US9271092B2 - Medical implant system - Google Patents

Medical implant system Download PDF

Info

Publication number
US9271092B2
US9271092B2 US13/371,763 US201213371763A US9271092B2 US 9271092 B2 US9271092 B2 US 9271092B2 US 201213371763 A US201213371763 A US 201213371763A US 9271092 B2 US9271092 B2 US 9271092B2
Authority
US
United States
Prior art keywords
abutment
fixture
bone fixture
deformable element
contact surface
Prior art date
Legal status (The legal status 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 status listed.)
Active, expires
Application number
US13/371,763
Other languages
English (en)
Other versions
US20120172658A1 (en
Inventor
Goran Bjorn
Marcus ANDERSSON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cochlear Ltd
Original Assignee
Cochlear Ltd
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
Priority claimed from AU2009903789A external-priority patent/AU2009903789A0/en
Application filed by Cochlear Ltd filed Critical Cochlear Ltd
Publication of US20120172658A1 publication Critical patent/US20120172658A1/en
Assigned to COCHLEAR LIMITED reassignment COCHLEAR LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ANDERSSON, MARCUS, BJORN, GORAN
Priority to US15/049,895 priority Critical patent/US11166752B2/en
Application granted granted Critical
Publication of US9271092B2 publication Critical patent/US9271092B2/en
Priority to US17/521,437 priority patent/US20220061889A1/en
Active legal-status Critical Current
Adjusted expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04R—LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS
    • H04R25/00—Electric hearing aids
    • H04R25/60—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles
    • H04R25/604—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers
    • H04R25/606—Mounting or interconnection of hearing aid parts, e.g. inside tips, housings or to ossicles of acoustic or vibrational transducers 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0048—Connecting the upper structure to the implant, e.g. bridging bars
    • A61C8/005—Connecting devices for joining an upper structure with an implant member, e.g. spacers
    • A61C8/0068—Connecting devices for joining an upper structure with an implant member, e.g. spacers with an additional screw

Definitions

  • the present invention relates generally to bone conduction devices, and more particularly, to infection prevention measures associated with percutaneous bone conduction devices.
  • Bone-anchored medical implant systems are used to connect or fixate hearing devices to a recipient, directly to the bone or skull of the recipient.
  • Some applications include hearing implants such as bone conduction devices marketed by Cochlear Bone Anchored Solutions AB in Sweden.
  • Such bone conduction devices sometimes comprise, in the case of percutaneous bone conductions devices as is shown by way of example in FIG. 27 d in black-box format, an external, removable unit 2759 including a vibrator 2761 which transforms sound into mechanical vibrations.
  • Percutaneous bone conductions devices conduct those mechanical vibrations via an abutment 2763 and a bone fixture 2765 of the implant, into the bone of the skull.
  • Passive transcutaneous bone conduction devices conduct those mechanical vibrations through skin of the recipient to an implantable component which includes a bone fixture.
  • a hearing device of the bone conduction device type typically includes an anchoring element or fixture, in the form of, for example, an implanted titanium screw, corresponding to the bone fixture, installed in the bone behind the external ear and the sound is transmitted via the skull bone to the cochlea (inner ear), irrespective of any disease, injury or other dysfunction of the middle ear.
  • an anchoring element or fixture in the form of, for example, an implanted titanium screw, corresponding to the bone fixture, installed in the bone behind the external ear and the sound is transmitted via the skull bone to the cochlea (inner ear), irrespective of any disease, injury or other dysfunction of the middle ear.
  • the skin is penetrated, which makes the vibratory transmission very efficient.
  • This arrangement can also be used in connection with facial prostheses, such as, for example, some of those marketed by Cochlear Limited, Australia.
  • the implants which are used with percutaneous bone conduction devices are sometimes provided in two pieces.
  • One piece comprises the screw-shaped anchoring element (fixture or anchor) and the other piece comprises the abutment, which penetrates the skin.
  • This two-piece design allows the surgical implantation to be carried out as a two-step procedure.
  • the fixture is inserted and maintained unloaded during a healing period of some months or so.
  • the second step of the surgical procedure i.e. the connection of the abutment by means of an abutment screw, is executed.
  • the two-part design may allow for the implants to be up-graded, if desirable, without removing the fixture or anchor. Furthermore, if the abutment is damaged, it can then be replaced without need of removal of the bone anchored screw or fixture.
  • the bacteria may enter the implant-tissue interface by two different routes—an external route on the external surface of the abutment, and an internal route which starts at the top of the abutment and travels via internal parts (screw connection) of the implant system and may exit at the abutment-fixture-soft tissue junction or interface.
  • the external route is the most open route, but the bacteria may also reach the implant-tissue interface from the internal route, known as the internal micro-leakage pathway.
  • Some aspects of the present invention are generally directed to an implant including a bone fixture configured to anchor to bone of a recipient, and a structural component configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture, wherein at least one of the bone fixture or the structural component includes a deformable element configured to deform to form an anti-microbial seal between the bone fixture and the structural component, and the at least one deformable element and the respective at least one bone fixture or structural component form a monolithic structure.
  • Some other aspects of the present invention are generally directed to an implant, comprising a bone fixture configured to anchor to bone of a recipient, a structural component configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture, and a screw configured to bolt the structural component to the bone fixture, wherein the implant includes an anti-microbial seal between the structural component and the screw.
  • Some other aspects of the present invention are generally directed to an implant, comprising, a bone fixture configured to anchor to bone of a recipient, and a structural component configured to be connected to the bone fixture and connect a functional component of the implant to the bone fixture, wherein at least one of the bone fixture or the structural component includes a deformable element configured to plastically deform to form an anti-microbial seal between the bone fixture and the structural component.
  • Some other aspects of the present invention are generally directed to a method of attaching an abutment to an implanted bone fixture to form a percutaneous implant, comprising positioning the abutment in contact with the implanted bone fixture, and applying a torque of about 15 Ncm or more to a component of the percutaneous implant threadably engaged with the implanted bone fixture, thereby driving the abutment towards the bone fixture via reaction against the implanted bone fixture, wherein the applied torque is sufficient to at least one of deform material of at least one of the bone fixture and the abutment to form an anti-microbial seal between the bone fixture and the abutment, or deform material of at least one of an abutment screw and the abutment to form an anti-microbial seal between the abutment screw and the abutment.
  • FIG. 1 shows an example of a medical implant system to which various aspects of the present disclosure may be applied;
  • FIG. 2 shows a cross section of the medical implant system of FIG. 1 ;
  • FIG. 3 shows a perspective view of the medical implant system of FIG. 1 ;
  • FIG. 4 shows a cross section exploded view of the components of the medical implant system of FIG. 1 ;
  • FIG. 5 a shows one embodiment of an abutment screw of one aspect of the disclosure
  • FIG. 5 b shows a cross section of the abutment screw of FIG. 5A ;
  • FIG. 5 c shows a close up view of the deformable element of FIG. 5B ;
  • FIG. 6 shows a cross section of the abutment screw of FIG. 5A in an abutment
  • FIG. 7 shows a close-up cross section view of a seal provided between the abutment screw of FIG. 5A and the abutment;
  • FIG. 8 shows a cross section of an alternative embodiment of the abutment screw of FIG. 5A ;
  • FIG. 9 a shows a cross section of yet a further alternative of the abutment screw of FIG. 5A ;
  • FIG. 9 b shows a perspective view of the abutment screw of FIG. 9A ;
  • FIG. 10 shows a close-up cross section view of a seal provided between the abutment screw of FIG. 9 a and the abutment;
  • FIG. 11 shows a perspective view of one embodiment of an abutment
  • FIG. 12 shows a cross section of the abutment of FIG. 11 ;
  • FIG. 13 shows a close-up view of a seal provided between the abutment screw and the abutment of FIG. 11 ;
  • FIG. 14 shows a cross section of one embodiment of a fixture
  • FIG. 15 shows a perspective view of one embodiment of an abutment for use with the fixture of FIG. 14 ;
  • FIG. 16 shows a perspective view of another embodiment of an abutment for use with the fixture of FIG. 14 ;
  • FIG. 17 shows a perspective view of yet another embodiment of an abutment for use with the fixture of FIG. 14 ;
  • FIG. 18 shows the abutment of any one of FIGS. 15 to 17 in place in the fixture of FIG. 14 ;
  • FIG. 19 shows a close-up view of the seal provided by the arrangement of FIG. 18 ;
  • FIG. 20 shows a different embodiment of an abutment
  • FIG. 21 shows the abutment of FIG. 20 engaging with a fixture
  • FIG. 22 shows a close-up of a seal provided by the arrangement of FIG. 21 ;
  • FIG. 23 shows an embodiment of a medical implant system with a seal provided between the abutment and the abutment screw;
  • FIG. 24 shows another embodiment of a medical implant system with a seal provided between the abutment and the fixture
  • FIG. 25 shows another embodiment of a medical implant system with a seal provided between the abutment and the abutment screw as well as between the abutment and the fixture;
  • FIG. 26 a shows a flow chart of a method of implanting a medical implant system
  • FIG. 26 b shows a specific example of the method of FIG. 26 a
  • FIG. 27 a shows a cross section of the arrangement of the first step of the method of FIG. 26 b;
  • FIG. 27 b shows a cross section of the arrangement of the second step of the method of FIG. 26 b ;
  • FIG. 27 c shows a cross section of the arrangement of the third step of the method of FIG. 26B ;
  • FIG. 27 d shows in black-box format a functional conceptual external removable unit of a percutaneous bone conduction device including a vibrator, along with an implant;
  • FIG. 28 shows a close-up cross section view of a seal provided between the abutment screw of FIG. 5 a and the abutment in an alternate embodiment
  • FIG. 29 shows a close-up cross section view of a seal provided between the abutment screw of FIG. 9 a and the abutment in an alternate embodiment
  • FIG. 30 a shows a close-up view of a seal provided between the abutment screw and the abutment of FIG. 11 in an alternate embodiment
  • FIG. 30 b shows a close-up view of the seal provided by the arrangement of FIG. 18 in an alternate embodiment
  • FIG. 31 shows an alternate embodiment of a medical implant system with a seal provided between the abutment and the abutment screw;
  • FIG. 32 shows another embodiment of a medical implant system with a seal provided between the abutment and the fixture.
  • FIG. 33 shows another embodiment of a medical implant system with a seal provided between the abutment and the abutment screw as well as between the abutment and the fixture.
  • FIG. 1 shows a side view of a medical implant system 100 .
  • the implant system has an abutment 10 that enables a hearing device to be coupled through a percutaneous connection to a bone anchoring device in the form of fixture 20 .
  • Abutment 10 is connected to fixture 20 .
  • Fixture 20 has a base collar 21 and screw threads 22 . In use, screw threads 22 is screwed into bone of the recipient (sometimes herein also referred to as the user) to fixate and retain fixture 20 to the user's skull.
  • abutment 10 is connected to and retained to fixture 20 by abutment screw 30 .
  • Abutment screw 30 has head 31 , a well 32 within the head 31 to receive an insertion tool or the like, and an apical outer screw threaded section 34 on an elongate main body 33 .
  • abutment screw 30 may be an M 1.8 titanium screw and the well 32 in head 31 may be a tubular hex configuration for receiving and cooperating with the insertion tool (not shown).
  • the apical outer screw threaded section 34 engages with inner screw thread 23 of the fixture 20 upon turning of the insertion tool.
  • FIG. 3 shows a perspective view of the medical implant system 100 .
  • the abutment interior 13 is visible, showing the abutment interior base 14 .
  • abutment screw 30 with head 31 and hexagonal well 32 .
  • the fixture 20 with base collar 21 and outer screw thread 22 is also visible.
  • FIG. 4 shows a cross section view of three constituent parts of the medical implant system 100 , with those parts separated from one another for clarity. There shown are abutment screw 30 , abutment 10 and fixture 20 .
  • FIG. 5A shows an exemplary embodiment of abutment screw 30 .
  • abutment screw head includes a base 35 which includes a deformable element in the form of a flange 36 , which is angled downwards and outwards away from the head at a flange angle of about 10 degrees (in one example), as is more clearly seen in FIG. 5C .
  • FIGS. 5B and 5C show a cross section view of the abutment screw 30 of FIG. 5A . In these views, the deformable element in the form of the flange 36 is more clearly visible.
  • the outer portion of the flange 36 corresponding to at least part of the deformable element of the abutment screw 30 , has a flat portion 37 (see FIG. 5C ) which, in use, rests on a corresponding contact surface, in this case, the abutment interior base 14 as shown in FIG. 6 .
  • the deformable element is able to deform to form a seal.
  • flat portion 37 comes into contact with the corresponding contact surface or abutment interior base 14 .
  • the deformable element corresponding to flange 36 with flat portion 37 is pressed downwards (which may cause the edge to move outwards) against the corresponding contact surface or abutment interior base 14 and thereby deform to provide a seal between the abutment screw 30 and the corresponding contact surface, in this case abutment interior base 14 .
  • the deformable element deforms a sufficient amount to provide a seal between the abutment screw 30 and the abutment 10 , upon tightening of the abutment screw 30 .
  • the deformable element may deform upon application of downward pressure on the implant system or on a part thereof, such as on the screw head 31 .
  • the type of deformation may be plastic, elastic or a combination of both.
  • FIG. 7 shows a close up view of this engagement between the abutment screw 30 and the abutment 10 , and in particular, shows how the deformation of the deformable element as flange 36 and the flat portion 37 is deformed and pressed into the surface of the abutment interior base 14 , to provide a seal.
  • the corresponding contact surface in this case the abutment interior base 14 , may itself also deform slightly to further increase the seal formed therebetween.
  • FIG. 28 shows a close up view of engagement between the abutment screw 30 and the abutment 10 in an alternate embodiment, which depicts the flange 36 being pressed into the surface of the abutment interior base 14 , to provide a seal.
  • FIG. 28 shows a close up view of engagement between the abutment screw 30 and the abutment 10 in an alternate embodiment, which depicts the flange 36 being pressed into the surface of the abutment interior base 14 , to provide a seal.
  • the corresponding contact surface in this case the abutment interior base 14 , may itself deform slightly to further increase the seal formed therebetween.
  • the degree of resulting deformation of the abutment screw and/or the abutment may vary between embodiments. In some embodiments, all or substantially all of the overall deformation may occur in the abutment screw 30 , while in some embodiments, all or substantially all of the deformation may occur in the abutment 10 , while in some embodiments, the amount of deformation may be more evenly distributed between these two components.
  • the screw head 31 of abutment screw 30 may in some embodiments, have a well 32 as shown in FIGS. 5A , 5 B, 5 C and 6 , which may assist in providing the deformable element as flange 36 , in other embodiments, head 31 need not have a well.
  • the deformable element may be provided by any suitable structure, and may include the provision of an annular relief 38 above flange 36 to enhance the deformation, as shown in FIG. 8 .
  • the screw head 31 of abutment screw 30 may in some embodiments, have a screw thread which may assist in providing the deformable element as flange 36 (not shown).
  • the deformable element may be provided on the base of the head 31 by way of an annular ring 39 extending about the outer edge of the abutment screw head base 35 .
  • FIG. 9B shows a perspective view of this arrangement.
  • the deformable element in the form of annular ring 39 is deformed so as to form a seal between the abutment screw 30 and the abutment 10 .
  • FIG. 10 shows a close up view of this seal formed by the deformation of the deformable element.
  • the abutment interior base 14 may also be slightly deformed.
  • the deformable element in the form of the annular ring may be provided on the abutment itself.
  • the deformable element may be a protrusion having a triangular cross-section or semi-circular cross section extending from a generally planar surface of a component of the medical implant.
  • FIG. 11 shows a perspective view of abutment 10 showing abutment interior 13 providing an abutment receiving well for receiving the abutment 10 , and abutment interior base 14 . Without abutment screw 30 , the through bore 16 , into which abutment screw 30 is inserted in use, is visible. In this embodiment, the deformable element is provided by an annular ring 17 surrounding the through bore 16 .
  • FIG. 12 shows a cross section view of abutment 10 with annular ring 17 surrounding through bore 16 .
  • the base 35 (in this case providing the corresponding contact surface) of head 31 will be compressed over deformable element, in this case, annular ring 17 , so as to deform it to provide a seal between abutment screw 30 and abutment 10 .
  • deformable element in this case, annular ring 17
  • the base 35 of head 31 may be planar rather than angled as in a previous example.
  • FIG. 13 shows a close up view of the seal so formed, showing the deformation of deformable element, in this case, annular ring 17 .
  • FIG. 30 a shows an alternate embodiment where the deformable element is located on the abutment screw 30 and element 17 presses into the screw 30 , thereby forming a seal.
  • the height of annular ring 17 is about 0 05 mm and the width of annular ring 17 is about 0.05 mm (prior to deformation).
  • any other suitable dimensions may be used, including but not limited to about 0.01 mm to about 0.1 mm, about 0.04 mm, about 0.06 mm, about 0.03 mm and about 0.07 mm or any combination thereof.
  • the above embodiments have provided examples of forming the seal between the abutment screw 30 and the abutment 10 .
  • the seal may alternatively, or also, be formed between the fixture 20 and the abutment 10 , as will now be detailed.
  • fixture 20 is provided with an annular corner 26 on lip 25 of the abutment receiving well, which defines the fixture interior 24 .
  • the abutment base 12 of abutment 10 is received in fixture interior 24 to be retained by tightening the abutment screw 30 as previously described.
  • FIGS. 15 , 16 and 17 show various examples of abutment 10 configurations that may be used in this aspect.
  • the fixture interior 24 of the fixture 20 has a bottom geometrical configuration, for instance a lobe shaped geometrical configuration 27 , and the protruding bottom part of the abutment 10 has a corresponding geometrical configuration 18 as illustrated in FIGS. 15 , 16 and 17 , to prevent otherwise resist against rotation between these two parts when coupled together.
  • the abutment 10 may have a substantially curved, conical outer surface with the upper edge having the wider diameter and the bottom, fixture-connecting part having a smaller diameter, as illustrated.
  • a feature in these particular embodiments for the three different examples of abutments 10 illustrated in FIGS. 15 , 16 and 17 may be that the bottom tapered outer surface 12 which cooperates with the annular corner 26 of the fixture 20 when the two parts are coupled together as shown in FIG. 18 . This provides a concave outer contour of the connection between the abutment and the fixture.
  • the deformable element is provided by the annular corner 26 .
  • the abutment base 12 (in this case acting as the corresponding contact surface) is pressed down onto annular corner 26 , which deforms to provide a seal between abutment 10 and fixture 20 .
  • FIG. 19 shows a close up view of the seal formed therebetween.
  • the deformable element may also deform upon application of other force, such as by downward pressure on abutment 10 , rather than, or in conjunction with, tightening of the abutment screw 30 .
  • the outer surface of the abutment 10 and/or the fixture 20 might be modified in order to improve the skin tissue integration.
  • Different types of structured or coated surfaces might be used, for instance hydroxyapatite (HA) coated surfaces.
  • HA hydroxyapatite
  • the coating might be applied on the fixture and the abutment separately, or applied on a pre mounted implant device.
  • the deformable element may be provided on the abutment 10 as shown in FIG. 30 b , which corresponds to the view of FIG. 19 , and, in some embodiments, the deformable element may be in the form of an annular ring, as depicted in FIGS. 20 and 21 .
  • the deformable element is provided by abutment annular corner 19 on the abutment base 12 .
  • the lip 25 of fixture 20 may be a more conventional rounded shape, which provides the corresponding contact surface for the deformable element, in this case, abutment annular corner 19 .
  • abutment 10 is placed in the fixture 20 and when abutment screw 30 is tightened, abutment 10 is pressed down onto fixture 20 .
  • deformable element (abutment annular corner 19 ) will be deformed against the lip 25 to form a seal between the abutment 10 and the fixture 20 .
  • FIG. 22 is a close up view of the seal formed between the abutment 10 and the fixture 20 of FIG. 21 .
  • FIG. 23 shows an example of another embodiment of a medical implant system 100 , comprising abutment 10 , fixture 20 and abutment screw 30 .
  • the system is designed so as to provide a seal between the abutment 10 and the abutment screw 30 .
  • this seal is provided by an arrangement similar and/or the same as that described earlier with reference to FIGS. 5A , 5 B, 5 C, 6 and 7 .
  • FIG. 5A , 5 B, 5 C, 6 and 7 With respect to the embodiment of FIG.
  • the deformable element is provided on the abutment screw 30 in the form of an angled flange that upon tightening of abutment screw 30 (or application of other force), deforms against the corresponding contact surface (in this case abutment interior base 14 ) to form the seal.
  • FIG. 31 depicts an alternate embodiment where engagement between the abutment screw 30 and the abutment 10 is depicted, and the abutment interior base 14 of abutment 10 deforms. Specifically, flange 36 is pressed into the surface of the abutment interior base 14 , to provide a seal. As will be understood from FIG.
  • the corresponding contact surface in this case the abutment interior base 14 , may itself deform slightly to further increase the seal formed therebetween.
  • the degree of resulting deformation of the abutment screw and/or the abutment may vary between embodiments. In some embodiments, all or substantially all of the overall deformation may occur in the abutment screw 30 , while in some embodiments, all or substantially all of the deformation may occur in the abutment 10 , while in some embodiments, the amount of deformation may be more evenly distributed between these two components.
  • FIG. 24 shows another embodiment of a medical implant system 100 comprising abutment 10 , fixture 20 and abutment screw 30 .
  • the system is designed to provide a seal between abutment 10 and fixture 20 .
  • the seal is provided by the same arrangement as described earlier with reference to FIGS. 14 to 19 . That is, that the deformable element is provided on the fixture 20 in the form of an annular corner 26 provided on the lip 25 of fixture 20 , that upon tightening of abutment screw 30 9or application of other force), deforms against the corresponding contact surface (in this case abutment base 12 ) to form the seal.
  • FIG. 32 depicts an alternate embodiment where engagement between the bone fixture 20 and the abutment 10 is depicted.
  • the depicted deformation of the abutment 10 is a result of the annular corner 26 of lip 25 of the fixture 20 being pressed into the surface of the abutment 10 , to provide a seal.
  • the corresponding contact surface in this case the annular corner 26 , may itself deform slightly to further increase the seal formed therebetween.
  • the degree of resulting deformation of the fixture 20 and/or the abutment 10 may vary between embodiments. In some embodiments, all or substantially all of the overall deformation may occur in the abutment 10 , while in some embodiments, all or substantially all of the deformation may occur in the bone fixture 20 , while in some embodiments, the amount of deformation may be more evenly distributed between these two components.
  • FIG. 25 shows yet another embodiment of a medical implant system 100 comprising abutment 10 , fixture 20 and abutment screw 30 .
  • the system is designed to provide a seal between the abutment 10 and the abutment screw 30 as well as between the abutment 10 and fixture 20 .
  • the first seal is provided by the same arrangement as described above with reference to FIG. 23 . That is, that the deformable element is provided on the abutment screw 30 in the form of an angled flange that upon tightening of abutment screw 30 (or application of other force), deforms against the corresponding contact surface (in this case abutment interior base 14 ) to form the seal.
  • the second seal is provided by the arrangement described above with reference to FIG.
  • FIG. 25 is a combination of both the arrangements of FIGS. 23 and 24 .
  • FIG. 33 depicts yet another embodiment of a medical implant system 100 comprising abutment 10 , fixture 20 and abutment screw 30 .
  • the system is designed to provide a seal between the abutment 10 and the abutment screw 30 as well as between the abutment 10 and fixture 20 .
  • the first seal is provided by the alternate arrangement as described above with reference to FIG. 23 and FIG. 31 .
  • the deformable element is provided on the abutment 10 (in this case (in this case, abutment interior base 14 ) such that that upon tightening of abutment screw 30 (or application of other force), the abutment 10 deforms against the corresponding contact surface of the abutment screw 30 to form the seal.
  • the second seal is provided by the arrangement described above with reference to the alternate arrangement described above with reference to FIG. 24 and FIG. 32 .
  • FIG. 25 is a combination of both the alternate arrangements of FIGS. 23 and 24 described above.
  • the provision of the deformable element(s) in the various components of the medical implant system 100 provide for a unique method of implanting the medical implant system.
  • FIG. 26 a The steps of one possible method of implanting the medical implant system 100 are shown in FIG. 26 a .
  • the abutment 10 is located in the abutment receiving well of fixture interior 24 of the already implanted fixture.
  • the abutment screw 30 is inserted in the through bore 16 of the abutment 10 and into the fixture 20 .
  • force is applied to the implant system until the deformable element(s) deforms to provide the seal(s) between the various components of the medical implant system, thereby reducing the risk of infection in the user or patient.
  • the force may be applied by way of pressure on the abutment.
  • the same steps 200 and 201 may be used, however, in step 202 ′, the force may be applied by way of tightening the abutment screw 30 .
  • the abutment screw is tightened using a torque of greater than about 15 Ncm, and including about 15 Ncm to about 20 Ncm, and about 20 Ncm to about 30 Ncm. In one particular example, the torque used is about 25 Ncm.
  • the, or part of, the surfaces of one or more of the components, such as the abutment screw 30 may be coated with a friction-reducing material such as diamond like carbon (DLC). In these embodiments, the required torque or other force will be reduced.
  • a friction-reducing material such as diamond like carbon (DLC).
  • FIGS. 27 a , 27 b and 27 c illustrate these steps 200 , 201 and 202 ′.
  • the abutment 10 is located inside fixture 20 .
  • fixture 20 has already been implanted and anchored in the bone 50 of the patient's skull, in a previous procedure and allowed to heal.
  • This example method therefore begins with the location of the abutment 10 in fixture 20 . This is done through an opening created in the tissue 5 of the patient.
  • the abutment screw 30 is inserted into the abutment 10 and the fixture 20 and in FIG. 27 c , the abutment screw 30 is tightened using an insertion tool 40 .
  • This tightening causes any deformable elements in the system to deform and form seals to reduce the risk of bacteria entering into the micro leakage path and thus reducing risk of infection.
  • the seals may be provided as previously described, between the abutment screw 30 and the abutment 10 , the abutment 10 and the fixture 20 , or both, with the locations of these discernible from the dotted lines superimposed on FIG. 27 c.
  • Embodiments utilizing multiple deformable elements may use different types of deformable elements/deformable elements of different geometries as detailed herein and/or variations thereof.
  • the medical implant system for attaching a hearing device to a user.
  • the medical implant system comprises a fixture, an abutment and an abutment screw for connecting the abutment to the fixture.
  • a deformable element that deforms to form a seal between the one or more components of the medical implant system.
  • an abutment for use in a medical implant system comprising a fixture, the abutment and an abutment screw.
  • the abutment comprises a through bore for receiving the abutment screw and a deformable element that is deformed against the abutment screw when the abutment screw is inserted in the through bore and tightened.
  • an abutment screw that comprises a head, an elongate main body and a deformable element that may be deformed between the abutment screw and an abutment to provide a seal upon inserting the abutment screw through the through bore of the abutment and tightening the abutment screw.
  • a fixture for use in a medical implant system comprises a main body, an abutment receiving well and a screw thread for anchoring the fixture into bone.
  • a deformable element is provided as an annular corner of the abutment receiving well.
  • the medical implant system comprises a fixture, an abutment and an abutment screw.
  • the method involves locating the abutment in an abutment receiving well of the fixture, inserting the abutment screw in a through bore of the abutment and into the fixture, and applying a force to the implant.
  • this force is provided by tightening the abutment screw until a deformable element deforms to provide a seal between one or more of the components of the implant system.
  • the seals formed by the embodiments detailed herein and/or variations thereof may form a hermetic seal.
  • the seal is an air tight seal.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Otolaryngology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurosurgery (AREA)
  • Physics & Mathematics (AREA)
  • Acoustics & Sound (AREA)
  • Signal Processing (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dental Prosthetics (AREA)
  • Prostheses (AREA)
US13/371,763 2009-08-13 2012-02-13 Medical implant system Active 2031-03-13 US9271092B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US15/049,895 US11166752B2 (en) 2009-08-13 2016-02-22 Medical implant system
US17/521,437 US20220061889A1 (en) 2009-08-13 2021-11-08 Medical implant system

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
AU2009903789A AU2009903789A0 (en) 2009-08-13 Implant device
AU2009903789 2009-08-13
AU2009905020 2009-10-14
AU2009905020A AU2009905020A0 (en) 2009-10-14 Implant device
PCT/AU2010/000401 WO2011017733A1 (fr) 2009-08-13 2010-04-09 Système d'implant médical

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2010/000401 Continuation WO2010093459A1 (fr) 2009-02-12 2010-02-12 Configuration de vanne destinée à être utilisée avec un compteur d'eau
PCT/AU2010/000401 Continuation WO2011017733A1 (fr) 2009-08-13 2010-04-09 Système d'implant médical

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US15/049,895 Division US11166752B2 (en) 2009-08-13 2016-02-22 Medical implant system

Publications (2)

Publication Number Publication Date
US20120172658A1 US20120172658A1 (en) 2012-07-05
US9271092B2 true US9271092B2 (en) 2016-02-23

Family

ID=43585751

Family Applications (3)

Application Number Title Priority Date Filing Date
US13/371,763 Active 2031-03-13 US9271092B2 (en) 2009-08-13 2012-02-13 Medical implant system
US15/049,895 Active 2034-04-15 US11166752B2 (en) 2009-08-13 2016-02-22 Medical implant system
US17/521,437 Pending US20220061889A1 (en) 2009-08-13 2021-11-08 Medical implant system

Family Applications After (2)

Application Number Title Priority Date Filing Date
US15/049,895 Active 2034-04-15 US11166752B2 (en) 2009-08-13 2016-02-22 Medical implant system
US17/521,437 Pending US20220061889A1 (en) 2009-08-13 2021-11-08 Medical implant system

Country Status (3)

Country Link
US (3) US9271092B2 (fr)
EP (2) EP2464312B1 (fr)
WO (1) WO2011017733A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10448136B2 (en) 2011-12-07 2019-10-15 Cochlear Limited Electromechanical transducer with mechanical advantage
US10477332B2 (en) 2016-07-18 2019-11-12 Cochlear Limited Integrity management of an implantable device
US10897677B2 (en) 2017-03-24 2021-01-19 Cochlear Limited Shock and impact management of an implantable device during non use
US11223912B2 (en) 2017-07-21 2022-01-11 Cochlear Limited Impact and resonance management
US11432084B2 (en) 2016-10-28 2022-08-30 Cochlear Limited Passive integrity management of an implantable device

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2252079A1 (fr) * 2009-05-14 2010-11-17 Oticon A/S Appareil auditif de conduction osseuse ancré sur l'os
EP2464312B1 (fr) 2009-08-13 2015-10-28 Cochlear Limited Système d'implant médical
ES2557581T3 (es) * 2010-12-23 2016-01-27 Straumann Holding Ag Cabeza de tornillo mejorada
US20120294466A1 (en) * 2011-05-18 2012-11-22 Stefan Kristo Temporary anchor for a hearing prosthesis
US11843918B2 (en) 2011-10-11 2023-12-12 Cochlear Limited Bone conduction implant
US20130096366A1 (en) * 2011-10-12 2013-04-18 Wim Bervoets Implantable medical device
US20140179985A1 (en) 2012-12-21 2014-06-26 Marcus ANDERSSON Prosthesis adapter
US10757516B2 (en) 2013-10-29 2020-08-25 Cochlear Limited Electromagnetic transducer with specific interface geometries
EP3131312A1 (fr) * 2013-11-25 2017-02-15 Oticon Medical A/S Systeme d'interconnexion de prothese auditive
US9800982B2 (en) 2014-06-18 2017-10-24 Cochlear Limited Electromagnetic transducer with expanded magnetic flux functionality
EP3209243A4 (fr) * 2014-08-28 2018-08-01 Cochlear Limited Dispositif de fixation osseuse pour prothèse médicale
EP3203926B1 (fr) * 2014-10-12 2019-09-11 T.A.G. Medical Devices - Agriculture Cooperative Ltd. Ensemble pilier dentaire angulaire
US10980617B2 (en) * 2015-02-23 2021-04-20 Maurice Valen Implantable surgical screw for bone reconstruction
US11224470B2 (en) * 2018-05-09 2022-01-18 Warsaw Orthopedic, Inc. Bone screw and method of manufacture
WO2020129021A1 (fr) * 2018-12-21 2020-06-25 Cochlear Limited Implant avancé à conduction osseuse
DE102019001715A1 (de) * 2019-03-12 2020-09-17 Bruno Spindler Montageschnittstelle zwischen einer Suprakonstruktion und einem Implantatkörper
US20220370107A1 (en) * 2019-10-25 2022-11-24 Cochlear Limited Advanced tools for bone conduction implantation
USD1097157S1 (en) * 2023-03-03 2025-10-07 Abanza Tecnomed, S.L. Medical implant

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4498461A (en) 1981-12-01 1985-02-12 Bo Hakansson Coupling to a bone-anchored hearing aid
US5702342A (en) 1993-10-14 1997-12-30 Otologics Llc. Directionally-controllable mounting apparatus
WO1998055049A1 (fr) 1997-06-06 1998-12-10 P & B Research Ab Systeme d'ancrage et de transfert d'energie destine a des implants
US6447295B1 (en) 1999-04-15 2002-09-10 Nobel Biocare Ab Diamond-like carbon coated dental retaining screws
US20030124491A1 (en) * 2001-12-27 2003-07-03 Aichi Steel Corporation Dental magnetic attachment
US20050014108A1 (en) * 2003-05-16 2005-01-20 Wohrle Peter S. Dental implant system
US7065223B2 (en) 2004-09-09 2006-06-20 Patrik Westerkull Hearing-aid interconnection system
US20090082817A1 (en) * 2007-07-20 2009-03-26 Cochlear Limited Coupling apparatus for a bone anchored hearing device

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5447434A (en) * 1994-02-14 1995-09-05 Shaw; Leon Micromechanical seal
US5622500A (en) * 1994-02-24 1997-04-22 Core-Vent Corporation Insertion tool/healing collar/abutment
SE503791C2 (sv) * 1994-12-02 1996-09-02 P & B Res Ab Anordning vid hörapparat
US7476228B2 (en) * 2002-10-11 2009-01-13 Abdou M Samy Distraction screw for skeletal surgery and method of use
EP3326570B1 (fr) * 2007-09-18 2019-07-03 Biomet 3i, LLC Vis pour un système d'implant dentaire à stabilité améliorée
EP2464312B1 (fr) 2009-08-13 2015-10-28 Cochlear Limited Système d'implant médical

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4498461A (en) 1981-12-01 1985-02-12 Bo Hakansson Coupling to a bone-anchored hearing aid
US5702342A (en) 1993-10-14 1997-12-30 Otologics Llc. Directionally-controllable mounting apparatus
WO1998055049A1 (fr) 1997-06-06 1998-12-10 P & B Research Ab Systeme d'ancrage et de transfert d'energie destine a des implants
US6447295B1 (en) 1999-04-15 2002-09-10 Nobel Biocare Ab Diamond-like carbon coated dental retaining screws
US20030124491A1 (en) * 2001-12-27 2003-07-03 Aichi Steel Corporation Dental magnetic attachment
US20050014108A1 (en) * 2003-05-16 2005-01-20 Wohrle Peter S. Dental implant system
US7065223B2 (en) 2004-09-09 2006-06-20 Patrik Westerkull Hearing-aid interconnection system
US20090082817A1 (en) * 2007-07-20 2009-03-26 Cochlear Limited Coupling apparatus for a bone anchored hearing device

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
European Search Report and Search Opinion for European Application No. 10807771.0 mailed Feb. 25, 2013 (6 pages).
International Search Report of PCT/AU2010/000401, mailed Jun. 3, 2010, 8 pages.
Written Opinion of PCT/AU2010/000401, mailed Jun. 3, 2010, 7 pages.

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10448136B2 (en) 2011-12-07 2019-10-15 Cochlear Limited Electromechanical transducer with mechanical advantage
US10477332B2 (en) 2016-07-18 2019-11-12 Cochlear Limited Integrity management of an implantable device
US11432084B2 (en) 2016-10-28 2022-08-30 Cochlear Limited Passive integrity management of an implantable device
US10897677B2 (en) 2017-03-24 2021-01-19 Cochlear Limited Shock and impact management of an implantable device during non use
US11223912B2 (en) 2017-07-21 2022-01-11 Cochlear Limited Impact and resonance management

Also Published As

Publication number Publication date
US11166752B2 (en) 2021-11-09
EP3000441A1 (fr) 2016-03-30
US20220061889A1 (en) 2022-03-03
US20120172658A1 (en) 2012-07-05
EP3000441B1 (fr) 2020-11-18
EP2464312A1 (fr) 2012-06-20
EP2464312B1 (fr) 2015-10-28
EP2464312A4 (fr) 2013-03-27
US20160242814A1 (en) 2016-08-25
WO2011017733A1 (fr) 2011-02-17

Similar Documents

Publication Publication Date Title
US9271092B2 (en) Medical implant system
US11882409B2 (en) Bone anchor fixture for a medical prosthesis
US12490034B2 (en) Bone conduction implant
US11889272B2 (en) Implantable medical device
US10681478B2 (en) Percutaneous vibration conductor
US7409070B2 (en) Implant device
AU740669B2 (en) Bone-anchoring element
US20130281764A1 (en) Transcutaneous bone conduction device
US10425750B2 (en) Prosthesis adapter
US10848882B2 (en) Implant abutment
US10003898B1 (en) Flexible connection bone conduction device
US8454668B2 (en) Anchoring element
US9308103B1 (en) Osseointegrated mount for prosthetic limb and peripheral nerve interface

Legal Events

Date Code Title Description
AS Assignment

Owner name: COCHLEAR LIMITED, AUSTRALIA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BJORN, GORAN;ANDERSSON, MARCUS;SIGNING DATES FROM 20120221 TO 20120227;REEL/FRAME:028650/0458

STCF Information on status: patent grant

Free format text: PATENTED CASE

MAFP Maintenance fee payment

Free format text: PAYMENT OF MAINTENANCE FEE, 4TH YEAR, LARGE ENTITY (ORIGINAL EVENT CODE: M1551); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY

Year of fee payment: 4

MAFP Maintenance fee payment

Free format text: PAYMENT OF MAINTENANCE FEE, 8TH YEAR, LARGE ENTITY (ORIGINAL EVENT CODE: M1552); ENTITY STATUS OF PATENT OWNER: LARGE ENTITY

Year of fee payment: 8