[0001] Packing of Biological Samples

Abstract

A packing and transportation device for biological samples, including an insert, a fixing strip, a fixing element, a temperature sensor, a plurality of labels, a delivery pouch sized and shaped to receive delivery documents, and a transport bag configured to receive sample containers. The insert includes a plurality of notches sized and shaped to receive the fixing strip, the fixing element, and the temperature sensor. At least one of the plurality of labels includes patient information.

Description

Technical Field

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 356,788, filed on June 29, 2022, entitled "Packaging For Biological Samples", the content of which is hereby incorporated by reference in its entirety.

[0002] Technical Field

[0003] The present disclosure generally relates to the packaging of biological samples, and more particularly to packaging for securing biological samples for shipping and transportation.

Summary of the Invention

Means for Solving the Problems

[0003] Summary

[0004] One embodiment of the present disclosure provides a packaging and transportation device for biological samples, the packaging and transportation device including an insert, a fixing strip, a fixing element, and a temperature sensor, wherein the insert has a plurality of notches sized and shaped to receive the fixing strip, the fixing element, and the temperature sensor, the temperature sensor, a plurality of labels, a shipping pouch sized and shaped to receive shipping documents, and a transport bag configured to receive a sample container.

[0004]

[0005] In some embodiments, the plurality of notches includes a first notch, a second notch, and a third notch. The first notch of the insert may be configured to receive and store the fixing strip, the second notch of the insert may be configured to receive and store the temperature sensor, and the third notch of the insert may be configured to receive and store the fixing element.

[0005]

[0006] In some embodiments, the insert is disposed between the transport bag and the plurality of labels. The insert can be disposed between the transport bag and the plurality of labels, and the transport bag can be disposed between the delivery pouch and the insert.

[0006]

[0007] In some embodiments, the inner delivery container is sized and shaped to receive the transport bag and the cooling engine, and the inner delivery container is smaller in size than the packaging and transport device. The plurality of labels includes a first label configured to be affixed to the sample container and a second label configured to be affixed to the inner delivery container. The fixing strip can be configured to leave a mark on the inner delivery container when removed or changed.

[0007]

[0008] In some embodiments, the insert includes three or more fixing strips. The three or more fixing strips can be disposed within a plurality of cutouts of the insert.

[0008]

[0009] In some embodiments, the fixing strip is disposed within one of the plurality of cutouts of the insert. The insert can include four or more fixing elements. The four or more fixing elements can be disposed within a plurality of cutouts of the insert.

[0009]

[0010] In some embodiments, the patient information includes patient identification information. The patient identification information includes the patient's name, date of birth, age, etc.

[0010]

[0011] In some embodiments, the packaging and transport device is a cooling engine, and further includes a cooling engine configured to maintain a temperature range of about -80°C to about 10°C during operation of the cooling engine.

[0011]

[0012] In some embodiments, the transport bag includes an absorbent sheet configured to absorb leakage of the sample container. The transport bag can be configured to withstand up to 95 kPa without leakage.

[0012]

[0013] In some embodiments, the packing and transporting device includes two or more labels.

[0013]

[0014] In some embodiments, the temperature sensor is disposed within one of a plurality of notches of the insert. The insert may be disposed between the plurality of labels and one of the delivery pouch and the transport bag.

[0014]

[0015] In some embodiments, the patient information includes anonymized patient information.

[0015]

[0016] In some embodiments, the packing and transporting further includes a kit container that houses the insert, the plurality of labels, the delivery pouch, and the transport bag.

[0016]

[0017] Another embodiment of the present disclosure provides a packing and transporting device for a biological sample, the device being a packing kit, an insert having a fixing strip, a fixing element, and a temperature sensor, the insert including a plurality of notches sized and shaped to receive the fixing strip, the fixing element, and the temperature sensor, a plurality of labels including one or more of patient information and destination information, a transport bag configured to receive a sample container for housing the biological sample, a packing kit including a delivery pouch, a cooling engine configured to maintain a temperature range of about 0°C to about 10°C, an inner delivery container, and an outer delivery container sized and shaped to receive the inner delivery container, the cooling engine, and the packing kit. In some embodiments, the inner delivery container includes an area for receiving at least one of the plurality of labels, and the inner delivery container is sized and shaped to receive the cooling engine and the transport bag.

[0017]

[0018] In some embodiments, the insert is disposed between the transport bag and the plurality of labels. The transport bag may be disposed between the delivery pouch and the insert.

[0018]

[0019] Another embodiment of the present disclosure provides a method for packaging a biological sample. The method includes providing a packaging kit having a transport bag and an insert for storing a fixing element, a fixing strip, and a temperature sensor; fixing a sample container with the fixing element, wherein the sample container contains a biological sample; attaching a first label to the fixed sample container, wherein the first label contains at least one piece of patient information; inserting the sample container with the label attached into the transport bag; placing the transport bag into an inner delivery container, wherein the inner delivery container contains a cooling engine and a temperature sensor; closing the inner delivery container such that the transport bag, the cooling engine, and the temperature sensor are disposed therein; fixing the inner delivery container in a closed position using the fixing strip such that it is apparent that an attempt has been made to access the interior of the inner delivery container; and attaching a second label to the inner delivery container, wherein the second label contains at least one of patient information and destination information.

[0019]

[0020] In some embodiments, the packaging kit further includes a delivery pouch and a plurality of labels including the first label and the second label. Within the packaging kit, the insert may be disposed between the transport bag and the plurality of labels. Within the packaging kit, the transport bag may be disposed between the delivery pouch and the insert.

[0020]

[0021] In some embodiments, the method further includes removing the fixing strip from a first notch of the insert, removing the temperature sensor from a second notch of the insert, and removing the fixing element from a third notch of the insert.

[0021]

[0022] In some embodiments, the first notch of the insert is configured to receive and store the fixing strip. The second notch of the insert may be configured to receive and store the temperature sensor. The third notch of the insert may be configured to receive and store the fixing element.

[0022]

[0023] In some embodiments, the method further comprises operating a cooling engine, whereby the cooling engine is configured to maintain the inner delivery container within a predetermined temperature range when the operated cooling engine is disposed within the inner delivery container. The predetermined temperature range can be from 0°C to 10°C.

[0023]

[0024] In some embodiments, the method further comprises transporting an inner delivery container having a second label to a destination.

[0024]

[0025] In some embodiments, the method further comprises collecting a biological sample from a patient.

[0025]

[0026] In some embodiments, the method further comprises combining the biological sample with a transport medium, wherein the transport medium is configured to prevent degradation of the biological sample. The biological sample can include a plurality of tumor tissues collected from a patient.

[0026]

[0027] In some embodiments, the method further comprises the transport bag including an absorbent sheet configured to absorb a leak of the sample container.

[0027]

[0028] In some embodiments, the securing strip is configured to leave a mark on the inner delivery container if removed or altered.

[0028]

[0029] In some embodiments, the packaging kit includes three or more securing strips. The packaging kit can include four or more securing elements. The packaging kit can include two or more labels.

[0029]

[0030] In some embodiments, the transport bag is configured to withstand up to 95 kPa without leakage.

[0030]

[0031] In some embodiments, the patient information is anonymized patient information. The patient information may include patient identification information. The patient information may include the patient's name, date of birth, and / or age.

[0031]

[0032] In some embodiments, the packaging kit includes a kit container configured to receive and store a shipping bag and an insert.Another embodiment of the present disclosure provides a method for packaging a biological sample, the method comprising receiving an outer delivery container having a cooling engine, an inner delivery container, and a packaging kit, the packaging kit having a transport bag, a delivery pouch, a plurality of labels, and an insert for storing a fixing element, a fixing strip, and a temperature sensor; removing the cooling engine, the inner delivery container, and the packaging kit from the outer delivery container; removing the transport bag, the delivery pouch, the plurality of labels, and the insert from the packaging kit, the insert including a notch sized and shaped to receive the fixing element, the fixing strip, and the temperature sensor; removing the fixing element, the fixing strip, and the temperature sensor from the insert; placing the biological sample in a sample container, the biological sample including tumor tissue and a transport medium; fixing the sample container with the fixing element; attaching a first label of the plurality of labels to the fixed sample container, the first label including at least one of patient information and destination information; inserting the sample container with the label attached into the transport bag, the transport bag including an absorption sheet configured to absorb leakage of the sample container with the label attached therein; operating the cooling engine, whereby the cooling engine is configured to maintain the inner delivery container within a predetermined temperature range when the operated cooling engine is placed within the inner delivery container; placing the transport bag, the cooling engine, and the temperature sensor within the inner delivery container; closing the inner delivery container such that the transport bag, the cooling engine, and the temperature sensor are disposed within the interior of the inner delivery container; fixing the inner delivery container in a closed position using the fixing strip such that access to the interior of the inner delivery container is prevented, the fixing strip being configured to leave a mark or residue on the inner delivery container if removed or altered; and attaching a second label of the plurality of labels to the inner delivery container, the second label including at least one of patient information and destination information.

[0032] Brief Description of the Drawings

[0033] The following detailed description of embodiments of the packaging of biological samples will be better understood when read in conjunction with the accompanying drawings of the exemplary embodiments. However, it should be understood that the present disclosure is not limited to the exact arrangements and means presented.

Brief Description of the Drawings

[0033]

Figure 1

[0034] FIG. 1 is a front perspective view of a packaging container according to an exemplary embodiment of the present disclosure.

Figure 2

[0035] FIG. 2 is a top perspective view of a cooling block according to an exemplary embodiment of the present disclosure.

Figure 3

[0036] FIG. 3 is a top perspective view of an inner delivery container according to an exemplary embodiment of the present disclosure.

Figure 4

[0037] FIG. 4 is a top perspective view of a packaging kit according to an exemplary embodiment of the present disclosure.

Figure 5

[0038] FIG. 5 is an exploded view of the internal components of the packaging kit of FIG. 4 according to an exemplary embodiment of the present disclosure.

Figure 6

[0039] FIG. 6 is a flowchart showing a method of packaging a biological sample according to an exemplary embodiment of the present disclosure.

Figure 7

[0040] FIG. 7 is a flowchart showing a method of packaging a biological sample according to an exemplary embodiment of the present disclosure.

Modes for Carrying Out the Invention

[0034] Detailed Description

[0041] Exemplary embodiments of the present disclosure provide a packaging and transportation device for biological samples. An embodiment of the present disclosure is illustrated as an exemplary device in FIGS. 1-5. In use, the packaging and transportation device (the "device") 100 can be used for the packaging and transportation (e.g., delivery) of biological samples. The device 100 can include an outer delivery container 102, an inner delivery container 106, and a packaging kit 108 for packaging and transporting biological samples. In some embodiments, the device is used for the packaging and transportation of tumor tissues. For example, the device 100 can provide a packaging kit 108 for packaging and fixing one or more biological samples for delivery or transportation. The biological sample can be a tumor tissue collected from a patient. For example, a sample of tumor tissue removed from a patient can be placed in a tumor tissue container or sample container such as a vial for storing the tumor tissue. In some embodiments, the sample of tumor tissue is taken from a cancer patient. The tumor tissue can be combined with a medium / reagent to maintain the lifespan of the tumor tissue and prevent contamination or degradation of the tumor tissue.

[0035]

[0042] In some embodiments, the sample of tumor tissue is stored in a sample container together with a medium / reagent. The medium can be a transport medium such as a cryogenic transport medium configured to improve and extend the preservation of biological substances (e.g., cells, tissues, organs). In some embodiments, the sample of tumor tissue is stored in a sample container together with HypoThermosol. Thereafter, the sample container can be sealed and fixed using the packaging kit 108.

[0036]

[0043] In use, the device 100 can be sent to a medical institution (e.g., a hospital, an outpatient center, a surgical center, a clinic, etc.). At the medical institution, tumor tissue can be extracted from a cancer patient. The extracted tumor tissue can be packaged using the device 100 and sent to a processing facility for processing (e.g., cell amplification). For example, the tumor tissue can contain white blood cells (e.g., T lymphocytes or T cells). The tumor tissue can be sent to a processing facility for T cell amplification. The amplified T cells can be sent back to the medical institution and administered to the patient, for example, by infusion, for the treatment of cancer.

[0037]

[0044] In practice, the apparatus 100 may be provided to a medical institution to assist in transporting a biological sample to another location, such as another medical institution or a processing facility. The apparatus 100 can provide the medical institution with appropriate labels, monitors, sensors, packaging, and cooling means for protecting and storing the biological sample during transportation or delivery. The apparatus 100 may include an outer delivery container 102, a packaging kit 108, an inner delivery container 106, and a cooling engine 104. The cooling engine 104 may be disposed and housed within the inner delivery container 106. In some embodiments, when the apparatus 100 is sent to a medical institution for packaging a biological sample, the packaging kit 108, the inner delivery container 106, and the cooling engine 104 are disposed within the outer delivery container 102. For example, the cooling engine 104 may be disposed within the inner delivery container 106, and the inner delivery container 106 and the packaging kit 108 may be disposed within the outer delivery container 102 of the apparatus 100. The outer delivery container 102 may be sealed to fix the packaging kit 108 and the inner delivery container 106 that houses the cooling engine 104 within the outer delivery container 102. In some embodiments, a plurality of packaging kits 108, inner delivery containers 106, and / or cooling engines 104 are disposed within the outer delivery container 102.

[0038]

[0045] In some embodiments, the outer delivery container 102 is sent to a medical institution and includes an inner delivery container 106, a packaging kit 108, and a cooling engine 104. The medical institution can use the packaging kit 108 to fix a biological sample and then place the packaging kit 108 and the cooling engine 104 that houses the fixed biological sample into the inner delivery container 106. In some embodiments, the medical institution uses the inner delivery container 106 to send the biological sample fixed via the packaging kit 108 and the cooling engine 104 to a manufacturing facility. For example, the inner delivery container 106 can be configured to receive the cooling engine 104 and the biological sample fixed via the packaging kit 108 and transport the fixed biological sample safely and securely to another medical institution or processing facility. In some embodiments, the medical institution can use the outer delivery container 102 to send the cooling engine 104 and the biological sample fixed via the packaging kit 108 to another medical institution or processing facility.

[0039]

[0046] In some embodiments, the packaging kit 108 includes one or more components for sealing, fixing, and monitoring a biological sample. The packaging kit 108 can be used to seal and fix a biological sample and placed into the inner delivery container 106 together with the cooling engine 104. The cooling engine 104 can be configured to maintain the biological sample within a predetermined temperature range. For example, the cooling engine 104 can be configured to maintain the biological sample at a temperature of -80°C to 10°C to ensure the preservation of the biological sample during the transportation and delivery of the device 100. In some embodiments, the cooling engine 104 is a container of dry ice or other cooling materials configured to maintain a biological sample (e.g., tumor tissue) at a temperature of -80°C to 10°C.

[0040]

[0047] Referring to FIG. 1, the apparatus 100 may include an outer delivery container 102. The outer delivery container 102 may be sized and shaped to receive a packing kit 108, an inner delivery container 106, and a cooling engine 104. In some embodiments, the outer delivery container 102 is configured to receive and secure the packing kit 108, the inner delivery container 106, and the cooling engine 104. For example, the outer delivery container 102 can store and secure the packing kit 108, the inner delivery container 106, and the cooling engine 104 for delivery to a medical institution. The outer delivery container 102 may be configured to accommodate the packing kit 108, the inner delivery container 106, and the cooling engine 104 for transporting the packing kit 108, the inner delivery container 106, and the cooling engine 104 to a medical institution. The outer delivery container 102 may be configured to keep the packing kit 108, the inner delivery container 106, and the cooling engine 104 stored within a single package during transportation. A medical institution can receive the outer delivery container 102 containing the packing kit 108, the inner delivery container 106, and the cooling engine 104, fix a biological sample collected from a patient, and safely transport the biological sample to another location such as a processing facility. In some embodiments, the processing facility uses the inner delivery container 106 to transport the processed biological sample (e.g., amplified T cells) back to the location (e.g., a medical institution) where the apparatus 100 was sent.

[0041]

[0048] In some embodiments, the outer delivery container 102 may be configured to be reused multiple times. For example, the outer delivery container 102 may be configured to be sent to a medical institution and then used by the medical institution to secure the cooling engine 104 and a biological sample fixed using the packing kit 108 for transportation to another location such as a processing facility. The outer delivery container 102 may be substantially rectangular in shape. In some embodiments, the outer delivery container 102 may be circular, octagonal, or any other suitable shape. In some embodiments, the outer delivery container 102 is made of cardboard. In some embodiments, the outer delivery container 102 may be made of a polymer or metal.

[0042]

[0049] Referring to FIG. 2, the apparatus 100 may include a cooling pack or a cooling engine 104. The cooling engine 104 may be configured to maintain an article stored within the apparatus 100 within a predetermined temperature range. The cooling engine 104 can be stored and housed within an inner delivery container 106. For example, when the inner delivery container 106 is being transported within the outer delivery container 102, the cooling engine 104 can remain within the inner delivery container 106. In some embodiments, the cooling engine 104 has an operating state and a non-operating state. In some embodiments, the cooling engine 104 is removed from the inner delivery container 106 only for the purpose of activating or deactivating the cooling engine 104. The cooling engine 104 can be sent to a medical institution in a non-operating state and can be activated by a user when a biological sample (e.g., a tumor tissue sample) is placed within the inner delivery container 106. For example, the outer delivery container 102 is sent to a medical institution together with a packing kit 108 and a non-operating cooling engine 104 housed within the inner delivery container 106. Thereafter, the user can remove the cooling engine 104 from the inner delivery container 106, activate the cooling engine 104, return the cooling engine 104 within the inner delivery container 106, use the packing kit 108 to label and fix the biological sample, and then place the biological sample within the inner delivery container 106 with the cooling engine 104 operating. In practice, the apparatus 100 can be sent to a medical institution with the cooling engine 104 not operating. When the biological sample is fixed within a sample container using the packing kit 108, the user can activate the cooling engine 104 and then place the sample container adjacent to the cooling engine 104 within the inner delivery container 106. The user can then transport the inner delivery container 106 to another location. In some embodiments, the inner delivery container 106 is disposed within the outer delivery container 102 and the outer delivery container 102 is transported to another location. In some embodiments, the cooling engine 104 is configured to maintain the biological sample at a temperature of about 2°C to about 8°C. In some embodiments, the cooling engine 104 can be configured to maintain the biological sample at a temperature of -80°C to about 10°C, about -75°C to about 0°C, or about -60°C to about -10°C.

[0043]

[0050] Referring to FIG. 3, the apparatus 100 may include an inner delivery container 106. The inner delivery container 106 may be sized and shaped to receive a cooling engine 104 and a biological sample secured via a packaging kit 108. The inner delivery container 106 may also be sized and shaped to be disposed within an outer delivery container 102. The inner delivery container 106 may be sent to a medical institution so that the medical institution can send the cooling engine 104 and the biological sample secured via the packaging kit 108 to another medical institution or a processing facility. The inner delivery container 106 may be substantially rectangular in shape. In some embodiments, the inner delivery container 106 may be circular, triangular, square, or any other suitable shape. The inner delivery container 106 may be made of a lightweight but strong material to enable easy transportation of the cooling engine 104 and the biological sample secured via the packaging kit 108 while protecting the biological sample. In some embodiments, the inner delivery container 106 is made of cardboard. In some embodiments, the inner delivery container 106 may be made of a polymer, metal, or any other suitable material.

[0044]

[0051] In some embodiments, the inner shipping container 106 includes a region 107. The region 107 can be a region on the outer surface of the inner shipping container 106. The region 107 can be configured to receive a label. The label can be disposed within the packaging kit 108 and removed from the packaging kit 108 and disposed on the region 107. In some embodiments, the user can write or print on the region 107. The user can use the label or write or print the destination to which the biological sample secured via the packaging kit 108 is to be sent. In some embodiments, the inner shipping container 106 is configured to be folded. For example, the inner shipping container 106 can be folded to resemble a substantially rectangular box. In some embodiments, the inner shipping container 106 includes an upper panel 125 and an extension portion 126 extending from the upper panel 125. The extension portion 126 can have a flap 127 that can be received within the front wall 129. Thereby, the inner shipping container 106 can be self-sealing without the need for tape or other sealing means. In some embodiments, the inner shipping container 106 is composed of a single member that can be folded to resemble a rectangular box. In some embodiments, the inner shipping container 106 and / or the outer shipping container 102 include portions configured to receive individualized branding or other information.

[0045]

[0052] Referring to FIGS. 4 and 5, the packaging kit 108 may include a kit container 109. The kit container 109 may be configured to store and secure various components of the packaging kit 108. For example, the packaging kit 108 may include one or more labels, one or more fixing functions, one or more monitors, one or more sensors and / or packaging, and they may be stored within the kit container 109. In some embodiments, the kit container 109 is substantially rectangular in shape. In some embodiments, the kit container 109 may be of any suitable shape. The kit container 109 may be sized and shaped to store all of the components of the packaging kit 108 internally and may be sized and shaped to fit within the outer delivery container 102 and / or the inner delivery container 106. For example, the kit container 109 may be sized and shaped such that the packaging kit 108 can be placed within the outer delivery container 102 and / or the inner delivery container 106 during transportation of the packaging kit 108 to / from a medical institution.

[0046]

[0053] In some embodiments, the kit container 109 is configured to be folded. For example, the kit container 109 can be folded to resemble a substantially thin rectangular box. The kit container 109 may have a thickness determined by the components disposed within the packaging kit 108. For example, the kit container 109 may have a thickness of about 1.5 inches. In some embodiments, the kit container 109 may have a thickness of about 0.5 inches to about 12 inches, about 1 inch to about 10 inches, about 2 inches to about 8 inches, about 3 inches to about 6 inches, greater than 12 inches or less than 0.5 inches. In some embodiments, the kit container 109 includes an upper panel 131 and an extension portion 135 extending from the upper panel 131. The extension portion 135 may have a flap 133 that can be received within the front wall 137. Thereby, the kit container 109 can be self-sealing without the need for tape or other sealing means. In some embodiments, the kit container 109 is composed of a single member that can be folded to resemble a rectangular box.

[0047]

[0054] In some embodiments, the kit container 109 includes a slot 121. The slot 121 can be a notch within the kit container 109 that is sized and shaped to receive and secure a label 124. For example, a portion (e.g., a corner) of the label 124 can be inserted into the slot 121 to secure the label 124 in place during movement or transportation of the packaging kit 108. In some embodiments, the kit container 109 includes a plurality of slots 121. For example, the kit container 109 can include a number of slots 121 corresponding to the number of labels 124 such that each label 124 is secured within its respective slot 121. The slots 121 can be disposed at the corners of the kit container 109 such that the corners of the label 124 can be inserted into the slots 121 to secure the label 124 when the label 124 is disposed within the kit container 109.

[0048]

[0055] In some embodiments, the packaging kit 108 includes one or more components for securing one or more biological samples for transportation. As shown in FIG. 5, the packaging kit 108 can include one or more of a delivery pouch 110, a transport bag 112, a securing strip 114, a sensor 116, a securing element 118, an insert 120, and a label 124. In some embodiments of the packaging kit 108, each component is stacked on top of one another for easy storage and transportation. For example, during transportation of the packaging kit 108, the delivery pouch 110 can be placed on top of the transport bag 112, the transport bag 112 can be placed on top of the insert 120, and the insert 120 can be placed on top of the label 124. Each component of the packaging kit 108 can be stacked in layers on top of one another to reduce the overall size of the packaging kit 108. In some embodiments, the insert 120 can be disposed between the label 124 and the transport bag 112, and the transport bag 112 can be disposed between the delivery pouch 110 and the insert 120.

[0049]

[0056] In some embodiments, the delivery pouch 110 is configured to receive one or more labels 124. For example, the delivery pouch 110 can be configured to receive one or more labels 124, and destination information can be placed on the one or more labels 124. In some embodiments, the packaging kit 108 includes two labels 124, one being a label 124 for the sample container and the other being a label 124 for the inner delivery container 106. The label 124 can be a patient-specific label that includes information associated with a given patient. In use, the one or more labels 124 can be configured to include destination information and can be placed within the delivery pouch 110, on the inner delivery container 106, and / or on the sample container. The delivery pouch 110 can be placed on the inner delivery container 106. For example, the delivery pouch 110 that houses the label 124 or delivery documents (e.g., a bill of lading) can be placed in the area 107 of the inner delivery container 106. By placing the delivery pouch 110 that includes the label 124 in the area 107, the courier can easily view the destination of the inner delivery container 106. In some embodiments, the delivery pouch 110 has a width of 6 inches and a length of 9 inches. In some embodiments, the delivery pouch 110 can have a width of 1 inch to 12 inches, 3 inches to 9 inches, or 6 inches to 8 inches, and can have a length of 1 inch to 15 inches, 3 inches to 12 inches, or 6 inches to 9 inches.

[0050]

[0057] In some embodiments, the delivery pouch 110 is configured to receive delivery documents such as a bill of lading. The user can insert the bill of lading into the delivery pouch 110 and seal the delivery pouch 110. The bill of lading can include destination information about where and how the inner delivery container 106 is to be transported. In some embodiments, the delivery documents (e.g., a bill of lading) are printed by a medical institution. The medical institution can pre-print the delivery documents that include information other than patient-specific information.

[0051]

[0058] In some embodiments, insert 120 is composed of a foam. In some embodiments, insert 120 may be composed of cardboard, a polymer, or any other suitable type of protective material. Insert 120 may have a thickness of from about 2 inches to about 0.1 inches, from about 1.75 inches to about 0.5 inches, or from about 0.75 inches to about 1 inch. In some embodiments, insert 120 has a thickness of about 0.75 inches.

[0052]

[0059] In some embodiments, one or more fixing strips 114, sensors 116, and one or more fixing elements 118 are disposed within insert 120. For example, insert 120 may include notches 122a, 112b, and 122c sized and shaped to receive fixing strip 114, sensor 116, and fixing element 118, respectively. In some embodiments, notch 122a is sized and shaped to secure fixing strip 114, notch 122b is sized and shaped to secure sensor 116, and notch 122c is sized and shaped to receive fixing element 118. Notches 122a, 122b, and 122c are configured to secure strip 114, sensor 116, and fixing element 118 to prevent damage to them during transportation.

[0053]

[0060] In some embodiments, insert 120 may include three notches 122a, one notch 122b, and two notches 122c. In some embodiments, insert 120 may include any number of notches 122a, 122b, and 122c. For example, insert 120 may include a number of notches 122a, 122b, and 122c corresponding to the number of fixed strips 114, sensors 116, and fixed elements 118. In some embodiments, notch 122b is disposed between two notches 122c, and one or more notches 122a are disposed below notches 122b and 122c. Notch 122c may be configured to receive two or more fixed elements 118. In some embodiments, one or more notches 122c are each configured to receive four fixed elements 118. In some embodiments, notch 122c may be configured to receive any number of fixed elements 118. In some embodiments, each notch 122a is configured to receive one fixed strip 114.

[0054]

[0061] In some embodiments, one or more fixed elements 118 are configured to ensure closure of a sample container that receives a biological sample. For example, as described above, the biological sample may be disposed within a culture medium (e.g., a transport medium) within the sample container. The sample container may be secured with one or more fixed elements 118 to prevent leakage or contamination of the biological sample within the sample container. In some embodiments, fixed element 118 is a flexible film or an adhesive or a self-sealing thermoplastic. For example, fixed element 118 may be paraffin film, which may be secured around the sample container, such as adjacent to the opening of the sample container, when the biological sample and the culture medium are disposed within the sample container. In some embodiments, fixed element 118 may be tape, cellophane, Teflon, or any other suitable type of sealing element. In some embodiments, packaging kit 108 includes two or more fixed elements 118. For example, packaging kit 108 may include two, three, four, five, six, seven, eight, nine, ten, or more than ten fixed elements 118.

[0055]

[0062] In some embodiments, the transport bag 112 is configured to receive and be fixed to a biological sample. For example, the transport bag 112 may include an adhesive portion containing an adhesive, and the transport bag 112 can be folded, and the adhesive portion can be adhered to another portion of the transport bag 112 to seal the transport bag 112. The transport bag 112 may include an absorption sheet 111. The absorption sheet 111 can be configured to indicate that a sample container holding a biological sample has leaked or been damaged. The absorption sheet 111 can be an absorption pad configured to absorb liquid. In some embodiments, the absorption sheet 111 is configured to indicate when it has absorbed liquid. For example, the absorption sheet 111 may change color when it absorbs liquid, thereby indicating that the sample container holding the biological sample has leaked or been damaged during transportation. When a sample container holding a biological sample is placed inside the transport bag 112, the transport bag 112 can be placed inside the inner delivery container 106 adjacent to the cooling engine 104 also placed inside the inner delivery container 106. The transport bag 112 can be a liquid-tight transport bag of 95 kPa. For example, since the transport bag 112 is a liquid-tight transport bag of 95 kPa, the transport bag can withstand 95 kPa without leakage and can safely transport the sample container holding the biological sample. In some embodiments, the transport bag 112 can be any type of bag configured to withstand pressure and prevent leakage.

[0056]

[0063] In practice, a medical institution receiving the device 100 can place a sample container holding a biological sample inside a transport bag 112 having an absorption sheet 111. The transport bag 112 can be placed adjacent to the cooling engine 104 inside the inner delivery container 106. The medical institution can transport or arrange for the transportation of the inner delivery container 106 containing the transport bag 112 with the biological sample and the cooling engine 104. The receiving side (e.g., the processing facility) of the inner delivery container 106 can analyze the absorption sheet 111 to determine whether the sample container holding the biological sample has leaked or been damaged during transportation.

[0057]

[0064] In some embodiments, the packaging kit 108 includes a securing strip 114. The securing strip 114 can be an anti-tampering strip and can be used to secure the inner shipping container 106. In some embodiments, the inner shipping container 106 has an open position and a closed position. In the open position, access to the interior of the inner shipping container 106 is possible. In the closed position, access to the interior of the inner shipping container 106 is not possible and the components stored inside are secure. The packaging kit 108 can include one or more securing strips 114 for securing the inner shipping container 106 in the closed position.

[0058]

[0065] The securing strip 114 can be disposed over the inner shipping container 106 in a manner that prevents access to the inner shipping container 106 and maintains the inner shipping container 106 in the closed position. For example, when the securing strip 114 is affixed to the inner shipping container 106 while the inner shipping container 106 is in the closed position, access to the interior of the inner shipping container 106 is not possible without modifying, damaging, or removing the securing strip 114. In some embodiments, the packaging kit 108 includes three securing strips 114 configured to be disposed at different locations on the inner shipping container 106 while the inner shipping container 106 is in the closed position. The securing strip 114 can be disposed over the inner shipping container 106 such that access to the interior of the inner shipping container 106 is prevented when the securing strip 114 is disposed over the inner shipping container 106 while the inner shipping container 106 is in the closed position. In some embodiments, the securing strip 114 is used to prevent the inner shipping container 106 from being placed in the open position without removing the securing strip 114, thereby preventing access to the interior of the inner shipping container 106.

[0059]

[0066] The securing strip 114 can be an anti-tampering strip or tape. For example, the securing strip 114, when placed, can be difficult to remove without causing visible damage to the securing strip 114. In some embodiments, removing the securing strip 114 causes visible damage to the inner delivery container 106, thereby indicating to people that the inner delivery container 106 has been tampered with or accessed. Removing the securing strip 114 can leave residues or traces on the inner delivery container 106, indicating that the inner delivery container 106 has been tampered with.

[0060]

[0067] The packaging kit 108 can include one or more labels 124. The label 124 can be configured to include destination information such as a place where a medical institution intends to transport a biological sample, such as a processing facility. The label 124 can include anonymized information associated with the patient from whom the biological sample was collected. The anonymized patient information can be a number associated with the patient without revealing the patient's identifying information (e.g., name). Alternatively, the label 124 can include the patient's identifying information (e.g., name, date of birth, age, etc.). In some embodiments, one label 124 is placed on the sample container that houses the biological sample, and one label 124 is placed within the delivery pouch 110 and on top of the inner delivery container 106. In some embodiments, each label 124 includes different information. For example, one label 124 can include destination information pasted on the inner delivery container 106, and another label 124 can include anonymized patient information to be placed on the sample container that houses the biological sample. In some embodiments, each label 124 includes anonymized patient information and destination information. In other embodiments, each label 124 includes the patient's identifying information (e.g., name). In other embodiments, one label 124 includes destination information inserted into the delivery pouch 110 placed on top of the inner delivery container 106, and another label 124 includes the patient's identifying information (e.g., name) placed on the sample container that houses the biological sample.

[0061]

[0068] In some embodiments, the label 124 includes an adhesive so that it can be easily attached to the inner delivery container 106. The label 124 can be disposed within the delivery pouch 110 to protect the label 124 from damage. In some embodiments, the packaging kit 108 includes two or more labels 124. For example, the packaging kit 108 can include two, three, four, five, six, seven, eight, nine, ten or more than ten labels 124.

[0062]

[0069] In some embodiments, the packaging kit 108 includes a sensor 116. The sensor 116 can be a temperature sensor configured to monitor the temperature of the inner delivery container 106 during the transportation of the biological sample. In some embodiments, the sensor 116 is configured to communicate with a remote server and notify a person when the temperature inside the inner delivery container 106 deviates from a predetermined range during the transportation of the biological sample. In some embodiments, when activated, the sensor 116 is configured to record the temperature data inside the inner delivery container 106. The sensor 116 can be configured to transmit an alert or a warning when the temperature inside the inner delivery container 106 deviates from a predetermined temperature range. The sensor 116 can be configured to connect and / or communicate with an electronic device (e.g., USB, Bluetooth, Near Field Communication (NFC)). The sensor 116 can be configured to transmit the detected temperature during the transportation of the biological sample so that the user can determine whether the temperature has deviated from a predetermined temperature range. Deviation from the predetermined temperature range can cause the biological sample to deteriorate.

[0063]

[0070] In practice, a medical institution can receive an apparatus 100 that may include an inner delivery container 106, a cooling engine 104, and a packaging kit 108. Each of the inner delivery container 106, the cooling engine 104, and the packaging kit 108 can be removed from the outer delivery container 102. A biological sample can be collected from a patient and added to a transport medium. The biological sample can be stored in a sample container in combination with the transport medium. A label 124 including one or more of unspecified patient information and destination information can be added to the sample container. In some embodiments, a label 124 including patient identification information (e.g., name, date of birth, age, etc.) and destination information is added to the sample container. The sample container can be fixed using a fixing element 118 from the packaging kit 108. The cooling engine 104 can be activated and placed inside the inner delivery container 106 together with a sensor 116 from the packaging kit 108. The fixed sample container can be placed inside a transport bag 112. Then, the transport bag 112 can be placed inside the inner delivery container 106 adjacent to the activated cooling engine 104 and the sensor 116. The inner delivery container 106 can be sealed and fixed using a fixing strip 114. Another label 124 including one or more of unspecified patient information and destination information can be inserted into the delivery pouch 110 and then this label 124 can be pasted onto the inner delivery container 106. In some embodiments, a label 124 including one or more of patient identification information (e.g., name, date of birth, age, etc.) and destination information is inserted into the delivery pouch 110 and then this label 124 is pasted onto the inner delivery container 106. The inner delivery container 106 storing the biological sample and the cooling engine 104 can be transported to another location such as another medical institution or a processing facility.

[0064]

[0071] Referring to FIG. 6, in some embodiments, the apparatus 100 is used in a method for packaging a biological sample. In some embodiments, the method includes providing (201) an apparatus 100 that includes an inner delivery container 106, a cooling engine 104, and a packaging kit 108. In some embodiments, a packaging kit 108 can be provided, and the packaging kit 108 can include a transport bag 112 and an insert 120 for storing one or more fixing elements 118, one or more fixing strips 114, and a sensor 116 (e.g., a temperature sensor). In some embodiments, the sample container can be fixed with the fixing element 118 (202), and the sample container can include a biological sample that can be collected from a patient. In some embodiments, the packaging kit 108 can include a plurality of labels 124. In some embodiments, the biological sample can be combined with a transport medium, and the transport medium can be configured to prevent degradation of the biological sample.

[0065]

[0072] In some embodiments, a first label of a plurality of labels 124 is attached to a fixed sample container (203). In some embodiments, the first label may include at least one of patient information and destination information. In some embodiments, the sample container with the label attached can be inserted into a transport bag 112 (204), and the transport bag 112 can be placed inside an inner delivery container 106 (205). In some embodiments, the transport bag 112 may include an absorbent sheet 111 configured to detect leakage of the sample container with the label inside the transport bag 112. In some embodiments, the inner delivery container 106 may include a cooling engine 104 and a sensor 116 that may be a temperature sensor. In some embodiments, the inner delivery container 106 is closed (206) such that the transport bag 112, the cooling engine 104, and the sensor 116 are disposed inside the inner delivery container 106. In some embodiments, the inner delivery container 106 may be fixed in a closed position using one or more fixing strips 114 so as to prevent access to the inside of the inner delivery container 106 (207). In some embodiments, one or more fixing strips 114 are configured to leave a mark or residue on the inner delivery container 106 when removed or changed. In some embodiments, a second label from the plurality of labels 124 is attached to the inner delivery container 106 (208). In some embodiments, the second label may include patient information and destination information. In some embodiments, the inner delivery container 106 may include the second label and is transported to the destination.

[0066]

[0073] Referring to FIG. 7, in some embodiments, the apparatus 100 is used in a method for packaging a biological sample. In some embodiments, the method includes receiving (209) an outer delivery container 102 having a cooling engine 104, an inner delivery container 106, and a packaging kit 108. In some embodiments, the packaging kit 108 includes a transport bag 112, a delivery pouch 110, a plurality of labels 124, and an insert 120 for storing a fixing element 118, a fixing strip 114, and a temperature sensor. In some embodiments, the cooling engine 104, the inner delivery container 106, and the packaging kit 108 are removed from the outer delivery container 102 (210). In some embodiments, the transport bag 112, the delivery pouch 110, the plurality of labels 124, and the insert 120 are removed from the packaging kit 108 (211), and the insert 120 includes a notch sized and shaped to receive the fixing element 118, the fixing strip 114, and the temperature sensor. In some embodiments, the fixing element 118, the fixing strip 114, and the temperature sensor are removed from the insert 120 (212). In some embodiments, the biological sample is placed in a sample container (213), and the biological sample includes tumor tissue and a transport medium. In some embodiments, the sample container is fixed by the fixing element 118 (214). In some embodiments, a first label of the plurality of labels 124 is attached to the fixed sample container (215), and the first label includes at least one of patient information and destination information. In some embodiments, the sample container with the label attached is inserted into the transport bag (216), and the transport bag 112 includes an absorption sheet 111 configured to absorb leakage of the sample container with the label in the transport bag 112. In some embodiments, the cooling engine 104 is activated (217), whereby the cooling engine 104 is configured to maintain the inner delivery container 106 within a predetermined temperature range when the activated cooling engine 104 is placed in the inner delivery container 106. In some embodiments, the transport bag 112, the cooling engine 104, and the temperature sensor are placed in the inner delivery container 106 (218).In some embodiments, the inner delivery container 106 is closed (219) such that the transport bag 112, the cooling engine 104, and the temperature sensor are disposed inside the inner delivery container 106. In some embodiments, the inner delivery container 106 is secured in a closed position using a fixed strip 114 (220) such that access to the interior of the inner delivery container 106 is prevented, and the fixed strip 114 is configured to leave a mark or residue on the inner delivery container 106 when removed or altered. In some embodiments, a second label of the plurality of labels 124 is affixed to the inner delivery container 106 (221), and the second label includes at least one of patient information and destination information.

[0067]

[0074] In some embodiments, one or more fixed strips 114 are removed from the notch 122a, the sensor 116 is removed from the notch 122b, and one or more fixing elements 118 are removed from the notch 122c. In some embodiments, the cooling engine 104 can be activated such that the cooling engine 104 is configured to maintain the inner delivery container 106 within a predetermined temperature range when the cooling engine 104 is activated and disposed within the inner delivery container 106. In some embodiments, the predetermined temperature range can be from 0°C to 10°C.

[0068]

[0075] In some embodiments, the outer delivery container 102 is received by a user and includes the cooling engine 104, the inner delivery container 106, and the packaging kit 108. In some embodiments, the user can remove the cooling engine 104, the inner delivery container 106, and the packaging kit 108 from the outer delivery container 102, and can remove the transport bag 112, the delivery pouch 110, the plurality of labels 124, and the insert 120 from the packaging kit 108.

[0069]

[0076] As used herein, the term “about” or “substantially” is used to provide literal support for a number that is close to or approximately the exact number that precedes the term, as well as for a number that is close to or approximately the number that precedes the term. When determining whether a number is close to or approximately a specifically recited number, an unrecited number that is close to or approximates the specifically recited number may be a number that provides substantial equivalence to the specifically recited number in the context in which it is presented. It is to be understood that all numerical values and ranges disclosed herein are approximate values and approximate ranges, whether or not the term “about” is used therewith. As used herein, the term “about” in connection with a number may refer to a value that is ±0.01% (including the boundary values), ±0.1% (including the boundary values), ±0.5% (including the boundary values), ±1% (including the boundary values), ±2% (including the boundary values), ±3% (including the boundary values), ±5% (including the boundary values), ±10% (including the boundary values) or ±15% (including the boundary values) of that number. It is further to be understood that when a numerical range is disclosed herein, any numerical value falling within that range is specifically disclosed.

[0070]

[0077] Those skilled in the art will appreciate that modifications can be made to the exemplary embodiments shown and described above without departing from the broad inventive concept. It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of the structure and arrangement of components shown in the specification and the drawings. Rather, the specification and drawings provide examples of the contemplated embodiments. The embodiments and claims disclosed herein are further capable of other embodiments and can be practiced and carried out in various ways.

[0071]

[0078] The specific features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments can be combined. Unless specifically indicated otherwise herein, the terms "a", "an", and "the" are not limited to one element and should instead be read as meaning "at least one". Finally, unless specifically indicated otherwise herein, the disclosed or claimed methods should not be limited to performing the steps in the order described, and one of ordinary skill in the art can readily understand that the steps can be performed in any practical order.

Claims

1. A packaging and transport device for biological samples, Insert and, Fixed strip and Fixed elements, A temperature sensor, wherein the insert includes a plurality of notches of a size and shape that accommodate the fixing strip, the fixing element, and the temperature sensor, A plurality of labels, wherein at least one of the plurality of labels includes patient information, A shipping pouch of a size and shape suitable for receiving shipping documents, A transport bag configured to accept sample containers and Packaging and transport equipment including.

2. The packaging and transport apparatus according to claim 1, wherein the plurality of notches include a first notch, a second notch, and a third notch.

3. The packaging and transport apparatus according to claim 2, wherein the first notch of the insert is configured to receive and store the fixing strip, the second notch of the insert is configured to receive and store the temperature sensor, and the third notch of the insert is configured to receive and store the fixing element.

4. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the insert is placed between the transport bag and the plurality of labels.

5. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the insert is positioned between the transport bag and the plurality of labels, and the transport bag is positioned between the delivery pouch and the insert.

6. The packaging and transport apparatus according to any one of claims 1 to 3, further comprising an inner delivery container of a size and shape that can accommodate the transport bag and the cooling engine, the inner delivery container being smaller in size than the packaging and transport apparatus.

7. The packaging and transport apparatus according to claim 6, wherein the fixing strip is configured to leave a trace on the inner delivery container if it is removed or altered.

8. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the fixing strip is positioned in one of the plurality of notches of the insert.

9. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the insert includes three or more of the fixing strips, or the insert includes three or more of the fixing strips, and the three or more fixing strips are arranged in the plurality of notches of the insert.

10. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the insert includes four or more of the fixing elements, or the insert includes four or more of the fixing elements, and the four or more fixing elements are arranged in the plurality of notches of the insert.

11. The packaging and transport apparatus according to any one of claims 1 to 3, further comprising a cooling engine configured to maintain a temperature range of about -80°C to about 10°C during operation of the engine.

12. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the temperature sensor is located in one of the plurality of notches of the insert.

13. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the transport bag is configured to withstand up to 95 kPa without leakage.

14. The packaging and transport apparatus according to any one of claims 1 to 3, wherein the insert is positioned between the plurality of labels and one of the delivery pouch and the transport bag.

15. The packaging and transport apparatus according to any one of claims 1 to 3, further comprising a kit container for housing the insert, the plurality of labels, the delivery pouch and the transport bag.

16. A method for packaging biological samples, To provide a packaging kit having a transport bag, a fixing element, a fixing strip, and an insert for storing a temperature sensor, The method involves fixing the sample container with the fixing element, wherein the sample container contains the biological sample, and the fixing method involves The first label is affixed to the fixed sample container, the first label including patient information, Insert the sample container with the label attached into the transport bag, The transport bag is placed inside an inner delivery container, the inner delivery container includes a cooling engine and a temperature sensor. The inner delivery container is closed so that the transport bag, the cooling engine, and the temperature sensor are placed inside the inner delivery container. The inner delivery container is secured in a closed position using the fixing strip so that it is clear that an attempt was made to access the inside of the inner delivery container, The method involves affixing a second label to the inner delivery container, wherein the second label includes patient information and / or destination information. A method that includes this.

17. The method according to claim 16, wherein the packaging kit further comprises a delivery pouch and a plurality of labels including the first label and the second label.

18. The method according to claim 17, wherein, within the packaging kit, the insert is positioned between the transport bag and the plurality of labels.

19. The method according to claim 17, wherein, within the packaging kit, the transport bag is positioned between the delivery pouch and the insert.

20. Removing the fixing strip from the first notch of the insert, Removing the temperature sensor from the second notch of the insert, Removing the fixing element from the third notch of the insert and The method according to any one of claims 16 to 18, further comprising:

21. The method according to claim 20, wherein the first notch of the insert is configured to receive and store the fixing strip.

22. The method according to claim 20, wherein the second notch of the insert is configured to receive and house the temperature sensor.

23. The method according to claim 20, wherein the third notch of the insert is configured to receive and store the fixing element.

24. The method according to any one of claims 16 to 18, further comprising operating the cooling engine such that the cooling engine is configured to maintain the inner delivery container within a predetermined temperature range when the operated cooling engine is placed inside the inner delivery container.

25. The method according to claim 24, wherein the predetermined temperature range is 0°C to 10°C.

26. The method according to any one of claims 16 to 18, wherein the biological sample comprises a plurality of tumor tissues recovered from a patient.

27. The method according to any one of claims 16 to 18, wherein the fixing strip is configured to leave a trace on the inner delivery container if it is removed or altered.

28. The method according to any one of claims 16 to 18, wherein the packaging kit includes three or more fixing strips.

29. The method according to any one of claims 16 to 18, wherein the packaging kit includes four or more fixing elements.

30. The method according to any one of claims 16 to 18, wherein the transport bag is configured to withstand up to 95 kPa without leakage.

31. The method according to any one of claims 16 to 18, wherein the packaging kit includes a kit container, the kit container is configured to receive and store the transport bag and the insert.

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