Judy Kay Hendricks

US Patent:

6528277, Mar 4, 2003

Filed:

Oct 27, 2000

Appl. No.:

09/698573

Inventors:

Judy K. Hendricks - Albuquerque NM
Shaundrea L. Rechsteiner - Lambertville MI
Joel R. Gorski - Marrietta GA
Adam Lee - Toledo OH
Roger Fiske - Findlay OH

Assignee:

3M Innovative Properties Company - St. Paul MN

International Classification:

C12Q 122

US Classification:

435 31, 435 14, 435 26, 435 29, 4352874, 4352871, 4352831, 435807, 435810, 422 50

Abstract:

This invention relates to a container and method for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. The invention relates to test indicators containing controlled volumes of compressed, gas-permeable materials, and modified caps comprising one or more apertures, sterilant permeable inserts, protruding members, or a combination thereof, and to methods for using test indicators for determining the efficacy of different types of sterilization processes. If proper sterilization conditions are not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions are met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process.

US Patent:

20010006610, Jul 5, 2001

Filed:

Oct 9, 1998

Appl. No.:

09/168671

Inventors:

MICHAEL J MILLER - ROCHESTER NY, US
JUDY K. HENDRICKS - ALBUQUERQUE NM, US

International Classification:

B01J010/00

US Classification:

422/129000

Abstract:

This invention is directed to sterilization indicator systems for determining the effectiveness of sterilization processes. Test indicator devices comprise a container that is open on one end and has liquid impermeable and substantially gas non-absorptive walls which surround the biological or chemical material to be used as the indicator system. the opening contains a barrier that allows fluid such as gas to flow from the outside, through the plug and into the interior chamber containing the indicator system providing the detection. The entire indicator is further contained within a sealed pouch that is liquid impermeable and gas permeable under the conditions of a gas over steam sterilization system. The flexible pouch allows the test indicator to properly function while protecting the indicator from the environment while maintaining reliability of the test results. Although such sterilization indicators can be used in a wide variety of procedures, the indicators of the invention are particularly useful in evaluating the effectiveness of air overpressure sterilization.

US Patent:

20020037546, Mar 28, 2002

Filed:

Sep 19, 2001

Appl. No.:

09/956153

Inventors:

Judy Hendricks - Albuquerque NM, US
Shaundrea Rechsteiner - Lambertville MI, US
Joel Gorski - Marrietta GA, US

International Classification:

C12Q001/22

US Classification:

435/031000

Abstract:

This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening. The opening is filled with a compressed cylindrical foam insert and the test indicator is placed into the sterilization chamber. The foam insert regulates the amount of sterilant such as steam, gas, chemicals or plasma entering the test indicator. After the sterilization cycle is complete, the foam insert is removed and the remaining components of the enzyme system are combined. If the proper sterilization conditions were not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions were met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process. Results are available in from a few seconds to a few hours. The test indicator can also be placed into a container with material such that the designs simulates an environmental parameter test of the sterilization process.

US Patent:

20020058296, May 16, 2002

Filed:

Sep 13, 2001

Appl. No.:

09/951068

Inventors:

Michael Miller - Rochester NY, US
Judy Hendricks - Albuquerque NM, US

International Classification:

C12Q001/22
A61L002/08
B29D022/00

US Classification:

435/031000, 422/026000, 428/035400

Abstract:

This invention is directed to sterilization indicator systems for determining the effectiveness of sterilization processes. Test indicator devices comprise a container that is open on one end and has liquid impermeable and substantially gas non-absorptive walls which surround the biological or chemical material to be used as the indicator system, the opening contains a barrier that allows fluid such as gas to flow from the outside, through the plug and into the interior chamber containing the indicator system providing the detection. The entire indicator is further contained within a sealed pouch that is liquid impermeable and gas permeable under the conditions of a gas over steam sterilization system. The flexible pouch allows the test indicator to properly function while protecting the indicator from the environment while maintaining reliability of the test results. Although such sterilization indicators can be used in a wide variety of procedures, the indicators of the invention are particularly useful in evaluating the effectiveness of air overpressure sterilization.

US Patent:

59898526, Nov 23, 1999

Filed:

Nov 2, 1998

Appl. No.:

9/184352

Inventors:

Judy K. Hendricks - Albuquerque NM
Shaundrea L Rechsteiner - Lambertville MI
Joel R. Gorski - Marrietta GA

Assignee:

North American Science Associates - Northwood OH

International Classification:

C12Q 122
C12Q 154
C12Q 132
C12Q 102

US Classification:

435 31

Abstract:

This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening. The opening is filled with a compressed cylindrical foam insert and the test indicator is placed into the sterilization chamber.

US Patent:

58306838, Nov 3, 1998

Filed:

Oct 24, 1996

Appl. No.:

8/735992

Inventors:

Judy K. Hendricks - Albuquerque NM
Shaundrea L. Rechsteiner - Lambertville MI
Joel R. Gorski - Marrietta GA

Assignee:

North American Science Associates, Inc. - Northwood OH

International Classification:

C12Q 122
C12Q 154
C12Q 132
C12Q 102

US Classification:

435 31

Abstract:

This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening. The opening is filled with a compressed cylindrical foam insert and the test indicator is placed into the sterilization chamber.

US Patent:

58708855, Feb 16, 1999

Filed:

Oct 24, 1996

Appl. No.:

8/736310

Inventors:

Harold A. Biddle - Kansas OH
Dale L. Byerly - Toledo OH
Judy K. Hendricks - Albuquerque NM

Assignee:

North American Science Associates, Inc. - Northwood OH

International Classification:

B65B 6302

US Classification:

53436

Abstract:

This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening. The opening is filled with a compressed cylindrical foam insert and the test indicator is placed into the sterilization chamber.

US Patent:

54864593, Jan 23, 1996

Filed:

Jan 30, 1995

Appl. No.:

8/380195

Inventors:

Jeffrey C. Burnham - Maumee OH
George J. Hageage - Maumee OH
Douglas Jambard-Sweet - Maumee OH
Judy Hendricks - Findlay OH

Assignee:

Medical College of Ohio - Toledo OH

International Classification:

C12Q 122
G01N 2100

US Classification:

435 31

Abstract:

The invention is directed to biological processes and apparatus for determining the efficacy of a sterilization cycle based upon the recovery of activity of interactive enzyme systems comprising enzymes, coenzymes, catalysts, cofactors, substrates or any other necessary reagents. The invention provides a vital process for expediting sterility verification before utilization of the articles thought to be sterilized. The invention involves the rapid detection of any surviving interactive enzymatic activity which directly relates to the probability of any biological spores surviving in a test sample. An absence of a change indicates that the sterilization process had inactivated the enzyme system thereby preventing the interactive reaction from taking place which is a rapid equivalent to directly detecting the survivability of bacterial spores in a similar test. The methods and apparatus of the invention are useful in the health care industry such as in hospitals, laboratories, and research institutions, in food and environmental technology, and in all technologies which utilize sterilization in manufacturing, production or waste disposal.