Sterility breach detection system and controller system for a sterilization container

Patent metadata

Field	Value
Publication number	US-10987185-B2
Application number	US-201816145497-A
Country	US
Kind code	B2
Filing date	Sep 28, 2018
Priority date	Sep 28, 2018
Publication date	Apr 27, 2021
Grant date	Apr 27, 2021

Abstract

The present disclosure provides sterilization containers with features for sealing a volume against an ingress of contaminants. The present disclosure also provides a sterility breach detection system for detecting whether the sterilization container seal has been breached, which potentially could compromise the sterility of any contents of the container. Further, the present disclosure provides a controller system for detecting, tracking, and alerting a user to the state of a sterilization container, such as whether the container seal has been breached. The sterility breach detection system and/or the controller system may utilize a smart gasket to detect breaches in a seal of a sterilization container, and a controller in operative communication with the smart gasket may activate an indicator to alert a user to a detected breach in the seal.

First claim

What is claimed is:

1. A sterilization container system, comprising:
a sterilization container including
a container body,
a container lid, the container body and container lid together defining a container interior,
a container gasket for sealing the container interior against an ingress of contaminants, and
a transmission pathway embedded in the container gasket; and

a controller,
wherein the controller is configured to process a signal transmitted along the transmission pathway to determine whether a breach exists in the container gasket, and
wherein the transmission pathway is a metal wire.

2. The sterilization container system of claim 1 , further comprising a ground wire coaxial with the transmission pathway.

3. The sterilization container system of claim 2 , wherein the container body and the container lid are each formed from a metallic material such that the container body is metallic and the container lid is metallic.

4. The sterilization container system of claim 3 , wherein the container gasket is a dielectric material disposed between the metal wire transmission pathway, the metallic container body, and the metallic container lid.

5. The sterilization container system of claim 1 , wherein the controller is configured to send and receive the signal.

6. The sterilization container system of claim 1 , wherein the controller is configured to process the signal using time domain reflectometry.

7. The sterilization container system of claim 1 , wherein the container gasket defines a sealing pathway, and wherein the transmission pathway is coextensive with the sealing pathway.

8. The sterilization container system of claim 1 , wherein the controller is sterilizable with the container body and container lid.

9. The sterilization container system of claim 1 , wherein the controller is attached to the container body.

10. The sterilization container system of claim 1 , wherein the transmission pathway includes local variances in impedance.

11. The sterilization container system of claim 1 , wherein the controller is configured to establish a baseline signal value before the sterilization container undergoes a sterilization protocol.

12. The sterilization container system of claim 11 , wherein the controller is configured to send a detection signal along the transmission pathway after the sterilization container undergoes the sterilization protocol.

13. The sterilization container system of claim 12 , wherein the controller is configured to compare the detection signal to the baseline signal value to determine whether a breach exists in the gasket.

14. The sterilization container system of claim 12 , further comprising:
an indicator for indicating a state of the sterilization container to a user of the sterilization container.

15. The sterilization container system of claim 14 , wherein the controller is configured to activate the indicator if the detection signal exceeds a predetermined signal value.

16. A sterilization container system, comprising:
a sterilization container including a container body and a container lid, the container body and container lid together defining a container interior, the sterilization container further including a container gasket for sealing the container interior against an ingress of contaminants and a transmission pathway embedded in the container gasket;
a sensor attached to the sterilization container;
an indicator disposed on the sterilization container for indicating a state of the sterilization container to a user of the sterilization container; and
a controller in operative communication with the sensor,
wherein the transmission pathway is a metal wire, and
wherein the controller is configured to process data from the sensor to activate the indicator.

17. The sterilization container system of claim 16 ,
wherein the controller is configured to send a signal along the transmission pathway, receive a reflected signal, and process the reflected signal, and
wherein the controller is configured to activate the indicator if the reflected signal indicates the sterilization container is not sealed against the ingress of contaminants.

18. The sterilization container system of claim 16 , further comprising:
a plurality of sensors in operative communication with the controller.

19. The sterilization container system of claim 18 , wherein each sensor of the plurality of sensors is selected from the group consisting of temperature sensor, relative humidity sensor, accelerometer, pressure sensor, light sensor, ambient noise sensor, magnetic field sensor, Global Positioning Satellite (GPS) receiver, hydrogen peroxide sensor, ozone sensor, ethylene oxide sensor, and force sensor.

20. A sterilization container system, comprising:
a sterilization container including
a container body,
a container lid, the container body and container lid together defining a container interior,
a container gasket for sealing the container interior against an ingress of contaminants, and
a transmission pathway embedded in the container gasket;

a plurality of sensors;
an indicator for indicating a state of the sterilization container to a user of the sterilization container; and
a controller in operative communication with the transmission pathway and the plurality of sensors,
wherein the transmission pathway is a metal wire,
wherein the controller is configured to process a signal transmitted along the transmission pathway to determine whether a breach exists in the container gasket, and
wherein the controller is configured to activate the indicator to indicate to a user that a breach exists in the container gasket.

Assignees

• O & M Halyard Inc

Inventors

• Wang Ruoya
• Cote Anne E
• Wu Kun-Chi
• White Tracy J
• Meadows Vernon
• Madsen Edward B

Classifications

• A61L2103/15

  Laboratory, medical or dentistry appliances, e.g. catheters or sharps · CPC title

• A61L2/28

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title

• A61B2050/0066

  with additional sealing means, e.g. O-ring · CPC title

• A61B2090/081

  for contamination or dirt · CPC title

• A61B2050/005

  with a lid or cover · CPC title