The invention pertains to the field of storage and transport of biological material, and more particularly, to a shock absorbing device to protect cryopreserved biological material.
Most or all biologic-based materials, including medicines, vaccines, cell and gene therapies, and engineered tissue products, are subject to hypothermic storage of varying duration to attempt to ensure survival, recovery during an ex vivo storage interval, and return to normal biologic function following an ex vivo storage interval. Current methods deploy various insulated shipping containers and biopreservation media of varying formulas. One method of storing and transporting blood or other biological fluid, for example, includes containing the fluid in deformable thermoplastic bags, which are then placed within a hard, typically metal, cassette. The cassettes provide an ability to organize and store the plastic bags in cryogenic freezers, as well as to provide protection for the bags. Typically the cassettes are sized to hold the plastic bags with minimal excess space to spread the biological fluid uniformly and facilitate a uniform rate of freezing and/or thawing.
Freezing some materials to cryogenic temperatures (e.g. temperatures to as low as −196 degrees Celsius or colder), including storage container material and biological material, can make the material brittle and susceptible to damage from shock normally encountered during transport. Thermoplastic bags containing biological fluid, as discussed in the example above, when frozen, can become brittle. A plurality of the frozen cassettes discussed above, containing the thermoplastic bags of biological fluid, can be secured within a dry vapor shipper to maintain the cryogenic temperature during shipping. Shock and vibration experienced by the dry vapor shipper can be transmitted to the plurality of cassettes and the plastic bags within, causing one or more of the plastic bags to fracture, resulting in a catastrophic loss of biological fluid. In the case of cell and gene therapy products, the lost fluid might have been a life-saving material made for a single patient at a very high monetary cost.
A shock absorbing device protects cryogenically frozen biological material by absorbing, dampening, or attenuating physical forces that would otherwise cause cryogenic storage and/or shipping materials to be damaged.
In an embodiment, the shock absorbing device includes an outer sleeve defining an interior volume and having an opening configured to pass a biological material container into the interior volume; and a foam sleeve in the interior volume, the foam sleeve having an opening and an interior cavity, the opening of the foam sleeve aligned with the opening of the outer sleeve to pass the biological material container into the interior cavity.
In another embodiment, the shock absorbing device includes a first layer having a first side and a second side; a foam layer having a first side and a second side, the first side of the foam layer adjacent and facing the second side of the first layer; and a liner layer to retain the foam layer, the liner layer having a first side and a second side, the first side of the liner layer adjacent and facing the second side of the foam layer.
In the following description, reference is made to the accompanying drawings that form a part thereof, and in which is shown by way of illustration specific exemplary embodiments in which the present teachings may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present teachings and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the present teachings. The following description is, therefore, merely exemplary.
The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an”, and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
When an element or layer is referred to as being “on”, “engaged to”, “connected to” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to”, “directly connected to” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Spatially relative terms, such as “inner,” “outer,” “beneath”, “below”, “lower”, “above”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
The term “elastic deformation” is understood to be a reversible change in the dimensions of a material, in which the material has a first set of dimensions when no forces are applied to it, the material transitions to a second set of dimensions when forces are applied to it, and the material transitions back to its original set of dimensions when the forces are no longer applied. Such deformation includes but is not limited to changes in spatial dimensions and combinations thereof (e.g., changes in volume, cross-sectional profile, and diameter), and can result from forces including, but not limited to, forces of compression and/or stretching under tension.
As discussed above, a shock absorbing device protects cryogenically frozen biological material by absorbing, dampening, or attenuating physical forces that would otherwise cause cryogenic storage and/or shipping materials to be damaged.
The outer sleeve 12 can have an opening 14 configured to pass a biological material container (e.g., a cassette, not shown) into an interior volume 16. A securing element, such as flap 18 can be closed and/or sealed over the opening 14 to close the opening 14 and secure the biological material container therein. Any now-known or future developed fastening element can be used to close or seal, or in some embodiments re-close or re-seal, the flap 18, such as but not limited to hook and loop, adhesive, buttons, zippers, clips, magnets, and snaps. In the instant embodiment, the fastening element is a pressure sensitive adhesive 22 on the flap 18, which can seal the flap 18 to an outer surface of another portion of the outer sleeve 12. The flap 18 and opening 14 could be positioned alternatively, such as by turning the flap 18 perpendicularly from the orientation shown in
In some embodiments, the foam of the foam sleeve 26 can be or can include a reticulated foam. Reticulated foam is a very porous, low density solid foam. Reticulated foams have few, if any, intact cells (bubbles) 34 or polyhedra cell windows (faces) 36. In a reticulated foam only the lineal boundaries (edges) 38 where the cell windows 36 meet remain, and the polyhedra cell windows 36 are missing. The solid component of a reticulated foam may be an organic polymer like polyurethane, a ceramic, or a metal.
When at ambient temperatures, the foam sleeve 26 can be flexible and deformable, in which case the foam sleeve 26 can conform around a cryogenically frozen biological material or a cryogenically frozen container of biological material (such as the biological material container 30). During use of the shock absorbing container 10, the cryogenically frozen biological material and/or the container of cryogenically frozen biological material can be quickly placed through the opening 14 of the outer sleeve 12 and through the opening 29 of the foam sleeve 26 into an interior volume 39 of the foam sleeve 26. The foam sleeve 26 being unfrozen or at ambient temperature, can deform to the shape of the biological material container 30, and can quickly become rigid as the foam sleeve quickly cryogenically freezes. When the temperature of the foam sleeve 26 drops below a certain temperature, such as 0 degrees Celsius, the material becomes rigid. The rigid material has increased brittleness—more so with the net-like, low density structure of reticulated foam. In the frozen, brittle state, the foam sleeve 26 can endure small fractures in the faces 36 and/or edges 38, or in the case of reticulated foam, just the edges 38, during shocks or vibrations. These fractures absorb or dampen the shock or vibration forces, thereby attenuating or eliminating transmission of the forces to the biological material container 30 in the interior volume 39 and/or the biological material therein. Generally, faces 36 of non-reticulated foam can withstand a greater force before breaking than mere edges 38 of reticulated foam. Accordingly, reticulated foam can provide shock absorption of lower forces, and non-reticulated foam can provide shock absorption of higher forces.
The foam sleeve 26 can entirely encircle the interior cavity 39 intended to snugly hold the biological material container 30, with one continuous piece or with a plurality of pieces; or the foam sleeve 26 can include separated pieces on opposing sides of the interior cavity 39.
Similarly, in the embodiment of
In order to standardize the exterior dimensions of the outer sleeve 12 while accommodating biological material containers 30 of different sizes, a total thickness T2 of the foam sleeve 26, 42 can be varied.
When at ambient temperatures, the foam sleeve 26 is flexible and deformable. During use of the shock absorbing device 10, a cryogenically frozen biological material container 30 encasing a cryogenically frozen bag of biological fluid is quickly placed through the opening 14 of the outer sleeve 12, through the opening 29 of the foam sleeve 26, into the interior cavity 32. The foam sleeve 26, being unfrozen or at ambient temperature, can deform to the shape of the biological material container 30, and can quickly become rigid as the foam sleeve quickly cryogenically freezes. When the temperature of the foam sleeve 26 drops below 0 degrees Celsius, the material becomes rigid. The rigid material increases brittleness, moreso with the net-like, low density structure of a reticulated foam. In the frozen, brittle state, the foam sleeve 26 endures small fractures in bubble faces, or in the case of reticulated foam, bubble edges or strands, during shocks or vibrations. These fractures absorb or dampen the shock or vibration forces without transmitting the forces to the biological material container 30 and the thermoplastic bags therein. In this manner, shock and vibration energy is dissipated, attenuating or preventing transmission of the shock to the biological material container 30 and its contents.
Additionally, the shock absorbing device 10 can include an inner liner and/or a liquid-absorbing liner.
The liquid-absorbing liner 68 in
The center portion 91 of the top flap 90 and/or other portions of the first side wall 98 and/or the fourth side wall 104 can include adhesive to adhere and/or seal the first side wall 98 to the fourth side wall 104. The first, second, third, and fourth side walls 98, 100, 102, 104 can be pre-creased as shown in
It is to be understood that the embodiments of the invention herein described are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims, which themselves recite those features regarded as essential to the invention.
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Entry |
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International Search Report for PCT/US2021/026213 dated Jul. 28, 2021. |
Number | Date | Country | |
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20210315201 A1 | Oct 2021 | US |