Apparatus and methods for making, storing, and administering freeze-dried materials such as freeze-dried plasma

• US 7,776,022 B2
• Filed: 03/19/2007
• Issued: 08/17/2010
• Est. Priority Date: 03/19/2007
• Status: Expired due to Fees

• Current Assignee: Hemcon Life Sciences, Inc.
• Original Assignee: Hemcon Medical Technologies Inc. (Tricol International Group Ltd.)
• Inventors: Morgan, John W., McCarthy, Simon J, Block, William D.
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US11/725,352
• Publication Number:
  US 20080234652A1
• Time in Patent Office: 1,247 Days
• Field of Search: 604/403, 604/408, 604/410, 604/415, 383/210.1, 206/363
• US Class Current: 604/408
• CPC Class Codes: A61B 50/10 Furniture specially adapted for surgical or diagnostic appliances or instruments
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2027 having frangible parts
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61M 2039/1061 Break-apart tubing connectors or couplings
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04

Abstract

A freeze-dried material is stored in a first chamber of a container along with a reconstituting liquid for the freeze-dried material, which is stored in a second chamber of the container. A sealing wall within the container forms a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid. At least one valve assembly in the sealing wall selectively opens a region of the sealing wall to establish fluid flow communication between the first and second chambers, allowing the freeze dried material to be reconstituted. The reconstituted freeze-dried material can be administered from the same container to a recipient.

Claims

1. Apparatus comprising:

a dry freeze-dried material,

a reconstituting liquid for the freeze-dried material, and

a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,

wherein the valve assembly includes a normally closed septum operative in a normally closed condition maintaining closure between the first and second chambers and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum,

wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.

2. Apparatus according to claim 1

further including an outer skirt overlaying an exterior wall of the container in a region of the sealing wall.

3. Apparatus according to claim 2

wherein the outer skirt includes a tear member coupled to a pulling member to tear the outer skirt for removal.

4. Apparatus according to claim 2

wherein the flexible container includes an integral administration port for administering material from the container.

5. Apparatus according to claim 1

wherein the freeze-dried material includes freeze-dried human plasma.

6. Apparatus comprising:

a dry freeze-dried material,

a reconstituting liquid for the freeze-dried material, and

a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,

wherein the valve assembly includes a normally closed septum operative in a normally closed condition maintaining closure between the first and second chambers and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum,

wherein the valve assembly includes a pressure sensitive valve operative between a normally closed condition normally resisting fluid flow communication between the first and second chambers and an opened condition establishing fluid flow condition communication between the first and second chambers in response to a pressure differential applied across the valve, and a normally closed septum associated with the valve operative in a normally closed condition maintaining closure between the first and second chambers independent of the valve and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum and a pressure differential applied across the valve.

7. Apparatus according to claim 6 wherein the pressure sensitive valve comprises a flap valve.

8. Apparatus according to claim 6 wherein the septum includes a tear member coupled to a pulling member to at least partially tear the septum.

9. Apparatus comprising:

a dry freeze-dried material,

a reconstituting liquid for the freeze-dried material, and

a flexible container including first chamber sized and configured to hold the freeze-dried material in a dry state, a second chamber sized and configured to hold the reconstituting liquid in a wet state, a sealing wall within the flexible container sized and configured to form a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid, and at least one valve assembly in the sealing wall operative to open a region of the sealing wall to establish fluid flow communication between the first and second chambers,

wherein the valve assembly includes a normally closed septum operative in a normally closed condition maintaining closure between the first and second chambers and an opened condition establishing fluid flow communication between the first and second chambers in response to at least a partially tearing of the septum,

further including an outer skirt overlaying an exterior wall of the container in a region of the sealing wall,

wherein at least a portion of the exterior wall of the container overlaid by the outer skirt includes placations.