Devices for tissue cryopreservation and recovery
Inventors
Khristov, Vladimir Rouskov • Miminishkis, Arvydas • Bharti, Kapil
Assignees
US Department of Health and Human Services
Publication Number
US-11819020-B2
Publication Date
2023-11-21
Expiration Date
2038-01-31
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Abstract
Disclosed devices for recovering cryopreserved tissue can comprise a receptacle that receives a sealed, frozen tissue container containing cryopreserved tissue and cryopreservation media, with at least one recovery media chamber and a waste material chamber fluidly coupled to the tissue container receptacle. The recovery device can be inserted into a regulator apparatus that facilitates thawing and warming of the media and tissue, and regulation of the flow of recovery media through the tissue container to flush out the thawed cryopreservation media into the waste chamber. The regulator can identify the tissue based on an ID tag on the tissue container and automatically apply an appropriate algorithm for thawing, culturing, and maintaining the tissue in a viable state.
Core Innovation
The invention discloses devices and systems for recovering cryopreserved tissue, which include a receptacle that receives a sealed, frozen tissue container containing cryopreserved tissue and media. The device features at least one recovery media chamber and a waste material chamber fluidly coupled to the tissue container receptacle. This arrangement facilitates thawing, warming, and the controlled flow of recovery media through the tissue container to flush out the cryopreservation media into the waste chamber, while maintaining the tissue under conditions that preserve viability.
The device can be inserted into a regulator apparatus that reads an identification tag on the tissue container to automatically apply an appropriate algorithm for thawing, culturing, and maintaining the tissue. The regulator apparatus controls environmental parameters such as temperature and gas levels, enabling nearly fully automated recovery and maintenance of the tissue in a sterile environment. The recovery media chambers may be configured to contain multiple media types, which can be introduced to different sides of a tissue sheet during recovery.
The problem solved by this invention arises from the difficulty in cryopreserving and recovering sheets or three-dimensional tissue constructs that tend to suffer mechanical and chemical damage during freezing and thawing. Conventional methods require multiple manual steps transferring tissues between containers, risking contamination, variability, and needing specialized facilities and trained personnel. The invention aims to simplify, speed up, and secure the recovery and culturing process by reducing the number of handling steps, maintaining sterility, and enabling operation outside specialized culture rooms, even with minimal infrastructure or human intervention.
Claims Coverage
The patent includes several independent claims defining a tissue recovery device, a regulator apparatus, and a tissue container, covering key features related to device construction, media flow control, and automated tissue recovery.
Recovery device with detachable housing components and integrated fluid chambers
A device comprising first and second housing components that attach and detach to form a receptacle for a sealed tissue container, including at least one recovery media chamber fluidly coupled to the receptacle and a waste material outlet to conduct waste media out of the device, thereby facilitating thawing and culturing within the tissue container.
Puncturing elements for fluid communication
The device includes at least one puncturing element to create an opening in the tissue container for conducting recovery media into the container and a second puncturing element to conduct waste media out through the waste outlet, enabling controlled fluid flow while maintaining sterility.
Multiple recovery media chambers and media container configuration
The device may contain two or more recovery media chambers for different media types, and the recovery media chambers can receive insertable and removable media containers that are manually actuatable to dispense desired amounts of media.
Valve regulation and active waste management
The device can include a valve positioned along a conduit between the recovery media chamber and tissue container receptacle, controlled by a valve controller, and the waste outlet can be connectable to an active vacuum apparatus for drawing waste material out.
Regulator apparatus with automated identification and heating control
A regulator apparatus includes a housing to receive the recovery device, an identification tag reader to determine tissue information from the tissue container, at least one heater to warm the tissue container and media, a control system programmed with algorithms for recovery, and a valve controller to manage flow of recovery media.
Tissue container design with identification tag
A tissue container comprising a basin, tissue well holding the tissue, cryopreservation media enclosed by a sealed lid, and an identification tag on any part of the container to identify the tissue. In some claims, the tissue is a sheet of epithelial tissue with cryopreservation media containing sodium alginate.
The independent claims collectively define a device and system enabling automated recovery and culturing of cryopreserved tissues within a sealed environment, using fluid control via puncturing elements and valves, identifiable tissue containers, and a regulator apparatus that provides controlled environmental conditions based on automatically identified tissue information.
Stated Advantages
Simplifies, speeds up, and reduces risk to tissue during recovery, culturing, and maintenance from cryopreservation.
Reduces contamination risk and variability by maintaining a sterile, contained environment throughout recovery.
Requires fewer human resources and less infrastructure, enabling operation outside specialized cell culture rooms.
Allows nearly fully automated recovery processes guided by automated tissue identification and control algorithms.
Enables storage and recovery of complex tissue sheets and three-dimensional constructs with reduced mechanical and chemical damage.
Documented Applications
Recovery of cryopreserved biological materials such as single-cell suspensions, monolayer tissue sheets, three-dimensional tissue constructs, and vascularized tissue constructs.
Recovery and preparation of epithelial tissue sheets, including retinal pigment epithelium on scaffolds, for transplantation into patients.
On-demand availability of tissues for transplantation procedures in operating rooms without need for extensive cell culture facilities.
Use in clinical settings including hospitals and clinics for tissue preparation prior to transplantation or biological testing.
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