U.S. patent application number 13/939936 was filed with the patent office on 2013-11-07 for systems and methods for installing ankle replacement prostheses.
The applicant listed for this patent is Inbone Technologies, Inc.. Invention is credited to Mark A. Reiley.
Application Number | 20130297035 13/939936 |
Document ID | / |
Family ID | 38041929 |
Filed Date | 2013-11-07 |
United States Patent
Application |
20130297035 |
Kind Code |
A1 |
Reiley; Mark A. |
November 7, 2013 |
Systems and methods for installing ankle replacement prostheses
Abstract
An ankle implant for use in ankle arthroplasty in total ankle
replacement is provided. The implant includes an upper prosthesis
anchored to the tibia and a lower prosthesis anchored to the talus.
The lower prosthesis is operable associated with the upper
prosthesis. The implant also includes a stem which is rigidly
removably connected to the second member. The stem includes a
portion for attachment to the calcaneous. The stem is be adapted to
be in a first position in the calcaneous when the stem is in a
first relative position with respect to the lower prosthesis, and
to provide for a second position in the calcaneous when the stem is
in a second relative position with respect to the lower
prosthesis.
Inventors: |
Reiley; Mark A.; (Piedmont,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Inbone Technologies, Inc. |
Boulder |
CO |
US |
|
|
Family ID: |
38041929 |
Appl. No.: |
13/939936 |
Filed: |
July 11, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13233693 |
Sep 15, 2011 |
8496712 |
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13939936 |
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11648042 |
Dec 29, 2006 |
8034114 |
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13233693 |
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11038803 |
Jan 19, 2005 |
7314488 |
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11648042 |
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10699999 |
Nov 3, 2003 |
6875236 |
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11038803 |
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09935479 |
Aug 23, 2001 |
6673116 |
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10699999 |
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09694100 |
Oct 20, 2000 |
6663669 |
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09935479 |
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Current U.S.
Class: |
623/21.18 |
Current CPC
Class: |
A61F 2002/30332
20130101; A61B 17/1775 20161101; A61F 2/4202 20130101; A61B 17/1717
20130101; A61F 2002/30604 20130101; A61F 2002/4207 20130101; A61F
2002/4205 20130101; A61F 2002/30607 20130101; A61B 17/72 20130101;
A61F 2002/4217 20130101; A61B 17/7258 20130101; A61F 2/4606
20130101; A61F 2002/30331 20130101 |
Class at
Publication: |
623/21.18 |
International
Class: |
A61F 2/42 20060101
A61F002/42 |
Claims
1. An implant for use in ankle arthroplasty comprising: a first
member for cooperation with the tibia; a second member for
cooperation with the talus and operably associated with the first
member; and a third member rigidly removably connectable to said
second member, said third member including a portion thereof for
attachment to the calcaneous, said third member adapted to provide
for a first position in the calcaneous when said third member is in
a first relative position with respect to said second member and to
provide for a second position in the calcaneous when said third
member is in a second relative position with respect to said second
member.
2. The implant of claim 1, wherein one of said second member and
said third member comprises a protrusion and wherein the other of
said second member and said third member defines a cavity for
receiving the protrusion.
3. The implant of claim 2, wherein the protrusion has a periphery a
portion of which is conofrustrical.
4. The implant of claim 1, further comprising a bearing member
positioned between said first member and said second member, said
bearing member moveably associated with said first member and with
said second member.
5. The implant of claim 1, wherein said second member comprises a
first portion operably associated with said first member and a
second portion removably attached to said first portion, said
second portion for cooperation with the talus.
6. The implant of claim 5, wherein said second portion has an
enlarged surface area to provide additional support for the implant
on the talus.
7. The implant of claim 1, further comprising a fastener to connect
said third member to said second member.
8. A kit for use in assembling an implant for use in ankle
arthroplasty comprising: a first member for cooperation with the
tibia; a second member operably associated with the first member; a
third member rigidly removably connectable to said second member,
said third member including a portion thereof for attachment to the
talus; and a fourth member rigidly removably connectable to said
second member, said fourth member including a portion thereof for
attachment to the talus, the fourth member having at least one
dimension different that a dimension of said third member.
9. The kit of claim 8, wherein one of said second member and said
third member comprises a protrusion and wherein the other of said
second member and said third member defines a cavity for receiving
the protrusion.
10. The kit of claim 9, wherein the protrusion has a periphery a
portion of which is conofrustrical.
11. The kit of claim 8, further comprising a bearing member
positioned between said first member and said second member, said
bearing member moveably associated with said first member and with
said second member.
12. The kit of claim 8, further comprising a tibia connecting
member operably associated with the first member.
13. The kit of claim 8, wherein said fourth member includes a
portion thereof for attachment to the calcaneus.
14. The kit of claim 8, wherein said second member comprises a
first portion operably associated with said first member and a
second portion removably attached to said first portion, said
second portion for cooperation with the talus.
15. The kit of claim 14, wherein said second portion has an
enlarged surface area to provide additional support for the implant
on the talus.
16. The kit of claim 8, further comprising a fastener to connect
said third member to said second member.
17. A talar component for use in an implant for use in ankle
arthroplasty comprising: a first member for cooperation with the
talus; and a second member rigidly removably connectable to said
first member, said second member including a portion thereof for
attachment to the calcaneous, said second member adapted to provide
for a first position in the calcaneous when said second member is
in a first relative position with respect to said first member and
to provide for a second position in the calcaneous when said second
member is in a second relative position with respect to said first
member.
18. The talar component of claim 17, wherein one of said first
member and said second member comprises a protrusion and wherein
the other of said first member and said second member defines a
cavity for receiving the protrusion.
19. The talar component of claim 18, wherein said protrusion has a
periphery a portion of which is conofrustrical.
20. The talar component of claim 17, wherein said first member
comprises a first portion and a second portion removably attached
to said first portion, said second portion for cooperation with the
talus.
21. The talar component of claim 20, wherein said second portion
has an enlarged surface area to provide additional support for the
implant on the talus.
22. The talar component of claim 17, further comprising a fastener
to connect said second member to said first member.
23. A method for providing ankle arthroplasty comprising: providing
an ankle prosthesis kit including an tibial component, a bearing
component, a talar articulating component, a first talar mounting
component, and a second talar mounting component having at least
one dimension different than the first talar mounting component;
cutting an incision in the patient; Preparing the talar cavity and
the tibia cavity; implanting the tibial component into the tibial
cavity; selecting one of the first talar mounting component and the
second talar mounting component; implanting the selected one of the
first talar mounting component and the second talar mounting
component into the talar cavity; and positioning the bearing
component between the tibial component and the selected one of the
first talar mounting component and the second talar mounting
component.
Description
RELATED APPLICATIONS
[0001] This application is a division of co-pending U.S. patent
application Ser. No. 11/038,803, filed Jan. 19, 2005, which is a
division of U.S. patent application Ser. No. 10/699,999, filed Nov.
3, 2003 (now U.S. Pat. No. 6,875,236), which is a division of U.S.
patent application Ser. No. 09/935,479, filed Aug. 23, 2001 (now
U.S. Pat. No. 6,673,116), which is a continuation-in-part of U.S.
patent application Ser. No. 09/694,100, filed Oct. 20, 2000 (now
U.S. Pat. No. 6,663,669), which claims the benefit of U.S.
Provisional Patent Application Ser. No. 60/160,892, filed Oct. 22,
1999, all of which are incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The invention relates to ankle replacement prostheses,
systems, and associated surgical procedures.
BACKGROUND OF THE INVENTION
[0003] Until the early to mid 1970's, patients with injured or
diseased ankle joints commonly resulting from osteoarthritis
(age-related wear of the joints), or rheumatoid arthritis
(generalized joint inflammation causing destructive changes), or
traumatic arthritis (damage to a joint from a direct injury), had
few satisfactory options when their ankle joints failed.
Non-surgical options included weight loss, activity modification,
medication, injections, braces and therapeutic shoes. The available
surgical techniques included ankle arthroscopy (endoscopic
examination of the joint), ankle arthrotomy (cutting into the joint
to expose the interior) and debridement (opening the joint and
removing bone spurs), osteotomy (cutting the bone to realign the
joint), ankle fusion (removing the joint and making it stiff), and
total ankle arthroplasty (removing the ankle joint and replacing it
with an artificial substitute).
[0004] Many of the prior art surgical procedures were riddled with
problems for the patient. While early success was realized, there
was a high long-term term failure rate due to complications such as
infection, loosening, and collapse, which lead to additional
extensive surgical procedures.
[0005] Previous ankle replacement systems typically include a talar
member, fixed to the talus, as one of their main functioning
components. The talus, however, is relatively small, providing a
small area of bone for fixation. Also, in most of these ankle
replacement systems, the talar component is cemented to the talus.
The combination of fixation with bone cement to a small fixation
area allows for erosion of the cement from the fixation area and an
increase in compliance due to formation of a soft tissue capsule
over time. This contributes to aseptic loosening and migration of
the device.
[0006] Previous ankle replacement systems are typically installed
through incisions made at or near the ankle and make use of
extramedullary alignment and guidance techniques. Such surgical
procedures require making large incisions at the ankle, moving the
tendons and other soft tissue aside; and separating the tibia and
fibula from the talus--essentially detaching the foot from the
leg--to install the device. Such procedures subsequently require
complicated extramedullary realignment and reattachment of the
foot. These procedures commonly result in infection and extended
healing time with possible replacement failure from improper
extramedullary realignment. The surgery also has increased risks
associated with cutting or damaging neighboring nerves and tendons
which may lead to further complications.
[0007] There remains a need for a total ankle replacement system
that reduces the occurrence of subsidence and aseptic loosening
while retaining the majority of the foot's natural motion.
SUMMARY OF THE INVENTION
[0008] The invention provides an implant for use in ankle
arthroplasty which overcomes the problems and disadvantages
associated with current strategies and systems in total ankle
replacement (TAR).
[0009] The present invention may include a first member anchored to
the tibia and a second member anchored to the talus and operable
associated with the first member. The invention may also include a
third member which is rigidly removably connected to the second
member. The third member may include a portion for attachment to
the calcaneous. The third member may be adapted to be in a first
position in the calcaneous when the third member is in a first
relative position with respect to the second member, and to provide
for a second position in the calcaneous when the third member is in
a second relative position with respect to the second member.
[0010] The present invention may also include a fourth member which
is rigidly removably connected to the second member. The fourth
member may have at least one dimension which is different than a
dimension of the third member, such that the fourth and third
members are interchangeable.
[0011] Another object of the invention is to provide a method or
providing ankle arthroplasty. The method may include providing a
prosthesis kit including a tibial component, a bearing component, a
talar articulating component, a first talar mounting component, and
a second talar mounting component. The second talar mounting
component has at least one dimension different than the first talar
mounting component. The method may further include preparing the
talar cavity and the tibia cavity. The method may further include
implanting the tibial component into the tibial cavity. The method
may further include selecting either the first talar mounting
component or the second talar mounting component and implanting the
selected talar mounting component into the talar cavity. The method
may further include positioning the bearing component between the
tibial component and the selected talar mounting component.
[0012] Other objects, advantages, and embodiments of the invention
are set forth in part in the description which follows, and in
part, will be obvious from this description, or may be learned from
the practice of the invention.
DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a view of the lower leg and foot skeleton.
[0014] FIG. 2 is a lateral view of a human foot and lower leg
skeleton with the fibula shown in an assembly format and having a
planarly resected tibia and talus.
[0015] FIG. 2a is a posterior view of a human foot and lower leg
skeleton with the fibula not shown and planar cuts of the tibia and
talus are depicted.
[0016] FIG. 3 shows an intramedullary guidance system for providing
intramedullary alignment of the tibial and/or talar cuts, one end
of the system being oriented toward the tibia and the other end
oriented toward the talus.
[0017] FIG. 4 is a lateral view of a lower leg and foot
demonstrating the intramedullary insertion of a guide pin through
the superior part of the tibia and terminating in the talus.
[0018] FIG. 5 is a lateral view of a lower leg and foot
demonstrating the intramedullary insertion of a guide pin through
the plantar surface of the calcaneus, passing through the talus and
terminating in the tibia at variable lengths.
[0019] FIG. 5a is a sectional view of a foot and depicts the
insertion and removal of a guide pin through the plantar surface of
the calcaneus, passing through the talus and terminating in the
tibia, to produce an intramedullary channel, which may be made of
various dimensions by using the guide pin to also direct the course
of intramedullary reamers.
[0020] FIG. 6 is a lateral sectional view of the lower leg and foot
showing the guide pin surrounded by the reaming instrument creating
the intramedullary passage.
[0021] FIG. 7 is a lateral view and partial cross section of the
human lower leg and foot showing the intramedullary channel and a
resected portion of the anterior lower tibia to allow easier
insertion of an intramedullary cutting guide.
[0022] FIG. 8 is a posterior section of the lower leg and foot with
the fibula not shown and depicting the insertion of the
intramedullary cutting guide between the tibia and the talus.
[0023] FIG. 9 is a perspective view of a talo-calcaneal reaming
jig.
[0024] FIG. 9a is a lateral/partial sectional view depicting the
insertion of the reaming tool in the talo-calcaneal reaming jig for
the posteriorly directed inferior stem to help support the talar
component (the drill hole and stem can be only in the talus or
extend into the calcaneus for increased stability, and the
anterior-posterior position of the talar support stem can be
variable).
[0025] FIG. 9b is a cross-sectional view of the talo calcaneal jig
and channel as positioned on the talus.
[0026] FIG. 9c is a sectional view of resultant channel after the
jig is removed, also showing the talar support stem.
[0027] FIG. 10 is a lateral cross-sectional view of the upper
prosthetic body, showing the tibial stem and tibial component.
[0028] FIG. 10a is a side view of an alternative embodiment of an
upper prosthetic body with a shorter tibial stem than shown in FIG.
10.
[0029] FIG. 11 shows the insertion of a tibial stem through the
calcaneus and talus, and (if needed) through an anti-rotational
sleeve.
[0030] FIG. 12 is a perspective view of the optional
anti-rotational sleeve for the tibial stem.
[0031] FIG. 13 is a lateral cross sectional view of the tibial stem
in the lower tibia and fixed with screws and (optionally) with the
anti-rotational sleeve.
[0032] FIG. 14 shows a lateral cross sectional view of a lower
prosthetic body in the foot, including the talar component with
posterior fixation blade (if needed), talar fixation stem
(extending into the calcaneus), and anterior talo-calcaneal
fixation screws.
[0033] FIG. 15 shows both the upper and lower prosthetic
bodies.
[0034] FIG. 16 shows an alternative lower prosthetic unit, with
talar fixation stem at various angles.
[0035] FIG. 17 shows another alternative lower prosthetic unit,
with talar fixation stem at various angles.
DESCRIPTION OF THE INVENTION
I. Anatomy of the Ankle
[0036] Referring to FIG. 1, the foot comprises fourteen phalanges
or toe bones 11 connected to the metatarsus bones 13. There are
also seven tarsal bones 14, of which the talus 15 supports the
tibia 16 and the fibula 18, and the heel bone or calcaneus 17. Of
the tarsal bones, the talus 15 and the calcaneus 17 are the largest
and are adjacent to each other. The other tarsal bones include the
navicular 19, three cuneiforms 21, and the cuboid 23.
II. Intramedullary Guidance System
[0037] In performing a total ankle replacement procedure, it is
desirable to cut away bone on the inferior end of the tibia 16
and/or the superior end of the talus 15, to thereby form a planar
surface or surfaces 25, as FIG. 2 and FIG. 2a shows (in FIG. 2a,
the tibia 16 and talus 15 have been resected with the removed
portions shown in phantom lines, leaving two planar surfaces
25).
[0038] A planar surface increases the amount of bone available for
the fixation of a selected prosthetic base. This provides greater
stability and less stress absorption. This also decreases the
probability of prosthesis loosening and subsidence.
[0039] FIG. 3 shows the components of an intramedullary guidance
system 10 for providing a desired alignment of the tibia and talar
before and while the tibial and/or talar cuts shown in FIG. 2 are
made.
[0040] As shown in FIG. 3, the system 10 includes an intramedullary
guide pin 27. The intramedullary guide pin is made, e.g., of an
inert material used in the surgical arts, such as surgical steel.
The guide pin 27 may possess a range of desired diameters 29,
depending upon the function or functions it is intended to
perform.
[0041] For example, the diameter 29 may be relatively small, e.g.,
about 2 mm to 4 mm, if the pin 27 is to be used principally to form
an intramedullary void, as will be described later. The diameter 29
can be made larger, e.g., upwards to about 10 mm, if the pin 27 is
to be used to guide passage of a surgical instrument, such as an
intramedullary reamer or drill, to form an enlarged intramedullary
void, as will also be described later.
[0042] In use, the guide pin 27 may be introduced through the tibia
(as FIG. 4 shows) or through the calcaneus (as FIG. 5 shows).
Before the guide pin 27 is introduced, the foot and ankle are first
aligned in an acceptable position. One skilled in the art will
recognize that this may require surgically opening the ankle joint
to loosen contractures (permanent contraction of muscles,
ligaments, tendons) and scarring.
[0043] When introduced through the tibia (see FIG. 4), a minimal
exposure 200 is made at the tibial tubercle with an awl. Once the
exposure has been made, the exposure may be kept open under
distraction, pulling of the skin, or any other method common in the
surgical arts. Non invasive visualization of the procedure can be
accomplished through fluoroscopy or real time MRI, as well as
through other means well known to those skilled in the art.
Alternatively, or in conjunction with such less invasive means of
visualization, open visualization may be used for part and/or all
of the procedure.
[0044] In this approach, the guide pin 27 passed through the tibia
16, the tibial plafond, and enters the talus.
[0045] When introduced through the calcaneus (see FIG. 5), the
guide pin 27 is placed retrograde through a minimal exposure in the
calcaneus 17. The exposure may be kept open under any method common
in the surgical arts and previously discussed. As with the tibial
approach, non invasive visualization of the calcaneus approach can
be accomplished through fluoroscopy or real time MRI, as well as
through other means well known to those skilled in the art.
Alternatively, or in conjunction with such less invasive means of
visualization, open visualization may be used for part and/or all
of the procedure.
[0046] In this approach, the guide pin 27 passes through the
calcaneus, through the talus 15, through the tibial plafond, and
into the tibial shaft.
[0047] As FIG. 5a shows, upon removal, the guide pin 27 leaves
behind an intramedullary guide void or passage 28 through the
region where the tibia adjoins the talus. The passage 28 is sized
according to the diameter 29 of the guide pin 27, or with a reamer
to an appropriate size consistent with the size of the bones (the
calcaneus, the talus, and the tibia).
[0048] As FIG. 7 shows, once the passage 28 is formed, an anterior
section S of the tibia 16 can be removed by cutting, to expose the
anterior portion of the ankle joint and the guide passage 28.
[0049] As shown in FIG. 3, the system 10 also includes an
intramedullary cutting guide 31, which is introduced into the ankle
through an anterior surgical approach. In use, the intramedullary
cutting guide 31 functions to guide the saw blade used to create
the planar surfaces 25 on the tibia and/or talus, as shown in FIG.
2. For this purpose, the cutting guide includes one or more cutting
slots 33, through which the saw blade passes. As shown in FIG. 3,
the cutting guide 31 also includes an intramedullary locating
feature, which in the illustrated embodiment takes the form of an
intramedullary locating post 35 (see FIG. 3).
[0050] In use (see FIG. 8), the intramedullary cutting guide 31 may
be inserted anteriorly into the ankle joint after the resection of
a small amount of bone from the anterior "lip" of the tibia. The
alignment post 35 fits into the intramedullary guide passage 28 in
both the talus and tibia. The intramedullary post 35 aligns the
cutting guide 31 in the desired orientation with the talus 15 and
tibia 16. Intramedullary guidance enables the surgeon to produce
bony cuts that more closely approximate the mechanical axis of the
leg, which extramedullary guides, cannot do.
[0051] Oriented by the intramedullary post 35, the upper slot 33 of
the cutting guide 31 is aligned with the tibial shaft. The lower
slot 33 is aligned in the same direction into the dome of the
talus. The intramedullary post 35 maintains alignment as a bone saw
is passed through the slots 33, across the end regions of talus and
tibia. The aligned planar surfaces 25 are thereby formed with
intramedullary guidance. Removal of the cutting guide 31 exposes
these planar surfaces 25, as FIG. 2 and FIG. 2a show. With
intramedullary guidance, the cuts are superior to cuts using
extramedullary guidance. Extramedullary guidance systems rely on
surface bony prominences and visualization of the anterior ankle
joint. These landmarks are inconsistent and can misdirect bony cuts
by the surgeon.
[0052] The intramedullary guidance system 10 can be conveniently
used with various surgical instruments or prosthetic parts. Because
extramedullary alignment is avoided, more precise alignment can be
made.
[0053] For example, as shown in FIG. 6, prior to removal of the
guide pin 27 and the use of the cutting guide 31 to form the tibial
and talar cuts, the guide pin 27 can serve an additional function,
namely, to guide the passage of an intramedullary reaming device or
a cannulated drill 30. In this arrangement, the guide pin 27 is
used to direct the reaming device 30 over it. A minimally larger
exposure will be required on the bottom of the foot to allow the
passage of the reaming device or drill bit over the guide pin
27.
[0054] Depending upon the manner in which the guide pin 27 is
inserted, the reaming device 30 can be guided by the intramedullary
guide pin 27, either along a superior path, through the tibia and
into the talus (as FIG. 4 shows), or along an inferior path,
through the calcaneus and talus and into the tibia (as FIG. 5
shows). Guided by the pin 27, the reaming device 30 leaves behind
an enlarged intramedullary void or passage 28.
[0055] Alternatively, the guide pin 27 and reaming device 30 may be
placed through the tibia or calcaneus simultaneously, or a reaming
rod may be placed through the tibia or calcaneus without a guide
pin 27, although it is preferable to use a guide pin. The reamer
device 30 is preferably 5, 6, 7, 8, 9, or 10 mm wide, depending on
the size of the patient's tibia 16.
[0056] In this arrangement, the alignment post 35 of the cutting
guide 31 is sized to fit into the enlarged reamed intramedullary
passage 28. As before described, the post 35 aligns the cutting
guide 31 in the desired orientation with the talus and tibia for
forming the end cuts, as well maintain the alignment of the reamed
intramedullary passage 28.
[0057] The size of the alignment post 35 of the cutting guide 31
depends upon how the intramedullary channel is formed. For example,
if just a guide pin is used to form the channel, the post 35 will
be sized smaller than if an intramedullary reamer is used in
forming the channel. If just the guide pin is used to form the
channel, straightforward, minimally invasive percutaneous access
can be used to insert the guide pin into the calcaneus, into the
talus and tibia, thereby forming the relatively small diameter
intramedullary channel.
[0058] An upper prosthesis body may be fixed directly to planar cut
of the tibia with or without a tibial stem. A lower prosthesis body
of the talus may likewise be fixed directly to the planar cut of
the talus, or with a fixation stem into the talus or into both the
talus and the calcaneus. The upper and lower prosthesis bodies may
be used in combination or singly. As will now be described in
greater detail later, stemmed upper or lower prostheses may be
located on the planar cuts, either individually or in
combination.
III. Stemmed Upper Prosthetic Device
[0059] The reamed intramedullary passage 28 formed in the tibia
using the intramedullary guidance system 10 can, e.g., serve to
accept a stemmed upper prosthetic body 170, as FIG. 10 shows. The
stemmed upper prosthetic body can take various forms. Certain
representative embodiments are found in U.S. patent application
Ser. No. 09/694,100, now U.S. Pat. No. 6,663,669, filed Oct. 20,
2000, entitled "Ankle Replacement System," which is incorporated
herein by reference.
[0060] In one embodiment (FIG. 10), the upper prosthetic body 170
comprises an elongated tibial stem 150. The tibial stem 150 may be
made of any total joint material or materials commonly used in the
prosthetic arts, including, but not limited to, metals, ceramics,
titanium, titanium alloys, tantalum, chrome cobalt, surgical steel,
or any other total joint replacement metal and/or ceramic, bony
in-growth surface, sintered glass, artificial bone, any uncemented
metal or ceramic surface, or a combination thereof. The tibial stem
150 may further be covered with one or more coatings such as
antimicrobial, antithrombotic, and osteoinductive agents, or a
combination thereof. These agents may further be carried in a
biodegradable carrier material with which the pores of tibial stem
150 may be impregnated. See U.S. Pat. No. 5,947,893.
[0061] The tibial stem 150 may be variable lengths, e.g., from 2 cm
to 30 cm and variable widths, e.g., from 6 to 12 mm. In the
preferred embodiment, the tibial stem 150 is preferably
approximately 6 inches in length. Of course, it should be
understood that the disclosed tibial stem could be of virtually any
length, depending upon the size of the patient, his or her bone
dimensions, and the anticipated future mobility of the patient. For
example, as FIG. 10a shows, the upper prosthetic body 170' can
comprises a shorter tibial stem 150' having a diameter generally
the same size (or slightly larger) than the guide pin that forms
the passage 28. The body 170' can also include several short,
spaced apart derotation pegs 171.
[0062] The tibial stem 150 may be inserted into the reamed
intramedullary passage 28 either superiorly (through the tibia), or
inferiorly (through the calcaneus and talus and into the tibia),
depending upon the path along which the guide pin 27 and reaming
device 30 have followed.
[0063] For example, as depicted in FIG. 4, when the passage 28 is
made by the pin 27 and reaming device 30 superiorly through the
tibia, the tibial stem 150 is inserted in a superior path through
the tibia. Alternately, as depicted in FIGS. 11 to 13, when the
passage 28 is made by the pin 27 and reaming device 30 retrograde
through the calcaneus, the tibial stem 150 may be introduced
inferiorly through the retrograde passage 28 through the calcaneus
and talus into the tibia (FIG. 11).
[0064] The stem 150 is fixed in the lower tibia (FIG. 13). The
tibial stem 150 may be fixed in the tibia 16 with
poly(methylmethacrylate) bone cement, hydroxyapatite, a ground bone
composition, screws, or a combination thereof, or any other
fixation materials common to one of skill in the art of prosthetic
surgery. An anti-rotational sleeve 406 (see FIG. 12) can also be
used alone or in combination with other fixation devices.
[0065] In a preferred embodiment, the tibial stem 150 is fixed to
the tibia 16 with screws 125a and 125b. If screws are used, they
can extend anteriorly, posteriorly, medially, laterally and/or at
oblique angles, or any combination thereof.
[0066] Optionally, a sleeve 406 (see FIGS. 11 and 12) may be placed
about the stem 150, e.g., as the stem is passed between the talus
and tibia. The sleeve 406 engages bone along the passage 28. The
sleeve 406 imparts an anti-rotational feature, including, e.g.,
outwardly extending fins. The sleeve 406 may be used in combination
with the screws or alone without the screws.
[0067] The distal end of the tibial stem 150 may additionally have
interlocking components, common to those of skill in the art, at
its lower surface to allow other components of the upper prosthesis
body to lock into the tibial stem. In a preferred embodiment, the
tibial stem 150 has a Morse Taper 115b at its lower surface to
which a concave dome 155 is attached. The dome 155 can be made of a
plastic, ceramic, or metal. The dome 115 articulates with the lower
ankle joint surface, which can be the talus bone itself or a lower
prosthetic body fixed to the talus, as will now be described.
IV. Stemmed Lower Prosthesis Body
[0068] A lower prosthetic body can be supported on the talus,
either alone or in association with an upper prosthetic body
mounted in the tibia. The upper prosthetic body may be stemmed, as
just described, or affixed directly to the tibia without use of a
stem. Likewise, the lower prosthetic body may be stemmed or affixed
directed to the talus. Certain representative embodiments are found
in U.S. patent application Ser. No. 09/694,100, now U.S. Pat. No.
6,663,669, filed Oct. 20, 2000, entitled "Ankle Replacement
System," which is incorporated herein by reference.
[0069] In one embodiment, the stem for the talar component does not
extend beyond the inferior surface of the talar. In another
embodiment, a subtalar joint (i.e., the joint formed between talus
and calcaneus) is fused to allow fixation of the lower prosthesis
body to both the talus and calcaneus. The subtalar joint may be
fused using any method common to those of skill in the surgical
arts including, but not limited to, fusion with, for example, poly
(methylmethacrylate) bone cement, hydroxyapatite, ground bone and
marrow composition, plates, and screws, or a combination
thereof.
[0070] FIG. 14 shows one method of fusing the talus 15 to the
calcaneus 17 using a stem 110, a plate 130, and screws 133a, 133b.
The talo-calcaneal stem 110 is shown with a Morse Taper 115a
protruding from the stem 110 and extending beyond the proximal
(top) surface of the talus 15. In another embodiment, the Morse
Taper could extend down from the talar component into the stem.
FIG. 14 also shows an arrangement in which the lower end of the
tibia has not been cut and does not carry a prosthesis.
[0071] The talo-calcaneal stem 110 may be made of various materials
commonly used in the prosthetic arts including, but not limited to,
titanium, titanium alloys, tantalum, chrome cobalt, surgical steel,
or any other total joint replacement metal and/or ceramic, bony
in-growth surface, sintered glass, artificial bone, any uncemented
metal or ceramic surface, or a combination thereof. The
talo-calcaneal stem 110 may further be covered with various
coatings such as antimicrobial, antithrombotic, and osteoinductive
agents, or a combination thereof. These agents may further be
carried in a biodegradable carrier material with which the pores of
the surface of the talo-calcaneal stem 110 may be impregnated. See
U.S. Pat. No. 5,947,893, which is incorporated herein by reference.
If desired, the talo-calcaneal stem may be coated and/or formed
from a material allowing bony in-growth, such as a porous mesh,
hydroxyapetite, or other porous surface.
[0072] The talo-calcaneal stem 110 may be any size or shape deemed
appropriate to fuse the subtalar joint of a patient and is
desirably selected by the physician taking into account the
morphology and geometry of the site to be treated. For example, the
stem 110 may be of variable lengths, from 2 cm to 12 cm, and
variable widths, from 4 to 14 mm. In a preferred embodiment, the
talo-calcaneal stem 110 is approximately 65 to 75 mm in length and
approximately 7 to 10 mm wide. While in the disclosed embodiment
the stem 110 has a circular cross-section, it should be understood
that the stem could formed in various other cross-sectional
geometries, including, but not limited to, elliptical, polygonal,
irregular, or some combination thereof. In addition, the stem could
be arced to reduce and/or prevent rotation, and could be of
constant or varying cross-sectional widths.
[0073] The physician is desirably able to select the desired size
and/or shape based upon prior analysis of the morphology of the
target bone(s) using, for example, plain film x-ray, fluoroscopic
x-ray, or MRI or CT scanning. The size and/or shape is selected to
optimize support and/or bonding of the stem to the surrounding
bone(s).
[0074] As FIGS. 9a to 9c show, the talo-calcaneal stem 110 can be
passed from the top of the talus 15 into the distal calcaneus 17
through a cavity 601 that is drilled through the talus 15 and
calcaneus 17. The cavity 601 is preferably drilled after the
surface of the talus 15 has cut and flattened, and after the
location of the upper prosthesis body.
[0075] A suitable jig 600 (see FIG. 9) may be placed in the joint
to assist with locating and placing the cavity 601. Certain
representative embodiments are found in U.S. patent application
Ser. No. 09/694,100, now U.S. Pat. No. 6,663,669, filed Oct. 20,
2000, entitled "Ankle Replacement System," which is incorporated
herein by reference. The jig 600 includes a drill guide 620 and a
post 610 that, in use, rests in the intramedullary passage 28 (see
FIGS. 9a and 9b). The drill guide 620 can extend from posterior to
anterior (as FIG. 9 shows), or alternatively, from anterior to
posterior.
[0076] The drill bit 603 for the jig 600 (see FIG. 9a) is
preferably about 1/2 mm wider than the width of the talo-calcaneal
stem 110. The talo-calcaneal stem 110 may be further adapted so
that the talo-calcaneal stem 110 is inserted as the cavity is being
drilled or so that the talo-calcaneal stem itself is used to drill
the hole.
[0077] Once the cavity 601 is formed, any easily accessed cartilage
from the talo-calcaneal joint may be scraped, e.g., using a small
angled curet or any other instrument commonly used in the surgical
arts. The subtalar joint can then be fused by passing a
talo-calcaneal stem 110 down the cavity 601. The cavity 601 may be
partially filled with a bone cement prior to the installation of
the talo-calcaneal stem 110 to help fix the talo-calcaneal stem 110
to the subtalar joint. Desirably, the stem 110 incorporates screw
holes or other openings to accommodate interlocking hardware, such
as screws, to increase fixation and minimize rotation.
[0078] The stem 110 desirably includes a Morse Taper 115a. A cap
160a fits on the Morse Taper 115a to form an articulating joint
surface with the upper prosthesis. The upper surface of the cap 160
can be designed to fit the particular needs and walking
requirements anticipated by the physician and patient. For example,
a low demand surface, such as for an individual of advanced years
having a less-active lifestyle, could comprise a simple smooth arc,
without the "peaks and valleys" of the talus 15 that run from
anterior to posterior. In addition, a low demand surface may not
require a difference in the anterior to posterior talar width,
which in an adult male can be approximately 4 to 5 mm wider in its
anterior portion than its posterior portion. A higher demand
surface, for a more active individual, may incorporate the trochlea
(valley) in the talus as well as various other anatomical features
found on the talus.
[0079] Desirably, as best seen in FIG. 16, the stem 110a extends
downward from the cap 160a, forming an angle .alpha.0 relative to
the vertical axis--taken relative to the longitudinal axis of cap
160a (front to rear of the foot). In one embodiment, the angle
.alpha.0 will range from 105.degree. to 205.degree., depending upon
the size and orientation of the calcaneus 17 as well as the
position of the lower prosthesis body. Moreover, as best seen in
FIG. 17, the stem may form an angle .beta.0 relative to the
vertical axis--taken relative to the transverse axis of the cap
160b (medial to lateral side of the foot). In a preferred
embodiment, the angle .beta.0 will range from 155.degree. (on the
medial side of the foot) to 240.degree. (on the lateral side of the
foot), depending upon the size and orientation of the calcaneus 17
as well as the position of the lower prosthesis body. Desirably,
the lower portion of the stem of the implant will not extend
outside of the calcaneus.
[0080] As shown in FIG. 14, a plate 130 may be fixed to the top of
the talus 15. The plate 130 can have an overhang portion 131 which
allows the plate 130 to overlap both the talus 15 and part of the
calcaneus 17. The plate 130 and overhang portion 131 may be made of
various materials commonly used in the prosthetic arts including,
but not limited to, polyethylene, biologic type polymers,
hydroxyapetite, rubber, titanium, titanium alloys, tantalum, chrome
cobalt, surgical steel, or any other total joint replacement metal
and/or ceramic, bony in-growth surface, sintered glass, artificial
bone, any porous metal coat, metal meshes and trabeculations, metal
screens, uncemented metal or ceramic surface, other bio-compatible
materials, or any combination thereof. The plate 130 and overhang
portion 131 may further be covered with various coatings such as
antimicrobial, antithrombogenic, and osteoinductive agents, or a
combination thereof. See U.S. Pat. No. 5,866,113 to Hendriks, et
al, incorporated herein by reference. These agents may further be
carried in a biodegradable carrier material with which the pores of
the plate 130 and overhang portion 131 may be impregnated. In one
preferred embodiment, the tray comprises a metal-backed
polyethylene component.
[0081] The plate 130 and/or the overhang portion 131 may be fixed
to the subtalar joint 90 with poly(methylmethacrylate) bone cement,
hydroxyapatite, a ground bone and marrow composition, screws, or a
combination thereof, or any other fixation materials common to one
of skill in the art of joint replacement surgery. In a preferred
embodiment, the plate 130 and overhang portion 131 are fitted over
the Morse Taper 115a of the talo-calcaneal stem 110 and fixed to
the talus 15 and calcaneus 17 with screws 133a and 133b. In another
embodiment, the posterior overhang portion 131 can be
eliminated.
[0082] The lower prosthesis body may be formed in a single unit or,
as illustrated, as a multi-component prosthesis.
[0083] In other embodiments, the upper prosthesis body may
additionally comprise a fibular prosthesis of any variety known in
the art of joint replacement. The fibular prosthesis would replace
the inferior end of the fibula, especially when this prosthesis is
used to revise a total ankle replacement system that has removed
the distal end of the fibula. In still further embodiments, either
the lower prosthesis body, upper prosthesis body, or both, as
described above, may be fixed into strengthened or fortified bone.
The bones of the subtalar joint, tibia, or fibula may be
strengthened prior to or during fixation of the prosthesis using
the methods described in U.S. Pat. No. 5,827,289 to Reiley. This
type of bone strengthening procedure is particularly suggested for
osteoporotic patients who wish to have a total ankle
replacement.
[0084] It should be appreciated that installed prosthetic system
need not include a calcaneal stem. Thus, the system would only
include the tibial stem, the tibial component and the talar
component. In this case there would be not Morse Taper holes or
stems on the under surface of the talar component, just a flat or
minimally stem component with or without screw holes for screw
fixation.
[0085] Likewise, the installed prosthetic system need not include a
tibial stem component. In this case, the system would include the
tibial component without the Morse Taper attachments on its
superior surface, the talar component, and the calcaneal stem
component.
[0086] Furthermore, the installed prosthetic system need not
include any stemmed component being utilized. However, the
intramedullary guidance system 10, deployed either superiorly from
the tibia, or inferiorly from the calcaneus, would still provide
intramedullary alignment of the tibial and talar cuts. In this
arrangement, the tibial component and the talar component would be
utilized, without Morse Taper stems or holes on either implant, but
the intramedullary guidance system would still be used to insure
properly aligned cuts in the talus and tibia.
[0087] It should be understood that the devices and methods of the
present invention could be used as an index (initial) total ankle
replacement, as well as a revision ankle replacement. If used as a
revision device, only a portion of the disclosed methods and
devices may be necessary in conjunction with such a procedure.
[0088] Other embodiments and uses of the inventions described
herein will be apparent to those skilled in the art from
consideration of the specification and practice of the inventions
disclosed. All documents referenced herein are specifically and
entirely incorporated by reference. The specification should be
considered exemplary only with the true scope and spirit of the
invention indicated by the following claims. As will be easily
understood by those of ordinary skill in the art, variations and
modifications of each of the disclosed embodiments can be easily
made within the scope of this invention as defined by the following
claims.
* * * * *