper collection timing was adhered to. After all the samples are collected (and/or therapeutic agents used) for the specific clinical experiment, or other protocol, the device is locked (e.g., motor will not move to allow access to any of the enclosures) not allowing the user to make any changes to the collected samples. In certain embodiments, there is an option for extra collection devices or therapeutic agents as desired by the research or protocol in case the user misses a collection or treatment phase. The dispensing device can be stored in a fridge or freezer as needed by the experiment/researcher. The dispensing device can be sent to the facility conducting the test or providing the user care (e.g., through the mail or other postal service, or delivered by the user). Once the device the device is returned to the researcher or medical personal they can unlock the device (e.g., allow motor to move to various accessible positions) exposing all the used collection devices for further processing and access the digital recording. Examples of data recorder from the device include: i) general temperature of the device, and ii) time stamps for the moment the specimen collection device (or therapeutic) is removed and reinserted into the chambers. In certain embodiments, the systems and devices record both the time a specimen collector device is being picked up and collected. This feature allows for time-sensitive applications such as monitoring Dim Light Melatonin Onset or Cortisol Awakening Response (e.g., via saliva collection). In some embodiments, the systems and devices comprise a light intensity measurement component (e.g., for external or environmental light sensing and recording).

Although only a few exemplary embodiments have been described in detail, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this disclosure. Accordingly, all such modifications and alternative are intended to be included within the scope of the invention as defined in the following claims. Those skilled in the art should also realize that such modifications and equivalent constructions or methods do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions, and alterations herein without departing from the spirit and scope of the present disclosure.

Claims

CLAIMS We claim:

1. A system comprising: a) a dispensing device comprising: i) a plurality of enclosures, wherein each enclosure comprises a compartment comprising an opening, wherein said compartment is configured to contain at least one specimen collector (SC) and/or at least one therapeutic agent (TA), ii) a motor, iii) a cover operably attached to said motor and moveable by said motor between a plurality of positions, wherein each of said plurality of positions allows one, and only one, of said plurality of enclosures to be accessible by a human hand via said opening while all other of said enclosures are blocked from human hand access, and wherein said plurality of positions are sufficient such that each of said plurality of enclosures is accessible by a human hand in one of said plurality of positions; iv) a motor control component operably linked to, and activates, said motor to move said cover between said plurality of positions, and v) at least one presence sensor configured to sense the presence or absence of said at least one SC and/or TA before and after each enclosure has been accessible by a human hand; and b) a data recording component (DRC) that is either part of said dispensing device or is part of a separate electronic device (SED), and is operably linked to said at least one presence sensor, wherein said DRC, based on said at least one presence sensor, is configured to record: i) if and/or when said at least one SC and/or TA is removed from each of said enclosures, and ii) in the instance when at least one of said SC's is removed, if and/or when said SC is returned to each of said enclosures.

2. The system of Claim 1, wherein said motor control component moves said cover between said plurality of positions based on a schedule.

3. The system of Claim 2, wherein said schedule comprises: A) a pre-determined schedule, B) a user input schedule, C) a combination of said pre-determined schedule and said user input schedule, D) a regular schedule, or E) irregular schedule.

4. The system of Claim 1, wherein said motor control component moves said cover between said plurality of positions based on: A) input by a user into said motor control component, and/or B) a SC or TA being removed from one or more enclosures; and/or C) a SC placed in one or more enclosures.

5. The system of Claim 1, further comprising a specimen collector (SC) in at least some, or all, of said enclosures.

6. The system of Claim 1, further comprising a therapeutic agent (TA) in at least some, or all, of said enclosures.

7. The system of Claim 1, wherein said cover comprises a generally circular and flat surface with a notch opening therein that, when over an opening in one of said enclosures, allows a human hand to retrieve a specimen collector or therapeutic agent therefrom.

8. The system of Claim 1, wherein, for said enclosures that are blocked, said cover is close enough to said opening in each of said enclosures, but does not touch said opening in each of said enclosures, such that a human hand cannot reach into said blocked enclosures.

9. The system of Claim 1, wherein, for said enclosures that are blocked, said cover is mated to said opening in each of said blocked enclosures.

10. The system of Claim 1, wherein said motor prevents said cover from being moved, without breaking said cover or said motor, in each of said plurality of positions.

11. The system of Claim 1, wherein said at least one presence sensor comprises a plurality of presence sensors, such that each of said enclosures has their own presence sensor.

12. The system of Claim 1, wherein said at least one presence sensor is positioned such that it interrogates the enclosure that is not blocked.

13. The system of Claim 1, wherein said dispensing device further comprises: v) a user interaction and/or display component, wherein said user interaction and/or display component provides at least one of the following: A) an audio or visual signal to said user that one of said enclosures is accessible, or will accessible in a set period of time; B) a wireless signal to said SED indicating that one of said enclosures is accessible, or will be accessible in a set period of time; C) an audio or visual signal to said user providing instructions of actions to take prior to one of said enclosures being accessible; and D) a wireless signal to said SED providing instructions to take prior to one of said enclosures being accessible.

14. The system of Claim 1, further comprising said SED, wherein said SED comprises an app that provides at least one of the following: A) an audio, visual, or vibrating signal to said user that one of said enclosures is accessible, or will be accessible in a set period of time; and B) an audio or visual signal to said user providing instructions prior to one of said enclosures being accessible.

15. The system of Claims 13 and 14, wherein said audio signal is an alarm and/or wherein said visual signal is a countdown timer based on said set period of time.

16. The system of Claim 12, wherein: A) said user interaction and/or display component comprises a graphical user interface and/or display screen, or B) wherein said dispensing device comprises at least one display screen present on said cover.

17. The system of Claim 14 and 15, wherein said instruction are selected from the group consisting of: brush teeth, do not brush teeth, eat food, do not eat food, rinse out mouth, do not rinse out mouth, exercise, do not exercise, take a therapeutic, do not take a therapeutic, how said SC should be used once retrieved, how said TA should be used once retrieved, to take one's temperature, urinate, do not urinate, defecate, do not defecate, and to weigh themselves.

18. The system of Claim 1, wherein said dispensing device further comprises at least one or a plurality of temperature sensors, wherein at least one of said temperature sensors is present in, or near, at least one, or each, of said enclosures.

19. The system of Claim 18, wherein said DRC is operably linked to said plurality of temperature sensors, and wherein said DRC, based on said temperature sensors, is configured to record the temperature of said plurality' of enclosures.

20. The system of Claim 1, wherein said dispensing device comprises at least one light intensity measurement component.

21. The system of Claim 1, wherein said SC comprises at least one of the following: a saliva collection device, a urine collection device, a semen collection device, a blood spot collection device, a blood sample collection device, a stool sample collection device, a cheek swab collection device, an exhaled breath collection device, a tear collection device, a mucus collection device, a vaginal discharge collection device, a vaginal swab collection device, and a hair sample collection device.

22. The system of Claim 1, wherein said TA is selected from the group consisting of: a pharmaceutical agent, a suppository, a cream, a probiotic, a prebiotic, a supplement, and an antibiotic.

23. The system of Claim 2, wherein said dispensing device or said SED further comprises a start control, wherein said start control is configured such that when it is activated, said schedule is initiated.

24. The system of Claim 1, wherein said SED comprises a smartphone, tablet computer, notebook computer, or desktop computer, and wherein said SED is operably linked to said at least one presence sensor via a wireless connection.

25. The system of Claim 2, wherein said motor control component is configured to activate said motor to move said cover according to said schedule such that some, or all, of said plurality of enclosures are accessible at some point during said schedule.

26. The system of Claim 25, wherein motor control component, based on said schedule, allows one of said enclosures to be accessible for every incremental period of time until all of said plurality of enclosures have been accessible.

27. The system of Claim 26, wherein said incremental period of time is about 5 minutes, or about 10 minutes, or about 20 minutes, or about 30 minutes, or about 1 hour or about 12 hours.

28. The system of Claim 1, wherein said dispensing device is configured to be stored: at room temperature, in a refrigerator, or in a freezer.

29. The system of Claim 1, further comprising at least one, or a plurality of, cooling components, wherein at least one of said cooling components is present in said dispensing device, or in each of said enclosures.

30. The system of Claim 1, wherein said dispensing device further comprises a power cord configured to plug into a power source.

31. The system of Claim 1, wherein said dispensing device further comprises a battery power source.

32. The system of Claim 1, wherein said dispensing device is shaped and sized to be transmitted through a postal service or package delivery service.

33. The system of Claim 1, further comprising a packaging component, wherein said packaging component is configured to enclose said dispensing device such that is may be transmitted through a postal service or package delivery service.

34. The system of Claim 1, wherein said dispensing device further comprises a graphical user interface that allows all of said enclosures to be unlocked.

35. The system of Claim 1, wherein said plurality of enclosures each have a generally pie slice shape or generally tubular shape.

36. The system of Claim 1, wherein said plurality of enclosures comprises at least 5 ... 10 ... 20 ... 36 ... or 50 enclosures.

37. The system of Claim 1, wherein each of said enclosures contains one, and only one, of said SCs or said TAs.

38. The system of Claim 1, wherein said motor control component comprise a real-time clock.

39. The system of Claim 2, wherein said motor control component comprises non- transitory computer memory comprising one or more computer programs, wherein said one or more computer programs comprises instructions for implementing said schedule.

40. The system of Claim 1, wherein said DRC comprises: A) non-transitory computer memory; or B) non-transitory computer memory comprising one or more computer programs, wherein said one or more computer programs comprises instructions for recording if and/or when said at least one SC and/or TA is removed from each of said enclosures.

41. The system of Claim 40, wherein said one or more computer programs further comprises instructions for recording if and/or when said SC is returned to each of said enclosures.

42. The system of Claim 1, wherein said SED is part of said dispensing device.

43. A system or device comprising: a dispensing device comprising: i) a plurality of enclosures, wherein each enclosure comprises a compartment comprising an opening, wherein said compartment is configured to contain at least one specimen collector (SC) and/or at least one therapeutic agent (TA), ii) a motor, iii) a cover operably attached to said motor and moveable by said motor between a plurality of positions, wherein each of said plurality of positions allows one, and only one, of said plurality of enclosures to be accessible by a human hand via said opening while all other of said enclosures are blocked from human hand access, and wherein said plurality of positions are sufficient such that each of said plurality of enclosures is accessible by a human hand in one of said plurality of positions; iv) a motor control component operably linked to, and activates, said motor to move said cover between said plurality of positions, and v) at least one presence sensor configured to sense the presence or absence of said at least one SC and/or TA before and after each enclosure has been accessible by a human hand.

44. The system or device of Claim 43, further comprising: a data recording component (DRC) that is either part of said dispensing device or is part of a separate electronic device (SED), and is operably linked to said at least one presence sensor, wherein said DRC, based on said at least one presence sensor, is configured to record: i) if and/or when said at least one SC and/or TA is removed from each of said enclosures, and ii) in the instance when at least one of said SC's is removed, if and/or when said SC is returned to each of said enclosures.

45. The system or device of Claim 43, further comprising a specimen collector (SC) in at least some of said enclosures.

46. The system or device of Claim 43, further comprising a therapeutic agent (TA) in at least some of said enclosures.

47. A method comprising: a) employing the systems or device of any of Claims 1-46 by retrieving said SC or TA through said opening when said one enclosure is accessible; and b) performing at least one of the following: i) collecting a biological specimen with said retrieved SC to generate a utilized SC and returning said utilized SC to said enclosure prior to it being in accessible, and/or ii) ingesting or injecting said TA.

48. The method of Claim 47, wherein the person performing steps a) and b) are performed by a user.

49. The method of Claim 47, wherein the person performing steps a) and b) is not a user.

50. The system of Claim 47, wherein said motor control component moves said cover between said plurality of positions based on a schedule.

51. The method of Claim 50, further comprising c) repeating steps a) and b) until all, or a subset, of said plurality of enclosures have been made accessible according to said schedule.