TRACEABILITY AND MONITORING OF A STERILISATION CASE AND THE CONTENT OF SAME

• US 20170224859A1
• Filed: 11/13/2015
• Published: 08/10/2017
• Est. Priority Date: 11/13/2014
• Status: Abandoned Application

• Current Assignee: Analytic- Tracabilite Hospitaliere
• Original Assignee: Analytic-Tracabilite Hospitaliere
• Inventors: COTEROT, Mathieu, BRONINX, Geoffrey
• Application Number:
  US15/514,570
• Publication Number:
  US 20170224859A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• 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 50/33 Trays
• CPC Class Codes: A61B 50/34 Baskets
• CPC Class Codes: A61B 90/96 using barcodes
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

The present invention concerns, in this example, a sterilization case (200) for surgical instruments (210) including an electronic identity device (100) for the monitoring and traceability of the case and the content of same, the electronic device (100) including:—a measurement module (10) for taking at least one measurement relative to at least one parameter representative of an environmental condition to which the sterilization case (200) is exposed and for generating an item of digital measurement data (D_M) depending on the measurement,—a storage module (20) for storing the generated item of measurement data (D_M),—a communication module (30) suitable for cooperating with the storage module (20) in order to transmit the item of measurement data (D_M) to an external reader (300, 300′) when the external reader (300, 300′) interacts with the communication module (30).

Claims

1-20. -20. (canceled)

21. A sterilization container for surgical instruments comprising an electronic identity device for the monitoring and traceability of said container and of the instruments that it contains, said electronic device comprising:

a measurement module configured to take at least one measurement relating to at least one parameter representative of an ambient condition to which said sterilization container and said instruments are subjected and generate a piece of digital measurement data on the basis of said measurement taken,

a memorisation module configured to memorise said piece of measurement data generated,

a communication module suitable for cooperating with said memorisation module in order to transmit said piece of measurement data to an external reader when said external reader interacts with said communication module,

wherein said sterilization container comprises a protective case enclosing said electronic identity device, said case being at least partially formed from an impermeable and thermally insulating material in order to protect said electronic identity device, in particular when passing through an autoclave.

22. The sterilization container according to claim 21, wherein the protective case is at least partially formed from a material suitable for resisting pressures substantially between approximately 0 and 16 bar and/or temperatures substantially between approximately −

20°

C. and 200°

C.

23. The sterilization container according to claim 21, wherein the protective case comprises two half-shells rigidly assembled to each other with a sealing joint.

24. The sterilization container according to claim 23, wherein the half-shells and the sealing joint are at least partially formed from at least one of the polymers chosen from the following:

polysulfones, polyphenylsulfone resins, polyetherimides, polyamides, polyformaldehyde, butylene polyterephthalate.

25. The sterilization container according to claim 21, wherein said measurement module comprises a temperature probe.

26. The sterilization container according to claim 25, wherein said temperature probe comprises a thermostat configured to detect an ambient temperature outside of said protective case greater than a predetermined threshold temperature between 100°

and 130°

Celsius.

27. The sterilization container according to claim 26, wherein said protective case comprises an insert passing all the way through, made from a material suitable for conducting heat, and wherein said thermostat is in direct contact with said insert.

28. The sterilization container according to claim 26, wherein said protective case has a thinner section of wall, and wherein said thermostat is placed against the inner wall of said protective case at said thinner section of wall.

29. The sterilization container according to claim 21, wherein said measurement module comprises a pressure sensor.

30. The sterilization container according to claim 21, wherein said measurement module comprises a humidity sensor.

31. The sterilization container according to claim 21, wherein said measurement module comprises a vibration sensor.

32. The sterilization container according to claim 21, wherein said measurement module comprises an accelerometer.

33. The sterilization container according to claim 21, wherein said measurement module is synchronised with an internal clock in such a way that said piece of digital measurement data is timestamped.

34. The sterilization container according to claim 21, comprising, on one of its lateral walls, a reading zone having a matrix barcode, the optical reading of said code by an external optical reader triggering the transmission of the piece of digital measurement data to said reader.

35. The sterilization container according to claim 21, wherein said communication module is suitable for communicating with said external optical reader via a Bluetooth wireless communication protocol.

36. The sterilization container according to claim 21, wherein the electronic identity device comprises a processing module configured to process the digital measurement data memorised in the memorisation module and generate a warning signal when the data contains a piece of information that does not comply with a predetermined vigilance rule.

37. The sterilization container according to claim 36, wherein the electronic identity device comprises a warning module that cooperates with the processing module and is configured to emit an alert upon reception of a warning signal.

38. The sterilization container according to claim 21, wherein said electronic device comprises a rapid-recharge power supply module.

39. The sterilization container according to claim 38, wherein said power supply module comprises a thermoelectric generator configured to convert the thermal energy provided when passing through an autoclave into electric energy.

40. An Assembly for the monitoring and traceability of surgical instruments, comprising:

a sterilization container according to claim 21 comprising said surgical instruments, and

an eternal reader suitable for communicating with the electronic identity device of said container.