Electrode array packaging system

• US 11,660,445 B2
• Filed: 05/25/2016
• Issued: 05/30/2023
• Est. Priority Date: 09/23/2015
• Status: Active Grant

• Current Assignee: Cochlear Limited
• Original Assignee: Cochlear Limited
• Inventors: Walling, Grahame Michael David, Leigh, Charles Roger Aaron
• Primary Examiner(s): Holmes, Rex R
• Assistant Examiner(s): Ghand, Jennifer L
• Application Number:
  US15/164,789
• Publication Number:
  US 20170080211A1
• Time in Patent Office: 2,561 Days
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

An apparatus, including a sterilely sealed package, and an electrode assembly sterilely sealed in the package, wherein the apparatus is configured to enable testing for an open circuit between two electrodes of the electrode assembly with the electrode assembly sterilely sealed in the package.

Claims

1. An apparatus, comprising:

a sterilely sealed package; and

an electrode assembly sterilely sealed in the package, wherein the apparatus is configured to enable testing, with a conductive material, for an open circuit between two electrodes of the electrode assembly with the electrode assembly sterilely sealed in the package, wherein

the apparatus is configured to disable the enablement of the testing for the open circuit while the electrode assembly is sterilely sealed in the package.

2. The apparatus of claim 1, wherein:

the electrode assembly is in a state prepared for direct implantation into a recipient upon opening of the package.

3. The apparatus of claim 2, wherein at least one of:

the apparatus includes components separate from the package within the package that envelope the two electrodes that are configured to enable the testing for the open circuit;

or

the apparatus includes components that are integral to the package that are configured to establish a conductive path between the two electrodes to enable the testing for the open circuit.

4. The apparatus of claim 1, wherein:

the apparatus provides conductivity between two electrodes of the electrode assembly sufficient to enable testing for an open circuit between the two electrodes while also enabling testing for a short circuit between the two electrodes with the conductivity present between the two electrodes.

5. The apparatus of claim 4, wherein the apparatus includes an electrically conductive foam portion that directly contacts the two electrodes.

6. The apparatus of claim 1, wherein at least a portion of the package is made of the conductive material and is in direct contact with electrodes of the electrode assembly.

7. A method, comprising:

obtaining an electrode array within a sealed package sterilely isolated from an external environment thereof;

testing, with a conductive material, for an open circuit between two electrodes of the electrode array while the electrode array is sterilely isolated from the external environment within the sealed package; and

testing for a short circuit in the electrode array while the electrode array is sterilely isolated from the external environment within the sealed package.

8. The method of claim 7, further comprising:

eliminating the sterile isolation after testing and implanting the electrode array in a human recipient.

9. The method of claim 8, wherein:

the action of implanting the electrode array includes implanting the electrode array into the human recipient after eliminating the sterile isolation without adding material to or removing material from the electrode array.

10. The method of claim 8, wherein:

the action of testing for an open circuit includes testing for the open circuit while the recipient is under anesthesia and prepared for implantation; and

the method further includes determining whether to implant the electrode array in the recipient based on the testing.

11. The method of claim 7, further comprising:

manipulating package material forming the sterile isolation from a first state to a second state and subsequently testing for one of the open circuit or the short of the electrode array while the electrode array is sterilely isolated from the external environment.

12. The method of claim 11, further comprising:

testing for the other of the open circuit or the short circuit while the package material is in the first state.

13. The method of claim 7, wherein:

the action of testing is executed during storage.

14. The method of claim 7, wherein:

the action of testing for an open circuit is executed by establishing a conductive path of solid material between the two electrodes.

15. The method of claim 14, wherein:

the solid is a solid other than foam.

16. The method of claim 15, wherein:

the solid material is in the form of a body that includes a discrete passageway therein that establishes the conductive path.

17. The method of claim 7, wherein:

the action of testing is executed immediately after packaging and immediately prior to implantation of the electrode array into a recipient.

18. The method of claim 7, wherein the action of testing for an open circuit includes utilizing the package which is made of the conductive material and is in direct contact with the two electrodes of the electrode assembly to provide a conductive path between the two.

19. The method of claim 7, wherein:

the method further comprises opening the package;

the electrode array is stored in the sterile environment established by the package until the package is opened.

20. An apparatus, comprising:

a package; and

an electrode array sterilely sealed in the package, wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode array with a conductive material, wherein at least one of;

the apparatus is configured to alternately provide and eliminate the electrical conductivity between the two electrodes, with the conductive material, while sterilely sealed in the package;

or

the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.

21. The apparatus of claim 20, wherein:

the apparatus is configured to alternately provide and eliminate the electrical conductivity between the two electrodes, with the conductive material, while sterilely sealed in the package.

22. The apparatus of claim 20, wherein:

the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.

23. The apparatus of claim 22, wherein:

the apparatus is configured to vary the impedance via magnetic manipulation of a component within the package by a magnetic field extending through the package.

24. The apparatus of claim 20, wherein:

the package includes a foam portion that provides the electrical conductivity.

25. The apparatus of claim 20, wherein:

the apparatus is configured to controllably initiate the establishment of the electrical conductivity between the two electrodes via material completely within the package that is also sterilely sealed in the package.

26. The apparatus of claim 20, wherein:

the apparatus is configured to have the electrical conductivity between the two electrodes at all times while the electrode array is sterilely sealed in the package.

27. A system, comprising:

a package; and

a cochlear implant comprising an electrode array and a receiver-stimulator sealed within the package, wherein the system is configured to enable open circuit testing with a conductive material and short circuit testing of the electrode array while the electrode array is sealed in the package.

28. The system of claim 27, wherein:

the electrode array is a curved electrode array in a curved orientation.

29. The system of claim 28, wherein:

the electrode array is curved to subtend an angle of at least 360 degrees.

30. The system of claim 27, wherein:

the electrode array includes recessed electrodes.

31. The system of claim 27, wherein:

the electrode array is sterilely sealed within the package, and wherein the electrode array includes a plurality of electrodes and a plurality of leads.

32. The system of claim 27, wherein:

the package is heat sealed to establish a completely sterilely sealed package, thereby sterilely sealing the cochlear implant in the package.