U.S. patent application number 13/371763 was filed with the patent office on 2012-07-05 for medical implant system.
Invention is credited to Marcus Andersson, Goran BJORN.
Application Number | 20120172658 13/371763 |
Document ID | / |
Family ID | 43585751 |
Filed Date | 2012-07-05 |
United States Patent
Application |
20120172658 |
Kind Code |
A1 |
BJORN; Goran ; et
al. |
July 5, 2012 |
MEDICAL IMPLANT SYSTEM
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.
Inventors: |
BJORN; Goran; (Onsala,
SE) ; Andersson; Marcus; (Goteborg, SE) |
Family ID: |
43585751 |
Appl. No.: |
13/371763 |
Filed: |
February 13, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/AU2010/000401 |
Apr 9, 2010 |
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13371763 |
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Current U.S.
Class: |
600/25 |
Current CPC
Class: |
A61B 17/686 20130101;
H04R 25/606 20130101 |
Class at
Publication: |
600/25 |
International
Class: |
H04R 25/00 20060101
H04R025/00 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 13, 2009 |
AU |
2009903789 |
Oct 14, 2009 |
AU |
2009905020 |
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.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] 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.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The present invention relates generally to bone conduction
devices, and more particularly, to infection prevention measures
associated with percutaneous bone conduction devices.
[0004] 2. Related Art
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
SUMMARY
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Embodiments of the present invention are described below
with reference to the attached drawings, in which:
[0014] FIG. 1--shows an example of a medical implant system to
which various aspects of the present disclosure may be applied;
[0015] FIG. 2--shows a cross section of the medical implant system
of FIG. 1;
[0016] FIG. 3--shows a perspective view of the medical implant
system of FIG. 1;
[0017] FIG. 4--shows a cross section exploded view of the
components of the medical implant system of FIG. 1;
[0018] FIG. 5a--shows one embodiment of an abutment screw of one
aspect of the disclosure;
[0019] FIG. 5b--shows a cross section of the abutment screw of FIG.
5A;
[0020] FIG. 5c--shows a close up view of the deformable element of
FIG. 5B;
[0021] FIG. 6--shows a cross section of the abutment screw of FIG.
5A in an abutment;
[0022] FIG. 7--shows a close-up cross section view of a seal
provided between the abutment screw of FIG. 5A and the
abutment;
[0023] FIG. 8--shows a cross section of an alternative embodiment
of the abutment screw of FIG. 5A;
[0024] FIG. 9a--shows a cross section of yet a further alternative
of the abutment screw of FIG. 5A;
[0025] FIG. 9b--shows a perspective view of the abutment screw of
FIG. 9A;
[0026] FIG. 10--shows a close-up cross section view of a seal
provided between the abutment screw of FIG. 9a and the
abutment;
[0027] FIG. 11--shows a perspective view of one embodiment of an
abutment;
[0028] FIG. 12--shows a cross section of the abutment of FIG.
11;
[0029] FIG. 13--shows a close-up view of a seal provided between
the abutment screw and the abutment of FIG. 11;
[0030] FIG. 14--shows a cross section of one embodiment of a
fixture;
[0031] FIG. 15--shows a perspective view of one embodiment of an
abutment for use with the fixture of FIG. 14;
[0032] FIG. 16--shows a perspective view of another embodiment of
an abutment for use with the fixture of FIG. 14;
[0033] FIG. 17--shows a perspective view of yet another embodiment
of an abutment for use with the fixture of FIG. 14;
[0034] FIG. 18--shows the abutment of any one of FIGS. 15 to 17 in
place in the fixture of FIG. 14;
[0035] FIG. 19--shows a close-up view of the seal provided by the
arrangement of FIG. 18;
[0036] FIG. 20--shows a different embodiment of an abutment;
[0037] FIG. 21--shows the abutment of FIG. 20 engaging with a
fixture;
[0038] FIG. 22--shows a close-up of a seal provided by the
arrangement of FIG. 21;
[0039] FIG. 23--shows an embodiment of a medical implant system
with a seal provided between the abutment and the abutment
screw;
[0040] FIG. 24--shows another embodiment of a medical implant
system with a seal provided between the abutment and the
fixture;
[0041] 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;
[0042] FIG. 26a--shows a flow chart of a method of implanting a
medical implant system;
[0043] FIG. 26b--shows a specific example of the method of FIG.
26a;
[0044] FIG. 27a--shows a cross section of the arrangement of the
first step of the method of FIG. 26b;
[0045] FIG. 27b--shows a cross section of the arrangement of the
second step of the method of FIG. 26b; and
[0046] FIG. 27c--shows a cross section of the arrangement of the
third step of the method of FIG. 26B;
[0047] FIG. 28--shows a close-up cross section view of a seal
provided between the abutment screw of FIG. 5a and the abutment in
an alternate embodiment;
[0048] FIG. 29--shows a close-up cross section view of a seal
provided between the abutment screw of FIG. 9a and the abutment in
an alternate embodiment;
[0049] FIG. 30a--shows a close-up view of a seal provided between
the abutment screw and the abutment of FIG. 11 in an alternate
embodiment;
[0050] FIG. 30b--shows a close-up view of the seal provided by the
arrangement of FIG. 18 in an alternate embodiment;
[0051] FIG. 31--shows an alternate embodiment of a medical implant
system with a seal provided between the abutment and the abutment
screw;
[0052] FIG. 32--shows another embodiment of a medical implant
system with a seal provided between the abutment and the fixture;
and
[0053] 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.
DETAILED DESCRIPTION
[0054] 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.
[0055] As can be seen in FIG. 2, which shows a cross section view
along the line A-A' of FIG. 1, abutment 10 is connected to and
retained to fixture 20 by abutment screw 30. Abutment screw 30 has
head 31, a well 32 within the head 31 to receive an insertion tool
or the like, and an apical outer screw threaded section 34 on an
elongate main body 33. In some examples, abutment screw 30 may be
an M 1.8 titanium screw and the well 32 in head 31 may be a tubular
hex configuration for receiving and cooperating with the insertion
tool (not shown). The apical outer screw threaded section 34
engages with inner screw thread 23 of the fixture 20 upon turning
of the insertion tool.
[0056] FIG. 3 shows a perspective view of the medical implant
system 100. In this view, the abutment interior 13 is visible,
showing the abutment interior base 14. Also visible in this view is
abutment screw 30 with head 31 and hexagonal well 32. The fixture
20 with base collar 21 and outer screw thread 22 is also
visible.
[0057] 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.
[0058] FIG. 5A shows an exemplary embodiment of abutment screw 30.
In particular, abutment screw head includes a base 35 which
includes a deformable element in the form of a flange 36, which is
angled downwards and outwards away from the head at a flange angle
of about 10 degrees (in one example), as is more clearly seen in
FIG. 5C. FIGS. 5B and 5C show a cross section view of the abutment
screw 30 of FIG. 5A. In these views, the deformable element in the
form of the flange 36 is more clearly visible.
[0059] 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 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. In one example, when the
abutment screw 30 is screwed down into the inner screw thread 23 of
fixture 20, flat portion 37 comes into contact with the
corresponding contact surface or abutment interior base 14. When
the abutment screw 30 is screwed further downwards, 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. In other words, 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.
[0060] 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.
[0061] In the various examples detailed herein and/or variations
thereof, the type of deformation may be plastic, elastic or a
combination of both.
[0062] 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. In some cases, the
corresponding contact surface, in this case the abutment 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 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. As will be understood from FIG. 28, in this
alternate embodiment, 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.
[0063] 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.
[0064] This thereby provides a seal at the abutment and abutment
screw interface, to reduce the risk of bacterial infection via the
micro leakage pathway.
[0065] While the screw head 31 of abutment screw 30 may in some
embodiments, have a well 32 as shown in FIGS. 5A, 5B, 5C and 6,
which may assist in providing the deformable element as flange 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 an annular relief 38 above flange 36
to enhance the deformation, as shown in FIG. 8.
[0066] 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).
[0067] In another embodiment, as shown in a cross section view in
FIG. 9A, 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. As in the previous example, when abutment
screw 30 is tightened into position, 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. Again, in some cases, the abutment 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 14 abutment 10, and element 39 presses into the
abutment 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 from FIG. 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.
[0068] FIG. 11 shows a perspective view of abutment 10 showing
abutment interior 13 providing an abutment receiving well for
receiving the abutment 10, and abutment interior base 14. Without
abutment screw 30, the through bore 16, into which abutment screw
30 is inserted in use, is visible. In this embodiment, the
deformable element is provided by an annular ring 17 surrounding
the through bore 16. FIG. 12 shows a cross section view of abutment
10 with annular ring 17 surrounding through bore 16. Again, as
abutment screw 30 is inserted into through bore 16 and tightened,
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. This again provides a
barrier to bacteria entry into the micro leakage path and reduces
risk of infection. In this case, the base 35 of head 31 may be
planar rather than angled as in a previous example.
[0069] 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 the abutment screw 30 and element 17 presses
into the screw 30, thereby forming a seal.
[0070] 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.
[0071] 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.
[0072] In one embodiment of this aspect, as shown by way of example
in FIG. 14, 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.
[0073] 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
FIGS. 15, 16 and 17, to prevent otherwise resist against rotation
between these two parts when coupled together.
[0074] The abutment 10 may have a substantially curved, conical
outer surface with the upper edge having the wider diameter and the
bottom, fixture-connecting part having a smaller diameter, as
illustrated. A feature in these particular embodiments for the
three different examples of abutments 10 illustrated in FIGS. 15,
16 and 17 may be that the bottom tapered outer surface 12 which
cooperates with the annular corner 26 of the fixture 20 when the
two parts are coupled together as shown in FIG. 18. This provides a
concave outer contour of the connection between the abutment and
the fixture.
[0075] 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. FIG. 19 shows a
close up view of the seal formed therebetween.
[0076] 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.
[0077] 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.
[0078] In a further embodiment of this aspect, the deformable
element may be provided on the abutment 10 as shown in FIG. 30b,
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. In the embodiment of FIG. 20, the
deformable element is provided by abutment annular corner 19 on the
abutment base 12. In this embodiment, 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. As in the previous example,
abutment 10 is placed in the fixture 20 and when abutment screw 30
is tightened, abutment 10 is pressed down onto fixture 20. In this
arrangement, deformable element (abutment annular corner 19) will
be deformed against the lip 25 to form a seal between the abutment
10 and the fixture 20.
[0079] FIG. 22 is a close up view of the seal formed between the
abutment 10 and the fixture 20 of FIG. 21.
[0080] FIG. 23 shows an example of another embodiment of a medical
implant system 100, comprising abutment 10, fixture 20 and abutment
screw 30. In this example, the system is designed so as to provide
a seal between the abutment 10 and the abutment screw 30. In this
case, 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. With respect to the embodiment of FIG. 23, 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. 31, in this
alternate embodiment, 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.
[0081] FIG. 24 shows another embodiment of a medical implant system
100 comprising abutment 10, fixture 20 and abutment screw 30. In
this example, the system is designed to provide a seal between
abutment 10 and fixture 20. In this case, the seal is provided by
the same arrangement as described earlier with reference to FIGS.
14 to 19. That is, that the deformable element is provided on the
fixture 20 in the form of an annular corner 26 provided on the lip
25 of fixture 20, that upon tightening of abutment screw 30 9or
application of other force), deforms against the corresponding
contact surface (in this case abutment base 12) to form the seal.
FIG. 32 depicts an alternate embodiment where engagement between
the bone fixture 20 and the abutment 10 is depicted. The depicted
deformation of the abutment 10 is a result of the annular corner 26
of lip 25 of the fixture 20 being pressed into the surface of the
abutment 10, to provide a seal. As will be understood from FIG. 32,
in this alternate embodiment, 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.
[0082] FIG. 25 shows yet another embodiment of a medical implant
system 100 comprising abutment 10, fixture 20 and abutment screw
30. In this example, 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. In this case, 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. 24. That is, that the deformable element is provided on the
fixture 20 in the form of an annular corner 26 provided on the lip
25 of fixture 20, that upon tightening of abutment screw 30 9or
application of other force), deforms against the corresponding
contact surface (in this case abutment base 12) to form the seal.
Accordingly, the arrangement of FIG. 25 is a combination of both
the arrangements of FIGS. 23 and 24.
[0083] 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 FIGS. 5 to 10 as well as FIGS. 11 to 13. By
way of example, FIG. 33 depicts yet another embodiment of a medical
implant system 100 comprising abutment 10, fixture 20 and abutment
screw 30. In this example, 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. In this case, the first
seal is provided by the alternate arrangement as described above
with reference to FIG. 23 and FIG. 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), 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.
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),
the abutment 10 deforms against the corresponding contact surface
(annular corner 26 provided on the lip 25 of fixture 20) to form
the seal. Accordingly, the arrangement of FIG. 25 is a combination
of both the alternate arrangements of FIGS. 23 and 24 described
above.
[0084] 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.
[0085] 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.
[0086] The steps of one possible method of implanting the medical
implant system 100 are shown in FIG. 26a. At step 200, the abutment
10 is located in the abutment receiving well of fixture interior 24
of the already implanted fixture. At step 201, the abutment screw
30 is inserted in the through bore 16 of the abutment 10 and into
the fixture 20. In step 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.
[0087] In another example, as shown in FIG. 26b, 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. 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.
[0088] 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.
[0089] FIGS. 27a, 27b and 27c illustrate these steps 200, 201 and
202'. In FIG. 27a, the abutment 10 is located inside fixture 20. In
this example, fixture 20 has already been implanted and anchored in
the bone 50 of the patient's skull, in a previous procedure and
allowed to heal. This example method therefore begins with the
location of the abutment 10 in fixture 20. This is done through an
opening created in the tissue 5 of the patient.
[0090] In FIG. 27b, the abutment screw 30 is inserted into the
abutment 10 and the fixture 20 and in FIG. 27c, 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.
[0091] 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. 27c.
[0092] Embodiments utilizing multiple deformable elements may use
different types of deformable elements/deformable elements of
different geometries as detailed herein and/or variations
thereof.
[0093] 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.
[0094] 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.
[0095] 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.
[0096] 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.
[0097] 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.
[0098] 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.
[0099] 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.
[0100] 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.
[0101] 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.
* * * * *