U.S. patent application number 15/139558 was filed with the patent office on 2017-03-23 for variable prosthesis.
The applicant listed for this patent is Biomet Manufacturing, LLC. Invention is credited to Nicholas M. Cordaro, Aaron P. Smith, Kevin T. Stone.
Application Number | 20170079799 15/139558 |
Document ID | / |
Family ID | 48524554 |
Filed Date | 2017-03-23 |
United States Patent
Application |
20170079799 |
Kind Code |
A1 |
Smith; Aaron P. ; et
al. |
March 23, 2017 |
VARIABLE PROSTHESIS
Abstract
The present teachings are directed to a shoulder prosthesis
having an adjustable radial offset and/or angular inclination
provided by relative rotation of an adapter interdisposed between a
stem and a head. In one example, a prosthesis has a stem having a
first longitudinal axis. The prosthesis can also include an adaptor
including a first taper. The first taper can have a first taper
axis. The prosthesis can include a head supported by the adaptor.
The head can be selectively oriented and then coupled to the first
taper and the combination can be selectively orientated and the
coupled to the stem.
Inventors: |
Smith; Aaron P.; (Warsaw,
IN) ; Stone; Kevin T.; (Winona Lake, IN) ;
Cordaro; Nicholas M.; (North Webster, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biomet Manufacturing, LLC |
Warsaw |
IN |
US |
|
|
Family ID: |
48524554 |
Appl. No.: |
15/139558 |
Filed: |
April 27, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14257526 |
Apr 21, 2014 |
9326862 |
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15139558 |
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13309973 |
Dec 2, 2011 |
8702804 |
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14257526 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/4051 20130101;
A61F 2/3859 20130101; A61F 2002/3611 20130101; A61F 2002/30395
20130101; A61F 2002/30537 20130101; A61F 2/3662 20130101; A61F
2002/30507 20130101; A61F 2002/4037 20130101; A61F 2002/30593
20130101; A61F 2002/30339 20130101; A61F 2/40 20130101; A61F
2002/30474 20130101; A61F 2002/305 20130101; A61F 2002/30484
20130101; A61F 2002/30332 20130101; A61F 2002/365 20130101; A61F
2/3609 20130101; A61F 2002/3054 20130101; A61F 2/4014 20130101;
A61F 2002/30538 20130101; A61F 2002/30392 20130101 |
International
Class: |
A61F 2/36 20060101
A61F002/36; A61F 2/40 20060101 A61F002/40 |
Claims
1. (canceled)
2. A method of implanting a prosthesis system in a patient,
comprising: determining an anteversion angle of a natural bone
relative to a pelvis of the patient; selecting an adapter having an
adapter center axis and an adapter offset connection, wherein the
adapter offset connection has an adapter connection center axis;
selecting a head having a head center axis and an offset head
connection, wherein the offset head connection has a head
connection center axis; selecting a distance offset between the
adapter connection center axis and the head connection center axis
based on the determined anteversion angle; and rotating the
selected adapter relative to the selected head to achieve the
selected distance offset between the adapter connection center axis
and the head connection center axis.
3. The method of claim 2, wherein selecting the distance offset
includes selecting a radial distance offset between the adapter
connection center axis and the head connection center axis.
4. The method of claim 2, wherein the prosthesis comprises a
femoral prosthesis, the natural bone comprises a natural femur, and
the selected head comprises a selected femoral head.
5. The method of claim 2, wherein the adapter offset connection
includes a female locking taper.
6. The method of claim 4, further comprising: providing the adapter
connection center axis substantially through a center of the
adapter offset connection.
7. The method of claim 2, wherein rotating the selected adapter
relative to the selected head to achieve the selected distance
offset between the adapter connection center axis and the head
connection center axis includes forming the selected distance
offset at or between a maximum offset and a substantially zero
offset.
8. The method of claim 7, wherein selecting the head includes
selecting a head member having a curved articulating surface
configured to articulate relative to the pelvis when replacing at
least a portion of the natural bone.
9. The method of claim 8, wherein selecting the head further
includes selecting the head member to include a substantially
planar surface opposed to the curved articulating surface and
configured to interconnect with a stem, wherein the stem is
configured to be implanted into the natural bone.
10. The method of claim 7, wherein the maximum offset is defined as
positioning the adapter connection center axis away from the head
center axis a maximum distance.
11. The method of claim 7, wherein the substantially zero offset is
defined as generally aligning the adapter connection center axis
and the head center axis.
12. A method of implanting a femoral prosthesis system in a
patient, comprising: selecting a femoral head having a head center
axis, an offset head connection, and a curved articulating surface,
wherein the offset head connection has a head connection center
axis that is displaced a distance from the head center axis,
wherein the curved articulating surface is configured to articulate
within at least one of a an acetabular prosthesis or an acetabulum
in a pelvis of the patient, selecting an adapter having an adapter
center axis and an adapter offset connection, wherein the adapter
offset connection has an adapter connection center axis that is
displaced a distance from the adapter center axis; selecting a
distance offset between the adapter connection center axis and the
head connection center axis based on a determined anteversion angle
of a femur relative to the pelvis of the patient; and rotating the
selected adapter relative to the selected femoral head to achieve
the selected distance offset between the adapter connection center
axis and the head connection center axis.
13. The method of claim 12, wherein the selected distance offset is
a radial distance offset between the adapter connection center axis
and the head connection center axis.
14. The method of claim 12, further comprising measuring a position
of the femur relative to the acetabulum in the pelvis to determine
the anteversion angle.
15. The method of claim 14, further comprising: obtaining access to
a hip joint between the femur and the pelvis; resecting a natural
femoral head of the femur; and implanting the selected femoral head
to replace the resected femoral head.
16. The method of claim 15, wherein the selected distance offset is
at or between a maximum offset and a minimum offset; wherein the
maximum offset is a maximum displacement of the adapter connection
center axis and the head center axis; and wherein the minimum
offset is a substantial alignment of the adapter connection center
axis and the head center axis.
17. The method of claim 16, further comprising: implanting a
femoral stem into the femur; connecting the selected adapter to the
femoral stem; and connecting the selected femoral head to the
selected adapter.
18. The method of claim 17, wherein connecting the selected femoral
head to the selected adapter includes: fixing the selected femoral
head to the selected adapter, wherein fixing the selected femoral
head to the selected adapter occurs after rotating the selected
femoral head to the selected adapter to achieve the selected
distance offset.
19. A method of implanting a prosthesis system in a patient,
comprising: selecting an adapter having an adapter center axis and
an adapter offset connection, wherein the adapter offset connection
has an adapter connection center axis; selecting a femoral head
having a head center axis and an offset head connection, wherein
the offset head connection has a head connection center axis;
selecting a distance offset between the adapter connection center
axis and the head connection center axis based on an anteversion
angle of a natural femur relative to a pelvis of the patient; and
rotating the selected adapter relative to the selected femoral head
to achieve the selected distance offset between the adapter
connection center axis and the head connection center axis.
20. The method of claim 19, wherein selecting the distance offset
includes selecting a radial distance offset between the adapter
connection center axis and the head connection center axis.
21. The method of claim 19, further comprising: providing the
adapter connection center axis substantially through a center of
the adapter offset connection.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/309,973 filed Dec. 2, 2011. The entire
disclosure of the above application is incorporated hereby by
reference.
BACKGROUND
[0002] The present teachings relate to a prosthesis for replacing
and reconstructing a portion of the joint and more specifically to
a modular prosthesis.
[0003] The shoulder joint is considered to be one of the most
complex joints in the body. The scapula, the clavicle and the
humerus all meet at the shoulder joint. The head of the humerus
fits into a shallow socket of the scapula called the glenoid fossa
to form a mobile joint. When the joint is articulated, the humeral
head moves in the glenoid fossa to provide a wide range of motion.
The shoulder joint may suffer from various maladies including
rheumatoid arthritis, osteoarthritis, rotator cuff arthroplasty, a
vascular necrosis, bone fracture or failure of previous joint
implants. If severe joint damage occurs and no other means of
treatment is found to be effective, then a total shoulder
reconstruction may be necessary.
[0004] A shoulder joint prosthesis generally includes the
replacement of the ball of the humerus and, optionally, the socket
of the shoulder blade with specially designed artificial
components. The bio-kinematics, and thus the range of motion in the
shoulder vary greatly among prospective patients for reconstruction
shoulder surgery. The humeral component typically has a metal shaft
or stem with a body portion that is embedded in the resected
humerus and a generally hemispherical head portion supported on the
stem. The head slidingly engages a glenoid implant on the glenoid
fossa. During reconstructive surgery, the components of the
prosthesis are matched with the bio-kinematics of the patient in an
effort to maintain the natural range of motion of a healthy
shoulder joint. Thus, a shoulder prosthesis design must be readily
adaptable to a wide range of bio-kinematics for
prospectivepatients.
[0005] In this regard, shoulder prostheses are generally available
as either unitary structures or modular components. With unitary
shoulder prosthesis, a large inventory of differently sized
prostheses must be maintained to accommodate the different bone
sizes and joint configurations of the prospective patients. With
such unitary shoulder prosthesis, the patient is typically
evaluated by x-ray to determine the approximate prostheses size
needed for reconstruction. A number of differently sized prostheses
are selected as possible candidates based upon this preliminary
evaluation. Final selection of the appropriately sized prosthesis
is made during the surgery. With unitary shoulder prosthesis, each
design represents a compromise that is unable to achieve all of the
natural range of motion of a healthy shoulder joint because of the
fixed geometric configuration in their design.
[0006] Modular prostheses systems which reduce the need to maintain
large inventories of various sized components are well known in the
art. Conventionally, the humeral prosthesis includes two
components--a humeral stem component and a spherical head
releasably coupled to the stem. Alternately, a three component
design is known in which the stem and shoulder are interconnected
with an adapter. In either of the two-piece or three-piece designs,
a radial offset or angulator inclination of the head relative to
the stem is provided in individual components. For example, in the
three-piece design, an adapter may be configured with a fixed
radial offset of 2 millimeters or an angular inclination of 5
degrees. Different radial offsets or angular inclinations are
achieved through the use of different adapters or heads. In this
regard, conventional modular shoulder prosthesis kits include
multiple redundant components such as adapters and heads to achieve
a range of prosthetic options. While providing an advantage over
the unitary design in reducing the number of components needed, a
rather large inventory of head components and/or adapter components
must be maintained to provide the desired range of geometric
configurations with the conventional modular shoulder prostheses.
Therefore, there is a need for modular shoulder prostheses which
are readily adaptable to provide a range of geometric
configurations, i.e. radial offsets of angular inclination while
minimizing the number of components required.
SUMMARY
[0007] In accordance with the present teachings, a modular joint
prosthesis system is provided. Specifically, a humeral component
for a total shoulder prosthesis includes an adapter and a head
component which cooperate to provide a range of radial offsets
and/or angular inclinations and which are adapted to be used in
conjunction with a stem.
[0008] In one embodiment, a humeral component for a total shoulder
prosthesis is provided for adjustable radial offset of the head
with respect to the stem. The shoulder prosthesis includes an
adapter interposed between a stem and a head. The adapter is
eccentrically coupled to the stem such that relative angular
positioning of the adapter on the stem will effect a first
adjustment in the radial offset. Likewise, the head component is
eccentrically coupled to the adapter as such that relative angular
position of the head on the adapter will effect a second radial
offset adjustment. By selectively positioning the adapter and the
head component with respect to the stem, an infinite adjustment of
the radial offset within a given range may be achieved. In one
example, indicia are provided at the interface between the adapter
and the head to indicate the offset vector (i.e., offset amount and
direction).
[0009] In another embodiment, a humeral component for a total
shoulder prosthesis is provided for adjustable angular inclination
of the head component relative to the stem component. The shoulder
prosthesis includes an adapter interposed between a stem and a
head. The adapter is coupled to the stem in a first angled or
non-orthogonal orientation such that relative rotational
positioning of the adapter on the stem will effect a first
adjustment in the direction of the angular inclination. Likewise,
the adapter is coupled to the head in a second angled or
non-orthogonal orientation as such that relative rotational
position of the head on the adapter will effect a second adjustment
in the direction of the angular inclination. By selectively
positioning the adapter and the head component with respect to the
stem, an infinite adjustment of the angular inclination within a
given range may be achieved.
[0010] In et another embodiment, the present teachings include an
adapter interposed between a stem and a head. The adapter includes
a ball stud having a shank coupled to the stem and a ring coupled
to the head. The ring has a spherical bearing surface which
cooperates with a ball portion of the ball stud such that an
angular adjusted between the ball stud and the ring may be
effected. The ring is eccentrically coupled to the head such that
relative angular positioning of the ring in the head will effect an
adjustment in the radial offset.
[0011] The joint prosthesis system of the present teachings
provides great flexibility in the adjustment of important
bio-kinematic parameters for the prosthesis systems while
minimizing the number of components required for the modular
system.
[0012] Also provided according to the present teachings is a
shoulder prosthesis comprising a stem having a first longitudinal
axis. The shoulder prosthesis can also include an adaptor including
a first taper. The first taper can have a first taper axis. The
shoulder prosthesis can also include a plurality of indicia. The
shoulder prosthesis can include a head rotatably supported by the
adaptor. The head can have a semi-spherical articulating surface.
The head can be coupled to the first taper and can be positionable
relative to the stem through rotation of the adaptor about the
first taper axis for adjusting a radial offset of the head relative
to the longitudinal axis of the stem. The plurality of indicia can
indicate an alignment of the radial offset.
[0013] Further provided is a shoulder prosthesis comprising a stem
having a longitudinal axis and a proximal face. The proximal face
can define a bore. The shoulder prosthesis can include an adaptor
having a first portion coupled to a second portion. At least a
portion of the first portion can be received within the bore of the
stem to couple the adaptor to the stem. The first portion can also
have a first diameter. The second portion can have a second
diameter different than the first diameter, and can define a first
taper. The adaptor can also include a plurality of indicia. The
shoulder prosthesis can include a head having a bottom face
opposite a semispherical reticulating surface. The bottom face can
have a second taper that mates with the first taper of the second
portion to couple the head to the adaptor. The rotation of the
adaptor relative to the stem can adjust the radial offset of the
head relative to the longitudinal axis of the stem. The plurality
of indicia on the adaptor can indicate an alignment of the radial
offset.
[0014] According to the present teachings, provided is a shoulder
prosthesis comprising a stem having a longitudinal axis and a
proximal face. The proximal face can define a bore. The shoulder
prosthesis can include an adaptor having a first portion opposite a
second portion. At least a portion of the first portion can be
received within the bore of the stem to couple the adaptor to the
stem. The first portion can have a first diameter and can be
positioned about a first axis. The second portion can have a second
diameter smaller than the first diameter. The second portion can
define a first taper and can be positioned about a second axis. The
second axis can be offset from the first axis. The adaptor can also
include a plurality of indicia. The shoulder prosthesis can also
include a head having a semispherical articulating surface and a
bottom face opposite the semispherical articulating surface. The
head can also include a third axis, which can be offset from the
first axis and the second axis. The bottom face can have a second
taper that mates with the first taper of the second portion to
couple the head to the adaptor. The rotation of the adaptor
relative to the stem can adjust the radial offset of the head
relative to the longitudinal axis of the stem. The plurality of
indicia on the adaptor can indicate an alignment of the radial
offset.
[0015] A femoral prosthesis system according to various embodiments
is disclosed. The system can include a femoral head having an
articulating surface defining a diameter and a generally opposed
surface, a head female taper formed into the femoral head through
the opposed surface, wherein a head center axis of the femoral head
is offset a first radial distance from a head taper center axis of
the head female taper. The system can further include an adapter
having a first side and a second generally opposed second side, the
adapter further having an outer surface defining an adapter male
taper and an adapter female taper formed into the adapter from the
first side, wherein the adapter has an adapter center axis offset a
radial distance from an adapter female taper axis. The system can
also include a femoral stem having a body and a neck, wherein the
neck extends at an angle relative to the body and the neck has an
outer surface that defines a neck male taper. The femoral head, the
adapter, and the neck are selectively connected to achieve a
selected femoral head offset relative to the femoral stem.
[0016] A femoral prosthesis system according to various embodiments
is disclosed. The system can include a femoral head sized and
shaped for articulation with at least one of an acetabulum or an
acetabular prosthesis. The femoral head can have an articulating
surface defining more than a hemisphere and a diameter, an opposite
surface generally opposed to the articulating surface, a head
female taper formed into the femoral head through the opposite
surface, and a head center axis of the femoral head is offset a
first radial distance from a head taper center axis of the head
female taper, wherein the head center axis is defined through a
portion of the articulating surface defining an axis of motion with
a pelvis of a patient. The system can further have an adapter
having a first side and a second side generally opposed to the
first side, the adapter further having an outer surface defining an
adapter male taper and an adapter female taper formed into the
adapter from the first side, wherein the adapter has an adapter
center axis offset a radial distance from an adapter female taper
axis. The system can also include a femoral stem having a body and
a neck, wherein the neck extends at an angle relative to the body
and the neck has an outer surface that defines a neck male taper.
The femoral head, the adapter, and the neck can be selectively
connected to achieve a selected femoral head offset relative to the
femoral stem.
[0017] A method of implanting a femoral prosthesis system according
to various embodiments is disclosed. The method can include
determining an anteversion angle of a femur relative to a pelvis of
the patient. The method can also include selecting an adapter
having an adapter center axis and an adapter offset connection,
wherein the adapter offset connection has an adapter connection
center axis and selecting a femoral head having a head center axis
and an offset head connection that has a head connection center
axis. The selected adapter can be rotated relative to the selected
femoral head to achieve a selected offset of the adapter connection
center axis relative to the head connection center axis. The
selected offset of the adapter connection center axis relative to
the head connection center axis can be based on the determined
anteversion angle.
[0018] Further areas of applicability will become apparent from the
description provided herein. It should be understood that the
description and specific examples are intended for purposes of
illustration only and are not intended to limit the scope of the
present teachings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The drawings described herein are for illustration purposes
only and are not intended to limit the scope of the present
teachings in any way.
[0020] FIG. 1 is an exploded front view of a modular shoulder
prosthesis system in accordance with the present teachings;
[0021] FIG. 2 is a normal view of the adapter and head components
of the device illustrated in FIG. 1 shown in an assembled
state;
[0022] FIG. 3 is an exploded front view of an alternate embodiment
of the modular shoulder prosthesis system illustrated in FIG.
1;
[0023] FIG. 4 is a cross-sectional view of the adapter and head
shown in FIG. 3 arranged to provide a maximum radial offset;
[0024] FIG. 5 is a cross-sectional view of the adapter and head
shown in FIG. 4 and arranged to provide a minimum radial
offset;
[0025] FIG. 6 is an exploded front view of a second alternative
embodiment of a modular shoulder prosthesis system according to the
present teachings;
[0026] FIG. 7 is a normal view of the adapter and head illustrated
in FIG. 6 shown in an assembled state;
[0027] FIG. 8 is an alternate embodiment of the modular shoulder
prosthesis system illustrated in FIG. 6;
[0028] FIG. 9 is a partial cross-sectional view showing the adapter
and head of FIG. 8 arranged to provide a maximum angular
inclination;
[0029] FIG. 10 is an illustration of the adapter and head similar
to that shown in FIG. 9 and arranged to provide a minimum angular
inclination;
[0030] FIG. 11 is an exploded front view of a third alternative
embodiment of a modular shoulder prosthesis system according to the
present teachings;
[0031] FIG. 12 is a normal view of the adaptor and head components
of the device shown in FIG. 11 oriented in a first position;
[0032] FIG. 13 is a normal view similar to FIG. 12 with the
components oriented in a second position;
[0033] FIG. 14 is an exploded plan view of a variable femoral
prosthesis, according to various embodiments;
[0034] FIG. 15 is a plan view along line FIG. 15-FIG. 15 of FIG.
14;
[0035] FIG. 16A is a cross-section view of a variable femoral head
in a first orientation;
[0036] FIG. 16B is a plan view of a variable femoral head in a
second orientation;
[0037] FIG. 16C is a plan view of a variable femoral head in a
third orientation;
[0038] FIG. 17 is a cross-section view of a variable femoral head
in a fourth orientation;
[0039] FIG. 18 is an exploded plan view of a variable femoral
prosthesis, according to various embodiments;
[0040] FIG. 19 is an environmental view of an implanted variable
hip prosthesis;
[0041] FIG. 20 is an environmental view of a variable femoral
prosthesis illustrating variable varus and valgus positions;
and
[0042] FIG. 21 is an environmental view of a variable femoral
prosthesis illustrating variable anteversion and retroversion
positions.
DETAILED DESCRIPTION
[0043] The following description is merely exemplary in nature and
is not intended to limit the present teachings, application, or
uses. It should be understood that throughout the drawings,
corresponding reference numerals indicate like or corresponding
parts and features. Although the following description is related
generally to a modular joint prosthesis system which provides
adjustment of the radial offset and/or angular inclination of the
head relative to the stem, it will be understood that the system as
described and claimed herein can be used in any appropriate
surgical procedure. Thus, it will be understood that the following
discussions are not intended to limit the scope of the present
teachings and claims herein.
[0044] With reference now to FIG. 1, shoulder prosthesis 20 in
accordance with the present teachings is illustrated to include a
stem 22, an adapter 24 and a head 26. Stem 22 includes a rod
portion 28 adapted to be received in the medullary canal of the
humerus. A plurality of fins 30 are formed near the upper end of
rod 28 for locating and fixing the stem within a humerus. A male
taper 32 extends obtusely from rod 28 to provide a location for
interconnecting stem 22 with adapter 24. Male taper 32 extends from
stem 22 along axis 34. Stem 22 is of the type manufactured and sold
by Biomet, Inc. as a component in its Bi-Angular.RTM. Shoulder
System.
[0045] Adapter 24 is a generally cylindrical disc having a female
taper 36 formed therein for receiving male taper 32 of stem 22. The
outer surface 38 of adapter 24 defines a male taper. Female taper
36 is eccentrically located in adapter 24 such that central axis 34
of female taper 36 is not collinear with central axis 40 of adapter
24. Instead, central axis 40 is radially offset from central axis
34 by an amount indicated as ra.
[0046] Head 26 includes a semispherical surface 42 defined about
central axis 44. Bottom face 46 is formed opposite semispherical
surface 42 and has a female taper 48 formed therein which is
configured to receive adapter 24 along central axis 40. In this
regard, female taper 48 is formed eccentrically within head 26 such
that a radial offset r.sub.b exists between central axis 40 and
central axis 44.
[0047] As previously described, the eccentric relationship of
central axes 34, 40 and 44 provide an arrangement whereby a
relative rotational positioning of adapter 24 with respect to head
26 adjusts the radial offset within a given range. As best seen in
FIG. 2, relative positioning of adapter 24 within female taper 48
of head 26 causes centroid 50 defined by female taper 36 to trace a
helical path 52 relative to centroid 54 defined by central axis 40.
Helical path 62 terminates at centroid 56 defined by central axis
34. A maximum radial offset is achieved when centroid 50 is located
directly opposite centroid 56. Similarly, a minimum offset is
achieved when centroid 50 aligns with centroid 56. In one example,
the maximum radial offset is 10 mm and the minimum radial offset is
0 mm. However, one skilled in the art will recognize that the range
of offset may be modified based on the design criteria for a given
modular prosthesis system.
[0048] With continuing reference to FIG. 2, the shoulder prosthesis
20 is provided with indicia 64 facilitating adjustment and
alignment of the radial offset. Specifically indicia 60 includes a
first set of indicators 62 formed on adapter 24 and a second set of
indicators 64 formed on bottom face 46 of head 26. First and second
indicators 62, 64 have a magnitude value associated therewith
indicating the amount of radial offset. Furthermore, head
indicators 64 include an enlarged arrowhead which indicate the
direction of the radial offset. In this manner, indicia 60 provide
a radial offset vector which may be utilized to precisely align
adapter 24 and head 26 and achieve the desired radial offset.
[0049] For example, as shown in FIG. 2, adapter indictor 62.10
associated with a 10 millimeter offset is aligned with head
indictor 64.10 associated with 0,10 offset. Thus, the relative
angular position of adapter 24 with respect to head 26 shown in
FIG. 2 provides a 10 millimeter offset and the direction of the
offset is indicated by arrowhead 64.10. The radial offset may be
reduced by removing adapter 24 from head 26, rotating adapter 24
until indicia 60 are properly aligned and inserting adapter 24 into
female taper 48 of head 26. For example, an offset of 4 millimeters
would be obtained by aligning adapter indictor 62.4 with head
indictors 64.4 at which point a 4 millimeter offset in the
direction of arrowhead 64.4 would be achieved. In one example, a
threaded through bore 66 may be formed in adapter 24 for receiving
a threaded member to facilitate a disassembly of adapter 24 from
head 26. In certain applications, a removeable plug (not shown) in
the form of a bio-compatible cement or the like may be disposed in
bore 66 to minimize joint fluid from entering the interface between
the adapter 24 and the head 26 through the bore 66.
[0050] With reference now to FIGS. 3 through 5, an alternate
embodiment of the present teachings is illustrated in which the
adapter has a first male taper adapted to engage the stem and a
second male taper adapted to engage the head. With reference now to
FIG. 3, stem 22' includes a rod portion 28' and a female taper 32'
formed in the end opposite rod 28' which defines central axis 34'.
Stem 22' is of the type manufactured and sold by Biomet as a
component of its Bio-Modular.RTM. Shoulder System. Adapter 24' has
a first male taper 36' adapted to be inserted into female taper 32'
and a second male taper 38' formed along central axis 40'. Head 26'
includes a semispherical surface 42' defined about central axis
44'. Bottom face 46' has a female taper 48' formed therein which is
adapted to receive male taper 38' of adapter 24'. Central axis 40'
is offset from central axis 34' as indicated at ra' and central
axis 44' is offset from central axis 40' as indicated at r.sub.b'.
As in the first embodiment, relative rotational positioning of
adapter 24' and head 26' provides an adjustable radial offset for
shoulder prosthesis 20'.
[0051] With reference now to FIG. 4, central axis 34' of male taper
36' is located directly opposite central axis 44' of head 26' to
provide a maximum radial offset. With reference now to FIG. 5, head
26' has been rotated 180 degrees relative to adapter 24' such that
central axis 44' is collinear with central axis 34'. In this
orientation, a minimum radial offset is provided. Indicia similar
to that described above with reference to FIG. 2 facilitates
alignment of shoulder prosthesis 20'.
[0052] Based on the foregoing detailed description, one skilled in
the art will readily recognize that one aspect of the present
teachings is directed to an adapter and head having eccentric
configurations such that a relative rotation therebetween provides
an adjustable range of offset configuration.
[0053] With reference now to FIGS. 6 through 10, a second
alternative embodiment of the present teachings is illustrated
which provides for adjustment of the angular inclination between
the stem component and the head component in a manner similar to
that described with reference to the radial offset. Specially, the
shoulder prosthesis system 120 of the second alternative embodiment
includes a stem 122, a head 124 having a first angular orientation
and an adapter 126 interconnecting the stem 122 and the head 124
such that the adapter 126 has a second angular inclination. The
adapter 124 is configured to be rotatably positionable with respect
to the head 126 such that the angular inclination of the head 126
relative to the stem 122 may be adjusted.
[0054] With specific reference to FIG. 6, shoulder prosthesis 120
includes stem 122 having rod 128 extending therefrom. A plurality
of fins 130 are formed longitudinally along rod 128 parallel to
central longitudinal axis A near the upper end of stem 122. A male
taper 132 extends from rod 128 at an obtuse angle a with respect to
the central longitudinal axis A and defines a central axis 134.
[0055] Adapter 124 is a generally cylindrical disc having a female
taper 136 formed therein. The outer surface of adapter 124 defines
a male taper 138. The central axis 140 of adapter 124 is configured
at a first angular orientation with respect to central axis 134.
Specifically, central axis 140 is defined by the angle at which
female taper 130 is oriented relative to the bottom surface 125 of
adapter 124. In one example, central axis 140 is disposed at a +5
degree angular inclination with respect to central axis 134.
[0056] Head 126 includes a semispherical surface 142 and a flat
bottom face 146 having a female taper 148 formed therein. Female
taper 148 defines central axis 144 which is disposed at an angular
inclination relative to a central axis 140. Specifically, central
axis 144 is defined by the angle at which female taper 144 is
oriented relative to bottom face 146. In one example, central axis
144 is disposed at a -5 degree angular inclination with respect to
central axis 140.
[0057] The relative rotational position of adapter 124 with respect
to the head 126 defines the adjustment to the prosthesis
inclination relative to central axis 34. For example, as
illustrated in FIG. 6, adapter 126 provides a +5 degree inclination
which is canceled by the -5 inclination provided in head 126. Thus,
when adapter 124 and head 126 are assembled a net zero angular
inclination is achieved. An angular adjustment may be provided by
rotating adapter 124 relative to head 126 such that a net angular
inclination is provided. For example, when adapter 124 is rotated
clockwise 90 degrees, the angular inclination of central axis 140
combines with the angular inclination of central axis 144 to
provide a +5 degree angular inclination of head 126 relative to
central axis 134. Likewise, an additional 90 degree rotation of
adapter 124 will provide an overall adjustment of +10 degrees in
the angular inclination. In one example, a range of angular
inclination is provided between OQ and IOQ. However, one skilled in
the art will recognize that the range of angular inclination may be
modified based on the design criteria for a given modular
prosthesis system.
[0058] With continuing reference to FIG. 7, adapter 124 and head
126 are provided with inclination indicia 160 which facilitates
identification of the magnitude and direction of the angular
inclination provided by shoulder prosthesis system 120.
Specifically, angular indicia 160 includes a first indictor 162 on
adapter 124 and a plurality of second indicators 164 provided on
bottom face 146 of head 126. Adapter indicator 162 is an arrowhead
which indicates the direction of the angular inclination. Head
indicators 164 provide a magnitude of angular inclination as well
as an alignment mark which cooperates with adapter indictor 162 to
provide the angular inclination vector (i.e. magnitude and
direction).
[0059] With reference now to FIGS. 8 through 10, an alternate
embodiment to the second alternative embodiment is illustrated in
which the adapter has a first male taper adapted to engage the stem
and a second male taper adapted to engage the head. With reference
now to FIG. 8, stem 122' includes a rod portion 128' and a female
taper 132' formed in the end opposite rod 128' which defines
central axis 134'. Adapter 124' has a first male taper 136' adapted
to be inserted into female taper 132' and a second male taper 138'
formed along central axis 140'. Head 126' includes a semispherical
surface 142' defined about central axis 144'. Bottom face 146' has
a female taper 148' formed therein which is adapted to receive male
taper 138' of adapter 124'. Central axis 140' is angularly inclined
relative to central axis 34' and central axis 144' is angularly
inclined relative to central axis 140'. Relative rotational
positioning of adapter 124' and head 126' provides an adjustable
angular inclination for shoulder prosthesis 120'.
[0060] With reference now to FIG. 9, the angular inclination of
central axis 134' of male taper 136' is complementary with the
central axis 144' of head 26' to provide a maximum angular
inclination. With reference now to FIG. 10, head 126' has been
rotated 180 degrees relative to adapter 124' such that the angular
inclination of central axis 144' is opposing central axis 134' to
provide a minimum angular inclination.
[0061] From the foregoing description of various embodiments, one
skilled in the art will readily recognize that the present
teachings are directed to a modular shoulder prosthesis in which
the radial offset and/or the angular inclination (i.e. inversion
and retroversion) of the head relative to the stem may be adjusted
by relative rotational positioning of an adapter interdisposed
between the stem and head components of the shoulder prosthesis. In
this way, a range of radial offsets and/or angular inclinations may
be provided without requiring numerous additional components. The
various embodiments have discussed a radial offset adjustment or an
angular inclination adjustment independently; however, one skilled
in the art will readily recognize that a shoulder prosthesis system
may incorporate both aspects of a radial and angular adjustment.
Where a single adapter utilized to interconnect the stem and the
head, an interrelationship exists between the radially offset
adjustment and the angular inclination adjustment. In combination,
a system could be employed which utilized two intermediate adapters
such that the radial offset and angular inclination adjustment are
isolated and thus independent. For example, the interface between a
first adapter and a second adapter would provide the desired radial
adjustment as described in particular reference to the first
embodiment and the interface between the second adapter and the
head would provide the angular inclination as described with
reference to the second alternative embodiment. In such a system,
each of the radial offset and angular inclination adjustments would
be provided by a single interface, thereby minimizing the
interrelation between both adjustments resulting from a single
intermediate adapter.
[0062] With reference now to FIGS. 11-13, a third alternative
embodiment of the present teachings is illustrated which provides
for adjustment of both the radial offset and the angular
inclination. Specifically, the shoulder prosthesis 210 is provided
and includes a stem 212, an adaptor 214 and a head 216. The stem
212 includes a longitudinal axis A along its length and further
includes a rod portion 218 adapted to be received into the
medullary canal of the humerus. A plurality of fins 220 are formed
near the proximal end of the rod 218 for locating and fixing the
stem 212 within the humerus whereby the proximal end of the rod 218
has a substantially larger body than that of the distal end and
includes a proximal face 222 having a bore 224 formed therein along
a central axis 226 for receiving the adaptor 214. The proximal face
222 extends from the stem 212 along axis 226 and provides a
location for interconnecting the stem 212 with the adaptor 214.
Further, the proximal face 222 provides sufficient clearance for
angular and radial adjustments of the adaptor 214 and the head 216
as will be discussed in more detail below.
[0063] The adaptor 214 is a generally cylindrical member including
an outer ring 228 having a central axis 230 and a ball stud 232
rotatably connected to the ring 228. The ring 228 includes an
attachment aperture 234 having a central axis 236
formed therethrough for rotatable engagement with the ball stud
232. The ring 228 further includes an outer surface having a male
taper 238 for engagement with the head 216.
[0064] The ball stud 232 includes a shank segment 233 for
engagement with the bore 224 of the stem 212 and a divided ball
segment 240 for attachment to attachment aperture 234 of the ring
228. The ball stud 232 further includes a second bore 242 formed
therein for interaction with a fastener 244 for selectively
securing the ring 228 to the ball stud 232 in a fixed orientation.
Fastener 244 includes a wedge portion 254 and a set screw 256 as
best shown in FIG. 11. Set screw 256 is received by a central bore
of the wedge 254, whereby as the set screw 256 is driven into the
wedge 254, the wedge 254 expands within the attachment aperture 234
of the ring 228 thereby securing the ring 228 and ball stud 232 in
a fixed relationship. In this regard, the central axis 236 of the
ball stud 232 is concentric with central axis 226 of the proximal
face 222 and is received by the attachment aperture 234 such that
the central axis 236 of the ball stud 232 is eccentric to the
central axis 230 of the ring 228 as indicated by ra.
[0065] The head 216 is rotatably supported by the adaptor 214 and
includes a semispherical surface 246 defined about a central axis
248 adapted for mating engagement with the glenoid cavity of a
scapula. The head 216 further includes a bottom surface 250 formed
opposite the semispherical surface 246 having a female taper 252
for mating engagement with the male taper 238 of the ring 228. In
this regard, the female taper 252 is received eccentrically within
the head 216 such that a radial offset r.sub.b exists between the
central axis 230 of the ring 228 and the central axis 248 of the
head 216. While the present teachings disclose a head 216 for
mating engagement with the glenoid cavity of a scapula, it is
anticipated that the head 216 could also be received by a
prosthetic device replacing a severely damaged glenoid cavity and
should be considered within the scope of the present teachings.
[0066] As previously described, the eccentric relationship of the
central axes 230, 236 and 248 provides an arrangement whereby a
relative rotational positioning of the adaptor 214 with respect to
the head 216 or a relative rotational positioning of the adaptor
214 with respect to the ball stud 232 or a combination thereof
adjusts the radial offset of the head 216 relative to the
longitudinal axis A of the stem 212.
[0067] With particular reference to FIG. 13, relative positioning
of the head 216 to the longitudinal axis A of the stem 212 is
accomplished by a first radial adjustment method. In the first
radial adjustment method, the relative positioning of the ring 228
within the female taper 252 of the head 216 causes the central axis
248 of the head 216 to be rotated relative to the central axis 230
of the ring 228. The radial offset between the central axis 248 and
the central axis 230 is again denoted by rb at its minimum and by
rb' at its maximum value. FIG. 12 further traces the movement of
axis 248 from rb to rb' as indicated by path 249, while each
position along path 249 signifies a potential adjustment of the
head 216 relative to the longitudinal axis A of the stem 212.
[0068] With particular reference to FIGS. 12 and 13, relative
positioning of the head 216 to the longitudinal axis A of the stem
212 is accomplished by a second radial adjustment method. In the
second radial adjustment method, the relative positioning of the
central axis 230 of the ring 228 and the central axis 236 of the
ball stud 232 causes the central axis 248 of the head 216 to be
rotated. Again, ra is used to designate the minimum offset between
the central axis 230 of the ring 228 and the central axis 236 of
the ball stud 232 while ra' is used to designate the maximum
offset. FIG. 13 further traces the movement of axis 248 from ra to
ra' as indicated by path 251, while each position along path 251
signifies a potential adjustment of the head 216 relative to the
longitudinal axis A of the stem 212. For discussion purposes, the
head 216 does not rotate relative to the ring 228 when making an
adjustment of the ball stud 232 relative to the ring 228, but it
should be understood that both adjustment methods could be used
concurrently to achieve an overall desired radial offset of the
head 216 relative to the longitudinal axis A of the stem 212.
[0069] In addition to providing a radial offset, the shoulder
prosthesis 210 further provides an angular adjustment of the head
216 relative to the longitudinal axis A of the stem 212 for both
inversion and retroversion adjustments. As best shown in FIG. 13,
the central axis 248 of the head 216 rotates about the central axis
236 of the ball stud 232, which is concentric with the central axis
226 of the first bore 224. As previously discussed, the divided
ball segment 240 of the ball stud 232 rotatably supports the ring
228 while the ring 228 supports the head 216. By articulating
either the head 216 or the ring 228, the ring 228 will rotate on
the divided ball segment 240 of the ball stud 232, thereby
providing the head 216 with an angular adjustment relative to the
longitudinal axis A of the stem 212. For discussion purposes, the
first and second radial adjustment methods are not utilized while
making an angular adjustment of the head 216, however, it should be
understood that both adjustment methods may be used concurrently
with the angular adjustment method and with one another to achieve
an overall desired angular and radial relationship of the head 216
relative to the longitudinal axis A of the stem 212.
[0070] With continuing reference to FIGS. 12 and 13, the shoulder
prosthesis is provided with indicia 260 facilitating adjustment and
alignment of the radial offset. Specifically, indicia 260 includes
a first set of indicators 262 formed on the ring 228 and a second
set of indicators 264 formed on the bottom face 250 of the head
216. First and second indicators 262, 264 have a magnitude value
associated therewith indicating the amount of radial offset.
Furthermore, the head indicators 264 include an enlarged arrowhead
which indicates the direction of the radial offset. In this manner,
indicia 260 provide a radial offset vector which may be utilized to
precisely align the adaptor 214 and the head 216 and achieve the
desired radial offset.
[0071] Disclosed above is a prosthesis that can be used in various
embodiments to repair a proximal portion of a humerus. The
prosthesis, according to various embodiments, can also be used to
repair or replace a proximal portion of a femur 522 (FIG. 19). A
variable femur prosthesis 300 is illustrated in FIG. 14. The
variable femoral prosthesis 300 can include portions similar to the
prosthesis illustrated in FIG. 1 as described further herein. For
example, the variable femoral prosthesis 300 can include a stem
302, an adapter 304, and a femoral head 306. Each of the stem 302,
the adapter 304, and the femoral head 306 can be similar to
prosthetic portions, such as those described above, but formed to
replace a proximal femoral portion. In addition, the various
portions of the femoral prosthesis 300 can be similar to those
commercially available, such as the Femoral Prosthesis sold as the
Magnum.TM. Femoral Prosthesis sold by Biomet, Inc.
[0072] The stem 302 can include a rod portion 310 that is formed to
be positioned within a femoral canal that can be reamed or formed
within a femur, as illustrated in FIG. 19. The rod 310 can extend
along an axis 312 and can terminate at an upper edge 314 that can
be positioned near a proximal portion of the femur. A neck 316 can
extend from a proximal portion or terminal end of the rod 310. The
neck 316 can include an external surface that defines a male taper
318. The neck 316 can extend along an axis 320. The neck axis 320
and the rod axis 312 can form an angle 322 relative to one another.
The angle 322 can generally be an obtuse angle.
[0073] The adapter 304 can be formed to include an external surface
330 that defines a male taper. The adapter 304 can also terminate
in a surface 332. A central axis 334 can be an axis that is defined
through a center of the male taper 330 or the end surface 332. A
female taper 340 can also be defined by a depression or bore of the
adapter 304. The female taper 340 can define a central axis 342
that is eccentric or offset by a radial offset ra. The radial
offset ra can be about 0.1 millimeters (mm) to about 10 mm, and
further can be about 0.1 mm to about 5 mm, and can further be about
3 mm to about 5 mm, inclusive. Accordingly, the radial offset ra of
the adapter 304 can allow the adapter 304 to have an edge that is
positioned a greater distance from the neck 316 that another edge,
as discussed further herein.
[0074] The adapter 304 can further include a further tapered
surface or stem facing taper surface 350 that can assist in
providing clearance around the neck 316 relative to the femoral
stem 302. Additionally, depressions, such as a depression 352 can
assist in inserting or engaging the adapter 304 into the head 306.
It will be further understood, however, that the adapter 304 can
include a threaded aperture similar to the threaded aperture 66
discussed above for removal of the adapter 304 from the head
306.
[0075] The femoral head 306 can be formed to have an exterior
articulating surface 360 that is substantially smooth or otherwise
provided to articulate with a portion of either an acetabular
prosthesis or a natural acetabulum of a patient. The exterior
surface 360 of the femoral head 306 can define any selected portion
of a sphere. For example, the exterior surface 360 can define a
hemisphere or more than a hemisphere. The femoral head 306 can also
include a stem facing surface 362 into which the articulating
surface 360 terminate. The stem facing surface 360 can be
substantially flat or in an appropriate configuration to allow for
clearance of the anatomy relative to the femoral head 306.
[0076] Formed into the femoral head 306 through the stem facing
surface 362 can be a female taper 364. The female taper 364 can
define a taper axis 366 that is generally defined through a center
of the female taper 364. The femoral head 306 can define a head
middle axis 368 that is generally defined through a center of the
femoral head 306. The taper axis 366 and the head axis 368 can be
offset from one another radially by a radial offset r.sub.b. The
head radial offset r.sub.b can be any appropriate offset, such as
within the range discussed above. For example, the head radial
offset r.sub.b can be about 0.1 mm to about 10 mm, further can be
about 0.1 mm to about 5 mm, and can further be about 3 mm to about
5 mm, inclusive. Accordingly, the femoral head 306 can include an
external edge or surface that extends beyond or is positioned away
from a portion of the neck 316 in a first direction and a lesser
distance away from the neck 316 in another direction.
[0077] As discussed above and further herein, the male taper 318,
the female taper 340, the male taper 330, and the female taper 364,
can be formed of any appropriate taper dimension. For example, a
morse type taper or other self locking taper configurations can be
provided. Self locking tapers generally have complimentary angles
of about 3-5 degrees. Accordingly, the male taper can have an
external taper angle of about 3-5 degrees from a central axis while
the female taper can have an internal complimentary taper of about
3-5 degrees central axis of the female taper. The taper dimensions
can allow for a sufficiently locking configuration or fixed
configuration between the female and female tapers when
interconnected.
[0078] The femoral head 306 can be generally spherical and include
a center 380 where a radius extends from the center 380 to the
surface 360 of the femoral head 306. The radius 382 can be any
appropriate size, such as about 10 millimeters (mm) to about 50 mm,
including about 10 mm to about 35 mm, and further including about
11 to about 11 mm. The femoral head 306 can define a portion of a
sphere generally to the flat or rear side 362. The portion of the
sphere defined by the femoral head 306 can be an appropriate mount
such as about 50% to about 95%, about 55% to about 90%, and further
including about 60% to about 80%. Accordingly, the femoral head 306
can define more than a hemisphere of a sphere. The articulating
surface 360 can be provided to articulate for a selected range of
motion with the acetabular prosthesis or acetabulum of the patient
with a greater portion of the sphere defined by the femoral head
306.
[0079] With reference to FIG. 15, a view from plane FIG. 15 in FIG.
14 is illustrated. Generally, the rear surface 362 of the femoral
head 306 is illustrated. The femoral head 306 defines the female
taper 364 discussed above. Positioned within the female taper is
the adapter 304. As illustrated in FIG. 15, the adapter 304, when
positioned within the female taper 364 defined by the femoral head
306, is offset by the radial offset r.sub.b such that a first
distance 390 is defined from one edge of the adapter 304 to a first
edge of the stem facing side 362 and a second distance 392 is
defined between the adapter 304 and a second edge of the stem
facing side 362. The first distance 390 can differ from the second
distance 392. The radial offset rb, therefore, positions the
adapter 304 in a non-central or off center axis location within the
femoral head 306. Additionally, the female taper 340 of the adapter
304 is offset a first distance 394 from a first edge of the adapter
in a second distance 396 from a second side of the adapter 304. The
first distance 394 and the second distance 396 can differ.
Accordingly, the female taper 340 includes the radial offset ra
within the adapter 304.
[0080] It is further understood that the male and female tapers in
the respective femoral head 306 and adapter 304 can be reversed.
Similarly, the male taper 318 of the neck 316 and the female taper
340 of the adapter can be reversed. Thus, although respective axes
of the male and female tapers can be maintained at radial offset
positions, as discussed above, the taper connections can be
reversed in selected embodiments.
[0081] The female taper 340 can be offset from the center axis 366,
as illustrated in FIG. 15. The adapter 304, however, can be rotated
within the female taper 364 within the femoral head 306.
Accordingly, the center 342 of the female taper 340 in the adapter
304 can move along an ellipsis 400 by rotating the adapter 304
relative to the femoral head 306.
[0082] The ellipsis 400 can be similar to the ellipsis 52 discussed
above relative to the prosthesis 26. Accordingly, the center 342 of
the female taper 340 of the adapter 304 can be moved relative to
the center 366 of the femoral head 306. The amount of offset from
the center 366 of the femoral head 306 can be defined by the amount
of rotation of the adapter 304 relative to the femoral head 306.
The amount of rotation can be indicated by a first marking 402 on
the adapter 304 and one or more markings 404 positioned on the stem
facing side 362 of the femoral head 306. The adapter marking 402
can be similar to the markings 62 discussed in FIG. 2. The femoral
head marking 404 can also be similar to the prosthesis markings 64
discussed in FIG. 2. Accordingly, the amount of offset that will be
achieved by positioning the adapter 304 at a selected rotational
position within the femoral head 306 can be determined by matching
the indications 402 on the adapter 304 with markings 404 on the
femoral head 306 and referring to the result. Appropriate markings
can be provided to indicate an amount of change at about 1 degree
changes and/or about 2 degree markings. Generally, a maximum amount
of ante version angle change markings can include about five
degrees to about 10 degrees. Similarly, the markings can show varus
and valgus position and rotation or selection of position of the
head can be used to achieve a selected varus and valgus offset.
[0083] As discussed further herein, the radial offset rb of the
femoral head 306 and the radial offset ra of the adapter 304 can be
used to compensate for or achieve a selected amount of anteversion
or angle offset required due to acetabular prosthesis placement in
or natural acetabular anatomy of a patient. For example, an
anteversion of a patient can be about five degrees to about 10
degrees. A prosthesis, however, positioned within a femur is
positioned at a selected orientation and must articulate with the
acetabulum or an acetabular prosthesis in an appropriate manner. If
a femoral prosthesis is positioned within the femur at an
orientation that does not allow for an achievement of a selected
anteversion, the adapter 304 can be rotated to a selected position
relative to the femoral head 306 to allow for the femoral head 306
to be positioned at a selected orientation relative to the
remaining anatomy of the patient when connected to the neck 316.
The head 306 and adapter 304 can, therefore, achieve a range of
offset angles between the femur and the pelvis. Accordingly, the
adapter 304 and the femoral head 306 can be provided to minimize
inventory of selected femoral heads, femoral stem prosthesis to be
positioned of the femur. Also, the range of offsets can allow for a
selected orientation of the femoral prosthesis to be placed in the
femur bone of the patient to maintain a selected bone mass relative
to the femoral prosthesis. Moreover, an offset can be selected to
compensate for less than optimal femural stem 302 placement or
acetabular prosthesis placement.
[0084] With continuing reference to FIG. 15 and addition reference
to FIGS. 16A, 16B, 16C, and 17, exemplarily placements of the
adapter 304 relative to the femoral head 306 are illustrated. With
initial reference to FIG. 16A, the femoral head 306 includes or
defines the center head axis 368, as discussed above. The female
taper 340 and the adapter 304 defines the middle axis of the taper
342. When rotated to a selected position and the adapter 304 is
positioned in the femoral head 306, a selected offset of 410 can be
achieved. The offset of 410 can be a maximum offset of the center
of the female taper 342 relative to the center of the femoral head
368. The maximum offset 410 can be any appropriate amount such as
about one mm to about 20 mm, including about two mm to about 15 mm,
and further including about 2 mm to about 10 mm. The amount of
offset can be selectively achieved, by rotating the adapter 304, as
discussed in relation to FIG. 15.
[0085] As illustrated in FIGS. 16B and 16C the adapter 304 can also
be rotated to move the taper 340 in a direction transverse to a
line or axis 307 defined by the back face 362 of the femoral head
304. The line 307 can be a center line of the head, or any other
line that is generally in the same plane or parallel to a plane of
the back surface 362. Generally, the line 307 is provided to
illustrate a "right" or "left" movement of the taper 340 relative
to the head 306. "Right" and "left", here, are understood to be
relative terms, used to identify relative movement of the taper 340
and not necessarily an actual direction of the taper 340.
[0086] Regardless, as illustrated in FIG. 16B the taper 340 can be
positioned a distance 307a to the "right" of the line 307. The
taper 340, however, is a distance 309a from a line 309 defined
relative to the head 306. The adapter 304 can also be rotated
relative to the head 306 to place the taper 340 a distance 307b to
the "left" of the line 307, as illustrated in FIG. 16C. When the
taper 340 is to the "left," however, the taper 340 can maintain the
distance 309a from the line 309. Thus, the taper 340 can be rotated
"left" or "right" relative to the head 306 (e.g. to create selected
anteversion or retroversion offset, as illustrated in FIG. 21). In
rotating the adapter 304, however, the taper 340 can also be moved
"up" and "down" (again it is understood that "up" and "down" are
merely for descriptive differences in position and not necessarily
absolute positions of the taper 340) as illustrated in FIG. 16A
(e.g. to create selected varus and valgus offset as illustrated in
FIG. 20).
[0087] By rotating the adapter 304, relative to the femoral head
306, an offset of about, nearly, or exactly zero can also be
achieved when the center of the femoral head 368 and the center of
the female taper 342 are substantially aligned, as illustrated in
FIG. 17. It will be understood that having substantially zero
offset can be understood to include a small amount of error offset
that is due to manufacturing tolerances, thus, a zero offset may
actually be a non-zero amount. However, substantially no offset can
be about 0.0 mm to about 0.3 mm, including amount 0.0 mm to about
0.02 mm and further including about 0.01 to about 0.015 mm.
[0088] As discussed above, by rotating the adapter 304 relative to
the femoral head 306, the selected offset can be achieved between
the maximum "UP" offset 410, as illustrated in FIG. 16A and
substantially zero offset 412, illustrated in FIG. 17.
Additionally, "left" and "right" offset can be achieved by rotating
the adapter 304. Accordingly, the single combination of the adapter
304 and the femoral head 306 can allow for a femoral prosthesis to
be positioned within the patient at any of the plurality of offsets
achievable by rotating the adapter 304 relative to the femoral head
306. Additionally, in various embodiments, the interconnection of
the adapter 304 with the femoral head 306 can be achieved with
substantially no further adhesives or connection mechanism between
the various components, including the adapter 304, the femoral head
306, and the femoral stem 302. It will be understood, however, that
in selected embodiments additional connection mechanisms can be
provided between the various components. For example, adhesives or
other materials can be positioned to interconnect the various
components. For example, a mechanical interconnection, such as a
screw or the like, can be provided through various tapped or
untapped holes formed within the femoral head 306 or the adapter
304. Additionally, as discussed further herein, various portions of
the prosthesis, according to various embodiments, can be
interconnected with fixation or locking portions to allow for
achieving a selected orientation of the femoral head relative to a
femoral stem.
[0089] With reference to FIG. 18, a variable femoral prosthesis 450
is illustrated. The variable femoral prosthesis 450 can be similar
to the prosthesis 410 illustrated above in FIG. 11. However, the
femoral prosthesis can include a femoral stem 452 that extends
along a first axis 454 and a neck portion 456 that extends along a
second axis 458. Generally, an angle 459 can be defined between the
stem axis 454 and the neck axis 458. The angle 459 can be an
appropriate angle, such as an obtuse angle. The neck 456 can
further define a bore 460 for receiving a ball stud 462.
[0090] The femoral prosthesis 450 further includes an adapter 464.
The adapter 464 can define an exterior surface or male taper 466.
Additionally, the adapter 464 defines an attachment aperture 468
for rotatable engagement with the ball stud 462. The ball stud 462
includes a divided ball segment 470 through which a fastener 472
can engage an internal bore 474. The fastener 472 first passes
through a wedge 476 and fixes the wedge 476 within the divided ball
portion 470 once the divided ball portion 470 is in the attachment
aperture 468. Accordingly, the wedge 476 can wedge the divided ball
portion 470 to engage the attachment aperture 468 and the fastener
472 can hold the wedge relative to the divided ball portion 470
within the adapter 464. Accordingly, the adapter 464 can be fixed
relative to the neck 456. The divided ball portion 470 can also be
made as one piece with the neck 456.
[0091] A femoral head 480 can include an articulation surface 482
similar to the articulation surface of the femoral head 306
discussed above. Additionally, the femoral head 480 can include a
stem facing surface 484 into which a female taper 486 is defined.
Thus, the articulation surface 482 of the head 480 can define more
than a hemisphere or selected portion of a sphere, as discussed
above. For example, the articulation surface 482 can be about 55%
to about 95% of a sphere, including about 60% to about 80%,
inclusive.
[0092] The femoral head 480 can define a central axis 490.
Additionally, the adapter 464 defines an adapter central axis 492
and an aperture central axis 494 is defined through the adapter and
the attachment aperture 468. The central axis 494 through the
attachment aperture 468 is eccentric or readily offset by a
distance ra from the central axis 492 of the adapter 464.
Additionally, a center axis 496 through the taper 486 in the
femoral head 480 can be defined. Accordingly, a radial offset of n,
between the center axes of the head 490 in the center axis of the
taper 486 can be formed. In this manner, the center axis 492 of the
adapter 464 can be positioned substantially in the center or
aligned with the center axis 496 of the taper 486, but is offset by
the radial distance rb from the center of the head axis 490. As
discussed above, in relation to FIGS. 11-13, the adapter 464 can be
rotated relative to the ball stud 462 and the femoral head 480 can
be rotated relative to the adapter 464 to achieve selected radial
offsets of the femoral head 480 relative to the femoral neck 456.
As discussed above, the adapter 464 can be rotated relative to the
ball stud 232 that is fixed and within the neck 456 to achieve
selected offsets due to the radial offset ra of the center of the
ball stud 462 relative to the center axis 492 of the adapter 464.
Similarly, rotating the femoral head 480 relative to the adapter
464 achieves a selected offset due to the radial offset rb of the
center axis 490 of the femoral head and center axis 496 of the
taper 486. Again, appropriate offsets can be achieved within the
range as discussed above for achieving a selected implantation
offset within a patient.
[0093] With reference to FIG. 19, a femoral prosthesis according to
various embodiments can be positioned relative to a pelvis 520 of a
patient. The femoral prosthesis can be a part of a system that can
include an acetabular prosthesis or a prepared acetabulum. An
acetabulum can be prepared to receive a femoral head, such as the
femoral head 306 or an acetabular prosthesis 522 can be positioned
within the prepared acetabulum 520. It will be understood, however,
that the femoral head 306, according to various embodiments, can
articulate with the prosthetic acetabulum or with a natural
acetabulum. Additionally, the femoral stem can be positioned in a
femur 524 such as the femoral stem 302. The adapter 304 can be
positioned within the femoral head 306 in an appropriate manner to
achieve an alignment along a selected axis, such as an articulation
axis 526 to achieve a selected position, such as an anteversion or
other offset position, as discussed herein, of the femur 524
relative to the pelvis 520 after implantation. As discussed above,
the adapter 304 can be rotated relative to the femoral head 306 to
achieve the selected offset.
[0094] In implanting and preparing to implant the variable
prosthesis, such as the variable femoral prosthesis 300, a surgeon
can determine a desired offset, including at least one of an
anteversion angle, a retroversion angle, a varus angle, or a valgus
angle. In one example, the surgeon can review image data or
visually inspect and manually measure the patient to determine a
selected or optimal offset. The head, adapter, and stem can then be
properly rotated to achieve the selected offset and the variable
prosthesis can be implanted. In various embodiments, the surgeon
may also re-measure, initially measure, or visually inspect the
patient after preparing or implanting at least one of the stem 302
or the acetabular prosthesis 522 to determine an optimal angle or
offset. Again, the head, adapter, and stem can then be properly
rotated to achieve the selected offset and the variable prosthesis
can be implanted based on the measurement and/or determination
after preparing or implanting at least one of the stem 302 or the
acetabular prosthesis 522. Thus, the determination of the
appropriate offset can be made and the appropriate position of the
head and adapter can be made at a selected appropriate time.
[0095] As an example, an illustrated in FIGS. 20 and 21 the
variable femoral prosthesis can be positioned within a patient in
the selected offset, which can include a selected anteversion
angle, retroversion angle, varus angle, or valgus angle. The offset
of the variable prosthesis, however, can be positioned within the
patient based upon an orientation of an adapter 304 relative to the
femoral head 306 and the femoral stem 302. As discussed above and
illustrated in FIGS. 16A and 17, the adapter 304 can be rotated
relative to the femoral head 306 to position the taper 340
generally along an axis, but closer to or further away from a
central axis that is defined through an apex of the head 306. It
will also be understood, however, as illustrated in FIGS. 16B and
16C, that the taper 340 can be rotated relative to a central axis
defined generally on a plane defined by the backside of the head
306 to move the taper 340 between two sides of the femoral head
306.
[0096] As illustrated, therefore, positions of the taper 304 and
the femoral head 306 relative to the femoral stem 302 allows for
movement of the femoral head 306 relative to the femoral stem 302.
The adapter 304 can be rotated around within the femoral head 306
in substantially 360 degrees. Accordingly, movement of the femoral
adapter 304 relative to the femoral head 306 and the stem 302 can
form or move the head 306 in a varus direction 550 or a valgus
direction 552, as illustrated in FIG. 20. The direction can be
based on the patient's anatomy and relative to the femoral stem 302
that defines an axis 302a generally through the stem 302.
[0097] In a selected orientation, the femoral head can be aligned
with an axis through a trunion 554 or neck of the femoral stem 302,
such that the femoral head 306 can include the central axis that is
substantially aligned with the axis of the trunion 554. In a
selected orientation, however, the rotation of the adapter 304
and/or the femoral head 306 can move the femoral head 306 to a
varus direction 550, as illustrated by phantom head position 550a.
Alternatively, the adapter 304 and/or the femoral head 306 can be
rotated to move the femoral head 306 in a valgus direction 552, as
illustrated in phantom head position 552a. The varus and valgus
directions, 550, 552, respectively, can be achieved within the
anatomy of the patient.
[0098] In addition, due to rotation of the femoral head 306 and/or
the femoral adapter 304, the femoral head 306 can also be moved in
an anteversion direction 560 or in a retroversion direction 562, as
illustrated in FIG. 21. Again, the femoral stem 302 can define the
central axis 302a and the trunion or neck axis 554 that can be
aligned with a central axis of the femoral head 306 in a selected
position. The femoral adapter 304 and/or the femoral head 306,
however, can be rotated to move the femoral head 306 in an
anteversion direction 560 as shown in phantom head position 560a.
Alternately, the adapter 304 and/or the femoral head 306 can be
rotated to move the femoral head 306 in a retroversion direction
562 as shown by phantom head position 562a. Again, the anteversion
and retroversion directions, 560, 562, respectively, can be
anatomical positions relative to the femur 524 and the pelvis
520.
[0099] Accordingly, movement of the femoral head 306 in any one of
the varus directions, valgus direction, anteversion direction, or
retroversion direction can be substantially relative to the
patient. The rotation of the femoral head 306 and/or the adapter
304 relative to the stem 302 positioned in the femur 524, however,
can achieve the various directions relative to the pelvis 520 to
achieve a selected position of the femur 524 relative to the pelvis
520. Thus, the combination of the head 306 and the adapter 304 can
achieve various and selection offsets of the head 306 relative to
the stem 302.
[0100] It is understood that the implantation of the femoral
prosthesis, according to various embodiments, can be achieved with
generally known surgical techniques. Generally, access can be
achieved to the femoral joint and either or both of the femur 524
and the pelvis 520 can be prepared for implantation for selected
prostheses. The variable prosthesis as discussed herein, however,
can allow for a physician or surgeon to implant a prosthesis with
an appropriate offset, as discussed above, even after preparing the
acetabulum and the femur to maintain a selected amount of bone
after implantation or based upon an anatomy or bone structure of a
patient. For example, achieving a position of a fixed or
non-variable prosthesis relative to a patient may be difficult if a
bone structure or anatomy does not allow for extensive reaming or
preparation for various prostheses. Nevertheless, the prosthetic
devices can be specifically designed for selected patients, but a
variable prosthesis can minimize selection and minimize inventory
at a selected implantation facility therefore allowing greater
variability with a single prosthetic device for multiple
patients.
[0101] In reference to all of the above-described embodiments,
various tapered surfaces have been referenced at interfaces between
the stem, adapter and head. In one example, these tapered surfaces
are configured as self locking tapers, such as morse-type tapers
which provide a self locking interface. Locking tapers can include
complementary angles of about 3 degrees to about 5 degrees,
inclusive. While morse-type tapers are described herein, one
skilled in the art will readily recognize that other means may be
incorporated for providing a locking interface between the various
components of the prosthesis system. In this regard, one or more
interfaces may be interlocked with the use of an additional
fastener to insure locking engagement therebetween.
[0102] Moreover, the various components can be formed with
generally known techniques. For example, the heads, adapters and
stems can be formed with various forging or casting techniques and
selected finishing procedures can be applied to their respective
surfaces. The tapers can also be formed in the various components
with selected milling techniques or can be formed with casting and
forging techniques.
[0103] While specific examples have been described in the
specification and illustrated in the drawings, it will be
understood by those of ordinary skill in the art that various
changes can be made and equivalents can be substituted for elements
thereof without departing from the scope of the present teachings.
Furthermore, the mixing and matching of features, elements and/or
functions between various examples is expressly contemplated herein
so that one of ordinary skill in the art would appreciate from the
present teachings that features, elements and/or functions of one
example can be incorporated into another example as appropriate,
unless described otherwise, above. Moreover, many modifications can
be made to adapt a particular situation or material to the present
teachings without departing from the essential scope thereof.
Therefore, it is intended that the present teachings not be limited
to the particular examples illustrated by the drawings and
described in the specification, but that the scope of the present
teachings will include any embodiments falling within the foregoing
description.
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