Three envelope package for sterile specimens

• US 5,031,762 A
• Filed: 08/17/1989
• Issued: 07/16/1991
• Est. Priority Date: 10/07/1987
• Status: Expired

• Current Assignee: Cryolife Incorporated
• Original Assignee: Albert E. Heacox
• Inventors: Heacox, Albert E.
• Primary Examiner(s): Foster, Jimmy G.
• Application Number:
  US07/395,297
• Time in Patent Office: 698 Days
• Field of Search: 62/55.5, 62/371, 62/372, 62/457.9, 220/901, 206/63.3, 206/63.5, 206/205, 206/210, 206/213.1, 206/438, 206/439-441, 604/289, 604/290, 623/11, 623/15, 623/66
• US Class Current: 206/210
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A01N 1/0268 Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
• 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

Abstract

A three-envelope package for preserving tissue specimens or other sterile objects. A sterile tissue sample is sealed within an innermost envelope sterile inside and out. The innermost envelope is sealed within the sterile interior of an intermediate envelope equipped with a peel-back seal for subsequent opening. Both the inside and the outside of the intermediate envelope are sterile. The intermediate envelope is sealed within the sterile interior of an outermost envelope, made of foil or another substance impermeable to a storage medium, such as liquid nitrogen. The outermost envelope provides complete impermeability to liquid nitrogen, eliminating the possibility of nitrogen seepage through the peel-back seal of the intermediate envelope. When the envelope package is removed from storage, the intermediate envelope is removed from the outermost envelope and can be opened in an assumed non-sterile environment, without contaminating the innermost envelope or the tissue specimen therein.

Claims

1. A package for storing a sterile specimen in a cryogenic liquid medium comprising:

an outermost envelope having a non-sterile exterior impervious to the cryogenic liquid storage medium and having closure means impenetrably sealed against the liquid storage medium to define a closed sterile interior,

an intermediate envelope removably received within the outer envelope having a closed sterile interior, and

an innermost envelope removably received within the interior of the intermediate envelope, the innermost envelope having a sterile exterior and defining a closed sterile interior for containing a transplantable tissue so that the impervious outermost envelope protects against contact by the liquid storage medium, and the intermediate envelope maintains the sterile exterior of the innermost envelope irrespective of possible contamination occurring to the exterior of the intermediate envelope during removal from the outer envelope, said package being in the cryopreserved state.

2. The envelope package as in claim 1, wherein:

the intermediate envelope comprises a peelback opening having a pair of surfaces defining the interior of the intermediate envelope and releasably bonded together along a predetermined course at the periphery of the interior; and

the bond of the surfaces being selectively separable by peeling back one such surface relative to the other surface, thereby exposing the sterile interior of the intermediate envelope and the sterile innermost envelope received within, without subjecting the interior of the innermost envelope to possible contamination on the exterior of the intermediate envelope,

so that the intermediate envelope is openable without subjecting the innermost envelope to possible contamination on the exterior of the intermediate envelope.

3. The package defined in claim 1 wherein the outermost envelope is comprised of polyimide.

4. The package of claim 1, 2 or 3 wherein the outermost envelope is a polyimide/fluorinated ethylene polypropylene laminate.

5. The package of claim 1 wherein the innermost envelope is comprised of polyimide.

6. The package of claim 1, 2 or 5 wherein the innermost envelope is a polyimide/fluorinated ethylene polypropylene laminate.

7. The package of claim 1, 2, 3 or 5 in combination with a transplantable tissue contained within the innermost envelope.

8. A method of protecting a tissue sample from damage upon cryopreservation and thawing, and maintaining its suitability for transplant into a patient in need of such treatment, comprising:

placing a transplantable tissue sample into a sterile cavity of an innermost envelope in conjunction with a suitable medium;

sealing said innermost envelope;

placing the sealed innermost envelope into the cavity of an intermediate envelope;

sealing the intermediate envelope;

placing the sealed intermediate envelope into an outermost envelope;

sealing the outermost envelope;

maintaining the outermost envelope in a suitable cryogenic freezing medium for a time period and at a temperature effective for cryogenically preserving the tissue contained in the innermost envelope; and

incubating the transplantable tissue to a temperature suitable for implanting the patient in need of such treatment.

9. A package for storing a transplantable tissue in cryogenic liquid nitrogen comprising:

an outermost envelope defining a closed sterile interior and having a non-sterile exterior, the envelope being impervious to liquid nitrogen and bacteria and having a closure means impenetrably sealed against liquid nitrogen and defining a closed sterile interior;

an intermediate envelope impervious to bacteria and removably received within the interior of the outer envelope, and defining a closed sterile interior, and an inner envelope imprevious to bacteria, removably received within the interior of the intermediate envelope, having a sterile exterior and defining a closed sterile interior suitable for containing a transplantable tissue,

said outer envelope being useful for protecting the intermediate envelope against contact with liquid nitrogen,

said intermediate envelope maintaining the sterile exterior of the inner envelope irrespective of possible contamination to the exterior of the intermediate envelope during removal from the outer envelope.

10. The package of claim 9 wherein the outermost envelope has an edge which is welded shut for impermeability to liquid nitrogen, so that the outer envelope may be opened by cutting.