U.S. patent application number 14/658518 was filed with the patent office on 2015-11-12 for modular attachment mechanism in prosthetic implants.
The applicant listed for this patent is Biomet Manufacturing, LLC. Invention is credited to Troy W. Hershberger, Joshua R. PORTER, Aaron P. Smith.
Application Number | 20150320562 14/658518 |
Document ID | / |
Family ID | 50931816 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150320562 |
Kind Code |
A1 |
PORTER; Joshua R. ; et
al. |
November 12, 2015 |
Modular Attachment Mechanism In Prosthetic Implants
Abstract
Disclosed is an apparatus that can be positioned in a subject to
include, selectively, a modular connection portion. The modular
connection portion can be provided to allow for soft tissue
connection that replaces a greater trochanter of a natural femur.
The soft tissue connection portion can include a plurality of
regions to allow for reattachment of soft tissue in a plurality of
position to mimic a natural anatomy. A method of using, selecting,
and implanting the prosthesis is also disclosed.
Inventors: |
PORTER; Joshua R.; (Winona
Lake, IN) ; Hershberger; Troy W.; (Winona Lake,
IN) ; Smith; Aaron P.; (Warsaw, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biomet Manufacturing, LLC |
Warsaw |
IN |
US |
|
|
Family ID: |
50931816 |
Appl. No.: |
14/658518 |
Filed: |
March 16, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13714570 |
Dec 14, 2012 |
8979940 |
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14658518 |
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Current U.S.
Class: |
623/22.41 ;
623/22.4 |
Current CPC
Class: |
A61F 2002/3674 20130101;
A61F 2002/30481 20130101; A61F 2/30739 20130101; A61F 2/32
20130101; A61F 2002/30433 20130101; A61F 2002/30387 20130101; A61F
2/367 20130101; A61F 2/3662 20130101; A61F 2002/30607 20130101;
A61F 2/3609 20130101; A61B 17/842 20130101 |
International
Class: |
A61F 2/30 20060101
A61F002/30; A61F 2/36 20060101 A61F002/36; A61F 2/32 20060101
A61F002/32 |
Claims
1. A method of implanting a prosthesis in a proximal femur,
comprising: forming an incision in a patient; evaluating a patient
and resecting a proximal femur; selecting a prosthesis including a
connection for a soft tissue connection portion; after forming the
incision, determining whether a soft tissue connection portion is
to be connected to the prosthesis; if it is determined that a soft
tissue connection portion is to be connected to the prosthesis,
selecting and connecting the soft tissue connection portion; and
implanting the prosthesis into the patient.
2. The method of claim 1, wherein the soft tissue connection
portion is connected to the prosthesis, further comprising:
connecting a soft tissue of the patient to the connected soft
tissue connection portion.
3. The method of claim 2, wherein connecting the soft tissue
includes connecting with a locking member the soft tissue to a
first soft tissue connection region of the soft tissue connection
portion to immobilize a portion of the soft tissue to the soft
tissue connection portion.
4. The method of claim 3, further comprising; frictionally holding
the soft tissue to the soft tissue connection portion with a porous
portion at a second soft tissue connection region of the soft
tissue connection portion.
5. The method of claim 4, wherein connecting with the locking
member includes: clamping between the first soft tissue connection
region and a washer a portion of soft tissue to be immobilized; and
passing a screw through the washer to engage the soft tissue
connection portion.
6. The method of claim 5, wherein frictionally holding the soft
tissue to the second soft tissue connection region occurs a
distance from a location of the first soft tissue connection
region.
7. The method of claim 2, further comprising: selecting on the
selected soft tissue connection portion at least a first soft
tissue connection region and a second soft tissue connection region
spaced apart from the first soft tissue connection region; wherein
connecting the soft tissue of the patient to the connected soft
tissue connection portion includes connecting a first portion of
the soft tissue to the first region and connecting a second portion
of the soft tissue to the second region.
8. The method of claim 7, wherein selecting and connecting the soft
tissue connection portion includes connecting the soft tissue
connection portion that includes at least two of an anterior facet
(AF), a lateral facet (LF), a posterior facet (PF), or a superior
posterior facet (SPF); wherein selecting at least the first soft
tissue connection region and the second soft tissue connection
region spaced apart from the first soft tissue connection region
includes selecting for the first soft tissue connection region one
of the anterior facet (AF), the lateral facet (LF), the posterior
facet (PF), or the superior posterior facet (SPF) and selecting for
the second soft tissue connection region a different one of the
anterior facet (AF), the lateral facet (LF), the posterior facet
(PF), or the superior posterior facet (SPF).
9. A system of a prosthesis to replace a proximal femoral portion,
comprising: a stem portion; a neck portion including a head
connection region; a soft tissue connection mechanism formed by at
least a portion of the neck portion including a male taper
extending away from the head connection region; and a soft tissue
connection portion defining a female taper to engage the male taper
and having at least a first tissue connection region spaced apart
from a second tissue connection region.
10. There system of claim 9, wherein the first region and the
second region are substantially planar and meet at a raised
region.
11. There system of claim 9, wherein the first region is a first
portion of a curve of the soft tissue connection portion and the
second region is a second portion of the curve of the soft tissue
connection portion.
12. There system of claim 11, wherein the soft tissue connection
portion extends superiorly of the head connection region.
13. There system of claim 9, further comprising: a modular soft
tissue connection portion configured to be connected to the soft
tissue connection portion.
14. There system of claim 9, wherein the stem portion and the neck
portion are configured to be connected and implanted in an absence
of the soft tissue connection portion.
15. The system of claim 9, further comprising: a washer fixation
system to immobilize soft tissue to the first region; wherein the
second region includes a porous surface to frictionally engage the
soft tissue.
16. A system of a prosthesis to replace a proximal femoral portion,
comprising: a stem portion; a neck portion including a head
connection region; a soft tissue connection mechanism formed by at
least a portion of a lateral region of the neck portion including
one of a tapered rail, wherein the tapered rail includes an edge
that tapers outwardly from a central axis of the tapered rail or a
groove to engage the tapered rail; and a soft tissue connection
portion defining the other of the tapered rail or the groove that
engages the tapered rail to fix the soft tissue connection portion
of the soft tissue connection mechanism; wherein the soft tissue
connection portion includes at least a first region for connection
of soft tissue offset at an angle relative to a second region for
connection of soft tissue.
17. There system of claim 16, wherein the first region and the
second region are substantially planar.
18. There system of claim 17, wherein the first region is a first
portion of a curve of the soft tissue connection portion and the
second region is a second portion of the curve of the soft tissue
connection portion.
19. There system of claim 16, wherein the soft tissue connection
portion extends superiorly of the head connection region.
20. There system of claim 16, further comprising: a modular soft
tissue connection portion configured to be connected to the soft
tissue connection portion.
21. There system of claim 16, wherein the stem portion and the neck
portion are configured to be connected and implanted in an absence
of the soft tissue connection portion.
22. The system of claim 16, wherein the soft tissue connection
portion extends from a first end to a second end, wherein the first
end includes a bulbous region.
23. A kit for a system of a prosthesis to replace a proximal
femoral portion, comprising: a stem portion; a neck portion
including a head connection region; a soft tissue connection
mechanism formed by at least a portion of the neck portion; and a
plurality of soft tissue connection portions, wherein each of the
plurality of soft tissue connection portions include a different
external dimension to engage soft tissue.
24. The kit of claim 23, wherein the neck portion includes a male
taper; wherein each of the plurality of soft tissue connection
portions includes a female taper to engage the male taper.
25. The kit of claim 23, wherein the neck portion includes a soft
tissue connection mechanism formed by at least a portion of the
neck portion including a tapered rail, wherein the tapered rail
includes an edge that tapers outwardly from a central axis of the
tapered rail; wherein each of the plurality of soft tissue
connection portions includes a groove to engage the tapered rail to
fix the soft tissue connection portion of the soft tissue
connection mechanism; wherein each of the plurality of the soft
tissue connection portion includes at least a first region for
connection of soft tissue offset at an angle relative to a second
region for connection of soft tissue.
26. The kit of claim 25, wherein in each of the plurality of soft
tissue connection portions the first region is at least one of a
different size or spaced a different distance from the second
region.
27. The kit of claim 24, wherein each of the plurality of the soft
tissue connection portion includes at least a first region for
connection of soft tissue offset at a different angle relative to a
second region for connection of soft tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/714,570 filed on Dec. 14, 2012. The entire
disclosure of the above application is incorporated herein by
reference.
FIELD
[0002] The subject disclosure is related to prosthetic implants
positioned in an anatomy, and particularly to modular mechanisms
for soft tissue attachments to prosthetic implants.
BACKGROUND
[0003] A prosthesis can be positioned in a subject, such as a human
patient, for replacing a portion of an anatomy. Portions of anatomy
may be required to be replaced due to disease, injury, or other
reasons. For example, a prosthetic implant can be positioned in a
femur to replace a portion of the proximal femur, including at
least a femoral head, due to disease or wear of a natural femoral
head. When preparing an anatomy for the prosthesis, however, soft
tissue portions and boney portions of the anatomy may need to be
removed. For example, the femoral head is near a greater trochanter
to which several soft tissue, including muscle attachments, occur.
An extensor muscle is connected to the greater trochanter. During
preparation of the femur for the prosthesis, the proximal femur
including the greater trochanter may need to be resected. In this
case, resection or removal of the extensor muscles may be
necessary.
SUMMARY
[0004] A proximal femoral prosthesis can be positioned to replace a
portion of a femoral head and can also include portions allowing
for connection of soft tissue that is disconnected during resection
of a proximal femur. For example, as discussed above, during
resection of the proximal femur, a greater trochanter may be
completely or partially resected thereby disconnecting the extensor
muscle from the femur. The proximal femoral prosthesis can include
an area for allowing reconnection of the soft tissue to the
proximal femur prosthesis.
[0005] The proximal femoral prosthesis, however, may not always
need to replace a portion of the greater trochanter and/or the
extensor mechanism may be resected entirely. Accordingly, a soft
tissue connection portion can be modular to be connected to the
femoral prosthesis only when a greater trochanter is necessary to
be resected in a procedure. Additionally, the modular soft tissue
connection portion can include various shapes and sizes to be
selected for optimal connection area of the soft tissue to the
prosthesis. In other words, described herein is a method and
apparatus to provide for connection areas of soft tissue in one or
more anatomical mimicking locations, including lateral, medial,
posterior, and anterior. According to various embodiments, a
modular soft tissue attachment portion can be connected to the
proximal femoral prosthesis to allow for connection of soft tissue
to the proximal femoral prosthesis. For example, the modular soft
tissue connection or attachment portion can allow connection of an
extensor muscle to the proximal femoral prosthesis member and can
include a plurality of positions and in a large or different areas
for connection of the soft tissue.
[0006] According to various embodiments, a soft tissue portion can
be selected to be connected to a soft tissue connection portion of
a prosthesis in at least two positions. This can include selecting
at least a first soft tissue connection region and a second soft
tissue connection region spaced apart from the first soft tissue
connection region. Wherein the selection and/or connection includes
selecting an anatomical re-creation of a soft tissue connection to
a resected greater trochanter of a patient. The soft tissue
selected for connection can include a hip extensor mechanism.
[0007] Further areas of applicability will become apparent from the
description provided herein. The description and specific examples
in this summary are intended for purposes of illustration only and
are not intended to limit the scope of the present disclosure.
DRAWINGS
[0008] The drawings described herein are for illustrative purposes
only of selected embodiments and not all possible implementations,
and are not intended to limit the scope of the present
disclosure.
[0009] FIG. 1 is a lateral plan view of a greater trochanter in
femur of a natural patient;
[0010] FIG. 2 is an exploded view of a femoral prosthesis having a
soft tissue connection portion, according to various
embodiments;
[0011] FIG. 3 is an assembled prospective view of the prosthesis of
FIG. 2;
[0012] FIG. 4 is a top view of a femoral prosthesis with a soft
tissue connection portion, according to various embodiments;
[0013] FIG. 5 is a top view of the femoral prosthesis of FIG. 4
with soft tissue connected to the soft tissue connection
portion;
[0014] FIG. 6 is an elevational view of a femoral prosthesis and
soft tissue connection portion, according to various
embodiments;
[0015] FIG. 7 is a side elevational exploded view of a femoral
prosthesis and soft tissue connection portion;
[0016] FIG. 8 is a top elevational view of an assembled prosthesis
according to FIG. 7;
[0017] FIG. 9 is a lateral elevational view of a femoral
prosthesis, according to various embodiments;
[0018] FIG. 10 is a prospective view of a femoral prosthesis with
an exploded soft tissue connection portion, according to various
embodiments;
[0019] FIG. 11 is an exploded prospective view of a femoral
prosthesis of the soft tissue connection portion, according to
various embodiments;
[0020] FIG. 12 is an assembled view of a femoral prosthesis with a
soft tissue connection portion, according to various
embodiments;
[0021] FIG. 13 is an assembled perspective view of a femoral
prosthesis with a soft tissue connection portion, according to
various embodiments; and
[0022] FIG. 14 is a view of a kit of a femoral prosthesis with a
plurality of soft tissue connection portions.
[0023] Corresponding reference numerals indicate corresponding
parts throughout the several views of the drawings.
DETAILED DESCRIPTION
[0024] Example embodiments are provided so that this disclosure
will be thorough, and will fully convey the scope to those who are
skilled in the art. Numerous specific details are set forth such as
examples of specific components, devices, and methods, to provide a
thorough understanding of embodiments of the present disclosure. It
will be apparent to those skilled in the art that specific details
need not be employed, that example embodiments may be embodied in
many different forms and that neither should be construed to limit
the scope of the disclosure. In some example embodiments,
well-known processes, well-known device structures, and well-known
technologies are not described in detail. Furthermore, different
features of separately discussed examples can be combined as
understood by one skilled in the art.
[0025] It is understood, as used herein, that intraoperative can
refer to an action taken by a user, such as a selection or
connection, after beginning an operative procedure. The beginning
of an operative procedure can be understood to be a time after a
surgeon has scrubbed and otherwise prepared for a surgical
procedure. It can also include after preparing a subject for an
incision or making an incision in a subject, such as the
patient.
[0026] With reference to FIG. 1, a natural femur 20 of a human can
include a shaft 22 and a femoral head 24. A greater trochanter 26
can include areas for connection of soft tissue, such as an
extensor muscle. The greater trochanter can include attachments
regions in substantially three dimensions around the greater
trochanter 26. These connection regions can include, as
schematically illustrated in FIG. 1, an anterior facet (AF) and
lateral facet (LF), a posterior facet (PF), and a superior
posterior facet (SPF). The four facets for attachment of soft
tissue to the greater trochanter allow for soft tissue connection
substantially around the greater trochanter 26 in all of the areas
substantially not impeded by movement of the femur 20 relative to
an acetabulum or a pelvis of a patient. Accordingly, a soft tissue
attachment prosthesis can include a surface with regions that
extend around the greater trochanter prosthetic area as well. That
is, a soft tissue connection portion can include a plurality of
separated soft tissue connection regions on the soft tissue
connection region (e.g. the regions separate from the connection to
the neck or stem portion) of the soft tissue connection
portion.
[0027] With reference to FIG. 2, a proximal femoral prosthesis 30
(also referred to solely as a proximal prosthesis) is illustrated.
The femoral prosthesis 30 can include a neck portion 32 and a stem
portion 34. Optionally interconnected to the neck portion 32 can be
a greater trochanter prosthesis or soft tissue attachment
prosthesis portion 36. The soft tissue prosthesis 36 is optional
and may not be necessary for a selected surgical procedure. For
example, if a femoral head, such as the femoral head 24 of the
femur 20, is resected and the soft tissue connection regions of the
greater trochanter 26 can be saved, then the soft tissue prosthesis
36 may not be necessary. In the case where the soft tissue
connection regions of the greater trochanter 26 can be saved the
femoral prosthesis 30 including generally only the neck portion 32
and the stem portion 34 can be positioned within the femur 20 to
replace the resected femoral head 24. Thus, the soft tissue
attachment 36 as a part of a prosthetic system is modular and
optional. The soft tissue attachment 36 can be provided for
intraoperative selection and connection to the femoral prosthesis
30 by a user, such as a surgeon.
[0028] If the greater trochanter 26 is resected then the soft
tissue attachment 36 can be interconnected to the modular neck
portion 32. The soft tissue attachment portion 36 can include one
or more soft tissue attachment regions 38 that can include,
optionally, bores or holes 40 for soft tissue attachment, such as
for passing a wire or suture to anchor tissue, and a porous region
42. The porous region 42 is optional and can include porous
materials, such as plasma coatings and porous metal constructs such
as Regenerex.RTM. porous metal sold by Biomet, Inc. or additively
manufactured constructs. The soft tissue attachment region 38 can
also include bores 39, such as tapped bores, for connection of soft
tissue connection or immobilization systems 46 that can include a
washer or spiked washer 48 and a screw 50 that passes through the
spiked washer 48 into the bore formed in the soft tissue attachment
portion 38. Such spiked washers can include those disclosed in U.S.
Pat. No. 8,118,868, incorporated herein by reference in its
entirety. The connection system 46 can provide an initial fixation
of soft tissue to the soft tissue connection portion while the
porous region 40 can provide a frictional holding of the soft
tissue and a region for soft tissue ingrowth. Similar soft tissue
connection portions and porous regions can be provided for similar
purposes in various embodiments, including those discussed
herein.
[0029] The soft tissue connection region 38 can be provided in a
shape to assist in providing anatomical matching connection regions
for soft tissue connection. For example, the soft tissue connection
portion 38 can extend superiorly of the stem 34 and near and/or
adjacent to the prosthetic head 80, as illustrated in FIG. 3.
Moreover, the soft tissue connection portion can include an arc
that curves around the neck 82, as illustrated in FIG. 3. Thus, the
soft tissue connection region 38 can substantially mimic each
and/or all of the facets of the natural femur 20, as illustrated in
FIG. 1. Further, the soft tissue connection region 38 can provide
the soft tissue connections 40 at an inferior position while the
porous region extends superiorly therefrom.
[0030] Extending from the soft tissue connection region 38 of the
soft tissue prosthesis member 36 can be a neck attachment region
60. The neck attachment region 60 can include a bore or passage 62
formed through a connection member 64. The passage 64 can be
tapered to assist in connection to a taper region 70 of the neck
portion 32. The connection member 64 can also define passages 66
for sutures, wire, suture anchors or other selected attachment
portions. The prosthetic neck portion 32 can include the taper
region 70 that can be positioned through the passage 62. Generally,
the soft tissue prosthetic member 36 can be moved in the direction
of arrow A to slide over the taper region 70 of the prosthetic neck
portion 32 to engage the prosthetic neck member 32. It is
understood that the taper region 70 can form a taper lock with the
passage 62 or can simply provide an interference of the prosthetic
neck portion 32 relative to the prosthetic soft tissue attachment
36. The taper neck region 70 can define a taper angle 72 relative
to a central axis 74 of the prosthetic neck portion 32. The taper
angle 72 can be selected for connection of the soft tissue
connection portion 36 relative to the prosthetic neck portion 32.
Additionally, the taper angle 72 can be selected for allowing for
ease of removal and disconnection of the soft tissue prosthetic
portion 36 relative to the neck portion 32.
[0031] Once the soft tissue prosthesis portion 36 is connected to
the prosthetic neck portion 32, the stem 34 can be connected with
the prosthetic neck portion 32 and in the appropriate manner, such
as an interconnection of the stem 34 with a mating portion 76 of
the prosthetic neck portion 32. It is understood that other locking
features can also be provided, such as a locking screw that passes
through the prosthetic neck portion 32 to engage the stem 34 as is
generally included in the OSS.TM. Orthopedic Salvage System
prosthesis, sold by Biomet, Inc.
[0032] Additionally, a prosthetic head 80, according to an
appropriate design or configuration can connect with a neck 82 of
the prosthetic neck portion 32. The neck 82 can include a male
taper, such as a self-locking taper, that engages a female taper
formed in the head 80 to allow for connection of the head 80
relative to the neck portion 32. It will be understood that the
male and female tapers can be revered between the neck portion 32
and the head 80. Appropriate connections of heads and types of
heads are included in the prosthetic or prosthesis system OSS.TM.
Orthopedic Salvage System, sold by Biomet, Inc.
[0033] As illustrated in FIG. 3, the assembled prosthesis 30 can
include the soft tissue connection member 36 interconnected with
the neck portion 32 and the stem portion 34. The assembly 30 can be
implanted to replace the resected femoral head and greater
trochanter of the femur 20. The femur 20 includes the greater
trochanter 26 that is naturally positioned relative to the femoral
head 24 and the shaft 22 of the femur in a selected natural
anatomical configuration. The anatomical configuration, however,
can also vary from patient to patient. Accordingly, the passage 62
can include a keyed portion, such as a portion that is
non-cylindrical or including a projection or depression to receive
or engage a projection or depression of the neck portion to allow
for selectively and fixedly rotationally positioning the soft
tissue connection 38 relative to the neck 82 of the neck portion
32, including around the axis 74. It is also understood that a
keyed configuration is not necessary and that only a smooth taper
or surface can be provided. In this manner, the neck portion 32 and
the soft tissue connection 38 can be connected in any selected
rotational orientation.
[0034] Returning reference to FIG. 2, the taper region 72 can
include a depression or groove 100 that can engage a projection 102
at the soft tissue connect portion 36. The neck portion 32 can
include a plurality of the grooves, 100a, 100b to allow for
rotationally positioning the modular soft tissue prosthetic member
36 relative to the neck 82 of the neck portion 32. The grooves 100
can be provided in any selected number around the taper region 72
or any appropriate region of the neck member 32. Accordingly, the
soft tissue prosthesis member 36 can be rotationally positioned at
different and selected positions relative to the neck 82 of the
neck portion 32.
[0035] As illustrated in FIG. 4, the soft tissue prosthetic member
36 can include a plurality of sides as illustrated as soft tissue
connection portion 36a. It is understood that the plurality of
sides as a plurality of connection regions can be included in the
prosthetic portion 36 illustrated in FIGS. 2 and 3 or the soft
tissue connection region 38 can include a radius or single curved
portion. The single curved portions can also define a plurality of
spaced-apart connection regions that can be used to mimic the
natural connection regions illustrated in FIG. 1, as discussed
above.
[0036] The soft tissue connection portion 38 of the tissue
connection portion 36 can include, either alternatively to the
radius or in addition to the radius, a first or major side 110 and
a second or minor side 112. For example, the sides 110, 112 can be
formed of porous material at the porous tissue connection region
40. The sides 110, 112 can be positioned relative to the neck 82
via the interconnection of the projection of 102 with one or more
of the grooves 100. Accordingly, as illustrated in FIG. 4, the
major side 110 is substantially lateral of the neck 82. It is
understood, however, that the major surface 110 can be rotated
around the axis 74 of the neck portion generally in the direction
of double-headed arrow B. In this way the major and minor surfaces
110, 112, can be positioned relative to the neck 82 at a selected
natural anatomical configuration to mimic or provide for
substantially anatomical matching connection regions for the soft
tissue. The natural anatomical configuration, including the
relative locations of the facets to the natural femoral head 24,
can be determined after incision into a patient to the view the
femur 20 or with imaging prior to the beginning of a procedure. The
natural anatomical configuration can then be mimicked, at least as
close as possible, by selectively positioning the soft tissue
connection portion relative to the neck portion 32.
[0037] The major surface 110 can meet the minor surface 112 at a
raised peak or hump 113. The peak 113 can include a thickened
porous region. In addition, the peak can provide additional
frictional holding of soft tissue placed near the peak 113, as
illustrated below.
[0038] For tissue connection and fixation, soft tissue can be
wrapped around the soft tissue connection region 38 such that it
engages both the major surface 110 and the minor surface 112.
Additionally, the porous portion 42 of the soft tissue connection
region 38 can provide an initial friction holding connection of the
soft tissue with the soft tissue connection region 38 and for
long-term ingrowth of the soft tissue to the soft tissue connection
region 38. The connections 46, or other appropriate locking
portions, can be provided to create initial and/or localized
immobilization of the soft tissue. As discussed above, the
supplemental or additional soft tissue connection portions,
including the screw and washer lock systems 46, including one or
more washer lock systems 46a and 46b, can be used to additionally
interconnect the soft tissue with the soft tissue connection
portion 36. Thus, both non-compressed tissue is provided for tissue
ingrowth in addition to immobilization, at a spaced apart location,
of the soft tissue connection portion 32. These connection regions
can provide substantially anatomical matching connections of the
soft tissue to mimic and/or copy the natural anatomical facets as
illustrated in FIG. 1.
[0039] With reference to FIG. 5, the soft tissue can include a
first piece 120 and a second soft tissue piece 122 that both
interconnect with the soft tissue connection region 38.
Additionally, both pieces of the soft tissue 120, 122 can wrap
around to contact both of the major and minor surfaces 110, 112 of
the soft tissue connection region 38. Accordingly, upon
implantation and connection of the soft tissue pieces 120, 122, a
substantial re-creation of the soft tissue connection from the
natural anatomy, as schematically illustrated in FIG. 1, can be
replicated due to the multiple surfaces and the selectable position
of the soft tissue connection member 36.
[0040] Additionally, the major and minor surfaces 110, 112, as
discussed above, can include additional facets that can be formed
on these surfaces. The facets allow for creation of places or
regions of attachment, including the four regions illustrated in
FIG. 1, such as the posterior facet, the lateral facet, the
anterior facet, and the superior posterior facet. Accordingly, the
interconnection or keyed relationship of the soft tissue connection
portion 36 relative to the neck portion 32, such as with the
projections and grooves 100, 102, can allow for selective
orientation of the various facets relative to a natural anatomy.
Accordingly, soft tissue can be interconnected with the prosthesis
in an appropriate and selected anatomical configuration. By
allowing the soft tissue to be connected in a substantially natural
anatomical configuration, biomechanics of a patient can be more
substantially recreated after the prosthesis is implanted.
[0041] With reference to FIG. 6, the soft tissue connection portion
36 can include a soft tissue attachment region, according to
various embodiments, that includes a substantially superior
extending region 120. The extending region 120 can also extend
medially over or towards the neck 82. The superior extending region
120 can be a portion of the soft tissue attachment region 38 and
can be formed of selected materials, such as porous coated
materials or completely porous metal constructs formed from metal
materials such as Regenerex.RTM. porous metals, sold by Biomet,
Inc. and/or additive manufacturing techniques. The superior region
120 can extend over a superior portion of the neck portion 32, such
as that substantially co-extensive with the neck 82 of the
prosthesis 30. The superior portion soft tissue connection region
120 can allow for connection of soft tissue in a region superior of
the femur 20. The length of the superior portion 120 can be
provided especially in an instance where soft tissue extending from
a superior region is resected. The length of the superior extending
portion 120 does not require soft tissue to extend as far towards
the stem 34 as when the superior region 120 were not provided.
[0042] The soft tissue connection portion 36 can further be
augmented or provided with one or a plurality of soft tissue
connection augments 122. The soft tissue connection augments 122
can be formed of selected materials, including porous coated metals
and/or porous constructs such as Regenerex.RTM. porous metal sold
by Biomet, Inc. or additively manufactured constructs. The soft
tissue augment portions 122 can be connected with the soft tissue
connection region 36 to provide a selected shape or to provide for
additional or selectively positioned soft tissue connection
surfaces. As illustrated in FIG. 6, the supplemental or augmented
soft tissue connection portion 122 can be fixed to the soft tissue
connection region 38 with a fixation member, such as a screw 124.
As specifically illustrated in FIG. 6, the augmented soft tissue
connection portion 122 can be positioned near the superior
connection portion 120 to assist in further enhancing or enlarging
an area for fixation of soft tissue relative to the soft tissue
portion 36. Accordingly, and according to the various embodiments
disclosed herein, the soft tissue connection portions can be
augmented with additional modular portions 122 to provide for
selected soft tissue connection regions. It is understood that the
augmented soft tissue connection portion 122 can be provided in the
appropriate shape or configuration for soft tissue connection.
Additionally, the augmented soft tissue portions 122 can be
provided in a kit, such as the kit 600 discussed below for
selection by a user intraoperatively during a procedure. The kit
600 can also include a plurality of the modular portions 122
including differing sizes, shapes, etc.
[0043] Additionally, it will be understood, that the prosthesis can
be implanted substantially only with the neck portion 32 and the
stem portion 34 to allow for a configuration when the greater
trochanter need not be resected or substantially resected. Thus,
the prosthesis assembly 30 can allow for selection of replacement
of the soft tissue connection member 36 or without the soft tissue
connection member 36.
[0044] According to various embodiments, as illustrated in FIGS. 7
and 8, a prosthesis 230 can include a neck portion 232 that can be
interconnected with a stem 234 and a soft tissue connection portion
236. The various portions of the prosthesis 230 can be similar, at
least in function and placement of the respective portions,
including the stem portion 34, the neck portion 32, and the soft
tissue connection portion 36, as discussed above. As illustrated in
FIGS. 7-8, and discussed below, the prosthesis 230 can be provided
in a different configuration as discussed in detail herein. Also,
the soft tissue connection portion 236 is optional.
[0045] As initially illustrated in FIG. 7, the neck prosthesis 232
can be implanted into the femur 20 with the stem 234 in a
configuration that does not include a connection of the soft tissue
connection portion 236. Accordingly, as discussed above, the neck
prosthesis 232 can be positioned in the femur 20 without requiring
a portion for reattaching soft tissue. This allows for an
intra-operative selection of a prosthesis with or without a soft
tissue connection portion. In a configuration where a soft tissue
connection is not selected, a flat or smooth side 240 is provided
to allow for positioning of the prosthesis relative to the femur
20.
[0046] Nevertheless, the soft tissue portion 236 can be
interconnected with the neck portion 232 to allow for soft tissue
connection to a soft tissue connection region 238. The soft tissue
connection region 238 can include porous material, including porous
coated metals and/or porous constructs such as Regenerex.RTM.
porous metal sold by Biomet, Inc. or additively manufactured
constructs. A bolt 244 can be passed through a passage 246 to
connect the soft tissue connection portion 236 to the femoral neck
portion 232. The femoral neck portion 232 can define a passage 248
to engage or connect with the bolt 244, such as with a threaded
interconnection between the bolt 244 and the passage 248 in the
neck portion 232.
[0047] Additionally, the soft tissue connection portion 236 can
define a second bolt passage 250. The second bolt passage 250 can
allow for connection of a soft tissue connection system 253 where a
bolt or screw 260 can pass through a spiked washer 262 to engage
the passage 250 in the soft tissue connection portion 236. As
discussed above, the soft tissue connection system 253 with the
soft tissue connection portion 236 can provide for at least an
initial connection or immobilization of soft tissue relative to the
soft tissue connection portion 236. As illustrated in FIG. 7, the
soft tissue connection system 253 can be positioned substantially
inferior on the soft tissue connection portion 236 such that a
major portion or large portion of the soft tissue connection region
236 is substantially mobile until tissue ingrowth occurs. Friction
between the soft tissue and the connection region 238, however, can
assist in holding the soft tissue in a selected location. Moreover,
the inferior placement of the soft tissue connection system 253
allows for a large and uninterrupted portion of the connection
region 238 to be provided for soft tissue ingrowth.
[0048] With additional reference to FIG. 8, the soft tissue
connection portion 236 can include a configuration that has an arc
or radius and/or can include sides, such as the major and minor
sides 110, 112 discussed above. As illustrated in FIG. 8, however,
a radius of the soft tissue connection portion can substantially
wrap around or define an arc, such as at least about an 180.degree.
arc relative to a central axis 264 of the prosthetic neck portion
232. The central axis 264 can be formed or defined through a
locking bolt hole 266 through which a locking bolt can pass to
engage the stem 234 to lock the neck portion 232 to the stem 234.
The axis 264 can also be defined relative to the soft tissue
connection portion 236 alone. The soft tissue connection portion
236, therefore, could be used to engage soft tissue in
substantially anatomical connection regions to mimic the natural
anatomical configuration, as discussed above.
[0049] Additionally, as discussed above, a plurality of the locking
washers 262a, 262b and 262c can be provided at various positions on
the soft tissue connection portion 236 to assist in creating the
substantially anatomical connection positions or regions. Although
it is not required to include at least three of the washers
262a-262c, a selected number can be provided, such as
intraoperatively selecting a number, to provide for an appropriate
or selected connection of the soft tissue relative to the soft
tissue connection portion 236. The washers 262a-262c can be
radially displaced at a selected angle 262x apart around the arc of
soft tissue connection portion 236. The prosthesis 230 can also be
positioned in the femur 20 to include a head 84 interconnected with
a stem 270.
[0050] The soft tissue connection portion 236 can include a
projection 280 that can include a keyed configuration, such as a
non-circular configuration, or a circular configuration with
projection 280 to be received in a depression 282 of the neck
portion 232. If the projection 280 is a keyed projection, the soft
tissue connection portion 236 can be rotated relative to the neck
portion 232 to allow for a selected position or orientation of the
soft tissue connection portion 236 relative to the neck portion 232
in one of a plurality of possible locations and/or configurations.
It is understood, however, that the soft tissue connection portion
236 can be connected to the neck portion 232 in any selected, such
as a single selected, configuration or location. The soft tissue
can then be connected to the soft tissue connection portion 236
once the prosthesis 230 is positioned within the anatomy.
[0051] With reference to FIGS. 9-11, a femoral prosthesis 330,
according to various embodiments can include a neck portion 332 to
which a stem 334 can be connected. A head 335 can also be connected
to a neck 337, as discussed above. The neck 337 can also define an
axis 337a. A soft tissue connection portion 336a, as illustrated in
FIG. 10, or 336b, as illustrated in FIG. 11, can be interconnected
with a dovetail rail 340. The dovetail rail 340 can define a
central axis 342 and an outer edge can form an angle 344 relative
to the central axis 342. The angle 344 can be an appropriate angle
such as about 20.degree. to about 40.degree., including about
2.degree. to about 3.degree., and further including about
2.degree.. The dovetail rail 340 can allow for a sliding
interconnection or a sliding positioning of the soft tissue
connection portion 336a and 336b by sliding a respective dove-tail
groove 350a and 350b formed through a surface, such as a superior
surface 352a and 352b of the respective soft tissue connection
portions 336a and 336b. Generally, the soft tissue connection
portions can be slid onto the dove-tail rail 340 generally in the
direction of arrow C. It is understood, however, that the dovetail
rail can be formed on the respective soft tissue connection
portions 336a and 336b and the dovetail groove can be formed into
the neck portion 332. This reverse configuration would still allow
the respective soft tissue connection portions 336a and 336b to be
slid onto the neck portion 332.
[0052] As is illustrated in FIGS. 10 and 11, the arrow C is in the
direction of a superior portion of the prosthesis 330, which
generally a superior position in an implanted position of the
patient. Accordingly, when soft tissues are connected to the soft
tissue connection portions 336a and 336b, the forces applied by the
soft tissue on the soft tissue portions 336a and 336b are generally
in the same direction as arrow C. As the dovetail rail 340 tapers
outwardly at the angle 344, the movement of the soft tissue
connection portions 336a and 336b in the direction of arrow C
further will lock and engage the soft tissue connection portions
336a and 336b with the neck portion 332 due to interaction with the
dovetail rail 340 and the respective grooves 350a and 350b. In
addition, a stop projection or portion can be formed opposite the
opening for the groove 350a, 350b to engage the dovetail rail 340
to stop movement of the soft tissue connection portion 336a,
336b.
[0053] The soft tissue connection portions 336a and 336b can
include exterior soft tissue connection regions 360a and 360b. The
soft tissue connection regions 360a, 360b can include the porous
coat or porous constructs discussed above, including Regenerex.RTM.
porous metal sold by Biomet, Inc. or additively manufactured
constructs. The soft tissue connection regions can be formed over
an interior or substrate that defines the respective grooves 350a
and 350b and also an internal surface or area 362a, 362b that can
fit over and/or around sides 364 and 366 of the neck portion 332.
Accordingly, the soft tissue connection portion 336a, 336b can
surround a portion of the neck component 332 similar to the soft
tissue connection portion 336 discussed above.
[0054] Accordingly, the soft tissue connection portions 336a, 336b
can allow for a connection of soft tissue at a plurality of
positions of a plurality of regions relative to the neck portion
332. The plurality of regions or areas of connection can allow for
a recreation of the natural soft tissue connection as illustrated
in the natural femur in FIG. 1. For example, the exterior soft
tissue connection regions 360a and 360b can define an arc having a
radius, as discussed above. Further, the exterior soft tissue
connection regions 360a and 360b can have straight surfaces, such
as the major and minor sides, 110, 112. The exterior soft tissue
connection regions 360a and 360b can be provided to define the
anatomical matching connections to allow the implant to
substantially mimic the anatomical facet connections.
[0055] Additionally, one or a plurality of soft tissue
immobilization systems 363a, 363b can be provided to interconnect
with the respective soft tissue connection portions 336a, 336b. The
soft tissue connection or immobilization portions 363a, 363b
specifically illustrated in FIGS. 10 and 11 can include a spiked
washer or compression washer. Although not specifically illustrated
in FIGS. 10 and 11 the washer can include a bore or passage for a
screw to pass there through. The soft tissue connection portion
336a and 336b can define bores to receive and connect with the
screws of the soft tissue immobilization portions 363a, 363b.
[0056] As illustrated in FIGS. 10 and 11, and discussed in relation
to the soft tissue connection portion 236 illustrated in FIG. 8,
the soft tissue connection regions 360a, 360b can extend a selected
portion around a central axis the neck portion 332 such as about
180.degree. or any selected amount. The porous areas soft tissue
connection regions 360a, 360b can be used to frictionally hold the
soft tissue in addition to or separately from the soft tissue
immobilization portions 363a, 363b. As illustrated, the soft tissue
immobilization portions 363a, 363b can be positioned substantially
inferior relative to the implant 332 and/or the soft tissue
connection regions 360a, 360b when the implant is positioned in the
selected anatomy. This, according the various embodiments described
herein, allows for a large, including greatest amount, of
uninterrupted contact surface area between the soft tissue and the
soft tissue connection regions 360a, 360b.
[0057] The soft tissue connection portions 336a, 336b can be slid
onto the dovetail rails 340 as discussed above. As further
discussed above, soft tissue connection on the soft tissue
connection regions 336a, 336b can assist in locking and holding
soft tissue connection portions 336a, 336b to the neck portion 332.
In addition, locking, either permanently or for initial connection,
members can be provided, for example as illustrated in FIG. 10, a
locking or fixing screw 370 can be used to pass through a bore 372
in a bottom or selected wall of the soft tissue connection portions
to engage a passage or bore 374 in the neck portion 332. The bore
374 can be formed near the dovetail rail 340 and can be threaded to
engage threads on the locking screw 370.
[0058] Additionally, or in alternative to the locking screw 370, a
locking bar 380 can be provided to interconnect the soft tissue
connection portion 336b with the neck portion 332. The locking bar
380 can include a deflectable tab or arm 382. The locking bar can
be pushed through a first passage 384 in a sidewall of the soft
tissue connection portion 336b to engage a groove or slot 386 in
the neck portion 332. The tab portion 382 can be deflected towards
a main portion or inwardly to allow passage of the locking bar 380
through the wall passage 384. Once the tab arm 382 has moved
through the passage 384 and passed at least a selected portion of a
wall, the tab 382 can deflect outwardly or away from the arm
portion to fixedly or lockingly engage the wall of the soft tissue
connection portion 336b. In this way, the locking bar 380 can be
held relative to the soft tissue connection portion 336b and the
neck portion 332.
[0059] Accordingly, in various embodiments, the locking screw 370
or the locking bar 380 can be used to selectively fix the soft
tissue connection portions 336a, 336b relative to the neck portion
332. It is understood that other selected locking configurations or
members can be selected to lock the selected soft tissue connection
portions 336a, 336b relative to the neck portion 332. Also,
additional or alternative locking portions can be used.
[0060] As discussed above, the soft tissue connection portions,
including the soft tissue connection portions 336a and 336b can
include a selected configuration of the respective soft tissue
connection regions to allow for positioning of the soft tissue
relative to the neck portion 332. As illustrated in FIGS. 12 and
13, the soft tissue connection portions can include alternative or
selectable shapes such as the soft tissue connection portion 436
illustrated in FIG. 12 or the soft tissue connection portion 536
illustrated in FIG. 13. The soft tissue connection portions 436,
536 can be interconnected with the neck portions in a selected
manner, such as with a dove-tail connection, as illustrated in FIG.
12 or the screw or dovetail connection as illustrated in FIG. 13.
Regardless, the soft tissue connection regions can include a
superior connection portions and medial lateral collateral of
selected designs.
[0061] As illustrated in FIG. 12, the soft tissue connection
portion of 436 can include a superior soft tissue connection region
438 that is substantially wide or has a width 440 transverse
relative to the central axis 337a of the neck 337 of the neck
portion 332. The width 440 can be a selected width such as about
4-5 cm, including about 3 cm. Additionally, the width 440 can allow
for a wide area of connection of soft tissue. Further, the width
can be carried throughout a dimension, such as a length 450 of the
soft tissue connection portion 436. Additionally, a soft tissue
immobilization system 451 can include a washer 452 and/or screw or
bolt (not illustrated here) connections that can be provided for
initial immobilization of soft tissue relative to the soft tissue
connection portion 436. As discussed herein, the soft tissue
immobilization system can be positioned inferiorly on the soft
tissue connection portion 436. Additionally, the neck portion 332
can be interconnected with a stem 454 and the head portion 335 as
discussed above. An exterior surface of the soft tissue connection
portion of 436 can also define an arc having a radius, as discussed
above. The arc can extend around a selected axis, such as the axis
337a of the neck 337. Alternatively, or in addition thereto, the
radius may also be defined within the soft tissue connection
portion of 436. Thus, the soft tissue connection portion of 436 can
define a plurality of connection regions to create the
substantially anatomical matching connections to mimic the natural
facet connections of the femur as illustrated in FIG. 1.
[0062] With reference to FIG. 13, the soft tissue connection
portion 536 can include a pinched or bulbous superior soft tissue
connection region 538. The superior soft tissue connection region
538 can extend superiorly relative to the neck portion 332. The
superior soft tissue connection region 538 can be provided to allow
for connection of soft tissue relative to the soft tissue
connection region 536. The bulbous superior connection portion 538
can include selected dimensions and be provided and formed for a
connection of soft tissue relative to the soft tissue connection
portion 536. The bulbous portion 536 can include a dimension, such
as a portion of a circumference or surface of a selected dimension
for soft tissue connection. The soft tissue connection portion 536
can also include a soft tissue immobilization system 539. The soft
tissue immobilization system 539 can include a washer 540 and/or
bolt or screw fixation (not illustrated in FIG. 13) portions
similar to those discussed above. Again, as discussed herein, the
soft tissue immobilization system 539 can be positioned inferiorly
on the soft tissue connection portion 536.
[0063] An exterior surface of the soft tissue connection portion of
536 can also define an arc having a radius, as discussed above. The
arc can extend around a selected axis, such as the axis 337a of the
neck 337. Alternatively, or in addition thereto, the radius may
also be defined within the soft tissue connection portion of 536.
Thus, the soft tissue connection portion of 536 can define a
plurality of connection regions to create the substantially
anatomical matching connections to mimic the natural facet
connections of the femur as illustrated in FIG. 1. Additionally,
the neck portion 332 can be connected with a stem portion 544 and
the head 335.
[0064] It is understood that the soft tissue connection portion,
according to the various embodiments as discussed herein, can
include a porous surface for soft tissue ingrowth. The porous
surface for soft tissue ingrowth can include a porous coating on a
substantially solid or non-porous substrate, such as a titanium or
stainless steel substrate. Alternatively, or in addition thereto,
the porous surface can include a porous construct, such as
Regenerex.RTM. porous metal sold by Biomet, Inc. or additively
manufactured constructs. either alone and/or to be fixed to a
substrate. As a further alternative to the soft tissue connection
portion can be formed entirely of a porous metal such as the
Regenerex.RTM. porous metal or additively manufactured constructs,
and be interconnected with the neck portion, according to the
various embodiments.
[0065] According to the various embodiments, the disclosed
prostheses as illustrated in FIGS. 2-14 include various embodiments
of soft tissue connection regions 38, 238, 360a, 360b, 438, and 538
that may or may not be used together or formed together in one
construct. The soft tissue connection regions can generally include
porous coated constructs and/or porous metal constructs. Moreover,
according to various embodiments, that may or may not be combined,
soft tissue immobilization systems 46, 46a, 46b, 253, 363a-363b,
451, and 539 can be positioned substantially inferior relative to
respective soft tissue connection portions and/or the anatomy into
which they are placed, as discussed above. This inferior placement,
according the various embodiments described herein, allows for a
large, including a greatest amount, of uninterrupted contact
surface area between the soft tissue and the soft tissue connection
regions, according to various embodiments.
[0066] Additionally, it is understood that the soft tissue
connection portions can be interconnected with the neck portions
according to the various embodiments. Accordingly, it is understood
that the variations and various embodiments disclosed herein can be
combined in appropriate manners, such as those understood by ones
skilled in the art, can provide a selection of configurations for
use by a selected user. Thus, it is understood, that the specific
embodiments treated herein are not understood to limit the various
combinations that further selected soft tissue connection
portions.
[0067] Additionally, it is understood that a kit 600, as
illustrated in FIG. 14, can be provided to include at least one
neck portion such as the dove-tail neck connection portion 332, the
stem portion 334, and a plurality of soft tissue connection
portions 602. The plurality of soft tissue connection portions 602
can include all those illustrated above for connection with the
selected neck portion, such as the neck portion 332. It will be
understood that any selected configuration of soft tissue
connection portion can be provided and selected by a user. The
plurality of soft tissue connection portions 602 can each include
different sizes, shapes, and configurations to allow intraoperative
selection by a user.
[0068] Accordingly, the kit 600 can be provided to a user for use
during a procedure. As discussed above, an intraoperative decision
can be made, such as after making an incision in the patient, to
select whether or not a soft tissue connection is necessary and,
then, a selection from the various plurality of soft tissue
connection portions 602 from the kit 600 can be made to provide for
a selected and patient-specific or an appropriate connection or
configuration. Thus, it is understood that the soft tissue
connection portions 602 provided in the kit 600 can be selected
intraoperatively by a user for providing an appropriate prosthesis
to a patient. The prosthesis can be substantially patient specific,
although not initially designed based upon data, such has image
data, of the patient. It is understood, however, that patient data
can be used to form a soft tissue connection portion that can be
one of at least a plurality of soft tissue connection portions
provided in the kit 600 or as an augment to the kit 600 for
selection by a user.
[0069] Generally, the femur 20 can be prepared as is generally
understood by one skilled in the art. For example, an incision can
be made and the user can inspect the subject. A proper resection
can then be made and the user can again inspect the subject. Based
on the inspection an evaluation and determination can be made as to
a select which, if any, of the plurality of soft tissue connections
portions, such as the soft tissue connection portions 602, can or
should be interconnected with a selected one of the neck portion.
Again, it is understood, that based on the determination that no
soft tissue connection portion need be selected. Additionally, a
set of instructions can be executed by a processor to determine
which soft tissue connection portion would be proper for a specific
subject. The instructions can include inputs for amount of tissue
resected, age of the subject, condition of the soft tissue, and
other proper inputs. Once selected, the soft tissue connection
portion can be connected with the neck portion. The connected soft
tissue connection portion and the neck portion can then be
connected to a stem either prior to or after implantation of the
stem. The procedure can then be completed as understood by one
skilled in the art.
[0070] The foregoing description of the embodiments has been
provided for purposes of illustration and description. It is not
intended to be exhaustive or to limit the disclosure. Individual
elements or features of a particular embodiment are generally not
limited to that particular embodiment, but, where applicable, are
interchangeable and can be used in a selected embodiment, even if
not specifically shown or described. The same may also be varied in
many ways. Such variations are not to be regarded as a departure
from the disclosure, and all such modifications are intended to be
included within the scope of the disclosure.
* * * * *