STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR

DEVELOPMENT

This invention was made with government support under (identify the contract) awarded by (identify the Federal agency). The government has certain rights in the invention.

BACKGROUND OF THE INVENTION

Field of the Invention

This invention generally relates to a secure refrigerated storage unit. In particular, the invention provides a secure refrigerated medical storage unit (e.g. refrigerator) for the storage of medicines, vaccines or other valuable products that must be stored in the cold.

State of Technology

Currently there are limited commercial options for secure refrigerated storage of medicines. This is in contrast to the more secure options which exist for storage of non-refrigerated medicines. Secure, refrigerated storage and monitoring of medicine removal presents a significantly higher challenge than non-refrigerated storage due to the need to ensure proper air circulation, temperature monitoring and electronic component robustness. The current commercial state of the art is a locked refrigerator which is connected to a secure electronic system that controls access to the entire refrigerator.

However, once the refrigerator is unlocked the entire refrigerator and all contents are open to access. This can allow the opener access to unauthorized medicine.

The undesired effects of lack of individual security compartments in a refrigerator are considerable. For example, access to medicines such as narcotics and opioids by non- authorized personnel creates a significant risk for health care providers, and deaths related to opioid abuse are a major concern for the US government and localities. Also, current practices pose a significant financial disadvantage for pharmacies, hospitals, and laboratories due to existing pharmacy processes and regulations that require a number of refrigerated medicines to be stored securely. In addition, some refrigerated medicines require both security and proximity to the patient for emergency purposes (such as cisatricurium). While there are some refrigerators that have locked access, they do not have the key desirable trait which is compartmentalization which allows both access to a single prescribed medicine and removes the potential for medical errors when removing the medicine from the refrigerator. Because such secure, compartmentalized refrigerated storage does not currently exist in a form which controls access to the single prescribed medicine, pharmacies must place these medicines in secured non-refrigerated local storage and reset the expiry date from (e.g.) 2 years to 28 days. This is a significant financial cost because the medicines must then be replaced every 28 days instead of, for example, every 2 years. The estimated wastage value due to reassignment of expiry date and procedural costs in replacing these medicines is often hundreds of thousands of dollars.

SUMMARY OF THE INVENTION

Other features and advantages of the present invention will be set forth in the description of invention that follows, and in part will be apparent from the description or may be learned by practice of the invention. The invention will be realized and attained by the compositions and methods particularly pointed out in the written description and claims hereof.

Provided herein are secure, compartmentalized, refrigerated storage systems (units) which address the shortcomings of existing product offerings. The systems have been designed to take into account airflow, to ensure rapid cooling of contents (e.g. after opening), as well as structural integrity and security, in order to meet or exceed regulatory standards for such a system. The system includes: i) a storage section, containing multiple sliding shelves, in which each shelf comprises at least one, and usually many, individually locking compartments, and ii) a non-refrigerated section for housing electrical and mechanical components. The design has been prioritized with respect to airflow to meet or exceed NIH/CDC/FDA standards requiring medicines and vaccines to be kept within 1.5 degrees Celsius of a target temperature in order to maintain their shelf life.

It is an object of this invention to provide a storage unit, comprising i) a cabinet; ii) a first door comprising at least one first reversible locking system and at least one first actuator configured to send and receive electronic signals from a controller, wherein the at least one first actuator controls the at least one first reversible locking system; iii) at least one refrigerated storage section comprising: at least one ventilated shelf or at least one ventilated drawer, and at least one ventilated compartment configured to be positioned on the at least one ventilated shelf or in the at least one ventilated drawer,

wherein the at least one ventilated compartment comprises at least one second reversible locking system and at least one second actuator configured to send and receive electronic signals from the controller, wherein at least one second actuator controls the at least one second reversible locking system; iv) at least one sensor in the at least one ventilated compartment operably linked to or linkable to a controller by a fiber optic cable positioned in the cabinet; and v) a non-refrigerated section for housing electrical and mechanical components. In some aspects, the at least one sensor is a temperature sensor, a weight sensor or a content sensor. In some aspects, the temperature sensor comprises an infrared camera operably linked to the controller via fiber optics. In further aspects, the refrigerated storage section comprises a second door comprising at least one third reversible locking system and at least one third actuator configured to send and receive electronic signals from the controller, wherein the at least one third actuator controls the at least one third reversible locking system. In yet further aspects, the at least one ventilated compartment comprises a lighting system which indicates when the at least one ventilated compartment is locked or unlocked. In additional aspects, the at least one ventilated compartment comprises at least one indicator light which indicates information pertaining to contents of the compartment. In further aspects, the at least one ventilated compartment of the refrigerated storage section includes a plurality of ventilated compartments, and wherein the refrigerated storage section is configured to maintain different compartments at different temperatures. In yet further aspects, the at least one ventilated compartment comprises at least one chimney, wherein walls of the chimney extend from an opening in the floor of the at least one ventilated compartment and form an opening into the at least one ventilated compartment. In other aspects, the ventilation is provided via raised slots which provide airflow and prevent the flow of liquid from the compartment.

Also provided is a storage unit, comprising i) a cabinet; ii) a first door comprising at least one first reversible locking system and at least one first actuator configured to send and receive electronic signals from a controller, wherein the at least one first actuator controls the at least one first reversible locking system; iii) at least one refrigerated storage section comprising: at least one ventilated shelf or at least one ventilated drawer, and at least one ventilated compartment configured to be positioned on the at least one ventilated shelf or in the at least one ventilated drawer, wherein the at least one ventilated compartment comprises at least one second reversible locking system and at least one second actuator configured to send and receive electronic signals from the controller, wherein at least one second actuator controls the at least one second reversible locking system; and wherein the at least one ventilated compartment comprises at least one temperature sensor operably linked to or linkable to a controller by a fiber optic cable positioned in the cabinet; and iii) a

non-refrigerated section for housing electrical and mechanical components. In some aspects, the at least one ventilated compartment comprises

one or both of a weight sensor and a content sensor. In further aspects, the refrigerated storage section comprises a second door comprising at least one third reversible locking system and at least one third actuator configured to send and receive electronic signals from the controller, wherein the at least one third actuator controls the at least one third reversible locking system. In additional aspects, the at least one ventilated compartment comprises a lighting system which indicates when the at least one ventilated compartment is locked or unlocked. And in yet further aspects, the at least one ventilated compartment comprises at least one indicator light which indicates information pertaining to contents of the compartment. In some aspects, the at least one ventilated compartment of the refrigerated storage section includes a plurality of ventilated compartments, and wherein the refrigerated storage section is configured to maintain different compartments at different temperatures.

In additional aspects, the at least one ventilated compartment comprises at least one chimney, wherein walls of the chimney extend from an opening in the floor of the at least one ventilated compartment and form an opening into the at least one ventilated

compartment. In further aspects, ventilation is provided via raised slots which provide airflow and prevent the flow of liquid from the compartment.

Also provided is a system comprising a storage unit of the preceding description operably connected or linked to a control station located remotely from the storage unit.

Also provided is a method of storing a material that is temperature sensitive, comprising placing the material in a ventilated compartment of the storage unit described above.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1A-F. Schematic representations of: A, front view of the exterior of an exemplary refrigeration unit with the exterior door in a closed position, and showing the connection to a controller; B, front view of an exemplary (optional) interior door when closed; C, front view an exemplary single interior compartment with two shelves; D, front view of two exemplary interior compartments, each with two shelves; E, front view of an exemplary interior compartment with two shelves and three individual locking compartments disposed on each shelf; E, top view of an exemplary perforated shelf.

Figure 2A-C. A, an exemplary lockable drawer/compartment; B, an exploded view of an exemplary lockable drawer; C, view of shelves with individual locking compartments positioned thereon.

Figure 3A-C. Internal view of a compartment with a chimney A, in the back corner; B, on the side; and C, in a front corner.

Figure 4. Exemplary compartment comprising a weight scale at the bottom.

Figure 5. Thermal distributions in Computational Fluid Dynamics (CFD) simulations. Case 1, no ventilation; Case 2, 10% porosity; Case 5, 40% porosity.

Figure 6. Simulated thermal cooling of medicine in various cases.

Figure 7. Block diagram of an exemplary system as disclosed herein.

Figure 8 A and B. A, drawer comprising multiple lockable compartments; B, unit with multiple, slidable drawers, each of which contains multiple lockable compartments.

DETAILED DESCRIPTION

The invention provides secure refrigeration units (e.g. refrigerators) for the monitoring and storage of medicines, vaccines or other valuable products that need to be stored in the cold and/or at a particular specified or preset temperature. Each unit comprises an external housing comprising a lockable door, and an internal storage section optionally comprising a door which is optionally lockable. The internal storage section comprises shelves which hold at least one, and typically a plurality of, individual lockable

compartments designed (configured) to hold contents of interest.

Exemplary key characteristics of this refrigerator are the i) ability to ensure circulated airflow via ventilated compartments, which have been optimized to balance good airflow against structural integrity; ii) ability to monitor the placement and/or removal of medicines from locked compartments via a control system; iii) optionally monitor material removals via a load cell which can tare prior to opening; iv) a central lock on the refrigerator door, actuated, by original, or existing IT; individual refrigerator drawers which are locked and unlock upon electronic actuation by the appropriate professional; v) shelves optionally have a light which indicates which one is unlocked; vi) individual locking, shelf compartments with vents which will allow airflow and which may be configured to various sizes; optionally an indicator light on each compartment to alert to the potential, or actual expiry of materials; vii) internal refrigerator temperature monitoring to ensure compliance with standards pertaining to the stored substance; viii) optional temperature monitoring within each compartment; xi) electronics space in each compartment to receive and send information associated with the refrigerator; x) the proposed refrigerator is scalable with respect to size and configuration including small refrigerators, larger (deli style) units found in hospitals, laboratories, cold rooms, and mobile units.

Further exemplary features of the invention are as follows:

1. A secure, compartmentalized, refrigerated, storage system which has been designed and optimized for a combination of airflow, to ensure rapid cooling of contents, as well as structural integrity and security, meeting or exceeding regulatory standards for such a device.

2. This system includes:

a. A storage section, containing multiple sliding shelves,

b. Each shelf comprising of many individually locking compartments, and

c. A non-refrigerated section for housing electrical and mechanical components.

3. Shelves which slide out for ease of access and are ventilated to allow airflow between shelves.

4. Compartments which house sensors for detecting the presence, temperature, and weight of secured contents.

5. A storage section which may itself be locked by original or existing hardware.

6. Compartments which are ventilated from via raised slots which provide airflow while protecting against spillage.

7. A unit which is scalable in size and configuration to include small refrigerators, larger (deli style) medical & laboratory units, cold rooms, and mobile units.

THE CABINET AND INTERNAL STORAGE SECTION

The refrigeration units provided herein generally comprise an exterior cabinet or housing having a rear wall, a front wall, opposite side walls, a top wall, and a bottom wall. The cabinet generally encloses one or more internal (refrigerated) storage sections and one or more mechanical and/or electrical compartments. The cabinet can be any that is suitable for the intended use of the unit e.g. see the cabinets/housings described in issued US patents 9,579,245 and 10,508,855 and references cited therein, without e.g. freezer compartments.

In some aspects, the present unit does not include a freezer compartment. The cabinet may comprise insulating material between the outer walls of the cabinet and the defining outer walls of the internal storage sections (e.g. a refrigeration liner) to help maintain the temperature of the internal storage section(s). The cabinet or portions of the cabinet, for example, the mechanical and/or electrical compartments, may be cooled, ventilated or equipped e.g. with a fan, for example, to maintain a temperature suitable for the electronic and/or mechanical components housed therein, such as to keep them at ambient temperature, etc.

For the present invention, with reference to Figure 1A, which shows an exemplary schematic front view of a unit, refrigerated unit 10 comprises cabinet 11, at least one mechanical/electronic space 12 for containing electronic or mechanical components, and external lockable door 20 (which may be the first door of the unit). External lockable door 20 is fitted with locking mechanism 21. Locking mechanism 21 is typically a remotely controllable actuator such as a solenoid or other electronically controllable mechanical means for locking. Locking mechanism 21 is electronically connected to controller 50, e.g. a computer, computer network or other computerized device. An attachment means such as hinges 22 secure external lockable door 20 to the front surface of cabinet 11 and permit the door to be opened.

Figure IB shows a schematic depiction of refrigerated unit 10, shown, for ease of viewing, without external lockable door 20. What is shown is optional internal door 30 (which may be the second door of the unit). Internal door 30 may also optionally be fitted with locking mechanism 31 with properties similar to those of locking mechanism 21. If present, internal door 30 may be secured to the outside of an internal storage section. If present, internal door 30 may be solid (opaque) or transparent so that the contents of the internal storage compartment (discussed below) can be viewed.

Figure 1C depicts an exemplary unit without showing either external lockable door 20 or optional internal door 30 (for ease of viewing) so that the viewer is looking directly into exemplary internal storage section 40. As can be seen, in some aspects, internal storage section 40 comprises at least one shelf 41. Typically, multiple (a plurality of) shelves are present. Shelf 41 is slidably or moveably positioned or secured within internal storage section 40 by means of a positioning or securing device 42, which may be, for example, brackets, bottom rails, drawer slides, etc. The shelves may be permanently affixed in the internal storage section 40, e.g. by attachment to the interior side walls of the housing such as by brackets, rails, etc.; or adjustably secured by placement (sliding onto) on adjustable brackets, rails, etc.

In other aspects, the unit comprises at least one ventilated drawer instead of shelves (although combinations of shelves and drawers are also encompassed). In this aspect, ventilated drawers are generally removably e.g. slidably attached e.g. to the inner walls of the interior storage section of the unit, or slidably attached to a shelf (usually ventilated) that is located underneath the drawer, etc. Attachment may be via any suitable means, e.g.

sliding rails, telescoping slides, ball bearing slides, etc. and a suitable number of rails may be present e.g. one or two per side, or one or two at the bottom of a drawer, etc. In this aspect, the individual locking compartments may be disposed within a drawer either permanently (i.e. built into the drawer) or removably (i.e. they can be removed and replaced). The compartments in a drawer (or on a shelf) may be all of the same size and shape, or they may differ from one another in size and shape. Further, combinations of permanently affixed and removable compartments are also encompassed, as are drawers with ventilated sections which are not intended to hold e.g. medications. For example, such sections may be present to serve as spacers, for extra ventilation, and/or as place holders for the future insertion of compartments. These aspects are illustrated in Figure 8A and B.

Typically, the shelves and/or drawers are ventilated to allow airflow around and between them. As used herein,“ventilated” refers to a component of a unit (e.g. a shelf, a drawer, etc.) having multiple openings that allow air to pass through the component so that air can circulate freely through and/or into and out of the component. The openings or holes may be of any suitable size and shape, e.g. circular holes, linear slots, etc. Figure IF shows shelf 41 with perforations 43.

Figure 1C depicts a unit with a single internal storage section 40. However, more than one internal storage section 40 may be present, as shown in Figure ID, each of which can be optionally fitted with an internal door 30 (not shown). For example, units comprising from about 1 to about 10 internal storage section 40 are also encompassed.

INDIVIDUAL LOCKABLE COMPARMENTS

The ventilated shelves or drawers of the unit are designed to accommodate one or more individual internal lockable refrigerator compartments (e.g. drawers). The compartments are placed (e.g. removably such as by sliding) onto a shelf by any suitable mechanism, many of which are known in the art. In addition, in some aspects, each shelf has an optional lighting system which indicates when a compartment associated with (located on) the shelf is unlocked. For example, the light can be off when no compartments on the shelf are unlocked and on when one or more compartments on the shelf are unlocked.

The individual internal compartments are generally rectangular, and generally comprise a bottom section, walls (e.g. a front wall, back wall and side walls), and a displaceable or removable top section or covering (lid), which may be a hinged lid, any or all of which may be advantageously ventilated e.g. by comprising openings such as slits or holes. As described in the Examples section below, the number, size and spacing of the ventilation openings has been optimized to balance good airflow with structural integrity, i.e. the airflow has been optimized without compromising the structural integrity and robustness of the components of the compartments. Within an individual unit, the ventilation of all shelves and of all compartments may be the same, or one or more shelves and/or one or more compartments may be different, thereby providing a plurality of microenvironments within the unit. In addition, if the bottom of a compartment includes ventilation openings (perforations), they may be coordinated between the shelf on which the compartment is placed, such that solid portions of the bottom of a compartment do not occlude an opening in the shelf and vice versa.

In some aspects, the compartments are ventilated from the bottom via raised slots (for example, at least one raised slot located between the compartment and the shelf or bottom of the drawer, which provides increased airflow and which also protects against spillage. The raised slots are generally present on the top of the shelf and the compartment rests on and slides along the raised slots during insertion of the compartment onto the shelf. Spillage from the compartment flows into and is retained in unraised sections of the shelf that do not have openings, e.g. between and/or directly underneath the compartment.

Further, the size of openings in the bottom of a compartment or in a shelf may be adjustable by providing a slidable floor with ventilation openings that, depending on its position, line up with and maximize airflow through the openings or do not line up with an thus occlude or partially occlude openings, thereby attenuating the airflow and providing an extra means of airflow control.

The bottom of a compartment may be substantially flat, so that the contents lie at loosely in random orientations on the bottom and may even be stacked on each other. Alternatively, holders, such as recessed spaces or undulations, may be present for fitting individual content items into the compartment, such as recessed spaces for tablets, undulations for receiving vials, etc. In addition, a control substance e.g. in a vial or other suitable container, may be present to be used as a standard for standardizing temperature readings.

Figure 2A depicts a schematic view of exemplary internal lockable compartment 100 comprising lid 110 and front housing 120 which contains locking mechanism 130. Locking engagement means 135 is present on lid 110 and engages with locking mechanism 130 to lock the compartment.

A more detailed view of an exemplary internal lockable compartment is shown in Figure 2B, and Figure 2C shows a view of an internal storage section comprising three shelves, each of which is loaded with a plurality of internal lockable compartments.

LOCKING MECHANISMS

For each component of the storage unit, e.g. doors and individual compartments, the locking mechanisms are capable of limiting access to the storage unit via electronic control. An exemplary locking mechanism may comprise a solenoid. Solenoids are but one example of a type of actuator that may be used to control access to the compartments, and other kinds of actuators may be used. For example, magnetic actuators, motors with appropriate linkages, or other kinds of actuators.

CHIMNEYS

In some aspects, the bottom surface of the compartment comprises ventilation openings in the form of one or more“chimneys”, e.g. internal“chimneys” (passages, channels, etc.) which are provided for airflow through the base of and into the compartment. The chimneys are advantageously raised so that in the event of spillage or breakage of medicines stored inside the compartment, the contents will remain in the compartment.

The chimneys are open at the bottom and the top and the sides are closed. As shown in Figure 3A, which is a view of exemplary compartment 100 without a front wall, chimney 60 comprises bottom opening 61, which is an opening in the bottom of floor of the compartment, and top opening 62 which opens into the compartment. Chimney 60 comprises front wall 63 and side wall 64. In this view, a section of the back wall of the compartment serves as a back wall of chimney 50 and is not numbered, and a section of the side wall of the compartment serves as a second side wall of chimney 60 and is also not numbered. In Figure 3A, one chimney is depicted but a plurality of chimneys may be included, e.g. in two, three or all four corners of compartment 100. In addition, in Figure 3A, chimney 50 is shown as positioned in the back, left comer of the compartment. However, this need not be the case as a chimney can extend along the entire length of any wall of the compartment or be centrally located against any wall of the compartment, (i.e. not in a comer), or combinations of these. For example, Figure 3B shows another view of an exemplary compartment with chimney 50 positioned away from the back wall of the compartment and comprising a back wall 65. Figure 3C depicts a view of a compartment without showing a back wall and looking toward the front of the compartment, where chimney 60 is positioned in a front comer.

LIGHTING

In addition, each compartment may be optionally equipped with one or more indicator lights. The lights may e.g., indicate that the compartment is locked or unlocked; or be preset to turn on at a particular date (e.g. to alert to the user to an impending (or past) expiration date of the contents); or to indicate to the user the identity of the contents (e.g. compartments with blue lights contain one type of vaccine or a particular dosage of a vaccine, and those with green lights indicate a different type of vaccine or dosage, etc.); or to indicate that the temperature within the compartment is or is not appropriate; or to indicate that the amount of e.g. medication in the compartment is mnning low, etc. An exemplary placement of indicator light 80 is shown in Figure IE.

SENSORS

In some aspects, each individual lockable compartment comprises at least one electronics element to receive and send information associated with that compartment. For example, the electronics element may comprise an electronic control system (linked to the external controller, described below) which comprises one or more sensors and/or actuators whereby the user adjusts conditions in and monitors the compartment. For example, the user can adjust and monitor the locking status and temperature and monitor the contents of an individual compartment by means of e.g. an actuator such as a solenoid, and/or an indicator of the locking status (locked or unlocked); an internal temperature sensor specific for that compartment to sense the internal temperature within the compartment (for example, a fiber optic temperature sensor system; see item 300 in Figure 2A); and/or an individual weighing system (e.g. a load cell) specific for that compartment to detect the placement into and/or removal from the compartment of individual vials, packages, etc. In this aspect, the load cell can tare prior to opening of the compartment and thus detect a difference in weight of the contents before, during and/or after contents are changed, e.g. added or removed. In addition, one or more infrared cameras may be connected to each compartment to sense the presence and/or the type of material stored therein. For example, IR scans of the material can be obtained to identity the material.

As shown in Figure 4, scale 401 may be arranged at a bottom portion of a compartment. Each compartment may have its own respective scale 401. The scale 401 may provide an internal facing floor to the compartment. The top surface 402 of the scale 401 may be arranged as the surface upon which materials or items to be stored are placed. The top surface 402 of the scale 401 may substantially fill an entirety of a bottom of a compartment, as illustrated in Figure 4. The scale 401 may include a transducer 403 which converts the load on top surface 402 to an electronic signal. The signal may be analog or digital. The scale 401 may include (e.g., integral with the transducer 403) an

analog-to-digital converter such that the scale’s output is a digital signal. The signal from the scale may be transmitted (wired or wirelessly) to the control station.

In Figure 7, discussed in detail below, scales 401 from respective compartments may be considered among input devices 720 to the computer system 700. The control system 700 may use the signals or data from scales 401 for inventory tracking. Changes in the weights sensed by scales 401 with each unlocking of respective compartments may be treated as a reflection of items added (e.g., if the weight goes up) or items removed (e.g., if the weight goes down) to a compartment.

Sensors may be arranged to detect temperatures of individual items within individual compartments.

For instance, as shown in Figure 4, one or more infrared cameras 410 may be arranged within or adjacent to each compartment. A fiber optic cable 411 (used generally herein to refer to a single fiber or a plurality of fibers, e.g., a fiber bundle) may be routed through the cabinet connecting (e.g., operably linking) the infrared camera to the controller. Such fiber optic connection may be provided for each of the infrared cameras, of which there may be a plurality, at least one for each compartment, for example. Each camera may capture data usable to produce a heat map. The control station (discussed below) may determine temperatures of individual items in respective individual compartments by differentiating different parts of the heat map, assigning each part of the map to a different item within the compartment, and identifying the sensed magnitude of infrared energy for the particular part of the heat map. An actual visual heat map may but need not necessarily be generated for this procedure. Data from one or more cameras 410 may be sufficient, but for ease of discussion is referred to in the collective as a heat map. Individual infrared spot detection on a heat map may be also or alternatively be used for detecting the presence or absence of items, and how many distinct items, exist in a compartment at any given time. Infrared spectra may also be collected to determine not only the presence or absence of items, but to identify items (e.g., particular chemical compositions as distinguished from other different chemical compositions).

SYSTEMS COMPRISING THE SECURE REFRIGERATED UNITS

Provided herein are integrated systems comprising at least one unit as described herein, and a controller. The controller may comprise one or more of the following: a microcontroller and/or a set of master-slave controllers; a barcode scanner; a database or network uplink to connect to e.g. information regarding stock inventory; inventory expiration dates; patient and prescription records; listing of personnel authorized to use the system (e.g. by password, voice activation, facial recognition, etc.).

Typically, the system comprises at least one user interface to display and enter data or to send instructions to a unit or a compartment in a unit. Information that may be displayed includes, for example, information regarding stored materials such as the current status and the history thereof e.g. type, quantity, expiration date, location in the unit (which compartment(s)), e.g. using a Radio Frequency Identification (RFID) tracking system; records of temperature, locking and unlocking, etc. of the compartment(s); patient information (e.g. records, prescriptions, etc.); and the like.

The user interface permits the user to enter instructions which cause various components of a unit to perform a function, such as to activate an actuator (e.g. a solenoid, linear solenoid, etc.) that locks or unlocks a door or compartment; or to increase or decrease the temperature of the housing, the internal section or one or more compartments. In some aspects, the instructions include instructing a door or compartment to unlock, but instructions to relock are not needed, as this may be the default setting of the locks.

CONTROLLER

Herein an exemplary controller may be referred to as a control station.

Figure 7 is a block diagram illustrating an exemplary computer system 700 which may be implemented in some embodiments. This example illustrates a computer system 700 such as may be used, in whole, in part, or with various modifications, to provide the functions of a control station, a central data system, a storage unit or compartment, and/or other components of embodiments. For example, various functions of the control station may be embodied in or controlled by the computer system 700, including, merely by way of example, receiving information from the user, visually or audibly notifying the user, receiving information from the storage unit, and controlling particular components of the storage unit.

In some embodiments, a system for monitoring and controlling a refrigerated medical storage unit is provided. The system may include a control station. The control station may receive temperature information from the refrigerated medical storage unit and may cause at least a portion of the temperature information to be stored. The control station may determine whether the temperature is outside a predefined range and may causes an alarm to be generated when the temperature is outside the predefined range. The control station may receive user authentication information from a user, and upon verification of the user authentication information, send unlock instructions to the refrigerated medical storage unit.

The control station may be remote from the medical storage unit. The control station may receive user authentication information from a user and, upon verification of the user authentication information, sends unlock instructions to the medical storage unit.

The control station is communicatively coupled with the storage unit. The communication link may have any hardware and/or software necessary to facilitate communication between the control station and the storage unit. In some embodiments the control station may be capable of receiving any information provided and transmitted by the storage unit and transmitting any instruction capable of being performed by the storage unit discussed herein. The control station may be located either locally or remote to the storage unit. Either wired or wireless communication methods may be used to establish the communication link. In some embodiments, the control station may be at least 50 feet from the storage unit.

In some embodiments the control station may control and monitor one or more of three primary functions: access control, environmental control (usually temperature, but possibly humidity, pressure, and/or other environmental parameters), and inventory control. In these embodiments, the storage unit will have any means necessary to acquire and transmit data relevant to such controls to the control station. Likewise, the control station will have any means necessary to receive such data and transmit instructions relevant to such controls to the storage unit.

In some embodiments, the control station may receive temperature information from the storage unit. The control station may determine whether or not the temperature is outside a predefined range. The control station may, in response to this determination control the storage unit's environmental control system, in the case of a refrigerator or freezer, the unit's refrigeration cycle, to maintain the temperature. If the temperature of the storage unit falls outside the predefined range, either above or below, the control station may cause an alarm to be generated. The alarm may include visual and/or audible indicators at the control station.

The control station may include a visual interface, such as a monitor or display screen, possibly with a touch screen or other input device such as a keyboard and mouse.

The visual interface may provide an interaction point for the use to manipulate the control station, and by extension, the storage unit. For example, a user may be able to define the predefined temperature range. In some embodiments, for refrigerator/freezer storage units, this range may have a high and low point definable between -6° and 37° F.

Temperature readings may be received by the control station continuously, or at predefined intervals of time. Both the predefined intervals of time, and the temperature range which defines when an alarm will generate, may be defined by a user. The control station may cause the received temperature readings to be stored, either local to the control station, or remotely, possibly at a data storage system which stores information for a plurality of control stations, which in turn may each control/monitor a plurality of storage units. A user may be able to define identification (or naming) of any particular storage unit or control station, either at a control station or at the data storage system.

Again, while the control station may receive temperature readings continuously or at certain intervals, the control station may cause such readings to be stored at yet another interval (or possibly continuously). This interval may also be defined by a user at the control station. In some embodiments, the control station may only cause temperature information to be stored when the temperature of the storage unit is outside the predefined range (i.e., when the alarm is activated). One example interval of time may be every 30 minutes. In other embodiments, any time interval between one minute and 120 minutes may be employed.

In some embodiments, when an alarm is generated, indicators may be generated besides any visual and/or audible indicators generated at the control station. This may, for example, occur via a visual or audible indicator at the storage unit, or at the data storage system. Additionally, when an alarm is generated, a bulletin may be displayed or printed at the control station and/or data storage system.

The bulletin may be displayed or printed at predefined intervals until the temperature is back within the predefined range. Again, the intervals at which the bulletin is displayed or printed may be defined by the user at the control station or data storage system. The bulletin may include a plurality of fields including identification of the storage unit, a date and time, the temperature of the storage unit when the alarm was generated and/or when the bulletin was displayed/printed. The bulletin may also include a field which allows a user to input/write what was done to resolve the alarm condition, and to affirm, possibly via signature, their responsibility for handling the bulletin.

In yet other embodiments, the control station may be able to cause audible or visual alarms when the change of temperature over time exceeds a certain predefined amount. The type of alarm expressed by the control station or storage unit may differ from that expressed by the outside-of-temperature-range alarm.

As previously discussed, the above method implemented by the storage unit, control station, and/or data storage system may also be implemented to control/monitor other environmental parameters. These parameters may include, for example, humidity, pressure, etc. Any sensor for monitoring temperature or other parameters in the storage unit, as well as the locking mechanism of the storage unit, may be replaceable by the user. Any such sensor may be either shared with the storage unit's independent environmental monitor/control system, or independent thereto.

The control station may also be configured to receive user authentication information from a user, and upon verification of the user authentication information, send unlock instructions to the locking mechanism of the storage unit. The user authentication information may include a username and a password, pin number, or other string. In some embodiments, a pin number may specify both the user and their authority to use the functions of the control station.

The storage unit may include a visual indicator which displays the current locked or unlocked state of the storage unit. Merely by way of example a light emitting diode may be either activated or inactivated when the unit is unlocked. This visual indicator may be tested by a user via instructing the control station to change the visual state of the visual indicator. In some embodiments, the lock mechanism itself may also be tested at the control station. The control station may also be capable of receiving information from a sensor or sensors on the storage unit which reflect the current position of the door, or other entry point, of the storage unit. In some embodiments, the control station may cause an alarm to generate if it detects that the door or other entry point of the storage unit remains open beyond a user predefined length of time. Similarly, the control station may also be capable of monitoring and controlling any light sources inside the storage unit.

In some embodiments, the control station may receive information from a user identifying what medications and/or other items are stored within the storage unit. The control station may cause such information to be stored, along with a time stamp or other indicator which specifies when such stocking occurred. Thereafter, the control station may store temperature over time data related to each medication and/or other items stored within the storage unit.

A user may be able to specify another acceptable temperature range for each medication and/or other item stored within the storage unit. This acceptable temperature range may be different from that specified for the storage unit as a whole. In some embodiments, the acceptable temperature range for a particular medication and/or other item may be narrower than the predefined temperature range for the storage unit as a whole (i.e., the acceptable temperature range will be a subset or sub-range of the predefined temperature range for the storage unit). Sensors may be arranged to detect temperatures of individual items within individual compartments. For instance, one or more infrared cameras 410 may be arranged within or adjacent to each compartment. Each camera may capture data usable to produce a heat map. The control station may determine temperatures of individual items in respective individual compartments by differentiating different parts of the heat map, assigning each part of the map to a different item within the compartment, and identifying the sensed magnitude of infrared energy for the particular part of the heat map. An actual visual heat map may but need not necessarily be generated for this procedure. Data from one or more cameras 410 may be sufficient, but for ease of discussion is referred to in the collective as a heat map. Individual infrared spot detection on a heat map may be also or alternatively be used for detecting the presence or absence of items, and how many distinct items, exist in a compartment at any given time. Infrared spectra may also be collected to determine not only the presence or absence of items, but to identify items (e.g., particular chemical compositions as distinguished from other different chemical compositions). Alarm data for alarms that occur while any particular medication and/or other item that is stored in the storage unit may also be stored for each such particular medication and/or other item. Therefore, whenever an alarm state occurs, information related to that alarm would be stored as particularly relating to medications and/or other items stored, such that a user or functions of the control station could reference such occurrences at a later date.

In some embodiments, a user may be able to specify to the control station that for any particular medication and/or item stored in the storage unit, access shall be limited or prohibited to such medication and/or item if an alarm has issued for the storage unit during the time the particular medication and/or item was stored in the storage unit. As an example, a user could specify that when a user enters authentication information into the control station and requests withdrawal of a certain medication and/or other item in a storage unit, a warning screen would be presented to the user indicating that at least one alarm condition has issued during the medication/item's storage in the storage unit. The user may be required to acknowledge receipt of such warning before access is allowed. In another embodiment, access to such medications/items which have experienced an alarm condition during their storage may be prohibited (and thus denial of deactivation of the locking mechanism on the storage unit). This may be a condition especially specified for medications/items where temperature control of the medications/items is critical to their viability.

Whatever the type of warning/prohibition, a user may specify which particular conditions cause what particular actions by the control station when withdrawal of an alarm affected medication/item is requested. For example, one or more limits on the amount of time a medication/item has spent outside of predefined ranges may be specified which in turn cause either a warning to be presented to a user requesting withdrawal, or access to be prohibited. In another example, one or more limits on the extent of temperature variance outside the predefined range may be specified which in turn cause either a warning to be presented to a user requesting withdrawal, or access to be prohibited. In yet another example, an algorithm which is a function of time spent by the medication/item outside of the predefined range, along with the temperature of the medication/item over such time may be specified which determines when a warning will be presented to a user requesting withdrawal, and/or access will be totally prohibited.

In some embodiments the control station and storage unit are configured such that if either the control station or the storage unit lose power, the locking mechanism of the storage unit will remain in a locked state. In other embodiments, the reverse will be true, and the storage unit will unlock under loss of power conditions. In any of the aforementioned embodiments, manual procedures may be available to open the storage unit. For example, the storage unit may have manual override unlocks, possibly that depend on the use of one, two, or more different keys/locks. In many embodiments, the control station and/or the storage until will have a battery or other backup power source in case of main power failure.

In some embodiments, at least a portion of the user authentication information received over time by the control station may be stored by the control station, or by the data storage system. The control stations and/or data storage system may also be able to conduct inventory control processes (either automatically via storage unit internal sensors, or via user input). This information may also be stored by the control system of data storage system.

In some embodiments, a user may be able to generate visually displayed or printed reports at either one or both of a control station or the data storage system. These reports may be available on-demand to a user or may be set to be displayed/printed by the control station/data storage system at user predefined intervals. The type of information presented in any report may be predefined by a user and may include any of the information discussed herein related to access control, inventory control, and/or environmental control. Note that any temperature data may be displayed/printed in either or both of degrees Celsius or degrees Fahrenheit.

In some embodiments, any failure of any one part of the invention, be it a portion or the entirety of the storage unit, the control system, and/or the data storage system, shall not cause failure of any other portion of the system. This may at least assist in ensuring security and viability of any items stored in the storage unit. For example, in many embodiments, failure of the locking mechanism of a storage unit will not cause failure of the temperature control/monitoring in that storage unit. Likewise, failure of the temperature

control/monitoring functions will not cause failure of the locking mechanism.

The computer system 700 is shown comprising hardware elements that may be electrically coupled via a bus 790. The hardware elements may include one or more central processing units (CPUs) 710, one or more input devices 720 (e.g., a mouse, a keyboard, a touchscreen, a mobile device, etc.), and one or more output devices 730 (e.g., a display device, a printer, etc.). The computer system 700 may also include one or more storage device 740. By way of example, storage device(s) 740 may be disk drives, optical storage devices, solid-state storage device such as a random access memory (“RAM”) and/or a read-only memory (“ROM”), which can be programmable, flash-updateable and/or the like.

The computer system 700 may additionally include a computer-readable storage media reader 750, a communications system 760 (e.g., a modem, a network card (wireless or wired), an infra-red communication device, Bluetooth™ device, cellular communication device, etc.), and working memory 780, which may include RAM and ROM devices as described above. In some embodiments, the computer system 700 may also include a processing acceleration unit 770, which can include a digital signal processor, a

special-purpose processor and/or the like.

The computer-readable storage media reader 750 can further be connected to a computer-readable storage medium, together (and, optionally, in combination with storage device(s) 740) comprehensively representing remote, local, fixed, and/or removable storage devices plus storage media for temporarily and/or more permanently containing

computer-readable information. The communications system 760 may permit data to be exchanged with a network, system, computer and/or other component described above.

The computer system 700 may also comprise software elements, shown as being currently located within a working memory 780, including an operating system 788 and/or other code 784. It should be appreciated that alternate embodiments of a computer system 700 may have numerous variations from that described above. For example, customized hardware might also be used and/or particular elements might be implemented in hardware, software (including portable software, such as applets), or both. Furthermore, connection to other computing devices such as network input/output and data acquisition devices may also occur.

Software of computer system 700 may include code 784 for implementing any or all of the function of the various elements of the architecture as described herein. For example, software, stored on and/or executed by a computer system such as system 700, can provide the functions of the control station, the data storage system, the storage unit, and/or other components of the invention such as those discussed above. Methods implementable by software on some of these components have been discussed above in more detail.

In addition, if drawers are present in the unit, a user may be able to provide a command remotely to cause a drawer of interest to slide out just prior to or concomitant with the unlocking of one or more compartments located in the drawer. USES

Uses of the secure refrigerated units described herein include but are not limited to: secure and refrigerated medicine storage in hospitals and pharmacies; secure storage of liquid, solid, lyophilized solids, etc.; secure e.g. vaccine storage in manufacturing or hospital facilities; in cold rooms for large amounts of storage, e.g. in commercial manufacturing and/or laboratory research settings; for secure storage of hazardous biological,

bacteriological, and viral samples which require controlled access; for commercial storage of food or ingredient storage in facilities that require or desire to closely monitor the status of stock, e.g. wines, cheeses, exotic spices, etc.

Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

In the description of the invention herein, it is understood that a word appearing in the singular encompasses its plural counterpart, and a word appearing in the plural encompasses its singular counterpart, unless implicitly or explicitly understood or stated otherwise. Furthermore, it is understood that for any given component or embodiment described herein, any of the possible candidates or alternatives listed for that component may generally be used individually or in combination with one another, unless implicitly or explicitly understood or stated otherwise. Moreover, it is to be appreciated that the figures, as shown herein, are not necessarily drawn to scale, wherein some of the elements may be drawn merely for clarity of the invention. Also, reference numerals may be repeated among the various figures to show corresponding or analogous elements. Additionally, it will be understood that any list of such candidates or alternatives is merely illustrative, not limiting, unless implicitly or explicitly understood or stated otherwise. In addition, unless otherwise indicated, numbers expressing quantities of ingredients, constituents, reaction conditions and so forth used in the specification and claims are to be understood as being modified by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter presented herein. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the subject matter presented herein are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

The following examples are included to demonstrate preferred embodiments of the invention. It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventor to function well in the practice of the invention, and thus can be considered to constitute preferred modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.

In the description of the invention herein, it is understood that a word appearing in the singular encompasses its plural counterpart, and a word appearing in the plural encompasses its singular counterpart, unless implicitly or explicitly understood or stated otherwise. Furthermore, it is understood that for any given component or embodiment described herein, any of the possible candidates or alternatives listed for that component may generally be used individually or in combination with one another, unless implicitly or explicitly understood or stated otherwise. Moreover, it is to be appreciated that the figures, as shown herein, are not necessarily drawn to scale, wherein some of the elements may be drawn merely for clarity of the invention. Also, reference numerals may be repeated among the various figures to show corresponding or analogous elements. Additionally, it will be understood that any list of such candidates or alternatives is merely illustrative, not limiting, unless implicitly or explicitly understood or stated otherwise. In addition, unless otherwise indicated, numbers expressing quantities of ingredients, constituents, reaction conditions and so forth used in the specification and claims are to be understood as being modified by the term "about."

Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the subject matter presented herein. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the subject matter presented herein are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

The following examples are included to demonstrate preferred embodiments of the invention. It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventor to function well in the practice of the invention, and thus can be considered to constitute preferred modes for its practice. However, those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.

All patents and publications mentioned in the specification are indicative of the level of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

EXAMPLE

Extensive computational research has been conducted to ensure the optimal design for rapid temperature compliance and return to temperature when contents are exposed to open conditions. The illustrations in Figures 5 and 6 demonstrate the benefit of ventilated storage. Computational Fluid Dynamics (CFD) analysis was conducted in ANSYS FLUENT software on geometries designed to represent compartments of varying degrees of ventilation inside countertop and undercounter- style refrigerators with 2 and 3 shelves, an evaporator, and a fan providing forced convection. Results showed that increased porosity of the compartment walls resulted in improved cooling. Structural Finite Element Analysis confirmed that increasing porosity also resulted in greater deflections and higher propensity for damage under applied stresses. Therefore, there is a trade-off observed between cooling performance and structural integrity. A critical point for the design, at which improvements in airflow cease to outweigh losses in design strength, is governed by the material and manufacturing method used for the compartments, as well as the strength requirements of the specific application environment.

While the invention has been described in terms of its preferred embodiments, those skilled in the art will recognize that the invention can be practiced with modification within the spirit and scope of the appended claims. Accordingly, the present invention should not be limited to the embodiments as described above but should further include all

modifications and equivalents thereof within the spirit and scope of the description provided herein.