Distribution method, apparatus, and system for substance units
The method and system for managing substance units through containerized tracking and user-specific distribution address inefficiencies in existing systems by ensuring accurate tracking and timely delivery, enhancing safety and compliance.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-09-30
- Publication Date
- 2026-04-09
AI Technical Summary
Existing systems for managing and distributing substance units, such as medications, face inefficiencies in tracking, dispensing, and ensuring proper identification and delivery to end users, particularly in ensuring timely and accurate distribution to individual consumers.
A method and system for managing substance units that involves loading them into containers with subsections, associating each unit with a unique ID, and using a data ledger to track and transfer units between containers while ensuring accurate dispensing based on user-specific demands, utilizing a blockchain for secure data storage and management.
Enables efficient, secure, and user-specific distribution of substance units by ensuring accurate tracking, timely delivery, and compliance with consumption programs, reducing errors and enhancing user safety.
Smart Images

Figure IL2025050876_09042026_PF_FP_ABST
Abstract
Description
[0001] DISTRIBUTION METHOD, APPARATUS, AND SYSTEM FOR
[0002] SUBSTANCE UNITS
[0003] RELATED APPLICATIONS
[0004] This application claims the benefit of priority of US Provisional Patent Application Nos. 63 / 703,979 and 63 / 703,980 filed on October 6, 2024, the contents of which are incorporated herein by reference in their entirety.
[0005] This application is also related to co-filed PCT Patent Application entitled “SUBSTANCE UNITS DISTRIBUTION DEVICES AND METHODS” (Attorney Docket No. 104565), the contents of which are incorporated herein by reference in their entirety.
[0006] The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirety.
[0007] FIELD AND BACKGROUND OF THE INVENTION
[0008] The present invention, in some embodiments thereof, relates to a distribution system and, more particularly, but not exclusively, to a distribution system for substance units.
[0009] U.S. Patent No. 10892048 discloses “Disclosed are various embodiments for automated pill identification using lighting devices and machine learning routines. A computing device may selectively control illumination of a pill provided at an imaging position by a pill dispensing system. The computing device may direct an imaging device to capture image data of the pill during illumination of the pill. Also, the computing device may generate a digital fingerprint of the pill and determine an identity of the pill based at least in part on a comparison of the digital fingerprint to a digital fingerprint library. A machine learning routine may be applied to improve future detection of the identity of the pill.” (abstract).
[0010] DE Patent No. 102014008692 discloses “Device for the automatic and timed dispensing of tablets (20) comprising a plurality of magazines (7.1, 7.2, 7.3, 7.4) for receiving a plurality of tablets (20), wherein the magazines (7.1, 7.2, 7.3, 7.4) are arranged on a holding part (2) each magazine (7.1, 7.2, 7.3, 7.4) is releasably connectable to the holding part (2), wherein one or more openings (12) in the holding part (2) are formed, wherein at the holding part (2) at least one Output mechanism for dispensing a tablet (20) from one or more magazines (7.1, 7.2, 7.3, 7.4) is arranged; characterized in that the holding part (2) is a flat plate for receiving a plurality of magazines (7.1, 7.2, 7.3, 7.4), wherein the magazines (7.1, 7.2, 7.3, 7.4) are designed as rotary magazines and each have a magazine rotor (30) have, wherein the flat plate recesses for receiving the plurality of magazines (7.1, 7.2, 7.3, 7.4), wherein the flat plate in the region of the recesses each having an opening (12), wherein the magazines (7.1, 7.2, 7.3, 7.4 ) are arranged horizontally in the operating state of the device, wherein on the device at least one inclined plane (11) for dispensing a tablet (20) from one or more magazines (7.1, 7.2, 7.3, 7.4) is provided, each magazine rotor (30) is driven by an electric stepper motor (8), wherein the output of a tablet by further rotation of the rotary magazine by the stepping motor (8) by a certain increment, and wherein the opening (12) ensures that the tablets only after a certain angle of rotation are ejected” (abstract).
[0011] U.S. Patent No. 4785969 discloses “An improved medication dispensing system is provided for controlled preprogrammed dispensing of medication to a patient and for creating a retrievable patient medication record. The system includes a dispensing unit located, for example, at patient bedside within a hospital room or the like and adapted to receive a pair of medication canisters having magazines with individual cassettes which have been preloaded in a preprogrammed manner in the hospital pharmacy or the like respectively to contain scheduled and unscheduled medications for administration to the patient. The dispensing unit is programmed according to individual patient needs to signal a nurse or other personnel at selected times when scheduled medication is prescribed, whereupon the scheduled medication can be accessed for dispensing only after entry of valid nurse or other personnel identification code into a dispensing unit memory. The unscheduled medications may be accessed by the nurse or other personnel in a similar manner but on an untimed basis as required by the patient. The dispensing unit further includes sensors for detecting removal of any medication cassette and for signaling the dispensing unit memory to create a corresponding patient medication record. A data transmission device is provided for selectively programming the dispensing unit memory and / or for reading the patient medication record from the memory.” (abstract).
[0012] China Patent Application No. 115771676 discloses “The invention discloses a use method of a multifunctional intelligent medicine box, which comprises a medicine box shell, and a control unit, a medicine storage tray, a medicine taking tray, a medicine distribution device, a humancomputer interaction device and the like which are arranged in the shell. The medicine taking tray can drive the medicine storage tray to rotate to the medicine sucking position of the medicine dispensing device, and medicines are placed into the medicine taking tray according to different prescriptions. The medicine storage rotary disc, the medicine taking rotary disc and the medicine distribution mechanism move simultaneously, so that medicines of multiple persons and multiple doses can be configured simultaneously, and the medicine dispensing time is shortened. Compared with the prior art, the invention can overcome the problems that the prior device can not simultaneously allocate multiple doses for multiple people and at one time, has single dispensing mode and low dispensing efficiency” (abstract). US Patent No. 9475633 discloses “An apparatus for dispensing medications, including: a portable cassette including with a body portion including a plurality of cassette compartments and at least one lid displaceable with respect to the body portion to enable access to the cassette compartments in a predetermined sequence; and a pill-dispenser including at least one dispensing compartment arranged to store respective pills of at least one respective medication; a dispensing element configured to release the respective pills from the at least one dispensing compartment; and a cassette element arranged to receive the portable cassette and displace the portable cassette so that at least one of the in respective pills falls into each cassette compartment. After the at least one of the respective pills fall into said each cassette compartment: the portable cassette is removable from the pill-dispenser; and the lid is displaceable to control access to the cassette compartments” (abstract).
[0013] U.S. Patent Application No. 2016199260 discloses “This invention is an apparatus that, connected to a computer program, controls the process of filling of pills in trays for medicine dispensers or pillboxes with multiple chambers. The apparatus is characterized by applying a control scanner and a precision weight for precise dispensing of the pills and by gate templates to guide the pills to selected chambers in the target pillboxes. Target chambers are automatically selected according to the pre-determined ingestion time. The pills will remain in the gate-template until the operator has conducted a visual inspection and / or performed a semi-automatic camera control to verify that the pills are properly distributed in the openings of the gate template. After the verification process, the pills are released into medication tray, by means of a mechanical device with double barrier plates, which are activated by a specialized release mechanism” (abstract).
[0014] U.S. Patent No. 4953745 discloses “The present invention relates to an apparatus for dispensing a selected one of a plurality of drugs. The apparatus includes a plurality of individual dispensing mechanisms which are contained within a cabinet. Each of the dispensing mechanisms is adapted to store a plurality of a selected drug unit and is responsive to a selected one of a plurality of drug dispense signals for dispensing the selected drug unit. A control unit is responsive to an input authorization signal representing an operator, a patient identification signal representing a patient for which a drug is to be selected, and a drug select signal representing the drug and the amount to be dispensed. The control unit generates a drug dispense signal corresponding to the selected drug to cause the respective dispensing mechanism to dispense the selected drug. The control unit can be preprogrammed with a prescribed schedule for a particular patient such that a drug can be dispensed for that particular patient only during a certain time period. The control unit also includes a recording device for recording each dispensing transaction including the identity of the operator, the identity of the patient for which the drug is to be dispensed, and the dispensed drug. The control unit also maintains an inventory of the stored drugs” (abstract).
[0015] U.S. Patent No. 5152422 discloses “A dispenser for dispensing predetermined pills in sequential order has a base with a cylindrical housing removably mounted on the base and has a pill container dispenser opening in the cylindrical housing. A pill container magazine is rotatably mounted inside the cylindrical housing and has a plurality of magazine sections thereon for holding a plurality of vertically stacked pill containers in stacked arrays. The pill container magazine in a manual embodiment has a plurality of shift knobs thereon for rotatably shifting the pill container magazine within the cylindrical housing between dispensing positions. A visual and audible signal system is mounted in the dispenser base and is actuated by a timer or clock mechanism to signal the time for a patient to take the pills in one pill container in the pill container magazine. A motorized unit has a standard commercial timer mounted beneath the rotatable magazine and has a mechanism for shifting the magazine between positions as the timer mechanism rotates to thereby automatically rotate and align the magazine with the appropriate pill container and set off the visual and audio alarm reminder” (abstract).
[0016] U.S. Patent No. 6021918 discloses “A central motor-driven disk is formed with a row of open-bottomed pill-receiving virtually contiguous tubes about its border. The disk is surrounded by a first and second ring also having rows of pill-receiving open-bottomed tubes, the tubes come in to registry one-by-one with dispensing openings in a housing which supports these elements. Pills drop through a dispensing opening into a delivery drawer in the housing. Tab portions on the disk and the rings effect the driving by the disk of the first ring and then also the second ring as the pills in the previous ring or disk are dispensed” (abstract).
[0017] U.S. Patent Application No. 20180319570 discloses “A dispenser or dispensing system. The dispenser can be a screw conveyor pill dispenser, tumbler pill dispenser, push-to-operate pill cap dispenser, twist-to-operate pill cap dispenser, or push-to-operate pill cap dispenser. The pill dispenser may include a pill dispenser control system that can interact with a personal device, such as a smart phone. The pill dispenser control system can implement communication with a personal device, pill identification, user identification and security, scheduling functions, and notifications. The pill dispenser can dispense pills manually, semi-automatically, or automatically” (abstract).
[0018] U.S. Patent No. 11577905 discloses “A storage and dispensing station for drugs is provided. The storage and dispensing station includes a receiving space for drug portions, the receiving space having a feed section with a base section and a dispensing opening, an ejection device for moving a drug portion through the dispensing opening, the ejection device having a slide which can be moved in the feed section towards the dispensing opening and a slide drive coupled to the slide for moving the slide, as well as a lock which can be moved in the feed section and which can be moved in the feed section such that when a drug portion is moved towards the dispensing opening, movement of drug portions in the feed section is prevented” (abstract).
[0019] U.S. Patent No. 10292906 discloses “An apparatus for dispensing pills comprising a pill storage section, a dispensing section located at a lower end of the storage section, an optical sensor, a memory, controller and wireless communication module and a supporting tray for one ringshaped blister pack. A springloaded lever is provided as push-out means in line with the respective pills of the blister pack and with the passage opening and can be operated for pushing out the pills to be dispensed through the passage opening. A motorized mechanism is provided as means for rotatable positioning of the blister pack stepwise relative to the part of the apparatus including the push-out means. Optical sensor detects presence of an object such as a person's hand at the passage opening and allows the pills to be dispensed automatically” (abstract).
[0020] U.S. Patent No. 10730687 discloses “An article dispensing apparatus includes a carousel and an upper casing with a dispensing face including a dispensing orifice through which the articles are dispensed. The carousel includes plural holding sections for holding the articles to be dispensed and is rotationally movable. A controller controls application of a force to cause the carousel to rotate relative to the dispensing face when an instruction to dispense an article is received. When the carousel is moved so that one of its holding sections having an article therein is aligned with the dispensing orifice, the article is allowed to be dispensed therethrough. A locking mechanism selectively engages the carousel to prevent any relative movement of the carousel when the article dispensing unit is not mounted on the main housing and disengages from the carousel to allow intended relative movement when the article dispensing unit is mounted on the main housing” (abstract).
[0021] U.S. Patent Application No. 2023120304 discloses “A multi-serving cartridge assembly is provided with a frame defining serving chambers to receive a supplement. A plurality of trap doors is connected to the frame with each trap door associated with a respective one of the plurality of serving chambers and moveable between a first closed position to enclose the associated serving chamber and a second open position to dispense the supplement therefrom. A dispensing system is provided with a housing including a cartridge bay shaped to receive a cartridge with a plurality of unique identifiers, and a computer control system to read the unique identifier, open the serving chamber, and send a signal to a remote system. A method of dispensing supplement from a cartridge is also provided” (abstract).
[0022] ES. Patent No. 1064932U discloses “Smart pill dispenser package comprising an internally hollow casing (1), a rotatable inner container (2) that houses a plurality of pads (3) including a ratchet and ratchet mechanism around an axis of the casing itself (1), means for driving the ratchet turn and means for indicating time, characterized by the fact that said casing (1) has an access for recharging the inner container, in which the outlet of the tablets (3) is carried out through the side wall of the housing (1) through an outlet port having a sliding cover (8) that is simultaneously synchronized with the actuation means and the time indicating means, and in which the inner container (2) has manual displacement means for recharging the tablets (3). ” (abstract).
[0023] GB Patent No. 2473433 discloses “A dispenser 10 comprises a clock 18 and a plurality of magazines 32, each magazine having a plurality of discrete compartments 40 for holding an item or items to be dispensed. The magazines dispense into respective dispensing chambers 66, from where the items are dispensed into a dispensing tray 26 at a particular time of day. Visual and audible alarms are activated on dispensing which turn off automatically on detection of removal of the items by a detector. The audible alarm may be a pre-recorded message, and an audio recording device may be provided for recording such a message. Each magazine 32 may have a fixed outer casing (35) an inner movable tray (33) which rotates about a central axis. Each dispensing chamber 66 may include a base member (68) movable by an actuator (72) between an open position in which an aperture is revealed for dispensing, and a closed position in which the aperture is covered and dispensing is prevented. The actuator (72) may be a solenoid. A detector may be provided for detecting when an item is removed from the dispensing tray 26. The items to be dispensed are preferably pills” (abstract).
[0024] China Patent No. 112849669 discloses “The invention discloses a magazine type one-key medicine dispensing and taking box, which comprises a lower box body, an upper box body and an upper box body ring, wherein the upper box body ring is fixedly connected with the upper box body; the first transmission device is used for pushing out the medicine in the medicine box device; a second transmission device for providing a driving force for the rotation of the medicine chest; the medicine chest is driven to rotate circumferentially through the second transmission device, one indexing area is enabled to accurately stay at the position of the push rod, and the push rod extends into the medicine chest to push the medicine; the medicine box device synchronously rotates along with the medicine box and is used for storing medicines and pushing the medicines in the medicine box out along the transverse direction by the pushing of the push rod; the center rotating shaft is sleeved in the medicine box, and the medicine box is driven by the second transmission device to rotate circumferentially around the center rotating shaft; the medicine taking box can be flexibly placed in or taken out relative to the lower box body and is used for collecting and temporarily storing the pushed medicines; the invention has the functions of dispensing medicines by one key and reminding medicine taking, and solves the problems that the old people take medicines on time, dispense medicines and the like” (abstract).
[0025] U.S. Patent No. 9251493 discloses “Medication errors happen frequently in hospital, home, and pharmacy environments. A medication verification and dispensing system provides protection against such errors. The apparatus includes a guide tube that receives a medication and imaging device(s) adjacent to the guide tube that take image(s) of the medication. The imaging devices(s) and light source(s) are oriented for capturing images that reveal markings, color, size, shape, etc., of the medication. A verification system uses a signature of the image to identify the medication or compares the image(s) to reference images to identify the medication and to a prescription record of the patient to ensure it is a correct medication, dose, amount, timing, etc., for administration. If the medication is correct, it is dispensed into a dispensing vessel that locks the medication inside, but unlocks when it recognizes a unique patient identifier worn by a patient that is a correct recipient for the medication” (abstract).
[0026] U.S. Patent Application No. 20140055267 discloses “Devices, systems and methods for monitoring medication are provided. A medication monitoring device according to one implementation includes a container configured to store a plurality of medication pills and a gating device connected at an opening of the container. The gating device is configured to electronically monitor the release of at least one of the medication pills. A system and method for monitoring the administration of medication to a patient are also provided. The system, according to one embodiment, comprises the medication monitoring device and a medication management server in communication with the medication monitoring device via a communication network” (abstract).
[0027] U.S. Patent No. 8727208 discloses “A pill identification device having a mechanical device that is adapted to roll a pill along various axes of the pill, an optical device to record or transmit images of the pill and an algorithm to compare an identifier of the pill to a database having known identifiers of known pills is disclosed. A method of identifying a pill using the pill identification device of the embodiment of this invention is disclosed herein. Also, a method of manufacturing the pill identification device of the embodiments of this invention is disclosed herein” (abstract).
[0028] Additional art includes U.S. Patent No. 9327088, U.S. Patent Application No. 20140131378, U.S. Patent Application No. 20140305961, and Korean Patent No. 101407667.
[0029] SUMMARY OF THE INVENTION
[0030] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.
[0031] Example 1. A method for managing an individually consumable bioactive substance unit as it travels along a distribution pathway of a substance units management system, comprising: loading the substance unit into at least one container, wherein the container comprises a plurality of subsections for a plurality of substance units, wherein each subsection is configured to be associated with a single substance unit of the plurality of substance units; storing substance unit data of the substance unit with relation to the subsection accommodating it; transferring the substance unit between subsections of the same container and / or between containers; and further storing substance unit data based on the transferring.
[0032] Example 2. The method according to example 1, wherein the further storing comprises relating the substance unit with a current subsection accommodating it.
[0033] Example 3. The method according to any of examples 1-2, wherein the transferring comprises dispensing the substance unit out of the container, and wherein the further storing comprises storing substance unit data based on the dispensing.
[0034] Example 4. The method according to any of examples 1-3, wherein said loading comprises physically inserting the substance unit into the container while reliably virtually inserting the substance unit into the system.
[0035] Example 5. The method according to example 4, wherein the reliably virtually inserting comprises atomically performing both the physical and virtual insertions.
[0036] Example 6. The method according to example 4, wherein the reliably virtually inserting comprises performing both the physical and virtual insertions substantially simultaneously.
[0037] Example 7. The method according to example 4, wherein the virtually inserting comprises associating the substance unit with a unique ID.
[0038] Example 8. The method according to example 4, wherein the associating comprises storing the unique ID in the substance unit data.
[0039] Example 9. The method according to any of examples 1-8, comprising performing the loading and the storing substantially simultaneously.
[0040] Example 10. The method according to any of examples 1-9, comprising performing the transferring and the further storing simultaneously. Example 11. The method according to any of examples 1-10, wherein said transferring comprises reporting on intention to transfer a substance unit, transferring said substance unit, and reporting on performing the transferring.
[0041] Example 12. The method according to any of examples 1-11, wherein the substance unit data comprises one or more of: tracking data; monitoring data; and substance data.
[0042] Example 13. The method according to example 12, comprises tracking a substance unit based on the tracking data.
[0043] Example 14. The method according to example 12 or example 13, wherein the tracking data comprises one or more of: the substance unit’s current container; the substance unit’s current subsection within its current container; the substance unit’s container history; and the substance unit’s subsections history.
[0044] Example 15. The method according to example 12, wherein the substance data comprises one or more of: substance units pharmaceutical code; substance unit type; active ingredients; ingredient percentages; dosage; brand; batch; manufacturer; manufacturing date; expiration date; manufacturing location; and manufacturing process.
[0045] Example 16. The method according to any of examples 1-15, wherein the storing comprises recording the substance unit data in a data ledger.
[0046] Example 17. The method according to any of examples 1-16, comprising storing container data. Example 18. The method according to example 17, wherein the storing container data comprises recording the container data in a data ledger.
[0047] Example 19. The method according to any of examples 17-18, wherein the container data comprises one or more of: a status of the at least one container; a current location of the at least one container; current container’ s holder; location history of the container; status history of the container; and history of container holders.
[0048] Example 20. The method according to example 19, wherein said status comprises one or more of: stored by the manufacturer, transported to a distribution site, loaded into a distribution device, stored by a end user, loaded to a dispensing device, and / or out of service.
[0049] Example 21. The method according to any of examples 1-20, wherein the substance unit is a human consumable substance unit.
[0050] Example 22. The method according to any of examples 1-21, wherein the substance unit is health- related.
[0051] Example 23. The method according to any of examples 1-22, wherein the substance unit is wellness-related.
[0052] Example 24. A method for managing at bioactive least one substance unit, comprising: collecting a plurality of substance units into at least one origin container, wherein each substance unit of the plurality of substance units is positioned at a different subsection of the at least one container; storing data of each substance unit with relation to the subsection occupying thereof; transferring substance units, one by one, from the at least one origin container to at least one different container, according to a distribution demand; storing a record of the at least one different container subsections that received a substance unit of said plurality of substance units, such that a data of each substance unit is associated with the subsection accommodating it ; and updating the recording of the at least one origin container subsections that delivered a substance unit to the at least one different container.
[0053] Example 25. The method according to example 24, wherein the at least one substance unit is a plurality of substance units. Example 26. The method according to example 24 or example 25, wherein the collecting comprises collecting the substance units at the manufacturer's facility.
[0054] Example 27. The method according to any of examples 24-26, wherein the collecting comprises collecting the substance units as they are manufactured.
[0055] Example 28. The method according to any of examples 24-27, wherein the at least one origin container is homogeneous with respect to the substance units occupying it.
[0056] Example 29. The method according to any of examples 24-27, wherein the at least one origin container is heterogeneous with respect to the substance units occupying it.
[0057] Example 30. The method according to example 29, wherein the at least one origin container comprises a combination of different types of substance units, commonly consumed by a specific consumption group.
[0058] Example 31. The method according to any of examples 24-30, wherein the substance units are identical in one or more of: size, shape, and form factor.
[0059] Example 32. The method according to any of examples 24-31, comprising providing the at least one different container to an end user.
[0060] Example 33. The method according to example 32, wherein the at least one different container is an end user’s personal container.
[0061] Example 34. The method according to any of examples 32-33, wherein the at least one different container contains a personalized combination of substance units.
[0062] Example 35. The method according to any of examples 24-34, wherein the distribution demand is user-specific.
[0063] Example 36. The method according to any of examples 24-35, comprising storing the at least one container.
[0064] Example 37. The method according to any of examples 24-36, comprising transporting the at least one container.
[0065] Example 38. The method according to example 37, wherein the transporting comprises transporting the container to a distribution site.
[0066] Example 39. The method according to example 38, wherein the transferring is performed at the distribution site.
[0067] Example 40. The method according to any of examples 24-39, wherein the transferring comprises transferring one or more of the substance units of said plurality of substance units from one subsection to another within the at least one container. Example 41. The method according to any of examples 24-40, wherein the transferring comprises dispensing more than one substance unit of said plurality of substance units from the at least one origin container, one by one to the at least one different container.
[0068] Example 42. The method according to example 41, wherein the more than one substance units are inserted into the at least one different container one by one.
[0069] Example 43. The method according to any of examples 24-42, wherein the transferring comprises selecting one or more specific substance units to be transferred.
[0070] Example 44. The method according to any of examples 24-43, wherein the transferring comprises transferring a substance unit from the at least one container to the at least one different container through one or more additional containers.
[0071] Example 45. The method according to any of examples 24-44, wherein the transferring comprises aligning at least one opening of the at least one container with at least one opening of the at least one different container.
[0072] Example 46. The method according to any of examples 24-45, wherein the transferring comprises transferring a substance unit to the at least one different container from a plurality of containers.
[0073] Example 47. The method according to example 43, wherein the selecting comprises considering the substance unit’s expiration date.
[0074] Example 48. The method according to example 43, wherein the selecting comprises considering the expiration dates of each of a plurality of substance units.
[0075] Example 49. The method according to any of examples 43-48, wherein the selecting comprises considering the substance unit’s location within the at least one container.
[0076] Example 50. The method according to any of examples 24-49, wherein the transferring comprises selecting a subsection for each substance unit of the plurality of substance units within the at least one different container.
[0077] Example 51. The method according to any of examples 24-50, comprising sealing the at least one origin container.
[0078] Example 52. The method according to any of examples 24-51, comprising sealing the at least one different container.
[0079] Example 53. The method according to any one of examples 51 and 52, wherein the sealing comprises tamper-evident sealing.
[0080] Example 54. The method according to example 53, comprising detecting if one or both of the at least one origin container and the at least one different container have been tampered with before performing the transferring. Example 55. A method for delivering a substance unit to an end user, who has at least one customized container and a dispensing device, the method comprising: receiving a consumption demand; selecting a substance unit from the plurality of substance units, based on the consumption demand; moving the substance unit within the customized container from one subsection to another subsection; and dispensing the substance unit out of the container.
[0081] Example 56. The method according to example 55, comprising providing the end user with the customized container.
[0082] Example 57. The method according to example 55 or example 56, comprising providing the end user with the dispensing device.
[0083] Example 58. The method according to any of examples 55-57, wherein the receiving comprises receiving the consumption demand from the end user.
[0084] Example 59. The method according to any of examples 55-58, wherein the receiving comprises receiving the consumption demand from one or more agents.
[0085] Example 60. The method according to example 59, wherein the one or more agents comprise one or more of: medical supervisor; health Insurer; and regulator.
[0086] Example 61. The method according to any of examples 55-60, wherein the consumption demand comprises a consumption program.
[0087] Example 62. The method according to example 61, comprising scheduling the dispensing based on the consumption program.
[0088] Example 63. The method according to any of examples 61-62, comprising sending the user reminders based on the consumption program.
[0089] Example 64. The method according to any of examples 61-63, wherein the consumption demand comprises a one-time consumption requirement.
[0090] Example 65. The method according to example 64, wherein the consumption demand comprises an immediate consumption requirement.
[0091] Example 66. The method according to example 64 or example 65, comprising determining whether to comply with the requirements. Example 67. The method according to any of examples 55-66, wherein the selecting comprises selecting a substance unit that meets the consumption demand and has the nearest expiration date. Example 68. The method according to any of examples 55-67, wherein the dispensing is contingent upon first identifying an end user.
[0092] Example 69. The method according to any of examples 55-68, wherein the receiving comprises receiving an interaction demand.
[0093] Example 70. The method according to example 69, comprising prompting the user based on the interaction demand.
[0094] Example 71. The method according to example 70, wherein the prompting comprises prompting the user to deposit a sample into the container.
[0095] Example 72. The method according to example 70, wherein the prompting comprises prompting the user to exhale into the container.
[0096] Example 73. A method for tracking a plurality of substance units, comprising: registering a substance unit of the plurality of substance units as it is inserted into one or more containers, wherein each container of the one or more origin containers comprises a plurality of subsections; storing a record of a subsection accommodating the substance unit; storing a record of the substance unit current subsection, upon transferring the substance unit between subsections of the container; storing a record of the substance unit current subsection at a different container, upon transferring the substance unit between containers; and tracking the substance unit based on the record thereof.
[0097] Example 74. The method according to example 73, wherein the plurality of substance units comprises individually consumable bioactive substance units.
[0098] Example 75. The method according to example 73 or example 74, comprising storing a record of the substance unit status, upon dispensing the substance unit out of the container.
[0099] Example 76. The method according to any of examples 73-75, comprising registering the container and / or storing a record of the container location.
[0100] Example 77. The method according to any of examples 73-76, comprising storing a record of a current location of the container, upon transportation of the container.
[0101] Example 78. A substance units management system, comprising: a controller, configured to produce a command to transfer a substance unit between subsections of a container or between containers; a movement mechanism, configured to move the substance unit based on the command; and a data ledger, configured to record the subsection accommodating the substance unit.
[0102] Example 79. The substance units management system according to example 78, wherein the movement mechanism is configured to move at least one other substance unit for moving the substance unit.
[0103] Example 80. The substance units management system according to any of examples 78-79, wherein the substance units management system is configured to communicate with at least one agent related thereto.
[0104] Example 81. The substance units management system according to any of examples 78-80, wherein the data ledger is implemented using a blockchain.
[0105] Example 82. The substance units management system according to any of examples 78-81 wherein the data ledger comprises more than one separate data ledger.
[0106] Example 83. The substance units management system according to example 82, wherein each one of the more than one separate data ledger is controlled by a separate agent than the others.
[0107] Example 84. A method for monitoring a plurality of individually consumable bioactive substance units contained within a container, wherein each substance unit of the plurality of substance units is positioned within a different subsection of the at least one container, wherein the method comprises: measuring the environment, by at least one environmental sensor; receiving a consumption demand; and selecting substance units based on the consumption demand and the measuring.
[0108] Example 85. The method according to example 84, wherein the at least one sensor environmental sensor is located within the container.
[0109] Example 86. The method according to any of examples 84-85, wherein the at least one sensor environmental sensor is located outside of the container.
[0110] Example 87. The method according to any of examples 84-86, wherein the at least one sensor comprises one or more of: temperature sensor; humidity sensor; light sensor; and chemical sensor.
[0111] Example 88. The method according to any of examples 73-75, wherein the at least one sensor is incorporated within the container. Example 89. The method according to any of examples 84-88, wherein the at least one sensor is incorporated within a device the container is loaded into.
[0112] Example 90. The method according to any of examples 84-89, wherein the measuring comprises measuring one or more environmental conditions that do not correspond to the recommended environmental conditions.
[0113] Example 91. The method according to example 90, comprising determining that one or more substance units are unsuitable for consumption based on the measuring.
[0114] Example 92. The method according to any of examples 84-91, comprising tracking an expiration date of each substance unit of said plurality of substance units.
[0115] Example 93. The method according to any of examples 84-92, determining that one or more substance units are unsuitable for consumption, based on the tracking.
[0116] Example 94. The method according to example 91 or example 93, comprising recording the one or more substance units as restricted substance units.
[0117] Example 95. The method according to any of examples 84-94, wherein the selecting comprises selecting at least one substance unit that meets the consumption demand and excluding the restricted substance units.
[0118] Example 96. The method according to example 95, comprising quarantining the restricted substance units.
[0119] Example 97. A method for reclaiming at least one substance unit from an end user container, comprising: selecting the at least one substance unit for the reclaiming; transferring the at least one substance unit from the end user container to a different container; and recording the substance unit as designated for reclaiming.
[0120] Example 98. The method according to example 97, wherein the different container is owned by an agent other than the end user.
[0121] Example 99. The method according to any of examples 97-98, comprising transporting the different container from the end user to the agent.
[0122] Example 100. The method according to any of examples 97-99, wherein the transferring is performed at a distribution site.
[0123] Example 101. The method according to any of examples 97-100, comprising recording the transferring.
[0124] Example 102. The method according to any of examples 97-101, comprising receiving a reclaiming request. Example 103. A method for managing a plurality of substance units, comprising: collecting a plurality of substance units; at least partially filling a plurality of containers with substance units of the plurality of substance units, wherein the plurality of containers are manufactured to be identical to each other; transporting the plurality of containers; and transferring at least one substance unit from the plurality of containers to at least one different container, wherein the at least one different container is manufactured to be identical to the plurality of containers.
[0125] Example 104. The method according to example 103, comprising storing the plurality of containers.
[0126] Example 105. The method according to any of examples 103-104, comprising providing the at least one different container to an end user.
[0127] Example 106. The method according to any of examples 103-105, comprising recording any relocation of a substance unit within and / or between containers.
[0128] Example 107. The method according to any of examples 103-106, comprising recording any relocation of a container.
[0129] Example 108. A method for managing a plurality of health-related substance units, comprising: producing the plurality of substance units; loading the plurality of substance units into one or more origin containers, wherein each container of the one or more origin containers comprises a plurality of subsections; recording details of each substance unit of the plurality of substance units each with respect to a subsection of the plurality of subsections accommodating thereof; transporting the one or more origin containers; receiving a distribution demand; loading the one or more origin containers into a distribution system; loading at least one customizable container into the distribution system; transferring one or more substance units from the one or more origin containers to the at least one customizable container; updating the records of the transferred substance units by associating each substance unit with a subsection of the at least one customizable container accommodating thereof; loading the at least one customizable container to a dispensing device; receiving a dispensing demand; and dispensing one or substance unit, based on the dispensing demand. Example 109. The method according to example 108, wherein the dispensing comprises dispensing the one or more substance unit, one by one.
[0130] Example 110. The method according to example 108 or example 109, wherein the distribution demand comprises a user-specific distribution demand.
[0131] Example 111. A method for tracking a plurality of individually consumable bioactive substance units, comprising: registering a substance unit of the plurality of substance units as it is inserted into an origin container, wherein the origin container comprises a plurality of subsections; registering the origin container; storing a record of the origin container location; storing a record of a subsection accommodating the substance unit; storing a record of a current location of the origin container, upon transportation of the container; storing a record of the substance unit current subsection, upon transferring the substance unit between subsections of the origin container; storing a record of the substance unit current subsection at a different container, upon transferring the substance unit between one or more containers; and tracking the substance unit based on the record thereof.
[0132] Example 112. The method according to example 111, comprising storing a record of the substance unit status, upon dispensing the substance unit out of the different container.
[0133] Example 113. The method according to any of examples 111-112, comprising storing a record of the substance unit current subsection at a different container, upon transferring the substance unit from the origin container to a customized container;
[0134] Example 114. A method for preparing a customized container, comprising: connecting more than one container to a container designated to be customized; and transferring substance units from the more than one container into the container designated to be customized, until obtaining a desired substance unit content within the container.
[0135] Example 115. The method according to example 114, comprising receiving a distribution demand, wherein the transferring comprises transferring substance units from the more than one container into the container designated to be customized based on the distribution demand.
[0136] Example 116. The method according to any of examples 114-115, wherein the connecting comprises connecting the more than one container in a series.
[0137] Example 117. The method according to any of examples 114-116, wherein the connecting comprises connecting the more than one container in parallel. Example 118. The method according to any of examples 114-117, wherein the connecting comprises connecting the more than one container simultaneously.
[0138] Example 119. The method according to any of examples 114-118, wherein the connecting comprises connecting the more than one container sequentially.
[0139] Example 120. The method according to any of examples 114-118, wherein the more than one container comprises at least origin container.
[0140] Example 121. A system for preparing a customized container, comprising: a plurality of containers, wherein each container is connected to at least one container of said plurality of containers; and a controller, instructing on the transfer of substance units between the containers.
[0141] Example 122.A method for transferring a substance unit from a first container to a second container, comprising: connecting the first container to the second container; transferring the substance unit between the first and the second container; and detecting the substance unit as it transferred between the containers.
[0142] Example 123. The method according to example 122, wherein the detecting comprises detecting the emergence of the substance unit from the first container.
[0143] Example 124. The method according to any of examples 122-123, wherein the detecting comprises detecting the entrance of the substance unit into the second container.
[0144] Example 125. The method according to any of examples 122-124, wherein the detecting comprises one or more of: imaging and scanning the substance unit
[0145] Example 126. The method according to any of examples 124-125, wherein the detecting comprises identifying the substance unit.
[0146] Example 127. The method according to any of examples 124-126, wherein the transferring is subject to the identifying.
[0147] Example 128. A method for managing the interaction between a first participant and a second participant involved in the distribution at least one substance unit, comprising: authenticating the first participant; verifying the authorization of the first participant; authenticating the second participant; verifying the authorization of the second participant; and allowing the interaction between the first and the second participants.
[0148] Example 129. The method according to example 128, comprising recording the interaction. Example 130. The method according to any of examples 128-129, wherein the first participant is one of: a container configured to contain the at least one substance unit and a device configured to manipulate the substance unit.
[0149] Example 131. The method according to any of examples 128-130, wherein the second participant is one of: a container configured to contain the at least one substance unit and a device configured to manipulate the substance unit.
[0150] Example 132. The method according to any of examples 128-131, wherein the interaction comprises transferring a substance unit from the first participant to the second participant.
[0151] Example 133. The method according to any of examples 128-132, comprising verifying that one or both of the first participant and the second participant are within an approved geofenced area.
[0152] Example 134. The method according to any of examples 128-133, wherein the one or both of the first and second participants are an entity and / or an agent.
[0153] Example 135. The method according to example 134, wherein the entity and / or an agent is one or more of: manufacturer, distributor, retailer, end user, regulator, and insurer.
[0154] Example 136. The method according to any of examples 128-135, wherein the substance unit comprises a health-related substance unit.
[0155] Example 137. The method according to any of examples 128-136, comprises verifying that the interaction is allowed.
[0156] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
[0157] As will be appreciated by one skilled in the art, some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and / or system of some embodiments of the invention can involve performing and / or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and / or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and / or by a combination thereof, e.g., using an operating system.
[0158] For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and / or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile storage, for example, a magnetic hard-disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is provided as well. A display and / or a user input device such as a keyboard or mouse are optionally provided as well.
[0159] Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.
[0160] A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.
[0161] Program code embodied on a computer readable medium and / or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.
[0162] Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).
[0163] Some embodiments of the present invention may be described below with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general-purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.
[0164] These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function / act specified in the flowchart and / or block diagram block or blocks.
[0165] The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks.
[0166] Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as tracking a substance unit, might be expected to use completely different methods, e.g., making use of expert knowledge and / or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.
[0167] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0168] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
[0169] In the drawings:
[0170] Figure 1 is a flowchart of an exemplary method for managing a substance unit according to some embodiments of the invention;
[0171] Figure 2 is a block diagram of a substance units management system 200 and the ecosystem thereof, according to some embodiments of the invention;
[0172] Figures 3A-E are a flowchart of an exemplary distribution pathway of a substance unit, managed by the substance units management system, according to some embodiments of the invention;
[0173] Figure 4 is a flowchart of an exemplary method for inserting substance units into the substance units management system, according to some embodiments of the invention;
[0174] Figures 5A-B are a flow-chart of an exemplary method for collecting and / or transporting a plurality of substance units by the substance units management system, according to some embodiments of the invention;
[0175] Figures 6A-D are a flowchart 600 of an exemplary method for distributing one or more substance units by the substance unit management system, according to some embodiments of the invention;
[0176] Figure 7 is a flowchart of an exemplary method for an end user using the substance units distribution device, according to some embodiments of the invention; Figure 8 is a flowchart of an exemplary method for an end user using the dispensing device, according to some embodiments of the invention;
[0177] Figures 9A-C are a flowchart of an exemplary method for dispensing substance units device, according to some embodiments of the invention;
[0178] Figure 10 is a flowchart of an exemplary method for monitoring the conditions within the system’s containers, according to some embodiments of the invention;
[0179] Figure 11 A is a schematic exploded view of an exemplary substance units managing device loaded with a container, according to some embodiments of the invention;
[0180] Figure 1 IB is a schematic exploded view of an exemplary substance units managing having magnetic field-generating coils, according to some embodiments of the invention;
[0181] Figure 11C is a schematic illustration of exemplary magnetic field-generating coils, according to some embodiments of the invention;
[0182] Figure 12 is a block diagram of a substance units management system, according to some embodiments of the invention;
[0183] Figure 13 is a block diagram of an exemplary data ledger, according to some embodiments of the invention;
[0184] Figure 14 is a block diagram of an exemplary controller, according to some embodiments of the invention;
[0185] Figure 15 is a block diagram of distribution device, according to some embodiments of the invention;
[0186] Figure 16 is a block diagram of a dispensing device, according to some embodiments of the invention;
[0187] Figure 17 is a flowchart of an exemplary method for authenticating the system’s participants, according to some embodiments of the invention;
[0188] Figure 18 is a flowchart of an exemplary method for transferring a substance unit between containers, according to some embodiments of the invention;
[0189] Figure 19A schematically illustrates movements of a substance unit from a first position to a later position within a portion of containers hive configuration along a path, according to some embodiments of the invention;
[0190] Figure 19B schematically illustrates movements of a plurality of substance unit 101 within a portion of containers hive configuration, according to some embodiments of the invention;
[0191] Figure 20 schematically illustrates a movement of a substance unit from a first position (e.g., first subsection) to a later position (e.g., later subsection) within a portion of substance units management system along a path, according to some embodiments of the invention; and Figure 21 schematically illustrates schematically illustrating authorization and / or authentication of the operations of the substance units management system according to some embodiments of the invention.
[0192] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
[0193] The present invention, in some embodiments thereof, relates to a distribution system and, more particularly, but not exclusively, to a distribution system for substance units.
[0194] Overview
[0195] An aspect of some embodiments of the invention relates to a controlled distribution of substances, for example, medical and / or wellness substances, using standardized components , optionally, from the production to the consumption and / or use thereof. In some embodiments, the standardized components may be substance units, containers, and / or devices for manipulating the substance units inside and / or between containers. In some embodiments, the components are tracked by a management system.
[0196] Herein, consumption is referred to as the block of using, the substance units, whether by ingesting, swallowing, applying topically, inhaling, and / or any other one-time use. In some embodiments, the substance unit is non-consumable, for example, a sensor and / or electric component. Accordingly, a consumer is referred to herein to as an individual who purchases, and / or uses the substance units, whether they are consumable and / or non-consumable.
[0197] In some embodiments, the system's containers have an identical design (e.g., manufactured to be uniform). This standardization (e.g., uniformity when empty) allows each container, to be adapted for multiple roles within the system. Additionally, the uniformity of the containers potentially facilitates interactions between them, such as the transfer of substance units between containers, and may allow for the construction of a container hive configuration, where multiple containers are connected to a target container to transfer substance units into it. In some embodiments, the containers are designed to accommodate the same maximum number of substance units.
[0198] In some embodiments, the system’s devices used to manipulate the substance units within the containers have an identical design (e.g., manufactured to be uniform). This uniformity in devices may potentially allow and / or facilitate the interaction between devices (for example connecting them for transferring substance units). A device may be used for multiple roles, such as loading, transferring, and / or dispensing substance units, and it can be compatible with different of the system’s containers. In some embodiments, the substance units, whether of different types and / or pharmaceutical codes or not, are designed to have a similar and / or substantially similar physical form (e.g., having the same shape, form factor and / or size), and optionally, the same color and / or pattern. This similarity potentially simplifies the production and / or packaging process and / or reduces their costs. The standardization may potentially simplify the process of distributing a plurality of substance units using a plurality of standardized containers. In some embodiments, even though the containers are designed to be identical, they serve different functions within the substance unit management system and / or the supply chain.
[0199] In some embodiments, manufacturer(s) provides primary containers which optionally comprise substance units collected at the production facility. In some embodiments, the substance units from these primary containers are transferred to target container(s). In some embodiments, the target container, optionally, used by an end user, is usually where the substance unit's path ends, for example by their dispensing and / or consumption.
[0200] In some embodiments, the primary container may receive the substance unit during any other stage during their path through the system, as long as it serves as the first point of entry for the substance units into the system.
[0201] In some embodiments, the substance units may be transferred to one or more secondary containers before being moved to a target container, and / or before their path ends prior to reaching a target container, for example, through dispensing or disposal. These transfers between containers may be carried out by the manufacturers, distributors, retailers, and / or suppliers for various purposes, such as organizing stock, facilitating distribution, and / or optimizing transportation logistics.
[0202] The containers may also be classified as origin containers and customized containers. An origin container refers herein to a container that contains the substance units after their production and / or collection, typically used for storing and transporting the substance units until and possibly during their distribution, and / or for later transferring substance units into a customized container and / or a container designated to be customized (such as an empty or partially empty container).
[0203] A customized container, on the other hand, is a container whose content (e.g., substance units) is tailored to the specific requirements (e.g., consumption program), needs, and / or preferences of a target audience. In some embodiments, the container is customized to meet the general needs of a target group and / or a specific entity (such as a retailer). Alternatively or additionally, the container is personalized to meet the needs of a specific end user. Usually, the customized container is provided to an end user and / or is configured to dispense the substance units to the end user. For example, a customized container may contain one or more substance unit types, pharmaceutical codes, and / or quantities based on consumption programs, preferences, or requirements of the end user. In addition, the substance units may be arranged in the container according to the specific consumption schedule or preferences of the end user.
[0204] In some embodiments, the origin containers may be primary containers. It should be noted that although in many examples in this document, the origin containers are used to fill another container that reaches the end user (e.g., consumer), in some embodiments, the origin containers themselves may be provided to the end user.
[0205] In some embodiments, the customized containers may be target containers. A secondary container may serve as both an origin container and / or a customized container. Also, a target or secondary container (even if customized) may serve to transfer one or more substance units into a different container. Likewise, any container (including primary and origin containers) may be used to receive substance units from other containers, provided that they are not full.
[0206] It should be noted that although in many examples in this document, a customized container is a non-primary container (e.g., a secondary and / or a target container), in some embodiments, the customized containers may be a primary container. For example, customized containers may be loaded directly at a production facility and / or receive substance units upon their insertion into the system (e.g., with the customization taking place at the production facility and / or during the initial insertion of the substance units into the system).
[0207] In some embodiments, the primary and / or origin containers are homogeneous, e.g., having substance units of the same pharmaceutical code and / or optionally the same batch. In some embodiments, the containers are heterogeneous, for example, comprise substance units of the same pharmaceutical code but different batch numbers and / or even different substances altogether. In some embodiments, the origin container is customized, for example comprises different substance units (e.g., by their pharmaceutical code) based on the consumption requirements of a target group or an individual.
[0208] In some embodiments, a target container may be homogeneous as well, and optionally customized. For example, the number of substance units and / or their expiration dates may be aligned with the preferences and / or consumption program of the user.
[0209] In some embodiments, the container provided to the user is a personal container, whether customized, personalized, and / or homogeneous, where only the end user and / or a caregiver thereof is authorized to use the container and / or receive substance units from it.
[0210] In some embodiments, a container may be a reclaimed container, e.g., containing reclaimed substance units that were previously allocated but are no longer needed and / or re-allocated. These reclaimed containers may hold substance units that have been returned from end users, distributors, or other agents in the supply chain. The reclaimed substance units may be transferred back into the system for redistribution, further processing, and / or safe disposal. In some embodiments an origin container may be reclaimed.
[0211] In some embodiments, the system’s standardized components are recorded by a data ledger of the system.
[0212] In some embodiments, when the plurality of substance units is first collected and / or inserted into the system’s containers, they are also registered in a data ledger. In some embodiments, this first entry involves reliably inserting the substance units into the management system, for example, potentially ensuring that their details are recorded and / or tracked from the moment they enter the system. This reliable insertion may be performed by collecting the substance units into primary container(s) in tight association and / or together with inserting the substance units into the management system. In some embodiments, the insertion process is concomitant and / or atomic, potentially ensuring that both the physical and virtual insertion steps are synchronized.
[0213] In some embodiments, each container that is at least partially filled with substance units is recorded in the system's data ledger, optionally, once it is sealed.
[0214] In some embodiments, each collected substance unit is recorded in the data ledger and / or associated with the container and / or a container's sublocation (e.g., subsection) accommodating thereof. Optionally, each substance unit may be individually identified with a unique identifier (ID), optionally, a virtual ID recorded in the data ledger, alternatively or additionally, a physical identifier such as a barcode, QR code, or RFID tag embedded on or attached to the substance unit. In some embodiments, the substance unit itself may be directly identified if at least part of it is imaged at a resolution high enough to distinguish between different types of substance units, or even between individual substance units. The ID can be a combination of one or more features, such as shape, texture, or unique markings, allowing for precise identification and tracking of the substance unit throughout its lifecycle. This potentially allows the system to track each substance unit (even conventional and / or non-smart substance units) individually throughout its lifecycle, from production, through distribution, to its final use or consumption by the end user.
[0215] In some embodiments, after being at least partially filled and / or sealed, the containers can be stored and / or transported. In some embodiments, the containers are stored and then transported, potentially reducing and / or avoiding the need for packing and / or repacking the substance units. Additionally, the registered containers and the record of the substance units occupying thereof potentially reduce and / or avoid the need for counting and / or recounting the units.
[0216] In some embodiments, the containers are packed in packages, optionally, each package contains a fixed number of containers. In some embodiments, each package is recorded in the data ledger. In some embodiments, each container is tracked, and / or its record is associated with the package accommodating thereof.
[0217] In some embodiments, the packages are arranged on pallets, optionally, each pallet contains a fixed number of packages, optionally the same number of containers within a package. In some embodiments, each pallet is recorded in the data ledger. In some embodiments, each package is tracked, and / or its record is associated with the pallet accommodating thereof. In some embodiments, the pallets can be transported and / or stored.
[0218] In some embodiments, any substance unit, container, package, and / or pallet can be individually traced based on their record, which optionally comprises geographic location and / or current owner. Alternatively, or additionally a container, package, and / or pallet may be tracked by using tracking technologies such as GPS tracking, and / or RFID technology.
[0219] In some embodiments, the containers are transported to distribution sites. In some embodiments, the substance units can be distributed to the consumer (e.g., an end user) directly from the containers (e.g., origin containers), optionally, by being transferred to another container (e.g., customized and / or personal container). This direct transaction potentially reduces and / or avoids the need to unload and / or store the substance unit at distribution sites (e.g., pharmacies).
[0220] An aspect of some embodiments of the invention relates to providing multiple tracking layers in a system for distribution of substance units, optionally, with the tracking layers interrelated. For example, one, two, three or all four of the following tracking layers may be provided. Such tracking may be recorded in a ledger structure (e.g., a distributed ledger such as a blockchain). The different layers may use a same such ledger or may use separate ledgers. Using a same ledger structure may assist in enabling queries across layers and / or providing answers which integrate data from the different layers. This may assist, for example, in testing, QA, compliance and / or recalls, any or all of which may be affected by the happenings at different layers.
[0221] (a) Substance-unit Level Tracking: each substance unit may be uniquely identified, for example with a history log of, for example, every location it visited and / or associated environmental / other substance unit / tamper data. Locations can include, for example, subsection, container and / or devices, such as distribution devices for transferring substance units between containers or out of containers.
[0222] (b) Subsection-Level Tracking: each subsection within a container can be uniquely identified, with a history log of, for example, every unit that occupied it and / or associated environmental / tamper data. This may be useful, for example, to identify crosscontamination between substance units occupying or passing through a same subsection, possibly at different times. (c) Container-Level Tracking: each container can have a unique ID, with records for example for location history, ownership changes, tamper events, manipulation, ingress and egress and / or aggregated environmental data from all subsections and / or from the container itself.
[0223] (d) Package / Pallet-Level Tracking: groups of containers can be organized into packages and / or pallets, each with unique IDs linked to their constituent container records. Tracking can include, for example, package / pallet-level location history, ownership changes, and / or environmental conditions when monitored at bulk transport level.
[0224] Additional layers may be provided, for example, tracking shipping containers and tracking manufacturing runs and / or locations.
[0225] An aspect of some embodiments of the invention relates to tracking and / or tracing a substance unit, optionally a conventional (non-smart) substance unit (e.g., a conventional pill) based on a record of its location.
[0226] In some embodiments, the tracking is managed by a substance unit management system. In some embodiments, once a component is physically inserted into the system’s supply chain, a virtual representation thereof is generated in the system’s software. In some embodiments, upon any positioning and / or relocation of a component related to the system, a record is automatically updated in the management system to reflect its new location. In some embodiments, the component location history is recorded, allowing tracing of the specific path of the specific component along a supply chain.
[0227] In some embodiments, the component may be a substance unit, optionally inserted into the system once loaded into a container associated with the system.
[0228] Alternatively, or additionally, the component may be a container, optionally inserted into the system once loaded with substance units and / or sealed after being loaded with substance units.
[0229] In some embodiments, each relocation of a substance unit within a container is recorded. Then, the substance unit can be tracked based on the record of its latest sublocation within the container.
[0230] In some embodiments, each transfer of a substance unit between containers is recorded. Then, the substance unit can be tracked based on the record of the new container and / or sublocation within the container accommodating the substance unit.
[0231] In some embodiments, each emergence of a substance unit from the system containers is recorded. In some embodiments, the record comprises the latest status of the dispensed substance unit, such as consumed and / or disposed of. In some embodiments, the status of substance units within the containers can also be modified. For example, a substance unit can be recorded as prohibited, for example, if it is recalled, expired, and / or suspected of being contaminated or spoiled.
[0232] In some embodiments, a substance unit can be tracked and / or traced along its entire distribution path, e.g., from its production to its end of life (e.g., consumption and / or disposal).
[0233] In some embodiments substance unit tracking may be performed for inventory count, allowing to count of substance units located in different geographic locations and / or owned by various entities. In some embodiments, tracking is performed to assess market supply levels, e.g., identifying whether there is a shortage or surplus of specific substance units. This potentially allows for adjustments in the production and / or distribution of the substance units accordingly.
[0234] In some embodiments, the tracking may be performed on the substance units of an individual user. This tracking can determine whether and / or when a substance unit purchased and / or provided to a user has been consumed, allowing the evaluation of the user's adherence to a prescribed consumption program (e.g., treatment). In some embodiments, the substance unit management system may prompt the user to consume its substance units according to the consumption program, optionally by sending reminders according to a required consumption schedule. This may potentially improve user adherence to the program thereof. In cases involving medical substance units, enhancing adherence to the treatment plan may potentially reduce medical complications and / or hospitalizations due to non-compliance, thereby having the potential advantage of saving costs and / or reducing the burden on healthcare systems.
[0235] An aspect of some embodiments of the invention relates to multi-directional substance unit management. In some embodiments, the distribution path of a substance unit, as managed by the substance unit management system, is not limited to the conventional linear path from manufacturer to consumer (e.g., down the supply chain) and allows reverse and / or lateral logistics.
[0236] In some embodiments, the system allows substance units to be managed in the reverse direction, e.g., up in the supply chain, for example, from the user to a manufacturer. Alternatively, or additionally, the system may support lateral movements, allowing substance units to be transferred between entities at the same level of the supply chain, such as from one retailer to another and / or between containers of the same entity. In some embodiments, a substance unit may be moved back and forth between entities of different levels of the supply chain.
[0237] In some embodiments, a reclaimed substance unit may be reclaimed by transferring it between containers and / or transporting the container thereof. In some embodiments, a substance unit may be transferred from a container of one entity to a container of another entity. For example, substance unit(s) may be returned by transfer from the end user’s container to a container of another entity, such as a regulator, retailer and / or a manufacturer. Alternatively, or additionally, the container accommodating the reclaimed substance unit may be transported as a whole, for example, the retailer may transport one or more containers back to a manufacturer and / or in case of contamination an end user's container may be reclaimed and transported as a whole. In some embodiments, this reclaimed container may be customized, for example, comprising substance units intended specifically for a particular entity and / or group, and / or containing reclaimed substance units that are to be handled and / or processed in the same way, optionally, of the same type, pharmaceutical code and / or bath.
[0238] In some embodiments, a substance unit may be returned and / or reclaimed for reasons such as recalls, expiration, and / or because they are no longer needed or suitable for the end user. In some embodiments, substance units which are recorded as recalled, expired, and / or spoiled are automatically routed to a designated container for destruction upon connection of the container to a distribution device. In some embodiments, returning these substance units includes a refund to the user and / or one or more agents along the supply chain, for potentially reducing the risk of improperly disposing of the substance units.
[0239] In some embodiments, a substance unit suited for use may be returned since it is no longer needed by the patient, for example, to a retailer and / or manufacturer. In some embodiments, this substance unit may be recycled, e.g., further distributed to another user. This usage has the potential advantage of reducing material waste, particularly in the medical field, where unused medications can be costly and / or wasteful. By allowing redistribution, the system potentially reduces unnecessary disposal of usable and / or valuable substances. In some embodiments, the user(s) returning the substance units (e.g. medication) may receive a financial refund and / or credit, potentially incentivizing them not to keep unnecessary unit substances.
[0240] In some embodiments, unneeded substance units may be transferred directly to another user who needs them, by lateral logistics.
[0241] Lateral logistics may also be used in cases of shortages, where one retailer with surplus units can provide them to another facing a shortfall, thereby potentially maintaining a balanced supply chain. Lateral logistics may also be used for customizing a container, which may be transferred between manufacturers and / or retailers, each loading it with different required substance units. Additionally, or alternatively, lateral logistics can facilitate redistributing units between pharmacies, clinics, or hospitals to meet immediate demand without waiting for new shipments.
[0242] Throughout these processes, the substance units' journey through the supply chain is tracked, and potentially each transfer is authenticated, potentially ensuring that returns whether lateral and / or reverse are properly managed. In some embodiments, the authentication process can include verifying the identity of the substance unit, checking its condition (e.g., expiration, contamination status and / or integrity), confirming the authorization of both the source and target devices and / or containers, and / or verifying that interaction between them is permitted. This authentication can be required by either or both of the source and target devices and / or agents responsible thereof, potentially ensuring that only authorized devices and / or containers can perform transfers. For example, the system may authenticate that the substance unit is authorized for transfer to a specific target device, or that the source device is permitted to initiate the transfer.
[0243] In some embodiments, one or more environmental conditions to which each substance unit is exposed, such as temperature, light, and humidity, are monitored and optionally recorded. Units exposed to extreme conditions that could compromise their integrity are flagged (e.g., recorded) as unsuitable for reuse. In such cases, the return of these units is designated for disposal and / or for further testing to assess their viability, potentially ensuring that only units maintained under proper conditions are considered for redistribution. Units exposed to extreme conditions that might merely shorten shelf life are flagged as such and their expiry date is adjusted accordingly. In some embodiments, such as with some food supplements, the potency of a substance unit exposed to extreme conditions is adjusted and the user is notified and / or a use regime takes the new potency into consideration.
[0244] In some embodiments, reverse logistics may be utilized for sending samples optionally, from the user to another entity, such as a lab, clinic, or hospital, for further analysis or testing. For example, biological samples such as blood, saliva, or urine may be collected from the user and transported back to a medical facility and / or testing center for diagnostic purposes. Additionally, reverse logistics may facilitate the return of substance units to the manufacturer for quality control, research, or product analysis.
[0245] Moreover, the use of reverse logistics allows the tracking of the sample’s journey, ensuring it is transported under the correct environmental conditions, such as temperature or humidity control, to preserve its integrity. Once the samples reach their destination, they can be used to verify treatment outcomes, adjust medication dosages, or inform further medical decisions. This process potentially allows samples to be transported while maintaining traceability and / or compliance with regulatory standards for handling sensitive materials.
[0246] An aspect of some embodiments of the invention relates to monitoring the environment of a substance unit within a container that accommodates it. This may involve continuously tracking key environmental parameters such as temperature, humidity, light exposure, and even potential contaminants to ensure the substance unit is maintained under optimal conditions optionally, throughout its storage and / or transport. In some embodiments, the container may be equipped with sensors that collect real-time data on environmental conditions and communicate this information to the system. If any of these conditions fall outside the recommended thresholds, the system may trigger alerts to the entity holding the container and / or the entity responsible for it. For example, if a manufacturer is storing containers under unsuitable conditions, the system can alert the relevant regulatory authority. Similarly, if an end user is storing a container in inappropriate conditions, the system may notify the user as well as a supervisor responsible for the user’s health or medication management.
[0247] In some embodiments, if a substance unit is maintained under improper conditions, it may be flagged (e.g., recorded) as unsuitable for consumption. The affected substance unit may be marked as prohibited for use. In some embodiments, this substance unit may be designated for disposal, quarantine, and / or be sent for further quality testing to assess any potential damage. In some embodiments, exposure to extreme environmental conditions may result in the system adjusting the expiration date of the substance unit and / or updating the recorded percentage of active ingredients based on predicted and / or measured degradation. This potentially ensures that only substances that meet the required quality standards are cleared for further use, and helps mitigate any risks associated with compromised products reaching the end user.
[0248] In some embodiments, a sensor for detecting potential or actual mechanical damage such as an accelerometer can be integrated into the container and / or device. This sensor may potentially detect mechanical damage to a container and / or the substance units stored within it. The accelerometer monitors sudden changes in movement, such as shocks, vibrations, and / or impacts that could indicate that the container has been dropped, mishandled, or subjected to conditions that could damage it and / or its contents. If such an event is detected, the accelerometer can trigger a notification in the system, flagging the container and / or the substance units within as potentially compromised.
[0249] In some embodiments, environmental monitoring may be a condition and / or primary step for lateral and / or reverse logistics as described herein.
[0250] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
[0251] Referring now to Figure 1, showing a flowchart 100 of an exemplary method for managing a substance unit, according to some embodiments of the invention.
[0252] Flowchart 100 comprises the method of: loading one or more substance units into one or more containers, such that each substance unit is placed within a subsection of a container (102); recording the location (e.g., subsection) of the substance unit within the container (104); transferring the substance unit into a subsection of an end user (e.g., consumer) customized container (106); providing the substance unit to the end user from the customized container (108); and tracking the substance unit, at any point throughout the flowchart, based on the record of the substance unit (110).
[0253] Referring now to some of the blocks in more detail:
[0254] At 102, Optionally, the loading may be carried out automatically by a robotic system and / or manually by a human operator. In some embodiments, the one or more containers comprise subsections and the substance units are placed such that each unit is positioned within its (one or more) exclusive subsection(s). Optionally, each subsection is sized and / or shaped to accommodate a single substance unit. Optionally, a substance unit may occupy more than one subsection. In some embodiments, multiple substance units may be grouped together and / or be treated as a group and / or single unit, potentially allowing for easier handling and / or management during the loading / transferring and / or dispensing processes.
[0255] In some embodiments, the substance units are in solid form. For example, the substance unit(s) are in the form of a disc, pill, tablet, capsule, caplet, lozenge, gum and / or any other solid form factor. The solid form may be spherical, disc-shaped, oval, cylindrical, cubical, diamond shapes, triangular, annular, almond-shaped, pentagon- shaped, lozenge-shaped, core rod, rectangular or any other geometric shape optionally suited for its intended use. In some embodiments, the substance units are designed to move by sliding or rolling within a container, allowing for controlled positioning and / or dispensing. Alternatively, or additionally, the substance units may be in the form of a liquid, gas, liquid-gel, powder, oil, foam, paste, and / or cream, for example, contained within capsules.
[0256] In some embodiments, the substance units comprise and / or are formed of a consumable substance, optionally, ingestible items, and / or any other administration method. The consumable substance units may be intended for human use and / or for veterinary (e.g., animal) use. Alternatively, or additionally the substance units are intended for external use, whether or not they involve direct interaction with the user’s body. Optionally, the substance units are configured to be returned after use to the same container or a different container within the system, for example after collecting a sample from a user. In some embodiments, the substance units may be medical-related and / or non-medical in nature. For example, in some embodiments, the substance unit(s) comprise one or more of medical / pharmaceutical substances, food additives / supplements, as well as cosmetics, hygiene products and / or cosmetic products. In some embodiments, the substance units are designated for oral consumption. Alternatively, or additionally, the substance units may be designated for rectal, vaginal, sublingual, buccal, ocular, optic, intranasal, topical, transdermal, inhaled, and / or injected use.
[0257] In some embodiments, the substance units comprise and / or are formed of a consumable substance, whether for medical use or not. For example, the units may consist of diagnostic tools, medical devices, or other materials used for health monitoring or treatment purposes (e.g., sensors). In another example, the substance units may be in the form of relatively small items such as electronic components (e.g., chips and / or sensors), and / or diamonds.
[0258] It is to be noted that the method of flowchart 100 may be particularly useful for consumable health-related substance units and in particular medical-related substance units. This method allows for maintaining the integrity of the supply chain, ensuring compliance with regulations, monitoring the quality of the substances throughout their lifecycle, ensuring the arrival of substance units to appropriate users, and / or evaluating the user’s compliance (e.g., adherence) with a use program (e.g., consumption program). By tracking each substance unit, it can be potentially verified that the substance units are stored and / or handled according to prescribed conditions, ensuring that they reach the end user in proper and / or optimal quality and / or provide a dependable complete record of the end user's usage of the substance units, potentially including precise absolute timing as well as relative timing to the use of other substance units. In some embodiments, the one or more substance units comprise a plurality of substance units such that some, and / or optionally all are identical in form factor, form, and / or size. Optionally such substance units are identical in form factor, form, and / or size despite some or all of them comprising different ingredients and / or dosages. In other embodiments, some and / or all the substance units of the plurality of substance units may differ from each other in their form, form factor and / or size.
[0259] In some embodiments, the substance units come in a small number of sizes (e.g. 10 or fewer or even 8 or fewer). In some embodiments, the sizes match the sizes of the subsections, in some cases allowing more than one unit in a single subsection or a single unit to occupy two or more subsections. In effect, units can function as modular components of larger effective units that occupy a subsection.
[0260] It should be noted that the one or more substance units may comprise any individual unit and / or element. For example, in some embodiments, the substance units can include or be in the form of sensors, chips, and / or other hardware components. In another example, the substance units may comprise samples for laboratory testing.
[0261] In some embodiments, the substance units are collected into one or more origin containers. An origin container, as referred to herein, may be any container designed for the collection and / or storage of substance units at the point of production and / or distribution. Typically, substance units from one or more origin containers are rearranged into customized containers. In some embodiments, the origin container may be provided eventually to an end user, alternatively or additionally, more than one origin user can be used for collecting substance units into a customized container.
[0262] In some embodiments, the substance units and / or container's contents may comprise one or more of the examples listed in the “ Exemplary Types of Substance Units and / or Container Contents” section. At 104, the recording comprises recording the data (e.g., details) of the substance unit with respect to the subsection(s) accommodating it within the container.
[0263] In some embodiments the details of the substance unit may comprise one or more of:
[0264] 1. A unique ID (e.g., provided by the system);
[0265] 2. Substance unit name (e.g., product name such as a medicine name), and / or drug nomenclature, for substance units which comprises drugs (e.g., chemical name, IUPAC name, generic or nonproprietary names, international nonproprietary names, trade names brand names.
[0266] 3. Substance unit pharmaceutical code (e.g., used in medical classification to uniquely identify medications, may be herein used to specify particular pharmaceutical product from a specific manufacturer);
[0267] 4. Substance unit classification and / or type (for example in medicines, drugs can be classified as analgesics, antibiotics, antihistamines, antivirals, or anti-inflammatory agents;
[0268] 5. Substance’s active ingredients and / or API (Active Pharmaceutical Ingredient) (e.g., molecule name and / or formulation name);
[0269] 6. Ingredients and their percentage;
[0270] 7. Substance unit dosage (e.g., mg of API (Active Pharmaceutical Ingredient) in the substance unit;
[0271] 8. Substance brand;
[0272] 9. Substance batch;
[0273] 10. Substance composition;
[0274] 11. Production date of the substance;
[0275] 12. The expiration date of the substance; and 13. Recommended storage conditions;
[0276] 14. Release form (e.g., IR - immediate release and / or XR - Extended release);
[0277] 15. Side effects;
[0278] 16. DDI (drug on drug constraints);
[0279] 17. Identifiers of other entities (whether communicating with the system or not, such as National Drug Code (NDC), administered by the Food and Drug Administration (FDA); the Drug Identification Number (DIN), administered by Health Canada under the Food and Drugs Act; the Hong Kong Drug Registration, administered by the Pharmaceutical Service of the Department of Health (Hong Kong); and the Anatomical Therapeutic Chemical Classification System (ATC, or ATC / DDD), administered by the World Health Organization product's leaflet; and
[0280] 18. Visual appearance optionally, at high resolution of the substance unit (to potentially allow individual identification of the substance unit in cases that there is a visual difference between the different substance units).
[0281] In some embodiments, the recording comprises updating the association between a substance unit and its location upon transferring thereof. In some embodiments, the recording includes documenting the new location of the substance unit, optionally along with a record (e.g., time-dependent record) of all intermediary locations (e.g., subsections) it passed through before reaching the new location. At 106, the customized container, as referred to herein, may be any container configured to be provided to an end user and / or to dispense substance unit(s) to an end user. Alternatively, or additionally, a customized container refers to a container associated with a particular user and / or a container that is at least partially filled with substance units customized for a specific end user and / or target group, optionally personalized.
[0282] In some embodiments, the contents of the customized container (e.g., type, pharmaceutical code and / or quantity of substance units) are personalized and / or tailored to a specific patient. In other embodiments, the contents of the customized container are customized according to a specific group, for example, containing substance units commonly consumed by members of that group. In some embodiments, the contents of the customized container may be homogeneous, optionally, the customized container and the origin container are the same.
[0283] In some embodiments, the customized container may be personal, where only an individual end user is authorized to consume its contents. In other embodiments, the customized container may be configured for use by a specific household and / or group, where the contents are shared among several authorized users. For example, in some embodiments, the customized container is used by a nurse and / or caregiver in a healthcare setting, where more than one individual receives their substance units. In some embodiments, only an authorized individual (e.g., a nurse) is authorized to retrieve substance units from the container and administer it to the users (e.g., consumers). In other embodiments, the more than one individual (e.g., end user) may be authorized to access the substance units themselves.
[0284] A substance units management system and an ecosystem thereof
[0285] Referring now to Figure 2, showing a block diagram of a substance units management system 200 and the ecosystem thereof, according to some embodiments of the invention.
[0286] In some embodiments, the substance units management system 200 is configured to manage a substance unit and / or a plurality of substance units, optionally from the production to the substance unit end of life (e.g., by consumption and / or disposal), alternatively or additionally, throughout a narrower range of a substance units life (for example from retailer to end user).
[0287] In some embodiments, the system comprises a data ledger 202, configured to track and / or record the location of the substance unit(s), and a controller 204, configured to determine where to locate a substance unit and / or whether to transfer the substance unit and / or where to. Additionally, in some embodiments, controller 204 is configured to integrate with external agents and / or entities, optionally, related to the distribution path of the substance unit(s).
[0288] In some embodiments, substance units are inserted into system 200 upon the production thereof. In some embodiments, this is performed by at least one substance unit manufacturer 206 or an agent thereof, which produces the substance units and optionally collects them into one or more containers (also referred to herein as origin containers). In some embodiments, the substance units manufacturer 206 provides the management system 200 input regarding the substance units (e.g., details), as described for example in blockl04 of flowchart 100.
[0289] In some embodiment, a substance units distributor 208 transports the origin container accommodating substance units from manufacturer 206 to a substance units aggregator and retailer 210. The substance units aggregator and retailer 210 block as an interface between distributors and / or manufacturers and an end user 212, which purchases and / or receives the substance unit(s) from aggregator and retailer 210.
[0290] In some embodiments, system 200 receives input from a supervisor 214 (e.g., medical supervisor and / or a caregiver) regarding the distribution requirements of the end user. For example, an attending physician may input a prescription into the system, dictating distribution demands (such as type, pharmaceutical code, and / or quantity of substance unit). Alternatively, or additionally to a physician, supervisor 214 can be one or more of a nurse, nutritionist, dietician, HCP (healthcare professional), hospital staff, a care giver, a fitness trainer and / or the user. Alternatively, or additionally, system 200 may receive input from regulator 216. For example, a health entity, such as the Ministry of Health and / or the health funds may allocate vaccines and / or supplements to the population and / or a group from the population.
[0291] In some embodiments, at least one health insurer 220 (e.g., health insurance company) may provide additional input and / or monitor the distribution of substance units. For example, the health insurer may input a prescription to the system upon its approval and / or monitor the delivery of substance units, for example, to potentially facilitate reimbursements to the end user (e.g., consumer). In some embodiments, health insurer 220 may play a role in authorizing and / or verifying prescription requests from the end user, potentially ensuring that the insured receives the permitted and / or necessary substance units as part of the end user's health plan(s).
[0292] In some embodiments, system 200 can be used by the external agents or entities for tracking substance units. For example, all substance units from a certain type and / or pharmaceutical code at storage may be tracked by a manufacturer, for example, for an inventory count. In another example, regulator 216 may track all substance units from a certain type and / or pharmaceutical code at storage and / or distribution sites in the event of a market shortage. In another example, one or more substance unit batches may be tracked for recall purposes, for example, by manufacturer 206 and / or regulator 216.
[0293] Exemplary distribution pathway of a substance unit
[0294] Referring now to Figures 3A-E, showing a flowchart 300 of an exemplary distribution pathway of a substance unit, managed by the substance units management system, according to some embodiments of the invention.
[0295] At 302-310, a substance unit is loaded into a container.
[0296] Referring to blocks 302-310 in more detail.
[0297] At 302, optionally, the container is positioned with respect to an outlet of a substance unit manufacturing system (e.g., in communication with the outlet) such that optionally, the substance unit that emerges from the production line, can be directly entered into the container. This potentially reduces and / or avoids contact with production workers and / or additional tools and / or containers, having the potential advantage of reducing substance unit friction and / or risk of substance unit contamination. In some embodiments, the container is loaded by use of a device configured to manage the collection and / or positioning of the substance units within the container (e.g., distribution device). Alternatively, or additionally, the container may be filled using a different mechanism than the device. Alternatively, or additionally to loading the substance unit as it is manufactured, it can be loaded at any other stage of the substance unit’s lifetime. For example, after being stored by the manufacturer, before transportation, at any other stage at the manufacturer's facility, and / or by an entity authorized by the manufacturer at that entity's facility and / or upon arrival at a distribution site.
[0298] At 304, optionally, the substance unit is detected as it emerges from the manufacturing outlet and / or as it enters into the container. In some embodiments, the detection is performed by a sensor (such as an optical sensor), which is optionally part of the device into which the container is loaded. Alternatively, or additionally, the sensor may be integrated into the container itself. Optionally an additional or alternative sensor is present in a different device and detects the transfer. It should be noted that detecting the substance unit as it enters into the container is not limited to the manufacturing stage and / or to the first entrance into a container. In some embodiments, each entrance and / or exit of the substance unit into or from a container may be detected. Optionally, the detecting includes identification and / or authentication of the substance unit and the entering and / or exiting are permitted only upon such identification and / or authentication.
[0299] At 306, in some embodiments, the details of the substance unit are recorded (e.g., in the data ledger), optionally, upon detection of the substance unit (entering into the container and / or emerging from the manufacturing outlet).
[0300] In some embodiments, the substance unit’s details comprise one or more of the details as described in Block 104 of flowchart 100.
[0301] At 307, the substance unit (and / or details thereof) is associated with an exclusive and / or specific location within the container (e.g., a subsection or a plurality of subsections within the container).
[0302] In some embodiments, the location is allocated prior to the positioning of the substance unit, and then the substance unit is placed accordingly. Alternatively, or additionally, the substance unit is first positioned within the container (e.g., within a container’s subsection) and then it and / or the details thereof are associated with the respective subsection. In some embodiments, the allocation is after the fact, namely once a substance unit is already positioned in a specific location.
[0303] At 308, the substance unit is collected and / or inserted into the container.
[0304] At 310, the substance unit is positioned within its allocated subsection. In some embodiments, the substance is directly positioned within its allocated subsection. In other embodiments, the substance unit is inserted into the container and then moved to its allocated subsection. In some embodiments, the container is loaded within a device, configured to move and / or position the substance units within the container.
[0305] At 312, optionally, the substance unit is stored by storing the container accommodating it. In some embodiments, storing the substance unit within the container potentially reduces the risk of substance unit loss and / or contamination. In addition, this configuration of storage potentially simplifies the performance of an inventory count or avoids the need for re-counting.
[0306] At 314, in some embodiments, the substance unit is transported by transporting the container accommodating it, optionally, to a distribution site. The substance unit, compartmentalized within the container (within the container’s subsections), is potentially subject to less friction and / or wear in comparison to un compartmentalized substance unit. In some embodiments, the containers are transported either within a device or, additionally, or alternatively, as standalone units.
[0307] At 316, in some embodiments, the substance unit is loaded into a distribution device by loading the container accommodating it.
[0308] At 318, optionally, the substance unit may be relocated within the container, by moving the substance unit from one of the container’s subsections to another.
[0309] At 320, intra-container relocation of the substance unit is recorded, by associating the substance unit with a new current subsection accommodating it. Optionally the relocation includes moving the substance unit via a plurality of subsections and each location along the path is recorded.
[0310] At 322, optionally, the substance unit may be relocation within another container, by moving the substance unit to a subsection of another container subsection. In some embodiments, the substance unit may be detected before, during and / or after transferring between containers. In some embodiments, the entrance of the substance unit into another container may be detected (e.g., by a sensor, as described for example in block 304). Alternatively, or additionally, the emergence of the substance unit from the container may be also detected. These detentions may trigger the system to update the substance unit’s record and / or confirm the successful completion of the transfer between containers. In some embodiments, any repositioning and / or movement of a substance unit can be considered a relocation. For example, the container’s subsections may be in the form of compartments and the substance units may be arranged in the compartments, such that each movement of a substance unit from one compartment to another is considered a relocation and is accordingly recorded. In other embodiments, certain repositioning and / or movement of substance units may not be considered a relocation. For example, a substance unit can move within a compartment without changing its overall location (for example, if the compartment is larger than the substance unit). In another example, substance units may be arranged on a track, where a plurality of substance units move together in such a way that the logical and / or relative position of each unit remains unchanged. This kind of repositioning may not be considered a relocation and, therefore, may not be recorded.
[0311] At 324, the inter-container relocation of the substance unit is recorded, by associating the substance unit with the current container and the current subsection accommodating it. Optionally this relocation includes moving the substance unit via a plurality of subsections in one or both containers and each location along the path is recorded.
[0312] At 325, in some embodiments, the substance unit can be tracked based on the record of its location within the container, for example, within an origin container. It should be understood that this tracking can be performed at any stage after the substance unit has been inserted into the system. In some embodiments, the tracking includes tracking a specific container accommodating the substance units and / or tracking the subsection between this container.
[0313] In some embodiments, this tracking may be performed for the purpose of inventory counting. In some embodiments, this tracking may be performed for the purpose of locating goods. In some embodiments, this tracking may be performed for disposal purposes, for example, if the substance unit is expired and / or a recall has been received.
[0314] At 326, in some embodiments, the substance unit is transferred into a customized container (e.g., a consumer's personalized container).
[0315] At 328, the transportation of the substance unit into the customized container is recorded. The substance unit is associated with a subsection of the customized container accommodating it.
[0316] At 330, optionally the customized container is loaded into a dispensing device (which can be also referred to herein as a customized-substance-units dispensing device). Alternatively, or additionally, the customized container may be stored by the user. In some embodiments, the dispensing device is personal, where only the specific end user is authorized to use it. Alternatively, or additionally, the dispensing device may be used by more than one end user. In some embodiments, the dispensing device may be used by a caregiver, for example, a nurse, who is authorized to dispense substance units and administer them to others (e.g., end users and / or patients).
[0317] At 332, optionally, the substance unit can be relocated within the customized container. This relocation involves updating the substance unit’s record. For example, the substance unit may be moved in preparation for the delivery, for example, to be placed in proximity to the customized container opening and / or next to other substance units designated to be provided together and / or in sequence with the substance unit. In another example, the substance unit may be moved to allow the egress of another substance unit. In yet another example the substance unit may be moved to a desired storage pattern within the container (e.g., distributing the substance units and / or collating them in a partially filled container).
[0318] In some embodiments, the substance unit may be transferred between personal containers, for example, from a container in storage to a container carried by the user. Optionally, this is done to separate useful and un-useful substance units to different containers. For example, substance units that are no longer of use because their shelf life expired or any other reason are collected into one container while the useful ones are positioned in another.
[0319] Referring now to A, in Figures 3C and 3D, representing a stage and / or a scenario where the substance unit is selected to be delivered to the user.
[0320] At 336, in some embodiments, the substance unit is moved within the container to reach the container’s and / or the dispensing device’s outlet opening. Optionally, the substance unit is transferred between the container’s subsections during this movement.
[0321] At 338, in some embodiments, the substance unit discharge is subject to (e.g., contingent upon) the identification of the user. In some embodiments, if the user identification fails, the substance unit remains contained within the customized container.
[0322] At 340, the substance unit is dispensed out of the dispenser.
[0323] At 342, in some embodiments, the use (e.g., consumption) of the substance unit is recorded. In some embodiments, data regarding the use is recorded and / or stored. For example, such data may comprise one or more of the following: the identity of the individual / entity that caused the egress of the substance unit from the container, the location of such use (geographic and / or by establishment), date of use; time of use with respect to other units of the same type and / or pharmaceutical code and / or of a different type and / or pharmaceutical code; if used according to the recommended schedule, for example, according to manufacturer's recommendations and / or doctor's prescription; and a period of time from the moment of receiving substance unit and until its consumption. In some embodiments, the data also specifies whether the use was performed in accordance with the user's use program and / or within an authorized deviation from that program. For example, an analgesic might be consumed within an allowable dosage range per a time window based on the user's pain level. In some embodiments, the data may comprise input and / or feedback from the user and / or supervisor, optionally provided via a user interface of the system. In some embodiments, the user interface may be in the form of a mobile application, a web-based dashboard, and / or an interactive device screen. In some embodiments, the input may comprise consumption-related reports, such as one or more of: side effects, efficacy, food ingestion, and / or mood. Alternatively, or additionally, the input may comprise consumption confirmation and / or an instruction / request to adjust usage schedules. In some embodiments, the use may optionally be reported to a supervisor of the user, such as an attending physician and / or guardian.
[0324] Referring now to B, in Figures 3C and 3D, representing a stage and / or scenario where the substance unit is not currently being delivered to the user. In some embodiments, the substance unit is currently not selected for delivery since another type and / or pharmaceutical code of substance unit is required. For example, if the unit substance is a food supplement and / or a medicine, it may not be selected since the current requirement is for another nutritional supplement or other medicine. In some embodiments, the substance unit is not selected since there is a priority to transfer other substance units first, for example with a closer expiration date. In some embodiments, the substance unit is prohibited from being selected, for example, if the substance unit is recalled, and / or expired and / or if the substance unit and / or the container is suspected of being contaminated, exposed to extreme environmental conditions and / or tampered with.
[0325] At 346, in some embodiments, the substance unit within a container can be tracked based on the records thereof, at any stage and / or point in time since the insertion of the substance unit into the system. For example, in some embodiments, the substance unit can be tracked to trace a recalled and / or expired substance unit provided to the user. It should be noted that this tracing can optionally be performed both in customized containers (usually owned by end users) and origin containers (usually owned by the manufacturer, distributor, and / or retailer). In another example, in some embodiments, the substance unit can be tracked to evaluate user compliance and / or adherence to a consumption program In some embodiments, the substance unit may be tracked until the end of its life (e.g., by being used and / or disposed of). In some embodiments, tracking such a substance unit may provide a record of its status (e.g., delivered, consumed, and / or available for delivery), optionally, details about the latest container and / or subsection accommodating it, as well as information regarding its departure from there. In some embodiments, the tracking may comprise knowing the geographical location of the unit, for example tracking an address and / or a current owner.
[0326] An additional benefit of this tracking may be the ability to maintain complete visibility of the inventory at all times, potentially knowing exactly where each substance unit is located and / or whether it has been used and / or in conditions to be used. This data allows to optimized inventory control by adjusting stock levels based for example, on actual usage and / or availability, which in turn can improve production rate management. Furthermore, the ability to track substance units in real-time and / or near real-time allows dynamic rerouting of products, avoids bottlenecks, and / or responds to changes in supply chain needs. At 348, in some embodiments, the customized container may be reloaded into a distribution device (together with the substance unit therein). In some embodiments, the container is reloaded into the device to refill its empty subsections with substance units intended for use and / or not for use.
[0327] At 350, optionally, during the refill, the substance unit may be relocated within the customized container and the relocation is recorded.
[0328] At 352, in some embodiments, the substance unit may be removed and / or replaced, optionally, during the refill. For example, if the substance unit is recalled and / or expired and / or not needed, the distribution device may remove it and / or replace it with another matching substance unit that is not recalled and / or expired. In another example, if the substance unit no longer needs to be consumed by the user, for example, due to changes in the user’s usage program (e.g., consumption program) (such as medical prescriptions), the substance unit may be removed and / or transferred into another customized container of the user, optionally by the distribution device during refill, alternatively or additionally, by the user’s dispensing device, after the refill.
[0329] At 354, in some embodiments, the substance unit within the customized container may be quarantined, optionally, within the subsection accommodating it. For example, if the substance unit has been identified as recalled and / or expired and / or if the substance is classified as allergenic to the user. In another example, the system may receive an input instructing to quarantine the substance unit, for example for a user’s physician and / or a nutritionist. In some embodiments, the substance unit is first transferred, optionally to a less active subsection (for example, distant from the container’s outlet opening), and then quarantined in this subsection. The substance unit and / or the subsection accommodating it are recorded as quarantined.
[0330] In some embodiments, the entire container accommodating the substance unit may be quarantined. For example, if contamination is detected within the container and / or if the container holds a material found to be allergenic to the user, the container may be quarantined, optionally for safety purposes. Optionally, all substance units within it may be recorded as prohibited.
[0331] At 356, data regarding the substance unit is stored. For example, the history of containers in which the substance unit was held, the history of subsections in which it was held and / or through which is moved, what other substance units occupied the same subsections earlier, and what substance units occupied the same container concomitantly, whether it was consumed or not, when it was consumed, and / or whether it was consumed according to a consumption plan / program.
[0332] In some embodiments, the data may include the history of the substance unit (e.g., a specific substance unit), which may comprise one or more of the following: the substance unit’s transactions (e.g., inter-containers and / or intra-container), environmental data such as temperature and / or humidity the substance unit has been exposed to, optionally showing changes over time, and / or links to potentially cross-reactive units. For example, the system could track whether the substance unit shared pathways with a contaminated unit, passed through a contaminated container, or was in contact with another unit from which it may have collected foreign material.
[0333] Exemplary method for tracking substance units
[0334] Referring now to Figure 4, showing a flowchart 400 of an exemplary method for inserting substance units into the substance units management system, according to some embodiments of the invention.
[0335] At blocks 402-404, in some embodiments, substance unit(s) are reliably inserted both physically and virtually into the substance units managing system (e.g., system 200), possibly simultaneously (e.g., substantially simultaneously). In some embodiments, alternatively or additionally to simultaneous insertion, the substance units can be associated with their location before and / or after their physical insertion. For example, substance units may be loaded into the system (e.g., into a container) first, and their locations can be associated with the corresponding data afterward. In another example, the substance unit may be associated with its allocated location (e.g., subsection) before being physically placed within it.
[0336] In more detail, at 402, substance units are physically inserted into the system by loading them into one or more containers (e.g., origin containers) while at 404, the substance units are virtually inserted into the system by recording the details of each substance unit with respect to its exclusive location within the origin containers and / or by associating the substance unit’s (e.g., the ID thereof) with its exclusive location and the substance unit data.
[0337] In some embodiments, this simultaneity may be achieved and / or ensured by dividing the virtual insertion into two steps. First reporting on an intention to insert a substance unit, and after confirming the physical insertion of the substance unit completing the virtual insertion of the substance unit. In some embodiments, the Intention, execution, and / or success of physically inserting a substance unit are directly recorded in the data ledger. Alternatively, or additionally, this information may be recorded locally within the device optionally until it can be synchronized with the system (e.g., system’s main controller and / or data ledger), potentially reducing and / or avoiding the risk of loss of information, even if real-time communication with the data ledger is unavailable.
[0338] In some embodiments, if the physical insertion fails, the system recognizes the failure. In some embodiments, each container that has been loaded with substance units (filled and / or partially filled with substance units) is recorded (e.g., registered) by the system. In some embodiments, the system provides a unique ID for each container before, during, and / or after the completion of the complete or partial filling. In some embodiments, the container is recorded once it is sealed.
[0339] In other embodiments, the insertion may be performed atomically, meaning that both the physical and virtual insertions occur as a single, indivisible transaction. This potentially ensures that the substance unit is only recorded as inserted if both the physical and virtual actions succeed, having the potential advantage of reducing the possibility of errors and / or inconsistencies between the two.
[0340] In some embodiments, once the substance units are loaded into the system, the system provides each substance unit a unique ID. Each ID is associated with the substance unit data, which optionally comprises the substance unit’s properties (details), current location, and / or location history.
[0341] In other embodiments, for example, if the origin container is homogeneous (e.g., comprises substance units with the same properties and / or history), first the system provides all a shared ID (for example a batch ID), and a unique ID is provided to each substance unit when it is transferred out of the origin container. Optionally, the shared ID may use the container’s ID. In some embodiments, together with the shared ID, the system records the quantity and / or the locations of the substance units within the container. For example, substance units of the same batch may be considered identical and be collected into a container as they are produced and receive a shared ID (a batch and / or container ID).
[0342] In some embodiments, the system assigns a unique ID to each subsection within the origin containers and links this unique ID with the unique ID of a substance unit that occupies the respective subsection. Alternatively, or additionally, the system assigns a unique ID to each container and provides indications for the subsections within it, linking the combination of the container ID and the location indication with the unique ID of the substance unit that occupies the location.
[0343] At blocks 406-408, in some embodiments, substance unit(s) are relocated both physically and virtually within a container, possibly simultaneously (e.g., substantially simultaneously). In some embodiments, alternatively or additionally to simultaneous relocation, the substance units can be associated with their new location before and / or after their physical transfer. 'Simultaneously,' as referred to herein (whether regarding insertion, relocation, and / or dispensing of substance units), means that the virtual and physical actions occur within a time frame (optionally a short time frame) of each other, for example, with a delay of no more than half a second, potentially ensuring that both the physical and virtual states are aligned in near real-time. For example, For example, about 0.1-1 seconds, or 0.5-2 seconds, or 0.2-1.5 seconds, or about 1 second, 0.5 second, or lower or higher or intermediate numbers of delay times. It should be noted that this time frame can be extended to any length, provided no events and / or alterations occur between the two actions.
[0344] At 406, one or more substance units are physically transferred between subsections and / or subsections of the container by moving them within the container, while at 408, the locations change of the substance units within the containers are virtually updated, optionally, by recording the current location (e.g., subsection) of each transferred substance unit. In some embodiments, recording the relocation may include recording a first and last subsection of a single relocation sequence, or a plurality or all of the subsections along the substance unit's path from a first to last subsection. This may include one or more time stamps.
[0345] At blocks 410-412, in some embodiments, substance unit(s) are transferred both physically and virtually between containers, optionally simultaneously (e.g., substantially simultaneously). At 406, one or more substance units are physically transferred between a subsection of one container to a subsection of another container, while at 408, the locations change of the substance units between the containers are virtually updated, optionally, by recording the current location (e.g., subsection) of each transferred substance unit.
[0346] In some embodiments, simultaneous transfer of substance unit(s) within a container or between containers may be achieved and / or ensured by dividing the virtual transfer into two steps. First, an intention to relocate a substance unit from one subsection to another (whether within the same container or to a different container) is reported. Then, after confirming the physical transfer of the substance unit, the virtual location update of the substance unit is completed. In some embodiments, the intention, execution, and / or success of physically transferring substance units are directly recorded in the data ledger. Alternatively, or additionally, this information may be recorded locally within the device optionally until it can be synchronized with the system (e.g., system’s main controller and / or data ledger), potentially reducing and / or avoiding the risk for data loss and / or discrepancies in tracking even if real-time communication with the data ledger is unavailable. In some embodiments, if the physical transfer fails, the system recognizes the failure.
[0347] At 414, data regarding the substance unit’s locations' history is collected, (e.g., recording in which container and / or subsection of the container a substance unit was placed at any point in time), optionally for a plurality of substance units. In some embodiments, this data is collected with respect to the substance units and can be used to infer the history of the subsections.
[0348] Alternatively, or additionally, the data can be collected with respect to the subsections (e.g., recording each subsection status (full or empty) and which substance unit occupies the subsections at any point in time. For the purposes of this document, it should be understood that any references to the movement and / or transfer of substance unit(s), whether from one container to another, within a container, and / or out of a container, implicitly include a record of such actions, regardless of whether explicitly stated.
[0349] Exemplary method for collecting and / or transporting substance units
[0350] Referring now to Figures 5A-B, showing a flow-chart 500 of an exemplary method for collecting and / or transporting a plurality of substance units by the substance units management system, according to some embodiments of the invention.
[0351] At 502, one or more substance units and / or a plurality of substance units are collected into one or more containers (e.g., origin containers).
[0352] In some embodiments, the container is homogeneous, e.g., comprises substance units identical by properties and / or history such as substance units (e.g., pills) of the same batch. In some embodiments, the origin container, optionally collected at manufacture, may be customized and comprise more than one type and / or pharmaceutical code of substance unit. In some embodiments, the customized origin container can contain substance units of different types that are taken together such as typical combinations of analgesics and / or a substance unit provided together with a substance unit for treating typical side effects of the first substance unit and / or a substance unit that enhances the beneficial effect of the other. In some embodiments the customized origin container may be group-customized, comprising substance units according to the needs of specific target groups (for example, commonly used medications for diabetics, and / or commonly recommended supplements for pregnant women). The combined origin containers may potentially facilitate the substance unit collection at the distribution sites, for users belonging to the target group. In some embodiments, the customized origin container may be tailored for a specific user (e.g., patient), optionally, collected from production according to the consumption requirements of a specific user, for example as prescribed by a general practitioner, by several prescribers and / or in view of a request of the user, such as for substance unit that does not require subscribing.
[0353] In some embodiments, the one or more containers are tamper-resistant and / or include tamper-evident mechanisms, to potentially reduce and / or prevent tampering of the substance units. In some embodiments, the container incorporates safety seals such as ultrasonic seals (e.g., when using ultrasonic vibrations to join and / or bond materials to create an airtight seal). In some embodiments, once a seal is breached, it can be detected, optionally, by detecting changes in the container’s interior conditions. For example, the container may comprise a humidity sensor which may sense changes in the humidity within the container due to the breach. In another example, the container may comprise a light sensor that can detect changes in light levels within the container.
[0354] In some embodiments, the container may comprise tamper-evident indicators, for example, seals, which are modified and / or damaged if tampered with. For example, in some embodiments, the container comprises breakaway seals that physically break apart when tampered with. In some embodiments, the origin containers’ opening(s) are plugged with a plug that comprises a tamper- evident seal.
[0355] In some embodiments, ultrasound waves may be used to create a unique acoustic signature or 'fingerprint' for the container. In some embodiments, if the seal is disturbed or broken, the ultrasound waves passing through will produce a different signal compared to a reference signal stored in a database (even if the container is reclosed). In some embodiments, the container (and / or a device the container is loaded into) may comprise at least one tamper-evident sensor, configured to detect unauthorized access and / or tampering with the container.
[0356] In some embodiments, the container comprises embedded ultrasound sensors that continuously monitor the structural integrity of the container (e.g., having ultrasound-based seal(s)). If tampered with, the sensors send a signal to the distribution system which alerts one or more of the entities communicating with the system, for example the manufacturer, system operator, user, and / or pharmacist. In some embodiments tamper evidence may potentially prevent a container from being used or at least prompt a user to alert them and / or allow the user to decide.
[0357] At 503, the details of the one or more origin containers are recorded in the system. In some embodiments, the system provides a unique ID to each container.
[0358] At 504, in some embodiments, each collected substance unit is recorded, optionally, with respect to its location within the container (e.g., associated with a subsection accommodating it).
[0359] At 506, the substance units are transported by transporting the one or more origin containers accommodating them. The one or more containers may be transported to storage and / or to the distribution site. In some embodiments, the origin container constitutes the final product provided to an end user (e.g., sent, optionally directly, to the user).
[0360] At 507, in some embodiments, the location and / or status of the container (e.g., upon transporting it) may be recorded. For example, upon transporting the container to an aggregator and / or retailer (e.g., 210), the container may be recorded as transported and / or arrived at an aggregator and / or retailer, and optionally associated with the details of the specific retailer and / or distributor (e.g., 208) responsible for the transportation. In some embodiments, the container is integrated into a device (e.g., distribution device), optionally, constituting a single unit. The device’s location and / or may be recorded, alternatively or additionally to recording the location and / or status of the container.
[0361] At 508, in some embodiments, the one or more origin containers are loaded into a substance unit distribution device (e.g., inserted into and / or mounted on the device). Alternatively, or additionally, the one or more containers are integrated into the device, optionally, provided as a single unit. In some embodiments, the distribution system and / or distribution device first performs an integrity test on the containers to ensure they have not been tampered with. If the container is identified as tampered with, the distribution device rejects (e.g., ejects) the container and the container is recorded accordingly. In some embodiments, the system alerts relevant entities, such as the user, the manufacturer, supplier, and / or pharmacist. Additionally, and / or optionally, the system reports the incident to the authorities.
[0362] At 510, in some embodiments, the method comprises measuring the conditions within the one or more origin containers (e.g., the environment of the substance units within the container). These measurements can be performed at any stage optionally, from the filling of the container, alternatively or additionally, before and / or during the filling of the container. In some embodiments, the one or more origin container comprises at least one sensor, such as a temperature sensor, a humidity sensor and / or a chemical sensor for detecting certain substances, such as contaminations and / or toxins.
[0363] Alternatively, or additionally, an external sensor can be used, such as a temperature sensor that measures the temperature of the container’s walls. In some embodiments, the system performs a periodic monitoring of the environment, alternatively or additionally, the monitoring is continuous. In some embodiments, the measured conditions are compared with the substance units’ recommended storage conditions. Optionally, if the conditions in the substance units’ environment exceed the recommended conditions, the system alerts the relevant entities, such as the user, the supplier and / or manufacturer. For example, the system sends an alert if the temperature and / or humidity in the container (optionally over time) do not correspond to the storage recommendations of the substance unit. In another example, the system sent an alert based on chemical sensor detections. In some embodiments, the presence of a specific chemical, optionally at, above, or below a certain concentration, may indicate contamination in the container and / or contamination, degradation and / or spoilage of the substance units. In another example, the system sends an alert when the presence of dust, powder, or small particles is detected, which may indicate the disintegration of substance units. In some embodiments, the at least one sensor comprises sensor(s) for detecting dust, such as optical particle sensors and dust sensors and / or electrostatic sensors (which detect changes in the electric charge of particles in the air or within a container).
[0364] In some embodiments, a sensor such as an accelerometer may be integrated into the container and / or device to detect actual or potential mechanical damage. This sensor may potentially identify a potential harm to the container, the substance units stored inside, and / or even the device itself by monitoring sudden movements like shocks, vibrations, or impacts. Such movements may indicate that the container or device has been dropped, mishandled, or exposed to damaging conditions. In some embodiments, upon detecting such an event, the accelerometer may trigger a notification within the system, and / or record the container and / or its contents as potentially compromised. Alternatively, or additionally, the accelerometer can detect damage to the container and / or device that could suggest improper operation and / or suspected tampering. In some embodiments, if such an event is detected, the accelerometer can trigger a notification within the system, recording the container, substance units, or device as potentially compromised and / or tampered with.
[0365] At 512, once recorded in the system, each substance unit can be tracked based on its record. Optionally, more than one substance unit can be tracked simultaneously. For example, tracking substance units of a certain type and / or pharmaceutical code for inventory counts, or tracking recalled batches (e.g., the substance units in these batches).
[0366] At 513, the one or more origin containers may be tracked by their records.
[0367] At 514, in some embodiments, at any stage from the sealing of the containers, they can be tested for detecting tampering, for example by examining its tamper-evident seal. For example, after storage, before shipment to a distribution site, and / or before dispensing a substance unit for use.
[0368] Exemplary method for distribution of substance units to end users
[0369] Referring now to Figures 6A-D, showing a flowchart 600 of an exemplary method for distributing one or more substance units by the substance unit management system, according to some embodiments of the invention.
[0370] At 602, a plurality of origin containers is provided, optionally, each comprising a plurality of substance units.
[0371] At 604, in some embodiments, the one or more origin containers are loaded into the substance unit distribution device. Alternatively, or additionally, the origin containers are stored external to the device and are loaded on the device, based on need (if and / or when one or more origin devices are selected for filling a customized container). At 606, in some embodiments, the distribution device performs a test to detect tampering for each container, for example by examining its tamper-evident seal. In some embodiments, the seal is comprised within the container plug(s), so they are examined for tampering before unplugging the device within the distribution system. If the seal is found to be intact, the container may be approved for further processing; however, if any tampering is detected, the container may be rejected by the system. Optionally, the container is quarantined until it is further inspected and / or discarded. In some embodiments, a tampering alert may be sent for example to one or more of the entities communicating with the system, such as the distributor, manufacturer, and / or regulator. In some embodiments, the container is recorded as tampered and / or as suspected of being tampered with. Optionally, the distribution device comprises a controller, configured to automatically document the results of these tampering tests in the data ledger, and / or update the system’s main controller, potentially allowing a transparent record of each container's condition upon arrival and processing.
[0372] At 608, at least one container is received, optionally, designated for use as a customized container. Herein, a customized container refers to a container that is at least partially filled within substance units customized according to a specific end user and / or a target group's needs and / or requests, optionally, the container’s content is personalized (e.g., patient-specific). It should be noted that block 608 and its following are not limited to customized containers and may also apply to containers that do not contain customized contents, including origin and / or non-customized containers (e.g., intended for general use).
[0373] In some embodiments, the container is personal, e.g., associated with a particular user (e.g., end user and / or a caregiver), optionally, regardless of its content (e.g., customized to be used by an authorized user). In some embodiments, this association may include exclusive authorization to use the device. In some embodiments, the at least one customized container is provided by a user (e.g., consumer), and optionally contains previously filled substance units. In some embodiments, one or more new and / or empty containers are provided by the system, optionally, based on a distribution demand. For example, the user provides the distribution demand (e.g., a prescription) and the system provides containers, optionally new containers accordingly. Optionally the customized container is an empty one ready to receive substance units from one or more other containers. Optionally the at least one customized container is provided by a service provider who fills customized containers for specific target audiences, such as specific users and / or members of one or more specific groups that require the same customization.
[0374] In some embodiments, the at least one customized container comprises more than one container, optionally based on the target audience's needs (e.g., target group needs, and / or a specific user’s needs. For example, the distribution device may include a customized container for a consumer to carry around, another customized container for storage, and / or a customized container for substance units that require room temperature storage, as well as another customized container for substance units that need to be refrigerated. In another example, some types and / or pharmaceutical codes of substance units may need to be kept separate from one or more other types and / or pharmaceutical codes of substance units (for any reason) and so will always be provided in separate containers.
[0375] At 610, the at least one customized container is loaded into the distribution device.
[0376] At 612, in some embodiments, whether new or used, the distribution device performs a tampering detection test on the customized container(s). This test can be performed before and / or after loading the customized container into the device.
[0377] At 614, a demand for substance unit distribution is received. In some embodiments, the user may provide a prescription (e.g., a medical prescription) and / or a requirement for over-the-counter substance units (such as over-the-counter drugs and / or food supplements). Alternatively, or additionally, the demand may be provided for example, by a supervisor (e.g., medical supervisor), such as an attending physician and / or a nutritionist.
[0378] At 616, origin containers are selected according to the distribution demand and / or according to their record in the system. In some embodiments, the selection is first based on identifying one or more origin containers that contain the required substance units (e.g., of a specific type, pharmaceutical code, brand, and / or dose). Subsequently, in some embodiments, selection of the suitable containers is made based on the expiration dates of their substance units. For example, the selected origin container may contain substance units with the earliest expiration date, alternatively or additionally, with an expiration date that does not occur before the end of the treatment and / or consumption plan. In some embodiments, the selected origin container(s) are homogeneous, such that each selected container contains substance units of the same type and / or pharmaceutical code, which are different from the substance units within other selected homogeneous origin containers. Alternatively, or additionally, the select origin container(s) may be heterogeneous, for example, group intended containers, which comprise several types and / or pharmaceutical codes of substance units, usually consumed by a specific group. For example, as previously described in blocks 402- 404 of flowchart 400. The heterogeneous may comprise more than one of the required substance units, and potentially reduce the number of required origin containers. This has the potential advantage of simplifying and / or shortening the distribution process.
[0379] At 618, in some embodiments, one or more substances from the selected containers are selected. In some embodiments, the selection comprises selecting the number of substance units (of each type and / or specific substance units) according to the required quantity. This quantification potentially reduces and / or avoids providing an excess amount of substance units (such as medication), as is the case with conventional / standard packages, having the potential advantage of reducing and / or avoiding waste of substance units as well as over use of the excess substance units (mistakenly and / or purposefully). In some embodiments, if the origin container(s) are heterogeneous by type and / or pharmaceutical code and the selection comprises selecting the suitable (e.g., required) substance unit(s). Alternatively, or additionally, the origin container(s) may be heterogeneous by expiration date, and the selection may comprise the substance unit with suitable and / or nearest and / or latest date. For example, selecting substance units with an expiration date that extends beyond the end of the treatment (e.g., use / consumption program) and / or meets any other shelf life requirement.
[0380] In some embodiments, the selecting comprises authenticating the substance unit.
[0381] In some embodiments, the authenticating includes identifying that the substance unit is recorded to be a controlled and / or verified product of an authorized manufacturer.
[0382] The authenticating may include verifying that a selected substance unit is not recorded as prohibited for use, such as an expired, recalled, and / or contaminated substance unit. In another example, substance units transferred and / or dispensed for disposal are authenticated as prohibited or intended for disposal.
[0383] In some embodiments, locations within the customized container(s) for placing the selected substance units are selected. In some embodiments, the selection comprises selecting a customized container if there is more than one. For example, a substance unit(s) that requires refrigeration is allocated to a refrigerated container. In another example, a substance unit for daily consumption is allocated to a container carried by the consumer.
[0384] In some embodiments, the selection comprises allocating each substance unit within a specific subsection of a container. The allocation may be based on the required order of egress for the substance units. Alternatively, or additionally, substance units are allocated to subsections that previously accommodated units of the same type and / or pharmaceutical code.
[0385] At 622, the origin containers are positioned with respect to a customized container such that they are in communication with each other potentially allowing substance units to transfer therebetween. In some embodiments, this positioning is performed by a human operator, alternatively or additionally by a robotic mechanism or automated system.
[0386] In some embodiments, optionally, once it is confirmed that the containers have not been tampered with, the containers are unsealed (e.g., unplugged) to expose the required openings thereof. The origin container is then positioned so that an opening thereof is adjacent to and / or aligns with an opening of the customized container, allowing the transfer of substance units between the containers (such that a substance unit ejected from the origin container can enter the customized container). In some embodiments, an adaptor and / or connector may be used for connecting both openings to potentially allow controlled transfer between the containers. In some embodiments, the adaptor and / or connector allow for substance unit exchange only between the origin and the customized container. In some embodiments, the time a substance unit spends within the adaptor and / or connector is controlled and / or known for potentially allowing a controlled and / or synchronized physical and / or virtual transfer. Optionally, this controlled transfer may be achieved by an adaptor and / or connector that is relatively small, such that the time that the substance unit spends therewithin is relatively small and / or known according to the distance. For example, the adaptor and / or connector is designed such that the distance between the openings does not exceed about 5 cm. For example, about 1-5 cm, or 2-10 cm, or 5-20 cm, or about 1 cm, or about 5.5 cm, or lower or higher or intermediate numbers of distances. In some embodiments, the adaptor and / or connector comprises a detection mechanism capable of identifying the substance unit as it passes through. This may include sensors that detect the presence of the unit and / or identify its shape and / or unique ID (for example, in cases where the ID is embedded in the unit itself. This embedded ID could be in the form of a barcode, RFID chip, and / o or another type of identifier that allows for automatic recognition of the substance unit.
[0387] In some embodiments, the customized container comprises more than one opening, potentially allowing to connect more than one origin container at the same time and potentially, to transfer substance units from more than one origin container simultaneously and / or in quick succession, with no need to reposition the openings. In some embodiments, the number of origin containers that can be connected to the customized container at the same time corresponds to the number of openings in the customized container. In some embodiments, the origin containers are positioned to surround the customized container.
[0388] At 624, one or more selected substance units are transferred from their origin container(s) and into the customized container. In some embodiments, the transfer includes moving the substance unit within its origin container until it emerges out from the origin container and into the customized container. In some embodiments, the substance unit is then moved within the customized container to reach its allocated location. In some embodiments, the customized container is empty before the transfer. In other embodiments, the customized container is partially full. In some embodiments, the customized container is full and is emptied or partially emptied (possibly into another container) before receiving a new substance unit. At 626, in some embodiments, the substance units within the origin container are rearranged (moved), optionally, for allowing the movement and / or egress of the selected substance units.
[0389] At 628, in some embodiments, the substance units are rearranged (moved) within the customized container, optionally, to allow the entrance and / or position of the selected substance units. Alternatively, or additionally, the substance unit within the containers may be rearranged to be ordered according to a current consumption program.
[0390] At 630, in some embodiments, one or more substance units may be replaced with other substance units, whether identical, similar, and / or different. For example, if the substance unit(s) are recalled and / or expired can be replaced with other matching substance units that have not been recalled and / or have longer expiration dates. In another example, a use demand (e.g., a prescription) may be changed, for example by a medical supervisor, before all the substance units are used (e.g., consume). These substance units may be replaced with the newly required substance units. In some embodiments, the customized container is loaded full and / or partially full into the distribution device, such that unrequired substance units are replaced with required ones.
[0391] At 623, in some embodiments, unneeded and / or inadequate-for-use substance units are removed from the customized container without being replaced. In some embodiments, the removed substance units (from blocks 630 and / or 623) are disposed of, for example, if they are recalled, expired, or suspected of being contaminated and / or spoiled. In some embodiments, unneeded (but adequate) substance units can be transferred to another container, such as an origin container, a customized container of another user who needs the substance units, and / or another customized container of the same user. For example, a substance unit that no longer needs to be consumed frequently or the use of which is temporarily ceased can be transferred from a customized container carried by the user to a customized container that is stored. Another example is an expensive and / or rare drug that can be moved from a customized container of a patient who no longer needs it (e.g., cured) to a customized container of a patient who does need it. Alternatively, or additionally the substance unit may be transferred into an origin container to be made available for purchase again.
[0392] At 634, in some embodiments, the origin containers are replaced with other origin containers that contain required / selected substance units (e.g., by a human operator and / or a robotic mechanism).
[0393] In some embodiments, alternatively or additionally to the configuration where origin containers are positioned to surround the customized container, the origin container may form another hive configuration, optionally comprising all the selected containers, as schematically shown for example in Figure 19B. The hive configuration potentially reduces and / or avoids the need for replacing origin containers.
[0394] In some embodiments, the origin containers comprise more than one opening, allowing a substance unit from another container to pass therethrough and optionally reach the customized container. In some embodiments, the hive may include more than one customized container, that optionally can be filed at the same time.
[0395] At 636, the origin containers are distanced from the customized container(s) and / or optionally, from each other.
[0396] At 638, once filed (and / or partially filed), the customized container(s) are sealed, optionally, with a tamper-evident seal. In some embodiments, the opening(s) of the customized container is resealed (e.g., replugged), where each plug comprises a new tamper-evident seal.
[0397] At 640, in some embodiments, the origin containers are sealed as well and / or optionally, removed from the distribution system. In other embodiments, the origin containers remain within the distribution system.
[0398] At 642, optionally, the customized container is unloaded from the distribution device.
[0399] At 644, the customized container(s) is provided to the end user (e.g., consumer), optionally having substance unit content that is tailored (e.g., personalized) by their properties and / or amount to the specific end user. In some embodiments, the customized container(s) are integrated into the device, optionally provided to the user as a single unit.
[0400] In some embodiments, the customized container is homogeneous (e.g., contains identical units). In some embodiments, the quantity of the identical substance units is customized to a specific user (e.g., customer), to a target group, and / or to personal consumption in general. Alternatively, or additionally, the user may be provided with homogeneous containers (e.g., collected at the manufacturer).
[0401] It is to be noted that throughout all the processes described in flowchart 600, each substance unit transfer between subsections of the same container and / or between containers is recorded (by the system’s data ledger). Additionally, in some embodiments, the subsection's history of each substance unit is recorded, and / or the substance unit’s history of each subsection.
[0402] At 648, at any point in time throughout the flowchart, a specific substance unit may be tracked based on its record.
[0403] At 650, data regarding the substance units' distribution is collected, for example, for learning about the consumption habits of end users and / or the recommendation of the medical supervisors. At 652, in some embodiments, one or more containers can be tracked, whether it’s a customized and / or origin container, provided to the user and / or still in the possession of the retailer, distributor, and / or manufacturer. It is to be noted that the tracking can be performed at any stage and / or point in time from the insertion of a container into the system.
[0404] In some embodiments, system devices (e.g., distribution devices and / or dispensing devices), whether integrated with the container and / or separable from it, may be registered in the system and optionally, any change in its location, status, and / or owner is recorded. In some embodiments, the device can be tracked based on this record. Alternatively, or additionally, the device may comprise sensors such as GPS, RFID, or biometric sensors that potentially facilitate real-time tracking. Tracking the system devices may reduce and / or avoid the risk of unauthorized use, theft, and / or misplacement. In some embodiments, a container can be tracked and / or traced based on the records thereof. Alternatively, or additionally, the container may comprise a tracking component, such as a barcode, RFID tag, GPS module, or other identification and tracking technology that allows for monitoring its location and status throughout the supply chain.
[0405] In some embodiments, tracking the location of devices(s) and / or container(s) can be part of the authentication process. In some embodiments, an authorized agent can only use a device assigned to them, and / or only within an approved facility or other geolocation. For example, a manufacturer may be restricted to using a device exclusively within their factory premises, optionally within a designated area optionally, cordoned off within the facility grounds. In another example, retailers may be allowed to use their devices and / or containers only within a defined sales area, such as a pharmacy and / or store and / or jurisdiction. Optionally, a specific retailer may be allowed to use the devices and / or containers only within their registered premises (e.g., a specific pharmacy and / or store). In some embodiments, the authorized agents are allowed to use containers that are assigned to them and / or to input or remove substance units for which they have been authorized. Geofencing may be applied to any approved facility, and optionally the boundaries can be recorded in the data ledger to potentially ensure that devices, containers, and / or substance units are only accessed and / or used within these predefined areas. In some embodiments, if a device, container, and / or substance unit moves and / or is operated outside the recorded boundaries, the system can trigger alerts, restrict access, and / or prevent further actions. In some embodiments, the geofencing data is continuously monitored and logged, potentially providing real-time tracking and / or a detailed record of any compliance and / or breach of location-based security protocols. In some embodiments a person and / or entity is authorized to use or manipulate containers, devices and / or specific types of substance units in a limited geolocation, for example based on jurisdiction, such as a doctor, nurse of pharmacist limited by their licenses. Exemplary methods for end users to use the substance units management system
[0406] Referring now to Figure 7, showing a flowchart 700 of an exemplary method for an end user using the substance units distribution device, according to some embodiments of the invention.
[0407] At 702, a demand for substance unit(s) is provided to the system, optionally, inserted into a substance units distribution system, alternatively or additionally, provided to a system's operator, such as a pharmacist (e.g., aggregator and retailer 210).
[0408] In some embodiments, the demand is provided by the user, optionally, at the distribution site. Alternatively, or additionally the demand can be provided remotely, for example via an online portal, an email, and / or a mobile application. In some embodiments, the demand may be provided by a physician of the end user (e.g., supervisor 214). For example, in some embodiments, an attending physician can load prescription(s) into the system. In some embodiments, the demand is based on a user’s medical prescription. Alternatively, or additionally, the demand includes over- the-counter substances such as over-the-counter drugs and / or food additives, optionally, selected by the end user.
[0409] At 704, at least one customized container is provided. In some embodiments, a customized container(s), optionally a new container, is provided by the system and / or by a system operator. Alternatively, or additionally, at least one customized container is provided by the user, for example, for refilling it, and / or for removing and / or replacing substance units within it. In some embodiments, a new container is provided even if a refill is required, having the potential advantage of reducing and / or avoiding the risk of contaminating the distribution device. Optionally, the refill can be performed later by the user, using a customized device (e.g., a dispensing device).
[0410] In some embodiments, the customized container is provided by the user to the system’s operator, optionally, at a distribution site. In other embodiments, the user is loading the customized container(s) into a distribution device.
[0411] In some embodiments, the user provides the customized container(s) loaded within the dispensing device. Optionally, the user connects the dispensing device to the distribution device, such that the dispensing device can participate in the process of transferring the substance units.
[0412] In some embodiments, the at least one customized container may be provided from one agent to another, for example, from one manufacturer to another manufacturer and / or from one aggregator / retailer to another aggregator / retailer. For example, in some embodiments, the at least one customized container may be first loaded with substance units by a first retailer (e.g., a first pharmacy), then be delivered to a second retailer (e.g., a second pharmacy) for further filing the container. In another example, the at least one customized container may be first loaded with substance units by a retailer and then be delivered to a manufacturer for further filing the container, for example, in cases where there are shortages in the market.
[0413] At 706, the at least one customized container, comprising substance units according to the provided demand, is received by the user, optionally at the distribution site. In some embodiments, the least one customized container is sent to the user, for example, if the demand has been provided remotely (e.g., online). In some embodiments, the user receives back the dispensing device, loaded with the at least one customized container.
[0414] Referring now to Figure 8, showing flowchart 800 of an exemplary method for an end user using the dispensing device, according to some embodiments of the invention.
[0415] It is to be noted that the method of flowchart 800 may be performed by an individual end user (e.g., consumer and / or patient) and / or by a caregiver (such as a nurse). In some embodiments, the use can be employed at a care facility (e.g., hospital) and / or privately by the user (e.g., at home).
[0416] At 802, optionally, once provided, the one or more customized containers can be stored by the user until use. For example, a container may include medication for a trip, so once provided, the container is stored until the trip, and throughout the trip as long as the substance units within it are not needed. Optionally a plurality of containers are purchased simultaneously and used in sequence, with some of them being sorted for later use.
[0417] At 804, the one or more customized containers are loaded into a dispensing device.
[0418] At 806, in some embodiments, before using the dispensing device, the user may be identified by the devices / system. In some embodiments, the user may be required to enter a personal identification number (PIN) or password to unlock the device. Optionally, the device may be paired with a smartphone application where the user logs in, and the app communicates with the dispensing device to authenticate the user. Alternatively, or additionally, other identification methods can be implemented, for example, one or more of biometric identification (fingerprint scanning, facial recognition, or iris scanning to authenticate the user based on unique biological characteristics), and / or voice recognition (where the user verifies their identity through a voice command or phrase).
[0419] At 808, optionally, the dispensing device may be used (by the user) for transferring substance units between containers. For example, in some embodiments, if a refill is required, a container with supplementary substance units may be provided. The user can then transfer the substance units to the dispensing container, which may also hold the remaining / other substance units the user needs. In another example, if it becomes necessary to start consuming substance units stored in a container designated for storage (e.g., storing also other substance units), the required units can be transferred to the container used for dispensing to the user.
[0420] At 810, in some embodiments, the user provides the device an input instructing the device to deliver at least one substance unit. In some embodiments, the user may provide a use (e.g., consumption) program that may comprise one or more of the frequency of use, hours of use, period of use, specific substance units for use, and / or the substance units' order of use. In some embodiments, the use demand is determined by the user, alternatively or additionally, by another agent communicating with the system such as a medical supervisor. For example, in some embodiments, the user may provide use / consumption instructions according to the prescription of its attending physician and / or use / consumption instructions from the manufacturer.
[0421] Alternatively, or additionally, the user’s input may include instruction for an immediate dispensing of a substance unit. For example, the user enters a request for an analgesic upon feeling pain, such as a headache.
[0422] At 812, in some embodiments, the user may receive remainders from the device and / or the system for using substance unit(s), optionally, according to the consumption program schedule.
[0423] In some embodiments, the device / system prompts the user to adhere to the consumption program by sending notifications or alerts when it's time to take the next dose. These prompts may be delivered through various means, such as audible alarms, visual notifications on the device, or push notifications sent to a paired smartphone application. Additionally, the system may provide reminders for upcoming doses, track missed doses, and offer suggestions for rescheduling consumption if necessary.
[0424] At 814, the user receives at least one substance unit from the dispensing device. In some embodiments, the user is authenticated prior to and / or upon the substance unit egress. In some embodiments, alternatively and / or additionally to the identification methods described in block 806, the user may be authenticated based on the acoustic characteristics of the user's oral cavity, and optionally by coupling the period of substance units dispensing to the period in which appropriate acoustic characteristics are measured. In some embodiments, the dispensing device comprises an authenticating mouthpiece. In some embodiments, the user is prompted to place the mouthpiece within the user's oral cavity. In some embodiments, the mouthpiece is configured to dispense the substance unit(s) therethrough, once the user is recognized / identified as the authorized consumer / device’s user. This “system-to-mouth” approach potentially reduces the risk of the substance unit(s) being consumed by an unauthorized consumer. Exemplary methods for providing substance units to end users
[0425] Referring now to Figures 9A-C, showing a flowchart 900 of an exemplary method for dispensing substance units device, according to some embodiments of the invention.
[0426] At 902, the dispensing device receives at least one customized container, optionally loaded by the user, loaded by the manufacturer and / or aggregator / retailer, and provided to the user pre- loaded.
[0427] At 904, a tampering detection test is performed on the customized containers, by the dispensing device, essentially as described for the origin containers. In some embodiments, if the container is identified as tampered with, the dispensing device (e.g., the system) rejects (optionally ejects) the container, and the container is recorded accordingly. In some embodiments, the system alerts relevant agents, such as the user, and / or system’s operator. Additionally, and / or optionally, the system automatically reports the incident to the authorities. If the container is confirmed to be intact, the dispensing device may unplug the at least one customized container’s openings.
[0428] At 906, delivery demands are received by the device / system (e.g., consumption program), optionally, provided by the user, alternatively or additionally by another agent (as a medical supervisor, for example, as described in block 810 of flowchart 800.
[0429] At 908, in some embodiments, the system sends reminders to the user to consume at least one substance unit, optionally via the dispensing device, alternatively or additionally, via one or more other external means, such as the patient's smartphone and / or smartwatch or any other user interface, for example, as described in block 812 of flowchart 800. External communication with the user potentially allows reaching the user(s), allows for reaching them even when they are far from the dispensing device, having the potential advantage of improving adherence to the consumption program.
[0430] At 910, in some embodiments, the system may receive input from the user, optionally, via the dispensing device, alternatively or additionally through other external means of communicating with the system. In some embodiments, the input may include a demand for consumption, for example as described in block 810 of flowchart 800.
[0431] At 912, the system determines whether to dispense one or more substance units, optionally based on predefined criteria such as the user’s consumption schedule, medication adherence, and / or a request from the user. In some embodiments, the system may also consider factors such as the expiration date of the substance units, updates to the user’s treatment plan, the risk of overconsumption, and / or the possibility of mixing incompatible substance units by the user. For example, the system may determine whether to comply with the user’s requirements based on whether the substance unit is safe to dispense at the requested time, potentially ensuring that the user does not exceed recommended doses, combine incompatible medications, and / or consume expired or recalled substance units. If the decision is negative, the system sends a notification to the user, providing the reason for the denial of the substance unit(s) dispensing. If the decision is positive, the system proceeds with dispensing the appropriate substance units and may notify the user that and / or when the substance units are ready for consumption.
[0432] At 914, in some embodiments, the substance unit dispensing is subject to authenticating the user as the authorized user. In some embodiments, the system recognizes the user based on one or more of the methods described, for example, in blocks 806 and / or 814 of flowchart 800. In some embodiments, this recognition is performed via the dispensing device, alternatively or additionally, through external devices such as the user's smartphone, smartwatch, or biometric authentication systems.
[0433] At 916, a specific substance unit is selected, within a specific subsection of the container(s). The selection complies with the consumption demand, e.g., based on the consumption program and / or user input. In some embodiments, the selection comprises selecting the substance unit with the closest expiration date among the substance units that meet the consumption demand. In some embodiments, the selection takes into account the storage conditions of the substance units optionally, from the moment they entered the system until the moment of selection. In some embodiments, the system may select a substance unit that has been stored under less optimal conditions for optionally consuming it before it degrades, possibly ahead of consuming a similar substance unit having a further expiry date and / or stored under more suitable conditions. Alternatively, or additionally, the system can employ a first in, first out (FIFO) method to potentially reduce and / or avoid prolonged retention of substance unit(s) within the container, thereby potentially improving the regular turnover of substance units and / or potentially maintaining the viability and / or freshness of the substance units. In some embodiments, the selection may prioritize the substance unit in a more accessible location for dispensing, among those that comply with the consumption demand. In some embodiments, the device may select substance elements such that minimal motion of substance elements is attempted. This may potentially reduce the hazard of wear and / or tear of substance elements and / or conserve power. In some embodiments, the selection considers additional substance units that should be dispensed, optionally, prioritizing a substance unit that can potentially expedite and / or simplify the egress of other units, either individually, in sequence, or as a group.
[0434] At 918, in some embodiments, substance units within the container may be relocated (transferred from one to another subsection within the container) once or more, optionally, to allow the egress of selected substance unit(s). At 920, in some embodiments, the substance units may be transferred between customized containers, optionally, for dispensing the substance units to the user. For example, a substance unit may be moved from a storage container to a portable container for easier access and / or for the sake of convenience during travel. Alternatively, a unit may be transferred from a refrigerated container to a non-refrigerated container if it no longer requires cold storage and / or if the consumption thereof is imminent. In some embodiments, the transfer (within and / or between containers) may also occur to ensure proper organization of the units based on the user's consumption program and / or storage preferences.
[0435] At 922, at least one substance unit (e.g., the selected substance unit(s)) is dispensed out of the container, and / or out of the dispensing device, to the user. In some embodiments, the dispensing device's opening(s) includes a tamper-evident mechanism to potentially ensure that the containers remain untampered when unplugged within the dispensing device. For example, the tamper-evident mechanism may include sensor(s) that alert the system and / or user if an entry of a substance and / or an object through the opening(s) of the device has been detected. In another example, the tamper- evident mechanism may allow only unidirectional exit of substance units.
[0436] In some embodiments, more than one substance unit is dispensed from the device in a single dispensing event, optionally one by one. In some embodiments, a plurality of substance units may be dispensed as a group, optionally exiting the container and / or the device one by one. In some embodiments, the substance elements are dispensed initially into a secondary container or chamber associated with the customized and / or origin container and delivered to the user from the secondary container or chamber. In some embodiments, as long as the substance units are within the secondary container and / or chamber they may be returned to the container from which they were dispensed and the process added to the record.
[0437] At 924, in some embodiments, the substance unit is recorded by the system as consumed (if it was consumed). In some embodiments, this consumption may be verified through sensors (as described for example in block 814 of flowchart 800), image processing (e.g., using a camera and / or image processing capability to confirm ingestion), and / or user confirmation. The system may also track and / or record the time and conditions of the consumption for compliance monitoring.
[0438] At 926, in some embodiments, at any point in time, throughout the flowchart, one or more specific substance units may be tracked based on the record thereof. This record may be used, for example, to trace recalled and / or expired substance units in the possession of users. In another example, substance units may be tracked for the purpose of transferring them between users, such as transferring an expensive and / or rare drug from a recovering and / or deceased user to another user. Additionally, or alternatively, substance unit(s) may be tracked to evaluate user(s) compliance with a consumption program and / or to analyze user(s) consumption habits. In some embodiments, tracking is used in managing a supply chain and potentially redirecting substance units according to the need in view of demands received and / or tracking of inventory at multiple levels.
[0439] At 928, in some embodiments, data can be collected optionally, with respect to other substance units and / or users. For example, this data may include information such as usage patterns, environmental conditions, user preferences, and / or compliance with prescribed consumption schedules, for a specific user. Alternatively, or additionally, the system may gather data on consumption groups such as users with a certain common disease, children, pregnant women, athletes, and / or other people under a diet and exercise regime, in different types of sports and / or weights. Optionally, user feedback is collected including data such as side effects, efficacy, and more.
[0440] At 930, in some embodiments, the container(s) within the dispensing device may be removed from the device and / or replaced with one or more other customized containers. In other embodiments, the container(s) is integrated into the dispensing device, so the whole containerdevice unit may be replaced. In some embodiments, the container may be refilled directly within the device without needing to physically replace the container.
[0441] At 932, in some embodiments, a container is sealed before its removal from the device. In some embodiments, the seal comprises a tamper-evident seal, for example, as described herein.
[0442] Monitoring the conditions of the substance units within the system
[0443] In some embodiments, the substance units management system comprises one or more sensors for monitoring environmental conditions within the containers (e.g., origin and / or customized containers). In some embodiments, the one or more sensors are located within the system’s devices (e.g., distribution device and / or dispensing device). Alternatively, or additionally, the one or more sensors may be integrated within the containers, having the potential advantage of allowing the monitoring of conditions therein, even when the containers are not loaded into a device, for example, when stored and / or transported.
[0444] In some embodiments, the one or more sensors include temperature, humidity, and / or light sensors. Additionally, or alternatively, the system may utilize one or more chemical sensors, designed to detect specific chemicals that indicate spoilage and / or contamination of substance units. These chemical sensors can be specially tailored to the type and / or components of substance units in a homogeneous container, where the components and their degradation products are known. In some embodiments, the at least one sensor comprises a sensor for detecting dust, powder, or small particles within the container, which may indicate the disintegration of substance units. For example, may detect the presence of small particles through light scattering techniques, where changes in light patterns indicate particle size and concentration. In another example, electrostatic sensors may detect changes in the electric charge of particles in the air or within a container. In some embodiments, if the monitoring findings are not within acceptable limits, such as not complying with the manufacturer's storage instructions for one or more of the substance units within the container, the container and / or substance units are recorded as such by the system. In some embodiments, the system alerts one or more of the agents communicating therewith.
[0445] In some embodiments, the shelf life (e.g., expiration date) of the substance units is updated based on the storage conditions thereof; if the conditions are maintained as per the manufacturer's guidelines, the expiration could be extended and / or not shortened. Conversely, if not stored according to instructions, the expiration could decrease, or the substance might even be categorized (e.g., recorded) as unusable.
[0446] In some embodiments, the substance units are sealed within the containers, and / or the conditions within the containers are monitored and / or controlled such that as long as a unit substance has not been delivered to a user (e.g., dispensed out of a container and / or dispensing device), it is considered 'unopened,' optionally, even if transferred between containers. This potentially reduces and / or prevents changes in required storage conditions, such as the need for refrigeration after opening, or alterations in the expiration date, for example, shortening the expiration date after opening.
[0447] In some embodiments, the container is configured to isolate the substance from the environment. For example, the container may feature light-blocking materials to prevent exposure to UV or visible light, which potentially reduces and / or avoids the degradation of light-sensitive substances. Alternatively, or additionally, the container may be equipped with moisture-resistant properties to potentially protect hygroscopic materials that absorb humidity. It may also incorporate heat-insulating layers to maintain a stable internal temperature, potentially reducing and / or preventing heat-induced degradation of the substance units.
[0448] Exemplary methods for measuring the substance units’ conditions
[0449] Referring now to Figure 10, showing a flowchart 1000 of an exemplary method for monitoring the conditions within the system’s containers, according to some embodiments of the invention.
[0450] At 1002, in some embodiments, the conditions (e.g., environment) within origin containers may be monitored (e.g., measured) while the containers are stored. This monitoring potentially allows for the detection of deviations from the recommended storage conditions of the stored substance units. In some embodiments, upon detection of a deviation from the recommended storage conditions, the system may issue an alert, for example to the manufacturer and / or regulator. In some embodiments, the affected substance units may be sent for testing to assess their integrity. Optionally, based on the results, the expiry date may be adjusted, the units may be cleared for continued use optionally with the original expiry date, and / or they may be discarded if found unsuitable for further use. In some embodiments, a substance unit may be repurposed based on the testing. For example, exposure to extreme conditions may reduce the percentage of the active ingredient in the unit (for example, as may happen with vitamins), and the records of the units will be updated accordingly. In some cases, the target audience for the substance units may also be adjusted, such as adjusting from human use to pet use. In some embodiments, the effect of the conditions is estimated without testing, such as based on prior research data.
[0451] In some embodiments, an origin container is heterogeneous, and the recommended storage conditions are identical for all units. In other embodiments, the container is heterogeneous, and the storage conditions are selected according to the most stringent requirement. For example, refrigeration is required if only some of the substance units demand it. In some embodiments, the system may avoid placing substance units with conflicting storage requirements in the same container. For example, substance units requiring refrigeration would not be stored with substance units that cannot tolerate refrigeration. In some embodiments, storing substance units in conditions that are more stringent than normally required may lead to extending the shelf life of those substance units in the system.
[0452] At 1004, in some embodiments, the conditions (e.g., environment) within origin containers may be monitored (e.g., measured) while the containers are transported. This monitoring allows the detection of any deviations from the recommended conditions during transportation.
[0453] In some embodiments, upon detection of a deviation from the recommended storage conditions, the system may issue an alert for example to the distributor, potential aggregator and / or retailer, and / or the regulator.
[0454] At 1006, in some embodiments, the conditions (e.g., environment) within origin containers may be monitored (e.g., measured) while the containers are located at a distribution site (e.g., positioned by an aggregator and / or retailer). Optionally, stored, alternatively or additionally, loaded into a distribution device. In some embodiments, upon detection of a deviation from the recommended storage conditions, the system may issue an alert for example to the aggregator and / or retailer, potential users (e.g., potential buyers), and / or the regulator. At 1008, in some embodiments, the conditions (e.g., environment) within containers may be monitored (e.g., measured). Optionally, while the containers are stored by an end user, alternatively or additionally, loaded into a dispensing device.
[0455] In some embodiments, upon detection of a deviation from the recommended storage conditions, the system may issue an alert, for example to the user, the user’s supervisor, and / or the regulator.
[0456] At 1010, in some embodiment, optionally, the measurement findings are considered in the substance unit management, (optionally, in any point and / or stage of the substance unit’s path). For example, exposure to non-suitable storage conditions may cause the system to record the substance unit as unsuitable for use, and as a result, it will not be selected for further use. In some embodiments, the substance unit may be entered into a quarantine status at its current location (e.g., subsection), and / or the system may instruct that it be disposed of and / or returned through the supply chain for disposal. In some cases, the system may direct that the unit undergoes testing to assess the damage caused by the environmental conditions update its record accordingly, and / or determine whether it can still be used.
[0457] Exemplary substance units aggregation method
[0458] In some embodiments, the substance units are collected into a plurality of containers (e.g., origin containers), optionally at a manufactory facility, and each substance unit is registered in the system, and from that point onward, it is tracked. In some embodiments, the containers (e.g., empty of substance units) are physically identical (and / or substantially identical), e.g., identical in size, and / or shape. Optionally, the containers may be identical in their internal organization, e.g., identical in size, shape, quantity, and / or organization of their subsections. In some embodiments, the substance units, even of different types and / or pharmaceutical codes, are identical in appearance (e.g., having the same size, shape, and / or form factor), having the potential advantage of simplifying the process of loading them into the containers and / or managing them throughout distribution. In some embodiments, each container comprises the same number of substance units. In some embodiments, each container is also registered in the system, and from that point onward, it is tracked.
[0459] Then, in some embodiments, the containers are organized into packages, where optionally, each package comprises a constant number of containers. For example, each package may comprise about 100 containers. For example, about 50-100 containers, or 10-150 containers, or 100-1000 containers, or about 100 containers, or about 150 containers, or lower or higher or intermediate numbers of containers. In some embodiments, each package is also registered in the system, and from that point onward, it is tracked.
[0460] In some embodiments, the location of each container, e.g., the specific package it is placed in, is recorded by tracking the container as it is loaded into the package and optionally associating their record accordingly. This tracking can be done, for example, by monitoring the container as it moves along a conveyor belt toward the packaging area or by scanning the container upon its entry into the package.
[0461] In some embodiments, the packages are organized into pallets, where optionally, each pallet comprises a constant number of packages. For example, each pallet may comprise about 100 packages. For example, about 50-100 packages, or 10-150 packages, or 100-12 1000 packages, or about 100 packages, or about 150 packages, or lower or higher or intermediate numbers of packages.
[0462] In some embodiments, each pallet is also registered in the system, and from that point onward, it is tracked. In some embodiments, the pallets can be tracked by using RFID tags that store their location data and update it at various checkpoints within the supply chain, or by GPS tracking if the pallets are being transported over long distances.
[0463] In some embodiments, this method allows locating a specific substance unit at various levels of packaging, whether it's within a container, a package, and / or a pallet and / or in which specific container, package, and / or pallet is it. Since the location at each level can be identified, the specific location of a specific substance unit (optionally, a conventional, non-smart substance unit) can also be determined.
[0464] In some embodiments, the origin containers (e.g., empty of substance units) are physically identical to the customized container. This identity potentially allows the use of origin container(s) by the end users and / or to use of customized containers for the initial entry of units into the system, e.g., for collecting substance units at the manufacturer facility.
[0465] In some embodiments, correspondingly, the distribution device and dispensing device may be the same device (which can be referred to as a substance unit managing device). Alternatively, or additionally, the devices may be identical and / or similar, at least by their hardware. The identity or similarity of the devices and containers potentially allows any device to be used with any container, or for devices and containers to be easily connected to create a hive system.
[0466] Exemplary substance units management system and the devices thereof Referring now to Figure 11A, showing a schematic exploded view of an exemplary substance units managing device 1700 loaded with a container 70, according to some embodiments of the invention.
[0467] In some embodiments, the substance units managing device and / or container is for example as described in Provisional Patent application having a docket number of 101581, filed on the same day as this document and by the same applicant, and the contents of which are hereby incorporated by reference. The substance unit managing device can be for example active container rig and / or substance unit distribution device, and / or a container may be for example an active container as described in 101581.
[0468] It should be understood that the specific provision and arrangement of modules in a substance unit managing device 1700 is variable according to the functionality implemented. As a class, substance units managing device 1700 are identified by the presence of one or more containers 70 (e.g., characterized as next described) for substance units 101, along with one or more attached components which provide and / or shape the functionality of the container 70; for example, by providing motive force for inserting, ejecting, arranging and / or rearranging the substance units 101 stored by of the container(s) 70; control of these activities and tracking their effects by “data twinning”; and sensing, such as sensing used in verification of substance units 101, and / or in authentication / authorization services.
[0469] In the illustrated example of Figure 11 A, substance units managing device 1700 is implemented with a modular design. Modular components of substance units managing device 1700 include container 70, controller 60, auxiliary controller 80, and transfer interface 50. Modular design is not an absolute requirement of an substance units managing device 1700. However, in some embodiments, modularity can be a preferred approach to implementation because of the expectation that containers 70 will provide mobile protective packaging within a distribution system for substance units 101. A given container 70 will potentially be reconfigured for use in several different substance units managing device 1700 over the course of its service lifetime.
[0470] For example, a container 70 may be part of substance units managing device 1700 defined at a pharmacy facility where it receives pills of one or more types and / or pharmaceutical codes defined by a patient’s active prescriptions. The container 70 is then received by the patient, who uses the container 70 in a different substance units managing device 1700 suited, e.g., to organizing the pills into groups according to time of dose consumption, providing reminders, and / or monitoring compliance. Conversely, it is anticipated that a same container 70 will potentially experience repeated turnover in its substance units 101 contents over the course of that service lifetime; e.g., at least transitory storage of a number of substance units 101 which is up to at least five, ten, fifty, a hundred, or more times its volumetric storage capacity for substance units 101. While the same container 70 may be used in this cycle for several iterations with the same patient and pharmacy, the contents of a container 70 are optionally exchanged (wholly or partially) into a new container 70 at any appropriate juncture, with the records of the identities of the contents being also updated appropriately.
[0471] Exemplary movement mechanism
[0472] Referring now to Figure 11B, showing a schematic exploded view of an exemplary substance units managing device 1700 having magnetic field-generating coils 2281, according to some embodiments of the invention.
[0473] Also referring to Figure 11C, showing a schematic illustration of exemplary magnetic field-generating coils 2281, according to some embodiments of the invention
[0474] Figures 11B-C, shows an exemplary movement mechanism of substance units managing device 1700, in the form of magnetic field-generating coils 2281. In some embodiments, the activation of magnetic field-generating coils 2281 moves a actuator 200 to move a substance unit 101 along a storage track of a container 70. Lid 71, upper part 74A and floor 74B of an insert, and base 75 are also indicated. Again, controller 2260 includes printed circuit board 2265, which itself comprises an array of magnetic field-generating coils 2281.
[0475] In Figure 1 IB, initial positions of an actuator 200 and a substance unit 101 are shown. The trail of darkened coils 2402 shown in Figure 11C indicates sequential activation with appropriate magnetic field strength and polarity to draw actuator 200 along the direction of arrow 2401.
[0476] Referring now to Figure 12, showing a block diagram of a substance units management system 1200, according to some embodiments of the invention.
[0477] In some embodiments, substance units management system 1200 comprises a data ledger 1202 configured to record all transactions within the system. In some embodiments, a transaction counts as one or more of: inserting a container into the system (e.g., registering an empty and / or loaded container), inserting a substance unit into the system (e.g., placing a substance unit within a container), moving and / or transferring a substance unit within a container and / or between containers, and / or dispensing a substance unit(s) from an origin or customized container.
[0478] In some embodiments, system 1200 comprises a main controller 1204 that orchestrates the activities across networked devices, substance units distribution device 1210, and substance units dispensing device 1214. In some embodiments, distribution device 1210 comprises a controller 1212 configured to control the substance unit movements for example, for filling at least one customized container 1208 from one or more origin containers 1206. In some embodiments, dispensing device 1214 comprises a controller 1216 configured to control the substance unit movements within and / or out of at least one customized container 1208.
[0479] In some embodiments, the main controller 1204 is linked to controller 1212 and / or controller 1216 to issue instructions for transferring substance unit(s) between subsections (within a container and / or between containers) and to receive status updates on the performance of the transfer tasks. Alternatively, or additionally, controller 1212 and / or controller 1216 may issue the transferring instructions and update main controller 1204.
[0480] In some embodiments, customized container 1008 is configured to interact with an end user 1018, who is the recipient of the dispensed substance units (e.g., a patient and / or consumer).
[0481] Referring now to Figure 13, showing a block diagram of an exemplary data ledger 1300, according to some embodiments of the invention.
[0482] In some embodiments, data ledger 1300 comprises a plurality of datasets (for example, in the form of tables) for recording and / or organizing data related to the substance units and / or containers inserted thereinto.
[0483] In some embodiments, one of these datasets e.g., maintained as tabular data and / or SQL database may be a substance units data (e.g., table) 1302, which stores and links data of the substance units. Optionally, the substance units data (e.g., table) 1302 contains a row for each substance unit inserted into the system and multiple columns for storing relevant data. These columns may include details such as pharmaceutical code, type, composition (including for example active substances, excipients, coating, preservatives, stabilizers and / or allergens optionally including amounts and / or concentrations), brand, batch, production location, production time, manufacturer’s storage instructions, manufacturer’s consumption instructions, expiration date, and expiration date from the moment of opening. In some embodiments, the substance units data (e.g., table) 1302 includes an ID column that records the unique identifier (ID) assigned to each substance unit, optionally provided by the substance unit management system. In some embodiments, the table may comprise a column for the current location of each substance unit, indicating the specific container and / or subsection that holds the unit. Furthermore, the table may include a column recording the status of each substance unit, such as delivered to a consumer, retailer, or distributor; produced; stored; consumed; or disposed of. Alternatively, or additionally, data ledger 1300 may comprise a separate table (not shown), such as a substance units location table, which records the current location of each substance unit for example by linking a substance unit's unique ID with the unique ID of the container’s subsection accommodating thereof. Optionally, the data ledger would include information over time for each substance unit, allowing to trace any and all details of its history in the system, including location within containers, ID of such containers, environmental details, location of the containers at any time, other substance units that were stored in the same container(s) before and / or at the same time as the substance unit and more.
[0484] In some embodiments, another dataset may be a container data (e.g., table)1306, which serves to record the containers and link data related to the containers. Optionally, this may include a table that includes a row for each container that is introduced into the system, with one or more columns storing relevant data about each container. Notably, in some embodiments, once a container is filled with at least one substance unit, it is added to the system for tracking. The columns in this table may include the container ID, the number of subsections within the container, subsection IDs, and / or other relevant indicators for these subsections, container’s type (origin / customized) container status, such as active / disposed, full (and / or partially full) / empty, and / or a current container’s owner such manufacture, distributor, retailer, user and / or the specific identity of this owner.
[0485] In some embodiments, another dataset may be a subsections data (e.g., table) 1306, which serves to record the subsections within the containers and link between data related thereto. Optionally, this includes a table having a row for each subsection of a container inserted into the system, with one or more columns for storing the relevant data. These columns may include a column for the ID of each subsection, a column for the ID of the subsection’s container, and a column for the ID of the current substance unit that occupies the subsection.
[0486] In some embodiments, another dataset may be a system’s devices data (e.g., table) 1307, which stores data related to the devices within the system. This can include a table having rows corresponding to each device in the system and columns for recording relevant data about each device, such as device ID, device type (e.g., origin and / or customized), the location of the device, the current operational status (e.g., active, inactive, malfunctioning), a current status in the supply chain (e.g., in storage, transported, supplied to the consumer) and / or the identity of an agent possessing the device's (a specific consumer, manufacturer, distributor and / or retailer).
[0487] In some embodiments, another dataset may be a substance units history data (e.g., table) 1308, which keeps records of the location history for each substance unit. This may include a table having, for each substance unit, a list, optionally a chronological list, of all the subsections (e.g., subsection IDs) that have accommodated it, optionally, starting from when it was inserted into the system until the substance unit reaches the end of its life (e.g., consumption and / or disposal). In some embodiments, the table specifies the time duration and / or dates that the substance units stayed in each subsection. In some embodiments, another table may be a subsection history data (e.g., table) 1310, which maintains records of the content history for each subsection. This table may include, for each subsection, a list, optionally a chronological list, of all the substance units, optionally, identified by their IDs, that have been stored within it. Optionally, the list covers the period from when each subsection is first used until it becomes inactive. In some embodiments, the table may record the specific time duration and / or dates that each substance unit occupied the subsection, as well as the times and / or periods when the subsections were vacant.
[0488] In some embodiments, another table may be an environment measurements data (e.g., table) 1312, which records data on environmental conditions and / or measurements within each container and / or subsection. Optionally, this data set includes a table having a row for each subsection inserted into the system, with one or more columns for storing the environmental measurements. These columns may include a column for temperature, humidity, light, concentration of chemical(s) and / or dust level.
[0489] In some embodiments, data ledger 1300 comprises a transaction log data (e.g., table) 1314, which records all transactions related to substance units and containers, and the exact time and / or date when the transaction occurred. In some embodiments, a transaction is considered as any record of the system, such as but not limited to, insertion of a new container, updating container location, insertion of a new substance unit, transfer of a substance unit between subsections of the same container and / or between container.
[0490] In some embodiments, data ledger 1300 comprises an entities / agents dataset (e.g., table) 1316, which records information about all entities and / or agents interacting with the system. This table may include rows for each entity, such as manufacturers, distributors, retailers, medical supervisors, insurers, and / or end users. The columns in this table might store various details like entity ID, entity type (e.g., manufacturer, distributor, retailer, etc.), contact information, roles within the system, and specific authorizations and / or restrictions associated with each entity. For example, a manufacturer may have permission to add new substance units, whereas a retailer might only have permission to sell and / or distribute these units. Alternatively, and / or additionally, this dataset could track relationships between entities, such as which distributor is associated with which retailer and / or which supervisor (e.g., supervisor 214) is linked to specific end users. This dataset potentially allows each agent's related transaction and / or interaction within the system to be managed according to the roles and responsibilities assigned to each entity / agent, having the potential advantage of enhancing traceability and / or accountability throughout the supply chain.
[0491] In some embodiments, data ledger 1300 is a distributed database (e.g., blockchain), having the potential advantage of increasing the secure and / or decentralized record of transactions. In some embodiments, each entry into tables like the container table, substance units table, and transaction log table is timestamped and linked into the blockchain, creating a verifiable and permanent record that is resistant to tampering. In some embodiments, data ledger 1300 is realized and / or implemented in layer 3 (L3) of the blockchain.
[0492] In some embodiments, data ledger 1300 may be managed by more than one entity, optionally having separated and / or different authorization. For example, only a manufacturer is authorized to record details of substance units, such as batch, manufacturing date, and / or process. In another example, only an authorized retailer may transfer substance units from origin container into a customized container.
[0493] In some embodiments, data ledger 1300 includes a plurality of separated data ledgers (e.g., parts of the data ledger), optionally owned by different entities (e.g., agents). For example, data ledger 1300 may be comprised of a separate data ledger for the manufacturer, retailers, medical supervisor, user, insurance company, and / or regulator.
[0494] In some embodiments, some parts of the data ledger may contain restricted information that is accessible only to authorized individuals and / or may be subject to a fee. Optionally, this information may be sensitive, personal, and / or of significant value. For example, sensitive medical information of a user may be accessible only to the user, their attending physician, or others who have received explicit permission from the user. In another example, valuable information, such as market demand data, might be accessible only upon payment.
[0495] In some embodiments of the invention, the data ledger is set up as a permissioned blockchain where only approved participants can see and / or add certain information. Different items may have different permission levels and / or different approved participants.
[0496] The ledger can be split into channels or sub-ledgers so that each participant sees only the information they are allowed to see. For example, a regulator might be able to view safety and tamper data, while an insurer might only see delivery and consumption records.
[0497] In some embodiments of the invention, the blockchain (or other ledger type) supports and / or executes smart contracts.
[0498] One exemplary smart contract relates to approving or blocking the transfer of a substance unit between containers, for example, based on checking of data associated with the containers and / or the substance unit.
[0499] Another exemplary contract which may be provided relates to record tamper events and optionally triggering quarantine actions. It is noted that such smart contracts can eb entirely data driven and not require human input. This can serve to increase the reliability of the distribution system as a whole. Another example contract relates to geofencing, for example, checking a location provided by a container (or other system component) and allowing access (e.g., opening a container or moving a substance unit out of the container), if the location matches a geofencing limitation (which may also be recorded on the blockchain).
[0500] Optionally, for example for security and / or safety reasons, the blockchain can store hashes of environmental sensor logs (like temperature or humidity data).
[0501] In some embodiments of the invention, multiple components of the distribution system, for example, containers and / or substance dispensers can have an loT gateway — a small embedded computer that connects to the network. This gateway can use a secure element (e.g., a security chip) to sign and send blockchain transactions, potentially ensuring the data comes from a trusted source and has not been altered.
[0502] Referring now to Figure 14, showing a block diagram of an exemplary controller 1200, according to some embodiments of the invention.
[0503] Main controller 1400 is a detailed embodiment of controller 204, shown in Figure 2, and / or main controller 1204, shown in Figure 12.
[0504] In some embodiments, main controller 1400 is configured to block as a central command unit for the substance units management system (e.g., system 200), and / or for interfacing with the data ledger (e.g., data ledger 204, 1204, and / or 1300). In some embodiments, controller 1400, is configured to fetch and update data from and to the tables within the data ledger to potentially reflect real-time conditions and / or changes across the system. In some embodiments, controller 1400 uses data from the data ledger for decision-making purposes for example, regarding management, movement, allocation, and / or selection of substance units.
[0505] In some embodiments, controller 1400 comprises a transaction management module 1402 which manages and / or processes the transactions associated with the substance units and / or containers, likely involving database interactions and record-keeping. In some embodiments, transaction management module 1402 may rely on a data management module 1404 to fetch and update the data necessary to process a transaction. In some embodiments, data management module 1404 manages the storage, retrieval, and synchronization of data within the system and interacts with the data ledger to retrieve and update information.
[0506] In some embodiments, controller 1400 comprises a communication module 1406, which manages communication between the controller and the system’s distribution devices and / or dispensing devices (e.g., the controllers thereof). In some embodiments communication module 1406, manages communication between the controller and the system’s sensors, located within the system’s containers (origin and / or customized containers) and / or devices (e.g., distribution devices and / or dispensing devices).
[0507] In some embodiments, controller 1400 comprises an identification module 1408, which is configured to assign unique IDs to different entities within the system, including each container, each subsection within the containers, and / or each substance unit inserted into the system. In some embodiments, each container is assigned a unique ID, and each subsection is given an ID that combines the container's ID with a subsection -specific identifier (which is not necessarily unique). In some embodiments, a transaction is created and recorded on the blockchain (e.g., data ledger 1300).
[0508] In some embodiments, controller 1400 comprises a tracking module 1410, which can provide, optionally on-demand, the details of each substance unit and / or container within the system, including a current location and / or status. In some embodiments, tracking module 1410 is separated into a substance units tracking module (which monitors each substance unit’s current status, current container, and / or current subsection within it) and a container tracking module (which monitors each container’s current status and / or location). In some embodiments, tracking module 1410 interacts with the data ledger to retrieve updated information regarding the substance units' and / or containers' location and / or status.
[0509] In some embodiments, controller 1400 comprises a substance units transfer module 1412, which issues instructions for the transfer of substance units between subsections within the same container, between containers, and / or out of the container. Alternatively, or additionally, the substance units transfer module 1412 communicates with the transfer modules of distribution devices and / or dispensing devices, which manage the movement of substance units and send updates to the substance units transfer module 1412.
[0510] In some embodiments, controller 1400 comprises an input module 1414, designed to receive and / or process data or signals from external agents associated with the system and process thereof. An example of such input may be an update from the manufacturer regarding a change in the consumption and / or storage instructions of a certain type and / or pharmaceutical code of substance units. In another example, the manufacturer may inform the system of a recall for a certain batch. In another example, such input may include a use program from an end user and / or a supervisor, such as a physician's prescription.
[0511] In some embodiments, the input is provided to the controller via a user interface that can be accessed by any authorized agent. The interface may be in the form of a mobile application, web portal, and / or physical device display. In some embodiments, each agent may have access to specific functions and / or information based on their role and / or authorization level within the system. For example, a supervisor (e.g., a physician) may have access to input and / or update prescriptions, optionally for users related thereto, while a manufacturer may have access to input production details of substance units, optionally produced thereby, such as batch number, expiration date, and / or production date. In some embodiments, controller 1400 comprises an alert module 1416 which generates alerts based on the system’s collected and / or updated data. In some embodiments, the alerts can be sent to a system operator as well as to one or more of the agents communicating with the system. For example, an alert may be sent (for example to the manufacturer and / or regulator) if there is concern about an impending shortage of a specific substance unit in the market, based on information regarding the number of substance units produced, those currently held by consumers, and / or consumption data. In another example, an alert may be sent if tampering is detected in one of the containers, or if contamination or spoilage of one of the substance units is identified.
[0512] Referring now to Figure 15, showing a block diagram of distribution device 1500, according to some embodiments of the invention.
[0513] In some embodiments, distribution device 1500 comprises a container(s) receptacle 1506 configured to receive one or more containers (e.g., customized and / or origin containers). In some embodiments, container(s) receptacle 1506 comprises a docking station for containers being loaded into the device, optionally securing them in place to be in communication with a movement mechanism 1504. In some embodiments, the one or more containers are integrated into the device, optionally, constituting a single unit.
[0514] In some embodiments, movement mechanism 1504 is configured to physically manipulate (e.g., move) substance units within the containers mounted on container(s) receptacle 1506. In some embodiments, the operation of movement mechanism 1504 is managed by controller 1502. In some embodiments distribution device 1500 comprises at least one sensor 1508 which provides the data to controller 1502 for evaluation. In some embodiments, at least one sensor 1508 comprises, for example, a sensor for detecting tampering and / or a sensor for measuring the container's conditions / environment.
[0515] In some embodiments, controller 1502 comprises a movement mechanism module 1518 which controls movement mechanism 1504. This module translates commands from a substance units transfer module 1512 into physical substance units movements within the container. In some embodiments, substance units transfer module 1512 determines whether to transfer a substance unit from an origin container to a customized container and / or relocating it within a container (e.g., origin and / or customized), optionally, based on the instructions of an allocation module 1522. In some embodiments, allocation module 1522, is configured to determine where to locate a substance unit within a customized container upon transfer of substance units from an origin container and / or where to relocate substance units within a container (e.g., customized and / or origin container). In some embodiments, controller 1502 comprises a substance units selection module 1523 that selects a specific substance unit for transfer, optionally based on input module 1514. In some embodiments, input module 1514 is configured to receive and / or process distribution demands, optionally user-specific demand, and adjust the selection allocation and transfer of substance units accordingly.
[0516] In some embodiments, controller 1502 comprises an origin containers management module 1510 which manages the recording and / or tracking of changes within the origin containers (e.g., the egress of substance units from the container and / or relocations of substance units within the container), In some embodiments, controller 1502 comprises a customized containers management module 1512 which manages the recording and / or tracking of changes within the customized containers performed by the distribution system (e.g., receiving substance units from the origin container, relocations of substance units within the container, and / or dispensing substance unit(s)). Optionally, modules 1510 and / or 1512 report to the system main controller and / or directly update the data ledger, optionally via communication module 1520. In some embodiments, communication module 1520 manages all communications between the device and the system’s main control, providing updates and receiving commands therefrom.
[0517] In some embodiments, a sensor module 1524 processes input from the at least one sensor, an optionally sends alerts accordingly. In some embodiments, if it is determined that the measured conditions within a container or any of its subsections are not within acceptable limits (deviating from recommended storage conditions or if there is detection of a substance indicating spoilage or contamination of the substance units), the system updates the record accordingly.
[0518] Referring now to Figure 16, showing a block diagram of a dispensing device 1600, according to some embodiments of the invention.
[0519] In some embodiments, dispensing device 1600 comprises a container(s) receptacle 1606, movement mechanism 1504, at least one sensor 1608 and / or controller 1602, for example, similar to as described for distribution device 1500.
[0520] In some embodiments, controller 1602 comprises a movement mechanism module 1618 which controls movement mechanism 1604, translating commands of a substance units transfer module 1613, and / or a substance units dispensing module 1614 into physical substance units movements within the customized container. In some embodiments, the substance units transfer module 1613 determines whether to transfer a substance within subsections of a container attached to the dispensing device 1600 (e.g. a customized or origin container) and / or between containers, optionally based on the instructions of an allocation module 1616. The allocation module 1616 is configured to determine where to locate a substance unit within a container upon the transfer of substance units within the container, and / or upon changes in the consumption program. For example, in some embodiments, the allocation module 1616 may command the rearrangement of the substance units within the customized container based on the consumption order of the substance units. In some embodiments, the allocation module 1616 determines the path within the container for a substance unit selected to be dispensed. In some embodiments, substance units dispensing module 1614 is configured to determine whether a substance unit be dispensed, selecting a specific substance unit and / or instructing dispensing thereof.
[0521] In some embodiments, controller 1602 comprises a customized containers management module 1610 which manages the recording and / or tracking of changes within the customized containers used by the end user.
[0522] In some embodiments, a communication module 1622 manages all communications between the device and the system’s main control, providing updates and receiving commands therefrom.
[0523] In some embodiments, a sensor module 1524 processes input from the at least one sensor, and optionally sends alerts accordingly for example, via notification module 1620. For example, in some embodiments, a sensor module 1524 may detect that the storage conditions within the containers correspond to the manufacturer's instructions, and / or that the substance units' quantity within the customized container may running low, and alert the user. In some embodiments, if it is determined that the measured conditions within a container or any of its subsections are not within acceptable limits (deviating from recommended storage conditions or if there is detection of a substance indicating spoilage or contamination of the substance units), the system updates the record accordingly.
[0524] In some embodiments, notifications module 1620 manages all notifications to the user. In some embodiments, notifications module 1620 is configured to send a reminder to the user to consume one or more substance units. The reminder may be in the form of a notification on the user's smartphone, a sound or visual alert on the dispensing device, an email, or a message on a connected smartwatch. The reminders can be scheduled according to the user’s consumption program and / or sent as needed based on system settings and / or user input, received by a user input module 1618. In some embodiments, a user interface (UI) is employed for delivering these notifications and / or reminders. The UI allows users to receive and interact with alerts through various platforms, such as mobile applications, web interfaces, or the dispensing device itself. Notifications, reminders, and updates can be accessed and managed through the UI.
[0525] In some embodiments, notifications module 1620 and the UI may allow communication between different entities and the user. For example, when the user consumes a substance unit, such as a medication, the UI can provide information about the brand and / or manufacturer of the substance unit, optionally, arriving from the manufacturer and / or retailer. It can also deliver messages and / or advertisements from the manufacturer and / or retailer to the user. In another example, the module can inform the user about the contents of the container. If the container has been loaded with substance units that have side effects such as pain and / or headaches, it may be automatically refilled with analgesics. The module could suggest taking analgesics at the same time as consuming the unit which may cause the discomfort. This information can be sourced from the user's physician or other authorized entities.
[0526] In some embodiments, input module 1618 allows the user to provide input, for example, to request for delivery of substance units (e.g., those that exceed the scope of the consumption program or are not managed by a consumption program), adjust their consumption program, request refills, and / or modify reminder settings. Additionally, or alternatively, input module 1618 may support more than one input method, such as touchscreen, voice commands, or connected devices like a smartphone, having the potential advantage of facilitating the user’s interaction with the system.
[0527] Exemplary methods for authenticating the system’s participants Referring now to Figure 17, showing a flowchart 1700 of an exemplary method for authenticating the system’s participants, according to some embodiments of the invention.
[0528] At 1702, a first participant related to the substance units management system is provided. In some embodiments, the participant may be a component of the system such as a container, device (e.g., distribution and / or dispensing devices) a hardware component, and / or a software component.
[0529] Alternatively, or additionally, the participant may be an agent, communicating with the system. The agent may include a business entity (for example the manufacturer or distributor) and / or one or more individuals authorized to operate in the system (e.g. a pharmacist or a manufacturer's operator).
[0530] In some embodiments, each participant that is registered (e.g., inserted) into the system is provided with a unique ID. In some embodiments, this ID is linked to all the details and / or authorizations of the specific participant. For example, a distributor responsible for shipping the container / devices may not be authorized to transfer substance units from one container to another and / or within a container. Conversely, a retailer (e.g., a pharmacist) may receive such authorization. In another example, an authorization may be granted to a specific retailer and not to others, e.g., a pharmacist might be authorized to receive and / or transfer prescription medications, whereas a nonpharmacist retailer may only be granted authorization to deal with containers that do not contain medical substances, such as food and / or dietary supplements. At 1704, the first participant is identified and / or authenticated. For example, the authentication process may involve biometric verification of the agents, such as fingerprint or facial recognition, or digital authentication methods, such as password entry, security tokens, or cryptographic keys. Alternatively, or additionally, the component is verified as related to the system and checked to ensure it has not been tampered with, employing methods such as scanning for tamper-evident seals or checking system logs for unauthorized access.
[0531] In some embodiments, authentication (optionally in the form of an ID recorded in the system) is provided to a container and / or a container loaded and / or integrated into a device, once loaded within substance units and sealed. In some embodiments, the device ID associated with the system is of particular use for nodes such as factories, which may own and manage numerous devices registered under their name optionally, organized in a hub (for example within a specific geofenced area). The ID potentially certifies the container being filled by an authorized manufacturer (e.g., factory).
[0532] At 1705, the first participant's authorization (e.g., stored in the data ledger) is verified and / or evaluated. In some embodiments, the actions (requests) authorized for the participant are based on this authorization. For example, a medical supervisor's request to access a user's private information and / or modify the consumption programs thereof will be allowed only if the medical supervisor has the necessary authority. Optionally, additional data is associated with the participant (such as permitted geographical location and / or time of day) and a deviation from the additional data prevents authorization.
[0533] At 1708, a request to interact to interact between the first and the second participant is received and / or generated by the system. Examples of such interaction may be transferring a substance unit between a first and / or a second container, loading a container into a device, and / or updating the consumption schedule of a user by another agent such as a medical supervisor. For example, in some embodiments, the system’s devices are configured not to respond to unauthorized and / or unrecognized entities and / or entities being at a geolocation for which they were not approved. In another example, the containers are configured not to open for an unauthorized and / or unrecognized device. At 1710, the second participant is identified and / or authenticated.
[0534] At 1711, the first participant's authorization (e.g., stored in the data ledger) is verified and / or evaluated.
[0535] At 1712, upon authentication and / or authorization evaluation of both participants, the interaction therebetween is allowed.
[0536] At 1714, the interaction is recorded (e.g., a record thereof is stored) in the data ledger optionally in association with the effect of such interaction.
[0537] In some embodiments of the invention, authorization is dependent on geographical location, time and / or devices it (an entity requiring authorization for an action, or the subject of the action) interacts with and / or has interacted with.
[0538] In an example of geofencing, a container or device includes a GPS module that knows its own location. Optionally and / or alternatively other positioning systems may be used, for example, Wi-Fi based and / or based on a cellular antenna and / or based on a beacon. This location may be compared to an allowed range of locations, for example, on the device, at the ledger and / or in other parts of the system. If compared locally, in one example, the device’s software compares this location to a predefined geofence — a set of allowed areas stored in its secure memory.
[0539] If the container or device is outside the allowed area, the system can, for example:
[0540] Lock the actuator so the container cannot open or move units;
[0541] Record the event in the data ledger (blockchain) so it is permanently stored; and / or
[0542] Send an alert to the regulator, manufacturer, or other authorized party in real time.
[0543] Such geofencing may be used to ensures that substance units are only handled in approved locations, potentially adding security against theft, tampering, or unauthorized distribution.
[0544] A similar process may be applied (in addition to or instead) with respect to time or history. For example, an activity may be allowed only if it is requested within a certain time window and / or after one or more actions was performed and / or providing certain action(s) (or locations) were not performed and / or a plurality of (ordered) actions.
[0545] Optionally and / or alternatively identification of the presence of an authorized individual (or authorized device) may be required, for example, by entering a code by the individual or by electronic handshaking with an electronic device of the individual, or an authorized device, for example, via Bluetooth.
[0546] Exemplary methods for transferring a substance unit between containers
[0547] Referring now to Figure 18, showing a flowchart 1800 of an exemplary method for transferring a substance unit between containers, according to some embodiments of the invention. At, 1802, an instruction to transfer a substance unit between containers is received. For example, transferring a substance unit from a first to a second container.
[0548] In some embodiments, the source of the instruction (e.g., entity and / or agent) is identified and / or authenticated. The system verifies whether the entity and / or agent has the authority to issue such an instruction. In some embodiments, both the first and second containers are identified and authenticated, and the system assesses whether they are suitable for the transfer. For example, the containers are inspected to ensure that they have not been tampered with. In some embodiments, the exemplary methods of transferring a substance unit described in flowchart 1800 may use exemplary methods for authenticating the system’s participants as described in flowchart 1700.
[0549] At 1804, the first and the second containers are loaded into a distribution device (and / or a personal device), optionally each to a different device, a first and a second device.
[0550] At 1806, in some embodiments, the first and the second devices are connected, potentially allowing the substance units to transfer therebetween. In some embodiments, the containers are connected such that their openings are aligned. In some embodiments, the connection between the containers is identified, for example by one or more sensors and / or connection mechanisms located at one or both of the containers. In some embodiments, an adaptor or connector serves to connect the openings. In some embodiments, at least one of the containers, optionally both, comprises mechanisms for identifying each other. For example, an optical detector and / or RFID reader may be used to confirm the connection and / or alignment of the containers and / or verify that the correct containers are connected.
[0551] It is to be noted, that the transfer can only occur between authenticated and / or approved containers, potentially ensuring that only authorized containers are permitted to accept substance units, only authorized containers are permitted to deliver substance units, and / or allows the substance units tracking. In some embodiments, the transfer can only occur within an approved predefined geographical area (e.g., geofenced location), such as a specific facility and / or zone. This geofencing potentially ensures that substance units are transferred, handled, and / or dispensed only within secure and / or authorized locations, having the potential advantage of reducing the risk of unauthorized access, theft, and / or tampering. In some embodiments, if the containers and / or devices are moved outside of the designated area and / or if an attempt is made to operate them outside the designated area, the system may restrict or prevent the transfer, trigger an alert, and / or mark them for recall. In some embodiments, the system continuously monitors the geolocation of the containers and devices, potentially ensuring compliance with predefined geographical restrictions. At 1806, a substance unit is extracted from the first container, and / or the first device which the first container is loaded into (1806). At 1808, the emergence of the substance unit is detected from the first container and / or from the first device (1808).
[0552] At 1810, in some embodiments, the substance unit is inserted into the second container and / or the second device which the second container is loaded into.
[0553] At 1812, the entrance of the substance unit into the second container and / or into the second device is detected. In some embodiments, one of the containers, optionally both, comprises at least one sensor (such as an optical detector, camera and / or RFID reader) for detecting the substance unit’s transfer (during its exit from the first container or entry into the second container). In some embodiments, the substance unit is imaged and / or scanned during the transfer.
[0554] In some embodiments, one or both of the containers and / or an adaptor / connector connecting them and / or a device in communication with one or both of them comprises a sensor configured to detect and / or identify the occurrence of a substance unit transfer, nearly simultaneously, e.g., when the unit exits the first container and enters the second. This synchronization potentially allows the substance unit to be identified at both the point of egress from the first container and the point of ingress into the second container, with both events occurring in rapid succession, having the potential advantage of reducing and / or avoiding opportunities for tampering with the substance unit’s transfer. In some embodiments, the system may utilize one or more identification scanners, optionally, positioned at the transfer ports of both containers (or adaptor / connector), designed to scan the substance unit as it passes between containers. In some embodiments, the scanners are configured to operate in sync, such that as the substance unit leaves the first container, it is immediately scanned, and its identity is verified. Once the substance unit enters the second container, a corresponding scanner verifies its arrival and matching identity. In some embodiments, the system verifies that the two scans are synchronous optionally, both in space and time. In some embodiments, the distance between the two scanning points is reduced and / or minimized, for potentially reducing the transfer time between the containers. The closer the two scanners are in space and the shorter the time between scans, potentially the more secure the transaction, as this reduces the risk of unauthorized interference and / or tampering during the transfer. In some embodiments, the ID of the substance unit may be embedded and / or imprinted on the substance unit itself, potentially allowing for direct identification during the transfer process. Since the substance unit is traveling from one port to the other, the same ID of the substance unit, and / or a portion of it, appears on the other side within a specified duration (e.g., expected number of milliseconds and / or seconds) after leaving the first port. The embedded ID allows the system to scan and verify the unit as it passes between containers, potentially ensuring its authenticity throughout the transfer. In some embodiments, the transfer is contingent upon identifying the first and second containers and / or the connected devices. This identification process may include verifying that both containers and / or devices are approved devices and / or are authorized for the transfer. In some embodiments, the substance unit itself is also verified to ensure it is approved for transfer. For example, this may involve confirming that the specific substance unit has not been marked as restricted, expired, recalled, or otherwise prohibited from further movement. In some embodiments, if either the containers, devices, and / or the substance unit fails verification, the system may prevent the transfer from proceeding.
[0555] At 1814, in some embodiments, the substance unit transfer is recorded (e.g., a record thereof is stored) in the data ledger.
[0556] Exemplary containers hive configuration
[0557] Referring now to Figure 19A, schematically illustrating movements of a substance unit 101 from a first position 200 A to a later position 200B within a portion of containers hive configuration 99 A along a path 201, according to some embodiments of the invention.
[0558] The illustrated hive configuration 99A comprises nine schematic representations of containers 70. These are shown in a grid array; however, it should be understood that connections among the containers 70 may take any other two- or three-dimensional configuration. The movement of the substance unit 101 along path 201 transitions through several containers (e.g., origin containers) before reaching its final position 200B in final container 211 (optionally, a customized container). The path starts from position 200A, where the substance unit is initially located, moving through connected containers as indicated by the directional arrows. Various containers within the hive, such as 208 and 209, are connected to form pathways that allow the substance unit to traverse freely and / or be directed therethrough based on specific system commands or conditions. The substance unit is prohibited from passing through container 205 and / or a portion of container 204. For example, container 205 may contain substance units that should be isolated from substance unit 101 (for example due to a risk of cross -contamination), and / or container 205 may be full and it is not desirable to remove units from it (for example, containing quarantined substance units).
[0559] The hive-like structure potentially enhances the system’s ability to handle complex logistics scenarios involving multiple substance units simultaneously.
[0560] Referring now to Figure 19B, schematically illustrating movements of a plurality of substance unit 101 within a portion of containers hive configuration, according to some embodiments of the invention. In some embodiments, alternatively and / or additionally to the hive configuration shown in Figure 19A, the final container 70T (e.g., target container) may be centralized and / or substantially centralized between a plurality of other containers (e.g., be positioned centrally in the hive configuration). Optionally, this container is a customized container and / or designated to be a customized container, centralized between a plurality of origin containers.
[0561] In some embodiments, this configuration potentially facilitates the transfer of substance units (e.g., a plurality of substance units) from the origin containers into the target (e.g., customized) container. This configuration potentially allows parallel and / or sequential transfer of more than one substance unit. For example, if the target container comprises more than one opening, each may be connected to another container. Alternatively, or additionally, the container connection may be in series and / or in parallel.
[0562] The illustrated hive configuration 1999A of Figure 19B comprises six schematic representations of container 70. The plurality of substance units 101 (e.g., comprising substance units 101a, 101b, 101c, and lOld) are moving from their start containers 70A, 70B, 70C, and 70E (e.g., origin containers) and / or from their start location (e.g., subsection) within the container to a final position within the final (e.g., target container) 70T. As shown in the figure, each substance unit may start at a different initial position within its respective starting container.
[0563] In some embodiments, the substance units can follow a direct path into the final container 70T, for example as illustrated by units lOla-c. Alternatively, or additionally, the path may involve transferring the units from the starting container to the final container via other intermediate containers, as demonstrated by unit lOld which moves from container 70D to container 70T through container 70E, and as demonstrated in the example shown in Figure 19A.
[0564] Exemplary method for managing sample units
[0565] In some embodiments, the substance unit management system can be operated to deliver (e.g., by reverse logistics) sample substance units (e.g., and / or sample units) to an agent such as a lab, clinic, research facility and / or hospital (e.g., additional examples of agents communicating with the system). In some embodiments, the reverse logistics may be alternatively and / or additionally to providing the user with substance units.
[0566] In some embodiments, the customized container used by the end user (e.g., customized container) is configured to contain a sample unit. In some embodiments, the container comprises at least one subsection for containing a sample unit, optionally, a designated subsection, such as a biological sample. In some embodiments, this designated subsection is in the form of and / or comprises a cell and the dispensing device is configured to dispense this cell for collecting the sample from the patient. For example, a sample of saliva, blood, urine, or any other sample. In some embodiments, the system prompts the user to provide a sample, for example, by notifying them to submit a sample. The system may issue reminders and / or alerts based on a preset schedule, the user's health data, and / or specific events, such as missed testing times. For example, the system may prompt a diabetic user to submit a blood sample for glucose testing at scheduled intervals and / or when a test is due. In some embodiments, the system may prompt the user to exhale into the container, optionally comprising a sensor configured to detect breath samples.
[0567] In some embodiments, upon deposit of the sample, the device withdraws the cell back to the container and records the sample’s details in the data ledger. Alternatively, or additionally, the container may comprise such a cell that can be sealed and located in any subsection.
[0568] In some embodiments, the container containing the unit sample may be transported to the relevant agent(s). Alternatively, or additionally, the customized container may be loaded into a distribution device (which in this case also functions as a collection device), and the sample unit is transferred into a container intended to collect samples and be sent to the agent.
[0569] In some embodiments, the sample unit can be tracked at any point from the moment it is deposited in the container until the moment the user receives results.
[0570] In some embodiments, the system monitors the conditions of the sample (e.g., within the container) and alerts (e.g., the user, the distributor, and / or the target agent such as a lab) if the conditions exceed the recommended storage parameters. For example, an alert may be triggered if the temperature becomes too high for a sample that needs to be kept refrigerated.
[0571] Exemplary distribution path of a substance unit
[0572] Referring now to Figure 20, schematically illustrating movement of a substance unit 101 from a first position (e.g., first subsection) 200A to a later position (e.g., later subsection) 200B within a portion 99A of distribution system 99 along path 201, according to some embodiments of the invention.
[0573] The illustrated portion 99A comprises nine schematic representations of containers 70. These are shown in a grid array; however, it should be understood that connections among the containers 70 (e.g., origin and / or customized containers) shown occur at different times and locations, and that the indicated connectivity represents a portion of the “logical” or “potential” connectivity of the global storage space which the containers 70 define. In this example, a substance unit 101 is first entered into the data ledger as occupying position 200A of container 208. For example, a substance unit manufacturer (e.g., manufacturer 206) has placed substance unit 101 in position as part of its packaging operations. The segment connecting container 208 and container 209 represents the first transfer (e.g., exchange) of substance unit 101 between different containers 70. This transfer represents, for example, movement from a holding container 208 used during manufacturing to an container 209 designated for use in shipment, or authorized movement from container 208 as received by a shipping service to an container 209 designated for conditions (e.g., environmental conditions) which are not considered suitable for container 208.
[0574] Optionally, shipping instructions are associated with substance unit 101; e.g., individually, according to type and / or pharmaceutical code, and / or associated with its group and / or original container 208. In the example shown, container 205 does not meet these conditions, which are optionally related to any meaningful parameter; e.g., age, general and / or specific history of previously contained substance units (e.g., over concerns for residue, radiation, and / or microbial contamination), features available for use in monitoring, environmental resistance, or another parameter.
[0575] The next indicated movement of substance unit 101 is to container 204. In this case, only a portion of container 204 is off limits for storage of this substance unit 101; e.g., the hatched-in lower left comer as marked. Partially disallowed regions may be defined, for example, to prevent substance unit 101 from contaminating a region reserved for the exchange and / or storage of high- sensitivity substance units, and / or because it itself is considered sensitive to potential contamination there; e.g., contamination due to residue, or another reason.
[0576] The movements indicated jointly for containers 210 are optionally performed, e.g., as part of operations by one or more agents (as described for example with respect to Figure 2) to optimize some aspect of their operations, e.g., to prospectively generate a mixed prescription for an end user (e.g., end user 212), as part of inventory confirmations, and / or for another reason.
[0577] At position (e.g., subsection) 200B, substance unit 101 reaches its last hosting container 211. It may be noted that the movements of substance unit 101 within hosting container 211 are complex; this is present as an indication of rearrangements of the substance unit 101 contained within container 211, optionally without exchanges, and optionally without immediate dispensing. For example, rearrangements are optionally completed a few minutes (e.g., at least 15 minutes) or hours (e.g., at least 2 hours) before dispensing. The rearrangements are optionally initiated in order to provide the end user with a mixed assortment of substance units as specified by a medication and / or supplement regime (e.g., consumption program). Proactive rearrangements in particular provide potential advantages by reducing latency and / or complexity at the movement of dispensing itself. For example, the dispensing arrangement of substance units is optionally configured to allow dispensing using a relatively simple and / or compact controller (e.g., controller 204). Exemplary types of Substance Units and / or Container Contents
[0578] The apparatus and methods described herein may be useful for tracking and / or dispensing many types of components. In particular, some embodiments of the invention support IDing and / or tracking of individual components and / or providing an ID for such components. For example, methods & apparatus described herein can be used to provide an ID for a component that is otherwise fungible (for example, pills in a container or blister-pack. Optionally and / or alternatively such components may have no ID. Optionally and / or alternatively such components have an ID, but it is only machine readable and / or otherwise less accessible. In contrast, some embodiments of the invention allow a human awareness (and / or machine awareness) even of each individual component, possibly without reading an ID or at least not rereading such ID when the component passes between system nodes / locations.
[0579] In some embodiments of the invention, the methods and apparatus described herein are used for small components, for example, components having a maximal dimension smaller than 100mm, 50 mm, 30 mm, 10 mm, 5 mm or smaller or intermediate sizes. Such component may be portable and / or may be provide din packs. In some cases, such components are too small to have an ID and / or for applicable individual tracking using existing methods. An example of a class of such components are pills, for example, pharmaceutical or nutritional. In some cases, it is desired to keep the actual ID a secret (or at least off hackable or easily available data systems), so the system ID is used. This may be, for example, for anonymous dispensing, for example, of cryptography keys. In some cases, the supplier may provide an ID to be used by the tracking system so that the product may be tracked, but the actual product may be anonymous (e.g., other than size and / or environmental requirements).
[0580] In some embodiments of the invention, the components are disposable - for examples swallowed. Some components are in use for longer times, such as between 1 minute and day or a week or a month or a year or smaller or intermediate or larger time periods. Such dispensed components may be registered. For example, a cellular telephone used to control a dispenser may also be used to photograph a usage location. In such way, failure can be tracked back, if needed. The user interface (e.g., of a cellular phone or other device) may include the option of entering a description related to use and / or fail, for example, location, cause or general notes. A user may enter the information and it may be stored in the ledger in association with the item ID. In medical example, a user may enter side effects and / or efficacy of a taken pill. In a wellness or cosmetic example, a user may store, for example, before and after images. In some embodiments of the invention, such storage is automatic. For example, a dispensing event may also provide an ID and location, for example, for a blockchain and this ID and location (or other access credentials) may be accessed by a separate system, for example, a maintenance system (e.g., of a car) to record information relating to the use of the dispensed component. In some embodiments of the invention, the dispensed component is electronic and may receive a dispensing code and / or its ID and / or other access credentials when it is dispensed, for example, using a blue tooth connection. This component can log its own information. Optionally and / or alternatively the code is otherwise received, for example, such component may scan a code on a display and / or receive a code wirelessly after it is activated, for example, from a cellular telephone or other connected device, for example, as part of setting up.
[0581] In some embodiments of the invention, the component will use the ID / access credentials to record operational and / or collected data, for example, in the ledger. Optionally, the ledger is used for allowing sharing of data, for example user-generated data, for example, as may be mandated by local laws. This may be especially useful if the component is an IOT (internet of things) device. In some cases, the dispensing event (and ledger tie-in) will occur at a distributer or by an installer, rather than an end user. In some embodiments of the invention, dispensing is by an end user and charging is at dispensing time. For example, a package of multiple components may be provided with no charge and when a user dispenses a component, the user is charged. Linking an ID (e.g., to a component and / or user account) may allow charging to be deferred and / or occur base don use, after dispensing. In some embodiments of the invention, the price is dynamic, and may eb affected, for example, by scarcity and / or fashion considerations. These may be calculated and / or provided by the dispensing system and / or by a third-party system, for example, a supplier and / or distributer, using the tracking and dispensing system described herein. A user is optionally instructed as to the price and / or price schedule before dispensing.
[0582] Use of after-dispensing tracking may be useful for component that wear out, for example, based on time or number of used (e.g., sensors, batteries, mechanical components such as switches and motors)
[0583] However, there is a particular benefit of tracking for some types of components which have previously been difficult to track.
[0584] For example, medical components often have stringent requirements and / or desires for safety, storage, time and / or use and / or ability to recall and / or control the dispensing. This includes, for example, medical devices / parts, pharmaceuticals, nutrients, wellness products and / or other items that come into contact with a body and / or into the body. Other components types, such as safety components may share some or all of these properties. For example, fire suppression balls may need support for recall and / or monitoring for age and / or environment. While fire balls may include an ID, it may require extra expense and complexity to add a suitable reader to a package. Perishable components, for example, may be sensitive to time and / or environmental conditions and tracking such may assist in problem detect and / or resolution, including reimbursement. In general, medical component may have the most potential advantages when the methods and apparatus of the present disclosure are used.
[0585] In some cases, the importance of tracking a component is to maintain a chain of tracking. One example may be tracking 3D printing supplies, where tracking may need to continue after a product is created with the supplies. In some embodiments of the invention, the 3D printer (or other assembly or manufacturing system) is manually and / or automatically (e.g., by Bluetooth or other wireless means or by scanning a code) updated as to the ID of the dispensed component. This ID may be associated with the finalized product for further tracking and / or for storage of information related thereto in the ledger.
[0586] In some embodiments, the substance units and / or any other container's content may comprise and / or be from the field of one or more of the following. It is noted that some of the component types may be rather large and a package for dispensing such components may be, for example, vehicle mounted, for example on a truck and / or in a shipping container. Dispensing may include matching up of an operator need (e.g., for a certain device) with a plan for arrangement of devices. By dispensing a particular and optionally tracked device, tracking may continue after installation, for example. It is also noted that some of the dispensed components.
[0587] The following list of examples is non-exhaustive of components which may be tracked and / or dispensed using a system such as described herein and is intended to show a broad range of possibilities. However, as noted, some particular types of components enjoy a particular and / or greater benefit when a tracking and / or dispensing system as described herein is used and the list is not intended to be a flat list showing equivalence between the application of the systems and methods described herein to such components. In particular items having to do with the human body and especially health and especially small components such as pills appear to benefit. It is noted that small components having to do with health are often consumables that an end user would want to carry around, which generally may make the tracking more difficult.
[0588] 1. Health and Medical
[0589] 1.1 Medical and Diagnostic Devices
[0590] • Portable Diagnostic Kits
[0591] • Lab-on-a-Chip Devices
[0592] • Biometric Sensors
[0593] 1.2 Pharmaceutical and Drug Delivery Units Multi-Modal Drug Delivery Systems
[0594] Controlled Release Capsules
[0595] Transdermal Patches
[0596] 1.3 Biochemical Sensors
[0597] • Glucose Monitors
[0598] • Lactate Sensors
[0599] • Hormone Level Detectors
[0600] • Neurotransmitter Sensors
[0601] 1.4 Personal Care and Cosmetic Items
[0602] • Skincare Samples
[0603] • Fragrance Capsules
[0604] • Single-Use Makeup Products
[0605] • Dental Hygiene Chews
[0606] 1.5 Cosmeceuticals and Wellness Products
[0607] • Collagen Supplements
[0608] • Antioxidant Capsules
[0609] • Herbal Extracts
[0610] • Aromatherapy Oils
[0611] 2. Environmental and Sustainability
[0612] 2.1 Environmental Sensors and Loggers
[0613] • Air Quality Monitors
[0614] • Water Purity Sensors
[0615] • Soil Moisture Sensors
[0616] • Weather Monitoring Devices
[0617] 2.2 Environmental Actuators
[0618] • Silica Gel Packs
[0619] • CO2 Absorbers
[0620] • Oxygen Scavengers
[0621] • Desiccants
[0622] 2.3 Biodegradable and Sustainable Materials
[0623] • Bioplastic Pellets
[0624] • Compostable Packaging
[0625] • Eco-Friendly Inks
[0626] • Sustainable Textiles Environmental Remediation Products
[0627] • Oil Spill Absorbents
[0628] • Heavy Metal Clean-Up Agents
[0629] • Biodegradation Microbes
[0630] • Phytoremediation Seeds Sustainable Energy Solutions
[0631] • Micro Wind Turbines
[0632] • Piezoelectric Generators
[0633] • Hydrogen Fuel Cells
[0634] • Energy Harvesting Devices echnology and Electronics Electronic Components and Hardware Elements
[0635] • Microchips and Microprocessors
[0636] • Integrated Circuits
[0637] • Sensors
[0638] • Actuators Energy Storage and Generation
[0639] • Micro Batteries
[0640] • Fuel Cells
[0641] . Solar Cells
[0642] • Supercapacitors Optical Components
[0643] • LEDs and Laser Diodes
[0644] • Photodetectors
[0645] • Lenses and Prisms Robotics and Automation Parts
[0646] • Microcontrollers
[0647] • Servo Motors
[0648] • Robotic Sensors
[0649] • Actuation Mechanisms Communication Devices
[0650] Wireless Transceivers
[0651] Antenna Modules
[0652] RFID Tags Bluetooth Beacons
[0653] 3.6 Wearable Technology Components
[0654] • Flexible Circuits
[0655] • Haptic Feedback Modules
[0656] 3.7 Data Storage and Transfer Devices
[0657] • Encrypted Flash Drives
[0658] • Data Capsules
[0659] • Optical Storage Media
[0660] • Solid-State Drives
[0661] 3.8 Home Automation Components
[0662] • Thermostat Modules
[0663] • Security Sensors
[0664] • Voice-Controlled Devices
[0665] 4. Food and Nutrition
[0666] 4.1 Food and Nutritional Substances
[0667] • Functional Chewing Gums
[0668] • Mints with Health Benefits
[0669] • Nicotine Gums
[0670] • Energy Bars
[0671] • Nutrient-Enriched Beverages
[0672] 4.2 Hydroponic and Aquaponic Supplies
[0673] • Nutrient Solutions
[0674] • pH Balancers
[0675] • Growth Medium Capsules
[0676] • Water Conditioners
[0677] 4.3 Culinary Innovations
[0678] • Flavor Capsules
[0679] • Food Freshness Indicators
[0680] • Molecular Gastronomy Kits
[0681] • Nutrient Boosters
[0682] 5. Scientific and Educational
[0683] 5.1 Chemical and Biological Assays
[0684] • Chemical Test Strips
[0685] • Biological Strip Assays Enzyme Activity Kits
[0686] DNA / RNA Sampling Units Educational and Research Tools
[0687] • Microscope Slides
[0688] • Sample Collection Kits
[0689] • Experiment Modules
[0690] • STEM Learning Kits Nanotechnology Products
[0691] • Nanoparticle Suspensions
[0692] • Carbon Nanotubes
[0693] • Quantum Dots
[0694] • Nano-Coatings Time-Sensitive and Perishable Goods
[0695] • Live Biological Samples
[0696] • Probiotics
[0697] • Reactive Chemicals
[0698] • Vaccines Bioinformatics Tools
[0699] • Gene Sequencing Chips
[0700] • Protein Analysis Kits
[0701] • Microarray Slides
[0702] • CRISPR Cas9 Components Educational Tools for Remote Learning
[0703] • Interactive Learning Modules
[0704] • Language Translation Devices
[0705] • Portable Science Kits
[0706] • Virtual Dissection Tools Exploratory and Scientific Instruments
[0707] • Drones with Specialized Sensors
[0708] • Subsurface Exploration Tools
[0709] • Atmospheric Sampling Devices
[0710] • Geological Survey Equipmentgriculture and Horticulture Agricultural Inputs • Seed Packets
[0711] • Fertilizer Pellets
[0712] • Pesticide Capsules
[0713] • Soil Conditioners
[0714] 7. Safety and Security
[0715] 7.1 Smart Packaging Components
[0716] • Temperature Indicators
[0717] • Time-Temperature Integrators
[0718] • Tamper- Evident Seals
[0719] • Interactive Labels
[0720] 7.2 Security and Authentication Devices
[0721] • Biometric Scanners
[0722] • Encryption Modules
[0723] • Secure Access Tokens
[0724] • Holographic Seals
[0725] 7.3 Emergency and Safety Supplies
[0726] • First Aid Components
[0727] • Water Purification Tablets
[0728] • Fire Suppression Balls
[0729] • Emergency Light Sources
[0730] 7.4 Anti-Counterfeiting Measures
[0731] • Smart Tags
[0732] • Invisible Inks
[0733] • Blockchain-Based Authenticity Certificates
[0734] • Secure Holograms
[0735] 7.5 Personal Safety Devices
[0736] • Location Trackers
[0737] • Health Alert Systems
[0738] • UV Exposure Monitors
[0739] 8. Transportation and Aerospace
[0740] 8.1 Automotive and Mechanical Parts
[0741] • Sensors (e.g., tire pressure, engine temperature)
[0742] • Micro Actuators
[0743] • Smart Fasteners Diagnostic Tools Aerospace Components
[0744] • Micro Thrusters
[0745] • Navigation Sensors
[0746] • Material Samples
[0747] • Satellite Components Marine and Underwater Equipment
[0748] • Submersible Sensors
[0749] • Buoyancy Control Devices
[0750] • Underwater Communication Modules
[0751] • Coral Restoration Units Space Exploration Supplies
[0752] • CubeS ats
[0753] • Astronaut Health Monitors
[0754] • Material Samples for Space Testing
[0755] • Radiation Shields onstruction and Manufacturing Building and Construction Materials
[0756] • Smart Sensors
[0757] • Insulation Materials
[0758] • Advanced Composites
[0759] • Nano-Enhanced Coatings Advanced Materials
[0760] • Graphene Sheets
[0761] • Aerogels
[0762] • Superconducting Materials
[0763] • Shape-Memory Alloys 3D Printing Materials
[0764] • Filament Spools
[0765] • Resin Cartridges
[0766] • Metal Powders
[0767] • Bioprinting Bioinks Entertainment and Lifestyle Entertainment and Media Devices • Game Cartridges
[0768] • Music Chips
[0769] • Augmented Reality Modules
[0770] • Virtual Reality Components
[0771] 10.2 Fashion Tech Accessories
[0772] • Smart Jewelry
[0773] • Interactive Clothing
[0774] • LED Accessories
[0775] • Mood-Sensing Wearables
[0776] 10.3 Sports and Fitness Equipment
[0777] • Performance Sensors
[0778] • Hydration Monitors
[0779] • Interactive Training Aids
[0780] 10.4 Consumer Convenience Products
[0781] • Self-Heating Meals
[0782] • Instant Cooling Packs
[0783] • Portable Water Filters
[0784] • Single-Use Toiletries
[0785] 11. Finance and Business
[0786] 11.1 Financial Technology Devices
[0787] • Cryptocurrency Hardware Wallets
[0788] • Secure Payment Chips
[0789] • Authentication Tokens
[0790] • Blockchain Nodes
[0791] 11.2 Logistics and Supply Chain Enhancements
[0792] • Real-Time Tracking Beacons
[0793] • Environmental Condition Loggers
[0794] • Smart Inventory Tags
[0795] • Automated Sorting Modules
[0796] 12. Emerging Technologies
[0797] 12.1 Quantum Computing Components
[0798] • Qubit Chips
[0799] • Quantum Dots
[0800] • Photon Detectors • Superconducting Circuits
[0801] 13. Veterinary and Animal Care
[0802] 13.1 Veterinary and Animal Care Products
[0803] • Pet Health Monitors
[0804] • Nutritional Supplements
[0805] • Behavioral Tracking Devices
[0806] • Microchip Implants.
[0807] Exemplary method for reusing and / or reclaiming substance units
[0808] In some embodiments, the substance unit management may utilize reverse and / or lateral logistics for redistributing excess and / or unused substance units, for example, managing returns due to product recalls, expiration, lack of use, and / or reallocating units to areas where demand is higher. Reverse logistics may involve returning units from the end user and / or retailer back to the manufacturer for disposal and / or quality testing. Additionally, or alternatively, users may return substance units that they no longer need to the retailer, allowing the redistribution of these units. In some embodiments, these returns are accompanied by a financial refund, potentially encouraging users to return unused and / or surplus substance units for repurposing and / or proper disposal. This has the potential advantage of improving inventory management and / or supporting environmental sustainability by reducing waste.
[0809] In some embodiments, lateral logistics may allow transferring units between distributors, manufacturers, and / or retailers, or other entities at the same level of the supply chain. In some embodiments, lateral logistics may allow transferring units between users, for example, from a patient who no longer needs a specific substance unit to another who does. In some embodiments, such transfers may require approval from an authoritative agent, such as the treating physician and / or a pharmacist, for example, to potentially ensure that the transaction adheres to medical guidelines and / or regulations. In some embodiments, the substance units management system is configured to provide an optional related service. It may be understood that when prescriptions are prepared prospectively, cases where a prescription remains unclaimed can occur. Since the system’s containers (e.g., origin and / or customized containers) are, in some examples, fully qualified as long-term storage for the substance units they contain (e.g., optionally as qualified as a pill bottle sealed by induction heating), this may not be an issue, even though the substance units have been transferred from their original packaging, and / or from an origin container to a customized container. However, there may be limitations asserted by regulations and / or manufacturer specifications regarding mixed containers; e.g., restrictions on how long a mixed combination of substance units can remain together within an container , and / or what degree of potentially cross-contaminating contact is permitted. Un-mixing (as an example) potentially helps preserve the shelf life of substance units affected.
[0810] Exemplary mass-storage devices
[0811] In some embodiments, end users (e.g., end user 212) are provided with mass-storage devices, which are provided with enough storage space to hold a larger portion of the end user’s personal inventory of substance units and / or customized containers than the dispensing device which they use for dispensing itself. Optionally, the dispensing device docks with the mass-storage device \. Additionally, or alternatively, the mass-storage device itself comprises a controller capable of driving the container directly. For example, the mass-storage device is itself a form of the dispensing device comprising a plurality of containers. In some embodiments, rearrangements of the substance units suitable to the regimen of an the end user are performed by the mass-storage device, e.g., by feeding the substance units in a type-mixed order into the container used with the dispensing device, from a starting state in which the substance units are arranged in separate storage areas according to type and / or pharmaceutical code.
[0812] Exemplary authentication and authorization process
[0813] Referring now to Figure 21, which schematically illustrates authorization and / or authentication of the operations of the substance units management system, according to some examples of the present disclosure. In some examples, docking combinations of the containers 70, and in particular exchanges of substance units 101 while docked (within a device), are performed according to a protocol which specifies a level of authentication, authorization (and optionally other validation) required. Furthermore, in some examples, operations which modify the ordering of substance units 101 even while remaining within a same container 70 are subject to authorization and authentication. Optionally, the level of validation required is dynamic and / or selected according to circumstances (e.g., as determined by one or more component-associated rules and / or programs). The descriptions in relation to Figure 21 relate to authentication and authorization occur at the level of containers 70. Insofar as this level of control discourages deliberate interference with the substance units management system (e.g., by reducing the value of even of successful interference), it allows the state of the data ledger 202_(e.g., previously shown in Figure 2) to serve as an adequate proxy for the actual state of system components in a large number of situations, even though the system regularly performs manipulations to internal arrangements of substance units which are not immediately confirmed by direct re-inspection. The focus of the authorization and authentication system relates in large part to preventing undetected changes which create skew between data ledger 202_and the actual situation. While physically preventing changes due to malicious intent may be impractical, incentives can be reduced, limiting risk. Furthermore, detection can be converted into mitigating actions which potentially preserve safety and limit losses. Reciprocal awareness of this is potentially a further discouragement to systematic abuse.
[0814] In Figure 21 the path beginning with node 2230 indicates an optional order in which information supporting required assertions (e.g., identifying information and / or information about pristine status) are collected, processed, and / or transmitted in communication with data ledger 202. For the sake of simplicity of descriptions, it should be understood that procedural variations (e.g., as indicated below for certain operations) can be applied in any suitable combination to get the intended effect of an accurately authenticated authorization to perform a transfer operation.
[0815] At node 2230, in some examples, to begin the process of authentication and authorization, agent 2220 (e.g., for example, the agents detailed in Figure 2) communicates their authentication credentials to data ledger 202 (a logical data connection is indicated by the wiggly line connecting them), optionally along with data describing the action they wish to authorize. The credentials optionally comprise any suitable combination authentication secrets, devices, and / or operations e.g., password entry, biometric identification, proof of possession of a trusted device, and / or another authentication token.
[0816] At node 2232, computational resources which maintain data ledger 202 consult the agent record 2221 associated with the provided authentication credentials, and determine that agent 2220 is properly identified, and at least potentially authorized for initiating the exchange (insofar as it may have been specified). Insofar as data ledger 202 itself is optionally distributed, responsibility for this determination optionally falls to any point of contact with the computational resources which maintain it. Optionally, synchronization mechanisms are in place throughout the distributed portion of data ledger 202 with sufficiently low latency to avoid such problems as double authorizations and other race conditions.
[0817] At node 2234, agent 2220 receives a transaction token (e.g., a passkey) which can now be used to begin a transaction. Accordingly, at node 2236, agent 2220 provides the transaction token to controller 204 (e.g., previously shown in Figure 2), while instructing it to begin a transaction. For the sake of simplicity, it is assumed in this example that the second action is implied by the first, e.g., because of details agent 2220 defined in the initial request to data ledger 202, but optionally these are two separate actions. Optionally, some feature of the transaction token is itself associated with an indication of the level of authorization of agent 2220. For example, controller 204 may “know” that it can only be operated by certain agents 2220, or operated only on conjunction with certain operations, and the transaction token may convey this information to controller 204. This principle of combining and coordinating global and local authorization knowledge optionally applies at any suitable stage of the process. Optionally, data ledger 202 (that is, the computing resources associated with it) directly informs controller 204 about the open transaction token, e.g., because it can be determined from data ledger 202 that there is a suitably authorized link pre-existing between controller 204 and agent 2220, and / or because agent 2220 informed data ledger 202 what controller 204 would be used. Optionally, awareness of the transaction token propagates locally among communication- capable components; e.g., controller 204, once aware of the transaction token and / or the operation details it defines, optionally broadcasts it to other potentially operable hardware in the vicinity.
[0818] At node 2238, controller 204 initiates a query for the authentication information of container 70, to which it is docked. As examples, the docking may have been pre-arranged by agent 2220, and / or it may be arranged automatically, e.g. , by signaling originating form data ledger 202 as a result of the early request by agent 2220.
[0819] At node 2240, container 70 produces the authentication information (this may be a passive operation on its own part, e.g., a function of its intrinsic physical properties).
[0820] At node 2242 this information returns to controller 204. Authentication information optionally comprises one or more pieces of information physically measured from container 70, e.g., by use of an interferometric method. In some examples, this information is used to detect tampering with and / or damage to container 70, and optionally to detect evidence of unauthorized use or an otherwise degraded state of its pristine status — that is, a deviation between what is recorded in data ledger 202 with regard to the contents of container 70, and what the actual state of those contents is.
[0821] In the example shown, the information is forwarded to the computational resources of data ledger 202, optionally along with the transaction token and / or information authenticating controller 204 itself (z.e., assuming one or both of these have not already been validated through the computational resources of data ledger 202). At node 2244, data ledger 202 is consulted to confirm that the information provided is sufficiently authenticating (e.g., of the identity and pristine status of container 70 and / or controller 204). As relevant, it is also verified that the agent 2220 indicated by the controlling transaction token is authorized to use controller 204 to modify container 70. At node 2246, controller 204 receives an authorization token with which it can initiate operations upon confirming it using a cryptographic secret in its possession.
[0822] In some examples, controller 204 receives a conditional authorization. For example, controller 204 optionally retains a portion of the physically identifying information for container 70 locally, and learns from its communications with data ledger 202 a template (e.g., a hash value) which allows it to verify that information for itself. Final authorization is conditional on successful verification. This has potential advantages for allowing multiple local measurement attempts, e.g., in case the physical information is subject to noise and / or requires a period of guided calibration.
[0823] It should be understood that portions of the communications of nodes 2238-2245 are optionally initiated at any stage once controller 204 and container 70 are interconnected, with missing information being verified once the transaction token is provided. Optionally controller 204 is configured to calculate basic information about the state and / or identifying information it receives from container 70, e.g., sanity checks and fixed identification data.
[0824] It should be noted that in some examples, authenticating information provided at node 2240 is at least partially destroyed once operations begin, because it is tied to a physical state of container 70 which is destroyed, e.g., when a port is opened, when a substance unit 101 is moved, and / or when elements internal to container 70 are operated. Accordingly, at node 2248, in an optional (and separately indicated) loop, controller 204 optionally establishes a local handshake identification with container 70, early enough to assure concurrency with the gathering of information of nodes 2238-2242. The local handshake identification provides an assurance that the authentication of container 70 is not rendered moot by a forced replacement. In a simple case, the handshake is simply a switch positioned where it is forced to change state when controller 204 and container 70 are separated. In some examples, the handshake involves the exchange of cryptographic secrets, increasing certainty that the original container 70 remains in place.
[0825] In some examples, at the conclusion of operations (e.g., once container 70 has been resealed and / or otherwise “locked down”), controller 204 repeats the measurement-based identification of nodes 2238-2242. The measurement data received (and / or some processed version of it, such as a hash) is forwarded to data ledger 202 to be recorded. This new information becomes part of the records relating to container 70, and restores to data ledger 202 an updated record of its physical state identifying information.
[0826] It should be understood that records for the substance units 101 themselves are optionally maintained in part by being linked to the histories of the containers 70 they have passed through over time. For example, environmental data are optionally measured at the level of containers 70, and propagated in data ledger 202 to substance units 101 via linking references. Conversely, the storage state of a container 70 is optionally maintained by links to certain details found in records for the substance units 101 it contains.
[0827] There is an additional sense in which the authentication of physical state information for a container 70 is an assurance that its ports actually are placed where they should be, relative to a port through which that data is sensed. When two containers 70 which are asserted to be docked with each other each meet that condition, it is an assurance that they actually are.
[0828] In some examples, controller 204 also validates itself physically, for example using one or more intrusion-detection mechanisms as also described herein in relation to containers 70. Additionally, or alternatively, container 70 itself comprises processing circuitry which is capable of critical aspects of authenticating tamper-evidencing, damage-evidencing and / or use-evidencing information. Either case provides a potential bulwark against a scenario in which a corrupted controller 204 could be used to do “something different” than what is ultimately reported to data ledger 202 and accepted as correct. However, e.g., insofar as operation of controllers 204 is already tied to operator credentials, and insofar as authentication and authorization are repeatedly performed within the system, scenarios where this is relevant may be relatively minor.
[0829] Optionally, dual authentication is used, e.g., using waveguides which relay an authenticating interference pattern from a first container 70, through a second container 70 and then to a controller 204 which then reports to data ledger 202 based on what was imaged from both. Optionally, a controller for the first container 70 performs the converse for the second and first containers 70.
[0830] General
[0831] It is expected that during the life of a patent maturing from this application many relevant substance units will be developed; the scope of the term substance units is intended to include all such new technologies a priori.
[0832] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.
[0833] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.
[0834] The term “consisting of’ means “including and limited to”.
[0835] The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and / or parts, but only if the additional ingredients, steps and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure. As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
[0836] Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
[0837] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.
[0838] As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
[0839] As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.
[0840] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
[0841] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
[0842] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.
Claims
WHAT IS CLAIMED IS:
1. A method for managing an individually consumable bioactive substance unit as it travels along a distribution pathway of a substance units management system, comprising: loading the substance unit into at least one container, wherein the container comprises a plurality of subsections for a plurality of substance units, wherein each subsection is configured to be associated with a single substance unit of the plurality of substance units; storing substance unit data of the substance unit with relation to the subsection accommodating it; transferring the substance unit between subsections of the same container and / or between containers; and further storing substance unit data based on the transferring.
2. The method according to claim 1, wherein the further storing comprises relating the substance unit with a current subsection accommodating it.
3. The method according to any of claims 1-2, wherein the transferring comprises dispensing the substance unit out of the container, and wherein the further storing comprises storing substance unit data based on the dispensing.
4. The method according to any of claims 1-3, wherein said loading comprises physically inserting the substance unit into the container while reliably virtually inserting the substance unit into the system.
5. The method according to claim 4, wherein the reliably virtually inserting comprises atomically performing both the physical and virtual insertions.
6. The method according to claim 4, wherein the reliably virtually inserting comprises performing both the physical and virtual insertions substantially simultaneously.
7. The method according to claim 4, wherein the virtually inserting comprises associating the substance unit with a unique ID.I l l8. The method according to claim 4, wherein the associating comprises storing the unique ID in the substance unit data.
9. The method according to any of claims 1-8, comprising performing the loading and the storing substantially simultaneously.
10. The method according to any of claims 1-9, comprising performing the transferring and the further storing simultaneously.
11. The method according to any of claims 1-10, wherein said transferring comprises reporting on intention to transfer a substance unit, transferring said substance unit, and reporting on performing the transferring.
12. The method according to any of claims 1-11, wherein the substance unit data comprises one or more of: tracking data; monitoring data; and substance data.
13. The method according to claim 12, comprises tracking a substance unit based on the tracking data.
14. The method according to claim 12 or claim 13, wherein the tracking data comprises one or more of: the substance unit’s current container; the substance unit’s current subsection within its current container; the substance unit’s container history; and the substance unit’s subsections history.
15. The method according to claim 12, wherein the substance data comprises one or more of: substance units pharmaceutical code; substance unit type; active ingredients;ingredient percentages; dosage; brand; batch; manufacturer; manufacturing date; expiration date; manufacturing location; and manufacturing process.
16. The method according to any of claims 1-15, wherein the storing comprises recording the substance unit data in a data ledger.
17. The method according to any of claims 1-16, comprising storing container data.
18. The method according to claim 17, wherein the storing container data comprises recording the container data in a data ledger.
19. The method according to any of claims 17-18, wherein the container data comprises one or more of: a status of the at least one container; a current location of the at least one container; current container’ s holder; location history of the container; status history of the container; and history of container holders.
20. The method according to claim 19, wherein said status comprises one or more of: stored by the manufacturer, transported to a distribution site, loaded into a distribution device, stored by an end user, loaded to a dispensing device, and / or out of service.
21. The method according to any of claims 1-20, wherein the substance unit is a human consumable substance unit.
22. The method according to any of claims claim 1-21, wherein the substance unit is health-related.
23. The method according to any of claims 1-22, wherein the substance unit is wellness-related.
24. A method for managing at bioactive least one substance unit, comprising: collecting a plurality of substance units into at least one origin container, wherein each substance unit of the plurality of substance units is positioned at a different subsection of the at least one container; storing data of each substance unit with relation to the subsection occupying thereof; transferring substance units, one by one, from the at least one origin container to at least one different container, according to a distribution demand; storing a record of the at least one different container subsections that received a substance unit of said plurality of substance units, such that a data of each substance unit is associated with the subsection accommodating it ; and updating the recording of the at least one origin container subsections that delivered a substance unit to the at least one different container.
25. The method according to claim 24, wherein the at least one substance unit is a plurality of substance units.
26. The method according to claim 24 or claim 25, wherein the collecting comprises collecting the substance units at the manufacturer's facility.
27. The method according to any of claims 24-26, wherein the collecting comprises collecting the substance units as they are manufactured.
28. The method according to any of claims 24-27, wherein the at least one origin container is homogeneous with respect to the substance units occupying it.
29. The method according to any of claims 24-27, wherein the at least one origin container is heterogeneous with respect to the substance units occupying it.
30. The method according to claim 29, wherein the at least one origin container comprises a combination of different types of substance units, commonly consumed by a specific consumption group.
31. The method according to any of claims 24-30, wherein the substance units are identical in one or more of: size, shape, and form factor.
32. The method according to any of claims 24-31, comprising providing the at least one different container to an end user.
33. The method according to claim 32, wherein the at least one different container is an end user’s personal container.
34. The method according to any of claims 32-33, wherein the at least one different container contains a personalized combination of substance units.
35. The method according to any of claims 24-34, wherein the distribution demand is user-specific.
36. The method according to any of claims 24-35, comprising storing the at least one container.
37. The method according to any of claims 24-36, comprising transporting the at least one container.
38. The method according to claim 37, wherein the transporting comprises transporting the container to a distribution site.
39. The method according to claim 38, wherein the transferring is performed at the distribution site.
40. The method according to any of claims 24-39, wherein the transferring comprises transferring one or more of the substance units of said plurality of substance units from one subsection to another within the at least one container.
41. The method according to any of claims 24-40, wherein the transferring comprises dispensing more than one substance unit of said plurality of substance units from the at least one origin container, one by one to the at least one different container.
42. The method according to claim 41, wherein the more than one substance units are inserted into the at least one different container one by one.
43. The method according to any of claims 24-42, wherein the transferring comprises selecting one or more specific substance units to be transferred.
44. The method according to any of claims 24-43, wherein the transferring comprises transferring a substance units from the at least one container to the at least one different container through one or more additional containers.
45. The method according to any of claims 24-44, wherein the transferring comprises aligning at least one opening of the at least one container with at least one opening of the at least one different container.
46. The method according to any of claims 24-45, wherein the transferring comprises transferring a substance unit to the at least one different container from a plurality of containers.
47. The method according to claim 43, wherein the selecting comprises considering the substance unit’s expiration date.
48. The method according to claim 43, wherein the selecting comprises considering the expiration dates of each of a plurality of substance units.
49. The method according to any of claims 43-48, wherein the selecting comprises considering the substance unit’s location within the at least one container.
50. The method according to any of claims 24-49, wherein the transferring comprises selecting a subsection for each substance unit of the plurality of substance units within the at least one different container.
51. The method according to any of claims 24-50, comprising sealing the at least one origin container.
52. The method according to any of claims 24-51, comprising sealing the at least one different container.
53. The method according to any one of claims 51 and 52, wherein the sealing comprises tamper-evident sealing.
54. The method according to claim 53, comprising detecting if one or both of the at least one origin container and the at least one different container have been tampered with before performing the transferring.
55. A method for delivering a substance unit to an end user, who has at least one customized container and a dispensing device, the method comprising: receiving a consumption demand; selecting a substance unit from the plurality of substance units, based on the consumption demand; moving the substance unit within the customized container from one subsection to another subsection; and dispensing the substance unit out of the container.
56. The method according to claim 55, comprising providing the end user with the customized container.
57. The method according to claim 55 or claim 56, comprising providing the end user with the dispensing device.
58. The method according to any of claims 55-57, wherein the receiving comprises receiving the consumption demand from the end user.
59. The method according to any of claims 55-58, wherein the receiving comprises receiving the consumption demand from one or more agents.
60. The method according to claim 59, wherein the one or more agents comprise one or more of: medical supervisor; health Insurer; and regulator.
61. The method according to any of claims 55-60, wherein the consumption demand comprises a consumption program.
62. The method according to claim 61, comprising scheduling the dispensing based on the consumption program.
63. The method according to any of claims 61-62, comprising sending the user reminders based on the consumption program.
64. The method according to any of claims 61-63, wherein the consumption demand comprises a one-time consumption requirement.
65. The method according to claim 64, wherein the consumption demand comprises an immediate consumption requirement.
66. The method according to claim 64 or claim 65, comprising determining whether to comply with the requirements.
67. The method according to any of claims 55-66, wherein the selecting comprises selecting a substance unit that meets the consumption demand and has the nearest expiration date.
68. The method according to any of claims 55-67, wherein the dispensing is contingent upon first identifying an end user.
69. The method according to any of claims 55-68, wherein the receiving comprises receiving an interaction demand.
70. The method according to claim 69, comprising prompting the user based on the interaction demand.
71. The method according to claim 70, wherein the prompting comprises prompting the user to deposit a sample into the container.
72. The method according to claim 70, wherein the prompting comprises prompting the user to exhale into the container.
73. A method for tracking a plurality of substance units, comprising: registering a substance unit of the plurality of substance units as it is inserted into one or more containers, wherein each container of the one or more origin containers comprises a plurality of subsections; storing a record of a subsection accommodating the substance unit; storing a record of the substance unit current subsection, upon transferring the substance unit between subsections of the container; storing a record of the substance unit current subsection at a different container, upon transferring the substance unit between containers; and tracking the substance unit based on the record thereof.
74. The method according to claim 73, wherein the plurality of substance units comprises individually consumable bioactive substance units.
75. The method according to claim 73 or claim 74, comprising storing a record of the substance unit status, upon dispensing the substance unit out of the container.
76. The method according to any of claims claim 73-75, comprising registering the container and / or storing a record of the container location.
77. The method according to any of claims 73-76, comprising storing a record of a current location of the container, upon transportation of the container.
78. A substance units management system, comprising: a controller, configured to produce a command to transfer a substance unit between subsections of a container or between containers;a movement mechanism, configured to move the substance unit based on the command; and a data ledger, configured to record the subsection accommodating the substance unit.
79. The substance units management system according to claim 78, wherein the movement mechanism is configured to move at least one other substance unit for moving the substance unit.
80. The substance units management system according to any of claims 78-79, wherein the substance units management system is configured to communicate with at least one agent related thereto.
81. The substance units management system according to any of claims 78-80, wherein the data ledger is implemented using a blockchain.
82. The substance units management system according to any of claims 78-81, wherein the data ledger comprises more than one separate data ledger.
83. The substance units management system according to claim 82, wherein each one of the more than one separate data ledger is controlled by a separate agent than the others.
84. A method for monitoring a plurality of individually consumable bioactive substance units contained within a container, wherein each substance unit of the plurality of substance units is positioned within a different subsection of the at least one container, wherein the method comprises: measuring the environment, by at least one environmental sensor; receiving a consumption demand; and selecting substance units based on the consumption demand and the measuring.
85. The method according to claim 84, wherein the at least one sensor environmental sensor is located within the container.
86. The method according to any of claims 84-85, wherein the at least one sensor environmental sensor is located outside of the container.
87. The method according to any of claims 84-86, wherein the at least one sensor comprises one or more of: temperature sensor; humidity sensor; light sensor; and chemical sensor.
88. The method according to any of claims 84-87, wherein the at least one sensor is incorporated within the container.
89. The method according to any of claims 84-88, wherein the at least one sensor is incorporated within a device the container is loaded into.
90. The method according to any of claims 84-89, wherein the measuring comprises measuring one or more environmental conditions that do not correspond to the recommended environmental conditions.
91. The method according to claim 90, comprising determining that one or more substance units are unsuitable for consumption based on the measuring.
92. The method according to any of claims 84-91, comprising tracking an expiration date of each substance unit of said plurality of substance units.
93. The method according to any of claims 84-92, determining that one or more substance units are unsuitable for consumption, based on the tracking.
94. The method according to claim 91 or claim 93, comprising recording the one or more substance units as restricted substance units.
95. The method according to any of claims 84-94, wherein the selecting comprises selecting at least one substance unit that meets the consumption demand and excluding the restricted substance units.
96. The method according to claim 95, comprising quarantining the restricted substance units.
97. A method for reclaiming at least one substance unit from an end user container, comprising: selecting the at least one substance unit for the reclaiming; transferring the at least one substance unit from the end user container to a different container; and recording the substance unit as designated for reclaiming.
98. The method according to claim 97, wherein the different container is owned by an agent other than the end user.
99. The method according to any of claims 97-98, comprising transporting the different container from the end user to the agent.
100. The method according to any of claims 97-99, wherein the transferring is performed at a distribution site.
101. The method according to any of claims 97-100, comprising recording the transferring.
102. The method according to any of claims 97-101, comprising receiving a reclaiming request.
103. A method for managing a plurality of substance units, comprising: collecting a plurality of substance units; at least partially filling a plurality of containers with substance units of the plurality of substance units, wherein the plurality of containers are manufactured to be identical to each other; transporting the plurality of containers; and transferring at least one substance unit from the plurality of containers to at least one different container, wherein the at least one different container is manufactured to be identical to the plurality of containers.
104. The method according to claim 103, comprising storing the plurality of containers.
105. The method according to any of claims 103-104, comprising providing the at least one different container to an end user.
106. The method according to any of claims 103-105, comprising recording any relocation of a substance unit within and / or between containers.
107. The method according to any of claims 103-106, comprising recording any relocation of a container.
108. A method for managing a plurality of health-related substance units, comprising: producing the plurality of substance units; loading the plurality of substance units into one or more origin containers, wherein each container of the one or more origin containers comprises a plurality of subsections; recording details of each substance unit of the plurality of substance units each with respect to a subsection of the plurality of subsections accommodating thereof; transporting the one or more origin containers; receiving a distribution demand; loading the one or more origin containers into a distribution system; loading at least one customizable container into the distribution system; transferring one or more substance units from the one or more origin containers to the at least one customizable container; updating the records of the transferred substance units by associating each substance unit with a subsection of the at least one customizable container accommodating thereof; loading the at least one customizable container to a dispensing device; receiving a dispensing demand; and dispensing one or substance unit, based on the dispensing demand.
109. The method according to claim 108, wherein the dispensing comprises dispensing the one or more substance unit, one by one.
110. The method according to claim 108 or claim 109, wherein the distribution demand comprises a user-specific distribution demand.
111. A method for tracking a plurality of individually consumable bioactive substance unit, comprising: registering a substance unit of the plurality of substance units as it is inserted into an origin container, wherein the origin container comprises a plurality of subsections; registering the origin container; storing a record of the origin container location; storing a record of a subsection accommodating the substance unit; storing a record of a current location of the origin container, upon transportation of the container; storing a record of the substance unit current subsection, upon transferring the substance unit between subsections of the origin container; storing a record of the substance unit current subsection at a different container, upon transferring the substance unit between one or more containers; and tracking the substance unit based on the record thereof.
112. The method according to claim 111, comprising storing a record of the substance unit status, upon dispensing the substance unit out of the different container.
113. The method according to any of claims 111-112, comprising storing a record of the substance unit current subsection at a different container, upon transferring the substance unit from the origin container to a customized container.
114. A method for preparing a customized container, comprising connecting more than one container to a container designated to be customized, and transferring substance units from the more than one container into the container designated to be customized, until obtaining a desired substance unit content within the container.
115. The method according to claim 114, comprising receiving a distribution demand, wherein the transferring comprises transferring substance units from the more than one container into the container designated to be customized based on the distribution demand.
116. The method according to any of claims 114- 115, wherein the connecting comprises connecting the more than one container in a series.
117. The method according to any of claims 114- 116, wherein the connecting comprises connecting the more than one container in parallel.
118. The method according to any of claims 114-117, wherein the connecting comprises connecting the more than one container simultaneously.
119. The method according to any of claims 114-118, wherein the connecting comprises connecting the more than one container sequentially.
120. The method according to any of claims 114-118, wherein the more than one container comprises at least origin container.
121. A system for preparing a customized container, comprising: a plurality of containers, wherein each container is connected to at least one container of said plurality of containers; and a controller, instructing on the transfer of substance units between the containers.
122. A method for transferring a substance unit from a first container to a second container, comprising: connecting the first container to the second container; transferring the substance unit between the first and the second container; and detecting the substance unit as it transferred between the containers.
123. The method according to claim 122, wherein the detecting comprises detecting the emergence of the substance unit from the first container.
124. The method according to any of claims 122-123, wherein the detecting comprises detecting the entrance of the substance unit into the second container.
125. The method according to any of claims 122-124, wherein the detecting comprises one or more of: imaging and scanning the substance unit.
126. The method according to any of claims 124-125, wherein the detecting comprises identifying the substance unit.
127. The method according to any of claims 124-126, wherein the transferring is subject to the identifying.
128. A method for managing the interaction between a first participant and a second participant involved in the distribution at least one substance unit, comprising: authenticating the first participant; verifying the authorization of the first participant; authenticating the second participant; verifying the authorization of the second participant; and allowing the interaction between the first and the second participants.
129. The method according to claim 128, comprising recording the interaction.
130. The method according to any of claims 128-129, wherein the first participant is one of: a container configured to contain the at least one substance unit and a device configured to manipulate the substance unit.
131. The method according to any of claims 128-130, wherein the second participant is one of: a container configured to contain the at least one substance unit and a device configured to manipulate the substance unit.
132. The method according to any of claims 128-131, wherein the interaction comprises transferring a substance unit from the first participant to the second participant.
133. The method according to any of claims 128-132, comprising verifying that one or both of the first participant and the second participant are within an approved geofenced area.
134. The method according to any of claims 128-133, wherein the one or both of the first and second participants are an entity and / or an agent.
135. The method according to claim 134, wherein the entity and / or an agent is one or more of: manufacturer, distributor, retailer, end user, regulator, and insurer.
136. The method according to any of claims 128-135, wherein the substance unit comprises a health-related substance unit.
137. The method according to any of claims 128-136, comprises verifying that the interaction is allowed.
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