Method of Forming a Sterilized Sensor Package and a Sterilized Sensor Package

• US 20080255440A1
• Filed: 07/13/2005
• Published: 10/16/2008
• Est. Priority Date: 08/10/2004
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Glejbol, Kristian, Buch-Rasmussen, Thomas, Eilersen, Michael
• Application Number:
  US11/660,035
• Publication Number:
  US 20080255440A1
• Time in Patent Office: Days
• US Class Current: 600/373
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A sensor package is provided comprising an implantable sensor having an electrode area and an electric contact area, the package comprising a shielding packaging enclosing at least the electrode area of the sensor while exposing the electric contact area. The sensor package fascilitates handling of the implantable sensor and provides for the possibility of sterilising the electric contact area leaving the electrode area protected.

Claims

1. A method of forming a sterilised sensor package for an electrochemical sensor, said method comprising the steps of:

providing a sterilised sensor having an electrode area and an electric contact area,

forming a shielding packaging that is impermeable to micro-organisms in such a manner that at least the electrode area is enclosed in the shielding packaging, the electric contact area extending outside the shielding packaging.

2. A method according to claim 1, wherein at least the electrode are of the sensor is sterilised by radiation.

3. A method according to claim 1, wherein the shielding packaging is impermeable to gas.

4. A method according to claim 1, and wherein the sensor comprises electronics, and wherein the method further comprising the step of connecting the electronics to the electric contact area succeeding sterilisation of the electrode area of the sensor.

5. A method according to claim 1, wherein the electronics are sterilised and enclosed by a further shielding packaging.

6. A method according to claim 3, wherein the electronics are sterilised by means of a gas.

7. A method according to claim 6, wherein the gas is ethylene oxide (EtO).

8. A method of sterilising a series of sensors according to claim 1,

wherein the test samples of the sterilised sensors are extracted;

that calculation of calibration parameters is performed by measurement; and

that the part of the sensors that projects outside the shielding packaging is provided with an information carrier that contains the calibration parameters.

9. A method according to claim 8, wherein passive circuits are used as information carrier.

10. A method according to claim 8, wherein active electronic circuits are used as information carrier.

11. A sensor package comprising an implantable sensor having electrodes and electric coupling areas, which sensor is kept temporarily sterile by means of a shielding packaging or housing, wherein a base packaging is provided that shields at least the electrodes;

and that the electric coupling areas are situated outside the base packaging.

12. A sensor package according to claim 11, wherein an additional packaging is provided configured for completely or partially shielding those parts of the sensor that project outside the base packaging.

13. A sensor package according to claim 12, wherein the additional packaging encloses the base packaging.

14. A sensor package according to claim 11, wherein the base packaging contains means for transdermal insertion of the electrodes of the sensor.

15. A sensor package according to claim 12, wherein the base packaging and the additional packaging adjoin each other along an endless rim comprising a tearing line or a rupture zone.

16. A sensor package according to claim 12, wherein at least a part of the base packaging is constituted by a form-stable housing.

17. A sensor package according to claim 14, wherein the means for transdermal insertion is a needle which is supported by the form-stable housing in such a manner as to enable withdrawal of the needle.

18. A sensor package according to claim 11, wherein the base packaging constitutes a form-stable sensor housing;

and that a rupture zone is provided in the housing between the electrode part and the electric coupling part of the sensor.

19. A sensor package according to claim 18, wherein the housing comprises a pair of polymeric half-parts configured for being joined and intended for receiving a sensor and means for implanting the sensor, wherein the part of the housing next to the electric coupling areas is configured for supporting the means for implanting the sensor in such manner that said means will be released during a withdrawal process.

20. A sensor package according to claim 19, wherein the part of the housing next to the electric coupling areas has mechanical coupling means for co-operating with a housing containing an electronic circuit.

21. A sensor package according to claim 11, wherein the base packaging constitutes a form-stable housing comprising and upper part and a lower part, which parts can be shifted a distance into each other by means of co-operating slide faces that constitute a barrier which is impermeable to micro-organisms when the parts are interconnected, wherein the upper part is secured to the means for transdermal insertion of the sensor and has a slit being open towards the lower part for slideably receiving the electric contact area of the sensor.

22. A sensor package according to claim 11, wherein the base packaging comprises a tube which is closed at the one end and the opposite end of which is configured for receiving a part of the sensor which is configured as a piston, which piston in combination with the interior wall of the tube constitutes a slide seal impermeable to micro-organisms and is situated between the electrodes and the electric coupling areas of the sensor.

23. A sensor package according to claim 22, wherein the tube is closed at the one end by means of a tear-off label.

24. A sensor package according to claim 22, wherein the piston is a support for a needle sensor.

25. A sensor package according to claim 24, wherein the piston face that faces away from the needle has electric coupling areas and has mechanical coupling means for cooperating with a housing for electronic circuits, whereby the electronic circuits can be interconnected with the electric coupling areas.

26. A sensor package according to claim 22, wherein the closed end of the piston has a base with an adhesive intended for adhesion of the tube to the body;

and that the tear-off label is secured by that adhesive.

27. A sensor package according to claim 22, wherein the sensor is flexible;

and that means are provided for transdermal insertion of the sensor, said means being slideably supported in the piston.

28. A sensor package according to claim 27, wherein the means for inserting the sensor is a needle having a longitudinal slit for receiving the electrode area of the sensor, said slit extending from the distal end of the needle, but not beyond the piston.

29. A sensor package according to claim 22, wherein the electric contact areas on the piston comprise concentric rings of electrically conductive material for cooperating with electric switches on a housing for an electronic circuit.

30. A sensor package according to claim 22, wherein the side of the piston that faces away from the sensor has mechanical coupling means for cooperating with a housing for an electronic circuit and means for cooperating with a rod for insertion of the sensor.