Freezing and thawing bag, mold, apparatus and method

• US 6,232,115 B1
• Filed: 11/25/1997
• Issued: 05/15/2001
• Est. Priority Date: 06/25/1996
• Status: Expired due to Term

• Current Assignee: Cesca Therapeutics Incorporated, New York Blood Center Incorporated
• Original Assignee: The Thermogenesis Corporation (Cesca Therapeutics Incorporated)
• Inventors: Rubinstein, Pablo, Coelho, Philip Henry
• Primary Examiner(s): Beisner, William H.
• Assistant Examiner(s): Olsen, Kaj K.
• Application Number:
  US08/978,171
• Time in Patent Office: 1,267 Days
• Field of Search: 435/288.1, 435/304.1, 435/307.1, 604/408, 604/410, 383/107, 383/907, 206/484
• US Class Current: 435/307.1
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61M 1/0277 Frames constraining or supporting bags, e.g. during freezing
• CPC Class Codes: B29C 65/04 Dielectric heating, e.g. high-frequency welding , i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 66/1312 Single flange to flange joints, the parts to be joined being rigid the parts to be joined being flexible B29C66/133
• CPC Class Codes: B29C 66/53262 Enclosing spouts between the walls of bags, e.g. of medical bags
• CPC Class Codes: B29C 66/54 Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
• CPC Class Codes: B29C 66/543 joining more than two hollow-preforms to form said hollow articles
• CPC Class Codes: B29C 66/7394 characterised by the material of at least one of the parts being a thermoset
• CPC Class Codes: B29C 66/83221 cooperating reciprocating tools, each tool reciprocating along one axis
• CPC Class Codes: B29L 2031/7148 Blood bags, medical bags
• CPC Class Codes: F25C 1/243 Moulds made of plastics e.g. silicone

Abstract

A bag, method of manufacture and process are disclosed for the cryopreservation of thermolabile substances. The bag is characterized as having substantially uniform thickness throughout its length and height. The bag features a radiused peripheral edge wall for stress relief and to provide the constant cross-section. A peripheral flashing circumscribes the radiused edge wall and provides a suitable purchase area for sealing so that the thus formed bag is less susceptible to fracture particularly when exposed to cryogenic temperatures. The uniform thickness of the bag promulgates uniform heat transfer to and from the contents of the bag in relation to any surrounding medium at a different temperature. The bag affords more space for efficient storage and reduces heat invasion into the contents of the bag when a plurality of bags are placed, with their larger planar surfaces, in contact with each other.

Claims

1. A breakage resistant medical freezing bag containing liquid, comprising, in combination:

a first bag portion formed from a blank of plastic sheet material having the ability to be deformed during bag fabrication; and

subsequently retain a shape after fabrication having the following characteristics;

a substantially planar outer wall, a radiused edge wall circumscribing said planar outer wall and peripheral flashing circumscribing said radiused edge wall,

a second bag portion sealed to said peripheral flashing and overlying said planar outer wall of said first bag portion, said first and second bag portions collectively defining a hollow enclosed volume to receive the liquid, said planar outer wall is spaced from said second bag portion by a dimension substantially equal to a radius of said radiused edge wall, said radiused edge wall dissipating forces engendered during phase change of the liquid in the bag during freezing and thawing,

wherein an interior of said bag communicates with an exterior by means of a portal,

wherein said portal extends through said flashing, and

wherein a partition is provided within said bag defining an area of demarcation in said bag including at least two compartments separated one from the other by said partition.

2. The bag of claim 1 wherein a second portal is provided such that one portal communicates with said first compartment and another portal communicates with said second compartment.

3. The bag of claim 2 wherein said compartments communicate with each other by a passageway.

4. The bag of claim 3 wherein said passageway includes means to prevent through communication therebetween.

5. The bag of claim 4 wherein said bag second portion is formed symmetrical to said first portion.

6. A breakage resistant medical freezing bag containing liquid, comprising, in combination:

a first bag portion formed from a blank of plastic sheet material having the ability to be deformed during bag fabrication; and

subsequently retain a shape after fabrication having the following characteristics;

a substantially planar outer wall, a radiused edge wall circumscribing said planar outer wall and peripheral flashing circumscribing said radiused edge wall,

a second bag portion sealed to said peripheral flashing and overlying said planar outer wall of said first bag portion, said first and second bag portions collectively defining a hollow enclosed volume to receive the liquid, said planar outer wall is spaced from said second bag portion by a dimension substantially equal to a radius of said radiused edge wall, said radiused edge wall dissipating forces engendered during phase change of the liquid in the bag during freezing and thawing,

wherein said bag second portion is formed symmetrical to said first portion,

wherein an interior of said bag communicates with an exterior by means of a portal,

wherein said portal extends through said flashing, and

wherein a partition is provided within said bag defining an area of demarcation in said bag including at least two compartments separated one from the other by said partition.

7. The bag of claim 6 wherein a second portal is provided such that one portal communicates with said first compartment and another portal communicates with said second compartment.

8. The bag of claim 7 wherein said compartments communicate with each other by a passageway.

9. The bag of claim 8 wherein said passageway includes means to prevent through communication therebetween.

10. The bag of claim 9 wherein said passageway has walls formed from material which can be fused to provide sealing.

11. The bag of claim 10 wherein at least one said portal is configured as an inlet tube having a series of constrictions along its length within which the liquid is contained, said constrictions allowing sealing thereat so that a series of liquid samples are formed between constrictions for individual removal.

12. A method for forming a bag, the steps including:

forming a first mold having a recess including a planar surface, a radiused periphery circumscribing said planar surface and a peripheral ledge circumscribing said radiused periphery and oriented parallel to said planar surface,

placing a blank of sheet material over said first mold, and causing the blank to conform to the mold, and retaining its conformation, including a planar surface, radiused periphery and peripheral ledge,

removing the conformed sheet from the mold,

closing the recess formed in the sheet with another sheet parallel to the planar surface,

wherein enclosing the bag is performed by forming a second mold having a mirror image of the first mold and placing a blank of sheet material over said second mold causing the blank to conform to the mold and forming the bag by registering the formed sheet from the first mold and formed sheet from the second mold together,

including forming a plurality of portals passing into an interior of the bag by providing a portal shaped recess on both the first mold and the second mold, and

providing a partition in the mold so that at least two compartments are defined within the mold so that each formed sheet when united will define two compartments in the bag.

13. The method of claim 12 including providing a passageway between the two compartments by providing an access in the mold adjacent the partition, bridging the partition and allowing communication between the first and second compartment.

14. The method of claim 13 including providing portals for all compartments.

15. The method of claim 14 including sealing the peripheral flashing of each formed sheet by adhering the peripheral flashing causing molecular excursions between the two formed sheets.

16. A breakage resistant medical bag formed by:

deforming a first sheet of pressure and/or thermosetting material which has a memory to retain its deformed state to maintain a planar outer wall, a radiused edge wall circumscribing said outer wall and peripheral flashing circumscribing said edge wall oriented parallel to said outer wall and defining a pocket,

sealing the pocket with a second sheet of material including a wall parallel to said planar outer wall,

said bag thereby defining a contoured, enclosed volume which receives a liquid therein constrained to conform to said contoured enclosed volume by virtue of said memory and by said radiused edge wall,

wherein enclosing the bag is performed by forming a second mold having a mirror image of the first mold and placing a blank of sheet material over said second mold causing the blank to conform to the mold and forming the bag by registering the formed sheet from the first mold and formed sheet from the second mold together,

including forming a plurality of portals passing into an interior of the bag by providing a portal shaped recess on both the first mold and the second mold, and

providing a partition in the mold so that at least two compartments are defined within the mold so that each formed sheet when united will define two compartments in the bag.

17. The bag of claim 16 including providing a passageway between the two compartments by providing an access in the mold adjacent the partition, bridging the partition and allowing fluid communication between the first and second compartment, and sealing the passageway after filling the bag with liquid.

18. A breakage resistant medical freezing bag containing liquid, comprising, in combination:

a first bag portion formed from a blank of plastic sheet material having the ability to be deformed during bag fabrication; and

subsequently retain a shape after fabrication having the following characteristics;

a substantially planar outer wall, a radiused edge wall circumscribing said planar outer wall and peripheral flashing circumscribing said radiused edge wall,

a second bag portion sealed to said peripheral flashing and overlying said planar outer wall of said first bag portion, said first and second bag portions collectively defining a hollow enclosed volume to receive the liquid, said planar outer wall is spaced from said second bag portion by a dimension substantially equal to a radius of said radiused edge wall, said radiused edge wall dissipating forces engendered during phase change of the liquid in the bag during freezing and thawing,

wherein an interior of said bag communicates with an exterior by means of a portal,

wherein said portal extends through said flashing,

wherein a partition is provided within said bag defining an area of demarcation in said bag including at least two compartments separated one from the other by said partition,

wherein a second portal is provided such that one portal communicates with said first compartment and another portal communicates with said second compartment,

wherein said compartments communicate with each other by a passageway,

wherein said passageway includes means to prevent through communication therebetween,

wherein said bag second portion is symmetrical to said first portion, and

wherein at least one said portal is configured as an inlet tube having a series of constrictions along its length within which the liquid is contained, said constrictions allowing sealing thereat so that a series of liquid samples are formed between constrictions for individual removal.

19. A breakage resistant medical bag formed by:

deforming a first sheet of pressure and/or thermosetting material which has a memory to retain its deformed state to maintain a planar outer wall, a radiused edge wall circumscribing said outer wall and peripheral flashing circumscribing said edge wall oriented parallel to said outer wall and defining a pocket,

sealing the pocket with a second sheet of material including a wall parallel to said planar outer wall thereby defining a contoured, enclosed volume which receives a liquid therein constrained to conform to said contoured enclosed volume,

wherein enclosing the bag is performed by forming a second mold having a mirror image of the first mold and placing said second sheet of material over said second mold causing said second sheet to conform to the mold and forming the bag by registering the formed sheet from the first mold and formed sheet from the second mold together,

further including forming a plurality of portals passing into an interior of the bag by providing a portal shaped recess on both the first mold and the second mold,

providing a partition in each mold so that at least two compartments are defined within each mold so that each formed sheet when united will define two compartments in the bag, and

providing a passageway between the two compartments by providing an access in each mold adjacent the partition, bridging the partition and allowing communication between the first and second compartment.

20. The bag of claim 19 including providing portals for all compartments.

21. The bag of claim 20 including sealing the peripheral flashing of each formed sheet by adhering the peripheral flashing causing molecular excursions between the two formed sheets.

22. The bag of claim 21 including forming one said portal as an inlet tube, forming a series of constrictions along its length within which liquid is contained, sealing the constrictions trapping the liquid into a series of samples for individual removal by severing at the constriction.

23. A breakage resistant medical bag formed by:

deforming a first sheet of pressure and/or thermosetting material which has a memory to retain its deformed state to maintain a planar outer wall, a radiused edge wall circumscribing said outer wall and peripheral flashing circumscribing said edge wall oriented parallel to said outer wall and defining a pocket,

sealing the pocket with a second sheet of material including a wall parallel to said planar outer wall thereby defining a contoured, enclosed volume which receives a liquid therein constrained to conform to said contoured enclosed volume,

providing a partition in the mold so that at least two compartments are defined within the mold so that each sheet when united will define two compartments in the bag, and

providing a passageway between the two compartments by providing an access in the mold adjacent the partition, bridging the partition and allowing communication between the first and second compartment.