# US 11,660,445 B2 · Electrode array packaging system

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- Number: US 11,660,445 B2
- Document ID: US11660445B2
- Status: Granted
- Kind: B2
- Application number: 15/164,789
- Filed: 2016-05-25
- Published: 2017-03-23
- Granted: 2023-05-30
- Earliest claimed: 2015-09-23
- Assignees: Cochlear Limited
- Applicants: Cochlear Limited
- Inventors: Grahame Michael David Walling; Charles Roger Aaron Leigh
- Web page: https://patentgrep.com/patent/US11660445B2

## CPC

- A61N 1/0541: {Cochlear electrodes}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61N 2001/37294: {Means for testing medical devices within the package prior to implantation}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 4)

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

### Claim 6 (depends on 1)

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.

### Claim 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.

### Claim 8 (depends on 7)

The method of claim 7, further comprising:
eliminating the sterile isolation after testing and implanting the electrode array in a human recipient.

### Claim 9 (depends on 8)

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.

### Claim 10 (depends on 8)

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.

### Claim 11 (depends on 7)

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.

### Claim 12 (depends on 11)

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.

### Claim 13 (depends on 7)

The method of claim 7, wherein:
the action of testing is executed during storage.

### Claim 14 (depends on 7)

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.

### Claim 15 (depends on 14)

The method of claim 14, wherein:
the solid is a solid other than foam.

### Claim 16 (depends on 15)

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.

### Claim 17 (depends on 7)

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.

### Claim 18 (depends on 7)

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.

### Claim 19 (depends on 7)

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.

### Claim 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.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 20)

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.

### Claim 23 (depends on 22)

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.

### Claim 24 (depends on 20)

The apparatus of claim 20, wherein:
the package includes a foam portion that provides the electrical conductivity.

### Claim 25 (depends on 20)

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.

### Claim 26 (depends on 20)

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.

### Claim 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.

### Claim 28 (depends on 27)

The system of claim 27, wherein:
the electrode array is a curved electrode array in a curved orientation.

### Claim 29 (depends on 28)

The system of claim 28, wherein:
the electrode array is curved to subtend an angle of at least 360 degrees.

### Claim 30 (depends on 27)

The system of claim 27, wherein:
the electrode array includes recessed electrodes.

### Claim 31 (depends on 27)

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.

### Claim 32 (depends on 27)

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.