CA2646887A1

CA2646887A1 - Elbow orthosis

Info

Publication number: CA2646887A1
Application number: CA002646887A
Authority: CA
Inventors: Boris P. Bonutti; Peter M. Bonutti; Kevin R. Ruholl; Glen A. Phillips
Original assignee: Individual
Current assignee: Bonutti Research Inc
Priority date: 2006-03-20
Filing date: 2007-03-20
Publication date: 2007-09-27
Also published as: WO2007109638A3; EP1998725A4; EP1998725A2; WO2007109638A2

Abstract

An orthosis for stretching tissue around a joint of a patient between first and second relatively pivotable body portions. The orthosis includes a first arm member affixable to the first body portion and including a first extension member extending therefrom. A second arm member affixable to the second body portion is also included and has a second extension member having an arcuate shape extending therefrom. A third arm member including a third extension member having an arcuate shape extending therefrom is interposed between the first and second arm members. The third arm member is operativcly connected to the first and second arm members, such that the first and third arm members travel along an arcuate path defined by the second extension member when the third arm member is moved from a first position to a second position relative to the second arm member. Furthermore, the first arm member can slide along the third extension member as the third ami member is moved from the first position to the second position relative to the second arm member.

Description

ELBOW ORTHOSIS

Field of the lnvention The present invention relates to an adjustable oa#hosis for stretching tissue in the hunian body. In particular, the present invention relates to an adjustable orthosis which can be used for stretching tissue such as ligarnents, tendons or muscles around a joint during flexion or extension of the joint.

Background of the Invention In a join.t, the rarige of motion depends upon the anatomy of that joint and on the particular genetics of each individual. Typically, joints move in two directions, tlexion 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.

When a joint is injured either by trauma or by surgery, sear 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.

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 joi.nt.
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. Patent Nos.: 6,599,263, entitled "Shoulder Orthosis;" 6,113,562, entitled "Shoulder Orthosis;"
5,848,979, entitled "Orthosis;" 5,685,830, entitled "Adjustable Orthosis Having One-Piece Connector Section for Flexing;" 5, 611, 764, entitled "Method of Increasing Range of Motion;" 5,503,619, entitled "Orthosis for Bending Wrists;" 5,456,268, entitled "Adjustable Orthosis;" 5,453,075, entitled "Orthosis with Distraction through Range of Motion;"

5,395,303, entitled "Orthosis with Distraction through Range of Motion;"
5,365,947, entitled "Adjustable Orthosis;" 5,285,773, entitled "Orthosis with Distraction througb Range of Motion;" 5,213,095, entitled "Orthosis with Joint Distraction;" and 5,167,612, entitled "Adjustable Orthosis," all to Bonutti and herein are expressly incorporated by rcference in their entirety.

Summary of the Invention 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 define on one side of the joint an inner sector which decreases in angle as the joi.nt is flexed and define on the opposite side of the joint an outer sector whicll decreases in angle as the joint is extended.

The orthosis includes a first arnl member affixable to the first body portion.
The first arm member has a first extension member extending 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. A th.ird arm member including a third extension member, having an arcuate shape extending therefrom, is interposed between the first and second arm members. The second and third arm members are operatively connected, such that the third. arm member travels along an arcuate path defined by the second extension member when the tlii.rd arm 1alember is moved from a first position to a second position relative to the second arm member. The first arm member is slidingly connected to the third extension menlber, such that the first arni member slides along an arcuate path defined by the third extension member when the third arm member is moved from the first position to the second position relative to the second arin member.

The orthosis further includes a drive assembly for selectively moving the third ai-m member relative to the second. extension member, The drive assetnbly is mounted onto the third ar.111 member, engagitig the second extension member. The drive assembly can be manually or automatically actuated to selectively move the third arm member relative to the second extension member.

Brief Description of the Drawings A more complete understanding of thc present invention, and the attendailt advantages and features thereof, will be more readily understood by reference to the followialg detailed description when considered in conjunction with the accompanying drawings wherein:
FIG. 1 is a schematic diagrani of the orthosis of the present invention in a flexed position;
FIG. 2 is a schematic diagram of the ortliosis of the present invention in an extended position;
FIG. 3 is a second schematic diagram of the orthosis of the present invention in a tlexed position;

FIG. 4 shows an adjustable first extension member of the orthosis of the present invention;
FIG. 5 shows the adjustable first extension member of FIG. 4 in a second position;

FIG. 6 shows a segmented first extension meniber of the prese7At invention;
FIG. 7 shows an arcuate first extension member of the present invention;
FIG. 8 shows an orthosis of the present invention;

FIG. 9 shows a non-circular arcuate shaped second extension member of the present invention;
FIG. 10 shows an alternative arcuate shaped second extension member of the present invention;

FIG. 11 shows a linear shaped second extension member of the present invention;
FIG. 12 shows an exemplary drive assembly of the present invention;

FIG. 13. depicts a f`irst side view of another orthosis of the present invention fox flexing and extending a joint in a patient;

FIG. 14 depicts an opposite side view of the ortllosis of FIG. 13;

FIG. 15 depicts a first arm member of tlie orthosis of FIG. 13;
FIG. 16 depicts a second alm member of the orthosis of FIG. 13;
FIG. 17 depicts a third arm na.ember of the orthosis of FIG. 13;
FIG. 18 depicts the drive assembly of the orthosis of FIG. 13;

FIG. 19 depicts the connectivity of the first, second, and third arm members of the orthosis of FIG. 13;

FIG. 20 depicts the orthosis of FIG. 13 in a nliddle flexed position; and FIG. 21 depicts the orthosis of FIG. 13 in a fully flexed position.
Detail Description of the Invention 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 joiiat an inner sector which decreases in angle as the joint is flexed (bent) and on the oppositc 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 treatnlent of flexion or extension contractures.

Iteferring now to the drawing figures in which like reference designators refer to like eleinents, tlrere is shown in FIG. 1, a sclaematic 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 17irst 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.

The first arm member 12 of the orthosis 10 includes a first extension member 18, which extends at angle a from the first arm member 12. The second arm member 14 of the orthosis includes a second extension member 20 extending therefroni and having an arcuate shape.

5 The first and second extension nlembers 18 and 20 are operatively connected at point "P,"
such that in operation the second extension member 20 travels along an arcuate patli 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 ann member 14 is moved from a first position to a second position relative to the first arnl 10 member 12. 'Ihe angle a between the Firsi extension member 18 and the first arm member 12 and the radiu.s of curvature of the second extension nieniber 20 are a functioYt of the joint to be treated and the degree of flexion or extension contractures.

The orthosis further includes a drive assembly 22 at point "P." The drive assembly connects the first and second extension members 18 and 20 far applying force to the first and second ann members 12 and 14 to pivot the first and second body portions relative to each other about the joint.

The orthosis 1.0 of the present invention is shown having an angle a 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 ann member 12. This position of point "P"
provides an angle 01 between the second arm member 14 and the joint axis 16, wherein /3l is the maximum aiagle of flexion. As sla.own in FIG. 2, the second extension member includes a stop 24. The stop 24 acts to limit the angle of maximum extension ybetween 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 -y. A decrease in the length of the stop 24 will increase the angle of maxin.aum extension y.

Referring to FIG. 3, the maximtlm flexion angle can be increased by increasing the angle a.
An increase i n. the angle a will move the point "P" to a location "in front of ' the plane "A."
This position of point "P" provides an angle /32 between the second arm member 14 and the joint axis 16 in maximum flexion, wherein /32 is greater than ~r. The greater the angle rx, the greater the angle of maximum flexion.

Alternatively, (not shown) a decrease in the angle a will move the point "P"
to a location "behind" the plane "A." This position of point "P" provides an angle 03 between the second arni lneinher 14 and the joint axis 16 in maximum flexion, wherein 03 is less than (3i. The smaller the angle cY, the smaller the angle /3 of maximum flexion.

Referring to FIG. 4, the first extension inena.ber 18 is selectively, pivotally connected at location 26 to the first arnl niember 12. The pivotal connection 26 of the first extensioii member 18 permits the angle a between the first extension niember 18 and the first aim 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 ai, 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 (3i. The second extension member stop 24 acts to Iiinit the angle of maximum extension y, between the second arm ineinber 14 and the joint axis 16, Referring to FIG. 5, in a second position 30 the angle a is increased to an angle aZ, 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 /3Z, wherein 02 is greater than ~1. The second extension membcr stop 24 acts to limit the angle of maximum extension -yz between the second arm member 14 and the joint axis, wherein -yz is less the yi.

The selective pivotal connection 26 of the flrst extension member 18 to the first arm menaber 12 can have a plurality of selectable positions, 'The angle a 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 a between the first arin mernber 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 ~.

'I'he 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 decrcase in angle as the joint is flexed (bent) and an increase in angle and the joint is extcnded (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).
The previous description of the first arm member 12 depicts a first extension 18 having a substantially linear shape, extending at an angle a from the first arm member 12. However, it is within the scope of the present invention that the first extension meinber 18 can be any shape extending from the ftrst arm member 12 which positions the point "P" in the desired relationship to the plane "A." Referring to FIG. 6, a segmented fist extension member is shown, including a first extension member segment 18a and a second extensioxi member segment l 8b. The first and second extension member segments l 8a and 18b extend from the first arm member 1.2, positioning the point "P" at an angle a from the first arm member 12.
Referring to FIG. 7, an arcuate first extension nZember 18c is shown. 'I'he arcuate extension member 18c extends from the first arm member 12, positioning the point "P" at an angle a frotn the first arm member 12.

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 arid 14 are connected with each other offset from the joint axis 16, The first arm member 12 of the orthosis 10 includes a first extension member 18, which extends at angle a from the first arni naember 12. The second arm nieiilber 14 of the orthosis 10 includes a second extension ineniber 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 extensioxi 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 a 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 ftinction of the joint to be treated and the degree of flexion or extension contractures.

A. first cuff 32 is attached to the first ami 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 meinber 12. A second.
cuff 34 is attached to the second arm 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.) In an exemplaiy 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 arn1 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 arnl 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.
A.s 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. The orthosis 10 may alternatively be configured to impart a constan.t force or load on the joint or may utilize the techniques of Static Progressive Stretch as described in co-pendiiig application serial no. 11 /203,516, entitled "Range of Motion System and Method", and filed on August 12, 2005, the entirety of which is incorporated by reference.

Additionally, i11e second extension member 12 can be made of a substantially rigid but flexible material, such that while the second extension menlber 12 is in the second position, the second extension member 12 acts like a spring, providing dynamic stretch to the connective tissue of the joint.

After the expiration of the treatment time, the second arm menlber 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 posifiion for removal of the orthosis 10.

The first and second ann members 12 and 14 are rigid xnembers made of, for example, aluminum, stainless steel, polymeric, or composite materials. The arnls are rigid so as to be able to transmit the necessary forces. It should be understood that any material of sufCcient rigidity can be used.

In an. embodiment, the coniponents 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.
In use, the orthosis 10 caai 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).

In an embodiment, the orthosis 10 i cludes 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 arouzld the body portions to clanip the cuffs 32 and 34 to the body portions.
The first cuff 32 is mounted for sliding movement on the first arnl ia.a.ember 12 and is slidable along the first arm member 12 in a manner as described below. The second cuff 34 is moullted for sliding rnovement on a second arm nlember 14 and is slidable along the second arm member 12 in a manner as described below.

Bending a Joint in Extension:
In operatio7l of the orthosis 10 to extend the joint, the orthosis 10 starts at a more flexed position. The first and secoiid cuffs 32 and 34 are clamped onto the first and second body portions, respectively, by straps, tightly eaa.ough so that the cuffs 32 and 34 can apply torque to the body portions to extend the joint. The second arrn 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 niember 14 is rotated to the second position the second extension meniber 20 travels along an arcuate path about and substantially through point "P." The orthosis 1.0 is maintained in the second position for a predetertnilaed treatment tinle providing a constant stretch to the joint.

As the orthosis 10 is rotated from the first position to the second positioii, 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 arnl meniber 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 movemeait 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 arnl mena.bers 12 and 14, helps to limit these distractive forces by counteracting the outward movement of the first and second arm nlembers 12 and 14. The cuffs 32 and 34 slide inwardly along the first and second arni 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 witli the beneficial effects of limited and controlled distraction.
Bending a Joint in Plexioll:
In operation of the orthosis 10 to flex the joint, the orthosis 10 starts at a more extended position. The -rirst 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. 'I'he second arm 3nember 14 is rotated from the first position to a second position, relative to the first arm i3lember 12, rotating the second body portion about the joint axis 16 stretching the joint. As the second arin inember 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.

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 Cirst and second arm members 12 and 14.
I'he first cuff 32 moves outwardly along the irst arm member 12. Similarly, the second cuff 34 moves outwardly along the second arm member 14. Because the cuffs 32 and 34 arc clamped onto the first and second body portions the inward pivoting movement of the first and second arm menibers 12 and 14 and the cuffs 32 and 34 causes the joint to be flexed as desired. I-Iowever, 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 dnring flexion. Thus, the detrimental effects of strong compressive forces nonnally generated in forced :f7exion of a joint are avoided, being replaced with the beneficial effects of liniited and contxolled compression.
Referring to FIG. 9, the second artn membei- 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 ann member 14 is moved froni 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.
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. 10, it is contemplated that the second extension member 20 or 44 can have a convex radius of curvature relative to the joint 1.6. Similar to the concave radius of curvature, the convex arcuate shape o C the second cxtension member 20 or 44 results in the second body portion rotating about the joint axis 16, when the second arna.
member 14 is moved from a first position to a second position relative to the first arm member 12, Referring to FIG. 11, the second arm member 14 of the orthosis 10 includes a second extension member 46 extending therefrom and having a linear shape. The first and second extension members 18 and 46 are operatively connected at point "P," such that in operation the second extension member 46 travels along a linear path through point "P."
The linear shape of the second extension member 46 results in the second body portion being translated with respect to the first body portion. The translational movemen.t of the second arm member 14 results in a distraction or coinpression 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.
A.s discussed further below, the hand pad can be mounted for translational and rotational movement on the base nleznber, Drive Assembly:
Referring to FIG. 12, the drive assembly 22 of the orthosis includes a gear system. As previously noted, the compoxients of the orthosis, including the drive assembly 22, can be made by injection moldirag a polymer. The drive assenably 22 is supported in the first extension member 18, including a gear 50 rotatable about point "P." A shaft 52, attached to tlae 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 tect1156 along an inner surface 58. The second extension member 20 is threaded tllrougli 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, pusliing or pulling the second extension member 20 through the first extension menlber 18. The drive assembly 22 includes a locking or breaking mechanism which prevents the gear 50 from rotating absent any applied force rotation of the knob 56. Such a lock or breaking mechanism can include a compression washer or other known gear locking or breaking mechanisms.
The drive assembly 22 is described as utilizing a gear system. fIowever, it is contemplated that other known drive systems can be used to move the second extension member through the first extension member 18, for example a friction type drive system. Regardless of the drive systenl 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 degrce 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 a3ot engage teeth 56.

ln an alternative embodiment, the drive assembly 22 of orthosis 10 in.
accordance with the present invention can be actuated by a motor instead of by a manually actuatable member.
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).

In an embodiment, an electric motor is m.oimted to the shaft 52 for rotation of the gear 50. A
battery provides electric power to the motor, Alteniatively, 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 menlbers 12 and 14 in orie 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.

It should be iinderstood that the particttlar physical arrangement of the na.otor, 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 aii electric nlotor, can also be used. For exaniple, the rise of a hydraulic or pneutnatic motor as the drive mechanism is eontemplated.

Referring to FIGS.13 and 14, an orthosis 80 of the present invention includes a first arm member 82 attachable to the first body portion and a second arxn znember 84 attachable to the second body portion, wherein the joint axis 86 is interposed between and offset from the first and second arm nlenibers 82 and 84. A third arni nlember 88 is interposed between the first and second arnl members 82 and 84, where the first and second arm members 82 and 84 are connected to the third arm member 88, offset from the joint axis 86.

The first arm nlember 82 of the orthosis 80 includes a first extension member 90, which extends fronl the first arni r-nember 82. The second arm member 84 of the orthosis 80 includes a second extension member 92 having an arcuate shape. The first and second extension members 90 and 92 are operatively connected to the third arm member 88, where the second extension niember 92 is operably connected to the third arm member 88 at a point "P," such that in operation the third member 88 travels along an arcuate path of the second extension rnenlber 92. The arcuate shape of the second extension nlena.ber 92 results in the first body portion ratating about the joint axis 86, when the first and third arm members 82 and 88 are moved from a first position to a second position relative to the second arm member 84. The radius of curvature of the second extension member 92 is a function of the joint to be treated and the degree of flexion or extension contractures.
A first cuff 94 is attached to the first arm na.ena.ber 82, whcrein the first cuff 94 is positionablc about the first body portion. The first cuff 94 is attached to the first body portion by cuff straps. The first cuff 94 secures the first body portion to the first arm member 82. A second cuff 96 is attached to the second arm member 84, wherein the second cuff 96 is positionable about the second body portion. The secotad cuff 96 is attached to the second body portion by a cuff strap(s) 98. The second cuff 96 secures the second body portion to the second arm member 84. The cuffs 94 and 96 can be provided in a variety of sizes or have adjustable sizes to fit about the body portions. (The term "cuff' as used herein means any suitable structure for transmitting the force of the orthosis 80 to the limb portion it engages.).
The first cuff 94 can be slidingly connected to the first arm member 82.
Referring to FIG. 15, a sliding bar 100 is affixed to the f=irst cuff 94, where the sliding bar 100 includes channels 102 positioned on opposite sides of the sliding bar 110. The first ari-n member 82 includes a main channe] 106 configured to slidingly receive the sliding bar 1.00. Pins 108 are positioned though opposite sides of the main channel 106 of the first ann member 82 and into the channels 102 to slidingly secured the sliding bar 100 in the main channel 106.
An adjustable member 110 can be threaded though the first arm member 82, into a channel 102 to adjustably secure the position of the sliding bar 102 in the main channel 106.
As suela, the position of the first cuff 94 can be adjusted with respected the first arni metnber 82, the position being secured with the adjustable meinber 110. Alternatively, the first cuff 94 can be free to slide with respect to the first ann menlber 82, thereby allowing the position of the first cuff 94 to self adjust during operation of the orthosis 80.

Similar to the first cuff 92, the second cuff 96 can be slidingly connected to the second arm member 84.

Referring to FIG. 16, the second extension member 92 has an arcuate shape, where the radius of curvature of the second extension menlber 92 is a function of the joint to be treated aild the degree of flexion or extension contractures. The second extension member 92 includes an iiiner surface 112 have a plurality of teeth 114 thereon. The second extension melnber 92 can include channels 115 disposed on opposite sides thereof.

Referring to FIG. 17, the third arm member 88 includes a third extension melnber 116 has an arcuate shape, where the radius of curvature of the third extension member 116 is a function of the joint to be treated and the degree of flexion or extension contractures. The third extension meinber 116 includes channels 118 disposed on opposite sides thereof. A drive housilig 120 is positioned proximal to a guide channel 122.

Referring also to FIGS. 18 and 19, a drive assembly 124 is positioned in the drive housing 120 of the third art-n member 88. The drive assembly 124 includes a drive gear 126 and a main gear 128, where the teeth of the drive gear 126 engage the teeth 130 of the main gear 128. A drive shaft 132 is connected to the drive gear 126, extending through the cover plate 134. A knob 133 can be affixed to the drive shaft 132 to facilitate rotation thereof. A
rotation of the drive shaft 132 rotates the drive gear 126, which in turn rotates the main gear 128. The main gear 128 is sized such that a portion of the gear teeth 130 protrudes into the guide chan.nel 122 of the third arm member 88, The second extension member 92 is positioned in the guide channel 122, such that the gear teeth 132 of the main gear 128 engage the teeth 114 on the inner surface 112 of the second extension member 92. A rotation of the dive shaft 132 rotates the drive gear 126, which in turn rotates the main gear 128, driving the second extension member 92 through the guide channel 122. The cover plate 134 is positioned over the guide channel 122, securing the second extension member 92 in the guide channel 122 aiid deFining a passage through which it travels.

Guide pins 135 can be positioned in the channels 115 of the secorad extension member 92, engaging on one side the third arm member 88 and on an opposite side the cover plate 134.
The guide pins 135 can be used to secure the second extension member 92 in the passage and control the tackirig of the third arm member 88 along the second extension member 92, The drive mechanism 22 can further include a locking mechanism. The locking mechanism can be used to secure the position of the second arm member 84 with respect to the third arm member 88. The locking meehansm can prevent the actuation of the drive assembly 124, securing the position of second and third ann members 84 and 88.
Alternatively, the locking mechanism can secure the second and third arm members 84 and 88, preventing an actuation of the drive mechanisnl 124 from moving the second and third arm melnbers 84 and 88. The locking mechanism can be utilized such that the orthosis 80 can be vi.sed as a static splint.
The first arin member 82 can be sliding affixed to the third arm menxber 88, `flie first extension member 90 is positioned about the third extension member 88, where an end portion 136 of the first extension meanber 90 is slidingly connected about the third extension member 118. Pins 140 are positioned through pin holes 142, provided on opposite sides of the end portion 136 of the lirst extension member 90, into the channels 118 of the third extension member 88, thereby allowing the end portion 136 of the first extension member 90 to slide along the arcuate path defined by the chaimels 118, rotating the first arm member 82 about the joint axis 86. The first arni member 82 can slide freely with respect to the third extension member 116. Alternatively, a push pin 144 can be positioned through the end portion 136 of the first extension member 92 into push pin hole 146 in the channels 118 of the third extension member 116. (See also FIG. 14). The push pin 144 prevents relative movement of the first arm member 82 with respect to the third arm member 88.

In an exe7nplary use, the orthosis 80 is operated to extend a joint in the following manner.
The first cuff 94 is fastened about the first body portion tightly enough that the first arm member 82 may apply torque to the first body portion without having the first cuff 94 slide along the first body portion. Similarly, the second cuff 96 is fastened securely around the second body portion so that the second arm member 84 may apply torque to the secoxid body poi-tion without the second cuff 96 sliding along the second body portion. The orthosis 80 is attached to the first and second body portions in a first position. The first and second arm members 82 and 84 are rotated from the first position to a second position, relative to the second arm member 84, rotating the first body portion about the joint axis 86 stretching the joint. As the first and second arm members 82 and 84 are rotated to the second position, the tllird arm member 88 travels along an arcuate path along the second extension member 92.
The orthosis 80 is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint. Additionally, the second extension member 92 can be made of a substantially rigid but flexible material, such that while the first arrni member 82 is in the second position the second extension member 92 acts like a spring, providing dynamic stretch to the connective tissue of the joint.

After the expiration of the treatment time, the first arm member 82 is moved back to the f-irst position, relieving the joint. Optionally, the first arm member 82 can be rotated to a third position, increasing the stxetch on the j oint. The first arm member 82 can be rotated at discrete time intenrals to incrementally increase the stretch of the joint through the treatment cycle. After completion of the treatment cycle, the first ann member 82 is returned to the first position for removal of the orthosis 80.

In another exemplary use, the push pin 144 is removed from the first and third arm menibers 82 and 88, such that as the first and third arni menlbers 82 and 88 are moved from a first position to a second position, witb respected to the second ann member 84, the first arm naetnber 82 can slide along the arcuate path of the third extension 116 of the third arm memÃber 88. This can be utilized to increase the range on motion of the orthosis 80. It is contemplated that the orthosis 80 can have a range of motion from around 15 degrees to around 145 degrees.

The first, second, and third arm members 82, 84, and 88 are rigid members made of, for example, aluminum, stainless steel, polymeric, or composite materials. The arms are rigid so as to be able to transnlit the necessary forces. It should be understood that any material of sufficient rigidity can be used.

In an embodiment, the components o' the orthosis 80 of the present invention are made by injection molding. Generally for injection molding, tool and die metal molds of the orthosis 80 cornponents are prepared. Hot, melted plastic niateria] 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 92 or 96 can be individual molded and attached. to the ann members 82 or 84. Alternatively, the cuff portions can be molded as an integrated part of the arm menlbers 82 or 84.

Similarly, the gears 132 and 134 are rigid members made of, for example, aluininum, stainless steel, polymeric, or composite materials. The gears 132 and 134 are rigid so as to be able to transmit the necessary forces.
Bending an Elbow ,loint Flexion:
In operation of the orthosis 80 to flex an elbow joint, the orthosis 80 stail:s at a more extended position. The first and second cuffs 94 and 96 are clanlped onto the foreann and bicep portions of the arm, respectively, by straps, tightly enough so that the cuffs 94 and 96 can apply torque to the body portions to flex the joint. The fixst and second arnl members 82 and 84 are rotated from the first position to a second position, relative to the second arin member 84, rotating the forearm about the elbowjoint axis 86 stretching the joint. As the first and second arm members 82 and 84 are rotated to the second position the third arm member 88 travels along the arcuate patli of the second extension member 92. The orthosis 80 is maintained in the second position for a predetermined treatment t7ime providing a constant stretch to the joint.

After the expiration of the treatment time, the first and second arrr- members 82 and 884are tiioved. back to the first position, relieving the joint. Optionally, the first and second arm members 82 and 84 can be rotated to a third position, increasing the stretch on. the joint, The first and second arnl members 82 and 84 can be rotated at discrete time intervals to incrementally increase the stretch of the joint through the treatment cycle.
Referring to FIG.
20, the treatment cycle can continue until the third arm member 88 traverses the second extension member 82. ACter completion of the treatment cycle, the first arld second arm members 82 and 84 are returned to the first position for removal of the orthosis 80.
Alternatively, the first arm member 82 can be released to move along the third arm member 88. Referring to FIG. 21, the first and third arm members 82 and 88 are rotated from the first position to a second position, relative to the second arm member 84, rotating the foreamr aboat the joint axis 86 stretching the joint. As the third arm member 88 is rotated to the second position, the first arm meznber 82 can travel along an arcuate path of the third extcnsion member 116, thereby increasing the range of motion.
Bending an Elbow Joint in Extension:
When an elbow joint is to be bent in extension, the first cuff 94 is connected with the forearm and the second cuff 96 is con:nected to the bicep. The first and second cuffs 94 and 96 are clamped onto the forearm and biceps respectively, by straps, tightly enough so that tl--ey can apply torque to flex the joint. The first and third arni members 82 and 88 are rotated from the first position to a second position, relative to the second arm member 84, rotating the forearm about the elbow joint axis 86 stretching the joint. As the first and third ann members 82 and 88 are rotated to the second position the third arm member 88 travels along the arcuate path of the second extension niember 92, The orthosis 80 is maintained in the second position for a predetennined treatment time providing a constant stretch to the joint.

After the expiration of the treatrnent time, the first and second arm members 82 and 84 are moved back to the first position, relieving the joint. Optionally, the first and second arm members 82 and 84 can be rotated to a third position, increasing the stretch ora the joint. The first and second arm members 82 and 84 can be rotated at discrete time intcrvals to incrernentally increase the stretch of the joint through the treatment cycle.
After completion of the treatment cycle, the first axid. second arm members 82 and 84 are retunled to the first position for removal of the orthosis 80.

Alternatively, the first ai-in niember 82 can be released to move along the third arm member 88. The first and third ann members 82 and 88 are rotated from the first position to a second.
position, relative to the second ann meniber 84, rotating the second body portion about the joint axis 86 stretching the joint. As the third arm member 88 is rotated to the second position, the first arm member 82 can travel along an arcuate path of the third extension member 116, thereby increasing the range of motion.

In the above description, the second andlor third extension members 92 and 116 are shown and described as having a substantially circuiar arcuate shape, positioning the axis of rotation at the joint axis 86. However, it is contemplated that the second aild/or third extension members 92 and 116 can have alternative shapes.

The drive assembly 124 is described as utilizing a gear system. However, it is contemplated that other known drive systems can be used to move the first extension member 90 with respect to the second extension member 92 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 freedoni (e.g. flexion and extension about the joint). Tlaus, drive assembly 124 can be con{igttred to allow free motion in one degree of freedom. This can be achieved in a number of different ways. For example, gear 128 can be positioned such that it does not engage teeth 130.

In an alternative embodiment, the drive assembly 124 of orthosis 80 in accordance with the present invention can be actuated by a motor instead of by a manually actuatable member, such as the knob 133. Likewise, the motor may be configured and adapted with gearing that causes the orthosis to cycle through a rajige of motion in a predetermined znanner, or alternatively maybe controlled by a programmable logic controller (PLC).

In an embodiment, an electric motor is mounted to the shaft 132 for rotation of the gear 128.
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 znicroprocessor and motor together can be used to cycle the second and third arm members 84 and 88 through extension and flexion; to move the first and second arm members 82 and 84 in one pivotal direclion a certain amount, hold there while tissue stretches, then move further in that direction; or in any other manner.

In another nlanner of use, the orthosis can be set to cycle to one end of thejoint'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. '1'he programming and control of the microprocessor is within the skill of the art as it relates to driving the motor to control the second and third arm members 84 and 88 to move in known manners. This embodiment is ideally suited for continuous passive motion exercise, because the orthosis is portable and because the i-notor can be programmed with the dcsired sequence of movements.

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 funetional elements are quite suitable, and thus, the invention is intended to cover any sueh arrangenaent, 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.

The present invention can further include a monitor for use with the orthosis 10, 80, which provides assurances the patient is properly using the orthosis 10, 80 during his/hcr 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 infornlation 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.

This analysis may be conducted remotely, thereby saving the time and expense of a home visit by a healthcare professional or technician. An exenaplary monitoring system is provided in U.S. Patent No. 7,182,738 entitled "Patient Monitoring Apparatus and Method for Orthosis and Other Devices," to Bonutti et al., the content of which is hercin expressly incorporated by reference in its entirety.

The components of the present invention are rigid j:nembers made of, for example, aluminurn, stainless steel, polymeric, or composite niaterials, The member and extensions are sufficiently rigid to transmit the necessary forces. It should be understood that any inaterial of sufficient rigidity might be used. For example, some components can be made by injection molding. Generally, for iia.jection molding, tool and die metal molds of the components are prepared. I-Iot, melted plastic material is injected into the niolds. The plastic is allowed to cool, forming components. The components are removed from the molds and assembled.

I~urthermore, it is contemplated that the components can be made of polyineric or composite materials such that the device can be disposable. lior exaniple, at least some or all of the components can be made of a biodegradable mateiial such as a biodegradable polymer.
llna.ozig the important properties of these polymers are their tendency to depolymerize relatively easily and their ability to forni environmentally benign byproducts when degraded or depolymerized. One such biodegradable naaterial is poly (hydroxyacids) ("PHA's") such as polyactic acid ("PLA") and polyglycolic acid ("PGA").

Additionally, the device can be made of a nornnagnetic material. In such instance, the device can be used as a positioning device for use in imaging devices, such as a MIU
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.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been parEicularly shown and described herein above. For example, although the examples presented identify the wrist joint, the present invention can be used for any joint. In addition, unless mention was made above to the contrary, it should be noted tllat all of the accompanying drawings are not 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.

Claims

1 An orthosis for stretching tissue around a joint of a patient between first and second relatively pivotable body portions, comprising:
a first arm member affixable to the first body portion;
a second arm member affixable to the second body portion; and a third arm member interposed between the first and second arm members, wherein the first arm member is slidingly connected to the third arm member and the third arm member is operatively connected to the second arm member such that the first and third arm members are movable from a first position to a second position relative to the second arm member.

2. An orthosis as set forth in claim 1 further comprising a first cuff attached to the first arm member.

3. An orthosis as set forth in claim 2 wherein the first cuff is fastenable about the first body portion tightly enough that the first arm member may apply a force to the first body portion without having the first cuff slide along the first body portion,

4. An orthosis as set forth in claim 2 wherein the first cuff is slidably mounted to the first arm member.

5. An orthosis as set forth in claim 1 further comprising a second cuff attached to the second arm member.

6. An orthosis as set forth in claim 5 wherein the second cuff is fastenable about the second body portion tightly enough that the second arm member may apply a force to the second body portion without having the second cuff slide along the second body portion.

7. An orthosis as set forth in claim 5 wherein the second cuff is slidably mounted to the second arm member.

8. An orthosis as set forth in claim 1 further comprising a drive assembly on the third arm member, the drive assembly engaging the second arm member for selectively moving the third arm member with respect to the second arm member.

9. An orthosis as set forth in claim 8 wherein the drive assembly includes a gear rotatably mounted in the third arm member.

10. An orthosis as set forth in claim 9 wherein the second arm member includes a plurality of teeth for engaging the gear.

11. An orthosis as set forth in claim 10 wherein the gear is manually rotatable for selectively moving the third arm member with respect to the second arm member.

12. An orthosis as set forth in claim 9 further comprising a motor operatively connected to the gear for selectively moving the third arm member with respect to the second arm member.

13. An orthosis as set forth in claim 8 wherein the drive assembly includes a locking assembly.

14. An orthosis as set forth in claim 1 wherein the second arm member includes a second extension member having an arcuate shape extending therefrom; and the third arm member includes a third extension member having an arcuate shape extending therefrom, wherein the first arm member is slidingly connected to the third extension member and the third arm member is operatively connected to the second extension member and travels along an arcuate path defined by the second extension member when the third arm member is moved from the first position to the second position.

15. An orthosis as set forth in claim 14, wherein the first arm member slides along an arcuate path defined by the third extension member as the third arm member is moved from the first position to the second position.

16. An orthosis as set forth in claim 15, wherein the joint defines a first plane substantially orthogonal to a longitudinal axis of the second arm member and a second plane substantially parallel to the longitudinal axis of the second arm member.

17. An orthosis as set forth in claim 16, wherein the second extension member extends from the second arm member, such that the operative connections of the first, second, and third arm members lie in the first plane.

18, An orthosis as set forth in claim 1, further comprising a locking pin removable positionable through the first and third arm members, such that the first arm member moves with the third arm member when the third arm member is moved from the first position to the second position relative to the second arm member.

19. An orthosis as set forth in claim 1, wherein the joint and the first and second body portions define on one side of the joint an inner sector which decreases in angle as the joint is flexed and define on the opposite side of the joint an outer sector which decreases in angle as the joint is extended, such that the operative connections of the first, second, and third arm members are located in the outer sector.

20. 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, comprising:
a first arm member affixable to the first body portion;
a second ann member affixable to the second body portion and including a second extension member having an arcuate shape extending therefrom;
a third arm member interposed between the first and second arm members, wherein the first arm member is slidingly connected to the third arm member and the third arm member is operatively connected to the second extension member and travels along an arcuate path defined by the second extension member when the third arm member is moved from a first position to a second position relative to the second arm member;
and a drive assembly on the third arm member, the drive assembly engaging the second extension member for selectively moving the first and third arm members with respect to the second arm member.

21. An orthosis as set forth in claim 20 wherein the third arm member includes a third extension member having an arcuate shape extending therefrom.

22. An orthosis as set forth in claim 21 wherein the first arm member slides along an arcuate path defined by the third extension member as the third arm member is moved from the first position to the second position relative to the second arm member.

23. An orthosis as set forth in claim 22 further comprising a locking pin removable positionable through the first and third arm members, such that the first arm member moves with the third arm member when the third arm member is moved from the first position to the second position relative to the second arm member.

24. An orthosis as set forth in claim 20 wherein the drive assembly includes a gear rotatably mounted in the third arm member.

25. An orthosis as set forth in claim 24 wherein the second arm member includes a plurality of teeth for engaging the gear.

26. An orthosis as set forth in claim 24 wherein the gear is manually rotatable for selectively moving the third arm member with respect to the second arm member.

27. An orthosis as set forth in claim 24 further comprising a motor operatively connected to the gear for selectively moving the third arm member with respect to the second arm member.

28. An orthosis as set forth in claim 20 wherein the drive assembly includes a locking assembly.