U.S. patent application number 15/239909 was filed with the patent office on 2016-12-08 for range of motion device.
The applicant listed for this patent is Bonutti Research, Inc.. Invention is credited to Boris P. Bonutti, Peter M. Bonutti, Glen Phillips, Kevin Ruholl.
Application Number | 20160354272 15/239909 |
Document ID | / |
Family ID | 37968679 |
Filed Date | 2016-12-08 |
United States Patent
Application |
20160354272 |
Kind Code |
A1 |
Bonutti; Boris P. ; et
al. |
December 8, 2016 |
RANGE OF MOTION DEVICE
Abstract
A device for moving a knee joint in a body of a patient is
provided. The device includes a first arm member coupled to a first
leg support configured to support an upper portion of a leg of the
patient, a second arm member coupled to a second leg support
configured to support at least one of a lower portion of a leg and
a foot of the patient, and a control assembly operatively connected
to the first and second arm members and configured to selectively
move the second arm member relative to the first arm member. The
control assembly includes a first motorized drive assembly coupled
to the first and second arm members and operable to drive movement
of the second arm member relative to the first arm member and a
second motorized drive assembly coupled to the first and second arm
members and operable to drive movement of the second arm member
relative to the first arm member.
Inventors: |
Bonutti; Boris P.;
(Effingham, IL) ; Bonutti; Peter M.; (Manalapan,
FL) ; Ruholl; Kevin; (Teutopolis, IL) ;
Phillips; Glen; (Effingham, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bonutti Research, Inc. |
Effingham |
IL |
US |
|
|
Family ID: |
37968679 |
Appl. No.: |
15/239909 |
Filed: |
August 18, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14454442 |
Aug 7, 2014 |
9445966 |
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15239909 |
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13494103 |
Jun 12, 2012 |
8814816 |
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14454442 |
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13151962 |
Jun 2, 2011 |
8206329 |
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13494103 |
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12272436 |
Nov 17, 2008 |
7981067 |
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13151962 |
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11533839 |
Sep 21, 2006 |
7452342 |
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12272436 |
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11261424 |
Oct 28, 2005 |
8066656 |
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11533839 |
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10795892 |
Mar 8, 2004 |
7112179 |
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11261424 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H 1/0281 20130101;
A61H 2203/00 20130101; A61H 1/0266 20130101; A61H 1/024 20130101;
A61F 2005/0139 20130101; A61H 1/02 20130101; A61F 5/0102 20130101;
A61H 1/0244 20130101; A61H 2001/027 20130101; A61H 2001/0207
20130101; A61H 1/0285 20130101; A61H 2201/5043 20130101; A61H 1/008
20130101; A61F 5/0125 20130101; A61H 1/0277 20130101 |
International
Class: |
A61H 1/02 20060101
A61H001/02; A61F 5/01 20060101 A61F005/01 |
Claims
1. A device for moving a knee joint in a body of a patient, the
device comprising: a first arm member coupled to a first leg
support configured to support an upper portion of a leg of the
patient; a second arm member coupled to a second leg support
configured to support at least one of a lower portion of a leg and
a foot of the patient; a control assembly operatively connected to
the first and second arm members and configured to selectively move
the second arm member relative to the first arm member, the control
assembly comprising: a first motorized drive assembly coupled to
the first and second arm members and operable to drive movement of
the second arm member relative to the first arm member; and a
second motorized drive assembly coupled to the first and second arm
members and operable to drive movement of the second arm member
relative to the first arm member.
2. The device for moving a knee joint in a body of a patient as set
forth in claim 1, wherein the first and second motorized drive
assemblies include at least one of a hydraulic and pneumatic
motor.
3. The device for moving a knee joint in a body of a patient as set
forth in claim 1, further comprising a monitor having a storage
medium, the monitor configured to track and store usage information
of the device.
4. The device for moving a knee joint in a body of a patient as set
forth in claim 3, wherein the monitor further comprises a display
for displaying positional information of the device.
5. The device for moving a knee joint in a body of a patient as set
forth in claim 3, wherein the monitor further comprises a data
transfer component for wirelessly transferring usage information of
the device.
6. The device for moving a knee joint in a body of a patient as set
forth in claim 1, further comprising a locking mechanism configured
to prevent actuation of at least one of the first motorized drive
assembly and the second motorized drive assembly.
7. The device for moving a knee joint in a body of a patient as set
forth in claim 1, further comprising a lower leg strap for securing
at least one of the lower portion of a leg and the foot of the
patient to the second leg support.
8. The device for moving a knee joint in a body of a patient as set
forth in claim 1, further comprising an upper leg strap for
securing an upper portion of a leg of the patient to the first leg
support.
9. The device for moving a knee joint in a body of a patient as set
forth in claim 1, further comprising a timer.
10. The device for moving a knee joint in a body of a patient as
set forth in claim 1, wherein the second drive assembly is
configured to move the second arm member to at least one of
increase and decrease a force exerted by the device.
11. The device for moving a knee joint in a body of a patient as
set forth in claim 1, wherein the first motorized drive assembly
includes a drive element configured to selectively move the second
arm member while the second motorized drive assembly is maintained
in a fixed position relative to the first and second arm
members.
12. The device for moving a knee joint in a body of a patient as
set forth in claim 1, wherein the second motorized drive assembly
includes a drive element configured to selectively move the second
arm member while the first motorized drive assembly is maintained
in a fixed position relative to the first and second arm
members.
13. The device for moving a knee joint in a body of a patient as
set forth in claim 1, wherein the second arm member further
comprises a telescoping member for adjusting the length of the
second arm member.
14. A device for moving a leg of a user into flexion and extension,
the device comprising: a base member; a first arm member coupled to
the base member; a second arm member coupled the first arm member;
a motorized drive assembly mounted to the base member and pivotably
coupled to the second arm member, the drive assembly configured to
selectively move the second arm member relative to the first arm
member; and a locking mechanism coupled to at least one of the
first and second arm members, the locking mechanism configured to
prevent actuation of the first motorized drive assembly.
15. The device for moving a leg of a user into flexion and
extension as set forth in claim 15, wherein the first arm member is
coupled to a first leg support configured to support an upper
portion of the leg and the second arm member is coupled to a second
leg support configured to support at least one of a lower portion
of the leg and a foot.
16. The device for moving a leg of a user into flexion and
extension as set forth in claim 15, further comprising a controller
configured to enable a user to selectively move the second arm
member to allow for angle control of the first and second arm
members.
17. The device for moving a leg of a user into flexion and
extension as set forth in claim 15, wherein the drive assembly
enables incremental movement of the device to move the leg of a
user.
18. The device for moving a leg of a user into flexion and
extension as set forth in claim 15, further comprising a monitor
having a storage medium, the monitor configured to track and store
usage information of the device.
19. The device for moving a leg of a user into flexion and
extension as set forth in claim 18, wherein the monitor further
comprises a data transfer component for wirelessly transferring
usage information of the device
20. The device for moving a leg of a user into flexion and
extension as set forth in claim 18, wherein the monitor further
comprises a display for displaying degrees of at least one of
flexion and extension.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation application of
U.S. patent application Ser. No. 14/454,442 filed on Aug. 7, 2014,
which is a continuation of U.S. patent application Ser. No.
13/494,103, which is a continuation of U.S. patent application Ser.
No. 13/151,962 filed on Jun. 2, 2011, which is a continuation
application of U.S. patent application Ser. No. 12/272,436 filed on
Nov. 17, 2008, which is a Continuation of U.S. patent application
Ser. No. 11/533,839 filed on Sep. 21, 2006, which is a
Continuation-In-Part of U.S. patent application Ser. No. 10/795,892
filed on Mar. 8, 2004, which is a Continuation-In-Part of U.S.
patent application Ser. No. 11/261,424 filed on Oct. 28, 2005. The
contents of each of the above-identified applications are herein
incorporated by reference in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to an adjustable orthosis for
stretching tissue in the human body. In particular, the present
invention relates to an adjustable orthosis which can be used for
stretching tissue such as ligaments, tendons or muscles around a
joint during flexion or extension of the joint.
BACKGROUND OF THE INVENTION
[0003] In a joint, the range of motion depends upon the anatomy of
that joint and on the particular genetics of each individual.
Typically, joints move in two directions, flexion and extension.
Flexion is to bend the joint and extension is to straighten the
joint; however, in the orthopedic convention some joints only flex.
For example, the ankle has dorsiflexion and plantarflexion. Other
joints not only flex and extend, they rotate. For example, the
elbow joint has supination and pronation, which is rotation of the
hand about the longitudinal axis of the forearm placing the palm up
or the palm down.
[0004] When a joint is injured either by trauma or by surgery, scar
tissue can form, often resulting in flexion or extension
contractures. Such conditions can limit the range of motion of the
joint, limiting flexion (in the case of an extension contracture)
or extension (in the case of a flexion contracture) of the injured
joint. It is often possible to correct this condition by use of a
range-of-motion (ROM) orthosis.
[0005] ROM orthoses are devices commonly used during physical
rehabilitative therapy to increase the range-of-motion over which
the patient can flex or extend the joint. Commercially available
ROM orthoses are typically attached on opposite members of the
joint and apply a torque to rotate the joint in opposition to the
contraction. The force is gradually increased to increase the
working range or angle of joint motion. Exemplary orthoses include
U.S. Pat. No. 6,599,263, entitled "Shoulder Orthosis;" U.S. Pat.
No. 6,113,562, entitled "Shoulder Orthosis;" U.S. Pat. No.
5,848,979, entitled "Orthosis;" U.S. Pat. No. 5,685,830, entitled
"Adjustable Orthosis Having One-Piece Connector Section for
Flexing;" U.S. Pat. No. 5,611,764, entitled "Method of Increasing
Range of Motion;" U.S. Pat. No. 5,503,619, entitled "Orthosis for
Bending Wrists;" U.S. Pat. No. 5,456,268, entitled "Adjustable
Orthosis;" U.S. Pat. No. 5,453,075, entitled "Orthosis with
Distraction through Range of Motion;" U.S. Pat. No. 5,395,303,
entitled "Orthosis with Distraction through Range of Motion;" U.S.
Pat. No. 5,365,947, entitled "Adjustable Orthosis;" U.S. Pat. No.
5,285,773, entitled "Orthosis with Distraction through Range of
Motion;" U.S. Pat. No. 5,213,095, entitled "Orthosis with Joint
Distraction;" and U.S. Pat. No. 5,167,612, entitled "Adjustable
Orthosis," all to Bonutti and herein are expressly incorporated by
reference in their entirety.
SUMMARY OF THE INVENTION
[0006] The present invention provides an orthosis for stretching
tissue around a joint of a patient between first and second
relatively pivotable body portions. The joint and the first and
second body portions defining on one side of the joint an inner
sector which decreases in angle as the joint is flexed and defining
on the opposite side of the joint an outer sector which decreases
in angle as the joint is extended.
[0007] The orthosis includes a first arm member affixable to the
first body portion. The first arm member has a first extension
member extending at an angle .alpha. therefrom. A second arm member
affixable to the second body portion is also included. The second
arm member has a second extension member having an arcuate shape
extending therefrom. The second and first extension members are
operatively connected, such that the second extension member
travels through the first extension member along an arcuate path
when the second arm member is moved from a first position to a
second position relative to the first arm member.
[0008] The orthosis further includes a drive assembly for
selectively moving the second extension member relative to the
first extension member. The drive assembly is mounted onto the
first extension member, engaging the second extension member. The
drive assembly can be manually or automatically actuated to
selectively move the second extension member relative to the first
extension member.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] A more complete understanding of the present invention, and
the attendant advantages and features thereof, will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0010] FIG. 1 is a schematic diagram of the orthosis of the present
invention in a flexed position;
[0011] FIG. 2 is a schematic diagram of the orthosis of the present
invention in an extended position;
[0012] FIG. 3 is a second schematic diagram of the orthosis of the
present invention in a flexed position;
[0013] FIG. 4 shows an adjustable first extension member of the
orthosis of the present invention;
[0014] FIG. 5 shows the adjustable first extension member of FIG. 4
in a second position;
[0015] FIG. 6 shows a segmented first extension member of the
present invention;
[0016] FIG. 7 shows an arcuate first extension member of the
present invention;
[0017] FIG. 8 shows an orthosis of the present invention;
[0018] FIG. 9 shows an orthosis of the present invention for
flexing and extending a wrist joint in a patient;
[0019] FIG. 10 shows a non-circular arcuate shaped second extension
member of the present invention;
[0020] FIG. 11 shows an alternative arcuate shaped second extension
member of the present invention;
[0021] FIG. 12 shows a linear shaped second extension member of the
present invention;
[0022] FIGS. 13A and B show exemplary drive assemblies of the
present invention;
[0023] FIG. 14 is a top plan view of portions of an articulating
hand pad support of the present invention;
[0024] FIG. 15 is a schematic sectional view of the articulating
hand pad support of FIG. 14;
[0025] FIG. 16 depicts a side view of another articulating hand pad
support of the present invention;
[0026] FIG. 17A depicts a top view of the articulating hand pad
support of FIG. 16;
[0027] FIG. 17B depicts a top view of the articulating hand pad
support of FIG. 16 with the pivoting plate removed;
[0028] FIG. 18 shows an orthosis of the present invention;
[0029] FIG. 19 shows a hand pad for the orthosis of FIG. 18;
[0030] FIG. 20 shows another hand pad for the orthosis of FIG.
18;
[0031] FIG. 21 is a schematic diagram of an orthosis of the present
invention;
[0032] FIG. 22 is a schematic diagram of the orthosis of FIG. 21 in
an extended position;
[0033] FIG. 23 is a schematic diagram of the orthosis of FIG. 21 in
a flexed position;
[0034] FIG. 24 is an isometric view of an orthosis of the present
invention;
[0035] FIG. 25 is a front view of the orthosis of FIG. 24;
[0036] FIG. 26 is a side view of the orthosis of FIG. 24;
[0037] FIG. 27 is a sectional view of a drive assembly of the
orthosis of FIG. 24;
[0038] FIG. 28 is a section view of an adjustable second cuff for
the orthosis of FIG. 24;
[0039] FIG. 29 is an expanded view of the drive assembly connection
to the first member of the orthosis of FIG. 24;
[0040] FIG. 30 is a top view of the drive assembly of the orthosis
of FIG. 24;
[0041] FIG. 31 is an expanded view of another drive assembly
connection to the first member of the orthosis of FIG. 24;
[0042] FIG. 32 depicts a bottom view of the orthosis of FIG.
24.
[0043] FIG. 33 depicts a bottom view of a first cuff of the
orthosis of FIG. 24;
[0044] FIG. 34 is a schematic diagram of an embodiment of an
orthosis of the present invention;
[0045] FIG. 35 illustrates another embodiment of the invention
utilizing a cushion or spring;
[0046] FIG. 36 is an embodiment of the invention illustrating the
use of a cam surface;
[0047] FIG. 37 is an embodiment of the invention utilizing a
slideable arcuate surface;
[0048] FIG. 38 illustrates features of an orthosis of the invention
where the relative positions of component parts of the orthosis are
adjustable;
[0049] FIG. 39 is an illustration of the use of gears with an
arcuate or cam surface of an orthosis of the invention;
[0050] FIG. 40 is a schematic diagram of an embodiment of the
invention using an arcuate path and gear or cam follower;
[0051] FIG. 41 illustrates the use of a multi-slotted component to
control movement of the orthosis; and
[0052] FIG. 42 illustrates an embodiment of the invention where
linear movement of a component is translated into rotational and
translational movement of another component of the orthosis.
DETAILED DESCRIPTION OF THE INVENTION
[0053] The present invention relates to an orthosis for moving a
joint between first and second relatively pivotable body portions.
The joint and the first and second body portions define on one side
(the flexor side) of the joint an inner sector which decreases in
angle as the joint is flexed (bent) and on the opposite side (the
extensor side) of the joint an outer sector which decreases in
angle as the joint is extended (straightened). The orthosis of the
present invention is affixable to either the flexor or extensor
side of the joint for treatment of flexion or extension
contractures.
[0054] Referring now to the drawing figures in which like reference
designators refer to like elements, there is shown in FIG. 1, a
schematic of the orthosis 10 of the present invention. The orthosis
10 includes a first arm member 12 attachable to the first body
portion and a second arm member 14 attachable to the second body
portion, wherein a joint axis of rotation 16 is interposed between
and offset from the first and second arm members 12 and 14. The
first and second arm members 12 and 14 are operatively connected to
each other offset from the joint axis 16.
[0055] The first arm member 12 of the orthosis 10 includes a first
extension member 18, which extends at angle .alpha. from the first
arm member 12. The second arm member 14 of the orthosis 10 includes
a second extension member 20 extending therefrom and having an
arcuate shape. The first and second extension members 18 and 20 are
operatively connected at point "P," such that in operation the
second extension member 20 travels along an arcuate path about and
substantially through point "P." The arcuate shape of the second
extension member 20 results in the second body portion rotating
about the joint axis 16, when the second arm member 14 is moved
from a first position to a second position relative to the first
arm member 12. The angle .alpha. between the first extension member
18 and the first arm member 12 and the radius of curvature of the
second extension member 20 are a function of the joint to be
treated and the degree of flexion or extension contractures.
[0056] The orthosis further includes a drive assembly 22 at point
"P." The drive assembly connects the first and second extension
members 18 and 20 for applying force to the first and second arm
members 12 and 14 to pivot the first and second body portions
relative to each other about the joint.
[0057] The orthosis 10 of the present invention is shown having an
angle .alpha. such that the operative connection, at point "P," of
the first and second extensions 18 and 20 is located in a plane "A"
passing through the joint axis 16, wherein plane "A" is
substantially orthogonal to a longitudinal axis of the first arm
member 12. This position of point "P" provides an angle
.beta..sub.1 between the second arm member 14 and the joint axis
16, wherein .beta..sub.1 is the maximum angle of flexion. As shown
in FIG. 2, the second extension member includes a stop 24. The stop
24 acts to limit the angle of maximum extension .gamma. between the
second arm member 14 and the joint axis 16. An increase in the
length of the stop 24 will decrease the angle of maximum extension
.gamma.. A decrease in the length of the stop 24 will increase the
angle of maximum extension .gamma..
[0058] Referring to FIG. 3, the maximum flexion angle can be
increased by increasing the angle .alpha.. An increase in the angle
.alpha. will move the point "P" to a location "in front of" the
plane "A." This position of point "P" provides an angle
.beta..sub.2 between the second arm member 14 and the joint axis 16
in maximum flexion, wherein .beta..sub.2 is greater than
.beta..sub.1. The greater the angle .alpha., the greater the angle
of maximum flexion.
[0059] Alternatively, (not shown) a decrease in the angle .alpha.
will move the point "P" to a location "behind" the plane "A." This
position of point "P" provides an angle .beta..sub.3 between the
second arm member 14 and the joint axis 16 in maximum flexion,
wherein .beta..sub.3 is less than .beta..sub.1. The smaller the
angle .alpha., the smaller the angle .beta. of maximum flexion.
[0060] Referring to FIG. 4, the first extension member 18 is
selectively, pivotally connected at location 26 to the first arm
member 12. The pivotal connection 26 of the first extension member
18 permits the angle .alpha. between the first extension member 18
and the first arm member 12 to be selectively increased and
decreased, increasing and decreasing the range of motion. In a
first position 28, the first extension member 18 is positioned at
an angle .alpha..sub.1, wherein the operative connection, at point
"P," of the first and second extension members 18 and 20 is located
in a plane "A" passing through the joint axis 16, wherein plane "A"
is substantially orthogonal to a longitudinal axis of the first arm
member 12. The first position 28 of point "P" provides a maximum
angle of flexion of .beta..sub.1. The second extension member stop
24 acts to limit the angle of maximum extension .gamma..sub.1
between the second arm member 14 and the joint axis 16.
[0061] Referring to FIG. 5, in a second position 30 the angle
.alpha. is increased to an angle .alpha..sub.z, positioning the
point "P" to a location "in front of" the plane "A." The second
position 30 of point. "P" provides a maximum angle of flexion of
.beta..sub.2, wherein .beta..sub.2 is greater than .beta..sub.1.
The second extension member stop 24 acts to limit the angle of
maximum extension .gamma..sub.2 between the second arm member 14
and the joint axis, wherein .gamma..sub.2 is less the
.gamma..sub.1.
[0062] The selective pivotal connection 26 of the first extension
member 18 to the first arm member 12 can have a plurality of
selectable positions. The angle .alpha. between the first arm
member 12 and the first extension 18 can be selectively increased
to move the point "P", on, "in front of" or "behind" the plane "A."
It is also envisioned that a positioned can be selected to increase
the angle .alpha. between the first arm member 12 and the first
extension 18 sufficiently to move the point "P" "in front of" plane
"A" and "above" the longitudinal axis of the first arm member 12,
maximizing the maximum angle of flexion .beta..
[0063] The orthosis 10 of the present invention can be connected to
the flexor side of the first and second body portions of the joint,
which results in a decrease in angle as the joint is flexed (bent)
and an increase in angle and the joint is extended (straightened).
Alternatively, orthosis 10 of the present invention can be
connected to the extensor side of the joint, which results in a
decrease in angle as the joint is extended straightened and an
increase in angle as the joint is flexed (bent).
[0064] The previous description of the first arm member 12 depicts
a first extension 18 having a substantially linear shape, extending
at an angle .alpha. from the first arm member 12. However, it is
within the scope of the present invention that the first extension
member 18 can be any shape extending from the first arm member 12
which positions the point "P" in the desired relationship to the
plane "A." Referring to FIG. 6, a segmented first extension member
is shown, including a first extension member segment 18a and a
second extension member segment 18b. The first and second extension
member segments 18a and 18b extend from the first arm member 12,
positioning the point "P" at an angle .alpha. from the first arm
member 12. Referring to FIG. 7, an arcuate first extension member
18c is shown. The arcuate extension member 18c extends from the
first arm member 12, positioning the point "P" at an angle .alpha.
from the first arm member 12.
[0065] Referring to FIG. 8, the orthosis 10 of the present
invention includes a first arm member 12 attachable to the first
body portion and a second arm member 14 attachable to the second
body portion, wherein the joint axis 16 is interposed between and
offset from the first and second arm members 12 and 14. The first
and second arm members 12 and 14 are connected with each other
offset from the joint axis 16.
[0066] The first arm member 12 of the orthosis 10 includes a first
extension member 18, which extends at angle .alpha. from the first
arm member 12. The second arm member 14 of the orthosis 10 includes
a second extension member 20, having an arcuate shape. The first
and second extension members 18 and 20 are operatively connected a
point "P," such that in operation the second extension member 20
travels along an arcuate path about and substantially through point
"P." The arcuate shape of the second extension member 20 results in
the second body portion rotating about the joint axis 16, when the
second arm member 14 is moved from a first position to a second
position relative to the first arm member 12. The angle .alpha.
between the first extension member 18 and the first arm member 12
and the radius of curvature of the second extension member 20 are a
function of the joint to be treated and the degree of flexion or
extension contractures.
[0067] A first cuff 32 is attached to the first arm member 12,
wherein the first cuff 32 is positionable about the first body
portion. The first cuff 32 is attached to the first body portion by
cuff straps. The first cuff 32 secures the first body portion to
the first arm member 12. A second cuff 34 is attached to the second
an member 14, wherein the second cuff 34 is positionable about the
second body portion. The second cuff 34 is attached to the second
body portion by cuff straps. The second cuff 34 secures the second
body portion to the second arm member 14. (The term "cuff" as used
herein means any suitable structure for transmitting the force of
the orthosis 10 to the limb portion it engages.)
[0068] In an exemplary use, the orthosis 10 is operated to extend a
joint in the following manner. The first cuff 32 is fastened about
the first body portion tightly enough that the first arm member 12
may apply torque to the first body portion without having the first
cuff 32 slide along the first body portion. Similarly, the second
cuff 34 is fastened securely around the second body portion so that
the second arm member 14 may apply torque to the second body
portion without the second cuff 34 sliding along the second body
portion. The orthosis 10 is attached to the first and second body
portions in a first position. The second arm member 14 is rotated
from the first position to a second position, relative to the first
arm member 12, rotating the second body portion about the joint
axis 16 stretching the joint. As the second arm member 14 is
rotated to the second position, the second extension member 20
travels along an arcuate path about and substantially through point
"P." The orthosis 10 is maintained in the second position for a
predetermined treatment time providing a constant stretch to the
joint. After the expiration of the treatment time, the second arm
member 14 is moved back to the first position, relieving the joint.
Optionally, the second arm member 14 can be rotated to a third
position, increasing the stretch on the joint. The second arm
member 14 can be rotated at discrete time intervals to
incrementally increase the stretch of the joint through the
treatment cycle. After completion of the treatment cycle, the
second arm member is returned to the first position for removal of
the orthosis 10.
[0069] The first and second arm members 12 and 14 are rigid members
made of, for example, aluminum, stainless steel, polymeric, or
composite materials. The arms are rigid so as to be able to
transmit the necessary forces. It should be understood that any
material of sufficient rigidity can be used.
[0070] In an embodiment, the components of the orthosis 10 of the
present invention are made by injection molding. Generally for
injection molding, tool and die metal molds of the orthosis 10
components are prepared. Hot, melted plastic material is injected
into the molds. The plastic is allowed to cool, forming components.
The components are removed from the molds and assembled. The cuff
portions 32 or 34 can be individual molded and attached to the arm
members 12 or 14. Alternatively, the cuff portions can be molded as
an integrated part of the arm members 12 or 14.
[0071] In use, the orthosis 10 can be connected to the flexor side
of the first and second body portions of the joint, which results
in a decrease in angle as the joint is flexed (bent) and an
increase in angle as the joint is extended (straightened).
Alternatively, orthosis 10 of the present invention can be
connected to the extensor side of the joint, which results in a
decrease in angle as the joint is extended straightened and an
increase in angle as the joint is flexed (bent).
[0072] In an embodiment, the orthosis 10 includes a first cuff 32
for attachment to a first body portion, and a second cuff 34 for
attachment to a second body portion. The first body portion is
joined to the second body portion at a joint, around which is
located, as is well known, soft tissue. Each of the first and
second cuffs 32 and 34 includes loop connectors for receiving
straps extending around the body portions to clamp the cuffs 32 and
34 to the body portions.
[0073] The first cuff 32 is mounted for sliding movement on the
first arm member 12 and is slidable along the first arm member 12
in a manner as described below. The second cuff 34 is mounted for
sliding movement on a second arm member 14 and is slidable along
the second arm member 12 in a manner as described below.
[0074] Bending a Joint in Extension:
[0075] In operation of the orthosis 10 to extend the joint, the
orthosis 10 starts at a more flexed position. The first and second
cuffs 32 and 34 are clamped onto the first and second body
portions, respectively, by straps, tightly enough so that the cuffs
32 and 34 can apply torque to the body portions to extend the
joint. The second arm member 14 is rotated from the first position
to a second position, relative to the first arm member 12, rotating
the second body portion about the joint axis 16 stretching the
joint. As the second arm member 14 is rotated to the second
position the second extension member 20 travels along an arcuate
path about and substantially through point "P." The orthosis 10 is
maintained in the second position for a predetermined treatment
time providing a constant stretch to the joint.
[0076] As the orthosis 10 is rotated from the first position to the
second position, extending the joint, the first and second cuffs 32
and 34 move along the first and second arm members 12 and 14. The
first cuff 32 moves inwardly along the first arm member 12.
Similarly, the second cuff 34 moves inwardly along the second arm
member 14. Because the cuffs 32 and 34 are clamped onto the first
and second body portions as described above, the outward pivoting
movement of the first and second arm members 12 and 14 and the
cuffs 32 and 34 causes the joint to be extended as desired.
However, this extension of the joint can place strong distractive
forces on the soft tissues around the joint. The sliding movement
of the cuffs 32 and 34, inwardly along the first and second arm
members 12 and 14, helps to limit these distractive forces by
counteracting the outward movement of the first and second arm
members 12 and 14. The cuffs 32 and 34 slide inwardly along the
first and second arm members 12 and 14 a distance far enough so
that the joint is only slightly distracted during extension. Thus,
the detrimental effects of strong distractive forces normally
generated in forced extension of a joint are avoided, being
replaced with the beneficial effects of limited and controlled
distraction.
[0077] Bending a Joint Flexion:
[0078] In operation of the orthosis 10 to flex the joint, the
orthosis 10 starts at a more extended position. The first and
second cuffs 32 and 34 are clamped onto the first and second body
portions, respectively, by straps, tightly enough so that the cuffs
32 and 34 can apply torque to the body portions to extend the
joint. The second arm member 14 is rotated from the first position
to a second position, relative to the first arm member 12, rotating
the second body portion about the joint axis 16 stretching the
joint. As the second arm member 14 is rotated to the second
position the second extension member 20 travels about and
substantially though point "P," along an arcuate path. The orthosis
10 is maintained in the second position for a predetermined
treatment time providing a constant stretch to the joint.
[0079] As the orthosis 10 is rotated from the first position to the
second position, flexing the joint, the first and second cuffs 32
and 34 move along the first and second arm members 12 and 14. The
first cuff 32 moves outwardly along the first arm member 12.
Similarly, the second cuff 34 moves outwardly along the second arm
member 14. Because the cuffs 32 and 34 are clamped onto the first
and second body portions the inward pivoting movement of the first
and second arm members 12 and 14 and the cuffs 32 and 34 causes the
joint to be flexed as desired. However, this flexion of the joint
can place strong compressive forces on the soft tissues around the
joint. The sliding movement of the cuffs 32 and 34, outwardly along
the first and second arm members 12 and 14, helps to limit these
compressive forces by counteracting the inward movement of the
first and second arm members 12 and 14. The cuffs 32 and 34 slide
outwardly along the first and second arm members 12 and 14 a
distance far enough so that the joint is only slightly compressed
during flexion. Thus, the detrimental effects of strong compressive
forces normally generated in forced flexion of a joint are avoided,
being replaced with the beneficial effects of limited and
controlled compression.
[0080] Referring now to FIG. 9, the orthosis 10 can be used to bend
a wrist in flexion or extension. The orthosis 10 includes a first
arm member 12 attachable to the forearm of a patient. The first
cuff 32 is clamped onto the forearm by straps. A second arm member
14, operatively connected to the first arm member 12, is attachable
to the hand of the patient, wherein the axis of the wrist joint is
interposed between and offset from the first and second arm members
12 and 14. The second arm member 14 includes a base member 36
attach thereto. A hand pad 38 is attached to the base member 36.
The hand pad 38 is clamped onto the hand by straps, tightly enough
so that the second arm member 14 can apply torque to the joint. The
hand pad 38 can be shaped to conform to the palm or the back
surface of the hand.
[0081] Bending Wrist in Flexion:
[0082] When a wrist is to be bent in flexion, the first cuff 32 is
connected with the forearm and the hand pad 38 is connected with
the palm of the hand. The first cuff 32 and hand pad 38 are clamped
onto the forearm and hand, respectively, by straps, tightly enough
so that they can apply torque to flex the joint. The second arm
member 14 is rotated from the first position to a second position,
relative to the first arm member 12, rotating the hand about the
wrist joint axis 16 stretching the joint. As the second arm member
14 is rotated to the second position the second extension member 20
travels along an arcuate path about and substantially through point
"P." The orthosis 10 is maintained in the second position for a
predetermined treatment time providing a constant stretch to the
wrist joint.
[0083] Bending Wrist in Extension:
[0084] When a wrist is to be bent in extension, the first cuff 32
is connected with the forearm and the hand pad 38 is connected with
the back surface of the hand. The first cuff 32 and hand, pad 38
are clamped onto the forearm and back surface of the hand,
respectively, by straps, tightly enough so that they can apply
torque to flex the joint. The second arm member 14 is rotated from
the first position to a second position, relative to the first arm
member 12, rotating the hand about the wrist joint axis 16
stretching the joint. As the second arm member 14 is rotated to the
second position the second extension member 20 travels along an
arcuate path about and substantially through point "P." The
orthosis 10 is maintained in the second position for a
predetermined treatment time providing a constant stretch to the
wrist joint.
[0085] In an embodiment, the hand pad 38 is removable attached to
the base member 36. The hand pad 38 includes a first surface, which
has a substantially convex shape, to conform to the palm of the
hand. A second surface, opposite the first surface, is also
included, having a substantially concave shape, to conform to the
back surface of the hand. The hand pad 38 can be removable attached
to the base member 36 such that the first or second surfaces
engages the hand of the patient.
[0086] For example, the hand pad 38 is removably secured to base
member 36 by detent pin 40. The removable securing of the hand pad
38 allows the orthosis 10 to be used for both flexion and extension
of the wrist. In flexion, the hand pad 38 is connected to the base
member 36 with the first surface facing "up" to conform to the palm
of the hand. In extension, the hand pad 38 is connected to the base
member 36 with the second surface facing "up" to conform to the
back surface of the hand.
[0087] The base member 38 can be mounted for sliding movement on
the second arm member 14 and is slidable along the second arm
member 14 in a manner as described below.
[0088] Bending Wrist in Extension:
[0089] In operation of the orthosis 10 to extend the wrist joint,
the orthosis 10 starts at a more flexed position. The first cuff 32
is connected with the forearm and the hand pad 38 is connected with
the palm of the hand. The first cuff 32 and hand pad 38 are clamped
onto the forearm and palm of the hand so as to apply torque to
extend the wrist joint. The second arm member 14 is rotated from
the first position to a second position, relative to the first arm
member 12, rotating the hand about the wrist joint axis 16
stretching the wrist joint. As the second arm member 14 is rotated
to the second position the second extension member 20 travels along
an arcuate path about and substantially through point "P." The
orthosis 10 is maintained in the second position for a
predetermined treatment time providing a constant stretch to the
joint.
[0090] As the orthosis 10 is rotated from the first position to the
second position, extending the joint, the base member 36 and hand
pad 38 move along the second arm member 14. The base member 36 and
hand pad 38 move inwardly along the second arm member 14. Because
the cuff 32 and hand pad 38 are clamped onto the forearm and hand
the outward pivoting movement of the first and second arm members
12 and 14 causes the joint to be extended as desired. However, this
extension of the joint can place strong distractive forces on the
soft tissues around the joint. The sliding movement of the base
member 36 and hand pad 38, inwardly along the second arm member 14,
helps to limit these distractive forces by counteracting the
outward movement of the second arm members 12 and 14. The base
member 36 and hand pad 38 slide inwardly along the second arm
member 14 a distance far enough so that the joint is only slightly
distracted during extension. Thus, the detrimental effects of
strong distractive forces normally generated in forced extension of
a joint are avoided, being replaced with the beneficial effects of
limited and controlled distraction.
[0091] Bending Wrist in Flexion:
[0092] In operation of the orthosis 10 to flex the wrist joint, the
orthosis 10 starts at a more extended position. The first cuff 32
is connected with the forearm and the hand pad 38 is connected with
the back surface of the hand. The first cuff 32 and hand pad 38 are
clamped onto the forearm and back surface of the hand so as to
apply torque to flex the wrist joint. The second arm member 14 is
rotated from the first position to a second position, relative to
the first arm member 12, rotating the hand about the wrist joint
axis 16 stretching the wrist joint. As the second arm member 14 is
rotated to the second position the second extension member 20
travels along an arcuate path about and substantially through point
"P." The orthosis 10 is maintained in the second position for a
predefined treatment time providing a constant stretch to the
joint.
[0093] As the orthosis 10 is rotated from the first position to the
second position, flexing the joint, the base member 36 and hand pad
38 move along the second arm member 14. The base member 36 and hand
pad 38 move outwardly along the second arm member 14. Because the
cuff 32 and hand pad 38 are clamped onto the forearm and hand the
inward pivoting movement of the first and second arm members 12 and
14 causes the joint to be flexed as desired. However, this flexing
of the joint can place strong compressive forces on the soft
tissues around the joint. The sliding movement of the base member
36 and hand pad 38, outwardly along the second arm member 14, helps
to limit these compressive forces by counteracting the inward
movement of the first and second arm members 12 and 14. The base
member 36 and hand pad 38 slide outwardly along the second arm
member 14 a distance far enough so that the joint is only slightly
compressed during extension. Thus, the detrimental effects of
strong compressive forces normally generated in forced flexion of a
joint are avoided, being replaced with the beneficial effects of
limited and controlled compression.
[0094] In the above description, the hand pad 38 is shown sliding
inwardly and outwardly along the second arm member 14. However, it
is contemplated that the hand pad 38 can slide in other directions.
For example, the hand pad 38 can slide substantially orthogonal to
the second arm member 14, wherein the substantially orthogonal
directions can have an arcuate path. Similarly, as discussed in
more detail below, it is contemplated within the scope of the
present invention that hand pad 38 can be connected to the second
arm member 14 such that hand pad 38 can exhibit both longitudinal
and orthogonal motion (and combinations thereof) with respect to
the second arm member 14.
[0095] In the above description, the second extension member 20 is
shown and described as having a substantially circular arcuate
shape, positioning the axis of rotation at the joint axis 16.
However, it is contemplated that the second extension member 20 can
have alternative shapes.
[0096] Referring to FIG. 10, the second arm member 14 is shown
having a non-circular arcuate shaped second extension member 44.
The non-circular arcuate shaped second extension member 44 provide
an axis of rotation which changes as the second arm member 14 is
moved from the first position to the second portion. As such, as
the second arm member 14 is moved from the first position to the
second portion the second body portion will exhibit both a
rotational motion, about the joint axis 16, and a translational
motion, distracting or compressing the joint.
[0097] In the previously described embodiments, the arcuate shape
of the second extension member 20 or 44 as shown have concave
radius of curvature relative to the joint 16. However, referring to
FIG. 11, it is contemplated that the second extension member 18 or
44 can have a convex radius of curvature relative to the joint 16.
Similar to the concave radius of curvature, the convex arcuate
shape of the second extension member 18 or 44 results in the second
body portion rotating about the joint axis 16, when the second arm
member 14 is moved from a first position to a second position
relative to the first arm member 12.
[0098] Referring to FIG. 12, the second arm member 14 of the
orthosis 10 includes a second extension member 48 extending
therefrom and having a linear shape. The first and second extension
members 18 and 48 are operatively connected at point "P." such that
in operation the second extension member 48 travels along a linear
path through point "P." The linear shape of the second extension
member 48 results in the second body portion being translated with
respect to the first body portion. The translational movement of
the second arm member 14 results is a distraction or compression of
the joint when the second arm member 14 is moved from a first
position to a second position relative to the first arm member
12.
[0099] As discussed further below, the hand pad can be mounted for
translational and rotational movement on the base member.
[0100] Drive Assembly:
[0101] Referring to FIGS. 9 and 13A, the drive assembly 22 of the
orthosis includes a gear system. As previously noted, the
components of the orthosis, including the drive assembly 22, can be
made by injection molding a polymer. The drive assembly 22 is
supported in the first extension member 18, including a gear 50
rotatable about point "P." A shaft 52, attached to the gear 50,
extends from first extension member 18. A knob 54 is connected to
the shaft 52, opposite the gear 50, for manually rotating the gear
50. The second extension member 20 includes a series of teeth 56
along an inner surface 58. The second extension member 20 is
threaded through the first extension member 18, such that the teeth
56 on the second extension member 20 engage the gear 50. The
rotation of the knob 56 causes the gear 50 to rotate, pushing or
pulling the second extension member 20 through the first extension
member 18. The drive assembly 22 includes a locking or breaking
mechanism which prevents the gear 50 from rotating absent am
applied force rotation of the knob 46. Such a lock or breaking
mechanism can include a compression washer or other known gear
locking or breaking mechanisms.
[0102] In another embodiment, as shown in FIG. 13B, the shaft 52 is
attached to the gear 50 and extends from first extension member 18.
The knob 54 is connected to the shaft 52 opposite the gear 50 for
manually rotating the gear 50. The second extension member 20
includes a series of teeth 56 along an inner surface 58. The teeth
56 can extend fully or partially along the width of the inner
surface 58. A secondary gear 51 is positioned between the gear 50
and the inner surface 58, where the secondary gear 51 engages gear
50. The second extension member 20 is threaded through the first
extension member 18, such that the teeth 56 on the second extension
member 20 engage the secondary gear 51. The rotation of the knob 56
causes the gear 50 to rotate, thereby rotating the secondary gear
51 and pushing or pulling the second extension member 20 through
the first extension member 18. The ratio between gear 50 and
secondary gear 51 is selected to permit an easy rotation of the
knob 54, moving of the second extension member 20 through the first
extension member 18. The drive assembly 22 includes a locking or
breaking mechanism which prevents the gear 50 from rotating absent
am applied force rotation of the knob 46. Such a lock or breaking
mechanism can include a compression washer or other known gear
locking or breaking mechanisms.
[0103] The drive assembly 22 is described as utilizing a gear
system. However, it is contemplated that other known drive systems
can be used to move the second extension member 20 through the
first extension member 18, for example a friction type drive
system. Regardless of the drive system used, the joint orthosis of
the present invention can act as a brace, restricting the relative
movement of the first and second body portions to one degree of
freedom (e.g. flexion and extension about the joint). Thus, drive
assembly 22 can be configured to allow free motion in one degree of
freedom. This can be achieved in a number of different ways. For
example, gear 50 can be positioned such that it does not engage
teeth 56.
[0104] In an alternative embodiment, the drive assembly 22 for an
orthosis 10 in accordance with the present invention can be
actuated by a motor instead of by a manually actuatable member,
such as the knob 54.
[0105] In an embodiment, an electric motor is mounted to the shaft
52 for rotation of the gear 50. A battery provides electric power
to the motor. Alternatively, the motor can be supplied with
external power. A microprocessor controls the operation of the
motor. The microprocessor and motor together can be used to cycle
the first and second arm members 12 and 14 through extension and
flexion; to move the first and second arm members 12 and 14 in one
pivotal direction a certain amount, hold there while tissue
stretches, then move further in that direction; or in any other
manner. In another manner of use, the orthosis can be set to cycle
to one end of the joint's range of motion and hold there for a
predetermined period of time, then cycle to the other end of the
joint's range of motion and hold there. The programming and control
of the microprocessor is within the skill of the art as it relates
to driving the motor to control the first and second arm members 12
and 14 to move in known manners. This embodiment is ideally suited
for continuous passive motion exercise, because the orthosis is
portable and because the motor can be programmed with the desired
sequence of movements.
[0106] It should be understood that the particular physical
arrangement of the motor, the battery, and the microprocessor is
not the only possible arrangement of those elements. The invention
contemplates that other arrangements of these or similarly
functional elements are quite suitable, and thus, the invention is
intended to cover any such arrangement. Additionally, another type
of power source, other than an electric motor, can also be used.
For example, the use of a hydraulic or pneumatic motor as the drive
mechanism is contemplated.
[0107] Referring to FIGS. 14 and 15, another embodiment in which
the hand pad 38 articulates with respect to the second arm member
14 is shown. The second arm member 14 has a circular base member 40
attached thereto. The circular base member 40 supports a circular
base plate 42. A circular cover 44 extends upwardly from the
circular base member 40 and has a portion 46 extending radially
inwardly toward a vertical axis 48 to define a slide chamber
50.
[0108] A hand pad support slider 52 is received in the slide
chamber 50. The support slider 52 has an upper portion 54 to which
the hand pad 38 is attached. The upper portion 54 is connected by a
neck 56 to a circular planar portion 58. Two annular bearing races
60 extend downwardly from the planar portion 58 and secure between
them a plurality of ball bearings 62. A washer 64 is disposed above
the bearings 62. The ball bearings 62 support the slider 52 and
thus the hand pad 38 for sliding movement in any direction within
the slide chamber 50. The hand pad 38 can be made self-centering by
springs 66.
[0109] Thus, the hand pad 38 is slidable relative to the circular
base member 40 in any direction for a limited extent. As indicated
by the arrow 68, the hand pad 38 is slidable fore and aft within
the extent of travel allowed by the support slider 52 within the
slide chamber 50. As indicated by the arrow 70, the hand pad 38 is
slidable laterally within the extent of travel allowed by the
support slider 52 within the slide chamber 50. With these two
combined, it can be seen that the roller bearing assembly provides
a compound of movement of the hand pad 38.
[0110] Referring to FIGS. 16, 17A and 178, another embodiment 80 in
which the hand pad 38 articulates with respect to the second arm
member 14 is shown. The second arm member 14 has a sliding base
member 82 slidingly mounted thereto in similar fashion to base
member 36. The sliding base member 82 supports a fixed base plate
84 attached thereto. A pivotal base plate 86 is pivotally connected
to the fixed base plate 84, where the pivotal base 86 plate can
arcuately pivot with respect to the fixed base plate 84 and the
second arm member 14.
[0111] The pivotal base plate 86 is pivotally secured to the fixed
base plate 84 by threaded members 88 and 90 extending through an
arcuate slot 92 in the pivotal base plate 86. The threaded members
88 and 90 are threaded in threaded holes 94 and 96 in the fixed
plate 84. In this manner the pivotal base plate 86 can travel along
the arcuate slot 92 with respect to the fixed base plate 84. The
hand pad (not shown) can be removable attached to the pivotal base
plate 86.
[0112] In instances where a joint is misaligned, fixing the
position of the joint can result in unwanted torsional forces being
applied to the joint. The articulation of the hand pad permits the
joint to self-align, such that the joint can be rotated about its
axis without the application of torsional forces on the joint.
[0113] Referring now to FIG. 18, an orthosis 100 can be used to
bend a wrist in flexion or extension. The orthosis 100 includes a
first arm member 102 attachable to the forearm of a patient. The
first cuff 104 is clamped onto the forearm by straps 106. A second
arm member 108, operatively connected to the first arm member 102,
is attachable to the hand of the patient, wherein the axis of the
wrist joint is interposed between and offset from the first and
second arm members 102 and 108. The second arm member 108 includes
articulating member 80 attached thereto. A hand pad can be attached
to the pivotal base plate 86. The hand is clamped onto the hand pad
by top member 110 and strap 112, tightly enough so that the second
arm member 108 can apply torque to the joint. The hand pad can be
shaped to conform to the palm or the back surface of the hand.
[0114] Referring to FIG. 19, a hand pad 114 is provided, where the
hand pad 114 can be removably attached to the pivotal base plate
86. For example, a hook and loop tape 116 can be provided on the
hand pad 114 and the pivotal base plate 86. The hand pad 114 is
shaped to conform to the palm of the hand.
[0115] Referring to FIG. 20, another hand pad 118 is provided,
where the hand pad 118 can be removably attached to the pivotal
base plate 86. Similarly, the hook and loop tape 116 can be
provided on the hand pad 118 and the pivotal base plate 86. The
hand pad 118 is shaped to conform to a top surface of the hand.
[0116] Another embodiment of an orthosis of the present invention
is in treatment of a toe of a patient's foot. While this embodiment
is believed to provide significant improvements in this area of
treatment, it may likewise be of benefit in treating other joints,
such as ankles, knees, hips, fingers, wrists, elbows, shoulders, or
the spine.
[0117] Furthermore, while many examples provided herein may
illustrate the invention used to treat the metatarsal and proximal
phalanx of the toe, these examples are non-limiting on other joints
of the toe that also may be treated by the present invention. It is
understood by those skilled in the art that the other joints of the
toe may be flexed or extended, without departing from the spirit
and scope of the invention. Additionally, the present invention is
described in use on the "big" toe or hallux on the foot. Thus, it
should be understood by those skilled in the art that the present
invention is equally applicable for use on the second, third,
fourth and minimus toes of the foot.
[0118] Each toe in the foot extends from the metatarsal bone and is
formed by the proximal phalanx, middle phalanx, and distal phalanx,
each of which is respectively pivotally connected to form a joint
there between. The orthosis of the present invention may be
configured to flex or extend (or both) a toe joint, where the joint
defines an inner sector on the flexor side that decreases in angle
as the joint is flexed (bent) and an outer sector on the extensor
side that decreases in angle as the joint is extended
(straightened).
[0119] Referring now to the figures in which like reference
designators refer to like elements, there is shown in FIG. 21, a
schematic of the orthosis 200 of the present invention. The
orthosis 200 includes a first member 202 attachable to a first body
portion, such as a user's foot. The shape and configuration of the
first member 202 may be selected to support or conform generally to
a patient's foot. For example, the first member 202 may be a
platform that contacts or supports the underside of a user's foot.
Sidewalls or curved edges may be provided to help position, cradle,
or securely hold the foot in proper position.
[0120] Alternatively, the first member 202 may have a profile or
shape that generally conforms to a user's arch, shoe size, or foot
width so that it fits more comfortably, holds the foot securely in
place, or improves alignment of the device so that the range of
motion imparted by the device corresponds to a joint's healthy
range of motion. This conforming shape or profile may be
accomplished, for instance, by providing interchangeable platforms
corresponding to different foot sizes and shapes. The
interchangeable platform may be selectively removed and replaced by
an interchangeable platform of a different size. Alternatively, the
first member 202 may have adjustable surfaces that can be resized
or repositioned to better support or correspond to a patient's
foot. For example, the overall length of the first member 202 may
be adjustable, or the width of the first member 202 near the toes
may be adjusted to account for different foot widths. In addition,
raised walls or edges that support the feet may be selectively
moveable so that they can be moved to accommodate different foot
sizes. Once the foot is in place and the edges are moved to their
desired position, they may be selectively locked or secured in
place to help hold the foot in place. Additionally, the first
member 202 may be configured with an arch, which in some instances
also may be adjustable such as by having interchangeable arch
inserts, by configuring the arch to be inflatable, or the like.
[0121] The first member 202 is operatively associated with or
connected to a second member 204 so that the first and second
members 202 and 204 may move or rotate with respect to each other.
As shown in FIG. 21, the supporting surface of the first member 202
may be offset from the supporting surface of the second member 204.
This amount of offset provided may vary from patient to patient or
from joint to joint, and in some cases an offset may not be
provided. Thus, it may be advantageous to allow the offset of the
orthosis 200 to be adjustable so that a physician or user may
change its size as needed to improve comfort, fit, or operation of
the orthosis 200.
[0122] In use, the second member 204 may be attachable to a second
body portion, such as at least one toe on the foot so that the
relative movement of the two members also causes movement of the
joint. As shown in FIG. 22, the orthosis 200 may have an axis of
rotation 206 that is aligned with the axis of rotation of the
joint. In this manner, the instantaneous axis of rotation (IAR) of
the first and second members 202 and 204 may better match the IAR
of the treated joint. As will be discussed in greater detail below,
while the axis of rotation 206 of the device is illustrated in
FIGS. 21-23 as occurring only along a single line, the axis of
rotation 206 may also shift or move depending on the relative
positioning of the first and second members 202 and 204 in a manner
that corresponds to changing axis of rotation that a joint may
experience through its range of motion. The first and second
members 202 and 204 are operatively connected to each other, offset
from the orthosis axis 206.
[0123] The first member 202 of the orthosis 200 includes a first
extension member 208 extending therefrom. The second member 204 of
the orthosis 200 includes a second extension member 210 extending
therefrom and having an arcuate shape. The first and second
extension members 208 and 210 are operatively connected at point
"P," such that in operation the second extension member 210 travels
along an arcuate path about and substantially through point "P."
The arcuate shape of the second extension member 210 results in the
toe rotating about the orthosis axis 206, or alternatively about a
moving IAR, when the second member 204 is moved from a first
position to a second position relative to the first member 202.
[0124] The first extension member 208 can extend substantially
vertically from the first member 12 or extend at an angle .alpha.
from the first member 202. In one embodiment of the invention, the
angle .alpha. and the radius of curvature of the second extension
member 210 are configured such that of the orthosis axis 206 is
aligned with the axis of rotation of the joint. The previous
description of the first member 202 depicts a first extension 208
having a substantially linear shape, extending at an angle .alpha.
from the first member 202. However, it is within the scope of the
present invention that the first extension member 208 can be any
shape extending from the first member 202 which aligns orthosis
axis 206 with the axis of rotation of the joint. Furthermore, as
mentioned previously and again below, in some instances the axis of
rotation of the joint may change or move slightly. Therefore, in
some instances it may be desirable for the orthosis to mimic the
IAR of the joint. As will be illustrated in detail below, this can
be accomplished in several ways. One modification of the embodiment
of the invention shown in FIG. 21, for instance, may be for the
second extension member 210 not to have a constant radius of
curvature.
[0125] The orthosis 200 further includes a drive assembly 212,
which is illustrated in FIG. 21 at or near point "P." In this
embodiment, the drive assembly 212 is operably connected to the
first and second extension members 208 and 210 for applying force
to the first and second members 202 and 204 to pivot the second
body portion about the orthosis axis 206. As will be shown below in
additional embodiments, the drive assembly 212 may be configured or
disposed to interact with or operate on one of the first or second
members 202 and 204 independently.
[0126] Referring to FIG. 22, in order for the orthosis 200 to
extend the joint the first and second members 202 and 204 may be
affixed to the first and second body portions, respectively,
tightly enough so that the first and second members 202 and 204 can
apply torque to extend the joint.
[0127] The second extension member 210 is moved through the drive
assembly 212 from a first position to a second position, relative
to the first extension member 208, rotating the second member 204
and the second body portion about the orthosis axis 206 stretching
the joint. As the second member 204 is rotated to the second
position, the second extension member 210 travels at least
partially through point "P" and may travel substantially through
this point for a large range of motion. Because the first and
second members 202 and 204 are affixed to the first and second body
portions, the outward pivoting movement of the second member 204
causes the joint to be extended as desired. The orthosis 200 may
then be maintained in the second position for a predetermined
treatment time providing a constant stretch to the joint. The
orthosis may alternatively be configured to impart a constant force
or load on the joint or may utilize the techniques of Static
Progressive Stretch as described in co-pending application Ser. No.
11/203,516, entitled "Range of Motion System and Method", and filed
on Aug. 12, 2005, the entirety of which is incorporated by
reference.
[0128] Returning to the example where the orthosis is maintained in
the second position, after the expiration of the treatment time,
the second member 204 may then be moved back to the first position,
relieving the joint. Optionally, the second member 204 can be
rotated to a third position, increasing the stretch on the joint,
or partially reducing it to allow limited relaxation of the
surrounding tissue. The second member 204 can be rotated at
discrete time intervals to incrementally increase, reduce, or vary
the stretch of the joint through the treatment cycle. After
completion of the treatment cycle, the second arm 204 is returned
to the first position for removal of the orthosis 200.
[0129] Referring to FIG. 23, in operation of the orthosis 200 to
flex the joint. The first and second members 202 and 204 are
affixed to the first and second body portions, respectively,
tightly enough so that the first and second members 202 and 204 can
apply torque to extend the joint. A cuff strap, laces, or other
retaining device may be used to securely associate respective body
portions of the joint with the first and second members 202, 204.
The second extension member 210 is moved through the drive assembly
212 from the first position to a second position, relative to the
first extension member 208, rotating the second member 204 and the
second body portion about the orthosis axis 206 stretching the
joint. As the second member 204 is rotated to the second position,
the second extension member 210 travels substantially through point
"P." Because the first and second members 202 and 204 are affixed
to the first and second body portions, the inward pivoting movement
of the second member 204 causes the joint to be flexed as desired.
The orthosis 200 is maintained in the second position for a
predetermined treatment time providing a constant stretch to the
joint.
[0130] After the expiration of the treatment time, the second
member 204 is moved back to the first position, relieving the
joint. Optionally, the second member 204 can be rotated to a third
position, thereby increasing, decreasing, or otherwise varying the
stretch on the joint. The second member 204 can be rotated at
discrete time intervals to incrementally increase the stretch of
the joint through the treatment cycle. After completion of the
treatment cycle, the second arm 204 is returned to the first
position for removal of the orthosis 200.
[0131] FIGS. 24-26 further illustrate several aspects of the
invention more concretely. An orthosis 220 of the present invention
includes a first member 221 having a first cuff 222 attachable to a
user's foot and a second member 223 having a second cuff 224
attachable to a toe of the user's foot, wherein the second member
223 is rotatable with respect to the first member 221 about an axis
of rotation 226. The first and second members 221 and 223 are
attached to the foot and toe of the user with the first and second
cuffs 222 and 224, such that as the second member 223 is rotated
about the axis of rotation 226, the toe is rotated about a joint
axis.
[0132] A first extension member 228 is affixed to and extends from
the first member 221, wherein a drive assembly 230 is positioned on
an end portion of the first extension member 228. A second
extension member 232 is similarly affixed to and extends from the
second member 223, wherein the second extension member 232 has an
arcuate shape. The second extension member 232 engages the drive
assembly 230 of the first extension member 228 at a point "P." An
actuation of the drive assembly 230 operates to move the second
extension member 232 through the drive assembly 230, such that the
second cuff 224 travels along an arcuate path "A" with respect to
the first member 221. The arcuate shape of the second extension
member 232 results in the toe rotating about the joint axis, as the
second cuff 224 is moved along the arcuate path "A." The drive
assembly 230 can be actuated to move the second cuff 224 and toe
from a first position to a second position relative to the first
cuff 222. Once again, the term "cuff" as used herein means any
suitable structure for transmitting the force of the orthosis 220
to the limb portion it engages.
[0133] The first extension member 228 can extend substantially
vertically from the first member 221 or extend at an angle .alpha.
from the first member 221, where the angle .alpha. and the radius
of curvature of the second extension member 232 (if constant) can
be configured such that of the axis of rotation 226 is aligned with
the joint axis of ration. As previously discussed, the curvature of
the second extension member 232 need not be constant, and therefore
the axis of rotation may shift or move in a manner that preferably
mimics or approximates the moving IAR the joint would normally
have. Another potential benefit of the orthosis 220 having the
capability of a moving IAR is when multiple joints are being
treated by the device. For instance, the range of motion of the tip
of a toe or finger may involve cooperative motion of two or more
joints. If the combined bending of the multiple joints causes the
overall motion to rotation about a moving axis, it would be
beneficial for the orthosis to approximate this moving IAR. Thus,
the curvature of the second extension member 232 may be complex in
order to better approximate a moving IAR.
[0134] Referring to FIG. 27, the drive assembly 230 can include a
housing 240 having a worm gear 242 therein. A first miter gear 244
is attached to the worm gear 242 such that a rotation of the first
miter gear 244 rotates the worm gear 242. The drive assembly 230
further includes a drive shaft 246 have a knob 248 at one end and a
second miter gear 250 at an opposite end. The second miter gear 250
is positioned within the housing 240, in engagement with the first
miter gear 244. A rotation of the knob 248 rotates the drive shaft
246 and the second miter gear 250, which in turn rotates the first
miter gear 244 and the worm gear 242.
[0135] A gear surface 252 of the second extension member 232
includes a plurality of teeth 254. The second extension member 232
is positioned throughout the housing 240, such that the worm gear
242 engages the teeth 254 of the second extension member 232. A
rotation of the knob 248 rotates the worm gear 242, which in turn
moves the second extension member 232 through the housing 240.
[0136] In an alternative embodiment, the drive assembly 230 for
orthosis 230 in accordance with the present invention can be
actuated by a motor instead of by a manually actuatable member,
such as the knob 248. Likewise, the motor may be configured an
adapted with gearing that causes the orthosis to cycle through a
range of motion in a predetermined manner, or alternatively maybe
controlled by a programmable logic controller (PLC).
[0137] In an embodiment, an electric motor is mounted to the drive
shaft 246 for rotation of the second miter gear 250. A battery or
other source of energy provides electric power to the motor.
Alternatively, the motor can be supplied with external power. A
microprocessor controls the operation of the motor. The
microprocessor and motor together can be used to cycle the second
cuff 34 through a plurality of positions that cause the joint to
undergo a range of motion, either by extension, by flexion, or
both. For example, the microprocessor may be used to move the
second cuff 34 in one pivotal direction a certain amount, hold
there while tissue stretches, then move further in that direction;
or in any other manner.
[0138] In another manner of use, the orthosis can be set to cycle
to one end of the joint's range of motion and hold there for a
predetermined period of time, then cycle to the other end of the
joint's range of motion and hold there. The programming and control
of the microprocessor is within the skill of the art as it relates
to driving the motor to control the second cuff 34 to move in known
manners. This embodiment is ideally suited for continuous passive
motion exercise, because the orthosis is portable and because the
motor can be programmed with the desired sequence of movements.
[0139] It should be understood that the particular physical
arrangement of the motor, the power source, and the microprocessor
is not the only possible arrangement of those elements. The
invention contemplates that other arrangements of these or
similarly functional elements are quite suitable, and thus, the
invention is intended to cover any such arrangement. Additionally,
another type of power source, other than an electric motor, can
also be used. For example, the use of a hydraulic or pneumatic
motor as the drive mechanism is contemplated.
[0140] The present invention can further include a monitor for use
with the orthosis 220, which provides assurances the patient is
properly using the orthosis 220 during his/her exercise period. For
instance, the monitor can have a position sensor, a temperature
sensor, a force sensor, a clock or timer, or a device type sensor
for monitoring the patient's implementation of a protocol. The
information obtained from these monitoring devices may be stored
for later analysis or confirmation of proper use or may be
transmitted in real-time during use of the device. The data
obtained from the monitor can be analyzed by a healthcare
professional or technician and the protocol can be adjusted
accordingly.
[0141] This analysis may be conducted remotely, thereby saving the
time and expense of a home visit by a healthcare professional or
technician. An exemplary monitoring system is provided in U.S.
Publication No. 20040215111 entitled "Patient Monitoring Apparatus
and Method for Orthosis and Other Devices," to Bonutti et al., the
content of which is herein expressly incorporated by reference in
its entirety.
[0142] In an exemplary use, the orthosis 220 is operated to rotate
a toe about a joint axis in the following manner. The first cuff
222 is fastened about the foot with one or more straps, laces, or
similar retaining device. Similarly, the second cuff 224 is
fastened securely to the toe of the user, such that the joint and
joint axis 226 is interposed between the first and second cuffs 222
and 224. The orthosis 220 is attached to the foot and toe in a
first position. The drive assembly 230 is actuated to move the
second extension member 232, such that the second cuff 224 travels
along an arcuate path from the first position to a second position,
relative to the first cuff 222, rotating the toe about the joint
axis stretching the joint. The orthosis 220 is maintained in the
second position for a predetermined treatment time providing a
constant stretch to the joint. After the expiration of the
treatment time, the second cuff 224 is moved back to the first
position, relieving the joint. Optionally, the second cuff 224 can
be rotated to a third position, thereby increasing or decreasing
the stretch on the joint. The second cuff 224 can be rotated at
discrete time intervals to incrementally increase the stretch of
the joint through the treatment cycle. After completion of the
treatment cycle, the second arm member is returned to the first
position for removal of the orthosis 220.
[0143] Referring to FIG. 28, the second member 223 can include an
attachment bracket 260 for adjustably attaching the second cuff 224
to the second extension member 232. The attachment bracket 260 can
include a toe rod 262 extending therefrom. The second cuff 224 can
be slideably mounted on the toe rod 262 to position second cuff 224
over the toe. Alternatively, the toe rod 262 can be of sufficient
length such that the second cuff 24 can be slidingly positioned on
a selected toe on the foot of the user, for example, the big toe,
minimus toe, or any toe therebetween.
[0144] The second cuff 224 can be positioned on the toe rod 262
with a first bracket 264, where the toe rod 262 passes through a
passage 266 in the first bracket 264. A set screw 268 is provided
to secure the first bracket 264 to the toe rod 262. When the set
screw 268 is loosened, the first bracket 264 is free to slide along
the toe rod 262. A tightening of the set screw 268 secures the
first bracket 264 in place on the toe rod 272.
[0145] The second cuff 224 can further include a second bracket
270, where the second bracket 270 can be pivotally mounted to the
first bracket 264. For example, the second bracket 270 can be
attached to the first bracket 264 with a pin or screw connector,
allowing the second bracket 270 to rotate with respect to the first
bracket 264.
[0146] Additionally, when a joint is flexed or extended a
compressive force may be applied to the connective tissue
surrounding the joint. It may be desirable to control the
compressive force, distracting the joint as the joint is flexed or
extended. "Distraction" is defined by one dictionary as "Separation
of the surfaces of a joint by extension without injury or
dislocation of the parts." (Taber's Cyclopedic Medical Dictionary,
16th Edition, 1989, page 521), and involves stretching rather than
compressing the joint capsule, soft tissue, ligaments, and
tendons.
[0147] Additionally, the second bracket 270 can be slideably
mounted to the first bracket 264. For example the second bracket
270 can be mounted to the first bracket 264 with a dovetail joint
272, allowing the second bracket 270 to slide with respect to the
first bracket 264. The sliding movement of the second cuff 224
helps to limit the distractive or compressive forces which can be
imparted on the joint by the rotation of the second cuff 224 with
respect to the first cuff 222.
[0148] The attachment bracket 260 can be pivotally mounted to the
second extension member 232. For example, the attachment bracket
260 can be attached to the second extension member 232 with a pin
or screw connector 274, allowing the attachment bracket 260 to
rotate with respect to the second extension member 232. The second
extension member 232 further includes an extension bracket 276
having a slotted portion 278. A set screw 280 is positionable
through the slotted portion 278, engaging the attachment bracket
260, such that the set screw 280 can be used to control the pivotal
position of the attachment bracket 260 with respect to the second
extension member 232.
[0149] The adjustable connection of the second cuff 224 to the
attachment bracket 260 and the pivotal connection of the attachment
bracket 260 to the second extension member 232 can be used to align
the second cuff 224 with the toe. The alignment of the second cuff
224 on the toe can be used to substantially limit the force applied
to the toe to that of a torque about the joint axis 226.
[0150] Bending a Joint in Extension:
[0151] In operation of the orthosis 220 to extend the joint, the
orthosis starts at a more flexed position. The first and second
cuffs 222 and 224 are clamped onto the foot and toe portions,
respectively, by straps 234, tightly enough so that the first and
second members 221 and 223 can apply torque to extend the joint.
The second extension member 232 is moved through the drive assembly
230 from the first position to a second position, relative to the
first extension member 228, rotating the second cuff 224 and the
toe about the orthosis axis 226 stretching the joint. As the second
cuff 224 is rotated to the second position the second extension
member 232 travels along an arcuate path "A" about and
substantially through point "P." The orthosis 220 is maintained in
the second position for a predetermined treatment time providing a
constant stretch to the joint.
[0152] As the orthosis 220 is rotated from the first position to
the second position, extending the joint, the second cuff 224 moves
along the first bracket 64. Because the first and second members
221 and 223 are clamped onto the foot and toe as described above,
the outward pivoting movement of the second cuff 224 causes the
joint to be extended as desired. However, this extension of the
joint can place strong distractive forces on the soft tissues
around the joint. The sliding movement of the second cuff 224 helps
to limit these distractive forces by counteracting the outward
movement. Thus, the detrimental effects of strong distractive
forces normally generated in forced extension of a joint are
avoided, being replaced with the beneficial effects of limited and
controlled distraction.
[0153] Bending a Joint Flexion:
[0154] In operation of the orthosis 220 to flex the joint, the
orthosis 220 starts at a more extended position. The first and
second cuffs 222 and 224 are clamped onto the foot and toe
portions, respectively, by straps 234, tightly enough so that the
first and second members 221 and 223 can apply torque to extend the
joint. The second extension member 232 is moved through the drive
assembly 230 from the first position to a second position, relative
to the first extension member 228, rotating the second cuff 224 and
the toe about the orthosis axis 26 stretching the joint. As the
second cuff 224 is rotated to the second position the second
extension member 232 travels along an arcuate path "A" about and
substantially through point "P." The orthosis 220 is maintained in
the second position for a predetermined treatment time providing a
constant stretch to the joint.
[0155] As the orthosis 220 is rotated from the first position to
the second position, flexing the joint, the second cuff 224 moves
along the first bracket 264. Because the first and second members
221 and 223 are clamped onto the foot and toe as described above,
the inward pivoting movement of the second cuff 224 causes the
joint to be flexed as desired. However, this flexion of the joint
can place strong compressive forces on the soft tissues around the
joint. The sliding movement of the second cuff 224 helps to limit
these compressive forces by counteracting the inward movement.
Thus, the detrimental effects of strong compressive forces normally
generated in forced flexion of a joint are avoided, being replaced
with the beneficial effects of limited and controlled
compression.
[0156] Referring to FIG. 29, the drive assembly 230 can be
adjustable mounted to the first extension member 228. The first
extension member 228 includes a longitudinal slotted section 282. A
threaded member 284 is positioned through the longitudinal slotted
section 282, where the threaded member 284 is threaded into a
threaded hole 286 in the drive assembly 230. The position of the
drive assembly 230 is secured on the first extension member 228 by
tightening the threaded member 284, compressing the first extension
member 228 between the threaded member 284 and the drive assembly
230. The position of the drive assembly 230 can be adjusted by
loosening the threaded member 284 and sliding the drive assembly
230 along the longitudinal slot 282. In this manner the position of
the drive assembly 230 can be adjusted to align the axis of
rotation 226 with the joint axis.
[0157] The drive assembly 220 can further include an indented
portion 288. The indented portion 288 in sized to receive the first
extension member 228 therein, such that the first extension member
228 slides through the indented portion 288 as the drive assembly
230 is moved along the first extension member 230. The indented
portion 288 is configured to align the drive assembly 230 with
respect to the first extension member 228. The indented portion 288
provides the further benefit of resisting a rotation of the drive
assembly 230 with respect to the first extension member 228 when
the orthosis 220 is in use.
[0158] Referring to FIG. 30, the drive assembly 230 can include a
pair of indented portions 288 and 290, positioned on opposite sides
on the drive assembly 230. As shown in FIG. 29, the first indented
section 288 can be used to position the drive assembly 230 in an
outer position on the orthosis 220, where the drive assembly 230 is
positioned on an outside surface 292 of the first extension member
228.
[0159] Alternatively, as shown in FIG. 31, the second indented
section 290 can be used to position the drive assembly 230 in an
inner position on the orthosis 220, where the drive assembly 230 is
positioned on an inner surface 294 of the first extension member
228. The threaded member 284 is positioned through the longitudinal
slotted section 282, where the threaded member 284 is threaded into
a second threaded hole 296 in the drive assembly 230.
[0160] In an embodiment, the first member 221 can be adjustable
mounted to the first cuff 222, such that the position of the second
cuff 224 can be adjusted to align the second cuff 224 with a toe of
interest and the joint axis of the toe. In instances where the
joint of a toe is misaligned, for example for toe deformations such
as hammer toe, bunion, etc., the linear and angular position of the
second cuff 224 can be adjusted with respect to the first cuff 222
aligning the second cuff 224 with the misaligned toe such that the
axis of rotation 226 of the orthosis 220 is aligned with the axis
of rotation of the toe joint. In the manner, the orthosis 220 can
be adjusted to prevent the unwanted application of torsional forces
to the toe joint.
[0161] Referring to FIG. 32, the first member 221 is adjustably
attached to a bottom surface of the first cuff 222. The first
member 221 can included a longitudinal slot. 300, through which a
pair of threaded members 302 and 304 are positioned, attaching the
first member 221 to the first cuff 222. The first member 221 can be
moved along the longitudinal slot 300 to laterally adjust the
position of the first member 221 with respect to the first cuff
222. The first member 221 is secured in position by tightening the
threaded member 302 and 304, compressing the first member 221
between the threaded members 302 and 304 and the bottom surface 298
of the first cuff 222.
[0162] The first member 221 can further include a second
longitudinal slot 306, parallel and offset from the first
longitudinal slot 300. The first member 221 can be attached to the
first cuff 222, using the second longitudinal slot 306 to
longitudinally adjust the position of the first member 221 with
respect to the first cuff 222. Similarly, the first member 221 can
be moved along the second longitudinal slot 306 to laterally adjust
the position of the first member 221 with respect to the first cuff
222.
[0163] It is also contemplated that the angular position of the
first member 221 can be adjusted with respect to the first cuff
222. In an embodiment, as shown in FIG. 33, the bottom surface 298
of the first cuff 222 includes a center threaded hole 308 and an
arcuate slot 310. An internally threaded fastener 312 is slidingly
positioned in the arcuate slot 310, opposite the bottom surface
298. The first member 221 is attached to the first cuff 222 by
positioning the threaded members 302 and 304 through a longitudinal
slot 300 or 306 of the first member 221 and engaging the threaded
hole 308 and the internally threaded fastener 312 in the arcuate
slot 310. The angular position of the first member 221 can be
adjusted with respect to the first cuff 222 by pivoting the first
member 221 about threaded member 302 in the center threaded hole
308, such that the internally threaded fastener 312 and the second
threaded member 302 travel along the arcuate slot 310. The first
member 221 is secured in position by tightening the threaded
members 302 and 304, compressing the first member 221 between the
threaded members 302 and the bottom surface 298 of the first cuff
222, and compressing the first member 221 and first cuff 222
between threaded member 304 and internally threaded fastener
312.
[0164] The bottom surface 298 of the first cuff 222 can further
include a second arcuate slot 314, where an internally threaded
fastener 316 is slidingly positioned in the second arcuate slot
314, opposite the bottom surface 298 of the first cuff 222. Similar
to arcuate slot 310, second arcuate slot 314 can be used to
angularly adjust the position of the first member 221 with respect
to the first cuff 222.
[0165] Specifically, the first member 221 is attached to the first
cuff 222 by positioning the threaded members 302 and 304 through a
longitudinal slot 300 or 306 of the first member 221 and engaging
the threaded hole 308 and the internally threaded fastener 316 in
arcuate slot 314. The angular position of the first member 221 can
be adjusted with respect to the first cuff 222 by pivoting the
first member 221 about threaded member 302 in the center threaded
hole 308, such that the internally threaded fastener 316 and the
second threaded member 304 travel along the arcuate slot 314. The
first member 221 is secured in position by tightening the threaded
member 302 and 304, compressing the first member 221 between the
threaded members 302 and the bottom surface 298 of the first cuff
222, and compressing the first member 221 and first cuff 222
between the threaded member 304 and internally threaded fastener
316.
[0166] It is also contemplated that the first member 221 can be
attached to the first cuff 221 using the arcuate slots 310 and 314
and the respected internally threaded members 312 and 316.
Specifically, the first member 221 is attached to the first cuff
222 by positioning the threaded members 302 and 304 through a
longitudinal slot 300 or 306 of the first member 221 and engaging
the internally threaded fastener 312 in the arcuate slot 310 and
the internally threaded fastener 316 in arcuate slot 314. The
angular position of the first member 221 can be adjusted with
respect to the first cuff 222 by pivoting the first member 221 such
that the internally threaded fasteners 312 and 316 travel along the
arcuate slots 310 and 314. The first member 221 is secured in
position by tightening the threaded member 302 and 304, the first
member 221 and first cuff 222 between the treaded members 302 and
304 and internally threaded fastener 312 and 316.
[0167] While the embodiment discussed above utilize a second
extension member having an arcuate shape to control movement of the
second member relative to the first, it should be understood that
skilled artisans having the benefit of this disclosure will
appreciate that other configurations may likewise provide similar
relative movement.
[0168] FIG. 34, for example, schematically illustrates an
embodiment of an orthosis 330 of the invention having a first
member 332 and a second member 334, both of which preferably having
sufficient structure or component parts to hold body members near
the treated joint or joints. In the embodiment illustrated in FIG.
34 the second member has a first pivoting contact point 336 about
which the geared body member may rotate. In this embodiment, the
first pivoting contact 336 does not move in relation to the first
body member 330, but as indicated in FIG. 32 one alternative
embodiment may allow relative movement that can be resisted by a
flexible device 338 such as a spring, compressed gas, foamed
material, elastomer or the like.
[0169] Returning once again to FIG. 34, the second member may have
an additional pivot contact 340, preferably disposed at a location
at or near the opposite end of the second member 334 from where the
first pivoting contact 336 is located. The second pivoting contact
340 may be configured with a drive assembly 344 that causes the
second member 334 to follow a predetermined path. Thus, the second
pivoting contact 340 in the embodiment of FIG. 34 is configured to
move relative to the first member 332 in order to cause the joint
to move from a first position to second one.
[0170] The drive assembly 344 illustrated in FIG. 34 is an arm or
linkage 346 connected between the second pivot connection 340 and a
rotating wheel 348. The wheel 348 may be configured so that the
linkage 346 can be selectively connected to it in different radial
distances from the center of rotation of the wheel. This allows the
range of motion to be adjustable by the care provider, physician,
or patient. As the wheel 348 is rotated, the linkage 346 moves in a
manner that causes the second member 334 to move in a particular
way.
[0171] The second member 334 (or alternatively the first member
332) may also have a sliding contact surface 342. The sliding
contact surface 342 allows the joint to rotate or move according to
its natural instantaneous axis of rotation. Thus, if the second
pivot contact 340 moves in a manner that does not always exactly
correspond to the axis of rotation of the joint, the sliding
contact surface 342 may move or adjust accordingly. Another
potential advantage of the sliding contact surface 342 is that it
may help facilitate proper alignment of the joint in the orthosis
during initial setup.
[0172] FIG. 34 illustrates some variations that may also be used in
orthosis of the invention. For instance, the first and or second
pivot contact may be configured with a cushion or spring 338 that
allows one or both ends of the second member to impart some
flexibility in the force imparted to the joint. As noted above, the
cushion or spring 338 may be made of a variety of suitable
materials and constructions to permit some flexibility in the
movement of the pivot points 336, 340.
[0173] The use of a spring or cushion allows the orthosis 330 to be
used in different treatment protocols than just by holding the
joint in a prescribed location for a period of time. Instead, the
orthosis can utilize the principles of static progressive stretch
as described in copending application Ser. No. 11/203,516, entitled
"Range of Motion System and Method", and filed on Aug. 12, 2005,
the entirety of which is incorporated by reference.
[0174] Thus, an orthosis 330 configured with a spring or cushion
338 can be moved from an initial position to a second position that
is determined not by position of the joint but instead by the
amount of force the orthosis 330 imparts on the joint. The joint
may then be subjected to this loading, and over time as the
surrounding tissue stretches the joint will move and the imparted
forces will be reduced. It should be noted that while FIG. 35
illustrates the cushion or spring 338 associated with the first
pivot contact 336, it is not required to be associated with it.
Instead, for example, the cushion or spring 338 may be associated
with the second pivot 340 so that it can flex or move in response
to resistive forces of the joint and nearby tissue. Likewise, there
may be a spring or cushion 338 associated with both pivot contacts
336, 340.
[0175] Another notable variation between the embodiments of FIGS.
34 and 35 is that the rotating wheel 348 in FIG. 34 has multiple
single point connections for connecting the linkage 346 at
different distances from the center of rotation of the wheel. In
contrast, the embodiment of FIG. 35 illustrates that an elongated
slot 350 may be used to connect the linkage 346. The advantage of
utilizing multiple single point connections may be ease of use and
the ability to quickly confirm the orthosis 330 is properly
configured for a prescribed treatment protocol, whereas one
potential advantage of utilizing an elongated slot 350 is the
ability to quickly adjust the settings without disassembling the
device.
[0176] FIG. 36 illustrates an embodiment of the invention where the
rotating wheel 348 is a cam surface 352. This embodiment is similar
to the use of cams and followers as described in U.S. Pat. No.
5,514,143, which is incorporated herein in its entirety. As shown,
the cam surface 352 may have varying distance from the center or
rotation of the wheel 348. If the wheel 358 is circular, for
example, the center of rotation may be located somewhere different
from the geometric center of the circle or at the center or
rotation of the shape. As it rotates, the circumferential outer
surface causes the linkage 346 to move to the second member 340 in
a desired manner. Additionally, the outer edge of the "wheel" 348
need not be round, but instead may be a cam surface 352 of varying
distance from the center or rotation. Likewise, the outer surface
may have varying radii of curvature as shown in FIG. 36.
[0177] The embodiments of FIGS. 37 and 38 further illustrate that a
cam surface 352 may be used to move the second member 332 in a
desired, perhaps complex way. As is the case for other embodiments
described herein, performance of the cam surface 352 may be
enhanced because of the ability to better mimic or replicate a
moving axis of rotation of the treated tissue and joint.
[0178] In FIG. 37, the cam surface 352 is associated with the first
member 332. Linkages or arms 346 of the second member 334 have cam
followers 354 that trace the cam surface 352 and cause the second
member 334 to move in a more complex manner than just by rotation
around a fixed axis.
[0179] The cam surface 352 of FIG. 37 also is associated with a
slot 356 that allows the relative location of the first and second
members 332 and 334 to be adjusted or moved without decoupling the
cam followers 354 from the cam surface 352. As shown, the slot 356
allows for horizontal adjustment repositioning. Although not shown,
vertical slots may also be provided, either alone or in combination
with a horizontal slot.
[0180] FIG. 38 illustrates an example where the linkage 346 is a
cam surface 352 that passes through two or more points 358, 360
that are stationary or fixed relative to the first member 332 when
the orthosis 330 is in use (i.e. after alignment is completed).
Once again, this embodiment may be configured to permit horizontal
adjustment, such as by providing slot 368, and likewise may be
configured to be vertically adjustable. In addition, this
embodiment also illustrates that the first and second members 332
and 334 may be represented by rotation about a pivot 370. Thus, the
use of horizontal, vertical, and rotational adjustment of the
relative positions of the first and second members 332 and 334 may
allow greater fitting of the orthosis 330 to the treated tissue and
joint.
[0181] FIG. 39 is an exploded view of how the cam surface 352 and
cam followers 354 may utilize a geared surface 372. Utilizing a
geared surface 372 may allow for a drive assembly 344 to automate
the movement of the orthosis 330.
[0182] FIGS. 40 and 41 schematically illustrate other ways in which
potentially complex movement of the second member 334 may be
controlled. FIG. 40 illustrates that the cam surface may not be
directly formed from a component part of either the first or second
members, but instead maybe associated with some other structure.
For instance, the orthosis 330 may be operatively connected to a
base unit 374 having a plurality of cam surfaces 376 corresponding
to different ranges of motion for related joints, such as when the
orthosis 330 can be used to treat a plurality of different toes or
a patient. Once the orthosis 181 is placed on the patient, the
second member 334 will be positioned to securely hold one of the
toes on the patient's foot and to engage with the cam surface 376
corresponding to that toe.
[0183] FIG. 41 shows that multiple cam surfaces or slots 378 may be
formed in a side panel 380. The side panel 380 may have a sliding
engagement of the second member 334. As the second member 334
moves, the engagement with the side panel 380 controls position and
movement. Moreover, one or more sides or edges of a slot 316 of the
embodiment of FIG. 41 may be geared to allow implementation of a
drive assembly 344.
[0184] FIG. 42 illustrates an embodiment where movement of at least
part of a linkage 346 may be linear, but when combined with a
rotational pivot 382, sliding slot 384, and possibly other
components or combinations described herein, the net effect on the
second member 334 is once again a controlled movement in a desired
manner.
[0185] The components of the present invention are rigid members
made of, for example, aluminum, stainless steel, polymeric, or
composite materials. The member and extensions are sufficiently
rigid to transmit the necessary forces. It should be understood
that any material of sufficient rigidity might be used. For
example, some components can be made by injection molding.
Generally, for injection molding, tool and die metal molds of the
components are prepared. Hot, melted plastic material is injected
into the molds. The plastic is allowed to cool, forming components.
The components are removed from the molds and assembled.
[0186] Furthermore, it is contemplated that the components can be
made of polymeric or composite materials such that the device can
be disposable. For example, at least some or all of the components
can be made of a biodegradable material such as a biodegradable
polymer. Among the important properties of these polymers are their
tendency to depolymerize relatively easily and their ability to
form environmentally benign byproducts when degraded or
depolymerized. One such biodegradable material is poly
(hydroxyacids) ("PHA's") such as polyactic acid ("PLA") and
polyglycolic acid ("PGA").
[0187] Additionally, the device can be made of a nonmagnetic
material. In such instance, the device can be used as a positioning
device for use in imaging devices, such as a MM device. It is also
contemplated that the device can be used as a positioning device
for use during surgical procedures, where it may be necessary to
adjust and hold the position of the joint.
[0188] In a method of manufacture, the cuffs can include a base
plate having a plurality a strap attached thereto, where the straps
are position about a body portion of a patient. The straps are
attached to the base plate using fastener elements, such as screws
threaded into the base plate. The screws can be removable to allow
for easy removal and/or replacement of the straps.
[0189] Alternatively, in an embodiment where the base plate is made
of a polymeric material, the straps can be welded to the base plate
using an energy welding technique such as, RF welding, ultra-sonic
welding, high frequency welding, etc. For example, in ultra-sonic
welding an acoustic tool in used to transfer vibrational energy
into the weld areas of the straps and the base plate. The friction
of the vibrating molecules generates heat, which melts the surface
material of the base plate in the welding area, at which point the
vibrational energy is stopped. Pressure is applied to the strap and
the base plate, allowing the melted material to solidify within the
material of the strap. In this method the strap is secured to the
base plate without the need of fasteners.
[0190] Similarly, where the cuffs are made of a polymeric material,
the cuff can be welded to the orthosis using energy welding
techniques. For example, the cuffs can be made of a substantially
rigid, flexible, or fabric polymeric material which can be welded
directly onto the arm members of the orthosis. It is also
contemplated that the straps can be an integral part of the cuffs.
For example, where the cuffs are made of a polymeric fabric, the
straps can be integrally formed in the fabric pattern when making
the cuffs.
[0191] All references cited herein are expressly incorporated by
reference in their entirety.
[0192] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described herein above. For example, although the
examples presented identify the toe joint, the present invention
can be used for any joint in the body of the patient. In addition,
unless mention was made above to the contrary, it should be noted
that not all of the accompanying drawings are to scale. A variety
of modifications and variations are possible in light of the above
teachings without departing from the scope and spirit of the
invention, which is limited only by the following claims.
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