U.S. patent application number 12/697847 was filed with the patent office on 2010-06-03 for acetabular shell system and method for making.
This patent application is currently assigned to Biomet Manufacturing Corp.. Invention is credited to Mukesh Kumar.
Application Number | 20100136214 12/697847 |
Document ID | / |
Family ID | 36941896 |
Filed Date | 2010-06-03 |
United States Patent
Application |
20100136214 |
Kind Code |
A1 |
Kumar; Mukesh |
June 3, 2010 |
Acetabular Shell System and Method for Making
Abstract
A method for forming an acetabular shell includes providing a
working surface such as a mandrel, and spraying the working surface
with a first layer of material having a first composition such as
aluminum oxide. After a suitable thickness is generated, the spray
composition is gradually changed to other compositions having
desired particle sizes and distribution. In one example, the
composition is changed to a mixture of aluminum oxide and titanium
oxide and/or titanium. As thickness builds up, the relative amount
of aluminum oxide is decreased such that the composition is all
titanium and titanium oxide. After a desired thickness is
generated, the acetabular shell is extracted off the mandrel.
Inventors: |
Kumar; Mukesh; (Warsaw,
IN) |
Correspondence
Address: |
HARNESS, DICKEY & PIERCE, P.L.C.
P.O. BOX 828
BLOOMFIELD HILLS
MI
48303
US
|
Assignee: |
Biomet Manufacturing Corp.
Warsaw
IN
|
Family ID: |
36941896 |
Appl. No.: |
12/697847 |
Filed: |
February 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11366727 |
Mar 2, 2006 |
7655162 |
|
|
12697847 |
|
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60658407 |
Mar 3, 2005 |
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Current U.S.
Class: |
427/2.27 |
Current CPC
Class: |
A61L 27/306
20130101 |
Class at
Publication: |
427/2.27 |
International
Class: |
A61L 27/32 20060101
A61L027/32 |
Claims
1. A method of making an implant for use in replacing a portion of
a patient's joint, the method comprising: providing a first die
defining a concave cavity having a textured die surface; providing
a second die defining a convex extension surface, the first and
second die collectively forming a die cavity; coating the textured
die surface with powdered metal; injecting a slurry of material
into the die cavity; casting the slurry of material thereby forming
a ceramic shell; removing the ceramic shell from the die cavity,
the ceramic shell having a first surface and a second surface, the
second surface being formed of metal from the powdered metal;
driving off excess fluid slurry by converting the ceramic shell to
a stable dome in an oven; locating the stable dome onto a mounting
instrument; plasma spraying a layer of material onto an outer
surface of the stable dome that corresponds to the second surface
of the ceramic shell; and sintering the ceramic shell.
2. The method of claim 1, further comprising polishing the second
surface of the ceramic shell.
3. The method of claim 1 wherein forming the ceramic shell
comprises casting a ceramic shell having a textured outboard
surface having a plurality of dimples, the textured outboard
surface adapted to accept the sprayed layer of material.
4. The method of claim 3 wherein plasma spraying the layer of
material comprises spraying titanium oxide onto the second surface
of the ceramic shell.
5. The method of claim 1 wherein the textured die surface includes
a plurality of outwardly extending knobs
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/366,727 filed Mar. 2, 2006, which claims
the benefit of a U.S. Provisional Application 60/658,407 filed on
Mar. 3, 2005. The disclosure of the above application is
incorporated herein by reference.
FIELD
[0002] This invention relates to acetabular shells and more
particularly to a method of making an implant such as an acetabular
shell by free form plasma (thermal) spray technology.
INTRODUCTION
[0003] In replacement hip surgery a femoral component can be
inserted into the prepared femur. The femoral component can include
a stem portion which projects into the femoral canal of the
prepared femur and has an integral or separate modular head of
substantially spherical shape. The ball-like head of the femoral
component is received within an acetabular cup component which is
implanted in the patient's hip socket, i.e., the acetabulum. The
acetabular cup has a substantially hemi-spherical bearing surface
for movement of the ball head of the femoral component during
action of the joint.
[0004] Various designs of acetabular cups are available and it is
often a multi-piece component having at least a separate outer
shell and an inner liner. Where the acetabular cup has an inner
liner, that inner liner is generally press-fitted into the outer
shell. In some designs of hip prostheses the material of the
bearing surface of the acetabular cup, e.g. its inner liner where
present, is of the same material as that of the ball head, e.g. for
a ceramic head, a ceramic bearing surface is provided (a so-called
ceramic-on-ceramic prosthesis) and for a metal head, a metal
bearing surface is provided (a so-called metal-on-metal
prosthesis). In some other designs, the acetabular bearing surface
is of polyethylene, as the acetabular cup is either provided with a
polyethylene inner liner or the acetabular cup is a single
component made entirely from polyethylene. The shape of the bearing
surface into which the ball head is received affects the degree of
movement available after implantation of the joint.
SUMMARY OF THE INVENTION
[0005] A method for forming an implant includes providing a working
surface such as a mandrel, and spraying the working surface with a
first layer of material having a first composition such as aluminum
oxide. After a suitable thickness is generated, the spray
composition is gradually changed to other compositions having
desired particle sizes and distribution. In one example, the
composition is changed to a mixture of aluminum oxide and titanium
oxide and/or titanium. As thickness builds up, the relative amount
of aluminum oxide is decreased such that the composition is all
titanium and titanium oxide. After a desired thickness is
generated, the acetabular shell is extracted off the mandrel.
[0006] A method of making an implant according to various features
includes forming a ceramic shell having a first surface and a
second surface. A first surface of the ceramic shell is located
onto a mounting instrument. A layer of material is sprayed onto the
second surface of the ceramic shell. The ceramic shell is then
sintered.
[0007] Further areas of applicability of the present invention will
become apparent from the detailed description provided hereinafter.
It should be understood that the detailed description and specific
examples, while indicating the embodiments of the invention, are
intended for purposes of illustration only and are not intended to
limit the scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present invention will become more fully understood from
the detailed description and the accompanying drawings,
wherein:
[0009] FIG. 1 illustrates an exemplary thermal spraying device
spraying a first layer of material onto a mandrel;
[0010] FIG. 2 illustrates a cross-sectional view of the mandrel of
FIG. 1;
[0011] FIG. 3 illustrates a partial cross-sectional view of the
spraying device and mandrel of FIG. 1 shown during an initial
spraying step;
[0012] FIG. 4 illustrates the cross-sectional view of FIG. 3, shown
during an intermediate spraying step;
[0013] FIG. 5 illustrates the cross-sectional view of FIG. 4 shown
during spraying of an outboard porous layer;
[0014] FIG. 6 illustrates the acetabular shell removed from the
mandrel;
[0015] FIG. 7 illustrates a cross-sectional view of the acetabular
shell of FIG. 6;
[0016] FIG. 8 illustrates a perspective view of a ceramic casting
according to a another embodiment;
[0017] FIG. 9 illustrates a perspective view of a ceramic shell
removed from the casting of FIG. 8;
[0018] FIG. 10 illustrates a perspective view of the ceramic shell
arranged on a mandrel and a spraying device spraying a layer of
material onto an outer concave surface of the ceramic shell;
[0019] FIG. 11 illustrates a cross-sectional view of the ceramic
shell having the layer of material sprayed thereon and defining an
acetabular shell; and
[0020] FIG. 12 illustrates the acetabular shell of FIG. 11 shown
during a sintering process.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] The following description of the embodiment(s) is merely
exemplary in nature and is in no way intended to limit the
invention, its application, or uses. Moreover, while the
description below is directed to an acetabular shell, the teachings
described herein may similarly be employed to form other implants,
such as, but not limited to femoral implants, tibial implants,
tibial trays, and glenoid implants.
[0022] With initial reference now to FIGS. 1 and 2, a thermally
stable mandrel and plasma spraying device are shown and identified
at reference 10 and 12 respectively. The mandrel 10 generally
defines a semi-hemispherical dome 14 and a longitudinal support
portion 16. While the mandrel 10 and spraying device 12 are shown
having specific geometries, it is appreciated that they are merely
exemplary and other mandrels and spraying devices may be similarly
employed.
[0023] The mandrel 10 is generally shaped inversely to a desired
acetabular shell. More specifically, the mandrel 10 defines the
semi-hemispherical dome 14 providing an outer convex surface 20
that corresponds to an inner concave surface of the acetabular
shell. In one example, the thermally stable mandrel 10 may be made
of tungsten. The outer convex surface 20 may be polished to a
roughness acceptable for articulating surfaces of acetabular
shells. The thermally stable mandrel 10 allows the generation of
multiple acetabular shells without the need of individual grinding
and polishing operations between subsequent shell formations.
[0024] With specific reference to FIG. 2, the mandrel 10 may be
mounted on a holding fixture 22. The holding fixture 22 may provide
a bearing set 26 for rotational capability. Other arrangements may
also be provided.
[0025] The mandrel 10 may define a coolant channel 28 for
communicating a coolant (not specifically shown) from an inlet 30
defined on the longitudinal portion 16 to an outlet 32 defined on
the longitudinal portion 16. As shown, the coolant channel 28 is
adapted to communicate fluid through the longitudinal portion 16,
around the semi-hemispherical portion 14 and back through the
longitudinal portion 16. The coolant port arrangement on the
mandrel 10 helps draw away heat to maintain an acceptable
temperature on the outer convex surface 20 and the mandrel 10 as a
whole during a spray event. It is appreciated that the coolant
channel 28 may be arranged differently on the mandrel 10 and/or
other cooling mechanism or techniques may be employed to maintain
acceptable mandrel temperatures during use. In one example, the
mandrel 10 is maintained under 200.degree. C. Other temperatures
are contemplated. In addition, while not specifically shown, heat
removal may be accomplished by flow of external gases over the
acetabular shell being created.
[0026] With continued reference to FIGS. 1 and 2 and additional
reference to FIG. 3, a method of making an acetabular shell
according to the present teachings will be described. In a
controlled atmosphere, very fine powder of aluminum oxide 38 is
sprayed onto the mandrel 10 such that a continuous layer of
aluminum oxide 38 is generated on the mandrel 10 on the outer
convex surface 20. The very fine powder exhausted from the spraying
device 12 may be in the molten, or semi-molten state. In one
example, prior to applying the aluminum oxide 38, a mold relief
agent may be applied to the mandrel 12 to facilitate removal of the
acetabular shell once completed.
[0027] Once a suitable thickness (such as, but not limited to, less
than 5 mm) of aluminum oxide 38 is sprayed onto the mandrel dome
14, the spray concentration changes to a mixture of aluminum oxide
and titanium oxide and/or titanium collectively identified at
reference 40 (FIG. 4). After a suitable thickness is generated
(such as, but not limited to, 5 mm), the proportions of aluminum
oxide is reduced causing the composition of titanium oxide and/or
titanium to increase. This layer is identified at reference 42
(FIG. 5). The thickness of layer 42 may be 3 mm, although other
thicknesses are contemplated.
[0028] Concurrently, the particle size of the titanium oxide and/or
titanium may be increased to generate a porous outer surface. It is
understood that while unique reference numerals 38, 40 and 42 have
been used to identify sequential layers of sprayed material, the
relative proportions of aluminum oxide, titanium oxide and/or
titanium in the sprayed material gradually change as desired. As a
result, there is not necessarily any identifiable transition
boundaries across the thickness of the sprayed material.
[0029] Turning now to FIG. 6, once a suitable thickness is achieved
(such as, but not limited to, 13 mm), a newly formed acetabular
shell 50 is extracted off the mandrel 10. The resulting acetabular
shell 50 provides an inner portion 52 having a concave inner
surface or articulating surface 54 of aluminum oxide, an
intermediate portion 58 comprising a ceramic composition changing
from aluminum oxide (from the articulating surface 54) to titanium
and titanium oxide and finally to an outer portion 60 comprising
porous titanium. The articulating surface of the acetabular shell
50 may then be polished to a desired roughness to serve as an
articulating surface. It is appreciated that other materials may be
used. For example, zirconia and/or other materials may be used for
the aluminum oxide. Likewise, any composition of cobalt, chromium
and/or molybdenum may be used for the titanium oxide and/or
titanium. In addition, the acetabular shell may alternatively be
made exclusively of one material.
[0030] In another embodiment, an implant such as a stem may take
the place of the mandrel 10. As a result, the sequential layers may
be sprayed directly onto the implant and remain on the implant as
an integral feature.
[0031] Turning now to FIGS. 8-12, a method of making an acetabular
shell according to an additional embodiment will be described. In
this embodiment, rather than forming all layers of an acetabular
shell by way of plasma spraying, a prefabricated ceramic shell 68
(FIG. 9) is used to define a template for receiving a subsequent
plasma spray.
[0032] As shown in FIG. 8, a ceramic shell 70 may be formed by way
of a casting process. In one example, a first and second die 72 and
74 are used to define a desired outboard surface 76 and an inboard
articulating surface 78 of the ceramic shell 70 (FIG. 9). As
illustrated in FIG. 8, the first die 72 defines a concave cavity 80
and the second die 74 defines a convex extension surface 82. The
concave cavity 80 defines a plurality of outward knobs 86. The
outward knobs 86 are operable to define a textured surface,
represented as dimples 90 on the outboard surface 76 of the cast
ceramic shell 68 (FIG. 9). The convex extension surface 82 is
operable to define the inboard articulating surface 78 of the cast
ceramic shell 68. In one example, the walls of the concave cavity
80 are coated with titanium powder such that a layer of titanium is
defined on outboard surface 76 of the cast ceramic shell 68.
[0033] During the casting process, a slurry of ceramic 92 is
delivered to the first and second die 72 and 74. In one example,
the slurry of ceramic 92 may be created in a fluid with binders and
deflocculating agents as desired. The particle size of the ceramic,
the quantity of binder and deflocculating agents and the ratio of
various components in the slurry may be adjusted to achieve a
slurry providing favorable casting properties. While the respective
die cavities 72 and 74 are shown in an open position in FIG. 8, it
is appreciated that the slurry of ceramic 92 may be delivered
through a port to a closed die cavity.
[0034] As shown in FIG. 9, the ceramic shell 68 defines a
hemispherical dome 96. It is appreciated that other shapes may be
alternatively formed. It is further appreciated that while the
textured surface is depicted as dimples 90, the first die 72 may be
configured to define any textured surface including, but not
limited to, ridges, notches and other configurations. Furthermore,
while the formation of the ceramic shell 68 has been described by
way of a casting process, other fabrication techniques may be used.
Once the ceramic shell 68 has been cast, the ceramic shell 68 is
dried or semi-dried into a stable dome 98. In one example, the
process of converting the ceramic shell 68 to a semi-dried, stable
dome 98 may be achieved in a baking oven 100. The baking oven 100
is operable to drive off any excess fluid slurry. Furthermore, any
binders and/or deflocculating agents may or may not be removed.
[0035] Turning now to FIG. 10, the stable dome 98 may be placed
onto a mandrel 110. The mandrel 110 may cooperate with a
longitudinal support portion 116, a holding fixture 122 and a
bearing set 126. Furthermore, the mandrel 110 may include a coolant
channel 128. Again, other configurations may be employed.
[0036] Next, a layer of titanium oxide 140 is sprayed with a plasma
sprayer 12 to a desired thickness. As best illustrated in FIG. 11,
mechanical interlocking is achieved between the titanium oxide 140
and the outboard textured surface 90 of the ceramic dome 98. The
interface between the textured surface 90 and the titanium oxide
140 resists torsional slippage and radial slippage of the titanium
oxide 140 relative the outboard surface 76 of the ceramic dome
98.
[0037] With reference now to FIG. 12, a newly formed acetabular
shell 150 is then placed into a baking oven 100 for a sintering
process. In one example, a sinter cycle may be performed as
follows. First, the oven temperature may be raised to 175.degree.
C. at 5.degree. C./min. The 175.degree. C. may be maintained for 4
hours. The temperature may be ramped to a peak temperature such as
1650.degree. C. at 5.degree. C./min (optionally lower temperatures
may be used i.e. 1300.degree. C.-1450.degree. C.). The peak
temperature may be maintained for 8 hours. It is appreciated that a
peak temperature of 1300.degree. C.-1450.degree. C. may be
maintained for longer periods than higher temperatures (such as
1650.degree. C.). The temperature may be ramped down to 600.degree.
C. at 5.degree. C./min. The 600.degree. C. temperature may be held
for 30 minutes.
[0038] It is appreciated that the sintering procedure explained
above is merely exemplary. As such, ramp rate, dwell time and dwell
temperatures (collectively referred to as variables) of the sinter
cycle may define other ranges. The variable assigned during the
sinter process may be chosen to discourage crack formation in the
structure. In one example, a thermally induced compressive stress
may be generated in the ceramic structure to discourage premature
failure.
[0039] Once the acetabular shell 150 is sintered, the concave inner
surface 78 may be polished to a desired roughness to serve as an
articulating surface.
[0040] While the invention has been described in the specification
and illustrated in the drawings with reference to various
embodiments, it will be understood by those skilled in the art that
various changes may be made and equivalents may be substituted for
elements thereof without departing from the scope of the invention
as defined in the claims. Furthermore, the mixing and matching of
features, elements and/or functions between various embodiments is
expressly contemplated herein so that one of ordinary skill in the
art would appreciate from this disclosure that features, elements
and/or functions of one embodiment may be incorporated into another
embodiment as appropriate, unless described otherwise above.
Moreover, many modifications may be made to adapt a particular
situation or material to the teachings of the invention without
departing from the essential scope thereof. Therefore, it is
intended that the invention not be limited to the particular
embodiment illustrated by the drawings and described in the
specification as the best mode presently contemplated for carrying
out this invention, but that the invention will include any
embodiments falling within the foregoing description and the
appended claims.
* * * * *