Pre-sterilized medical procedure kit packages

• US 4,523,679 A
• Filed: 03/05/1984
• Issued: 06/18/1985
• Est. Priority Date: 03/05/1984
• Status: Expired due to Fees

• Current Assignee: Sterling Drug, Inc. (GlaxoSmithKline PLC)
• Original Assignee: Sterling Drug, Inc. (GlaxoSmithKline PLC)
• Inventors: Hadtke, Frederick B., Paikoff, Myron, Hain, Robert W.
• Primary Examiner(s): Moy, Joseph Man-Fu
• Assistant Examiner(s): Ehrhardt, Brenda J.
• Application Number:
  US06/586,159
• Time in Patent Office: 470 Days
• Field of Search: 206/438, 206/440, 206/207, 206/210, 206/363, 206/367, 206/370, 206/484.1, 206/484.2, 206/570, 206/571, 206/572, 422/34, 422/300, 422/302
• US Class Current: 206/370
• CPC Class Codes: A61B 2090/3933 Liquid markers
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/206 Ethylene oxide
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: A61L 2202/182 Rigid packaging means
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001

Abstract

This invention provides medical procedure packages comprising a pre-sterilized kit within an outer package wrap, the packages being so designed that all components of the package are sterilized using sterilization methods which are compatible with the chemical compositions of the components and their stability to such sterilization methods, and wherein the internal sterility of the package is maintained from final package sealing until the package is delivered to a sterile operating room environment.

Claims

1. A medical procedure package comprising in combination:

A. a sealed, pre-sterilized outer package wrap containing therein;

B. an essentially unitary, two-compartment kit wrapped within an inner package wrap, the first of said compartments being relatively large and comprising;

(a) a medical procedure set-up tray and associated essential medical procedure components, said outer package wrap, set-up tray, essential medical procedure components and inner package wrap being sterilized by, and compatible with, ethylene oxide sterilization, and the second of said compartments being relatively small and comprising;

(b) a space sealed by a bacteria proof peelable barrier layer and holding a medicament containing rubber closured vial, said vial being separately sterilized by, and compatible with, heat sterilization.

2. A medical procedure package according to claim 1 wherein the interior of said outer package wrap and said tray and associated essential medical procedure components are sterilized by ethylene oxide and said peelable barrier seal is added after said vial, sterilized by heat sterilization, is added to saidd second compartment.

3. A medical procedure package according to claim 2 which is adapted for myelographic examination wherein said vial contains a myelographic radiopaque agent.

4. A medical procedure package according to claim 3 wherein said essential medical procedure components comprise scrubbing/cleansing means, local anesthesia producing means, local anesthetic injection means, sample/drug transfer means, drug injection means, fluid sampling means, patient covering means and swabbing/bandage means.

5. A medical procedure package comprising in combination:

A. a sealed, pre-sterilized outer package wrap containing therein;

B. an essentially unitary, two-compartment kit comprising a plastic envelope having two heat-sealed compartments, said kit containing in the first of said compartments;

(a) a medical procedure set-up tray and associated essential medical procedure components, said outer package wrap, set-up tray, essential medical procedure components and inner package wrap being sterilized by, and compatible with, ethylene oxide sterilization, and in the second of said compartments;

(b) a medicament containing rubber closured vial, said vial being separately sterilized by, and compatible with, heat sterilization, and wherein at least one of said first and second compartment contents (a) and (b) is wrapped within an inner package wrap.

6. A medical procedure package according to claim 5 wherein said envelope containing said tray and its associated essential medial procedure components and said outer package wrap are sterilized by ethylene oxide and said vial is heat sterilized and sealed within said second compartment.

7. A medical procedure package according to claim 6 which is adapted for myelographic examination wherein said vial contains a myelographic radiopaque agent.

8. A medical procedure package according to claim 7 wherein said essential medical procedure components comprise scrubbing/cleansing means, local anesthesia producing means, local anesthetic injection means, sample/drug transfer means, drug injection means, fluid sampling means, patient covering means and swabbing/bandage means.