# US 11,439,834 B2 · Fixation system for an implantable medical device

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- Number: US 11,439,834 B2
- Document ID: US11439834B2
- Status: Granted
- Kind: B2
- Application number: 17/361,126
- Filed: 2021-06-28
- Published: 2021-10-21
- Granted: 2022-09-13
- Earliest claimed: 2002-08-09
- Assignees: Cochlear Limited
- Applicants: Cochlear Limited
- Inventors: Peter Gibson; Lars Vendelbo Johansen
- Web page: https://patentgrep.com/patent/US11439834B2

## CPC

- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/36036: {of the outer, middle or inner ear}
- A61N 1/36038: {Cochlear stimulation}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/375: Constructional arrangements, e.g. casings
- A61F 11/20: Ear surgery
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- 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

A medical implant, such as an implantable component (22) of a tissue-stimulating prosthesis. One example of such a prosthesis being a cochlear implant. The component (22) is adapted to be implanted at or adjacent a tissue surface within the recipient, such as a bone surface. The component (22) has a housing and at least one flange (42) extending outwardly therefrom. The flange (42) can be secured to the tissue surface via a tissue fixation device, such as a bone screw (43).

## Claims

### Claim 1

An implantable component of a cochlear implant, comprising:
a housing containing electronic components of the implant;
a communications coil; and
two silicone rubber flanges configured to secure the implantable component to bone via respective bone screws extending through respective holes in the respective flanges to secure the implantable component to the bone, wherein
the housing and the communications coil are encased in an encasement,
the encasement is formed of silicone rubber,
the silicone rubber flanges are projections of the silicone rubber away from the encasement, and
the silicone rubber flanges are self-supporting distinct structural components.

### Claim 2 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the housing is formed of a ceramic.

### Claim 3 (depends on 2)

The implantable component of a cochlear implant of claim 2, wherein:
the flanges include biocompatible metallic material.

### Claim 4 (depends on 2)

The implantable component of a cochlear implant of claim 2, wherein:
at least a portion of the housing is made of a different material than that of at least a portion of the flanges.

### Claim 5 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are physically linked to the housing, and the housing has a design agnostic to a presence or absence of the flanges.

### Claim 6 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
respective bone screws extend through the respective holes and are screwed into bone of a skull; and
the bone screws have round heads.

### Claim 7 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are made integral with the implantable component.

### Claim 8 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are extensions of the implantable component.

### Claim 9 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are made of a non-magnetic material.

### Claim 10 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are configured to be manipulated to fit a shape of a person's skull by surgeon finger pressure only.

### Claim 11 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
respective bone screws extend through the respective holes and are screwed into bone of a skull; and
the flanges have been manipulated only to a relatively small degree to conform to the bone.

### Claim 12 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are integrally fixed portions of the implantable component.

### Claim 13 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are portions of a single sub-component of the implantable component.

### Claim 14 (depends on 1)

The implantable component of a cochlear implant of claim 1, wherein:
the flanges are integral parts of a body that has a portion that extends underneath the housing and between the bone and the housing when the implantable component is secured to the bone.

### Claim 15

An implantable component of a cochlear implant, comprising:
a housing containing electronic components of the implant;
a communications coil; and
two silicone rubber flanges configured to secure the implantable component to bone via respective bone screws extending through respective holes in the respective flanges to secure the implantable component to the bone, wherein
the housing has a coating of silicone rubber, and
the silicone rubber flanges are projections of silicone rubber of the silicone rubber coating away from the housing.

### Claim 16 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are self-supporting distinct structural components.

### Claim 17 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are located, with respect to a longitudinal axis of the implantable component, forward of the communications coil.

### Claim 18 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are located, with respect to a longitudinal axis of the implantable component, forward of the communications coil and equidistant from the longitudinal axis on respective sides of the longitudinal axis.

### Claim 19 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are configured to be cut-off by a surgeon during a surgical procedure of implanting the implantable component.

### Claim 20 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges extend from a lower surface of the housing, which lower surface of the housing faces a skull when the implantable component is implanted.

### Claim 21 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges have a thickness that allows the flanges to be suitably conformable during a surgical procedure of implanting the implantable component into a head of a person.

### Claim 22 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are neither integral extensions of the housing nor components formed separately and mounted to the housing.

### Claim 23 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are at least in part part of a distinct monolithic portion of the implantable component.

### Claim 24 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the silicone rubber flanges are at least in part monolithic with the coating.

### Claim 25 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
respective bone screws extend through the respective holes and are screwed into bone of a skull; and
the flanges have been manipulated only to a relatively small degree to conform to the bone.

### Claim 26 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the flanges are configured to be manipulated to fit a shape of a person's skull by surgeon finger pressure only.

### Claim 27 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the flanges are made of a non-magnetic material.

### Claim 28 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the housing is formed of a ceramic.

### Claim 29 (depends on 28)

The implantable component of a cochlear implant of claim 28, wherein:
the flanges include biocompatible metallic material.

### Claim 30 (depends on 15)

The implantable component of a cochlear implant of claim 15, wherein:
the flanges are integral parts of a body that has a portion that extends underneath the housing and between the bone and the housing when the implantable component is secured to the bone.
