Range of motion device

The present invention provides 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. The second extension member is operatively connected to the first extension member and 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.

FIELD OF THE INVENTION

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

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 tip or the palm down.

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 cotracture) 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 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

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.

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 α 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.

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.

DETAILED 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 portion is 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.

Referring now to the drawing figures in which like reference designators refer to like elements, there is shown inFIG. 1, a schematic of the orthosis10of the present invention. The orthosis10includes a first arm member12attachable to the first body portion and a second arm member14attachable to the second body portion, wherein a joint axis of rotation16is interposed between and offset from the first and second arm members12and14. The first and second arm members12and14are operatively connected to each other offset from the joint axis16.

The first arm member12of the orthosis10includes a first extension member18, which extends at angle α from the first arm member12. The second arm member14of the orthosis10includes a second extension member20extending therefrom and having an arcuate shape. The first and second extension members18and20are operatively connected at point “P,” such that in operation the second extension member20travels along an arcuate path about and substantially through point “P.” The arcuate shape of the second extension member20results in the second body portion rotating about the joint axis16, when the second arm member14is moved from a first position to a second position relative to the first arm member12. The angle α between the first extension member18and the first arm member12and the radius of curvature of the second extension member20are a function of the joint to be treated and the degree of flexion or extension contractures.

The orthosis further includes a drive assembly22at point “P.” The drive assembly connects the first and second extension members18and20for applying force to the first and second arm members12and14to pivot the first and second body portions relative to each other about the joint.

The orthosis10of the present invention is shown having an angle α such that the operative connection, at point “P,” of the first and second extensions18and20is located in a plane “A” passing through the joint axis16, wherein plane “A” is substantially orthogonal to a longitudinal axis of the first arm member12. This position of point “P” provides an angle β1between the second arm member14and the joint axis16, wherein β1is the maximum angle of flexion. As shown inFIG. 2, the second extension member includes a stop24. The stop24acts to limit the angle of maximum extension γ between the second arm member14and the joint axis16. An increase in the length of the stop24will decrease the angle of maximum extension γ. A decrease in the length of the stop24will increase the angle of maximum extension γ.

Referring toFIG. 3, the maximum flexion angle can be increased by increasing the angle α. An increase in the angle α wilt move the point “P” to a location “in front of” the plane “A.” This position of point “P” provides an angle β2between the second arm member14and the joint axis16in maximum flexion, wherein β2is greater than β1. The greater the angle α, the greater the angle of maximum flexion.

Alternatively, (not shown) a decrease in the angle α will move the point “P” to a location “behind” the plane “A.” This position of point “P” provides an angle β3between the second arm member14and the joint axis16in maximum flexion, wherein β3is less than β1. The smaller the angle α, the smaller the angle α of maximum flexion.

Referring toFIG. 4, the first extension member18is selectively, pivotally connected at location26to the first aim member12. The pivotal connection26of the first extension member18permits the angle α between the first extension member18and the first arm member12to be selectively increased and decreased, increasing and decreasing the range of motion. In a first position28, the first extension member18is positioned at an angle α1, wherein the operative connection, at point “P,” of the first and second extension members18and20is located in a plane “A” passing through the joint axis16, wherein plane “A” is substantially orthogonal to a longitudinal axis of the first arm member12. The first position28of point “P” provides a maximum angle of flexion of β1. The second extension member stop24acts to limit the angle of maximum extension γ1between the second arm member14and the joint axis16.

Referring toFIG. 5, in a second position30the angle α is increased to an angle α2, positioning the point “P” to a location “in front of” the plane “A.” The second position30of point “P” provides a maximum angle of flexion of β2, wherein β2is greater than β1. The second extension member stop24acts to limit the angle of maximum extension γ2between the second arm member14and the joint axis, wherein γ2is less the γ1.

The selective pivotal connection26of the first extension member18to the first arm member12can have a plurality of selectable positions. The angle α between the first arm member12and the first extension18can 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 α between the first arm member12and the first extension18sufficiently to move the point “P” “in front of” plane “A” and “above” the longitudinal axis of the first arm member12, maximizing the maximum angle of flexion β.

The orthosis10of 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, orthosis10of 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 member12depicts a first extension18having a substantially linear shape, extending at an angle α from the first arm member12. However, it is within the scope of the present invention that the first extension member18can be any shape extending from the first arm member12which positions the point “P” in the desired relationship to the plane “A.” Referring toFIG. 6, a segmented fist extension member is shown, including a first extension member segment18aand a second extension member segment18b. The first and second extension member segments18aand18bextend from the first arm member12, positioning the point “P” at an angle α from the first arm member12. Referring toFIG. 7, an arcuate first extension member18cis shown. The arcuate extension member18cextends from the first arm member12, positioning the point “P” at an angle α from the first arm member12.

Referring toFIG. 8, the orthosis10of the present invention includes a first arm member12attachable to the first body portion and a second arm member14attachable to the second body portion, wherein the joint axis16is interposed between and offset from the first and second arm members12and14. The first and second arm members12and14are connected with each other offset from the joint axis16.

The first arm member12of the orthosis10includes a first extension member18, which extends at angle α from the first arm member12. The second arm member14of the orthosis10includes a second extension member20, having an arcuate shape. The first and second extension members18and20are operatively connected a point “P,” such that in operation the second extension member20travels along an arcuate path about and substantially through point “P.” The arcuate shape of the second extension member20results in the second body portion rotating about the joint axis16, when the second arm member14is moved from a first position to a second position relative to the first arm member12. The angle α between the first extension member18and the first arm member12and the radius of curvature of the second extension member20are a function of the joint to be treated and the degree of flexion or extension contractures.

A first cuff32is attached to the first arm member12, wherein the first cuff32is positionable about the first body portion. The first cuff32is attached to the first body portion by cuff straps. The first cuff32secures the first body portion to the first arm member12. A second cuff34is attached to the second arm member14, wherein the second cuff34is positionable about the second body portion. The second cuff34is attached to the second body portion by cuff straps. The second cuff34secures the second body portion to the second arm member14. (The term “cuff” as used herein means any suitable structure for transmitting the force of the orthosis10to the limb portion it engages.)

In an exemplary use, the orthosis10is operated to extend a joint in the following manner. The first cuff32is fastened about the first body portion tightly enough that the first arm member12may apply torque to the first body portion without having the first cuff32slide along the first body portion. Similarly, the second cuff34is fastened securely around the second body portion so that the second arm member14may apply torque to the second body portion without the second cuff34sliding along the second body portion. The orthosis10is attached to the first and second body portions in a first position. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the second body portion about the joint axis16stretching the joint. As the second arm member14is rotated to the second position, the second extension member20travels along an arcuate path about and substantially through point “P,” The orthosis10is 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 member14is moved back to the first position, relieving the joint. Optionally, the second arm member14can be rotated to a third position, increasing the stretch on the joint. The second arm member14can 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 orthosis10.

The first and second arm members12and14are 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.

In an embodiment, the components of the orthosis10of the present invention are made by injection molding. Generally for injection molding, tool and die metal molds of the orthosis10components 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 portions32or34can be individual molded and attached to the arm members12or14. Alternatively, the cuff portions can be molded as an integrated part of the arm members12or14.

In use, the orthosis10can 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, orthosis10of 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 orthosis10includes a first cuff32for attachment to a first body portion, and a second cuff34for 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 cuffs32and34includes loop connectors for receiving straps extending around the body portions to clamp the cuffs32and34to the body portions.

The first cuff32is mounted for sliding movement on the first arm member12and is slidable along the first arm member12in a manner as described below. The second cuff34is mounted for sliding movement on a second arm member14and is slidable along the second arm member12in a manner as described below.

Bending a Joint in Extension:

In operation of the orthosis10to extend the joint, the orthosis10starts at a more flexed position. The first and second cuffs32and34are clamped onto the first and second body portions, respectively, by straps, tightly enough so that the cuffs32and34can apply torque to the body portions to extend the joint. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the second body portion about the joint axis16stretching the joint. As the second arm member14is rotated to the second position the second extension member20travels along an arcuate path about and substantially through point “P.” The orthosis10is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint.

As the orthosis10is rotated from the first position to the second position, extending the joint, the first and second cuffs32and34move along the first and second arm members12and14. The first cuff32moves inwardly along the first arm member12. Similarly, the second cuff34moves inwardly along the second arm member14. Because the cuffs32and34are clamped onto the first and second body portions as described above, the outward pivoting movement of the first and second arm members12and14and the cuffs32and34causes 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 cuffs32and34, inwardly along the first and second arm members12and14, helps to limit these distractive forces by counteracting the outward movement of the first and second arm members12and14. The cuffs32and34slide inwardly along the first and second arm members12and14a 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.

Bending a Joint Flexion:

In operation of the orthosis10to flex the joint, the orthosis10starts at a more extended position. The first and second cuffs32and34are clamped onto the first and second body portions, respectively, by straps, tightly enough so that the cuffs32and34can apply torque to the body portions to extend the joint. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the second body portion about the joint axis16stretching the joint. As the second arm member14is rotated to the second position the second extension member20travels about and substantially though point “P,” along an arcuate path. The orthosis10is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint.

As the orthosis10is rotated from the first position to the second position, flexing the joint, the first and second cuffs32and34move along the first and second arm members12and14. The first cuff32moves outwardly along the first arm member12. Similarly, the second cuff34moves outwardly along the second arm member14. Because the cuffs32and34are clamped onto the first and second body portion is the inward pivoting movement of the first and second arm members12and14and the cuffs32and34causes 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 cuffs32and34, outwardly along the first and second arm members12and14, helps to limit these compressive forces by counteracting the inward movement of the first and second arm members12and14. The cuffs32and34slide outwardly along the first and second arm members12and14a 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.

Referring now toFIG. 9, the orthosis10can be used to bend a wrist in flexion or extension. The orthosis10includes a first arm member12attachable to the forearm of a patient. The first cuff32is clamped onto the forearm by straps. A second arm member14, operatively connected to the first arm member12, 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 members12and14. The second arm member14includes a base member36attach thereto. A hand pad38is attached to the base member36. The hand pad38is clamped onto the hand by straps, tightly enough so that the second arm member14can apply torque to the joint. The hand pad38can be shaped to conform to the palm or the back surface of the hand.

Bending Wrist in Flexion:

When a wrist is to be bent in flexion, the first cuff32is connected with the forearm and the hand pad38is connected with the palm of the hand. The first cuff32and hand pad38are clamped onto the forearm and hand, respectively, by straps, tightly enough so that they can apply torque to flex the joint. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the hand about the wrist joint axis16stretching the joint. As the second arm member14is rotated to the second position the second extension member20travels along an arcuate path about and substantially through point “P.” The orthosis10is maintained in the second position for a predetermined treatment time providing a constant stretch to the wrist joint.

Bending Wrist in Extension:

When a wrist is to be bent in extension, the first cuff32is connected with the forearm and the hand pad38is connected with the back surface of the hand. The first cuff32and hand pad38are 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 member14is rotated from the first position to a second position, relative to the first arm member12, rotating the hand about the wrist joint axis16stretching the joint. As the second arm member14is rotated to the second position the second extension member20travels along an arcuate path about and substantially through point “P.” The orthosis10is maintained in the second position for a predetermined treatment time providing a constant stretch to the wrist joint.

In an embodiment, the hand pad38is removable attached to the base member36. The hand pad38includes 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 pad38can be removable attached to the base member36such that the first or second surfaces engages the hand of the patient.

For example, the hand pad38is removably secured to base member36by detent pin40. The removable securing of the hand pad38allows the orthosis10to be used for both flexion and extension of the wrist. In flexion, the hand pad38is connected to the base member36with the first surface facing “up” to conform to the palm of the hand. In extension, the hand pad38is connected to the base member36with the second surface facing “up” to conform to the back surface of the hand.

The base member38can be mounted for sliding movement on the second arm member14and is slidable along the second arm member14in a manner as described below.

Bending Wrist in Extension:

In operation of the orthosis10to extend the wrist joint, the orthosis10starts at a more flexed position. The first cuff32is connected with the forearm and the hand pad38is connected with the palm of the hand. The first cuff32and hand pad38are clamped onto the forearm and palm of the hand so as to apply torque to extend the wrist joint. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the hand about the wrist joint axis16stretching the wrist joint. As the second arm member14is rotated to the second position the second extension member20travels along an arcuate path about and substantially through point “P.” The orthosis10is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint.

As the orthosis10is rotated from the first position to the second position, extending the joint, the base member36and hand pad38move along the second arm member14. The base member36and hand pad38move inwardly along the second arm member14. Because the cuff32and hand pad38are clamped onto the forearm and hand the outward pivoting movement of the first and second arm members12and14causes 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 member36and hand pad38, inwardly along the second arm member14, helps to limit these distractive forces by counteracting the outward movement of the second arm members12and14. The base member36and hand pad38slide inwardly along the second arm member14a 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.

Bending Wrist in Flexion:

In operation of the orthosis10to flex the wrist joint, the orthosis10starts at a more extended position. The first cuff32is connected with the forearm and the hand pad38is connected with the back surface of the hand. The first cuff32and hand pad38arc clamped onto the forearm and back surface of the hand so as to apply torque to flex the wrist joint. The second arm member14is rotated from the first position to a second position, relative to the first arm member12, rotating the hand about the wrist joint axis16stretching the wrist joint. As the second arm member14is rotated to the second position the second extension member20travels along an arcuate path about and substantially through point “P.” The orthosis10is maintained in the second position for a predefined treatment time providing a constant stretch to the joint.

As the orthosis10is rotated from the first position to the second position, flexing the joint, the base member36and hand pad38move along the second arm member14. The base member36and hand pad38move outwardly along the second arm member14. Because the cuff32and hand pad38are clamped onto the forearm and hand the inward pivoting movement of the first and second arm members12and14causes 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 member36and hand pad38, outwardly along the second arm member14, helps to limit these compressive forces by counteracting the inward movement of the first and second arm members12and14. The base member36and hand pad38slide outwardly along the second arm member14a 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.

In the above description, the hand pad38is shown sliding inwardly and outwardly along the second arm member14. However, it is contemplated that the hand pad38can slide in other directions. For example, the hand pad38can slide substantially orthogonal to the second arm member14, 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 pad38can be connected to the second arm member14such that hand pad38can exhibit both longitudinal and orthogonal motion (and combinations thereof) with respect to the second arm member14.

In the above description, the second extension member20is shown and described as having a substantially circular arcuate shape, positioning the axis of rotation at the joint axis16. However, it is contemplated that the second extension member20can have alternative shapes.

Referring toFIG. 10, the second arm member14is shown having a non-circular arcuate shaped second extension member44. The non-circular arcuate shaped second extension member44provide an axis of rotation which changes as the second arm member14is moved from the first position to the second portion. As such, as the second arm member14is moved from the first position to the second portion the second body portion will exhibit both a rotational motion, about the joint axis16, and a translational motion, distracting or compressing the joint.

In the previously described embodiments, the arcuate shape of the second extension member20or44as shown have concave radius of curvature relative to the joint16. However, referring toFIG. 11, it is contemplated that the second extension member18or44can have a convex radius of curvature relative to the joint16. Similar to the concave radius of curvature, the convex arcuate shape of the second extension member18or44results in the second body portion rotating about the joint axis16, when the second arm member14is moved from a first position to a second position relative to the first arm member12.

Referring toFIG. 12, the second arm member14of the orthosis10includes a second extension member48extending therefrom and having a linear shape. The first and second extension members18and48are operatively connected at point “P,” such that in operation the second extension member48travels along a linear path through point “P.” The linear shape of the second extension member48results in the second body portion being translated with respect to the first body portion. The translational movement of the second arm member14results is a distraction or compression of the joint when the second arm member14is moved from a first position to a second position relative to the first arm member12.

As discussed farther below, the hand pad can be mounted for translational and rotational movement on the base member.

Referring toFIGS. 9 and 13A, the drive assembly22of the orthosis includes a gear system. As previously noted, the components of the orthosis, including the drive assembly22, can be made by injection molding a polymer. The drive assembly22is supported in the first extension member18, including a gear50rotatable about point “P.” A shaft52, attached to the gear50, extends from first extension member18. A knob54is connected to the shaft52, opposite the gear50, for manually rotating the gear50. The second extension member20includes a series of teeth56alone an inner surface58. The second extension member20is threaded through the first extension member18, such that the teeth56on the second extension member20engage the gear50. The rotation of the knob56causes the gear50to rotate, pushing or pulling the second extension member20through the first extension member18. The drive assembly22includes a locking or breaking mechanism which prevents the gear50from rotating absent am applied force rotation of the knob46. Such a lock or breaking mechanism can include a compression washer or other known gear locking or breaking mechanisms.

In another embodiment, as shown inFIG. 13B, the shaft52is attached to the gear50and extends from first extension member18. The knob54is connected to the shaft52opposite the gear50for manually rotating the gear50. The second extension member20includes a series of teeth56along an inner surface58. The teeth56can extend fully or partially along the width of the inner surface58. A secondary gear51is positioned between the gear50and the inner surface58, where the secondary gear51engages gear50. The second extension member20is threaded through the first extension member18, such that the teeth56on the second extension member20engage the secondary gear51. The rotation of the knob56causes the gear50to rotate, thereby rotating the secondary gear51and pushing or pulling the second extension member20through the first extension member18. The ratio between gear50and secondary gear51is selected to permit an easy rotation of the knob54, moving of the second extension member20through the first extension member18. The drive assembly22includes a locking or breaking mechanism which prevents the gear50from rotating absent am applied force rotation of the knob46. Such a lock or breaking mechanism can include a compression washer or other known gear locking or breaking mechanisms.

The drive assembly22is described as utilizing a gear system. However, it is contemplated that other known drive systems can be used to move the second extension member20through the first extension member18, 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 assembly22can be configured to allow free motion in one degree of freedom. This can be achieved in a number of different ways. For example, gear50can be positioned such that it does not engage teeth56.

In an alternative embodiment, the drive assembly22for an orthosis10in accordance with the present invention can be actuated by a motor instead of by a manually actuatable member, such as the knob54.

In an embodiment, an electric motor is mounted to the shaft52for rotation of the gear50. 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 members12and14through extension and flexion; to move the first and second arm members12and14in 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 members12and14to 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 programed with the desired 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 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.

Referring toFIGS. 14 and 15, another embodiment in which the hand pad38articulates with respect to the second arm member14is shown. The second arm member14has a circular base member40attached thereto. The circular base member40supports a circular base plate42. A circular cover44extends upwardly from the circular base member40and has a portion46extending radially inwardly toward a vertical axis48to define a slide chamber50.

A hand pad support slider52is received in the slide chamber50. The support slider52has an upper portion54to which the hand pad38is attached. The upper portion54is connected by a neck56to a circular planar portion58. Two annular bearing races60extend downwardly from the planar portion58and secure between them a plurality of ball bearings62. A washer64is disposed above the bearings62The hall bearings62support the slider52and thus the band pad38for sliding movement in any direction within the slide chamber50. The hand pad38can be made self-centering by springs66.

Thus, the hand pad38is slidable relative to the circular base member40in any direction for a limited extent. As indicated by the arrow68, the hand pad38is slidable fore and aft within the extent of travel allowed by the support slider52within the slide chamber50. As indicated by the arrow70, the hand pad38is slidable laterally within the extent of travel allowed by the support slider52within the slide chamber50. With these two combined, it can be seen that the roller bearing assembly provides a compound of movement of the hand pad38.

Referring toFIGS. 16,17A and17B, another embodiment80in which the hand pad38articulates with respect to the second arm member14is shown. The second arm member14has a sliding base member82slidingly mounted thereto in similar fashion to base member36. The sliding base member82supports a fixed base plate84attached thereto. A pivotal base plate86is pivotally connected to the fixed base plate84, where the pivotal base86plate can arcuately pivot with respect to the fixed base plate84and the second arm member14.

The pivotal base plate86is pivotally secured to the fixed base plate84by threaded members88and90extending through an arcuate slot92in the pivotal base plate86. The threaded members88and90are threaded in threaded holes94and96in the fixed plate84. In this manner the pivotal base plate86can travel along the arcuate slot92with respect to the fixed base plate84. The hand pad (not shown) can be removable attached to the pivotal base plate86.

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.

Referring now toFIG. 18, an orthosis100can be used to bend a wrist in flexion or extension. The orthosis100includes a first arm member102attachable to the forearm of a patient. The first cuff104is clamped onto the forearm by straps106. A second arm member108, operatively connected to the first arm member102, 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 members102and108. The second aim member108includes articulating member80attached thereto. A hand pad can be attached to the pivotal base plate86. The hand is clamped onto the hand pad by top member110and strap112, tightly enough so that the second arm member108can apply torque to the joint. The hand pad can be shaped to conform to the palm or the back surface of the hand.

Referring toFIG. 19, a hand pad114is provided, where the hand pad114can be removably attached to the pivotal base plate86. For example, a hook and loop tape116can be provided on the hand pad114and the pivotal base plate86. The hand pad114is shaped to conform to the palm of the hand.

Referring to FIG,20, another hand pad118is provided where the hand pad118can be removably attached to the pivotal base plate86. Similarly, the hook and loop tape116can be provided on the hand pad118and the pivotal base plate86. The hand pad118is shaped to conform to a top surface of the hand.

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.

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.

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).

Referring now to the figures in which like reference designators refer to like elements, there is shown inFIG. 21, a schematic of the orthosis200of the present invention. The orthosis200includes a first member202attachable to a first body portion, such as a user's foot. The shape and configuration of the first member202may be selected to support or conform generally to a patient's foot. For example, the first member202nay 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.

Alternatively, the first member202may 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 member202may 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 member202may be adjustable, or the width of the first member202near 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 member202may 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.

The first member202is operatively associated with or connected to a second member204so that the first and second members202and204may move or rotate with respect to each other. As shown inFIG. 21, the supporting surface of the first member202may be offset from the supporting surface of the second member204. 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 orthosis200to be adjustable so that a physician or user may change its size as needed to improve comfort, fit, or operation of the orthosis200.

In use, the second member204may 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 inFIG. 22, the orthosis200may have an axis of rotation206that is aligned with the axis of rotation of the joint. In this manner, the instantaneous axis of rotation (IAR) of the first and second members202and204may better match the IAR of the treated joint. As will be discussed in greater detail below, while the axis of rotation206of the device is illustrated inFIGS. 21-23as occurring only along a single line, the axis of rotation206may also shift or move depending on the relative positioning of the first and second members202and204in a manner that corresponds to changing axis of rotation that a joint may experience through its range of motion. The first and second members202and204are operatively connected to each other, offset from the orthosis axis206.

The first member202of the orthosis200includes a first extension member208extending therefrom. The second member204of the orthosis200includes a second extension member210extending therefrom and having an arcuate shape. The first and second extension members208and210are operatively connected at point “P,” such that in operation the second extension member210travels along an arcuate path about and substantially through point “P.” The arcuate shape of the second extension member210results in the toe rotating about the orthosis axis206, or alternatively about a moving IAR, when the second member204is moved from a first position to a second position relative to the first member202.

The first extension member208can extend substantially vertically from the first member12or extend at an angle α from the first member202. In one embodiment of the invention, the angle α and the radius of curvature of the second extension member210are configured such that of the orthosis axis206is aligned with the axis of rotation of the joint.

The previous description of the first member202depicts a first extension208having a substantially linear shape, extending at an angle α from the first member202. However, it is within the scope of the present invention that the first extension member208can be any shape extending from the first member202which aligns orthosis axis206with 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 inFIG. 21, for instance, may be for the second extension member210not to have a constant radius of curvature.

The orthosis200further includes a drive assembly212, which is illustrated inFIG. 21at or near point “P.” In this embodiment, the drive assembly212is operably connected to the first and second extension members208and210for applying force to the first and second members202and204to pivot the second body portion about the orthosis axis206. As will be shown below in additional embodiments, the drive assembly212may be configured or disposed to interact with or operate on one of the first or second members202and204independently.

Referring toFIG. 22, in order for the orthosis200to extend the joint the first and second members202and204may be affixed to the first and second body portions, respectively, tightly enough so that the first and second members202and204can apply torque to extend the joint. The second extension member210is moved through the drive assembly212from a first position to a second position, relative to the first extension member208, rotating the second member204and the second body portion about the orthosis axis206stretching the joint. As the second member204is rotated to the second position, the second extension member210travels at least partially through point “P” and may travel substantially through this point for a large range of motion. Because the first and second members202and204are affixed to the first and second body portions, the outward pivoting movement of the second member204causes the joint to be extended as desired. The orthosis200may 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.

Returning to the example where the orthosis is maintained in the second position, after the expiration of the treatment time, the second member204may then be moved back to the first position, relieving the joint. Optionally, the second member204can 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 member204can 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 arm204is returned to the first position for removal of the orthosis200.

Referring toFIG. 23, in operation of the orthosis200to flex the joint. The first and second members202and204are affixed to the first and second body portions, respectively, tightly enough so that the first and second members202and204can 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 members202,204. The second extension member210is moved through the drive assembly212from the first position to a second position, relative to the first extension member208, rotating the second member204and the second body portion about the orthosis axis206stretching the joint. As the second member204is rotated to the second position, the second extension member210travels substantially through point “P.” Because the first and second members202and204are affixed to the first and second body portions, the inward pivoting movement of the second member204causes the joint to be flexed as desired. The orthosis200is 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 member204is moved back to the first position, relieving the joint. Optionally, the second member204can be rotated to a third position, thereby increasing, decreasing, or otherwise varying the stretch on the joint. The second member204can 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 arm204is returned to the first position for removal of the orthosis200.

FIGS. 24-26further illustrate several aspects of the invention more concretely. An orthosis220of the present invention includes a first member221having a first cuff222attachable to a user's foot and a second member223having a second cuff224attachable to a toe of the user's foot, wherein the second member223is rotatable with respect to the first member221about an axis of rotation226. The first and second members221and223are attached to the foot and toe of the user with the first and second cuffs222and224, such that as the second member223is rotated about the axis of rotation226, the toe is rotated about a joint axis.

A first extension member228is affixed to and extends from the first member221, wherein a drive assembly230is positioned on an end portion of the first extension member228. A second extension member232is similarly affixed to and extends from the second member223, wherein the second extension member232has an arcuate shape. The second extension member232engages the drive assembly230of the first extension member228at a point “P.” An actuation of the drive assembly230operates to move the second extension member232through the drive assembly230, such that the second cuff224travels along an arcuate path “A” with respect to the first member221. The arcuate shape of the second extension member232results in the toe rotating about the joint axis, as the second cuff224is moved along the arcuate path “A.” The drive assembly230can be actuated to move the second cuff224and toe from a first position to a second position relative to the first cuff222. Once again, the term “cuff” as used herein means any suitable structure for transmitting the force of the orthosis220to the limb portion it engages.

The first extension member228can extend substantially vertically from the first member221or extend at an angle α from the first member221, where the angle α and the radius of curvature of the second extension member232(if constant) can be configured such that of the axis of rotation226is aligned with the joint axis of ration. As previously discussed, the curvature of the second extension member232need 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 orthosis220having 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 member232may be complex in order to better approximate a moving IAR.

Referring toFIG. 27, the drive assembly230can include a housing240having a worm gear242therein. A first miter gear244is attached to the worm gear242such that a rotation of the first miter gear244rotates the worm gear242. The drive assembly230further includes a drive shaft246have a knob248at one end and a second miter gear250at an opposite end. The second miter gear250is positioned within the housing240, in engagement with the first miter gear244. A rotation of the knob248rotates the drive shaft246and the second miter gear250, which in turn rotates the first miter gear244and the worm gear242.

A gear surface252of the second extension member232includes a plurality of teeth254. The second extension member232is positioned throughout the housing240, such that the worn gear242engages the teeth254of the second extension member232. A rotation of the knob248rotates the worm gear242, which in turn moves the second extension member232through the housing240.

In an alternative embodiment, the drive assembly230for orthosis230in accordance with the present invention can be actuated by a motor instead of by a manually actuatable member, such as the knob248. Likewise, the motor maybe 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 mounted to the drive shaft246for rotation of the second miter gear250. 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 cuff34through 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 cuff34in 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 joints 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 cuff34to 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 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.

The present invention can further include a monitor for use with the orthosis220, which provides assurances the patient is properly using the orthosis220during 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.

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.

In an exemplary use, the orthosis220is operated to rotate a toe about a joint axis in the following manner. The first cuff222is fastened about the foot with one or more straps, laces, or similar retaining device. Similarly, the second cuff224is fastened securely to the toe of the user, such that the joint and joint axis226is interposed between the first and second cuffs222and224. The orthosis220is attached to the foot and toe in a first position. The drive assembly230is actuated to move the second extension member232, such that the second cuff224travels along an arcuate path from the first position to a second position, relative to the first cuff222, rotating the toe about the joint axis stretching the joint. The orthosis220is 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 cuff224is moved back to the first position, relieving the joint. Optionally, the second cuff224can be rotated to a third position, thereby increasing or decreasing the stretch on the joint. The second cuff224can 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 orthosis220.

Referring toFIG. 28, the second member223can include an attachment bracket260for adjustably attaching the second cuff224to the second extension member232. The attachment bracket260can include a toe rod262extending therefrom. The second cuff224can be slideably mounted on the toe rod262to position second cuff224over the toe. Alternatively, the toe rod262can be of sufficient length such that the second cuff24can be slidingly positioned on a selected toe on the foot of the user, for example, the big toe, minimus toe, or any toe therebetween.

The second cuff224can be positioned on the toe rod262with a first bracket264, where the toe rod262passes through a passage266in the first bracket264. A set screw268is provided to secure the first bracket264to the toe rod262. When the set screw268is loosened, the first bracket264is free to slide along the toe rod262. A tightening of the set screw268secures the first bracket264in place on the toe rod272.

The second cuff224can further include a second bracket270, where the second bracket270can be pivotally mounted to the first bracket264. For example, the second bracket270can be attached to the first bracket264with a pin or screw connector, allowing the second bracket270to rotate with respect to the first bracket264.

Additionally, when a joint is flexed or extended a compressive force may be applied to the connective tissue surrounding the joint. It maybe 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.

Additionally, the second bracket270can be slideably mounted to the first bracket264. For example the second bracket270can be mounted to the first bracket264with a dovetail joint272, allowing the second bracket270to slide with respect to the first bracket264. The sliding movement of the second cuff224helps to limit the distractive or compressive forces which can be imparted on the joint by the rotation of the second cuff224with respect to the first cuff222.

The attachment bracket260can be pivotally mounted to the second extension member232. For example, the attachment bracket260can be attached to the second extension member232with a pin or screw connector274, allowing the attachment bracket260to rotate with respect to the second extension member232. The second extension member232further includes an extension bracket276having a slotted portion278. A set screw280is positionable through the slotted portion278, engaging the attachment bracket260, such that the set screw280Can be used to control the pivotal position of the attachment bracket260with respect to the second extension member232.

The adjustable connection of the second cuff224to the attachment bracket260and the pivotal connection of the attachment bracket260to the second extension member232can be used to align the second cuff224with the toe. The alignment of the second cuff224on the toe can be used to substantially limit the force applied to the toe to that of a torque about the joint axis226.

Bending a Joint in Extension:

In operation of the orthosis220to extend the joint, the orthosis starts at a more flexed position. The first and second cuffs222and224are clamped onto the foot and toe portions, respectively, by straps234, tightly enough so that the first and second members221and223can apply torque to extend the joint. The second extension member232is moved through the drive assembly230from the first position to a second position, relative to the first extension member228, rotating the second cuff224and the toe about the orthosis axis226stretching the joint. As the second cuff224is rotated to the second position the second extension member232travels along an arcuate path “A” about and substantially through point “P.” The orthosis220is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint.

As the orthosis220is rotated from the first position to the second position, extending the joint, the second cuff224moves along the first bracket64. Because the first and second members221and223are clamped onto the foot and toe as described above, the outward pivoting movement of the second cuff224causes 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 cuff224helps 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.

Bending a Joint Flexion:

In operation of the orthosis220to flex the joint, the orthosis220starts at a more extended position. The first and second cuffs222and224are clamped onto the foot and toe portions, respectively, by straps234, tightly enough so that the first and second members221and223can apply torque to extend the joint. The second extension member232is moved through the drive assembly230from the first position to a second position, relative to the first extension member228, rotating the second cuff224and the toe about the orthosis axis26stretching the joint. As the second cuff224is rotated to the second position the second extension member232travels along an arcuate path “A” about and substantially through point “P.” The orthosis220is maintained in the second position for a predetermined treatment time providing a constant stretch to the joint.

As the orthosis220is rotated from the first position to the second position, flexing the joint, the second cuff224moves along the first bracket264. Because the first and second members221and223are clamped onto the foot and toe as described above, the inward pivoting movement of the second cuff224causes 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 cuff224helps 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.

Referring toFIG. 29, the drive assembly230can be adjustable mounted to the first extension member228. The first extension member228includes a longitudinal slotted section282. A threaded member284is positioned through the longitudinal slotted section282, where the threaded member284is threaded into a threaded hole286in the drive assembly230. The position of the drive assembly230is secured on the first extension member228by tightening the threaded member284, compressing the first extension member228between the threaded member284and the drive assembly230. The position of the drive assembly230can be adjusted by loosening the threaded member284and sliding the drive assembly230along the longitudinal slot282. In this manner the position of the drive assembly230can be adjusted to align the axis of rotation226with the joint axis.

The drive assembly220can further includes an indented portion288. The indented portion288in sized to receive the first extension member228therein such that the first extension member228slides through the indented portion288as the drive assembly230is moved along the first extension member230. The indented portion288is configured to align the drive assembly230with respect to the first extension member228. The indented portion288provides the further benefit of resisting a rotation of the drive assembly230with respect to the first extension member228when the orthosis220is in use.

Referring toFIG. 30, the drive assembly230can include a pair of indented portions288and290, positioned on opposite sides on the drive assembly230. As shown inFIG. 29, the first indented section288can be used to position the drive assembly230in an outer position on the orthosis220, where the drive assembly230is positioned on an outside surface292of the first extension member228.

Alternatively, as shown inFIG. 31, the second indented section290can be used to position the drive assembly230in an inner position on the orthosis220, where the drive assembly230is positioned on an inner surface294of the first extension member228. The threaded member284is positioned through the longitudinal slotted section282, where the threaded member284is threaded into a second threaded hole296in the drive assembly230.

In an embodiment, the first member221call be adjustable mounted to the first cuff222, such that the position of the second cuff224can be adjusted to align the second cuff224with a toe of interest and the joint axis of the toe. In instances were 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 cuff224can be adjusted with respect to the first cuff222aligning the second cuff224with the misaligned toe such that the axis of rotation226of the orthosis220is aligned with the axis of rotation of the toe joint. In the manner, the orthosis220can be adjusted to prevent the unwanted application of torsional forces to the toe joint.

Referring toFIG. 32, the first member221is adjustably attached to a bottom surface of the first cuff222. The first member221can included a longitudinal slot300, through which a pair of threaded members302and304are positioned, attaching the first member221to the first cuff222. The first member221can be moved along the longitudinal slot300to laterally adjust the position of the first member221with respect to the first cuff222. The first member221is secured in position by tightening the threaded member302and304, compressing the first member221between the threaded members302and304and the bottom surface298of the first cuff222.

The first member221can further include a second longitudinal slot306, parallel and offset from the first longitudinal slot300. The first member221can be attached to the first cuff222, using the second longitudinal slot306to longitudinally adjust the position of the first member221with respect to the first cuff222. Similarly, the first member221can be moved along the second longitudinal slot306to laterally adjust the position of the first member221with respect to the first cuff222.

It is also contemplated that the angular position of the first member221can be adjusted with respect to the first cuff222. In an embodiment, as shown inFIG. 33, the bottom surface298of the first cuff222includes a center threaded hole308and an arcuate slot310. An internally threaded fastener312is slidingly positioned in the arcuate slot310, opposite the bottom surface298. The first member221is attached to the first cuff222by positioning the threaded members302and304through a longitudinal slot300or306of the first member221and engaging the threaded hole308and the internally threaded fastener312in the arcuate slot310. The angular position of the first member221can be adjusted with respect to the first cuff222by pivoting the first member221about threaded member302in the center threaded hole308, such that the internally threaded fastener312and the second threaded member302travel along the arcuate slot310. The first member221is secured in position by tightening the threaded members302and304, compressing the first member221between the threaded members302and the bottom surface298of the first cuff222, and compressing the first member221and first cuff222between threaded member304and internally threaded fastener312.

The bottom surface298of the first cuff222can further include a second arcuate slot314, where an internally threaded fastener316is slidingly positioned in the second arcuate slot314, opposite the bottom surface298of the first cuff222. Similar to arcuate slot310, second arcuate slot314can be used to angularly adjust the position of the first member221with respect to the first cuff222.

Specifically, the first member221is attached to the first cuff222by positioning the threaded members302and304through a longitudinal slot300or306of the first member221and engaging the threaded hole308and the internally threaded fastener316in arcuate slot314. The angular position of the first member221can be adjusted with respect to the first cuff222by pivoting the first member221about threaded member302in the center threaded hole308, such that the internally threaded fastener316and the second threaded member304travel along the arcuate slot314. The first member221is secured in position by tightening the threaded member302and304, compressing the first member221between the threaded members302and the bottom surface298of the first cuff222, and compressing the first member221and first cuff222between the threaded member304and internally threaded fastener316.

It is also contemplated that the first member221can be attached to the first cuff221using the arcuate slots310and314and the respected internally threaded members312and316. Specifically, the first member221is attached to the first cuff222by positioning the threaded members302and304through a longitudinal slot300or306of the first member221and engaging the internally threaded fastener312in the arcuate slot310and the internally threaded fastener316in arcuate slot314. The angular position of the first member221can be adjusted with respect to the first cuff222by pivoting the first member221such that the internally threaded fasteners312and316travel along the arcuate slots310and314. The first member221is secured in position by tightening the threaded member302and304, the first member221and first cuff222between the treaded members302and304and internally threaded fastener312and316.

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.

FIG. 34, for example, schematically illustrates an embodiment of an orthosis330of the invention having a first member332and a second member334, 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,34the second member has a first pivoting contact point336about which the geared body member may rotate. In this embodiment, the first pivoting contact336does not move in relation to the first body member330, but as indicated inFIG. 32one alternative embodiment may allow relative movement that can be resisted by a flexible device338such as a spring, compressed gas, foamed material, elastomer or the like.

Returning once again toFIG. 34, the second member may have an additional pivot contact340, preferably disposed at a location at or near the opposite end of the second member334from where the first pivoting contact336is located. The second pivoting contact340may be configured with a drive assembly344that causes the second member334to follow a predetermined path. Thus, the second pivoting contact340in the embodiment ofFIG. 34is configured to move relative to the first member332in order to cause the joint to move from a first position to second one.

The drive assembly344illustrated inFIG. 34is an arm or linkage346connected between the second pivot connection340and a rotating wheel348. The wheel348may be configured so that the linkage346can 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 wheel348is rotated, the linkage346moves in a manner that causes the second member334to move in a particular way.

The second member334(or alternatively the first member332) may also have a sliding contact surface342. The sliding contact surface342allows the joint to rotate or move according to its natural instantaneous axis of rotation. Thus, if the second pivot contact340moves in a manner that does not always exactly correspond to the axis of rotation of the joint, the sliding contact surface342may move or adjust accordingly. Another potential advantage of the sliding contact surface342is that is may help facilitate proper alignment of the joint in the orthosis during initial setup.

FIG. 34illustrates 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 spring338that 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 spring338maybe made of a variety of suitable materials and constructions to permit some flexibility in the movement of the pivot points336,340.

The use of a spring or cushion allows the orthosis330to 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.

Thus, an orthosis330configured with a spring or cushion338can 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 orthosis330imparts 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 whileFIG. 35illustrates the cushion or spring338associated with the first pivot contact336, it is not required to be associated with it. Instead, for example, the cushion or spring338may be associated with the second pivot340so that it can flex or move in response to resistive forces of the joint and nearby tissue. Likewise, there may be a spring or cushion338associated with both pivot contacts336,340.

Another notable variation between the embodiments ofFIGS. 34 and 35is that the rotating wheel348inFIG. 34has multiple single point connections for connecting the linkage346at different distances from the center of rotation of the wheel. In contrast, the embodiment ofFIG. 35illustrates that an elongated slot350may be used to connect the linkage346. The advantage of utilizing multiple single point connections may be ease of use and the ability to quickly confirm the orthosis330is properly configured for a prescribed treatment protocol, whereas one potential advantage of utilizing an elongated slot350is the ability to quickly adjust the settings without disassembling the device.

FIG. 36illustrates an embodiment of the invention where the rotating wheel348is a cam surface352. 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 surface352may have varying distance from the center or rotation of the wheel348. If the wheel358is 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 linkage346to move to the second member340in a desired manner. Additionally, the outer edge of the “wheel”348need not be round, but instead may be a cam surface352of varying distance from the center or rotation. Likewise, the outer surface may have varying radii of curvature as shown inFIG. 36.

The embodiments ofFIGS. 37 and 38further illustrate that a cam surface352may be used to move the second member332in a desired, perhaps complex way. As is the case for other embodiments described herein, performance of the cam surface352maybe enhanced because of the ability to better mimic or replicate a moving axis of rotation of the treated tissue and joint.

InFIG. 37, the cam surface352is associated with the first member332. Linkages or arms346of the second member334have cam followers354that trace the cam surface352and cause the second member334to move in a more complex manner than just by rotation around a fixed axis.

The cam surface352ofFIG. 37also is associated with a slot356that allows the relative location of the first and second members332and334to be adjusted or moved without decoupling the cam followers354from the cam surface352. As shown, the slot356allows for horizontal adjustment repositioning. Although not shown, vertical slots may also be provided, either alone or in combination with a horizontal slot.

FIG. 38illustrates an example where the linkage346is a cam surface352that passes through two or more points358,360that are stationary or fixed relative to the first member332when the orthosis330is in use (i.e. after alignment is completed). Once again, this embodiment may be configured to permit horizontal adjustment, such as by providing slot368, and likewise may be configured to be vertically adjustable. In addition, this embodiment also illustrates that the first and second members332and334may be represented by rotation about a pivot370. Thus, the use of horizontal, vertical, and rotational adjustment of the relative positions of the first and second members332and334may allow greater fitting of the orthosis330to the treated tissue and joint.

FIG. 39is an exploded view of how the cam surface352and cam followers354may utilize a geared surface372. Utilizing a geared surface372may allow for a drive assembly344to automate the movement of the orthosis330.

FIGS. 40 and 41schematically illustrate other ways in which potentially complex movement of the second member334may be controlled.FIG. 40illustrates 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 orthosis330may be operatively connected to a base unit374having a plurality of cam surfaces376corresponding to different ranges of motion for related joints, such as when the orthosis330can be used to treat a plurality of different toes or a patient. Once the orthosis181is placed on the patient, the second member334will be positioned to securely hold one of the toes on the patient's foot and to engage with the cam surface376corresponding to that toe.

FIG. 41shows that multiple cam surfaces or slots378may be formed in a side panel380. The side panel380may have a sliding engagement of the second member334. As the second member334moves, the engagement with the side panel380controls position and movement. Moreover, one or more sides or edges of a slot316of the embodiment ofFIG. 41may be geared to allow implementation of a drive assembly344.

FIG. 42illustrates an embodiment where movement of at least part of a linkage346may be linear, but when combined with a rotational pivot382, sliding slot384, and possibly other components or combinations described herein, the net effect on the second member334is once again a controlled movement in a desired manner.

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.

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”).

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

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.

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, ultrasonic 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.

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.

All references cited herein are expressly incorporated by reference in their entirety.

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.