CN-121985927-A - Elastomeric polymer container and heating element and related methods

Abstract

A flexible container useful for containing a liquid and freezing the liquid is described, as well as a flexible resistive heating element adapted to heat the frozen liquid to melt the frozen liquid.

Inventors

• M.W. JOHNSON

Assignees

• 恩特格里斯公司

Dates

Publication Date

20260505

Application Date

20240920

Priority Date

20230921

Claims (20)

1. 1. An elastomeric polymer container and a heating element, comprising: A container comprising an elastomeric polymer sidewall having an inner surface defining a container interior adapted to contain a fluid, and an outer surface, An elastic resistive heating element adapted to provide thermal energy to the interior through the elastic polymer sidewall.
2. 2. The elastomeric polymer container and heating element of claim 1, comprising: Said elastomeric polymer container, and The heating element is attached at an outer surface of the elastic polymer sidewall.
3. 3. The elastomeric polymer container and heating element of claim 1, comprising a multi-layer elastomeric polymer sidewall comprising: A first layer comprising a first elastomeric polymer layer, A second layer comprising a second elastic polymer layer, and The elastic resistance heating element is positioned between the first layer and the second layer.
4. 4. The elastomeric polymer container and heating element of claim 1, comprising: The container of the elastic polymer is made of a material, An outer reservoir comprising the resistive heating element and an interior, the elastomeric polymer container being contained within the interior of the outer reservoir, wherein the resistive heating element is positioned to allow thermal energy from the resistive heating element to pass through the elastomeric polymer sidewall to the container interior.
5. 5. The elastomeric polymer container and heating element of claim 4, wherein the outer reservoir comprises a protective housing comprising a sidewall comprising metal.
6. 6. The elastomeric polymer container and heating element of claim 4, wherein the outer reservoir comprises a protective housing comprising a sidewall comprising plastic.
7. 7. The elastomeric polymer container and heating element of claim 4, wherein the outer reservoir comprises an elastomeric sidewall made of an insulating material.
8. 8. The elastomeric polymer container and heating element of any one of claims 5 to 7, wherein the elastomeric container is removable from the interior of the outer reservoir.
9. 9. The elastomeric polymer container and heating element of any one of claims 1 to 8, the elastomeric container comprising: A first elastomeric polymer sidewall comprising a polymer sheet having a first sidewall perimeter, A second elastomeric polymer sidewall comprising a second polymer sheet having a second sidewall perimeter, A sealed container perimeter comprising the first sidewall perimeter joined to the second sidewall perimeter, An enclosure interior positioned between the first elastomeric polymer sidewall, the second elastomeric polymer sidewall and the container perimeter, A fluid outlet at the container periphery, the fluid outlet providing fluid communication between the interior and the container exterior.
10. 10. The elastomeric polymer container and heating element of any one of claims 1 to 8, comprising: a side wall of a tubular elastic polymer, A bottom elastomeric polymer sidewall at the bottom of the tubular elastomeric polymer sidewall, A top elastomeric polymer sidewall at the top of the tubular elastomeric polymer sidewall, An interior positioned between the tubular elastomeric polymer sidewall, the bottom elastomeric polymer sidewall, and the top elastomeric polymer sidewall, A fluid outlet at the top elastomeric polymer sidewall, the fluid outlet providing fluid communication between the interior and the container exterior.
11. 11. The elastomeric polymer container and heating element of claim 1, wherein the resistive heating element is adapted to provide thermal energy to a central region of the container.
12. 12. The elastomeric polymer container and heating element of claim 1, wherein the resistive heating element is adapted to provide a first flux of thermal energy to a central region of the container and a second flux of thermal energy to a peripheral region of the container, wherein a magnitude of the first flux is greater than a magnitude of the second flux.
13. 13. The elastomeric polymer container and heating element of any one of claims 1 to 12, which contains a biological material.
14. 14. The elastomeric polymer container and heating element of claim 13, wherein the biological material comprises frozen living cells.
15. 15. A method of storing a liquid biological material using the elastic polymer container and heating element of any one of claims 1-12, the method comprising adding a liquid biological material to the elastic polymer container.
16. 16. The method of claim 15, comprising freezing the liquid biological material contained in the elastomeric polymer container.
17. 17. A method of thawing frozen biological material using the elastic polymer container and heating element of any one of claims 1-14, the method comprising using the resistive heating element to generate thermal energy and applying the thermal energy to frozen biological material contained in the elastic polymer container.
18. 18. The method of claim 17, wherein the biological material comprises living cells.
19. 19. A method of thawing frozen biological material, the method comprising: Providing a frozen biological material contained in a container, the container comprising an elastomeric polymer sidewall having an inner surface defining a container interior adapted to contain a fluid, and an outer surface, and A biopharmaceutical fluid is thawed using a flexible resistive heating element to provide thermal energy to the interior through the flexible polymer sidewall.
20. 20. The method of claim 19, comprising providing thermal energy to a central region of the vessel.

Description

Elastomeric polymer container and heating element and related methods Technical Field The present invention relates to a flexible container (vessel) useful for containing liquids and frozen liquids, and a flexible resistive heating element adapted to heat the frozen liquid to melt the frozen liquid. Background The life sciences industry, particularly in the field of biotechnology and cell and gene therapy, relates to bioactive materials (also referred to herein simply as "biomaterials") that can be frozen and unfrozen during the steps of preparation, transport and use. The biological material may be a biological or pharmaceutically active material, such as a pharmaceutical compound, a protein, a living (living) cell, or other biological molecule or structure that may be used as a medicament, drug, or precursor of a medicament. These bioactive materials must be packaged, transported, and stored between the time the material is initially prepared and the time the material is used. Highly specialized packaging has been developed to safely contain, transport and store these bioactive materials in a manner that is safe and does not damage the bioactive materials. Typically, the bioactive material is frozen for storage and during transport. The frozen material may reduce the likelihood of chemical degradation of the bioactive material or slow or stop metabolic processes in living cells, i.e., slow or stop cell growth. Thus, the package for biological material is suitable for freezing and containing biological material in frozen form. Useful packaging versions include elastic polymer containers (sometimes referred to as "bags" or "pouches") adapted to contain and deliver bioactive materials and allow the bioactive materials to be frozen and unfrozen while in a reservoir (container). In various versions, the flexible container is an inner package assembly held by a more rigid outer package assembly that protects the inner container from physical or mechanical damage, and may incorporate additional useful features, such as insulation. Storage and transport of bioactive materials in a frozen state has become a common technique. While very effective for these purposes, and while these techniques provide significant benefits, the steps of freezing and subsequently thawing the biological material also create potential drawbacks. For example, freezing and thawing biological materials can cause physical damage to active pharmaceutical compounds and living cells, which can lead to inactivation of the biological material. Disclosure of Invention The present invention relates to devices and methods for containing, transporting and storing materials in a liquid or solid (frozen) state using flexible containers. The container may initially contain the material in a liquid state, and the liquid material may be frozen while held in the reservoir. The solid (frozen) material may then be thawed using a resistive heating element as described. The life sciences, pharmaceutical and biotechnology industries, in particular, in connection with cell and gene therapy, transport and store biological materials in frozen state. The material must eventually be thawed after freezing. A great deal of attention and research has focused on methods of freezing biological materials. Less research is directed to methods of thawing frozen biological material in a manner that reduces or minimizes damage to the material during the thawing step. Current thawing methods include convection heating and water bath heating, each of which applies an equal amount of thermal energy to all areas of the outer surface of the container. Applicants have identified examples of devices, systems, and methods that use resistive heating elements to apply a heat flux across the surface of an elastic container to defrost an entire amount of frozen biological material contained in the container, and to produce a rapid and uniform defrost of an entire volume of frozen liquid. Rapid and uniform thawing of the entire volume of frozen biological material in the container can effectively preserve the biological activity of the biological material, particularly frozen living cells. Additionally, the described containers and heating elements and related methods may allow thawing of high value drugs at the point of use (e.g., hospital, medical care clinic, home), i.e., at the location of the patient and the location of drug administration to the patient, rather than thawing biological material at a remote location and transporting the material to the point of use in an unfrozen condition. In one aspect, the following description relates to an elastomeric polymer container and a heating element. The container and heating element include a container comprising an elastomeric polymer sidewall having an inner surface defining a container interior adapted to contain a fluid and an outer surface, and an elastomeric resistive heating element adapted to provide thermal energy to the interi