MEDICAL IMPLANT SYSTEM
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.
The present application 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.
BACKGROUND1. Field of the Invention
The present invention relates generally to bone conduction devices, and more particularly, to infection prevention measures associated with percutaneous bone conduction devices.
2. Related Art
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 and passive transcutaneous bone conduction devices, an external, removable unit which transforms sound into mechanical vibrations. Percutaneous bone conductions devices conduct those mechanical vibrations via an abutment and a bone fixture 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.
SUMMARYSome 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 the present disclosure may be applied;
FIG. 2—shows a cross section of the medical implant system of
FIG. 3—shows a perspective view of the medical implant system of
FIG. 4—shows a cross section exploded view of the components of the medical implant system of
FIG. 6—shows a cross section of the abutment screw of
FIG. 7—shows a close-up cross section view of a seal provided between the abutment screw of
FIG. 8—shows a cross section of an alternative embodiment of the abutment screw of
FIG. 10—shows a close-up cross section view of a seal provided between the abutment screw of
FIG. 11—shows a perspective view of one embodiment of an abutment;
FIG. 12—shows a cross section of the abutment of
FIG. 13—shows a close-up view of a seal provided between the abutment screw and the abutment of
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. 16—shows a perspective view of another embodiment of an abutment for use with the fixture of
FIG. 17—shows a perspective view of yet another embodiment of an abutment for use with the fixture of
FIG. 18—shows the abutment of any one of
FIG. 19—shows a close-up view of the seal provided by the arrangement of
FIG. 20—shows a different embodiment of an abutment;
FIG. 21—shows the abutment of
FIG. 22—shows a close-up of a seal provided by the arrangement of
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. 28—shows a close-up cross section view of a seal provided between the abutment screw of
FIG. 29—shows a close-up cross section view of a seal provided between the abutment screw of
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.
As can be seen in
In one embodiment, 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
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.
As the contact surface increases by the deformation of the flange 36 and/or the abutment 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 of abutment screw 30 may in some embodiments, have a well 32 as shown in
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).
In another embodiment, as shown in a cross section view in
In one example, 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). 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 the abutment 10. In other embodiments and aspects, the seal may alternatively, or also, be formed between the fixture 20 and the abutment 10, as will now be detailed.
In one embodiment of this aspect, as shown by way of example in
In some exemplary embodiments of this aspect of the present invention, 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
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
In this example, the deformable element is provided by the annular corner 26. When the abutment 10 is placed in the fixture 20 and the abutment screw 30 is tightened as previously described, 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.
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.
In some embodiments, 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. In this case it should be understood that the coating 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 in
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 the abutment screw 30 as shown in
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 in
In another example, as shown in
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.
In
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
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
1. 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 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.
2. The implant of claim 1, wherein:
- the structural component is a skin-penetrating abutment of a percutaneous bone conduction device.
3. The implant of claim 1, wherein:
- the deformable element is part of the bone fixture.
4. The implant of claim 3, wherein:
- the deformable element is configured to deform against a contact surface of the structural component, and
- the deformable element includes an annular corner configured such that the corner deforms against the contact surface when the contact surface is pressed against the corner while the contact surface is at an oblique angle relative to the corner.
5. The implant of claim 1, wherein:
- the deformable element is part of the structural component.
6. The implant of claim 5, wherein:
- the deformable element is configured to deform against a contact surface of the bone fixture, and
- the deformable element includes an annular corner configured such that the corner deforms against the contact surface when the contact surface is pressed against the corner while the contact surface is at an oblique angle relative to the corner.
7. The implant of claim 1, wherein the implant is configured such that the structural component is configured to be bolted to the bone fixture, and wherein the deformable element deforms to form the seal upon tightening when the structural component is bolted to the bone fixture.
8. The implant of claim 1, wherein the at least one deformable element is configured to plastically deform to form the anti-microbial seal.
9. The implant of claim 1, wherein:
- the at least one deformable element of the bone fixture or the structural component is configured to deform against a contact surface of the other of the bone fixture or the structural component; and
- the deformation element deforms to compensate for surface imperfections of the contact surface to form the anti-microbial seal.
10. The implant of claim 1, wherein the at least one deformable element of the bone fixture or the structural component is configured to deform against a contact surface of the other of the bone fixture or the structural component, thereby reducing at least one of gaps or holes between the deformable element and the contact surface otherwise passable therethrough by microbes to form the anti-microbial seal.
11. The implant of claim 1, wherein the seal is air tight.
12. The implant of claim 1, further comprising:
- 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.
13. 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.
14. The implant of claim 13, wherein:
- the screw comprises a head atop an elongate main body, the head having a base, wherein the seal is located between the base of the head and a corresponding surface of the structural component.
15. The implant of claim 13, wherein:
- the seal includes at least one deformable element that, together with one of the screw or the structural component, forms a monolithic structure.
16. The implant of claim 13, wherein:
- the structural component is a skin-penetrating abutment of a percutaneous bone conduction device; and
- the screw is an abutment screw of a percutaneous bone conduction device.
17. The implant of claim 13, wherein:
- the seal includes at least one plastically deformable element.
18. The implant of claim 13, wherein:
- the screw includes a screw head configured to react against the structural component when the screw is screwed into the bone fixture, thereby driving the abutment to the bone fixture; and
- the seal is formed by a deformable flange located at a base-structural component interface, the flange including a tapered surface that extends away from a plane normal to a longitudinal axis of the screw at a flange angle, the deformable flange deforming upon tightening of the screw, thereby forming the seal.
19. The implant of claim 18, wherein:
- the deformable flange is part of the screw head.
20. The implant of claim 18, wherein:
- the flange angle is about 10 degrees.
21. The implant of claim 16, further comprising:
- an annular relief proximate the flange configured to enhance deformation thereof.
22. The implant of claim 13, wherein:
- the seal includes at least one deformable element in the form of an annular ring configured to deform against a contact surface of the respective screw or structural component.
23. The implant of claim 22, wherein:
- the annular ring has at least one of a semi-circular or a triangular cross-section.
24. The implant of claim 13, wherein:
- the screw includes a friction-reducing coating.
25. The implant of claim 24, wherein:
- the coating is diamond like carbon (DLC).
26. The implant of claim 13, wherein:
- the screw includes an annular angled ring extending outward and downward from a screw head thereof; and
- the annular angled ring is configured to deform against a contact surface of the structural component, thereby forming the seal.
27. The implant of claim 13, 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.
28. The implant of claim 13, wherein at least one of:
- the at least one deformable element and the respective at least one bone fixture or structural component form a monolithic structure; or
- the deformable element plastically deforms.
29. 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.
30. The implant of claim 29, wherein:
- the structural component is a skin-penetrating abutment of a percutaneous bone conduction device.
31. The implant of claim 29, wherein:
- both the bone fixture and the structural component include respective deformable elements configured to plastically deform to form an anti-microbial seal between the bone fixture and the structural component.
32. The implant of claim 29, further comprising:
- 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.
33. The implant of claim 32, wherein:
- the seal between the structural component and the screw is a second deformable element configured to plastically deform to form the seal.
34. 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.
35. The method of claim 34, wherein:
- the anti-microbial seal is gas tight.
36. The method of claim 34, wherein:
- the action of applying the torque includes applying the torque to the abutment screw, wherein the abutment screw is the component threadably engaged with the implanted bone fixture.
37. The method of claim 34, wherein the applied torque is about 25 Ncm or more.
Type: Application
Filed: Feb 13, 2012
Publication Date: Jul 5, 2012
Patent Grant number: 9271092
Inventors: Goran BJORN (Onsala), Marcus Andersson (Goteborg)
Application Number: 13/371,763
International Classification: H04R 25/00 (20060101);