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WO2011119367A2 - Protection d'implant pour aide auditive à ancrage osseux - Google Patents

Protection d'implant pour aide auditive à ancrage osseux Download PDF

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Publication number
WO2011119367A2
WO2011119367A2 PCT/US2011/028457 US2011028457W WO2011119367A2 WO 2011119367 A2 WO2011119367 A2 WO 2011119367A2 US 2011028457 W US2011028457 W US 2011028457W WO 2011119367 A2 WO2011119367 A2 WO 2011119367A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
shield
barrier
user
scalp
Prior art date
Application number
PCT/US2011/028457
Other languages
English (en)
Other versions
WO2011119367A3 (fr
Inventor
Kathleen M. Marotta
David M. Barrs
Original Assignee
Mayo Foundation For Medical Education And Research
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mayo Foundation For Medical Education And Research filed Critical Mayo Foundation For Medical Education And Research
Publication of WO2011119367A2 publication Critical patent/WO2011119367A2/fr
Publication of WO2011119367A3 publication Critical patent/WO2011119367A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/14—Materials or treatment for tissue regeneration for ear reconstruction or ear implants, e.g. implantable hearing aids

Definitions

  • the present invention relates to devices and methods for use with bone anchored devices including bone anchored hearing aids. More particularly, the present invention relates to a device and method for shielding a bone anchored hearing aid from hair growth or other interference.
  • a bone anchored hearing aid is a type of hearing aid based on bone conduction. It is primarily suited to people who have conductive hearing losses, unilateral hearing loss and people with mixed hearing losses who cannot otherwise wear "in the ear” or "behind the ear” hearing aids.
  • Bone anchored hearing aids transmit sound by direct conduction through bone to the inner ear, bypassing the external auditory canal and middle ear.
  • Bone anchored hearing aids include three main components: 1) an implanted portion or post; 2) an external abutment which couples to the implanted post; and 3) a sound processor.
  • the implanted portion or post as it is also referred to, is surgically embedded into the skull.
  • the abutment is then attached to the post.
  • a healing cap is used to protect the abutment.
  • the present invention is an implant shield for a bone anchored hearing aid including a flexible barrier configured to engage a scalp of a bone anchored hearing aid user.
  • the flexible barrier includes an implant opening through which an implant or other component of the bone anchored hearing aid can extend to enable an abutment and/or processor of the bone anchored hearing aid to be to be attached to the implant.
  • the present invention is a method for shielding a bone anchored hearing aid on a user from hair growth and/or other interference including the step of applying an implant shield to the scalp of the user around the portion of the hearing aid extending from the scalp.
  • FIG. 1 is a plan view of an implant shield in accordance with an embodiment of the present invention.
  • FIG. 2 is a schematic view of an implant shield in accordance with another embodiment of the present invention including a partially removed release liner.
  • FIG. 3 is a schematic view of an implant shield in use with a bone anchored hearing aid implanted within a user's skull in accordance with an embodiment of the present invention.
  • FIG. 1 shows an implant shield 10 according to an embodiment of the present invention.
  • the implant shield 10 can be used to facilitate a decrease in potential interference with an implanted device.
  • the implant shield 10 can be used with a bone anchored hearing aid to protect the hearing aid from hair growth and other interference.
  • the implant shield 10 may be used to prevent hair from being wrapped around external portions of the hearing aid and in some cases, may prevent hair or other debris from working its way down to a patient's skull.
  • Exemplary bone anchored hearing aids are sold and manufactured by Cochlear Limited of Sydney, Australia.
  • the implant shield 10 includes a flexible barrier 12.
  • the flexible barrier 12 has sufficient flexibility so as to be able to conform to and engage a scalp of a bone anchored hearing aid user.
  • the flexible barrier 12 includes an upper surface 14 and a lower surface 16 defining a thickness.
  • the thickness of the flexible barrier 12 ranges from about 0.020 to about 0.030 inches, although it can be formed from a variety of materials of varying thicknesses.
  • the flexible barrier 12 can have a variety of shapes. In some embodiments, as shown in FIG. 1, the flexible barrier 12 has a circular shape. In one embodiment, the flexible barrier 12 has a circular shape having a diameter of about 20-50 mm.
  • the flexible barrier 12 serves as a barrier between the user's scalp and external portions of an implanted device such as, for example, a bone anchored hearing aid.
  • the flexible barrier 12 includes an implant opening 18 extending through the upper and lower surfaces 14 and 16.
  • the post or other implantable portion of a bone anchored hearing aid can extend through the implant opening 18 to enable the abutment or other external portion of the bone anchored hearing aid to be to be attached to the post or other implantable portion.
  • the implant opening 18 can be located anywhere on the flexible barrier 12. In the illustrated embodiment, the implant opening 18 is at a center of the flexible barrier 12.
  • FIG. 1 shows an embodiment in which the flexible barrier 12 is circular and the implant opening 18 is at the center of the circular flexible barrier 12.
  • the implant opening 18 is sized and shaped so as to facilitate extension of the abutment or other external component of a bone anchored hearing aid through the opening 18.
  • the implant opening 18 has a circular shape and a diameter ranging from about 3 to about 5 mm.
  • the flexible barrier 12 has sufficient pliability such that it can be stretched so as to enlarge the implant opening 18.
  • the implant opening 18 is enlarged such that it can be slipped over the lateral most part of an implant such as for example, the abutment of a bone anchored hearing aid.
  • the implant opening 18 can include one or more slits 20 in the material surrounding the opening 18 to facilitate placement of the shield 10 over the abutment of a bone anchored hearing aid.
  • the opening 18 includes four slits 20. The flexible barrier 12 can then be placed against the user's scalp.
  • the flexible barrier 12 can also include one or more ventilation openings 22 surrounding the implant opening 18.
  • the ventilation openings 22 are for ventilation and may facilitate the escape of any bodily secretions.
  • the flexible barrier 12 includes four ventilation openings 22 surrounding the implant opening 18.
  • the ventilation openings 22 can have any size and shape.
  • the ventilation openings 22 are generally smaller in size than the implant opening 18.
  • the ventilation openings 22 have a circular shape with a diameter of about 1 mm.
  • the implant shield 10 merely rests against a surface of a user's scalp.
  • a variety of attachment devices and/or methods can be used to attach the implant shield 10 to a user's scalp.
  • adhesive can be used to attach the implant shield 10 to the user's scalp.
  • the adhesive can be applied to the user's scalp and/or the lower surface 16 of the flexible barrier 12.
  • sutures can be used to secure the implant shield to the user's scalp.
  • a combination of attachment devices and/or methods can be used.
  • FIG. 2 shows an implant shield 110 according to another embodiment of the present invention.
  • the implant shield 110 includes a flexible barrier 112 including an upper surface 114 and a lower surface 116. Additionally, the flexible barrier 112 includes an implant opening (not visible) and one or more ventilation openings 122.
  • the lower surface 116 of the flexible barrier 112 includes an adhesive 124 for securing the implant shield 110 to a user's scalp.
  • the implant shield 110 can also include a release liner 126 disposed over the lower surface 116 including the adhesive 124 to protect the adhesive 124 prior to use of the implant shield 110. The release liner 126 can be peeled away from the lower surface 116 of the implant shield 110 to expose the adhesive such that the implant shield 110 can be adhered to the user's scalp.
  • the implant shields 10 and 110 can be fabricated from a wide variety of materials.
  • the material used fabricate the implant shields 10 and 110 should be selected for its flexibility (i.e. its ability to conform to the user's scalp), pliability and biocompatibility.
  • the implant shields 10 and 110 can be fabricated from a biocompatible polymeric material.
  • the implant shields 10 and 110 can be fabricated from silicone sheeting.
  • the implant shields 10 and 1 10 can be fabricated from SILASTIC ® .
  • the thickness of the material used to fabricate the implant shield may also impact is flexibility as well as its pliability.
  • FIG. 3 shows an implant shield 10 as described above with reference to FIG. 1, in use.
  • a bone anchored hearing aid includes a surgically implanted post that is integrated into the user's skull 134, an external abutment that attaches to the post and extends away from the user's skull 134, and a sound processor that couples to the external abutment.
  • the implant shield 10 is positioned against a user's scalp 136 such that it is situated between the user's scalp 136 and an abutment 130 of a bone anchored hearing aid.
  • the implant shield 10 is installed after implantation of the post and the abutment 130 of a bone anchored hearing aid is complete and the area surrounding the bone anchored hearing aid is sufficiently healed.
  • the implant shield 10 is stretched such that the implant opening (not visible) is enlarged so as to fit over the widest portion of the abutment 130.
  • the implant shield 10 is placed around the abutment 130 and then slipped down on the abutment 130 until it rests on the user's scalp 136.
  • an adhesive can be applied to the user's scalp and/or to the lower surface of the flexible barrier prior to placing the implant shield 10 against the user's scalp 163 to promote adherence of the implant shield 10 to the user's scalp 136.
  • an antibiotic or other treatment may be applied to the user's scalp and/or to the lower surface of the implant shield 10 prior to placing the implant shield 10 against the user's scalp 136.
  • the implant shield 10 may hold the treatment in place against the user's scalp 136 and may protect the treatment from any interference.
  • the implant shield 10 can be applied to the patient's scalp 136 after implantation of the post so that it is present during the healing process. The abutment 130 can then be attached to the surgically implanted post through the implantation opening provided in the implant shield 10.
  • implant shield as described herein according to the various embodiments, can be used with any implanted device having an implanted portion and an external portion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention a pour objet une protection d'implant pouvant être placée contre le cuir chevelu de l'utilisateur pour protéger une aide auditive à ancrage osseux par rapport à la pousse des cheveux ou autre interférence. Des adhésifs peuvent être utilisés pour fixer la protection d'implant au cuir chevelu. Un mode de réalisation de la protection d'implant est une barrière en matière polymère souple ayant une ouverture d'implant à travers laquelle peut s'étendre une partie implantée ou autre de l'aide auditive.
PCT/US2011/028457 2010-03-24 2011-03-15 Protection d'implant pour aide auditive à ancrage osseux WO2011119367A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31708810P 2010-03-24 2010-03-24
US61/317,088 2010-03-24

Publications (2)

Publication Number Publication Date
WO2011119367A2 true WO2011119367A2 (fr) 2011-09-29
WO2011119367A3 WO2011119367A3 (fr) 2012-01-12

Family

ID=44673803

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/028457 WO2011119367A2 (fr) 2010-03-24 2011-03-15 Protection d'implant pour aide auditive à ancrage osseux

Country Status (1)

Country Link
WO (1) WO2011119367A2 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE523124C2 (sv) * 2001-06-21 2004-03-30 P & B Res Ab Kopplingsanordning för en tvådelad benförankrad hörapparat
SE523100C2 (sv) * 2001-06-21 2004-03-30 P & B Res Ab Benförankrad hörapparat avsedd för överledning av ljud
SE526548C2 (sv) * 2003-05-30 2005-10-04 Entific Medical Systems Ab Anordning vid implantat
SE531177C2 (sv) * 2007-05-24 2009-01-13 Cochlear Ltd Distans för implantat

Also Published As

Publication number Publication date
WO2011119367A3 (fr) 2012-01-12

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