U.S. patent application number 16/953761 was filed with the patent office on 2021-03-18 for multi-layered implant.
The applicant listed for this patent is Avalign Technologies, Inc.. Invention is credited to Daniel Steven Brox, Warren Scott Gareiss, James Clements Moore, David Lynn Walker, Sean Adam Walker.
Application Number | 20210079510 16/953761 |
Document ID | / |
Family ID | 1000005251402 |
Filed Date | 2021-03-18 |
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United States Patent
Application |
20210079510 |
Kind Code |
A1 |
Gareiss; Warren Scott ; et
al. |
March 18, 2021 |
MULTI-LAYERED IMPLANT
Abstract
A multi-layered implant and methods of forming the multi-layered
implant are disclosed. The multi-layered implant includes a Metal
Injection Molded body comprising a titanium alloy, a porous coating
layer on a first surface of the Metal Injection Molded body, and a
zirconium alloy layer on a second surface of the Metal Injection
Molded body. The first surface and the second surface are on
opposite sides of the Metal Injection Molded body. A zirconia layer
may be formed over the zirconium alloy layer. The porous coating
may be a titanium-based porous coating.
Inventors: |
Gareiss; Warren Scott;
(Columbia City, IN) ; Moore; James Clements;
(Portland, OR) ; Walker; Sean Adam; (Camas,
WA) ; Walker; David Lynn; (Camas, WA) ; Brox;
Daniel Steven; (Portland, OR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Avalign Technologies, Inc. |
Bannockburn |
IL |
US |
|
|
Family ID: |
1000005251402 |
Appl. No.: |
16/953761 |
Filed: |
November 20, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15195624 |
Jun 28, 2016 |
10865468 |
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16953761 |
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14061466 |
Oct 23, 2013 |
9404173 |
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15195624 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
C23C 8/80 20130101; C23C
8/10 20130101; A61F 2240/001 20130101; C23C 8/02 20130101; A61F
2/30767 20130101; A61F 2/3609 20130101; A61F 2002/30107 20130101;
B24B 31/06 20130101; A61F 2002/30084 20130101; C22F 1/186 20130101;
A61F 2/3859 20130101; A61F 2/0077 20130101; B22F 3/04 20130101 |
International
Class: |
C23C 8/10 20060101
C23C008/10; C23C 8/02 20060101 C23C008/02; C23C 8/80 20060101
C23C008/80; C22F 1/18 20060101 C22F001/18; B22F 3/04 20060101
B22F003/04; B24B 31/06 20060101 B24B031/06; A61F 2/36 20060101
A61F002/36; A61F 2/38 20060101 A61F002/38; A61F 2/00 20060101
A61F002/00; A61F 2/30 20060101 A61F002/30 |
Claims
1. A multi-layered implant, comprising: a Metal Injection Molded
body comprising a titanium alloy; a porous coating layer on a first
surface of the Metal Injection Molded body; and a zirconium alloy
layer on a second surface of the Metal Injection Molded body, the
first surface and the second surface being on opposite sides of the
Metal Injection Molded body.
2. The multi-layered implant of claim 1, wherein the porous coating
layer comprises a titanium-based porous coating.
3. The multi-layered implant of claim 1, further comprising a
zirconia layer over the zirconium alloy layer.
4. The multi-layered implant of claim 1, wherein the zirconium
alloy layer comprises a zirconium-niobium alloy.
5. The multi-layered implant of claim 1, wherein the multi-layered
implant is a knee implant, a shoulder implant, an ankle implant, a
spine implant, a disc implant, or a hip implant.
6. A knee implant, comprising: a titanium alloy substrate; a porous
coating layer on a first surface of the titanium alloy substrate; a
zirconium alloy layer on a second surface of the titanium alloy
substrate, the first surface and the second surface being on
opposite sides of the titanium alloy substrate; and a zirconia
layer over the zirconium alloy layer.
7. The knee implant of claim 6, wherein the porous coating layer
comprises titanium-based porous coating.
8. The knee implant of claim 6, wherein the zirconium alloy layer
comprises a zirconium-niobium alloy.
9. A method of manufacturing a multi-layered implant, the method
comprising: providing a Metal Injection Molded body comprising a
titanium alloy; applying a porous coating on a first surface of the
Metal Injection Molded body to form a porous coating layer, and a
zirconium alloy on a second surface of the Metal Injection Molded
body to form a zirconium alloy layer, the first surface and the
second surface being on opposite sides of the Metal Injection
Molded body; and oxidizing the zirconium alloy layer to form a
zirconia layer over the zirconium alloy layer.
10. The method of claim 9, wherein providing the Metal Injection
Molded body comprises receiving the Metal Injection Molded
body.
11. The method of claim 9, wherein providing the Metal Injection
Molded body comprises molding the Metal Injection Molded body.
12. The method of claim 9, wherein applying the zirconium alloy on
the second surface of the Metal Injection Molded body comprises
over-molding the zirconium alloy on the second surface of the Metal
Injection Molded body to form the zirconium alloy layer.
13. The method of claim 9, further comprising: sintering the Metal
Injection Molded body; and hot isostatic pressing the Metal
Injection Molded body.
14. The method of claim 13, wherein sintering the Metal Injection
Molded body comprises: sintering the porous coating on the first
surface of the Metal Injection Molded body; and sintering the
zirconium alloy on the second surface of the Metal Injection Molded
body.
15. The method of claim 9, further comprising polishing the
zirconium alloy layer.
16. The method of claim 15, wherein polishing the zirconium alloy
layer comprises applying an abrasive finishing process to the
zirconium alloy layer.
17. The method of claim 9, further comprising heat treating the
zirconium alloy layer.
18. The method of claim 9, wherein oxidizing the zirconium alloy
layer comprises heating the zirconium alloy layer in an oxidative
environment to form the zirconia layer.
19. The method of claim 9, further comprising mechanically
finishing the zirconia layer.
20. The method of claim 9, wherein the zirconium alloy comprises a
zirconium-niobium alloy.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 15/195,624, filed Jun. 28, 2016, and published
as U.S. Patent App. Pub. No. 2016/0305005 on Oct. 20, 2016, which
is a continuation-in-part of U.S. patent application Ser. No.
14/061,466, filed Oct. 23, 2013, and issued as U.S. Pat. No.
9,404,173 on Aug. 2, 2016, the disclosures of which are hereby
incorporated by reference herein.
TECHNICAL FIELD
[0002] The present application generally relates to a multi-layered
implant. In particular, the present application relates to an
implant including a titanium substrate layer, a zirconia layer, and
a titanium-based porous layer, and methods for forming such an
implant.
BACKGROUND
[0003] Known methods for producing metal bodies for medical
implants are not satisfactory for the range of applications for
which they are employed. For example, cobalt chrome alloy implants
are useful for high strength applications. Nevertheless, known
cobalt chrome alloy implants include nickel, which can cause
undesirable patient interactions for individuals having nickel
sensitivities and/or allergies. Further, known cobalt chrome alloy
implants are typically heavier than alternative implants, which may
lead to long term discomfort and/or complications when implanted in
a patient.
[0004] Titanium alloy implants provide an alternative nickel-free
implant for sensitive/allergic patients. Known titanium alloy
implants are useful, for example, for applications requiring lower
material strength. Titanium alloy implants may also be useful where
typical casting processes for many implants are not required. For
example, titanium alloy implants can be machined. However, titanium
alloy implants are expensive to machine in implant geometries.
[0005] Zirconium alloy implants having a zirconia surface
demonstrate improved wear performance over cobalt chrome and also
provide a nickel-free alternative for patients with nickel
sensitivities/allegories. Nevertheless, known zirconium alloy
implants cannot be used with cement-less interface applications
unless plasma sprayed and thus fail to capitalize on the improved
fixation durations and avoidance of negative patient interactions
provided by cementless interface applications.
[0006] Accordingly, there exists a need for implants that address
the above deficiencies and methods for manufacturing such
implants.
SUMMARY
[0007] Aspects of the present disclose are directed to a
multi-layered implant. Methods of forming a multi-layered implant
are also disclosed. In some embodiments, the multi-layered implant
includes a Metal Injection Molded body including a titanium alloy.
The multi-layered implant also includes a porous coating layer on a
first surface of the Metal Injection Molded body. The multi-layered
implant also includes a zirconium alloy layer on a second surface
of the Metal Injection Molded body. The first surface and the
second surface may be on opposite sides of the Metal Injection
Molded body.
[0008] In some embodiments, the porous coating layer may include a
titanium-based porous coating. The multi-layered implant may also
include a zirconia layer over the zirconium alloy layer. The
zirconium alloy layer may include a zirconium-niobium alloy. The
multi-layered implant may be a knee implant, a shoulder implant, an
ankle implant, a spine implant, a disc implant, or a hip
implant.
[0009] In some embodiments, a knee implant includes a titanium
alloy substrate, a porous coating layer on a first surface of the
titanium alloy substrate, a zirconium alloy layer on a second
surface of the titanium alloy substrate, and a zirconia layer over
the zirconium alloy layer. The first surface and the second surface
may be on opposite sides of the titanium alloy substrate.
[0010] In some embodiments, the porous coating layer may include a
titanium-based porous coating. The zirconium alloy layer may
include a zirconium-niobium alloy.
[0011] In some embodiments, a method of manufacturing a
multi-layered implant includes providing a metal injection molded
body that may include a titanium alloy, applying a porous coating
on a first surface of the metal injection molded body to form a
porous coating layer, applying a zirconium alloy on a second
surface of the metal injection molded body to form a zirconium
alloy layer, and oxidizing the zirconium alloy layer to form a
zirconia layer over the zirconium alloy layer. The first surface
and the second surface may be on opposite sides of the Metal
Injection Molded body.
[0012] In some embodiments, the Metal Injection Molded body may be
provided by receiving the Metal Injection Molded body and/or by
molding the Metal Injection Molded body. The zirconium alloy may be
applied on the second surface of the Metal Injection Molded body by
over-molding the zirconium alloy on the second surface of the Metal
Injection Molded body to form the zirconium alloy layer. The Metal
Injection Molded body may further be sintered and hot isostatic
pressed. Sintering can include the porous coating on the first
surface of the Metal Injection Molded body and sintering the
zirconium alloy on the second surface of the Metal Injection Molded
body.
[0013] In some embodiments, the zirconium alloy layer may be
polished by, for example, applying an abrasive finishing process to
the zirconium alloy layer. The zirconium alloy layer may also be
heat treated, and/or the zirconia layer may be mechanically
finished. The zirconium alloy layer may be oxidized by heating the
zirconium alloy layer in an oxidative environment to form the
zirconia layer. The zirconium alloy may include a zirconium-niobium
alloy.
[0014] Various additional features and advantages will become
apparent to those of ordinary skill in the art upon review of the
following detailed description of the illustrative embodiments
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The following detailed description is better understood when
read in conjunction with the appended drawings. For the purposes of
illustration, examples are shown in the drawings; however, the
subject matter is not limited to the specific elements and
instrumentalities disclosed. In the drawings:
[0016] FIG. 1 illustrates an exemplary process for forming a
multi-layered implant;
[0017] FIG. 2 illustrates a prospective view of a multi-layered
implant implanted into a knee of a patient; and
[0018] FIG. 3 illustrates a cross-sectional view of the
multi-layered implant depicted in FIG. 2.
DETAILED DESCRIPTION
[0019] A multi-layered implant that addresses the shortcomings of
conventional implants is described below. For example, the
multi-layer implant is nickel free to avoid material sensitivity
and allergy issues relative to cobalt chrome alloy implants and is
lighter relative to cobalt chrome alloy implants. The multi-layered
implant can be produced via a Metal Injection Molded (MIM) process
for better technical feasibility relative to cast implants, for
better economic feasibility relative to machined implants, and to
enable a combination of a titanium alloy body with zirconium alloy
that was not previously feasible.
[0020] The multi-layered implant also includes a cement-less,
porous coating for better bone in-growth and fixation relative to
cemented implants. In addition, the multi-layered implant can
include a zirconia articular surface for improved wear performance
relative to cobalt chrome alloy implants. That is, the multi-layer
implant combines materials and surfaces using technically and
economically feasible manufacturing processes to provide separate
benefits of different materials in a single implant.
[0021] The multi-layer implant can include a Metal Injection Molded
body having a first layer including a titanium alloy substrate. A
zirconium alloy is over-molded onto a first surface of the titanium
alloy substrate to form a second layer. The zirconium alloy is
oxidized to form a third zirconia layer. A porous titanium-based
coating is applied on a second surface of the titanium alloy
substrate to form a fourth layer. The first surface and the second
surface may be on opposite sides of the Metal Injection Molded
body. Although the first, second, third, and fourth layers have
been described above, the numerical reference to each layer is for
identification purposes only and does not limit the order of the
layers of the multi-layer implant. For example, the Metal Injection
Molded body could be a core, with the porous titanium-based coating
as a second layer, the zirconium alloy as a third layer, and the
zirconia as a fourth layer.
[0022] Referring to FIG. 1, a flow diagram depicting a method 100
of forming a multi-layered implant, such as the multi-layer implant
200 illustrated in FIGS. 2 and 3, is illustrated. The multi-layer
implant 200 can include three, four, or more layers. At step 102, a
Metal Injection Molding ("MIM") body 205 including a titanium alloy
is provided. For example, the titanium alloy may comprise
commercially pure titanium, a Ti-6Al-4V alloy, a Ti-6Al-4V ELI
alloy, a Ti-a3Nb-13Zr alloy, a Ti-12Mo-6Zr-2Fe alloy, a Ti-15Mo
alloy, a Ti-3Al-2.5V alloy, and/or a Ti-6Al-7Nb alloy, among
others. The titanium alloy MIM body 205 provides a viable
alternative implant for patients with nickel sensitivities and/or
allergies.
[0023] The MIM body 205 may be provided by molding the MIM body
205, storing an already molded MIM body 205, or receiving the MIM
body 205 in already molded form from another source, such as a
third-party manufacturer. The MIM body 205 may be the first layer,
or substrate or core, of the multi-layered implant 200. Molding the
MIM body 205 may include mixing a feedstock comprising one or more
metal powders and one or more binders.
[0024] At step 104, a porous coating is applied to one surface of
the MIM body 205. The one surface may be an implant-to-bone surface
of the multi-layer implant 200, which attaches to a bone of a
patient. The porous coating may be a titanium-based coating, such
as a titanium bead coating, an asymmetric titanium particle
coating, or a porogen-produced titanium coating. The porous coating
may define another layer over the MIM body 205, such as a second or
fourth layer of the multi-layered implant 200. The porous coating
may have an average pore size between 100 and 500 .mu.m for optimal
bone in-growth.
[0025] At step 106, a zirconium alloy is applied onto another
surface of the of the MIM body 205. In some embodiments, the
zirconium alloy may be over-molded onto the other surface of the
MIM body 205. The other surface may be an implant-to-implant
surface of the multi-layer implant 200, which contacts another
implant in the patient. The implant-to-implant surface may be on
the side opposite the implant-to-bone surface of the multi-layer
implant 200. The zirconium alloy may define another layer, such as
a second or third layer of the multi-layered implant 200. In some
embodiments, to over-mold the zirconium alloy, the MIM body 205 may
be placed in a second mold that is different from the mold used to
mold the MIM body 205. A second feedstock including one or more
metal powders and one or more binders are mixed together. The
second feedstock may then be injected into the second mold, thereby
forming an over-molded layer made up of the second feedstock
including zirconia alloy over the MIM body 205. The zirconium
alloys can be, for example, zirconium-niobium alloy, such as
zirconium-2.5 niobium, among others. Zirconium alloys are
particularly well suited to oxidation layer formation processes.
The over-molded part may contain binders at the conclusion of
over-mold processing, which may require removal.
[0026] At step 108, the multi-layer implant 200 may be sintered.
The resultant sintered porous coating may allow for cement-less
applications, which as compared to cemented implants, offer better
long-term implant-bone fixation and avoid negative patient
interactions that can result for patients with cement sensitivities
and/or allergies. The sintering step 108 will fuse the titanium
alloy MIM body 205 with the zirconium alloy layer 215. The
sintering step 108 may occur after the step 106 of applying the
zirconium alloy and before or after the application of the step 104
of applying the porous coating.
[0027] In some embodiments, the sintering step 108 can include
multiple sintering steps. For example, a first sintering step can
follow the step 106 of applying the zirconium alloy to fuse the
titanium alloy MIM body 205 with the zirconium alloy layer 215. A
second sintering step can follow step 104 of applying the porous
coating to improve the connection of the porous titanium-based
coating layer 210 to the titanium alloy MIM body 205. The two
sintering steps may be performed at the same or similar
temperatures for the same or similar time duration, at the same or
similar temperatures for different time durations, at different
temperatures for the same or similar time duration, or at different
temperatures for different time durations. For example, the first
and second sintering steps can be performed at similar temperatures
for different time durations. In such an example, the zirconium
alloy on the MIM body 205 can be sintered for a shorter time
duration than the porous coating on the MIM body 205.
[0028] At step 110, the multi-layer implant 200 may be hot
isostatic pressed. The hot isostatic pressing step 110 may occur
before or after the step 104 of applying the porous coating. The
multi-layer implant 200 can be placed in a chamber surrounded by an
inert fluid, which can be an inert gas, such as nitrogen, argon,
helium, neon, argon, krypton, xenon, and/or radon. The inert gas
applies a substantially even, predetermined pressure around the
entire exposed surface of the multi-layer implant 200 being
pressed. Applying pressure evenly effectively reduces the internal
porosity of the multi-layer implant 200, thereby improving the
mechanical properties such as hardness, smoothness, and uniformity,
while retaining a substantially similar shape. Improving the
mechanical properties may also partially result from increasing the
density of the multi-layer implant 200. Relative to an implant that
is not hot isostatic pressed, the higher density multi-layer
implant 200 has a reduced porosity and increased material
integrity. The pressure applied may be adjusted by introducing or
removing inert fluid to or from the chamber or by adjusting the
temperature of the contained fluid. In some examples, the
multi-layer implant 200 can be hot isostatic pressed at a pressure
between 15,000 to 30,000 pounds per square inch (psi) and at a
temperature range of 1500 to 2500 degrees Fahrenheit.
[0029] At step 112, the multi-layer implant 200 can be processed.
The processing can include one or more of a plurality of different
processing techniques described below. For example, processing the
zirconium alloy layer 215 may improve the surface characteristics,
such as grain size and smoothness, and improve acceptance of a
zirconia layer at step 114. The processing step 112 may result in
layers of the multi-layer implant 200 being more dense, smooth, and
uniform.
[0030] The processing step 112 may include thermally treating the
multi-layer implant 200 by heating the multi-layer implant 200 to a
temperature between 1,500 to 2,500 degrees Fahrenheit. Thermally
treating the multi-layer implant 200 in this manner may produce,
amongst other benefits, finer, more uniform grain boundaries
proximate the surface of the multi-layer implant 200 and, in some
cases, throughout the multi-layer implant 200. The thermal
treatment may, for example, encourage alloy elements and segregated
elements at grain boundaries to diffuse within the MIM body 205 and
evenly redistribute throughout the internal material. As a result,
thermal treating the multi-layer implant 200 may improve mechanical
properties, such as toughness and ductility.
[0031] In some examples, thermally treating the multi-layer implant
200 may also include a rapid quench step. Specifically, the
multi-layer implant 200 may be rapidly quenched at pressure within
a lower-temperature quenching fluid to rapidly reduce the
temperature of the multi-layer implant 200. The multi-layer implant
200 may, for example, be reduced within a short period of time in a
quenching fluid that is 150 degrees Fahrenheit or less. Rapid
quenching has been observed to more quickly reduce atomic movement
within the multi-layer implant 200 thereby reducing the amount of
time required to reset the multi-layer implant 200's microstructure
to result in finer, more uniform grain boundaries compared to
ambient cooling.
[0032] The processing step 112 may also include machining the
multi-layer implant 200 to conform the multi-layer implant 200 to
precise desired dimensions and to correct any introduced flaws in
the processing of the multi-layer implant 200.
[0033] The processing step 112 may also include a single state or a
multistage abrasive finishing process to encourage the zirconium
alloy layer 215 accept a zirconia layer at step 114. For example,
the multi-layer implant 200 may be tumbled via particle media that
is increasingly fine at each stage. In some embodiments, the
abrasive finishing process may include a first polishing step,
second polishing step, and a step of protecting an outer surface of
the zirconium alloy layer 215.
[0034] The processing step 112 may also include peening the
zirconium alloy layer 215 by, for example, blasting beads toward
the zirconium alloy layer 215. The beads may be spherical glass
bead, steel beads, ceramic beads, steel shot, or a combination
thereof. The zirconium alloy layer 215 may be peened to alter and
refine the zirconium alloy layer 215 surface microstructure as a
result of the compressive force applied by the peening media. For
example, prior to peening, the surface may define visible exterior
grain boundaries, which may reduce the surface's ability to accept
a satisfactory oxide layer. Following peening, the visual and
structural uniformities of the surface microstructure may be of
equal or greater quality than a forged surface. This plastic
deformation of the surface caused by the peening media's
compressive force is substantially permanent, and thus should not
return elastically to its original lattice microstructure.
[0035] The processing step 112 may also include grinding the
multi-layer implant 200. For example, the zirconium alloy layer 215
can be ground using a fine polishing compound via a contacting-type
grinding machine resulting in a substantially smooth, bright outer
surface with a reduced number of scratches and visible grain
boundary lines.
[0036] At step 114, the zirconium alloy layer 215 is oxidized to
define an oxygen rich film, such as a zirconia layer 220
illustrated in FIG. 3. A zirconia surface demonstrates improved
wear performance relative to cobalt chrome alloy and also provides
a nickel-free alternative for patients with nickel sensitivities
and/or allergies. The oxidizing step 114 may be accomplished either
actively or passively, or a combination thereof. Zirconium-2.5
niobium, for example, oxidizes when exposed to air, with or without
further intervention. However, the zirconium alloy layer 215 may
additionally or alternatively be exposed to heat for a
predetermined length of time to accelerate the oxidization process,
which may produce a harder, smoother, and more uniform oxidized
layer in reduced time as compared to passive oxidation. For
example, the zirconium niobium MIM bodies can be heated to above
150 degrees Fahrenheit in an oxidative environment.
[0037] Further, the zirconia layer 220 provides surface
characteristics, such as low friction coefficients, increased
hardness, and resistance to wear and corrosion, that may equal or
exceed those of wrought or forged oxidized zirconium-2.5 niobium
medical implants. The zirconia layer 220 may define an
implant-to-implant surface configured, adapted, and intended to
interface with a complimentary implant surface.
[0038] At step 116, the multi-layered implant 200 may be
post-processed. The post-processing step 116 of the multi-layered
implant 200 may be performed in accordance with the specifications
of desired implant. Surface finishing, such as mechanical grinding,
and/or surface enhancement may be provided to the porous coating
layer 210 and/or the zirconia layer 220 to result in a desired
exterior characteristic.
[0039] FIGS. 2 and 3 show an exemplary multi-layered implant 200 in
accordance with embodiments of the invention. FIG. 2 shows the
multi-layered implant 200 implanted into a femur of a patient. For
example, the multi-layered implant 200 may be a femoral knee
implant. The femoral knee implant 200 may then be paired with a
complimentary paired-knee member 300. Nevertheless, the
multi-layered implant 200 is not limited to femoral knee implants
and the multi-layered implant 200 may be shaped to form a variety
of other implants including for example, any joint implant, such a
uni-knee implant, a shoulder implant, an ankle implant, a spine
implant, a disc implant, a hip implant, or the like. The
paired-knee member 300 may be a multi-layered implant formed in
accordance with any of the above-disclosed processes.
Alternatively, the paired-knee member 300 may be formed of soft
plastic.
[0040] FIG. 3 is a cross-sectional view of the multi-layered
implant 200 depicted in FIG. 2. The multi-layered implant 200 may
be formed in accordance with the method 100. The multi-layered
implant 200 includes the MIM body 205, the porous coating layer
210, such as a porous titanium alloy layer 210. The porous coating
layer 210 may cover an entirety of the implant-to-bone surface of
the multi-layer implant 200, or may cover part of the
implant-to-bone surface of the multi-layer implant 200, such as the
portion directly contacting the bone. For example, the porous
coating layer 210 illustrated in FIG. 3, covers a majority, but not
all, of one side of the multi-layer implant 200. The porous coating
layer 210 can have a thicknesses of 0.010-0.080 inches. The
multi-layered implant 200 further includes the zirconium alloy
layer 215 over-molded on the MIM body 205. The zirconium alloy
layer 215 may cover an entirety of the implant-to-implant surface
of the multi-layer implant 200, or may cover part of the
implant-to-implant surface of the multi-layer implant 200, such as
the portion directly contacting another implant. For example, the
zirconium alloy layer 215 illustrated in FIG. 3, covers an entirety
of one side of the multi-layer implant 200. The zirconium alloy
layer 215 can have a thicknesses of 0.005-0.500 inches. The
multi-layered implant 200 further includes a zirconia layer 220
formed on the zirconium alloy layer 215. The zirconia layer 220 may
cover an entirety of the zirconium alloy layer 215, or may cover
part of the zirconium alloy layer 215, such as the portion directly
contacting another implant. For example, the zirconia layer 220
illustrated in FIG. 3, covers an entirety of the zirconium alloy
layer 215. The zirconia layer 220 can have a thicknesses of 2-20
microns, and provide a hard, uniform, smooth, and dense
surface.
[0041] Although various examples and embodiments of the
multi-layered implant 200, and methods for manufacturing the
multi-layered implant 200, have been disclosed, other
implementations of the multi-layered implant 200 and methods for
manufacturing the multi-layered implant 200 are contemplated. Many
variations are contemplated for different applications and design
considerations; however, for the sake of brevity, each and every
contemplated variation is not individually described. All
references to the multi-layered implant 200 or examples thereof are
intended to reference the particular example of the present
application and are not intended to be limiting. All methods
described herein can be performed in any suitable order unless
otherwise indicated herein.
* * * * *