U.S. patent application number 14/177732 was filed with the patent office on 2014-06-12 for malleolar replacement devices.
This patent application is currently assigned to GLOBAL ORTHOPAEDIC SOLUTIONS LLC. The applicant listed for this patent is Nicholas A. Abidi, Jonathan Borkowski. Invention is credited to Nicholas A. Abidi, Jonathan Borkowski.
Application Number | 20140163688 14/177732 |
Document ID | / |
Family ID | 45441559 |
Filed Date | 2014-06-12 |
United States Patent
Application |
20140163688 |
Kind Code |
A1 |
Abidi; Nicholas A. ; et
al. |
June 12, 2014 |
Malleolar Replacement Devices
Abstract
A prosthesis and kit for replacing an ankle joint, and methods
of applying the devices or systems. The prosthesis is an
intramedullary device directed towards replacement of either of the
tibia or fibula bone, wherein the prosthesis is a replacement for
the lateral malleolus or the medial malleolus, respectively.
Inventors: |
Abidi; Nicholas A.; (Scotts
Valley, CA) ; Borkowski; Jonathan; (Scotts Valley,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abidi; Nicholas A.
Borkowski; Jonathan |
Scotts Valley
Scotts Valley |
CA
CA |
US
US |
|
|
Assignee: |
GLOBAL ORTHOPAEDIC SOLUTIONS
LLC
SCOTTS VALLEY
CA
|
Family ID: |
45441559 |
Appl. No.: |
14/177732 |
Filed: |
February 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13178208 |
Jul 7, 2011 |
8647391 |
|
|
14177732 |
|
|
|
|
61362122 |
Jul 7, 2010 |
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Current U.S.
Class: |
623/21.18 |
Current CPC
Class: |
A61F 2/4202 20130101;
A61F 2002/4205 20130101; A61F 2002/30784 20130101; A61B 17/86
20130101; A61F 2002/421 20130101 |
Class at
Publication: |
623/21.18 |
International
Class: |
A61F 2/42 20060101
A61F002/42 |
Claims
1. An ankle prosthesis comprising: a proximal portion adapted for
insertion into an intramedullary canal of one of a human tibia and
a human fibula; and a distal portion coupled to the proximal
portion, the distal portion shaped similarly to a malleolus of the
one of a human tibia and a human fibula, wherein said distal
portion further includes a groove configured to receive a tendon
associated with a human ankle.
2. The ankle prosthesis of claim 1 further comprising at least one
hole located in said distal portion, said at least one hole capable
of receiving means for attaching the prosthesis to the ankle.
3. The ankle prosthesis of claim 2 further comprising a plurality
of holes located in said distal portion, said holes capable of
receiving means for attaching the prosthesis to the ankle.
4. The ankle prosthesis of claim 1 further comprising at least one
hole located in said proximal portion, said at least one hole
capable of receiving means for attaching the prosthesis to the one
of a human tibia and a human fibula.
5. The ankle prosthesis of claim 4, further comprising a plurality
of holes located in said proximal portion, said holes capable of
receiving means for attaching the prosthesis to the one of a human
tibia and a human fibula.
6. The ankle prosthesis of claim 1 wherein the distal portion has a
larger cross-sectional diameter than said proximal portion.
7. The ankle prosthesis of claim 6, wherein the proximal portion
comprises an insert that defines a distance that the proximal end
may be inserted into the intramedullary canal.
8. The ankle prosthesis of claim 1, wherein the distal portion is
coupled to the proximal portion by being integrally formed
therewith.
9. The ankle prosthesis of claim 1, wherein the proximal portion is
adapted for insertion into the intramedullary canal of the human
tibia and the tendon comprises the posterior tibial tendon.
10. The ankle prosthesis of claim 1, wherein the proximal portion
is adapted for insertion into the intramedullary canal of the human
fibula and the tendon comprises the peroneal tendon.
11. The ankle prosthesis of claim 1, wherein the distal portion
comprises a through bore configured to receive a pin for
syndesmotic fixation to the ankle.
12. The ankle prosthesis of claim 1, wherein the proximal portion
and distal portion comprise a porous material.
13. The ankle prosthesis of claim 12, wherein the porous material
comprises titanium.
14. The ankle prosthesis of claim 13, wherein the titanium is
sintered titanium.
15. The ankle prosthesis of claim 13, wherein the titanium
comprises a titanium porous coating.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional application of U.S.
patent application Ser. No. 13/178,208, filed on 7 Jul. 2011, and
entitled "Malleolar Replacement Devices," which claims the benefit
of U.S. Provisional Application, Ser. No. 61/362,122, filed on 7
Jul. 2010, which are both incorporated by reference herein in their
entireties.
BACKGROUND OF THE INVENTION
[0002] The invention relates to ankle replacement prostheses and
systems, as well as associated surgical instruments and procedures.
The present invention is more specifically directed towards
intramedullary ankle joint replacements.
[0003] Until the early- to mid-1970's, patients with injured or
diseased ankle joints commonly resulting from rheumatism, or
degenerative or traumatic arthritis, had few options when their
ankle joints failed. The most common procedure to help these
patients regain some use of their ankle was obliteration of the
joint by fusion, a procedure that is still commonly used today.
Fusion, however, rendered the ankle stiff and generally immobile
relative to the lower leg, resulting in limited use and additional
stresses on the knee and hip joints.
[0004] Probably the first reported use of a total ankle prosthesis
was by Buckholz in 1969. The medical community recognized that such
ankle replacement led to largely increased use of the ankle joint
because the replacement permitted ankle ranges of motion which
generally attempted to mimic the natural human joint. Since that
time, ankle replacement prostheses have become increasingly common
in use and improved in design.
[0005] Ankle fractures are particularly common in people having
bone disease, such as osteoporosis. Geriatrics, particularly women,
are very susceptible to ankle fractures, and the prognosis after
fracture is generally poor, even with the use of a prosthesis. In
general, currently used prostheses do not afford the necessary
flexibility required for an ankle joint and recovery can be slow
and arduous. The fusing together of bones or bone segments required
and carried out with prior prostheses limits the ability of the
ankle joint to completely heal properly, particularly with those
who may have had limited mobility prior to the ankle fracture.
[0006] Stability and weight bearing are other issues that are more
important when replacing an ankle joint as opposed to other joints.
For example, hip, shoulder, or knee joints are not required to bear
the load that is supported by an ankle joint. Consequently
replacement devices for these other joints do not necessarily
translate to possible replacement joints for an ankle joint.
SUMMARY OF THE INVENTION
[0007] The present invention is directed towards a prosthesis and
kit for replacing an ankle joint, and methods of applying the
devices or systems. The prosthesis is an intramedullary device
directed towards replacement of a portion of either a human tibia
or fibula bone, wherein the prosthesis is a replacement for the
lateral malleolus or the medial malleolus, respectively.
[0008] The device has a first end that is inserted into the
intramedullary canal of either the fibula or tibia. A second end of
the device is shaped and configured to assimilate the shape of the
lateral or medial malleolus, respectively. The device will be
secured to the respective tibia or fibula. Likewise, a system could
comprise two devices, wherein one is directed towards each of the
tibia and fibula.
[0009] The invention also contemplates methods of installing or
inserting the device, wherein the particular malleolus is resected,
sufficiently or completely so that the device will replicate the
contours of the bone once inserted. The first end of the device is
inserted into the intramedullary canal and secured to the bone.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a perspective view of an ankle joint.
[0011] FIG. 2 is a perspective view of the ankle joint of FIG. 1,
with a break being shown in the fibula bone.
[0012] FIG. 3A is a perspective view of an ankle replacement device
according to the present invention.
[0013] FIG. 3B is a second perspective view of the device of FIG.
3A.
[0014] FIG. 4 is a side view of the device of FIG. 3A.
[0015] FIG. 5 is a view of the ankle of FIG. 2 showing an incision
being made in the skin for eventual insertion of a prosthesis as
shown in FIG. 3A.
[0016] FIG. 6 demonstrates a prosthesis being inserted into the
incision of FIG. 5 to determine a properly sized prosthesis.
[0017] FIG. 7 demonstrates the ankle of FIG. 2 being resected to
prepare the ankle for placement of the device of FIG. 3A within the
ankle.
[0018] FIG. 8 depict the device of FIG. 3A being inserted into the
fibula.
[0019] FIG. 9 depicts the device of FIG. 3A being affixed to the
ankle.
[0020] FIG. 10 is a perspective view of the ankle of FIG. 1, with a
break being shown in the tibia bone.
[0021] FIG. 11A is a perspective view of a second ankle replacement
device according to the present invention.
[0022] FIG. 11B is second perspective view of the device of FIG.
11A.
[0023] FIG. 12 is a side view of the device of FIG. 11A.
[0024] FIG. 13 is a view of the ankle of FIG. 10 showing an
incision being made in the skin for eventual insertion of a
prosthesis as shown in FIG. 11A.
[0025] FIG. 14 demonstrates a prosthesis being inserted into the
incision of FIG. 13 to determine a properly sized prosthesis.
[0026] FIG. 15 demonstrates the ankle of FIG. 10 being resected to
prepare the ankle for placement of the device of FIG. 11A within
the ankle.
[0027] FIG. 16 depicts the device of FIG. 11A being inserted into
the ankle.
[0028] FIG. 17 depicts the device of FIG. 11A being affixed to the
ankle.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0029] Although the disclosure hereof is detailed and exact to
enable those skilled in the art to practice the invention, the
physical embodiments herein disclosed merely exemplify the
invention which may be embodied in other specific structures. While
the preferred embodiment has been described, the details may be
changed without departing from the invention, which is defined by
the claims.
[0030] FIG. 1 depicts a normal ankle joint, free of fracture. The
ankle generally consists of the distal ends of the fibula and tibia
bones, which are connected to the talus bone. The fibula bone
comprises the lateral malleolus, which is connected to the talus by
way of the lateral ligament. The tibia bone comprises the medial
malleolus, which is connected to the talus by way of the deltoid
ligament. The tibia and fibula are connected two one another by way
of the syndesmotic ligament.
[0031] If undue stress is put on the ankle joint, the joint may
fracture, with either the fibula or tibia fracturing, or possibly
both. Often a fracture will form at the proximal end of respective
malleolus, e.g. the lateral or medial malleolus. Such a fracture of
the lateral malleolus is shown in FIG. 2, wherein the fracture is
shown on the fibula at the proximal end of the lateral
malleolus.
[0032] FIGS. 3A-4 depict a prosthesis 100 according to the present
invention to address a fracture, as shown, in FIG. 2. The
prosthesis 100 generally comprises a proximal portion 102 and a
distal portion 104. The proximal portion 102 comprises an insert
106 adapted to be positioned within the intramedullary canal of the
fibula. The proximal portion 102 preferably has a smaller diameter
than the distal portion 104, so that when the insert 106 is
inserted into the intramedullary canal, there is a definite
distance that the prosthesis 100 may be inserted into the
intramedullary canal. The insert 106 can be of any shape, e.g. a
post, or wedge or multiple posts or wedges, that will allow the
insert 106 to be properly inserted and affixed within the
intramedullary canal. The insert 106 has at least one hole 108 and
preferably a plurality of holes 108 that will allow screws 110 (see
FIG. 7) to attach the prosthesis 100 to the fibula. A plurality of
holes 108 is preferable, in that it allows for the insert 106, and
the prosthesis 100 in general, to be attached at varying angles and
elevations, depending on a particular fracture or on other
characteristics, such as the age or gender of the patient.
[0033] Still referring to FIGS. 3A-4, the distal portion 104
generally forms a body 112 that is shaped and sized to follow the
contours of the lateral malleolus. The body 112 also has an opening
114, and preferably a plurality of openings 114. The openings 114
are generally used during the implantation of the prosthesis as an
insertion guide when positioning the prosthesis. The openings 114
may also receive screws 110 so that the distal portion 104 may also
be attached to the joint by way of screws 110 (see FIG. 7). As with
the insert 106, it is preferable for the body 112 to have a
plurality of openings 114 so that the prosthesis 100 can be
positioned at varying angles and elevations. A through bore 116 may
also be located on the body, which can receive a pin for
syndesmotic fixation, if necessary.
[0034] The prosthesis 100 is also designed to provide protection
for the ankle and surrounding tendons once the prosthesis 100 is
inserted. For example, a flange or groove 118 is located in the
body 112, which is intended to protect the peroneal tendon once the
prosthesis is properly positioned. The peroneal tendon will rest
within the groove 118, thereby allowing the groove to act as a
shield for the tendon. The body 112 may have a groove 118 on either
the right side or the left side of the body 112, or both sides of
the body 112, which will allow the prosthesis to be used for a
right or left ankle repair.
[0035] FIGS. 5-9 depict the prosthesis 100 being secured to the
fibula bone. Initially, a doctor, surgeon, or radiologist will take
a radiograph or X-ray of the ankle to assist with making a template
for the ankle and to assist in properly sizing a prosthesis to be
used in the ankle repair.
[0036] FIG. 5 shows a doctor or surgeon preparing the fractured
ankle of FIG. 2 for insertion of the prosthesis 100. An incision
over the lateral malleolus will be cut into the skin of the ankle
to thereby expose the malleolus. The tendons, e.g. the peroneal
tendon, will be mobilized by the surgeon.
[0037] FIG. 6 show a prosthesis 100 being inserted into the
incision. The prosthesis 100 is used as a trial implant to
determine the appropriate size for a prosthesis 100 that will
eventually be inserted into the incision. The use of a trial
implant will also assist in determining the necessary level of bone
resection that will be required for the fractured/comminuted
bone.
[0038] FIG. 7 demonstrates the bone being resected for insertion of
the prosthesis 100. An oscillating saw is used to cut the bone at
the levels of the trial implant (see FIG. 6). The bone is resected
so that once the prosthesis 100 is positioned, it will follow the
contours of the native lateral malleolus. Similarly, the
intramedullary canal will be resected so that it will be shaped to
receive the proximal portion 102 of the prosthesis. The resected
bone fragments will be detached from the ligamentous and tendon
attachments so that the properly sized and configured cavity will
remain within the ankle joint. The relevant canal, e.g. the
endosteal canal, will be enlarged with reamers on the lateral
malleolus to insure proper alignment within the cavity. The amount
of bone material that will be resected will depend on the size and
severity of the fracture.
[0039] FIG. 8 shows the proximal portion 102 of the prosthesis 100
being inserted into the intramedullary canal so that it may be
affixed to the fibula. The prosthesis 100 will be inserted so that
it is properly affixed to the fibula, but also to protect the
peroneal tendon with the use of the posterior groove 118 (see FIG.
4). The tendon will sit within the groove 118, thereby allowing the
groove 118 to protect the tendon. Similarly, as shown in FIG. 8,
enough of the lateral malleolus remains around the prosthesis 100
so that the prosthesis 100 is retained properly, which will prevent
the prosthesis from unnecessarily moving from side to side once
positioned in the ankle.
[0040] Once properly inserted, the prosthesis will mimic the shape
and contour of a portion of the fibula, particularly the lateral
malleolus, as shown in FIG. 9. The prosthesis 100 than can be
secured to the ankle joint using screws 110. Preferably, the
prosthesis 100 is locked in place by securing one or more, e.g.
two, screws 110 laterally through fibula, the syndesmosis, and
locking the screws to the tibia. Alignment guides may be used to
assist insertion of the screws. Screws 110 will also be used to
secure the distal portion 104 properly within the lateral
malleolus. The resultant arrangement allows for a repaired ankle
that will closely resemble the fibula bone prior to fracture,
thereby decreasing the amount of time needed for recovery and
increasing the chance that the patient will recover mobility and
stability of the ankle.
[0041] As noted above, a fracture may also occur in the tibia as
opposed to, or in addition to, the fibula. Such a fracture is
depicted in FIG. 10. Such a fracture typically happens at the
proximal end of the medial malleolus. FIGS. 11A-12 show a
prosthesis 200 according to the present invention for addressing
fractures as shown in FIG. 10. The prosthesis 200 is similar to the
prosthesis 100 described above in FIG. 3A-4, except that the
prosthesis 200 is directed towards a fracture of the tibia as
opposed to the fibula. That is, the prosthesis 200 is designed to
be shaped according to the contours of the medial malleolus as
opposed to the lateral malleolus.
[0042] Still referring to FIGS. 11A-12, the prosthesis comprises a
proximal portion 202 and a distal portion 204. The proximal portion
comprises an insert 206 that will be inserted into the
intramedullary canal of the tibia. As with the prosthesis 100, the
proximal portion 202 preferably has a smaller diameter than the
distal portion 204, so that when the insert 206 is inserted into
the intramedullary canal, there is a definite distance that the
prosthesis 200 may be inserted into the intramedullary canal. The
insert 206 can be of any shape, e.g. a post or wedge or multiple
posts or wedges, that will allow the insert 206 to be properly
inserted and affixed within the intramedullary canal. The insert
206 has a hole 208 or plurality of holes 208 for attachment to the
tibia by way of screws 210 (see FIG. 13). A plurality of holes 208
is preferable, in that it allows for the insert 206, and the
prosthesis 200 in general, to be attached at varying angles and
elevations, depending on a particular fracture or on other
characteristics, such as the age or gender of the patient.
[0043] Still referring to FIGS. 9A-10, the distal portion 204 of
the prosthesis 200 generally forms a body 212 that is shaped and
sized to follow the contours of the medial malleolus. The body 212
also has an opening 214, and preferably a plurality of openings
214. The openings 214 are generally used during the implantation of
the prosthesis as an insertion guide when positioning the
prosthesis. The openings 214 may also receive screws 210 so that
the distal portion 204 of the prosthesis 200 may also be attached
to the ankle joint by way of screws 210 (see FIG. 7). As with the
insert 206, it is preferable for the body 212 to have a plurality
of openings 214 so that the prosthesis 100 can be positioned at
varying angles and elevations. A through bore 216 may also be
located on the body, which can receive a pin for syndesmotic
fixation, if necessary.
[0044] The prosthesis 200 is also designed to provide protection
for the ankle and surrounding tendons, e.g. posterior tibial
tendon, once the prosthesis 200 is inserted. For example, a flange
or groove 218 is located on the body 212, which is intended to
protect the posterior tibial tendon once the prosthesis is properly
positioned. The posterior tibial tendon will rest within the groove
218, thereby allowing the groove to act as a shield for the tendon.
The body 112 may have a groove 218 on either the right side or the
left side of the body 212, or both sides of the body 212, which
will allow the prosthesis to be used for a right or left ankle
repair.
[0045] FIGS. 13-17 depict the prosthesis 200 being secured to the
tibia bone. Initially, a doctor, surgeon, or radiologist will take
a radiograph or X-ray of the ankle to assist with making a template
for the ankle and to assist in properly sizing a prosthesis to be
used in the ankle repair.
[0046] FIG. 13 shows a doctor or surgeon preparing the fractured
ankle of FIG. 10 for insertion of the prosthesis 200. An incision
over the medial malleolus will be cut into the skin of the ankle to
thereby expose the malleolus. The tendons, e.g. the posterior
tibial tendon, will be mobilized by the surgeon.
[0047] FIG. 14 show a prosthesis 200 being inserted into the
incision. The prosthesis 200 is used as a trial implant to
determine the appropriate size for a prosthesis 200 that will
eventually be inserted into the incision. The use of a trial
implant will also assist in determining the necessary level of bone
resection that will be required for the fractured/comminuted
bone.
[0048] Referring to FIG. 15, the tibia bone is resected so that
once the prosthesis 200 is positioned within the intramedullary
canal, it will follow the contours of the native medial malleolus.
An oscillating saw is used to cut the bone at the levels of the
trial implant (see FIG. 14). In the same fashion, the
intramedullary canal will be resected so that it will be shaped to
properly receive the proximal portion 202 of the prosthesis. The
resected bone fragments will be detached from the ligamentous and
tendon attachments so that the properly sized and configured cavity
will remain within the ankle joint. The relevant canal, e.g. the
endosteal canal, will be enlarged with reamers on the medial
malleolus to insure proper alignment within the cavity. The amount
of bone material that will be resected will depend on the size and
severity of the fracture.
[0049] FIG. 16 shows the proximal portion 202 of the prosthesis 200
being inserted into the intramedullary canal so that it may be
affixed to the tibia. Once properly inserted, the prosthesis 200
will mimic the shape and contour of a portion of the tibia,
particularly the medial malleolus, as shown in FIG. 17. The
prosthesis 200 than can be secured to the ankle joint using screws
210. One or more screws 210, e.g. three screws 210, preferably with
the screws 210 being in the form of offset screws, will pass
through the medial mallelolar cortex, through the intramedullary
canal, and ending in the distal side of the tibia, e.g. the tibial
metaphysic. The arrangement helps to promote boney in-growth into
the prosthesis, thereby increasing the recovery and stability of
the repaired ankle. The resultant arrangement allows for a repaired
ankle that will closely resemble the tibia bone prior to fracture,
thereby decreasing the amount of time needed for recovery and
increasing the chance that the patient will recover mobility and
stability of the ankle.
[0050] The prosthesis 200 will be inserted so that it is properly
affixed to the tibia, but also to protect the posterior tibial
tendon with the use of the posterior groove 218 (see FIG. 12). The
tendon will sit within the groove 218, thereby allowing the groove
218 to protect the tendon and also to prevent the prosthesis from
unnecessarily moving from side to side once positioned in the
ankle.
[0051] As such, the present invention is directed towards a
prosthesis generally comprising a proximal portion, that will be
inserted into the intramedullary canal of a specific bone of the
ankle joint, and a distal portion that is shaped and designed to
replicate the malleolus section of the particular bone that the
prosthesis is used in connection with. By using the prostheses to
replicate the shape and form of the bone prior to fracture, these
prostheses increase the stability of the ankle joint and also
decrease the recovery time, as the ankle joint is capable of
bearing weight sooner than prior art devices. Similarly, the
intramedullary design also promotes healing and recovery, in that
it fosters grafting of the prosthesis to the bone.
[0052] The prostheses of the present invention may be made of any
suitable biocompatible material. Preferably the prostheses are made
of a material that will help with in bone growth. A porous
material, e.g. sintered titanium, is one preferred material. For
example, the prosthesis 100, 200 may have a titanium porous
coating, which assists in bone growth.
[0053] It should also be understood that, if necessary, the present
invention contemplates a kit that will include both a prosthesis
100 for use with the fibula and a prosthesis 200 for use with the
tibia. However, one of the advantages of the present invention over
the prior art is that it is not necessary that both the fibula and
tibia be resected if one of the bones is not fractured. The
prostheses are inserted and attached independently from one
another, which also provides for a more efficient reconstruction
process for the ankle joint, since alignment of separate prostheses
for the fibula and tibia during surgery is not necessary. Likewise,
it should be understood that the use of screws 110, 210 refers
generally to attachment means for the ankle, e.g. pins, bolts,
screws, clamps, etc., that are commonly used in surgical
procedures. It is also understood that the length of the screws
210, 110 is determinative on the needs of a particular fracture,
including such factors as age of the person requiring the
prosthesis. For example, a screw may be sufficiently long so that
the screw will intersect syndesmotic ligament, or it may be
determined that a shorter screw will be sufficient. Any length of
screw 210 or other fastening device will fall within the scope of
the present invention.
[0054] The foregoing is considered as illustrative only of the
principles of the invention. Furthermore, since numerous
modifications and changes will readily occur to those skilled in
the art, it is not desired to limit the invention to the exact
construction and operation shown and described. While the preferred
embodiment has been described, the details may be changed without
departing from the invention, which is defined by the claims.
* * * * *