# US 8,787,607 B2 · Percutaneous bone conduction implant

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- Number: US 8,787,607 B2
- Document ID: US8787607B2
- Status: Granted
- Kind: B2
- Application number: 12/732,155
- Filed: 2010-03-25
- Published: 2010-11-11
- Granted: 2014-07-22
- Earliest claimed: 2009-03-25
- Assignees: Cochlear Limited
- Applicants: Marcus Andersson
- Inventors: Marcus Andersson
- Web page: https://patentgrep.com/patent/US8787607B2

## CPC

- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- H04R 25/606: {acting directly on the eardrum, the ossicles or the skull, e.g. mastoid, tooth, maxillary or mandibular bone, or mechanically stimulating the cochlea, e.g. at the oval window}
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/104: Silver, e.g. silver sulfadiazine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/406: Antibiotics
- A61L 2300/45: Mixtures of two or more drugs, e.g. synergistic mixtures
- A61L 2430/14: for ear reconstruction or ear implants, e.g. implantable hearing aids
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- H04R: LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS (producing sounds with frequency not determined by supply frequency G10K)

## Abstract

One embodiment relates to a percutaneous bone conduction implant. The implant includes a fixture configured to be anchored in the recipient's skull, and a skin-penetrating abutment configured to interface with the fixture and to permit the abutment to be removably attached to the fixture to form a fixture-abutment assembly. In an embodiment, at least one anti-microbial surface forms one or more surfaces of the formed fixture-abutment assembly located in an interior of the formed fixture-abutment assembly when the fixture is removably attached to the abutment with an abutment screw. The interior is substantially isolated from a surrounding environment of the fixture-abutment assembly.

## Claims

### Claim 1

A percutaneous bone conduction implant, comprising:
a fixture configured to be anchored in the recipient's skull; and
a skin-penetrating abutment configured to interface with the fixture and to permit the abutment to be removably attached to the fixture to form a fixture-abutment assembly,
wherein at least one anti-microbial surface forms one or more surfaces of the formed fixture-abutment assembly located in an interior of the formed fixture-abutment assembly when the fixture is removably attached to the abutment with an abutment screw, the interior being substantially isolated from a surrounding environment of the fixture-abutment assembly, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 2 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the fixture-abutment assembly includes an abutment screw, and wherein the at least one anti-microbial surface is located on the abutment screw.

### Claim 3 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the abutment has a substantially conical surface, located on the exterior of the abutment relative to the abutment, with a tapered exterior contour dimensioned to fit within a tapered interior contoured surface of a cavity of the fixture to provide a mechanically tight fit when the abutment is removably attached to the fixture, wherein the at least one anti-microbial surface is located at the interface of the conical exterior of the abutment and the tapered interior contoured face of the fixture.

### Claim 4 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein a first part of the fixture located opposite screw threads of the fixture and a first part of the abutment located adjacent to the first part of the fixture interface with each other with a conical fit when the abutment is removably attached to the fixture to form the fixture-abutment assembly, wherein the at least one anti-microbial surface is located at the interface of the first parts.

### Claim 5 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the interior of the formed fixture-abutment assembly is a closed environment hermetically isolated from an external environment of the formed fixture-abutment assembly.

### Claim 6 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the at least one anti-microbial surface is substantially isolated from an external environment of the formed fixture-abutment assembly such that the anti-microbial coating does not elute anti-microbial substances when there is a tight seal between the interior of the formed fixture-abutment assembly and the exterior of the formed fixture-abutment assembly.

### Claim 7 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the at least one anti-microbial surface is anti-microbially activated only when exposed to moisture, and wherein the interior of the formed fixture-abutment assembly is substantially isolated from an external environment of the formed fixture-abutment assembly such that the at least one anti-microbial surface in the interior is not exposed to moisture and therefore is not anti-microbially activated.

### Claim 8 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the at least one anti-microbial surface comprises silver.

### Claim 9 (depends on 1)

The percutaneous bone conduction implant of to claim 1, wherein the at least one anti-microbial surface is contained in a reservoir in the fixture-abutment assembly.

### Claim 10 (depends on 2)

The percutaneous bone conduction implant of to claim 2, wherein the abutment screw is made substantially of an anti-microbial material.

### Claim 11 (depends on 10)

The percutaneous bone conduction implant of claim 10, wherein the abutment screw is made substantially of silver or a silver alloy.

### Claim 12 (depends on 1)

The percutaneous bone conduction implant of claim 1, wherein the at least one anti-microbial surface comprises an anti-microbial coating, and wherein the anti-microbial coating has a first thickness corresponding to a first estimated efficacy achieved during exposure to an environment substantially devoid of proteins and acids, and wherein the first thickness is substantially less than a second thickness of an anti-microbial coating corresponding to a second estimated efficacy achieved during exposure to least one of proteins and acids, wherein the first estimated efficacy is about the same as the second estimated efficacy.

### Claim 13 (depends on 1)

The percutaneous bone implant of claim 1, wherein the anti-microbial surface is limited to interior surfaces of the formed fixture.

### Claim 14

A percutaneous bone conduction implant, comprising:
a fixture configured to be anchored in the recipient's skull; and
a skin-penetrating abutment configured to interface with the fixture and to permit the abutment to be removably attached to the fixture to form a fixture-abutment assembly,
wherein the abutment includes a first coupling portion adapted to receive a second coupling portion of a bone conduction device and to establish a mechanical connection with the bone conduction device,
and wherein at least one anti-microbial surface is present in the formed fixture-abutment assembly and located in an interior of the formed fixture-abutment assembly when the fixture is removably attached to the abutment with an abutment screw, the interior being substantially isolated from a surrounding environment of the fixture-abutment assembly, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 15 (depends on 14)

The percutaneous bone conduction implant of claim 14, wherein the at least one anti-microbial surface is configured to kill at least 99% of all bacteria by quantity that come into contact with the at least one anti-microbial surface.

### Claim 16 (depends on 14)

The percutaneous bone conduction implant of claim 14, wherein the at least one anti-microbial surface is located on surfaces that are at least one of on or adjacent to an abutment screw configured to screw into the fixture to releasably attach the abutment to the fixture, wherein the friction coefficient of the least one anti-microbial surface is about the same as the friction coefficient which would be present at the same surfaces without the at least one anti-microbial surface.

### Claim 17 (depends on 14)

The percutaneous bone conduction implant of claim 14, the friction coefficient of the surfaces with the at least one anti-microbial surface is the same as the friction coefficient which would be present at the same surfaces without the at least one anti-microbial surface.

### Claim 18 (depends on 14)

The percutaneous bone conduction implant of claim 14, wherein the at least one anti-microbial surface is a silver-based anti-microbial surface that kills Staph and Epidermidis and Methicillin resistant Staph Aureus (MRSA).

### Claim 19 (depends on 14)

The percutaneous bone implant of claim 14, wherein the anti-microbial surface is limited to interior surfaces of the formed fixture.

### Claim 20

A percutaneous bone conduction implant, comprising:
a fixture configured to be anchored in the skull of the recipient; and
a skin-penetrating abutment configured to interface with the fixture and to permit the abutment to be removably attached to the fixture to form a fixture-abutment assembly through which controlled vibrations can be directly transmitted from outside the recipient's body directly into the fixture-abutment assembly,
wherein the abutment is dimensioned to extend from the fixture to above an outer skin layer of the recipient when the fixture-abutment is located at a first body location located approximately adjacent a recipient's pinna and the fixture is anchored in the recipient's skull, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 21 (depends on 20)

The percutaneous bone implant of claim 20, further comprising at least one anti-microbial coating along one or more interior surfaces of the fixture.

### Claim 22 (depends on 20)

The percutaneous bone conduction implant of claim 20, further including an abutment screw adapted to extend through the abutment and screw into the fixture to removably attach the abutment to the fixture, wherein when the abutment screw is screwed into the fixture so that the abutment sealingly interfaces with the fixture to form the fixture-abutment assembly, a micro-leakage pathway is present, wherein the fixture-abutment is located at the first body location, extending from outside the recipient to a region between facing surfaces of the abutment screw and the abutment to at least one of (i) a region between facing surfaces of the abutment screw and the fixture and (ii) a region between facing surfaces of the abutment and the fixture,
wherein the at least one anti-microbial surface is located within the micro-leakage pathway.

### Claim 23

An implanted percutaneous bone conduction implant, comprising:
a fixture-abutment assembly implanted in the recipient's skull at a first body location, wherein the fixture-abutment assembly includes:
a fixture anchored in the recipient's skull; and
a skin-penetrating abutment releasably attached to the fixture extending from beneath a surface layer of an epidermis of the recipient to an exterior of the recipient above the surface layer of the epidermis of the recipient at the first body location,
wherein one or more anti-microbial surfaces are present on the fixture-abutment, the one or more surfaces being located in an interior of the formed fixture-abutment assembly when the fixture is removably attached to the abutment, the interior being substantially isolated from a surrounding environment of the fixture-abutment assembly, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 24 (depends on 23)

The percutaneous bone implant of claim 23, wherein the anti-microbial surface is limited to interior surfaces of the formed fixture.

### Claim 25 (depends on 23)

The percutaneous bone conduction implant of claim 23, wherein the first location is located approximately behind a pinna of the human body.

### Claim 26 (depends on 23)

The percutaneous bone conduction implant of claim 23, wherein the least one anti-microbial surface is anti-microbially activated only when exposed to moisture, and wherein the interior of the formed fixture-abutment assembly is substantially isolated from an external environment of the formed fixture-abutment assembly such that the at least one anti-microbial surface in the interior is not exposed to moisture and therefore is no anti-microbially activated.

### Claim 27

A method of implanting a percutaneous bone conduction implant, comprising:
anchoring a fixture in a recipient's skull; and
releasably attaching a skin-penetrating abutment to the fixture to form a fixture-abutment assembly,
wherein the action of releasably attaching the skin-penetrating abutment to the fixture includes establishing a hermetically sealed interior in the formed fixture-abutment assembly,
wherein at least one anti-microbial surface is present on an interior of the formed fixture-abutment assembly, the interior initially being hermetically sealed from an exterior of the formed fixture-abutment assembly, and
wherein, after a period of time after releasably attaching the skin-penetrating abutment to the fixture, the interior ceases to be hermetically sealed from the exterior of the formed fixture-abutment assembly while the skin-penetrating abutment is still releasably attached to the fixture, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 28 (depends on 27)

The method of claim 27, wherein the period of time is over about one year.

### Claim 29 (depends on 28)

The method of claim 28, wherein after the period of time, the at least one anti-microbial surface has about the same efficacy with respect to killing microbes as possessed by the surface when the abutment was releasably attached to the fixture.

### Claim 30 (depends on 27)

The method of claim 27, wherein the anti-microbial surface is silver-based, the method further comprising avoiding exposure of the at least one anti-microbial surface to at least one of proteins and acids.

### Claim 31

A percutaneous bone conduction implant, comprising:
a fixture configured to be anchored in a recipient's skull; and
a skin-penetrating abutment configured to interface with the fixture and to permit the abutment to be removably attached to the fixture to form an fixture-abutment assembly through which controlled vibrations can be directly transmitted from outside the recipient's body directly into the fixture-abutment assembly,
wherein the formed fixture-abutment assembly includes one or more surfaces located in an interior of the formed fixture-abutment assembly when the fixture is removably attached to the abutment with an abutment screw, the interior being substantially isolated from a surrounding environment of the fixture-abutment assembly, and
wherein at least one of the one or more surfaces are at least one of anti-adhesive, bacterial repellant or coated with an antibiotic agent, and
wherein one of the fixture and the skin-penetrating abutment is seated within a cavity of the other of the fixture and the skin-penetrating abutment such that abutting surfaces of the fixture and the skin-penetrating abutment interface together to form a mechanically tight fit.

### Claim 32 (depends on 27)

The method of claim 27, wherein the anti-microbial surface is limited to interior surfaces of the formed fixture.

### Claim 33 (depends on 31)

The percutaneous bone implant of claim 31, wherein the one or more surfaces is one or more anti-microbial surfaces limited to interior surfaces of the formed fixture.
