WO2019246149A1 - Systèmes et procédés de liaison et de stockage de produits biologiques - Google Patents

Systèmes et procédés de liaison et de stockage de produits biologiques Download PDF

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Publication number
WO2019246149A1
WO2019246149A1 PCT/US2019/037800 US2019037800W WO2019246149A1 WO 2019246149 A1 WO2019246149 A1 WO 2019246149A1 US 2019037800 W US2019037800 W US 2019037800W WO 2019246149 A1 WO2019246149 A1 WO 2019246149A1
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WO
WIPO (PCT)
Prior art keywords
biological sample
unique identifier
portions
sample
information
Prior art date
Application number
PCT/US2019/037800
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English (en)
Inventor
Rick W. OBRAY
Steven Richard Schone
Original Assignee
Regenerative Medical Technologies, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regenerative Medical Technologies, Inc. filed Critical Regenerative Medical Technologies, Inc.
Publication of WO2019246149A1 publication Critical patent/WO2019246149A1/fr

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/10—Protocols in which an application is distributed across nodes in the network
    • H04L67/1097—Protocols in which an application is distributed across nodes in the network for distributed storage of data in networks, e.g. transport arrangements for network file system [NFS], storage area networks [SAN] or network attached storage [NAS]
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/12—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Definitions

  • Systems and methods are disclosed herein that relate to the linking, storage, and/or accessing of samples, such as biologies.
  • inventive concepts disclosed herein may be used to provide systems and/or methods that allow a donor or donor representative of biologies, such as placental tissue, umbilical cord tissue, blood, DNA samples, and the like, to be provided with a means for linking a sample to a donor and accessing the sample at a later time, such as a QR code or other readable code.
  • this code or other linking means is something that can be kept with a donor, user, and/or customer and a duplicate of which is provided with the sample so that the donor/user/customer can present the code when the sample is needed and a medical practitioner and/or third-party, such as a lab technician, can use the code to access the sample.
  • a medical practitioner and/or third-party such as a lab technician
  • procedures and/or features are put in place to minimize the chances of samples being lost or linked with the wrong donor/user/customer.
  • the method may comprise sending a customer, donor, and/or user a kit comprising a bag or individual sample storage container marked with a trackable code.
  • the kit preferably also comprises one or more means for retrievably displaying the trackable code, such as a wristband, an item of jewelry, a wallet card or other card, or software and/or hardware configured to display the code as needed, such as mobile applications for a smartphone.
  • the method may further comprise receiving the container with the sample from the customer and linking the sample with the customer. This may be done, for example, by generating data in a computing system comprising the code and linking the code with a user profile of the customer and/or a related donor.
  • the sample may then be stored, preferably in a storage system comprising a database for tracking storage locations, trackable codes, user/donor data, etc.
  • the matching codes may be linked with a particular location within a storage container, in some such embodiments within a particular location within a particular storage container amongst a plurality of storage containers, such that the location can be easily identified using the trackable code.
  • the storage system is configured to allow an operator to scan or otherwise read the code and immediately generate information about the specific location of the sample and/or automatically retrieve the sample using the code.
  • the method may further comprise accessing the sample, again, preferably using the code.
  • the sample may be accessed, if desired, using the code alone.
  • a search may be conducted prior to accessing the sample. For example, if the code has been lost, a search may be conducted using other search parameters, such as customer name, donor name, donation type, donation date, physician name, storage container unit number and/or slot/location, etc. Either with such a search or using the code alone, the sample may then be accessed for later use by, for example, the donor or a family member of the donor.
  • FIG. l is a schematic diagram of a system for linking, storing, and tracking biologies or other samples according to some embodiments
  • FIG. 2 is a flow chart of a method for linking, storing, and tracking biologies or other samples according to some implementations.
  • FIG. 3 depicts another system for linking, storing, and tracking biologies or other samples according to other embodiments.
  • FIG. 1 depicts an example of a system 100 for linking and storing biologies for later access according to some embodiments.
  • System 100 allows a series of custom ers/donors 10 to provide a donation of live biologic material, such as umbilical cord tissue, placental tissue, blood samples, DNA, or the like, and have that material uniquely linked to them for later access.
  • live biologic material such as umbilical cord tissue, placental tissue, blood samples, DNA, or the like
  • one or more scannable or otherwise readable codes such as QR codes or other barcodes, for example, may be used to link the biologies to the donor to allow for such subsequent access when needed.
  • System 100 therefore comprises a first biologies sample l02a and a second biologies sample l02b. More particularly, sample l02a may comprise a blood bag and sample l02b may comprise a cord bag comprising umbilical cord tissue or placental tissue taken during a birthing procedure. Sample l02a is linked with a particular scannable code l04a and sample l02b is linked with another scannable code l04b. It is contemplated that codes l04a and l04b may be distinct to allow for identification of not only the specific donor of the respective biologies l02a/l02b, but also the specific type of biologies, at least in embodiments configured for processing multiple distinct types of biologies.
  • codes l04a and l04b may be identical if, for example, they both come from the same donor and/or comprise the same type of biologies. It is also contemplated that, in other embodiments, such as systems for storing, linking, and/or accessing a single type of biologies, that only one sample may be used per donor 10.
  • codes 104 may be placed on bags or other storage containers for the biologies 102.
  • a donor 10 may be provided with a kit comprising a bag or other container, preferably pre-labelled with code 104. Then, either the donor or a medical practitioner may place the biologies into the container having the code thereon, such as at the time of a birth either of the donor or by the donor’s mother, for example.
  • documents 106 may be provided with the kit comprising the bag/container.
  • this documentation may describe the process for creating a user profile and/or registering/linking the code(s) 104 with a customer/donor 10.
  • this document or documents may also comprise a scannable/readable code l04c.
  • code l04c may, but need not be, the same as codes l04a and/or l04b.
  • Additional items may be included in the customer/donor kit.
  • a bracelet l08a, ID/wallet card l08b, and/or other item, wearable or otherwise, that allows a donor/user to keep and/or display a code for accessing the biologies may be included in the kit or otherwise provided to the donor/customer 10.
  • Other examples of such means for retrievably displaying readable codes include watches, jewelry, and, as discussed below, software, such as mobile applications for smartphones and the like.
  • each of these items may be pre-printed or otherwise preconfigured with a scannable code.
  • bracelet l08a is provided with code l04d
  • wallet card l08b is provided with code l04e.
  • codes l04d and/or l04e match codes l04a and/or l04b such that each retrievable code matches a code on a bag or other biologies storage container and can therefore be used to allow for accurate and ready access to the biologies in the future, as needed.
  • Each of the various codes 104 may, in some embodiments, be linked to a donor/user profile or account, which may be established on a computing device and stored on server 110.
  • user profiles may comprise, for example, user profile information, such as a user and/or real name, contact information (e.g., email address, physical address, telephone number, etc.), and the like.
  • this user profile may also comprise medical information, such as medical conditions, vitals, allergies and medications, insurance information, and names and address of physicians, and/or emergency contacts, and the like.
  • the same code for accessing the biologies may be presented on a medical ID bracelet, card, or the like for first responders, or a different code may be presented on the same wearable or otherwise accessible item that allows for access to such medical information.
  • some embodiments may stand alone and serve for storing and accessing only biologies or other donated material.
  • users may access their storage/retrieval code 104 by way of a client device 120, such as a desktop or laptop computer, or any portable electronic device including, for example, a mobile application on a smartphone, a notebook computer, a tablet computer, a personal digital assistant, or the like.
  • client device 120 such as a desktop or laptop computer, or any portable electronic device including, for example, a mobile application on a smartphone, a notebook computer, a tablet computer, a personal digital assistant, or the like.
  • Some embodiments may be configured to provide security of the donated biologies and/or stored information in the user profile by requiring authenticating input, such as user name and/or password or other credentials, such as fingerprints, eye scanning, face scanning, or other biometrics.
  • the mobile application or other software may be configured to display one or more of the codes 104 that may be needed to access and/or retrieve the one or more biologies 102.
  • the codes provided to the donor/customer may include an embedded URL of a webpage.
  • a webpage may be automatically loaded.
  • This webpage may contain various types of information, such as medical information for the donor/user/customer, profile information, information about the current location of the biologics/sample, information about the tracking history of the sample, etc.
  • a storage facility may scan, read, or otherwise link each of the various codes 104 that may be associated with a given sample 102.
  • Each code 104 may then be associated with a particular storage location within the facility.
  • each of the various samples/biologics 102 is stored in a bag or other container having a readable code 104 that matches the code provided to the donor/user, as previously mentioned.
  • the processing of the biologies may comprise linking each of the received samples with a particular location and/or a user profile.
  • each storage location may have its own scannable or otherwise readable code and thus the input/processing procedure may comprise scanning both the sample code and the location code and linking them together in a database.
  • each of the storage units 130 may comprise its own scannable or otherwise readable code.
  • each of the various tissue samples within the unit may be accessible, such as by bringing up a list in any desired order of the samples therein.
  • some embodiments may be configured such that scanning a particular code from a user/donor 10, such as a code on the user’s bracelet, card, and/or smart phone, may result in immediate identification of the precise location of the sample, including the storage unit 130 of the sample and the specific location within that storage unit.
  • some embodiments may comprise robotics or other automated technology that retrieves the desired sample, in some such embodiments automatically, upon scanning/reading its accompanying code.
  • Some embodiments may comprise use of a centralized database in which all of the various codes are stored corresponding with each of the various samples being stored and/or specific storage locations.
  • manual searching of the master database may be provided for, either in addition to or in lieu of the automated searching and/or retrieval described herein.
  • searching may be provided for by donor/user name, tissue type, location, or otherwise on the master list.
  • the initial sample may be separated into a plurality of samples during processing. Preferably, each of these various sub-samples or aliquots will be labeled or otherwise linked with the same code.
  • FIG. 2 is a flow chart illustrating a method 200 for storing, linking, and retrieving biologies samples according to some implementations.
  • Method 200 may begin at step 205 at which point the biologies, tissue sample, or other sample that is being deposited for later access is received.
  • the sample may be put into a bag or other suitable container that preferably comprises means for linking a sample to a donor and accessing the sample at a later time, such as a QR code or other readable code.
  • the sample may be linked with its donor at 210.
  • the sample may be linked with its donor at 210.
  • the code or other linking means may be scanned and linked to a user profile associated with the donor.
  • step 210 may be performed prior to step 205 by simply linking the code or other linking means with a bag or other storage unit/means for storing biologies that is marked with such a code or other linking means.
  • the code or other linking means may be provided to the donor at step 215.
  • the code/linking means may be provided at the time of donation, other implementations are contemplated in which the code/linking means is provided to the donor/customer prior to receipt of the sample, such as by sending an unknown donor/pur chasers a kit comprising a bag or other storage means having a code or other linking means. With respect to the latter such implementations, the bag/storage means may therefore be pre-linked with the code.
  • the code may be linked with the sample and/or a storage location at the time of receipt of the sample.
  • the sample may then be processed and/or stored at step 220.
  • the code or other linking means may be electronically linked to a particular storage location.
  • a storage unit may be scanned or otherwise queried for available storage slots.
  • the code or other (preferably readable) linking means may then be linked with the specific location, in some cases including both a storage unit and specific location within the storage unit, within which the sample will be placed. This may be done via a manual input process. However, it may be preferred to provide automated linking and/or storage features to minimize the chance of misplaced samples. Thus, for example, in some
  • each storage location and/or storage unit may also comprise a code or other linking means, which code may comprise the same code type, such as a QR code, as used on the sample itself.
  • code may comprise the same code type, such as a QR code, as used on the sample itself.
  • step 220 may further comprise creating various sub-samples or aliquots using the received sample.
  • each of these various samples will be labeled or otherwise linked with the same code (preferably printed on the initial sample bag/container) at that time.
  • some embodiments and implementations may comprise providing a plurality of identical codes, one of which may be pre-printed on the container/bag, and the others of which may be used during processing for placement upon each sub-sample/aliquot.
  • a search may be conducted at step 225.
  • the search involves scanning, reading, or other use of the code and/or other linking means associated with the desired sample.
  • step 225 may comprise simply scanning the code using, for example, the bracelet, card, app, or other suitable means for displaying the code for
  • the system may be configured to provide a precise location of the sample upon scanning/reading. In some embodiments and implementations, the system may be configured to automatically retrieve the sample upon scanning/reading.
  • step 230 may therefore be combined with step 225.
  • step 225 comprises conducting a search using the code, this search may result in an identification of the location of the sample and/or manual retrieval of the sample at step 230. Additional searching that may be performed includes, for example, searching by customer name, donor name, donation type, donation date, physician name, storage container unit number, and/or
  • some embodiments and implementations may be configured with software modules for linking sample storage locations with the samples themselves.
  • the system may be configured with a unique, scannable, or otherwise readable code on each storage unit, such as a liquid nitrogen storage vat having a matrix of storage slots/locations. Scanning the code on a particular storage unit may result in identification of each sample stored therein and its position in the matrix or otherwise its position in the storage unit.
  • software modules may be configured to allow a practitioner/user to scan a code on a bracelet, card, mobile phone, etc., and this scanning may result in identification of the storage unit and/or storage location within a particular storage unit of the sample corresponding with the scanned code.
  • a software module or component may include any type of computer instruction or computer executable code located within a memory device and/or m-readable storage medium.
  • a software module may, for instance, comprise one or more physical or logical blocks of computer instructions, which may be organized as a routine, program, object, component, data structure, etc., that perform one or more tasks or implements particular abstract data types.
  • a particular software module may comprise disparate instructions stored in different locations of a memory device, which together implement the described functionality of the module.
  • a module may comprise a single instruction or many instructions, and may be distributed over several different code segments, among different programs, and across several memory devices.
  • Some embodiments may be practiced in a distributed computing environment where tasks are performed by a remote processing device linked through a communications network.
  • software modules may be located in local and/or remote memory storage devices.
  • data being tied or rendered together in a database record may be resident in the same memory device, or across several memory devices, and may be linked together in fields of a record in a database across a network.
  • embodiments and implementations of the inventions disclosed herein may include various steps, which may be embodied in machine-executable instructions to be executed by a general-purpose or special-purpose computer (or other electronic device).
  • the steps may be performed by hardware components that include specific logic for performing the steps, or by a combination of hardware, software, and/or firmware.
  • Embodiments and/or implementations may also be provided as a computer program product including a machine-readable storage medium having stored instructions thereon that may be used to program a computer (or other electronic device) to perform processes described herein.
  • the machine-readable storage medium may include, but is not limited to: hard drives, floppy diskettes, optical disks, CD-ROMs, DVD-ROMs, ROMs, RAMs, EPROMs, EEPROMs, magnetic or optical cards, solid-state memory devices, or other types of medium/machine- readable medium suitable for storing electronic instructions.
  • Memory and/or datastores may also be provided, which may comprise, in some cases, non-transitory machine-readable storage media containing executable program instructions configured for execution by a processor, controller/control unit, or the like, of a computer or other computing device, such as a mobile smartphone.
  • FIG. 3 depicts another embodiment of a system 300 for storage and retrieval of biologies or other samples.
  • System 300 comprises a plurality of storage containers 330a, 330b, through 330n, such as liquid nitrogen or cryogenic storage containers.
  • Each of the various storage containers 330 has internal storage slots or locations for storing a plurality of different biologies samples 302.
  • Each of the various biologies samples 302 preferably comprises a label having a scannable or otherwise readable code 304, as previously mentioned.
  • each of the various storage containers 330 comprises its own scannable or otherwise readable code 334 (334a, 334b, through 334n).
  • scanning code 334a on storage container 330a may display an inventory of the samples 302 contained therein, the locations of the samples 302 contained therein, locations of empty slots/spaces in the container 330a, and the like.
  • Codes 304 and/or 334 may be scanned/read by any suitable technology, such as by a scanner 325.
  • scanner 325 is depicted in FIG. 3 as being wired to computer 320, those of ordinary skill in the art will appreciate that a wireless scanner may be used, along with any suitable
  • each sample 302 within system 300 may be stored within a database, such as within memory of computer 320, for example.
  • each of the samples 302 may be scanned or otherwise have its respective scannable/readable code 304 input into system 300 upon being received in a particular storage slot/location of a particular storage container 330.
  • these codes 304 match the codes provided to the donor/users corresponding with each sample 302 so that the location of each sample 302 can easily be identified for retrieval as needed by, for example, scanning the code provided to the donor/user such as by way of, for example, a bracelet, card, smartphone display/app, etc.
  • each of the various slots/locations may also have its own scannable/readable code to allow for generation of various types of useful information upon scanning, such as the history of samples stored therein, for example.
  • each of the slots/locations for storage of samples 302 may be tracked within system 300 without requiring individual codes corresponding to each location.
  • each location may comprise a separate data structure within system 300 that may be linked by way of a suitable software module or machine-readable code to one or more samples 302 and/or their respective codes 304, such as preferably at least the current code 304 (or an indication of the location being empty) and, in some embodiments, an entire history or predetermined historical range of samples 302 in each location.
  • each of the various containers 330 is communicatively coupled, either wired or wirelessly, with computer 320 or another centralized computing device and/or database, as shown in the figure.
  • each container 330 may comprise its own computing and/or display module 335 (335a, 335b, through 335n).
  • each of the individual containers 330 may comprise hardware, firmware, software, and/or a display screen to allow for individual container querying, access, or any other control feature that may have otherwise only been available on a centralized computing device such as computer 320.
  • the goods, foodstuffs, samples, biological samples, and medical items may comprise any number of things, including, but not limited to, bodily fluids including, but not limited to, blood, nasopharyngeal secretions, urine, serum, lymph, saliva, milk, anal and vaginal secretions, and semen of any organism.
  • Samples may comprise cells or tissues obtained from heart, lung, liver, pancreas, breast, umbilical cord, brain, skin, muscle, bone, vessel, fat, intestine, colon, kidney, stomach, or any combination thereof.
  • Samples may comprise stem cells such as hematopoietic stem cells or mesenchymal stem cells or a combination thereof.
  • the goods, foodstuffs, samples and medical items may comprise mammalian samples taken from, including, but not limited to sheep, cow, horse, pig, goat, lama, emu, ostrich or donkey, chicken, turkey, goose, duck, game bird, human, fish, rabbit, guinea pig, rat or mouse, dog, and/or cat.
  • the goods, foodstuffs, samples and medical items may comprise environmental samples including, but not limited to, air, agricultural, water and soil samples.
  • the goods, foodstuffs, samples and medical items may comprise biological warfare agent samples, research samples, purified samples, such as purified genomic DNA, RNA, proteins, etc.; and raw samples (bacteria, virus, genomic DNA, etc.).
  • biological warfare agent samples such as purified genomic DNA, RNA, proteins, etc.
  • purified samples such as purified genomic DNA, RNA, proteins, etc.
  • raw samples bacteria, virus, genomic DNA, etc.
  • the goods, foodstuffs, samples and medical items may comprise food products.
  • the disclosure provides a sample comprising raw food products, fresh food products, cooled or frozen food products, or products that are generally heated prior to consumption.
  • the food product could be partially cooked.
  • the food product could be cooked but may require additional heating prior to consumption.
  • the food product may comprise meats, poultry, fish, seafood, fruits, and vegetables.
  • the food product may include meats (beef, pork, lamb, rabbit and/or goat), poultry, wild game (pheasant, partridge, boar and/or bison), fish, vegetables (veggie-patties, bakery hamburgers), combinations of vegetables and meat, egg products (quiches, custards, cheesecakes) and/or baked goods (batters, doughs, cakes, breads, muffins, biscuits, cupcakes, pancakes and the like whether baked, raw or partially baked).
  • the goods, foodstuffs, samples and medical items may be less than or equal to about 25 kilograms (kg) by weight.
  • the goods, foodstuffs, samples and medical items is about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16 s, about 17, about 18, about 19 , about 20, about 21, about 22, about 23, about 24, or about 25 kg.
  • the goods, foodstuffs, samples and medical items may be less than 1 kg.
  • the goods, foodstuffs, samples and medical items may be greater than or equal to about 25kg by weight.
  • the goods, foodstuffs, samples and medical items is about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, about 48, about 49, about 50, about 51, about 52, about 53, about 54, or about 55kg.
  • the sample is greater than 55 kg by weight.
  • Embodiment 1 A method comprising: (a) associating a unique identifier with a biological sample and one or more portions of the biological sample that is separated from the biological sample, wherein the unique identifier comprises updatable information to evaluate the biological sample or the one or more portions of the biological sample; and (b) employing a remote database or a cloud system to update the updatable information of the unique identifier.
  • Embodiment 2 The method of embodiment 1, wherein the unique identifier is associated with each of the one or more portions of the biological sample.
  • Embodiment 3 The method of embodiment 1, wherein the unique identifier is associated with a second portion of the biological sample.
  • Embodiment 4 The method of any one of embodiments 1-3, wherein the unique identifier identifies a location or temperature of the biological sample or the one or more portions of the biological sample.
  • Embodiment 5 The method of any one of embodiments 1-4, wherein the updatable information is updatable from a remote location.
  • Embodiment 6 The method of any one of embodiments 1-5, wherein the updatable information is updated automatically.
  • Embodiment 7 The method of any one of embodiments 1-5, wherein the updatable information is updated manually.
  • Embodiment 8 The method of any one of embodiments 1-7, wherein the updatable information is stored in a database.
  • Embodiment 9 The method of embodiment 8, wherein the database is a searchable database.
  • Embodiment 10 The method of embodiment 9, wherein the searchable database is searchable by a unique identifier, a genomic information, a proteomic information, an endosomic information, a medical history, genetically related biological samples, or any combination thereof.
  • Embodiment 11 The method of any one of embodiments 1-10, wherein the unique identifier correlates to a genomic information, a proteomic information, an endosomic information, a medical history, or any combination thereof.
  • Embodiment 12 The method of any one of embodiments 1-11, wherein the biological sample comprises a blood sample, a plasma sample, an extracellular fluid sample, a cell-free sample, a tissue sample, an isolated and purified cell, or any combination thereof.
  • Embodiment 13 The method of any one of embodiments 1-12, wherein the remote database or the cloud system instructs updating of the unique identifier with the updatable information following an event.
  • Embodiment 14 The method of any one of embodiments 1-13, wherein the remote database or the cloud system comprises more than one user portal.
  • Embodiment 15 The method of embodiment 14, wherein a user of the more than one user portal is a medical professional, a lab technician, a patient, or a regulatory compliance personal.
  • Embodiment 16 The method of embodiment 14 or 15, wherein a user accessing the remote database or the cloud system by one of the more than one user portals accesses the updatable information.
  • Embodiment 17 The method of any one of embodiments 1-16, further comprising tracking one or more events, wherein the one or more events comprises: packaging of a portion of the biological sample, administration of a portion of the biological sample or the one or more portions of the biological sample to a subject in need thereof, modification of a portion of the biological sample or the one or more portions of the biological sample, performing an analysis on the biological sample or the one or more portions of the biological sample, or any combination thereof.
  • Embodiment 18 The method of any one of embodiments 1-18, wherein the one or more portions of the biological sample is subjected to an analysis, and wherein the analysis is a genetic analysis, a proteomic analysis, a sequencing analysis, a cytological analysis, a kinetic analysis, a growth analysis, or any combination thereof.
  • Embodiment 19 The method of embodiment 18, wherein the analysis is the genetic analysis.
  • Embodiment 20 The method of any one of embodiments 1-19, wherein the unique identifier comprises a QR code.
  • Embodiment 21 The method of embodiment any one of embodiments 1-19, wherein the unique identifier comprises a barcode.
  • Embodiment 22 The method of any one of embodiments 1-21, wherein the unique identifier is scannable.
  • Embodiment 23 The method of any one of embodiments 1-22, wherein the biological sample or the one or more portions of the biological sample is prepared for a cellular- based or tissue-based therapy.
  • Embodiment 24 The method of any one of embodiments 1-3, wherein biological sample or the one or more portions of the biological sample is packaged or stored in a container and wherein the unique identifier is associated with the container.
  • Embodiment 25 The method of any one of embodiments 1-24, wherein the unique identifier identifies a subject, a subject’s race, or a subject’s sex from which the biological sample or the one or more portions of the biological sample is obtained.
  • Embodiment 26 The method of any one of embodiments 1-25, wherein the unique identifier comprises a medical history, a genetic information, a gender, an age, a smoking status, a cancer status, a hepatitis status, an HIV status, a blood type, or any combination thereof of the subject from which the biological sample or the one or more portions of the biological sample was obtained.
  • the unique identifier comprises a medical history, a genetic information, a gender, an age, a smoking status, a cancer status, a hepatitis status, an HIV status, a blood type, or any combination thereof of the subject from which the biological sample or the one or more portions of the biological sample was obtained.
  • Embodiment 27 The method of embodiment any one of embodiments 1-26, wherein the subject is an infant, an pregnant women, or a recently post-partum women.
  • Embodiment 28 The method of any one of embodiments 1-26, wherein the unique identifier identifies a related unique identifier associated with a subject that is genetically related to the subject from which the biological sample or the one or more portion of the biological sample is obtained.
  • Embodiment 29 The method of any one of embodiments 1-28, wherein the unique identifier identifies a subject from which the biological sample or the one or more portions of the biological sample is associated.
  • Embodiment 30 The method of any one of embodiments 1-29, wherein the subject is a subject receiving the biological sample or the one or more portions of the biological sample as part of a cellular-based or tissue based therapy.
  • Embodiment 31 The method of any one of embodiments 1-30, wherein the unique identifier identifies each portion of the one or more portions of the biological sample with at least 95% accuracy.
  • Embodiment 32 The method of any one of embodiments 1-31, wherein the biological sample comprises a stem cell.
  • Embodiment 33 The method of any one of embodiments 1-32, wherein the one or more portions of the biological sample comprise a stem cell.
  • Embodiment 34 The method of any one of embodiments 1-33, wherein the biological sample or the one or more portions of the biological sample is obtained from an umbilical cord tissue, a placenta tissue, a cord blood, or any combination thereof.
  • Embodiment 35 A wearable device comprising a unique identifier for a biological sample obtained from a subject, wherein the unique identifier comprises updatable information to evaluate the biological sample or any portion thereof, and wherein the unique identifier is in communication with a remote database or a cloud system to update the updatable information of the unique identifier.
  • Embodiment 36 The wearable device of embodiment 35, wherein the wearable device comprises a microchip.
  • Embodiment 37 The wearable device of embodiment 35-36, further comprising tracking one or more events, wherein the one or more events comprises: packaging a portion of the biological sample or the one or more portions of the biological sample, administration of a portion of the biological sample or the one or more portions of the biological sample to a subject in need thereof, modification a portion of the biological sample, performing an analysis on the biological sample or the one or more portions of biological sample, or any combination thereof.
  • Embodiment 38 The wearable device of embodiment 35-37, wherein a portion of the wearable device is scannable to automatically update the updatable information of the unique identifier.

Abstract

L'invention concerne des systèmes et des procédés de liaison, de suivi, de stockage et/ou d'accès à des échantillons biologiques, tels que des produits biologiques. Dans certains modes de réalisation, le système peut comprendre un kit comprenant un contenant de produits biologiques marqué avec un code lisible et un moyen pour afficher de manière récupérable le code pouvant être suivi. Le système peut en outre comprendre un ou plusieurs contenants de stockage pour stocker une pluralité d'échantillons et peut être configuré pour lier le ou les codes à un emplacement de stockage spécifique pour permettre un accès ultérieur auxdits échantillons, par exemple par balayage ou sinon lecture du code pour identifier l'emplacement de stockage souhaité.
PCT/US2019/037800 2018-06-18 2019-06-18 Systèmes et procédés de liaison et de stockage de produits biologiques WO2019246149A1 (fr)

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US9131884B2 (en) * 2003-09-11 2015-09-15 Theranos, Inc. Medical device for analyte monitoring and drug delivery
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