Note: Descriptions are shown in the official language in which they were submitted.
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PATELLAR ALIGNMENT DEVICE
FIELD OF THE INVENTION
The present invention relates generally to orthopaedic
braces. More particularly, the present invention relates
to orthopaedic braces used to stabilize and correct the
biomechanical alignment of the knee. The present invention
is particularly, but not exclusively, useful as a means of
correctly aligning the patella and biomechanically
stimulating muscle contraction thereby reducing or
eliminating pathological conditions of the patellofemoral
joint associated with patella malalignment.
BACKGROUND OF THE INVENTION
Pain in the patellofemoral joint, or pain in and
around the kneecap, is a frequent and increasingly common
problem and is particularly troublesome for athletes and
young women. Typically, patellofemoral joint pain is dull
and aching in character and is generally localized around
the patella. Chronic patellofemoral joint pain may also
lead to other maladies including tendinitis of the patellar
tendon, muscle atrophy and joint arthritis.
One type of patellofemoral joint pain is associated
with malalignment of the patella with respect to the
trochlear notch in the femur. For instance, the patella
may encroach too closely on either the medial or lateral
sides of the trochlear notch. A malalignment of this type
is referred to as a glide. A similar malalignment occurs
when the patella tilts or leans towards the medial or
lateral sides of the trochlear notch. In this case the
malalignment is referred to as a tilt. A third
malalignment type, known as a rotation, occurs when the
long axis of the patella fails to follow the long axis of
the femur. Finally, anteroposterior malalignment occurs
when the inferior pole of the patella is tilted posteriorly
when compared to the superior pole. In general, a given
patient may exhibit one or more of the four malalignment
types within a single knee. Diagnosis and treatment is
CA 02201776 2005-O1-14
further complicated by the possibility that a given
malalignment may have a different static and dynamic
configuration. '
Several methods have been developed to treat patellar
malalignment. Perhaps the most effective treatment has
been the employment of various physical therapy programs
designed to stretch the hamstring muscles and increase the
strength of the quadriceps muscles. In particular,
exercises which strengthen the vastus medialis oblique
muscle have been found to be beneficial in correcting
patellar malalignment. In practice, however, it has been
found that patients often find it difficult to selectively
exercise the vastus medialis oblique muscle making the
process of increasing the strength of this muscle
particularly difficult.
Another treatment method in common use is the
employment of a neoprene sleeve shaped to be slipped over
the patient's foot and worn over the effected knee.
Sleeves of this type often feature an opening for the
patient°s patella and are generally constructed of 1/8-inch
or 1/4-inch neopreneMrubber with a nylon outer and inner
covering. In use, the neoprene sleeve fits over the
patient°s knee and reduces excessive lateral (outside)
motion of the patella. Use of neoprene sleeves has been
found to be effective for treating patella malalignment in
a very limited number of cases. The inability of the
standard neoprene sleeve to provide an adequate alignment
force, however, has limited the effectiveness of the sleeve
in most maialignment cases.
A sleeve system which attempts to overcome the
inability of the standard sleeve to generate a sufficient
aligning force is disclosed in U.S. Patent 4,296,744 which
issued to Palumbo for an invention entitled '°Dynamic
Patellar Brace.°° The Palumbo device includes the use of a
neoprene sleeve with an aperture or hole for location of
the patella. In addition, the Palumbo device includes a
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bracing pad located by a set of straps. In use, the
bracing pad is positioned against one side of the patella
and the straps are used to pull the patella into alignment.
Although the Palumbo device may be used to create a
greater aligning force than would be attainable by the use
of a standard sleeve, there are still doubts as to whether
the force produced is great enough and particularly whether
the aligning force will remain constant as the patient
exercises. In greater detail, it may be appreciated that
the aligning force used in the Palumbo device is limited by
the ability of the bracing pad to apply force to the
patella. Since the bracing pad is held in place only by
the interaction of the pad material against the skin of the
patient, the ability of the bracing pad to align the
patella is necessarily limited. Additionally, it may be
appreciated that there will be a natural tendency for the
bracing pad to slip over the patella during the course of
exercise limiting the effectiveness of the bracing pad
still further.
A treatment method that overcomes the disadvantages of
the Palumbo device is the use of patellofemoral taping,
commonly known as the "McC~nnell Taping Technique." The
McConnell Technique applies a series of adhesive tape
strips to the patient's knee. The tape strips cross over
the patient's patella and wrap around to the back of the
knee. By applying the tape strips under tension, a
relatively large force may be applied to align the
patient's patella. Additionally, the tape strips may be
individually aligned for each~patient to account for the
various malalignment components present in a particular
knee. In general, the McConnell Technique has been found
to be highly effective at treating a number of different
and varying patellar malalignments. The McConnell
Technique, however, is subject to a number of
disadvantages. In particular, the McConnell Technique is
relatively inflexible after the tape has been first
3
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applied. In particular, once the series of tapes have been
applied to the patient's knee, there is no provision that
allows the tapes or the tension in a particular tape to be
adjusted to improve effectiveness of the procedure or to
correct a mistake in the original application.
Additionally, experience has demonstrated that application
of the taping system prescribed by the MCConnell Technique is
a time consuming process, particularly when performed by the
patient. Even when the tapes are correctly applied, there is
a possibility that the tapes will become subsequently
dislodged, particularly in the case of prolonged exercise and
particularly at the point of attachment of the tape with the
back of the knee where the tapes are subject to the greatest
amount of dynamic stress.
In light of the above, it is an object of the present
invention to provide a patellar alignment system that provides
an alignment force that is adequate to align a wide range of
patellar malalignments. It is another object of the present
invention to provide a patellar alignment system that provides
an alignment system that may be easily tailorable to individual
patients. It is yet another object of the present invention to
provide a patellar alignment system that may be easily applied
and easily adjusted after application. It is still another
obj ect of the present invention to provide a patellar alignment
system that is stable even under the rigors present during
intense exercise. It is yet another object of the present
invention to provide a patellar alignment system that is cost
effective to manufacture and relatively simple to operate.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is
provided an orthopaedic device for aligning the patella into
a proper anatomical orientation which comprises : a pad fixedly
adhereable to the leg of a patient to position said pad over
the patella; a sleeve formed with an aperture, a leg of the
patient being insertable into said sleeve to project said pad
through said aperture; a gripper fastened to said sleeve; and
an aligner having a first attachment and at least one second
4
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attachment, said first attachment being attachable to said pad
and said second attachment being attachable in a selectable
location on said gripper to generate a selectively orientable
force on said pad for aligning the patella.
According to a further aspect of the present invention
there is provided an orthopaedic device for aligning the
patella into a proper anatomical orientation which comprises:
means adherable over the patella of a patient for establishing
a first attachment point over the patella; a sleeve formed with
an aperture, a leg of the patient being insertable into said
sleeve to project said first attachment point through said
aperture; means for establishing a second attachment point to
said sleeve, said second attachment point being distanced from
said first attachment point; and means simultaneously
attachable to said first attachment point and to said second
attachment point for applying a selectively orientable force
to said first attachment point to align the patella.
According to the present invention, an orthopaedic device
for aligning the patella into a proper anatomical orientation
includes a patellar pad which can be affixed to
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the leg over the patella, a sleeve with a gripper which can
be placed on the leg to distance the gripper from the
patellar pad, and an aligner which is connectable to both
the pad and the gripper to create a aligning force on the
patella.
The patellar pad of the present invention includes a
patellar connector mounted to a flat flexible substrate.
The substrate has an adhesive backing on the surface that
is opposite to the patellar connector. In order to
stabilize and provide added reinforcement for the connector
on the substrate, the connector may be stitched onto the
substrate. Preferably, when mounted on the substrate, the
exposed portion of the connector has the loops or hooks
that are common to Velcro« (Velcro is a trademark of Velcro
USA Inc.) type fasteners.
The sleeve of the present invention is made of a
flexible, elastic material and has a substantially hollow
cylindrical shape which allows the sleeve to be positioned
over the leg. Further, the sleeve is formed with an
aperture which is dimensioned to permit projection of the
patellar connector through the aperture. The gripper is
fastened to the outer surface of the sleeve at a distance
from the aperture and, like the patellar connector, the
exposed portion of the gripper preferably has the loops or
hooks that are common to velcro type fasteners.
For the present invention, the aligner has a first
attachment which is connectable with the patellar connector
of the patellar pad and at least one second attachment
which is connectable with the gripper. More specifically,
and preferably, the aligner has a plurality of elastic
straps which extend from the first attachment, each of
which support a second attachment that is individually
engageable with the gripper. To accomplish the connections
with the gripper on the sleeve and the patellar pad affixed
to the patient's leg, the first and second attachments of
the aligner preferably have velcro type fasteners which are
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compatible with the respective fasteners on the gripper and
on the patellar connector. Further, the gripper is of a
sufficient size to allow for the selective placement of the
individual second attachments on the gripper.
5 In the operation of the present invention, the
adhesive surface of the patellar pad substrate is placed on
the leg to affix the patellar pad in a location over the
patella. The patient's leg, with patellar pad attached, is
inserted into the sleeve and the sleeve is positioned on
10 the leg to project the patellar connector through the
aperture of the sleeve. The first attachment of the
aligner is then attached to the patellar connector. With
the aligner attached to the patellar connector, the user is
then free to pull on the elastic straps of the aligner, and
15 to selectively locate attachment points for the second
attachments on the gripper creating an aligning force on
the patellar connector. As intended for the present
invention, the aligning force created on the patella will
have an appropriate magnitude and direction to effectively
20 eliminate glide, tilt, rotation and anteroposterior
malalignments and correctly align the patella into a proper
anatomical orientation.
In an alternative embodiment of the present invention,
an activator is attached to the inside of the sleeve to
25 contact the patient's vastus medialis oblique muscle. The
activator consists of a blunt probe and an attachment
means. Operationally, the probe is designed to function as
a means whereby the patient may positively isolate and
exercise the vastus medialis oblique. Additionally, the
30 interaction between the probe and the sleeve provides
manual stimulation to the vastus medialis oblique muscle
with an associated therapeutic effect.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of this invention, as well as the
35 invention itself, both as to its structure and its
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WO 96/10377 PCT/LTS95112621
operation, will be best understood from the accompanying
drawings, taken in conjunction with the accompanying
description, in which similar reference characters refer to
similar parts.
Figure 1 is a perspective view ,of the patellar
alignment device of the present invention operationally
positioned over a human leg and knee and shown from a
forward and medial point of reference;
Figure 2 is anatomical depiction of the major bone
structure of a human leg;
Figure 3 is an isometric view of the patellar pad of
the present invention;
Figure 4 is an isometric view of the sleeve of the
present invention;
Figure 5 is an isometric view of the aligner of the
present invention;
Figure 6 is a perspective view of the patellar pad of
the present invention operationally positioned over a human
leg and knee shown from a forward and medial point of
reference;
Figure 7 shows the patellar alignment device of the
present invention shown in Figure 1 now shown from an
anterior and lateral point of reference;
Figure 8 is a perspective view of the activator of the
present invention operationally positioned over a human leg
and knee and shown from a forward and medial point of
reference;
Figure 9 is an isometric view of the activator of the
present invention shown exploded for clarity;
Figure 10 is a side elevational view of the activator
of the present invention; and
Figure il is an isometric view of an alternative
embodiment of the activator of the present invention.
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WO 96/10377 PCT/US95/12621
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is an device and a method for
aligning the patella of the human knee into a proper
anatomical orientation. The general relationship between
5 the elements of the present invention and a patient's leg
are shown in Figure 1 where the patellar alignment device
is shown operationally positioned on a human leg 12. In
particular, it may be seen that the patellar alignment
device 10 includes a sleeve 14 and an aligner 16.
10 The use of the present invention may be better
understood by first referring to Figure 2 where the
anatomical components of the human leg 12 are shown.
Figure 2 shows that the human knee 18 comprises a hinged
joint between the femur 20 and the tibia 22. As shown in
15 Figure 2, the patella 24 is located in front of the hinged
joint connecting the femur 20 and the tibia 22. I n
general, the patella 24 serves as a fulcrum for tendons
connecting muscles in the upper and lower leg (not shown).
It may be appreciated that the patella 24 is not fixed
20 in location with respect to the knee 18. Instead, in
proper anatomical motion, the patella 24 slides up and down
in a line that generally parallels the major axis of the
f emur 2 0 .
It may also be appreciated that failure of the patella
25 24 to maintain the required alignment with the knee 18 and
the trochlear notch located in front of the femur 22 may
result in incorrect function of the knee 18 and irritation
to the patella 24 and other knee structures. In
particular, if the patella 24 operates too closely to the
30 medial side 26 of the knee 18 or too closely to the lateral
side 28 of the knee 18, a glide malalignment exists and
irritation may result. The same difficulties may arise if
the patella 24 tilts towards the medial side 26 or the
lateral side 28 of the knee 18. In addition, the patella
35 24 may be rotated with respect to the major axis of the
femur 20 once again with resulting irritation. Irritation
8
CA 02201776 2005-O1-14
F
and other joint maladies may also occur if the inferior
pole of the patella 24 is tilted posteriorly when compared
with the superior pole of the patella 24..
To correct patellar alignment, the present invention
provides a system of three basic components shown in
Figures 3, 4 and 5. The first of these components, the
patellar pad, is shown in Figure 3 and generally designated
30. In Figure 3, it can be seen that the patellar pad 30
includes a patellar connector 32 mounted to the front side
of a flat rectangular substrate 34. The back side of the
substrate 3~4 includes an adhesive coating (not shown)
protected by a peel-off backing 36. It may be appreciated
that the substrate 34 is constructed of compliant materials
that are able to closely follow the contours of the human
knee. Several types of commercially available medical
TM
adhesive tapes, such as Hypafix« Tape manufactured by Smith
and Nephew Donjoy Inc., are particularly suitable for this
purpose. These tapes may be used alone or in laminated
combinations to provide the desired combination of strength
and flexibility.
It may also be appreciated that the patellar connector
32 may be preferably constructed as a circular velcro patch
although other attachment devices axe practical. In cases
where velcro is used, however, reinforcing stitching 38 may
be added to ensure that the patellar connector 32 does not
separate from the patellar pad 3~.
The second major component, the sleeve, is shown in
Figure 4 and generally designated 14. In greater detail,
it can be seen that the sleeve 14 is a tube shaped
structure which includes a hole or aperture 42 near the
midpoint of the tube. In operation, the sleeve 14 is
designed to slipped over the patient's knee and the
aperture 42 is aligned over the patient's patella.
Diametrically opposed to the aperture 42, is a gripper
44. Operationally, the gripper 44 functions as a area of
attachment for the aligner I6 shown in Figure 1. As such,
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CA 02201776 2005-O1-14
-"-a
a
the gripper 44 may be fabricated from any material that
provides a large area of attachment and which allows the
sleeve 14 to accommodate the motion of the knee 18. '
Continuous loop velcro has been found to be suitable for
this purpose. In addition, it has been found to be
particularly efficient to implement the gripper 44 by
providing a nyloriMCOVer to the sleeve 14 which includes an
unbroken loop region suitable for anchoring hook type
velcro connectors as well known in the pertinent art.
Preferably, the sleeve 14 is constructed of neoprene
rubber. To increase the comfort of the patient, the sleeve
14 may be fabricated from multiple neoprene segments,
enhancing the ability of sleeve 14 to adhere to the
anatomical features of the patient's leg 12 and knee 18.
Additionally, the sleeve 14 may be fabricated with
outer and inner layers of nylon to further enhance the
patient's comfort and to provide additional durability.
Durability is further enhanced by including a row of
reinforcing stitching 46 along the periphery of the
aperture 42.
The third component of the present invention, the
aligner, is shown in Figure 5 and generally designated 16.
The structure of the aligner 16 consists of a plurality of
elastic straps 48 connected to an aligner body 50. It may
be appreciated that the aligner 16 is intended to be
stretched between the patellar connector 32 and the gripper
44. To that end, the aligner body 50 includes a first
connector 52 attachable with the patellar connector 32. In
a similar fashion, each elastic~strap 48 includes a second
connector 54 attachable with the gripper 44.
Preferably, the aligner body 50 and elastic straps 48
are fabricated from a single piece of elastic material such
as neoprene rubber. Additionally, the first connector 52
and second connector 54 are chosen to be compatible with
the patellar connector 32 and the gripper 44 and will
generally be fabricated as velcro type fasteners.
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In an alternative embodiment of the present invention,
an activator 56 is attached to the sleeve 14. The use of
the activator 56 in cooperation with the sleeve 14 is shown
in Figure 8 where the combination of the sleeve 14 and
activator 56 is shown operationally positioned over the
patient's knee 18. It may be appreciated from Figure 8
that correct positioning of the activator 56 locates the
activator 56 over the patient's vastus medialis oblique
muscle.
The structural details of the activator 56 are shown
in greater detail in Figure 9 where it may be seen that the
activator 56 includes a probe 58 attached to a post 60.
The post 60 is designed to selectively attachable to a
retainer 62. The selective attachment is accomplished by
a key 64 included on the post 60 and a passageway 66
included in the retainer 62. The combination of the post
60 and retainer 62 allows the activator 56 to be attached
to the sleeve 14 over the vastus medialis oblique muscle.
Attachment of the activator 56 to the sleeve 14 is
shown in greater detail in Figure 10 where it can be seen
that the post 60 is inserted through the sleeve 14. Once
the post 60 is inserted through the sleeve 14, the retainer
62 is engaged with the post 60 by aligning the key 64 and
the passageway 66. The retainer 62 may then be locked in
to position by rotating the retainer 62 around the post 60
so that the passageway 66 is no longer aligned with the key
64. The combination of the post 60 and the retainer 62 is
only one possible way in which the activator 56 may be
attached to the sleeve 14. 'In general, any fastening
method which securely attaches the activator 56 to the
sleeve 14 and allows for easy attachment and detachment may
be employed.
Operationally, it may be appreciated that the contact
of the probe 58 with the patient's vastus medialis oblique
muscle performs several functions. One function provided
by the probe 58 is to positively identify the location of
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the vastus medialis oblique muscle to the patient allowing
the patient to isolate and target the vastus medialis
oblique muscle during strength training exercises. To
perform this function, the probe 58 working with the sleeve
14 applies pressure to the patient's vastus medialis
oblique muscle. The pressure applied by the probe 58
allows the patient to tactilely located the vastus medialis
oblique muscle and to sense when a particular exercise has
caused the vastus medialis oblique muscle to become
contracted. The patient may then modify and optimize
exercises to have the greatest effect on the vastus
medialis oblique muscle.
A second function provided by the probe 58 is manual
stimulation of the patient's vastus medialis oblique
muscle. Alternatively stated, it may be appreciated that
the contact of the probe 58 with the vastus medialis
oblique muscle will provide a stimulating action as the
patient exercises and the vastus medialis oblique muscle
moves in relation to the probe 58 and the sleeve 14. The
stimulation associated with the use of the activator 56
enhances the patient's ability to strengthen the vastus
medialis oblique muscle.
To achieve the objectives of the present invention, it
may be appreciated that different shapes may be employed
for the probe 58. In particular, it may be appreciated
that a blunt bullet-shape may be appropriate for probe 58.
This configuration in shown in Figure 9. Alternatively, it
may be appreciated that more complex shapes may be
desirable. Figure 11 shows an 'alternative embodiment for
the probe 58 where the blunt bullet shape of Figure 9 has
been replaced with a cross or tee shape. In general, the
actual shape chosen for the probe 58 may be varied to
adjust the amount of tactile feedback and stimulation
provided by the activator 56.
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OPERATION
Application of the present invention begins by
placement of the patellar pad 30 and patellar connector 32
over the patient's patella 24 as shown in Figure 6. In
greater detail, the peel-off backing 36 is first removed
from the patellar pad 30. Once the peel-off backing 36 is
removed, the patellar pad 30 is placed over the patella 24
and pressed into place. The pressure sensitive adhesive on
the back of the patellar pad 30 forms a bond with the
patient's knee 18 holding the patellar pad 30 and patellar
connector 32 securely in place.
Referring now to Figure 1, it can be seen that
placement of the patellar pad 30 is followed by passing the
sleeve 14 over the patient's foot and around the patient's
knee 18 with the patient's patella 24 aligned with the
aperture 42. In this configuration, it may be appreciated
that the patellar connector 32 will protrude or project
from the aperture 42 in the sleeve 14. It may also be
appreciated that the gripper 44 mounted on the sleeve 14
will be positioned along the back of the patient's knee 18.
The position of the gripper 44 with respect to the back of
the knee 18 is easily seen in Figure 7.
Referring again to Figure 1, it can be seen that the
final step in application of the patellar alignment device
10 is the attachment of the aligner 16. To attach the
aligner 16, the first connector 52 is attached to the
patellar connector 32 included in the patellar pad 30. In
cases where velcro is used to implement the patellar
connector 32 and first connector 52, attachment of the
aligner 16 is simply a matter of placing the first
connector 52 firmly in contact with patellar connector 32
through the aperture 42.
Once the aligner 16 is connected to the patellar pad
30, each of the elastic straps 48 is passed around the
medial side 26 of the knee 18 and connected under tension
to the gripper 44. In cases where the gripper 44 and the
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second connector 54 are implemented as velcro fasteners,
attachment of the elastic straps 48 is simply a matter of
bringing each of the elastic straps 48 into contact with
the back of the sleeve 14 thereby bringing the second
connector 54 into contact with the gripper 44.
It may be appreciated that the gripper 44 is intended
to provide a number of possible points of attachment for
each of the elastic straps 48. By providing a number of
possible points of attachment, the force applied to the
10 patella may be adjusted to fit the needs of the individual
patient. Specifically, the magnitude and the direction of
the force applied by each elastic strap may be varied to
create the correct force required to properly align the
patient's patella. It may also be appreciated that the
15 number of elastic straps 48 employed may vary depending on
the actual condition sought to be addressed by a particular
implementation. Additionally, while the elastic straps 48
of the present invention will typically be deployed over
the medial side of 26 of the patient's knee 18 there may be
20 cases where it is advantageous to reverse the orientation
of the aligner 16 to deploy the elastic straps 48 over the
lateral side 28 of the knee 18.
While the particular orthopaedic device as herein
shown and disclosed in detail is fully capable of obtaining
25 the objects and providing the advantages herein before
stated, it is to be understood that they are merely
illustrative of the presently preferred embodiments of the
invention and that no limitations are intended to the
details of construction or design herein shown other than
30 as described in the appended claims.
14
