US20220061889A1 - Medical implant system - Google Patents
Medical implant system Download PDFInfo
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- US20220061889A1 US20220061889A1 US17/521,437 US202117521437A US2022061889A1 US 20220061889 A1 US20220061889 A1 US 20220061889A1 US 202117521437 A US202117521437 A US 202117521437A US 2022061889 A1 US2022061889 A1 US 2022061889A1
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- abutment
- implant
- fixture
- screw
- structural component
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- 239000007943 implant Substances 0.000 title claims abstract description 87
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 82
- 230000000845 anti-microbial effect Effects 0.000 claims abstract description 9
- 239000004599 antimicrobial Substances 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims description 16
- 210000001519 tissue Anatomy 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- 230000010354 integration Effects 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims 13
- 244000005700 microbiome Species 0.000 claims 1
- 210000003128 head Anatomy 0.000 description 10
- 208000015181 infectious disease Diseases 0.000 description 8
- 210000003625 skull Anatomy 0.000 description 6
- 241000894006 Bacteria Species 0.000 description 5
- 238000004873 anchoring Methods 0.000 description 5
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 235000000332 black box Nutrition 0.000 description 2
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- 229910052588 hydroxylapatite Inorganic materials 0.000 description 2
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 229910052719 titanium Inorganic materials 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- 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; DEAF-AID SETS; PUBLIC ADDRESS SYSTEMS
- H04R25/00—Deaf-aid sets, i.e. electro-acoustic or electro-mechanical hearing aids; Electric tinnitus maskers providing an auditory perception
- 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 e 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. 5 a shows one embodiment of an abutment screw of one aspect of the disclosure
- FIG. 9 b shows a perspective view of the abutment screw of FIG. 9A ;
- FIG. 12 shows a cross section of the abutment of FIG. 11 ;
- FIG. 16 shows a perspective view of 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. 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. 27 b shows a cross section of the arrangement of the second step of the method of FIG. 26 b ;
- 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. 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.
- 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 .
- the outer portion of the flange 36 corresponding to at least part of 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 .
- 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 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 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 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 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 .
- 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, 5B, 5C, 6 and 7 .
- FIG. 5A, 5B, 5C, 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.
- 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 9 or 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.
- 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 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 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.
- the seals formed by the embodiments detailed herein and/or variations thereof may form a hermetic seal.
- the seal is an air tight seal.
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Abstract
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.
Description
- The present application is a divisional application of U.S. patent application Ser. No. 13/371,763, filed Feb. 13, 2012, which is a continuation application of International Patent Application No. PCT/AU2010/000401, filed on Apr. 9, 2010, designating Goran Bjorn of Sweden and Dr. Marcus Andersson, also of Sweden, as inventors, which claims priority to Australian Provisional Patent Application No. 2009903789 entitled “Implant Device” filed on 13 Aug. 2009, and Australian Provisional Patent Application No. 2009905020 entitled “Implant Device” filed on 14 Oct. 2009, the entire content of each of these applications being hereby incorporated by reference herein in their entirety.
- 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. 27d in black-box format, an external,removable unit 2759 including avibrator 2761 which transforms sound into mechanical vibrations. Percutaneous bone conductions devices conduct those mechanical vibrations via anabutment 2763 and abone 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. The vibrations are transmitted mechanically via the skull bone and thereafter to the inner ear of a person with impaired hearing and allows for the hearing organ to register the sound. 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. In percutaneous bone conduction or anchoring arrangements, 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, in many exemplary embodiments, allows the surgical implantation to be carried out as a two-step procedure. In the first step of implanting such a two-pieced design, the fixture is inserted and maintained unloaded during a healing period of some months or so. After this healing period 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.
- A situation sometimes experienced with bone conduction devices in general, and percutaneous implant devices in particular, is the risk of infections and inflammation. This exists sometimes at the tissue-implant interface. The infections are a result of bacterial colonization at the area around the interface between the bone fixture and the abutment. This problem can be persistent and cause infections. Cleaning of the interface has utility, but even regular cleaning and disinfection is not always entirely successful. The risk of infections may also exist at the interface between separate components of totally implantable prostheses.
- With respect to a percutaneous bone conduction device, 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.
- Embodiments of the present invention are described below with reference to the attached drawings, in which:
-
FIG. 1 —shows an example of a medical implant system to which various aspects of e present disclosure may be applied; -
FIG. 2 —shows a cross section of the medical implant system ofFIG. 1 ; -
FIG. 3 —shows a perspective view of the medical implant system ofFIG. 1 ; -
FIG. 4 —shows a cross section exploded view of the components of the medical implant system ofFIG. 1 ; -
FIG. 5a —shows one embodiment of an abutment screw of one aspect of the disclosure; -
FIG. 5b —shows a cross section of the abutment screw ofFIG. 5A ; -
FIG. 5c —shows a close up view of the deformable element ofFIG. 5B ; -
FIG. 6 —shows a cross section of the abutment screw ofFIG. 5A in an abutment; -
FIG. 7 —shows a close-up cross section view of a seal provided between the abutment screw ofFIG. 5A and the abutment; -
FIG. 8 —shows a cross section of an alternative embodiment of the abutment screw ofFIG. 5A ; -
FIG. 9a —shows a cross section of yet a further alternative of the abutment screw ofFIG. 5A ; -
FIG. 9b —shows a perspective view of the abutment screw ofFIG. 9A ; -
FIG. 10 —shows a close-up cross section view of a seal provided between the abutment screw ofFIG. 9a and the abutment; -
FIG. 11 —shows a perspective view of one embodiment of an abutment; -
FIG. 12 —shows a cross section of the abutment ofFIG. 11 ; -
FIG. 13 —shows a close-up view of a seal provided between the abutment screw and the abutment ofFIG. 11 ; -
FIG. 14 —shows a cross section of one embodiment of a fixture; -
FIG. 15 —shows a perspective view of one embodiment abutment for use with the fixture ofFIG. 14 ; -
FIG. 16 —shows a perspective view of another embodiment of an abutment for use with the fixture ofFIG. 14 ; -
FIG. 17 —shows a perspective view of yet another embodiment of an abutment for use with the fixture ofFIG. 14 ; -
FIG. 18 —shows the abutment of any one ofFIGS. 15 to 17 in place in the fixture ofFIG. 14 ; -
FIG. 19 —shows a close-up view of the seal provided by the arrangement ofFIG. 18 ; -
FIG. 20 —shows a different embodiment of an abutment; -
FIG. 21 shows the abutment ofFIG. 20 engaging with a fixture; -
FIG. 22 —shows a close-up of a seal provided by the arrangement ofFIG. 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. 26a —shows a flow chart of a method of implanting a medical implant system; -
FIG. 26b —shows a specific example of the method ofFIG. 26 a; -
FIG. 27a —shows a cross section of the arrangement of the first step of the method ofFIG. 26 b; -
FIG. 27b —shows a cross section of the arrangement of the second step of the method ofFIG. 26b ; and -
FIG. 27c —shows a cross section of the arrangement of the third step of the method ofFIG. 26B ; -
FIG. 27d —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 ofFIG. 5a and the abutment in an alternate embodiment; -
FIG. 29 —shows a close-up cross section view of a seal provided between the abutment screw ofFIG. 9a and the abutment in an alternate embodiment; -
FIG. 30a —shows a close-up view of a seal provided between the abutment screw and the abutment ofFIG. 11 in an alternate embodiment; -
FIG. 30b —shows a close-up view of the seal provided by the arrangement ofFIG. 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; and -
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 amedical implant system 100. The implant system has anabutment 10 that enables a hearing device to be coupled through a percutaneous connection to a bone anchoring device in the form offixture 20.Abutment 10 is connected tofixture 20.Fixture 20 has abase collar 21 andscrew 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 retainfixture 20 to the user's skull. - As can be seen in
FIG. 2 , which shows a cross section view along the line A-A′ ofFIG. 1 ,abutment 10 is connected to and retained tofixture 20 byabutment screw 30.Abutment screw 30 hashead 31, a well 32 within thehead 31 to receive an insertion tool or the like, and an apical outer screw threadedsection 34 on an elongatemain body 33. In some examples,abutment screw 30 may be an M 1.8 titanium screw and the well 32 inhead 31 may be a tubular hex configuration for receiving and cooperating with the insertion tool (not shown). The apical outer screw threadedsection 34 engages withinner screw thread 23 of thefixture 20 upon turning of the insertion tool. -
FIG. 3 shows a perspective view of themedical implant system 100. In this view, theabutment interior 13 is visible, showing theabutment interior base 14. Also visible in this view isabutment screw 30 withhead 31 andhexagonal well 32. Thefixture 20 withbase collar 21 andouter screw thread 22 is also visible. -
FIG. 4 shows a cross section view of three constituent parts of themedical implant system 100, with those parts separated from one another for clarity. There shown areabutment screw 30,abutment 10 andfixture 20. -
FIG. 5A shows an exemplary embodiment ofabutment screw 30. In particular, abutment screw head includes a base 35 which includes a deformable element in the form of aflange 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 inFIG. 5C .FIGS. 5B and 5C show a cross section view of theabutment screw 30 ofFIG. 5A . In these views, the deformable element in the form of theflange 36 is more clearly visible. - In one embodiment, the outer portion of the
flange 36, corresponding to at least part of deformable element of theabutment screw 30, has a flat portion 37 (seeFIG. 5C ) which, in use, rests on a corresponding contact surface, in this case, theabutment interior base 14 as shown inFIG. 6 . The deformable element is able to deform to form a seal. In one example, when theabutment screw 30 is screwed down into theinner screw thread 23 offixture 20,flat portion 37 comes into contact with the corresponding contact surface or abutmentinterior base 14. When theabutment screw 30 is screwed further downwards, the deformable element corresponding to flange 36 withflat portion 37 is pressed downwards (which may cause the edge to move outwards) against the corresponding contact surface or abutmentinterior base 14 and thereby deform to provide a seal between theabutment screw 30 and the corresponding contact surface, in this case abutmentinterior base 14. In other words, the deformable element deforms a sufficient amount to provide a seal between theabutment screw 30 and theabutment 10, upon tightening of theabutment screw 30. - In other examples, 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. - In the various examples detailed herein and/or variations thereof, the type of deformation may be plastic, elastic or a combination of both.
-
FIG. 7 shows a close up view of this engagement between theabutment screw 30 and theabutment 10, and in particular, shows how the deformation of the deformable element asflange 36 and theflat portion 37 is deformed and pressed into the surface of theabutment interior base 14, to provide a seal. In some cases, the corresponding contact surface, in this case theabutment interior base 14, may itself also deform slightly to further increase the seal formed therebetween. In the same vein,FIG. 28 shows a close up view of engagement between theabutment screw 30 and theabutment 10 in an alternate embodiment, which depicts theflange 36 being pressed into the surface of theabutment interior base 14, to provide a seal. As will be understood fromFIG. 28 , in this alternate embodiment, the corresponding contact surface, in this case theabutment 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 theabutment screw 30, while in some embodiments, all or substantially all of the deformation may occur in theabutment 10, while in some embodiments, the amount of deformation may be more evenly distributed between these two components. - As the contact surface increases by the deformation of the
flange 36 and/or theabutment interior base 14, surface imperfections between the contacting surfaces might be compensated for, which reduces any gaps or holes for microbes (including fungi and bacteria) to pass through from the outside into the inside of the abutment. - This thereby provides a seal at the abutment and abutment screw interface, to reduce the risk of bacterial infection via the micro leakage pathway.
- While the
screw head 31 ofabutment screw 30 may in some embodiments, have a well 32 as shown inFIGS. 5A, 5B, 5C and 6 , which may assist in providing the deformable element asflange 36, in other embodiments,head 31 need not have a well. Further, the deformable element may be provided by any suitable structure, and may include the provision of anannular relief 38 aboveflange 36 to enhance the deformation, as shown inFIG. 8 . - The
screw head 31 ofabutment screw 30 may in some embodiments, have a screw thread which may assist in providing the deformable element as flange 36 (not shown). - In another embodiment, as shown in a cross section view in
FIG. 9A , the deformable element may be provided on the base of thehead 31 by way of anannular ring 39 extending about the outer edge of the abutmentscrew head base 35.FIG. 9B shows a perspective view of this arrangement. As in the previous example, whenabutment screw 30 is tightened into position, the deformable element in the form ofannular ring 39, is deformed so as to form a seal between theabutment screw 30 and theabutment 10.FIG. 10 shows a close up view of this seal formed by the deformation of the deformable element. Again, in some cases, theabutment interior base 14 may also be slightly deformed. In the same vein,FIG. 29 shows an alternate embodiment where the deformable element is located again on the interior 14abutment 10, andelement 39 presses into theabutment 10, thereby forming a seal. in another embodiment, the deformable element in the form of the annular ring may be provided on the abutment itself. As may be seen fromFIG. 10 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 ofabutment 10 showingabutment interior 13 providing an abutment receiving well for receiving theabutment 10, and abutmentinterior base 14. Withoutabutment screw 30, the throughbore 16, into whichabutment screw 30 is inserted in use, is visible. In this embodiment, the deformable element is provided by anannular ring 17 surrounding the throughbore 16.FIG. 12 shows a cross section view ofabutment 10 withannular ring 17 surrounding throughbore 16. Again, asabutment screw 30 is inserted into throughbore 16 and tightened, the base 35 (in this case providing the corresponding contact surface) ofhead 31 will be compressed over deformable element, in this case,annular ring 17, so as to deform it to provide a seal betweenabutment screw 30 andabutment 10. This again provides a barrier to bacteria entry into the micro leakage path and reduces risk of infection. In this case, thebase 35 ofhead 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. 30a shows an alternate embodiment where the deformable element is located on theabutment screw 30 andelement 17 presses into thescrew 30, thereby forming a seal. - In one example, the height of
annular ring 17 is about 0.05 mm and the width ofannular ring 17 is about 0.05 mm (prior to deformation). Of course, 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 theabutment 10. In other embodiments and aspects, the seal may alternatively, or also, be formed between thefixture 20 and theabutment 10, as will now be detailed. - In one embodiment of this aspect, as shown by way of example in
FIG. 14 ,fixture 20 is provided with anannular corner 26 onlip 25 of the abutment receiving well, which defines thefixture interior 24. Theabutment base 12 ofabutment 10 is received infixture interior 24 to be retained by tightening theabutment screw 30 as previously described.FIGS. 15, 16 and 17 show various examples ofabutment 10 configurations that may be used in this aspect. - In some exemplary embodiments of this aspect of the present invention, the
fixture interior 24 of thefixture 20 has a bottom geometrical configuration, for instance a lobe shapedgeometrical configuration 27, and the protruding bottom part of theabutment 10 has a correspondinggeometrical configuration 18 as illustrated inFIGS. 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 ofabutments 10 illustrated inFIGS. 15, 16 and 17 may be that the bottom taperedouter surface 12 which cooperates with theannular corner 26 of thefixture 20 when the two parts are coupled together as shown inFIG. 18 . This provides a concave outer contour of the connection between the abutment and the fixture. - In this example, the deformable element is provided by the
annular corner 26. When theabutment 10 is placed in thefixture 20 and theabutment screw 30 is tightened as previously described, theabutment base 12, (in this case acting as the corresponding contact surface) is pressed down ontoannular corner 26, which deforms to provide a seal betweenabutment 10 andfixture 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 theabutment screw 30. - In some embodiments, the outer surface of the
abutment 10 and/or thefixture 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. In this case it should be understood that the coaling might be applied on the fixture and the abutment separately, or applied on a pre mounted implant device. - In a further embodiment of this aspect, the deformable element may be provided on the
abutment 10 as shown inFIG. 30b , which corresponds to the view ofFIG. 19 , and, in some embodiments, the deformable element may be in the form of an annular ring, as depicted inFIGS. 20 and 21 . In the embodiment ofFIG. 20 , the deformable element is provided by abutmentannular corner 19 on theabutment base 12. In this embodiment, thelip 25 offixture 20 may be a more conventional rounded shape, which provides the corresponding contact surface for the deformable element, in this case, abutmentannular corner 19. As in the previous example,abutment 10 is placed in thefixture 20 and whenabutment screw 30 is tightened,abutment 10 is pressed down ontofixture 20. In this arrangement, deformable element (abutment annular corner 19) will be deformed against thelip 25 to form a seal between theabutment 10 and thefixture 20. -
FIG. 22 is a close up view of the seal formed between theabutment 10 and thefixture 20 ofFIG. 21 . -
FIG. 23 shows an example of another embodiment of amedical implant system 100, comprisingabutment 10,fixture 20 andabutment screw 30. In this example, the system is designed so as to provide a seal between theabutment 10 and theabutment screw 30. In this case, this seal is provided by an arrangement similar and/or the same as that described earlier with reference toFIGS. 5A, 5B, 5C, 6 and 7 . With respect to the embodiment ofFIG. 23 , the deformable element is provided on theabutment 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 theabutment screw 30 and theabutment 10 is depicted, and theabutment interior base 14 ofabutment 10 deforms. Specifically,flange 36 is pressed into the surface of theabutment interior base 14, to provide a seal. As will be understood fromFIG. 31 , in this alternate embodiment, the corresponding contact surface, in this case theabutment 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 theabutment screw 30, while in some embodiments, all or substantially all of the deformation may occur in theabutment 10, while in some embodiments, the amount of deformation may be more evenly distributed between these two components. -
FIG. 24 shows another embodiment of amedical implant system 100 comprisingabutment 10,fixture 20 andabutment screw 30. In this example, the system is designed to provide a seal betweenabutment 10 andfixture 20. In this case, the seal is provided by the same arrangement as described earlier with reference toFIGS. 14 to 19 . That is, that the deformable element is provided on thefixture 20 in the form of anannular corner 26 provided on thelip 25 offixture 20, that upon tightening ofabutment 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 thebone fixture 20 and theabutment 10 is depicted. The depicted deformation of theabutment 10 is a result of theannular corner 26 oflip 25 of thefixture 20 being pressed into the surface of theabutment 10, to provide a seal. As will be understood fromFIG. 32 , in this alternate embodiment, the corresponding contact surface, in this case theannular corner 26, may itself deform slightly to further increase the seal formed therebetween. The degree of resulting deformation of thefixture 20 and/or theabutment 10 may vary between embodiments. In some embodiments, all or substantially all of the overall deformation may occur in theabutment 10, while in some embodiments, all or substantially all of the deformation may occur in thebone 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 amedical implant system 100 comprisingabutment 10,fixture 20 andabutment screw 30. In this example, the system is designed to provide a seal between theabutment 10 and theabutment screw 30 as well as between theabutment 10 andfixture 20. In this case, the first seal is provided by the same arrangement as described above with reference toFIG. 23 . That is, that the deformable element is provided on theabutment 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 toFIG. 24 . That is, that the deformable element is provided on thefixture 20 in the form of anannular corner 26 provided on thelip 25 offixture 20, that upon tightening ofabutment screw 30 9or application of other force), deforms against the corresponding contact surface (in this case abutment base 12) to form the seal. Accordingly, the arrangement ofFIG. 25 is a combination of both the arrangements ofFIGS. 23 and 24 . - In yet further embodiments, any combination of any two or more of the seals previously described may be used, including two different seals provided between the
abutment 10 and theabutment screw 30 as shown inFIGS. 5 to 10 as well asFIGS. 11 to 13 . By way of example,FIG. 33 depicts yet another embodiment of amedical implant system 100 comprisingabutment 10,fixture 20 andabutment screw 30. In this example, the system is designed to provide a seal between theabutment 10 and theabutment screw 30 as well as between theabutment 10 andfixture 20. In this case, the first seal is provided by the alternate arrangement as described above with reference toFIG. 23 andFIG. 31 . That is, that 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), theabutment 10 deforms against the corresponding contact surface of theabutment 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 toFIG. 24 andFIG. 32 . That is, that the deformable element is again provided on the abutment 10 (in this case, abutment base 12) such that upon tightening of abutment screw 30 (or application of other force), theabutment 10 deforms against the corresponding contact surface (annular corner 26 provided on thelip 25 of fixture 20) to form the seal. Accordingly, the arrangement ofFIG. 25 is a combination of both the alternate arrangements ofFIGS. 23 and 24 described above. - It will be appreciated that the various deformable elements described may be provided by any suitable means, including by turning, during or after the usual component production process.
- 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. - The steps of one possible method of implanting the
medical implant system 100 are shown inFIG. 26a . Atstep 200, theabutment 10 is located in the abutment receiving well offixture interior 24 of the already implanted fixture. Atstep 201, theabutment screw 30 is inserted in the throughbore 16 of theabutment 10 and into thefixture 20. Instep 202, 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. In one example, the force may be applied by way of pressure on the abutment. - In another example, as shown in
FIG. 26b , thesame steps step 202′, the force may be applied by way of tightening theabutment screw 30. In one example, 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. - In some embodiments, 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. -
FIGS. 27a, 27b and 27c illustrate thesesteps FIG. 27a , theabutment 10 is located insidefixture 20. In this example,fixture 20 has already been implanted and anchored in thebone 50 of the patient's skull, in a previous procedure and allowed to heal. This example method therefore begins with the location of theabutment 10 infixture 20. This is done through an opening created in thetissue 5 of the patient. - In
FIG. 27b , theabutment screw 30 is inserted into theabutment 10 and thefixture 20 and inFIG. 27c , theabutment screw 30 is tightened using aninsertion 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 theabutment 10, theabutment 10 and thefixture 20, or both, with the locations of these discernible from the dotted lines superimposed onFIG. 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.
- In view of the above, it can be seen that in at least one aspect of the invention, there is a medical implant system for attaching a hearing device to a user is provided. In one form, the medical implant system comprises a fixture, an abutment and an abutment screw for connecting the abutment to the fixture. In this aspect, there is provided on one or more of these components, a deformable element that deforms to form a seal between the one or more components of the medical implant system.
- In view of the above, it can be seen that in at least one other aspect of the invention, there is an abutment for use in a medical implant system comprising a fixture, the abutment and an abutment screw. In one form, 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.
- In view of the above, it can be seen that in at least one other aspect of the invention, there is 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.
- In view of the above, it can be seen that in at least one other aspect of the invention, there is a fixture for use in a medical implant system. The fixture comprises a main body, an abutment receiving well and a screw thread for anchoring the fixture into bone. In one form, a deformable element is provided as an annular corner of the abutment receiving well.
- In view of the above, it can be seen that in at least one other aspect of the invention, there is a method of implanting a medical implant system into a user. 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. In one form, 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.
- In some embodiments, the seals formed by the embodiments detailed herein and/or variations thereof may form a hermetic seal. In some embodiments, the seal is an air tight seal.
- Throughout the specification and the claims that follow, unless the context requires otherwise, the words “comprise” and “include” and variations such as “comprising” and “including” will be understood to imply the inclusion of a stated integer or group of integers, but not the exclusion of any other integer or group of integers.
- It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.
- While various embodiments of the present technology have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the technology. For instance, features described as part of one implementation can be used on another implementation to yield a still further implementation. Thus, the breadth and scope of the present technology should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents. All patents and publications discussed herein are hereby incorporated in their entirety by reference thereto.
Claims (21)
1-17. (canceled)
18. 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.
19. The method of claim 18 , wherein:
the anti-microbial seal is gas tight.
20. The method of claim 18 , wherein the applied torque is about 25 Ncm or more.
21. 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
a path for microorganisms would extend from, with respect to a longitudinal axis of the implant, an outboard interface of the screw and the structural component and, with respect to the longitudinal axis of the implant, an outboard interface of the bone fixture with the structural component, but for one or more sealing features of the implant.
22. The implant of claim 21 , wherein:
the sealing feature(s) is established by at least a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw.
23. The implant of claim 21 , wherein:
the sealing feature(s) is established by at least two of a deformed portion of the bone fixture, a deformed portion of the structural component or a deformed portion of the screw.
24. The implant of claim 21 , wherein:
the sealing feature(s) is established by at least a deformed portion at an interface of the bone fixture and the structural component.
25. The implant of claim 21 , wherein:
the sealing feature(s) is established by at least a deformed portion at an interface of the bone fixture and the structural component and at least a deformed portion of the bone fixture or a deformed portion of the structural component.
26. The implant of claim 21 , wherein:
the bone fixture and the structural component have a male-female relationship.
27. The implant of claim 21 , wherein:
there is only one sealing feature.
28. The implant of claim 21 , wherein:
the sealing feature(s) is established by at least a deformed portion of the bone fixture or a deformed portion of the structural component, wherein the deformation was established via rotation of the screw that drove the bone fixture and the structural component towards each other.
29. The implant of claim 21 , wherein:
a base of a head of the screw is planar.
30. The implant of claim 21 , wherein:
the sealing feature(s) is established by an annular ring that had a dimension of between 0.01 mm to about 0.1 mm in an undeformed state.
31. The implant of claim 21 , wherein:
a surface of the structural component is configured to improve skin tissue integration.
32. The implant of claim 21 , wherein:
a surface of the structural component is coated to improve skin tissue integration.
33. The implant of claim 21 , wherein:
the sealing feature(s) is established by a deformable element that is monolithic with one of the structural component or the fixture and deformed against a corresponding contact surface of the other of the structural component or the fixture.
34. The implant of claim 21 , wherein:
the sealing feature(s) is established by deformation of structure of the implant, and all or substantially all of an overall deformation occurs in one of the structural component or the bone fixture.
35. The implant of claim 21 , wherein:
the sealing feature(s) is established by deformation of structure of the implant resulting from an application of a torque onto the screw of greater than about 15 Ncm.
36. The implant of claim 21 , wherein:
the sealing feature(s) is established by deformation of structure of the implant resulting from an application of a torque onto the screw of greater than about 20 Ncm.
37. The implant of claim 21 , wherein:
the sealing feature(s) is established by deformation of structure of the implant resulting from an application of a torque onto the screw of about 15 Ncm to about 30 Ncm.
Priority Applications (1)
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US17/521,437 US20220061889A1 (en) | 2009-08-13 | 2021-11-08 | Medical implant system |
Applications Claiming Priority (8)
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AU2009903789A AU2009903789A0 (en) | 2009-08-13 | Implant device | |
AU2009903789 | 2009-08-13 | ||
AU2009905020A AU2009905020A0 (en) | 2009-10-14 | Implant device | |
AU2009905020 | 2009-10-14 | ||
PCT/AU2010/000401 WO2011017733A1 (en) | 2009-08-13 | 2010-04-09 | Medical implant system |
US13/371,763 US9271092B2 (en) | 2009-08-13 | 2012-02-13 | Medical implant system |
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 |
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US15/049,895 Division US11166752B2 (en) | 2009-08-13 | 2016-02-22 | Medical implant system |
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US20220061889A1 true US20220061889A1 (en) | 2022-03-03 |
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US17/521,437 Pending US20220061889A1 (en) | 2009-08-13 | 2021-11-08 | Medical implant system |
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US15/049,895 Active 2034-04-15 US11166752B2 (en) | 2009-08-13 | 2016-02-22 | Medical implant system |
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EP2468210B1 (en) * | 2010-12-23 | 2015-11-11 | Straumann Holding AG | Improved screw head |
US20120294466A1 (en) * | 2011-05-18 | 2012-11-22 | Stefan Kristo | Temporary anchor for a hearing prosthesis |
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US20130096366A1 (en) * | 2011-10-12 | 2013-04-18 | Wim Bervoets | Implantable medical device |
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US10757516B2 (en) | 2013-10-29 | 2020-08-25 | Cochlear Limited | Electromagnetic transducer with specific interface geometries |
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US9800982B2 (en) | 2014-06-18 | 2017-10-24 | Cochlear Limited | Electromagnetic transducer with expanded magnetic flux functionality |
WO2016030853A2 (en) | 2014-08-28 | 2016-03-03 | Cochlear Limited | Bone fixture for a medical prosthesis |
MX2017004494A (en) * | 2014-10-12 | 2017-08-08 | T A G Medical Devices - Agriculture Coop Ltd | Angular dental abutment assembly. |
US10980617B2 (en) * | 2015-02-23 | 2021-04-20 | Maurice Valen | Implantable surgical screw for bone reconstruction |
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 |
US11224470B2 (en) * | 2018-05-09 | 2022-01-18 | Warsaw Orthopedic, Inc. | Bone screw and method of manufacture |
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Also Published As
Publication number | Publication date |
---|---|
US9271092B2 (en) | 2016-02-23 |
US20160242814A1 (en) | 2016-08-25 |
EP3000441A1 (en) | 2016-03-30 |
EP2464312A4 (en) | 2013-03-27 |
EP2464312A1 (en) | 2012-06-20 |
US11166752B2 (en) | 2021-11-09 |
WO2011017733A1 (en) | 2011-02-17 |
EP3000441B1 (en) | 2020-11-18 |
EP2464312B1 (en) | 2015-10-28 |
US20120172658A1 (en) | 2012-07-05 |
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