Method and sterilizing device for sterilizing an implantable sensor

• US 8,999,235 B2
• Filed: 11/02/2012
• Issued: 04/07/2015
• Est. Priority Date: 11/30/2011
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Harttig, Herbert, Heinrich, Ralf, Konig, Stefan
• Primary Examiner(s): Chorbaji, Monzer R
• Application Number:
  US13/667,778
• Publication Number:
  US 20130137950A1
• Time in Patent Office: 886 Days
• Field of Search: 422/1, 422/22, 422/24, 250/455.11, 250/492.1, 250/492.3, 250/506.1, 250/515.1, 604/199
• US Class Current: 422/22
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation

Abstract

A method for sterilizing an implantable sensor for sensing an analyte in a body tissue. The implantable sensor has a sensor part which can be introduced into the body tissue, at least one sensor electrode for sensing the analyte, and at least one electronics part. The electronics part has at least one electronic component and is connected to the sensor part. The method includes (a) introducing the implantable sensor into a package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield, (b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction, in particular with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged in such a way that the sensor part is sterilized by the sterilizing radiation.

Claims

1. Method for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part, the method comprising:

a) introducing the implantable sensor into at least one package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield that shields the electronics part;

b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged whereby the sensor part is sterilized by the sterilizing radiation.

2. The method of claim 1, wherein, after carrying out method step a), the implantable sensor has at least a first part and at least a second part, the first part being sterilized in method step b), the second part being shielded from the sterilizing radiation by the radiation shield in method step b), and wherein, after carrying out method step b), the method includes connecting the first part and the second part within the package.

3. The method of claim 2, the package being of a deformable design wherein when there is a deformation of the package after carrying out method step b), the first part and the second part are moved in relation to each other wherein the first part and the second part are connected to each other.

4. The method of claim 1 wherein the electronics part has a layered structure, the layered structure having at least one overlayer, wherein, in method step b), the overlayer is arranged relative to the radiation shield wherein the overlayer is at least partially sterilized by the sterilizing radiation, and wherein, after carrying out method step b), the overlayer is applied to the electronic component within the package without opening the package.

5. The method of claim 4 wherein the package has a deformable design and wherein deformation of the package moves the implantable sensor through at least one constriction, the overlayer being pressed onto the electronic component by the constriction.

6. The method of claim 5, wherein, during the deformation of the package, the radiation shield is separated from the package.

7. The method of claim 1 wherein, in method step a), at least one medical aid, the medical aid comprising at least one insertion aid, is additionally introduced into the package.

8. A sterilizing device for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, the sterilizing device comprising:

at least one implantable sensor for sensing the at least one analyte in the body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part;

at least one package, the package sealing the implantable sensor from bacteria and accommodating at least one radiation shield adapted to shield the electronic component of the electronics part during a radiation sterilization.

9. The sterilizing device of claim 8 wherein the sensor has at least a first part and at least a second part wherein the first part is sterilizable in the package during the radiation sterilization and the second part is shielded by the radiation shield during the radiation sterilization, the first part and the second part being connectable within the package after carrying out the radiation sterilization without opening the package.

10. The sterilizing device of claim 9 wherein the package has a deformable design wherein, during deformation of the package after carrying out the radiation sterilization, the first part and the second part are movable relative to each other whereby they are connected to each other.

11. The sterilizing device of claim of claim 8 wherein the electronics part has a layered structure, the layered structure having at least one overlayer, and wherein the package is configured such that, during the radiation sterilization, the overlayer is positioned relative to the radiation shield whereby the overlayer is at least partially sterilized by the sterilizing radiation while the electronic component is shielded by the radiation shield, the package being configured such that, after carrying out the radiation sterilization, the overlayer is attachable to the electronic component within the package without opening the package.

12. The sterilizing device of claim 11 wherein the package has a deformable design and is configured such that, when there is a deformation of the package, the implantable sensor is pulled through at least one constriction and the overlayer is pressed onto the electronic component by the constriction.

13. The sterilizing device of claim 12 wherein the package further comprises at least one finger protruding into an interior space of the packet wherein the radiation shield is insertable into the at least one finger from outside the interior of packet whereby, before the deformation of the package, the radiation shield can be inserted from the outside into at least one finger.

14. The sterilizing device of claim 13, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.

15. The sterilizing device of claim 12, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.

16. The sterilizing device of claim 12, wherein, during the deformation of the package, the radiation shield is separable from the package.

17. The sterilizing device of claim 16 wherein the package further comprises at least one finger protruding into an interior space of the packet wherein the radiation shield is insertable into the at least one finger from outside the interior of packet whereby, before the deformation of the package, the radiation shield can be inserted from the outside into at least one finger.

18. The sterilizing device of claim 16, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.

19. Method for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part, the method comprising:

a) introducing the implantable sensor into at least one package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield that shields the electronics part; and

b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged whereby the sensor part is sterilized by the sterilizing radiation;

wherein, after carrying out method step a), the implantable sensor has at least a first part and at least a second part, the first part being sterilized in method step b), the second part being shielded from the sterilizing radiation by the radiation shield in method step b), and wherein, after carrying out method step b), the method includes connecting the first part and the second part within the package.

20. The method of claim 19, the package being of a deformable design wherein when there is a deformation of the package after carrying out method step b), the first part and the second part are moved in relation to each other wherein the first part and the second part are connected to each other.

21. Method for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part, the method comprising:

a) introducing the implantable sensor into at least one package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield that shields the electronics part; and

b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged whereby the sensor part is sterilized by the sterilizing radiation;

wherein the electronics part has a layered structure, the layered structure having at least one overlayer, wherein, in method step b), the overlayer is arranged relative to the radiation shield wherein the overlayer is at least partially sterilized by the sterilizing radiation, and wherein, after carrying out method step b), the overlayer is applied to the electronic component within the package without opening the package.

22. The method of claim 21 wherein the package has a deformable design and wherein deformation of the package moves the implantable sensor through at least one constriction, the overlayer being pressed onto the electronic component by the constriction.

23. The method of claim 22, wherein, during the deformation of the package, the radiation shield is separated from the package.

24. Method for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part, the method comprising:

a) introducing the implantable sensor into at least one package, the package sealing the implantable sensor from bacteria and accommodating a radiation shield that shields the electronics part; and

b) irradiating the implantable sensor in the package with sterilizing radiation from at least one irradiating direction with electron radiation, the radiation shield shielding the electronic component of the electronics part from the sterilizing radiation, the radiation shield being arranged whereby the sensor part is sterilized by the sterilizing radiation;

wherein, in method step a), at least one medical aid, the medical aid comprising at least one insertion aid, is additionally introduced into the package.

25. A sterilizing device for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, the sterilizing device comprising:

at least one implantable sensor for sensing the at least one analyte in the body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part; and

at least one package, the package sealing the implantable sensor from bacteria and accommodating at least one radiation shield adapted to shield the electronic component of the electronics part during a radiation sterilization;

wherein the sensor has at least a first part and at least a second part wherein the first part is sterilizable in the package during the radiation sterilization and the second part is shielded by the radiation shield during the radiation sterilization, the first part and the second part being connectable within the package after carrying out the radiation sterilization without opening the package;

further wherein the package has a deformable design wherein, during deformation of the package after carrying out the radiation sterilization, the first part and the second part are movable relative to each other whereby they are connected to each other.

26. A sterilizing device for sterilizing an implantable sensor for sensing at least one analyte in a body tissue, the sterilizing device comprising:

at least one implantable sensor for sensing the at least one analyte in the body tissue, wherein the implantable sensor has at least one sensor part which can be introduced into the body tissue and has at least one sensor electrode for sensing the analyte and at least one electronics part, the electronics part having at least one electronic component and being connected to the sensor part; and

at least one package, the package sealing the implantable sensor from bacteria and accommodating at least one radiation shield adapted to shield the electronic component of the electronics part during a radiation sterilization;

wherein the electronics part has a layered structure, the layered structure having at least one overlayer, and wherein the package is configured such that, during the radiation sterilization, the overlayer is positioned relative to the radiation shield whereby the overlayer is at least partially sterilized by the sterilizing radiation while the electronic component is shielded by the radiation shield, the package being configured such that, after carrying out the radiation sterilization, the overlayer is attachable to the electronic component within the package without opening the package.

27. The sterilizing device of claim 26 wherein the package has a deformable design and is configured such that, when there is a deformation of the package, the implantable sensor is pulled through at least one constriction and the overlayer is pressed onto the electronic component by the constriction.

28. The sterilizing device of claim 27 wherein the package further comprises at least one finger protruding into an interior space of the packet wherein the radiation shield is insertable into the at least one finger from outside the interior of packet whereby, before the deformation of the package, the radiation shield can be inserted from the outside into at least one finger.

29. The sterilizing device of claim 28, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.

30. The sterilizing device of claim 27, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.

31. The sterilizing device of claim 27, wherein, during the deformation of the package, the radiation shield is separable from the package.

32. The sterilizing device of claim 31 wherein the package further comprises at least one finger protruding into an interior space of the packet wherein the radiation shield is insertable into the at least one finger from outside the interior of packet whereby, before the deformation of the package, the radiation shield can be inserted from the outside into at least one finger.

33. The sterilizing device of claim 31, the package having a deformable design wherein the implantable sensor is connected to a first package part of the package, the radiation shield being movable with a second package part of the package, the first package part and the second package part remaining connected to each other during deformation of the package such that a bacteria-sealed shielding of the implantable sensor is ensured.