KR-20260066794-A - Flexible polymer container and heating element and related method

KR20260066794AKR 20260066794 AKR20260066794 AKR 20260066794AKR-20260066794-A

Abstract

Flexible containers useful for holding and freezing liquids, and a flexible resistance heating element adapted to heat the frozen liquid to melt the frozen liquid are described.

Inventors

존슨 마이클 더블유.

Assignees

엔테그리스, 아이엔씨.

Dates

Publication Date: 20260512
Application Date: 20240920
Priority Date: 20230921

Claims (20)

As a flexible polymer container and heating element, A container comprising a flexible polymer sidewall having an outer surface and an inner surface defining the interior of the container adapted to accommodate a fluid; and A flexible resistance heating element adapted to provide thermal energy to the interior through the flexible polymer sidewall. A flexible polymer container and a heating element comprising
In paragraph 1, The above flexible polymer container; and The heating element attached to the outer surface of the flexible polymer sidewall A flexible polymer container and a heating element comprising
In claim 1, the multilayer flexible polymer sidewall comprises: A first layer comprising a first flexible polymer layer; A second layer comprising a second flexible polymer layer; and The flexible resistance heating element located between the first layer and the second layer A flexible polymer container and a heating element comprising
In paragraph 1, The above flexible polymer container; and The above resistance heating element and the external container including the interior A flexible polymer container and a heating element, comprising, wherein the flexible polymer container is accommodated within the interior of the outer container, and the resistance heating element is positioned to allow thermal energy from the resistance heating element to pass into the interior of the container through the flexible polymer sidewall.
In paragraph 4, the outer container comprises a flexible polymer container and a heating element, wherein the outer container comprises a protective housing comprising side walls comprising metal.
In paragraph 4, the outer container comprises a flexible polymer container and a heating element, wherein the outer container comprises a protective housing comprising side walls comprising plastic.
In paragraph 4, the outer container comprises flexible sidewalls made of an insulating material, and the flexible polymer container and heating element.
In any one of claims 5 to 7, the flexible container is a flexible polymer container and a heating element that is removable from the interior of the outer container.
In any one of claims 1 to 8, the flexible container is: A first flexible polymer sidewall comprising a polymer sheet having a first sidewall perimeter; A second flexible polymer sidewall comprising a second polymer sheet having a second sidewall periphery; A sealed container periphery comprising the first sidewall periphery coupled to the second sidewall periphery; A sealed interior located between the first flexible polymer sidewall, the second flexible polymer sidewall, and the periphery of the container; and A fluid outlet located at the periphery of the container that provides fluid communication between the interior and the exterior of the container. A flexible polymer container and a heating element comprising
In any one of paragraphs 1 through 8, Tubular flexible polymer sidewall; The lowest flexible polymer sidewall located at the bottom of the above-mentioned tubular flexible polymer sidewall; The uppermost flexible polymer sidewall located at the top of the above tubular flexible polymer sidewall; An interior located between the above tubular flexible polymer sidewall, the lowest flexible polymer sidewall, and the uppermost flexible polymer sidewall; and A fluid outlet in the uppermost flexible polymer sidewall providing fluid communication between the interior and the exterior of the container. A flexible polymer container and a heating element comprising
In claim 1, the flexible polymer container and heating element, wherein the resistance heating element is adapted to provide thermal energy to the central region of the container.
A flexible polymer container and a heating element according to claim 1, wherein the resistance 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, and the magnitude of the first flux is greater than the magnitude of the second flux.
A flexible polymer container and a heating element for accommodating a biological material, in any one of claims 1 to 12.
In paragraph 13, the biological material comprises a flexible polymer container and a heating element containing frozen biological cells.
A method for storing a liquid biological material using a flexible polymer container and a heating element according to any one of claims 1 to 12, comprising the step of adding the liquid biological material to the flexible polymer container.
A method according to claim 15, comprising the step of freezing the liquid biological material contained in the flexible polymer container.
A method for thawing a frozen biological material using a flexible polymer container and a heating element according to any one of claims 1 to 14, comprising the step of generating thermal energy using the resistance heating element and applying the thermal energy to the frozen biological material contained in the flexible polymer container.
In paragraph 17, the above biological material comprises living cells, a method.
As a method for thawing frozen biological materials, A step of providing a frozen biological material contained within a container comprising a flexible polymer sidewall having an outer surface and an inner surface defining the interior of the container adapted to accommodate a fluid; and Step of thawing a biopharmaceutical fluid using a flexible resistance heating element to provide thermal energy into the interior through the flexible polymer sidewall. A method including
A method according to claim 19, comprising the step of providing thermal energy to the central region of the container.

Description

Flexible polymer container and heating element and related method This description relates to flexible containers useful for holding and freezing liquids, and flexible resistance heating elements adapted to heat the frozen liquid to melt the frozen liquid. The field of life sciences, particularly in the fields of biotechnology and cell and gene therapy, involves biologically active materials (also referred to herein simply as “biological materials”) that can be frozen and non-frozen during the preparation, transport, and use stages. Biological materials may be biological or pharmaceutically active materials such as pharmaceutical compounds, proteins, living cells, or other biological molecules or structures useful as pharmaceutical agents, medicines, or precursors for pharmaceutical agents or medicines. These biologically active materials must be packaged, transported, and stored between the time of initial preparation and the time of use. Highly specialized packages have been developed to safely accommodate, transport, and store these biologically active materials in a manner that is safe and does not cause damage to the biological materials. Often, biologically active materials are frozen for storage and during transport. Freezing materials can reduce the potential for chemical degradation of biologically active materials or slow down or halt the metabolic processes of living cells, that is, slow down or halt cell growth. Therefore, packages for biological materials are adapted to be frozen and to accommodate the biological materials in a frozen form. Useful package formats include flexible polymer containers (sometimes referred to as "bags" or "pouches") adapted to accommodate and deliver biologically active materials and to allow the biological materials to freeze and thaw while inside the container. In various formats, the flexible container is an inner package component held in place by a rigid outer package component that protects the inner container from physical or mechanical damage and may include additional useful features such as insulation. Storing and transporting biologically active materials in a frozen state has become a common practice. While highly effective for this purpose and offering significant advantages, the steps of freezing and subsequently thawing biological materials also present potential drawbacks. For example, the freezing and thawing of biological materials can cause physical damage to active pharmaceutical compounds and living cells, which may lead to the inactivation of the biological materials. This description relates to methods and devices using a flexible container for receiving, transporting, and storing a material that is either in a liquid or solid (frozen) state. The container may initially receive a material in a liquid state, and the liquid material may be frozen while maintained within the container. The solid (frozen) material may be thawed using a resistance heating element as subsequently described. The life science, pharmaceutical, and biotechnology industries, particularly in relation to cell and gene therapy, transport and store biological materials in a frozen state. After freezing, the materials must eventually be thawed. Much interest and research have focused on methods for freezing biological materials. Less research has been conducted on methods for thawing frozen biological materials in a way that reduces or minimizes harm to the materials during the thawing phase. 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. The applicant has identified examples of methods, systems, and devices that apply heat flux through the surface of a flexible container, thaw a bulk volume of frozen biological material contained within the container, and use a resistance heating element to produce rapid and uniform thawing of the bulk volume of the frozen liquid. Rapid and uniform thawing of the bulk volume of frozen biological material within the container can be effective in preserving the biological activity of the biological material, particularly frozen living cells. Additionally, the described containers, heating elements, and related methods can enable the thawing of expensive medicines at the point of use (e.g., hospital, medical clinic, home), that is, at the patient's location and at the location where the medicine is administered to the patient, rather than thawing the biological material at a remote location and transporting the material to the point of use in a non-frozen state. In one aspect, the following description relates to a flexible polymer container and a heating element. The container and the heating element comprise a container having an outer surface and an inner surface defining the interior of the container adapted to receive a fluid; and a flexible resistance heating element adapted to provide thermal energy to t