Method of Increasing Range of Motion

1. Technical Field

The present invention relates to an orthosis for stretching tissue in the human body to regain joint motion and eliminate tissue contracture. In particular, the present invention relates to an orthosis which limits compressive forces on the soft tissue around a joint while it stretches tissue around a joint. The present invention also relates to a continuous passive motion system for joint therapy.

2. Description of the Prior Art

When the full range of movement of a joint is not available, such as after surgery or trauma, tissue around the joint stiffens and loses its ability to move through the extremes of motion. Various devices have been designed to regain range of motion.

U.S. Pat. No. 4,612,919 shows an adjustable limb support for adjustably orienting the forearm and upper arm of a human patient in a variety of angular relationships to therapeutically treat the contracted muscles in the patient's arm.

U.S. Pat. No. 4,848,326 shows a knee contracture correction device for straightening a contracted knee.

U.S. Pat. No. 4,538,600 shows an adjustable splint assembly with a lower strut and an upper strut pivotably connected to the lower strut. An external spring applies a force at the pivot point to align the upper and lower struts to straighten the limb to which the splint is attached. A similar device is also shown in U.S. Pat. No. 4,508,111. Similar devices are in use and are sold under the trademark DYNASPLINT by Dynasplint Systems, Inc.

U.S. Pat. No. 4,665,905 shows a dynamic elbow and knee extension device with a centrally positioned compression spring.

It is also known in the art to put a rigid element including a turnbuckle, on the inside angle of a joint, between two cuffs attached to limb segments and use the turnbuckle to vary the length of the rigid element to pull and push the limb segments relative to each other. It has been found that this device does not work very well in practice because it is cumbersome mad difficult to obtain relatively flail extension or flexion at the extremes of motion.

Each of the above-identified prior art devices, and each of the devices in use at the present time, does not apply adequate force in the appropriate planes. Further, each of these devices applies undesirable compressive forces on the soft tissues around a joint upon flexion and extension of the joint. None allows the patient to provide the proper therapy by himself, without the assistance of a therapist who manually stretches the joint. None allows the patient to control the therapy process in a self-directed manner.

Accordingly, it is desirable to provide a self-directed therapy device which not only enhances the range of motion of the joint but also limits compressive joint forces, distracts the joint and stretches soft tissue. "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.

The device should limit tissue damage by controlling the amount of force applied, and should apply a progressive gradual stretching action and have a locking mechanism to maintain a joint in a selected position, because tissue is viscoelastic. This is the best way to establish or reestablish a range of motion in the soft tissues around a joint, as it does not involve damaging the tissue.

An orthosis should also be lightweight and portable so that it can be used in a seated, upright, or functional position. This should be the case for both a stretching device and a continuous passive motion (CPM) device.

In the earlier filed co-pending applications identified above, there were disclosed orthoses having certain novel features and advantages. The present invention is an improved version of the earlier orthoses.

As in the earlier orthoses, a tower provides mechanical advantage for increasing the range of motion of the joint. A significant mechanical advantage is also gained through the use of a gear drive mechanism for transmitting to the joint the force applied by the patient. This allows the orthosis to be relatively small and light weight. This mechanical advantage can also be achieved through the use of drive mechanisms other than the gear drive. In any case, the drive mechanism can deliver appropriate force or greater force to stretch soft tissue.

In the present invention, the orthosis provides for distraction of the joint through the entire range of motion. The orthosis includes two relatively pivotable cuff arms. Each cuff arm has a cuff mounted on the cuff arm. The cuffs clamp onto the body portions on either side of the joint. The pivot axis of the cuff anus is spaced from the pivot axis of the joint. Movement of the cuff arms to extend the joint results in distractive forces being applied to the joint. These distractive forces arc limited and controlled by having the cuffs slidable on the cuff arms. The cuffs are selectively moved along the cuff arms, during relative movement of the cuff arms, to provide the proper amount of distractive forces to the joint and to limit compressive forces on the joint. Thus, the orthosis is well suited for stretching therapy.

The orthosis may also provides an optional system for continuous passive motion therapy for a joint. The orthosis is light weight and may be operated by an electric motor cycling it between flexion and extension. This may also be done in combination with the manual stretching therapy.

The foregoing and other features of the present invention will become apparent to one skilled in the art upon a consideration of the following description of the invention with reference to the accompanying drawings, wherein:

FIG. 1 is a view of an orthosis in accordance with the present invention;

FIG. 2 is an enlarged sectional view of a portion of the orthosis of FIG. 1 including the drive mechanism;

FIG. 3 is a sectional view through a cuff attachment point;

FIG. 4 is a sectional view through a cuff attachment point including the cuff actuator block;

FIG. 5 is a view showing the orthosis of FIG. 1 in two positions of its range of motion;

FIG. 6 is a view of an orthosis having an electric motor drive;

FIG. 7 is a view of a structure for varying angular attachment of the cuffs to the cuff arms;

FIG. 8 is a view of an orthosis having a fluid drive;

FIG. 9 is a plan view of an orthosis having an alternate electric chive, combined with a manual drive;

FIG. 10 is a view similar to FIG. 1 of an orthosis having structure for adjusting longitudinal placement of the cuffs relative to the body portions;

FIG. 11 is an end view of the orthosis of FIG. 10 showing structure for adjusting the width of a cuff;

FIG. 12 is an enlarged view of a portion of the orthosis of FIG. 10 showing structure for adjustably receiving a pin or K-wire;

FIG. 13 is a view of a portion of an orthosis including a slip clutch the drive mechanism;

FIG. 14 is a view similar to FIG. 13 illustrating a ratchet drive in the drive mechanism;

FIG. 15 is a top plan view of an arm actuator block that is disengageable from a ball thread lead screw, in an engaged condition;

FIG. 16 is a view similar to FIG. 16, with the arm actuator block in a disengaged condition;

FIG. 17 is a front elevational of the lead screw and arm actuator block of FIG. 15;

FIG. 18 is a schematic front elevational of a variable pitch lead screw;

FIG. 19 is a view of an orthosis being used in combination with a rollable foot rest for knee therapy; and

FIG. 20 is an end view of the foot rest of FIG. 19.

The present invention relates to an orthosis and particularly to an orthosis for moving a joint between first and second relatively movable body portions. The present invention is applicable to various orthosis constructions. As representative of the present invention, FIG. 1 illustrates generally an orthosis 10. In FIG. 1 the orthosis 10 is illustrated as attached to a human arm, for moving the elbow joint which is between the upper arm and the forearm.

It should be understood that the orthosis 10 can be used to extend or flex other joints in the body, such as a knee joint or a wrist joint or ankle joint, with the construction of the orthosis 10 in such case being varied to fit the particular application. The orthosis can be used, for example, to flex the ankle joint to stretch a tight achilles tendon in cerebral palsy or post traumatic contractures. It is especially useful in obtaining the last degrees of joint extension. The orthosis can be custom made to fit a particular individual, or can be an off the shelf item. The orthosis can also be used, for example, to eliminate contractures or stress soft tissue. It can be used for patients with cerebral palsy, stroke, spastic paralysis, as well as in post-traumatic or post-surgical cases. It can also be used, for example, in therapy after a knee replacement, in which the extremes of motion in extension or flexion are difficult to obtain without extensive intervention of a therapist.

The orthosis 10 includes a first cuff 12 for attachment to a first body portion 14 such as the forearm, and a second cuff 16 for attachment to a second body portion 18 such as the upper arm. (The term "cuff" as used herein means any suitable structure for transmitting the force of the orthosis to the limb portion it engages.) The first body portion 14 is joined to the second body portion 18 at the elbow joint designated A, around which is located, as is well known, soft tissue. Each of the first and second cuffs 12 and 16 includes a plurality of loop connectors 20 for receiving swaps extending around the body portions 14 and 18 to clamp the cuffs 12 and 16 to the body portions 14 and 18.

The first cuff 12 is mounted for sliding movement on a first cuff arm 22. (The term "cuff arm" as used herein means any suitable structure for transmitting the force of the orthosis to the cuff and thence to the limb portion.) The first cuff arm 22 is pivotally mounted by a pin 24 to a tower 26. The first cuff arm 22 includes a support 28. A first lever arm 30 extends from the tower 26 and is pivotally connected to the support 28 by a pin 32. The first lever arm 30 is pivotally connected to a cuff actuator block 34. The cuff actuator block 34 is fixed to the first cuff 12 and is slidable along the first cuff arm 22 in a manner as described below.

The second cuff 16 is mounted for sliding movement on a second cuff arm 40. The second cuff arm 40 is pivotally mounted by a pin 42 to the tower 26. The second cuff arm 40 includes a support 44. A second lever arm 46 extends from the tower 26 and is pivotally connected to the support 44 by a pin 48. The second lever arm 46 is pivotally connected to a cuff actuator block 50. The cuff actuator block 50 is fixed to the second cuff 16 and is slidable along the second cuff arm 40 in a manner as described below.

The tower 26 is a box-like structure including a lower housing 66 and an upper housing 70 joined by a front plate 51 and a back plate 53. A drive mechanism for the orthosis 10 is disposed substantially within the tower 26. The drive mechanism includes a manually actuatable knob 52 (FIG. 1) which is fixed to a shaft 54. The shaft 54 extends into the tower 26 and a gear 56 (FIG. 2) is fixed to the shaft. The gear 56 engages external gear teeth 58 on a gear 60. Rotation of the gear 56 about its axis causes rotation of the gear 60 about its axis.

The gear 60 is fixed to an externally threaded lead screw 62. One end of the lead screw 62 is journalled for rotation in a bushing 64 mounted in a lower housing 66 of the tower 26. The opposite end of the lead screw 62 is journalled for rotation in a bushing 68 mounted in an upper housing 70 of the tower 26. An arm actuator block or base link 72 has an internally threaded opening 74 through which the lead screw 62 extends in threaded engagement. As the lead screw 62 rotates, the actuator block moves axially along the lead screw 62 within the tower 26.

A pin 76 is fixed in the arm actuator block 72. The pin 76 extends through an opening 78 in a first portion 80 of the first lever arm 30. The Fast lever arm 30 is L-shaped, having an elbow portion 82 intermediate the first portion 80 and a second portion 84. An opening 86 extends through the elbow portion 82 of the first lever arm 30. A pin 88 fixed in the support 28 of the first cuff arm 22 extends through the opening 86. A slot 90 extends through the second portion 84 of the first lever arm 30.

The cuff actuator block 34 (FIG. 4) includes a pin portion 92 and a guide portion 94. The pin portion 92 has an open center and receives therein the slotted second portion 84 of the first lever arm 30. A pin 95 having its ends fixed in the pin portion 92 extends through the slot 90 in the lever arm portion 84, thus connecting the first lever arm 30 to the cuff actuator block 34.

Each cuff arm functions as a track along which its respective cuff slides. Each cuff arm may thus take any suitable shape. In a preferred embodiment, the cuff arms are U-shaped and include a bottom portion and upstanding side portions. Thus, the first cuff arm 22 is U-shaped and includes a bottom portion 96 and a side portion 98. Part of the guide portion 94 of the cuff actuator block 34 is supported on the bottom portion 96 of the First cuff arm 22. Part of the guide portion 94 is received in a slot 100 in the first cuff arm 22.

A bolt 102 extends through the slot 100 and with a nut 104 secures the cuff actuator block 34 to the shell 106 of the first cuff 12. The nut 104 is turned down only tightly enough to secure the cuff actuator block 34 for movement with the cuff shell 106, while allowing the shell 106 to slide relative to the first cuff arm 22. The head of the bolt 102 is within a layer 108 of padding on the inside of the shell 106.

The first cuff 12 is also slidably mounted to the first cuff arm 22 at a second location (FIGS. 3 and 5) by a bolt 110, red a nut 112. The bolt 110 extends through a slot 114 in the bottom portion of the First cuff arm 22 and through a bearing 116 which mounts the first cuff 12 for sliding movement relative to the first cuff arm 22. Again, the nut 112 is turned down only tightly enough to secure the bearing 116 for sliding movement with the shell 106, while allowing the shell 106 to slide relative to the first cuff arm 22.

The second cuff 16 is similar to the first cuff 12, differing in the illustrated embodiment only in that it is shorter to fit the second body portion 16 rather than the first body portion 14. Similarly, the second cuff arm 40 is similar to the first cuff arm 22, differing in the illustrated embodiment only in that it is shorter to fit the shorter second cuff 16. It should be understood that the cuffs are, in any particular embodiment, sized to fit the particular body portion (leg, arm, ankle, etc.) to which they are to be connected. Accordingly, the illustration of the second cuff being shorter than the first cuff is only in one particular application and is not to be considered limiting in any regard. All the other parts of the drive mechanism, etc. are similar between the two sides of the orthosis.

In accordance with a feature of the present invention, the pivot point of the cuff arms 22 and 40 is spaced outwardly from the joint A, so that the joint A can be distracted. The first body portion 14, the joint A, and the second body portion 16 define on one side of the joint A an inner sector "B" (inside the bend of the limb) which decreases in angle as the joint A is flexed (bent). The first body portion 14, the joint A, and the second body portion 16 define on the opposite side of the joint A an outer sector "C" which decreases in angle as the joint A is extended (straightened). The tower 26 is located in the outer sector "C".

The pivot axis of the cuff arms is represented by the point D in the outer sector C (see FIG. 1). The distance between the point D and a point E on the first cuff arm 22 is the same as the distance between the point D and a point P on the second cuff arm 40. The dotted line triangles in FIG. 1 illustrate the relative positions of the various points in FIG. 1.

Assuming that the first body portion 14 were securely fixed to the first cuff arm 22 by the first cuff 11, and that the second body portion 18 were securely fixed to the second cuff arm 4.0 by the second cuff 16, then upon rotation of the cuff arms relative to each other from a more flexed position to a more extended position, the points E and F would move upwardly as viewed in FIG. 1. Since the distance between the points A and D would not change, then the joint A would be subjected to distractive forces tending to pull the joint A apart.

It can thus be seen that, because the pivot point D of the cuff arms 22 and 40 is spaced outwardly from the joint A, when the orthosis 10 is extended, the joint A is distracted. Thus, the tower 26 provides a triangular or tripod effect and also serves to provide an increased moment arm for the first and second lever arms 30 and 46.

Such distraction of the joint is desirable, as noted above. However, it has been found an excessive amount of distractive force can be applied in this manner. Accordingly, in the orthosis 10 according to the present invention, the amount of distraction is controlled in a manner described below.

Extension

In operation of the orthosis illustrated in FIGS. 1-5, the knob 52 is rotated by the application of an external force. The knob 52 is fixed to the shaft 54 and the gear 56, and thus the gear 56 rotates. The gear 56 causes the gear 60 to rotate. The gear 60 is fixed to the lead screw 62, and thus the lead screw 62 rotates. Rotation of the lead screw 62 results in axial movement of the arm actuator block 72. The gearing provides a substantial mechanical advantage in the operation of the drive mechanism. The gear ratios may be selected to give the desired amount of cuff arm movement for a given amount of force input to the orthosis.

In operation of the orthosis 10 to extend the joint, the orthosis 10 starts at a more flexed position such as the position shown in dashed lines in FIG. 5. The first and second cuffs 12 and 16 are clamped onto the first and second body portions 14 and 18 (FIG. 1), respectively, by swaps through the loops 20, tightly enough so that the cuffs 12 and 16 can apply torque to the body portions 14 and 18 to extend the joint A.

The knob 52 is turned so that the arm actuator block 72 moves upward as viewed in FIGS. 2 and 5, that is, toward the upper housing 66. As the arm actuator block 72 moves upward, it moves the pin 76 upward also. The pin 76 applies an upwardly-directed force on the first portion 80 of the first lever arm 30. This force is transmitted to and through the pin 88, the support 28, and to the first cuff arm 22. The first cuff arm 22 pivots about the pin 24, toward the position shown in solid lines in FIG. 2.

The first lever arm 30 also applies an upwardly-directed force on the pin 95 fixed to the cuff actuator block 34. M the first cuff arm 22 pivots relative to the tower 26, the cuff actuator block 34, because it can slide along the first cuff arm 22, moves inwardly along the first cuff arm 22. The first cuff 12, which is fixed to the cuff actuator block 34, also moves inwardly along the first cuff arm 22. This can be seen clearly in FIG. 5 by comparing the distance marked G, to the distance marked H. The distance marked G is the distance between the end of the fast cuff 12 and the end of the first cuff arm 22 when the orthosis is in a relatively flexed condition. The distance marked H is the distance between the end of the first cuff 12 and the end of the first cuff arm 22 when the orthosis is in a relatively extended condition. The distance marked G is greater than the distance marked H.

The operation with respect to the second cuff arm 40 is similar. As the arm actuator block 72 moves upward, it applies an upwardly-directed force on the second lever arm 4.6. This force is transmitted to and through the support 44 to the second cuff arm 40. The second cuff arm 40 pivots about the pin 42, toward the position shown in solid lines in FIG. 2.

The second lever arm 46 also applies an upwardly-directed force on the cuff actuator block 50. As the second cuff arm 40 pivots relative to the tower 26, the cuff actuator block 50, because it can slide along the second cuff arm 40, moves inwardly along the second cuff arm 40. The second cuff 16, which is fixed to the cuff actuator block 50, also moves inwardly along the cuff arm 40. This can be seen clearly in FIG. 5 by comparing the distance marked I to the distance marked J. The distance marked I is the distance between the end of the second cuff 16 and the end of the second cuff arm 40 when the orthosis is in a relatively flexed condition. The distance marked J is the distance between the end of the second cuff 16 and the end of the second cuff arm 40 when the orthosis is in a relatively extended condition. The distance marked I is greater than the distance marked J.

Because the cuffs are clamped onto the first and second body portions as described above, the outward pivoting movement of the cuff arms and the cuffs causes the joint to be extended as desired. However, this extension of the joint, as described above, can place strong distractive forces on the soft tissues around the joint. The sliding movement of the cuffs, inwardly along the cuff arms, helps to limit these distractive forces by counteracting the outward movement of the cuff arms. Preferably, the cuffs slide inwardly along the cuff arms a distance far enough so that the joint is only slightly distracted during extension. Thus, the detrimental effects of strong distractive forces normally generated in forced extension of a joint are avoided, being replaced with the beneficial effects of limited and controlled distraction.

Flexion

In operation of the orthosis 10 to flex a joint, the orthosis 10 starts at a more extended position such as the position shown in solid lines in FIG. 5. The first and second cuffs 12 and 16 are clamped onto the first and second body portions 14 and 18 (FIG. 1), respectively, by straps through the loops 20, tightly enough so that the cuffs 12 and 16 can apply torque to the body portions 14 and 18 to extend the joint A.

The knob 52 is turned so that the arm actuator block 72 moves downward as viewed in FIGS. 2 and 5, that is, toward the lower housing. As the arm actuator block 72 moves downward, it applies a downwardly-directed force on the first portion 80 of the first lever arm 30. This force is transmitted to and through the pin 88, the support 28, and to the first cuff arm 22. The first cuff arm 22 pivots about the pin 24, toward the position shown in dashed lines in FIG. 5.

The first lever arm 30 also applies a downwardly-directed force on the pin 95 fixed to the cuff actuator block 34. As the first cuff arm 22 pivots relative to the tower 26, the cuff actuator block 34, because it can slide along the first cuff arm 22, moves outwardly along the first cuff arm 22. The first cuff 12, which is fixed to the cuff actuator block 34, also moves outwardly along the first cuff arm 22. This can be seen clearly in FIG. 5 by comparing the distance marked G, to the distance marked H. The distance marked G is the distance between the end of the first cuff 12 and the end of the first cuff arm 22 when the orthosis is in a relatively flexed condition. The distance marked H is the distance between the end of the first cuff 12 and the end of the first cuff arm 22 when the orthosis is in a relatively extended condition. The distance marked G is greater than the distance marked H.

The operation with respect to the second cuff arm 40 is similar. As the arm actuator block 72 moves downward, it applies a downwardly-directed force on the second lever arm 46. This force is transmitted to the second cuff arm 40. The second cuff arm 40 pivots about the pin 42 relative to the tower 26, toward the position shown in dashed lines in FIG. 2.

The second lever arm 46 also applies a downwardly-directed force on the cuff actuator block 50. As the second cuff arm 40 pivots relative to the tower 26, the cuff actuator block 50, because it can slide along the second cuff arm 40, moves outwardly along the second cuff arm 40. The second cuff 16, which is fixed to the cuff actuator block 50, also moves outwardly along the second cuff arm 40. This can be seen clearly in FIG. 5 by comparing the distance marked I to the distance marked J. The distance marked I is the distance between the end of the second cuff 16 and the end of the second cuff arm 40 when the orthosis is in a relatively flexed condition. The distance marked is the distance between the end of the second cuff 16 and the end of the second cuff arm 40 when the orthosis is in a relatively extended condition. The distance marked I is greater than the distance marked J.

Because the cuffs are clamped onto the first and second body portions as described above, the inward pivoting movement of the cuff arms and thus the cuffs causes the joint to be flexed as desired. However, this flexion of the joint can place strong compressive forces on the soft tissues around the joint. The sliding movement of the cuffs, outwardly along the cuff arms, helps to limit these compressive forces by counteracting the inward movement of the cuff arms. Preferably, the cuffs slide outwardly along the cuff arms a distance far enough so that the joint is actually distracted somewhat during flexion. Thus, the detrimental effects of the compressive forces normally generated in forced flexion of a joint are avoided, being replaced with the beneficial effects of a controlled amount of distraction.

The orthosis in accordance with the present invention may include means for monitoring the angle between the first and second cuff arms 22 and 40. In one embodiment, this may be a goniometer 120 as illustrated in FIG. 5. A slot 122 extends along the length of the tower 26. A pin 124 on the first lever arm 30 is visible through the slot 122. The position of the pin 124 is readable against a scale 126 indicating degrees of flexion of the joint. As the first and second lever arms 30 and 46 pivot relative to each other, the first lever arm 30 moves downward in the tower 126. The pin 124 moves along the slot 122 and indicates the relative position of the two cuff arms 22 and 40. Equivalent manners of measuring the angle between the two arms are possible and are included within the scope of the invention.

An orthosis in accordance with the present invention may include means for adjusting the angle between a cuff arm and the cuff attached thereto. This can be used to apply an initial biasing force in one direction, or to position the limb portion initially within the cuff. This can also be used to accommodate angular displacement between the first and second body portions. For example, in an elbow joint there is normally about a 7.degree. angle between the upper arm and the forearm.

In one embodiment, this may be a mechanism as illustrated in FIG. 7, which is a top plan view of a portion of a cuff arm 130. A cuff attachment screw 132 is movable in a slot 134 and can be slidably fixed in position with a nut 136, as in the embodiment of FIGS. 1-5. However, the opening in the bearing 138 through which the screw 132 extends is off-center of the bearing 138. Also, the bearing 138 has a marker 140 readable against a scale 142 on the bottom portion 144 of the cuff arm 130. Rotation of the beating 138 in the slot 134 moves the screw 132 off the longitudinal center line of the cuff arm 130. This causes the cuff (not shown in FIG. 7) fixed to the screw 132 to be rotated with respect to the cuff arm 130. The cuff can then be fixed in a given angular orientation relative to the cuff arm 132. Equivalent manners of setting an angular orientation between a cuff and its cuff arm are possible and are included within the scope of the invention.

The drive mechanism for an orthosis in accordance with the present invention can be actuated by an electric motor instead of by a manually actuatable member such as the knob 52. FIG. 6 illustrates one way of utilizing an electric motor for this purpose.

In FIG. 6, an electric motor 150 is mounted in the lower portion of a tower 152. The motor 150 is drivingly connected to a lead screw 154. The lead screw 154 moves the lever arms 30 and 46 in the same manner as in the embodiment of FIGS. 1-5. The lever arms 30 and 46 move the cuff arms 22 and 40 in the same manner as in the embodiment of FIGS. 1-5.

A battery 156 secured to the back plate of the tower 152 provides electric power to the motor 150 through wires 158. Alternatively, the motor could be supplied with external power. A microprocessor indicated schematically at 160 and mounted on the front plate 162 of the tower 152 controls the operation of the motor 150 through signals sent along wires 164. The microprocessor 160 and motor 150 together can be used to cycle the cuff arms 22 and 40 through extension and flexion; to move the cuff arms 22 and 40 in one pivotal direction a certain amount, hold there while tissue stretches, then move further in that direction; or in any other mariner. 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 160 is within the skill of the art as it relates to driving the motor to control the cuff arms 22 and 40 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 understood that the particular physical arrangement of the motor 150, the battery 156, and the microprocessor 160, which is illustrated and described herein, 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.

FIG. 9 illustrates an alternative method of using an electric motor drive. An electric motor 166 is mounted on the outside of a tower 168, on the front plate 170 of the tower 168. The motor 166 drives the shaft 54 which extends between the front plate 170 and the back plate 172 of the tower 168. The shaft 54 carries the gear 56, as in the embodiment of FIGS. 1-5. The motor 166 is supplied with electric power, and control signals, through wires 174. A manually actuatable member such as a knob 52 is also drivingly connected to the shaft 54. When the knob 52 is used to actuate the orthosis manually, the motor 166 freewheels. Thus, the orthosis illustrated in FIG. 9 can be used either manually, or with an electric motor drive, or both. Therefore, the orthosis is ideally suited for both stretching therapy and CPM therapy.

Another type of power source, other than an electric motor, can also be used. For example, FIG. 8 illustrates the use of a hydraulic or pneumatic motor 180 as the drive mechanism for an orthosis in accordance with the present invention. The motor 180 is fixed in the lower portion of a tower 182. Fluid under pressure is supplied to the motor through a port 184. Actuation of the motor 180 causes a piston 186 to move axially in the tower 182. The piston 186 is connected to the arm actuator block 72. Axial movement of the piston 186 causes axial movement of the arm actuator block 72 to drive the lever arms 30 and 46 and the cuff arms 22 and 40 in the same manner as in the embodiment of FIGS. 1-5. Thus, it can be seen that many different types of power sources are suitable for use with an orthosis in accordance with the present invention.

An orthosis in accordance with the present invention can also be used to move a joint when one or both of the bone portions around the joint has projecting pins or K-wires. For example, after some types of bone surgery, the surgeon leaves pins or K-wires projecting from the bone through the skin. The fact that the arm is in this condition does not mean that therapy can not be applied. Raffler, the pins or K-wires can be utilized to apply, directly to the bone, the force supplied by the orthosis.

The orthosis 190 illustrated in FIGS. 10-12 is one example. It should be understood that the design of such an orthosis can vary depending on the placement of the pins or k-wires and the therapy to be applied. The design will also vary depending on what particular joint is being moved by the orthosis.

In FIG. 10, the orthosis cuffs 192 each have longitudinally extending slots 196 for receiving cuff attachment screws 198. Each screw has an opening 200 for receiving a pin or K-wire 202. The screw 198 clamps onto the K-wire strongly enough to transmit torque to the bone through the pin or K-wire. As the cuffs slide along the cuff arms 204, and as the arms 204 pivot relative to the tower 205, the body portions to which the cuffs 192 are attached also are moved. Thus, the force of the orthosis is applied directly to bone through the pins or K-wires.

The opening 200 may be eccentrically located in the screw 198 as seen best in FIG. 12. Rotation of the screw 198 relative to the cuff 192 moves the pin 200 relative to the cuff 192. The cuff 192 can then be fixed in a given angular orientation relative to the body portion from which the pin 200 projects. This adjustment can be used to compensate for the particular location of the pins or K-wires, or can be used to apply an initial biasing force in one direction, or to position the limb portion initially within the cuff.

The cuff 192 may include, as best seen in FIG. 11, two cuff side portions 206 and 207 which are slidable relative to each other to position the cuff 192 as well as possible relative to the limb portion. A locking adjuster 208, which may be of a known construction to allow sliding movement then locking in position, is used to position the cuff side portions 206 and 207 relative to each other.

Further, the initial longitudinal positioning of a screw 198 along the cuff 192 can be adjusted using the positioner mechanism 209 shown in FIG. 10. The cuff attachment screw 198 is connected to a screw 210 which extends through a block 212 fixed to the cuff 192. The screw 210 is rotatable by an adjuster 214. Rotation of the screw 210 moves the cuff attachment screw 198 axially relative to the cuff 192. Again, this adjustment can be used to compensate for the particular location of the pins or K-wires, or can be used to apply an initial biasing force in one direction, or to position the limb portion initially within the cuff. It should be noted that this type of positioner mechanism, as well as the two-part cuff illustrated in FIG. 1, can be used in conjunction with orthoses other than the orthosis illustrated in FIGS. 10-12. It should also be noted flint, if threaded pins are used in the bone, as is sometimes done, the pins can be threaded directly into nuts on the orthosis.

Another advantage of the gear drive mechanism is that it can provide an automatic locking mechanism for blocking movement of the parts of the orthosis in an undesired direction. Because the mechanism is geared down substantially to provide a mechanical advantage, it is difficult to rotate the gears by moving the cuff arms relative to each other. Therefore, if force is applied to the orthosis to extend a joint slightly against the resistance of the soft tissues of the joint, then the force is released, the orthosis and joint will maintain that extended position, and will not revert to the starting position.

This "locking" ability can also be provided by means of a ratchet drive mechanism. Such a mechanism is indicated schematically in FIG. 14, which shows a ratchet drive mechanism 230 of a known construction disposed in the line of force transmission between the knob 52 and the shaft 54 carrying gear 56. The ratchet drive mechanism 230 is operative to allow rotation of the knob 52 and the shaft 54 in one selected direction of rotation, while blocking rotation of the knob 52 and the shaft 54 in the opposite direction. Thus, the patient can turn the knob 52 in the desired direction to move the joint to which the orthosis is attached from a first position to a second position, then release the knob 52. The ratchet mechanism holds the knob 52 from turning back in the opposite direction, thus holding the joint in the second position.

These locking mechanisms are desirable, to maintain a joint in a selected position, because tissue is viscoelastic. That is, tissue will stretch a certain amount, then if it is maintained in that stretched condition for a period of time, will be able to stretch even more. This is the best way to establish or reestablish a range of motion in the soft tissues around a joint, as it does not involve damaging the tissue.

Accordingly, with an orthosis in accordance with the present invention, a patient can apply force to stretch tissue a desired amount by moving the orthosis from a first position to a second position. The patient can then stop applying force to the orthosis. The orthosis remains in the second position. The patient allows the tissue to remain in the stretched condition. The patient can then apply force to stretch tissue a further desired amount by moving the orthosis from the second position to a third position. This repeated stretching and resting of the tissue properly reestablishes a range of motion in the joint.

The orthosis may include means for monitoring, controlling, and/or limiting the amount of force applied by the orthosis, or the range of motion of the orthosis. This can be done in many different ways. A few illustrative methods are shown and described next.

One method is by providing wrench flats 232 as shown in FIG. 14 on the shaft 54 connected to the knob 52. A torque wrench can be applied to file wrench flats 232, and the shaft 54 can be turned with the torque wrench. Thus, the patient will know how much torque it takes to turn the shaft at any point during extension or flexion. This can be translated in various ways into an indication of how much force is being applied to the joint.

Another way of monitoring, controlling, and/or limiting the amount of force applied by the orthosis, when the orthosis includes an electric motor drive, involves measuring the work being performed by the electric motor. A torque sensor indicated schematically at 234 (FIG. 6), which may be of a known construction, measures the torque on the lead screw 54 of the drive mechanism. This value is indicative of the work being performed by the motor 150 and of the force applied to the joint. Alternatively, the microprocessor 160 may include circuitry of a known construction for measuring the current drawn by the electric motor 150. Again, this value is indicative of the work being performed by the motor 150 and thus of the force being applied to the joint.

To provide a positive limiting of the force applied to the joint, a slip clutch can be placed in the drive mechanism. For example, in FIG. 13 there is illustrated a slip clutch 236 of a known construction, in the line of force transmission between the knob 52 and the shaft 54. The slip clutch 236 block transmission of force above a certain amount. Thus, no matter how much the patient turns the knob 52, an excessive amount of force is not applied to the joint. The slip clutch 236 can be of the type which is settable to a given force value, and the orthosis may thus be individualized for each patient and/or each therapy session.

Another method of limiting force applied to the joint tissues is to provide physical "stops" on the orthosis for limiting the range of motion of the orthosis and thus of the joint. There are many readily conceivable ways of doing this, and so they are not described in further detail herein.

In accordance with a further feature of the present invention, the drive mechanism for the cuff arms can be easily and quickly disengaged in case the patient wants to release force on the joint being moved.

An arm actuator block 240 (FIGS. 15-17) includes the openings 78 for the pins 76 which connect the lever arms to the arm actuator block 240. A slider 242 is slidably received in the arm actuator block 240. The slider 242 is fixed for axial movement with the arm actuator block 240. The slider 242 has two leg portions 244. Each leg portion has a cam slot 248. One or more ball members 250 is disposed between each leg portion and a lead screw 252, which preferably has a ball screw thread 254 formed thereon as best seen in FIG. 17. The ball members 250 are fixed for axial movement with the slider 242 and the arm actuator block 240.

A handle 256 including a push button 258 and a rod member 260 is fixed to and projects outwardly from the slider 24.2. The rod member 260 extends through a slot in file front plate (not shown) of the tower. The handle 256 is manually operable to move the slider 24.2 from a first position as shown in FIG. 15 to a second position as shown in FIG. 16.

When the slider 242 is in the first position as illustrated in FIG. 15, the ball members 250 are cammed radially inwardly into engagement with the ball screw thread 254 on the lead screw 252. Rotation of the lead screw 252 causes axial movement of the ball members 250, and thus results in axial movement of the slider 242 and of the arm actuator block 40. Axial movement of the arm actuator block 240, as described above, causes relative movement of the orthosis arms.

When the slider 242 is in the second position as shown in FIG. 16, the ball members 250 are cammed radially outwardly, by the ball screw thread 254, into the cam slots 248 in the slider leg portions 244. In this position, the ball members 250 are disengaged from the ball screw thread 54 of the lead screw 252. Rotation of the lead screw 252 does not result in axial movement of the ball members 250, the slider 242, or the arm actuator block 240.

Thus, there is provided an effective apparatus for disengaging the drive mechanism of an orthosis in accordance with the present invention. It is to be understood that other suitable mechanisms can be provided and are within the scope of the invention.

A gear drive mechanism for an orthosis of the present invention may include variable ratio gearing. For example, the lead screw 252 illustrated in FIG. 17 may be replaced with a lead screw 262 as illustrated in FIG. 18 which has a variable pitch. The gear teeth represented at 264 are closer together at the axial ends of the lead screw 262 than in the middle. The pitch 266 between adjacent teeth at the ends of the lead screw 262 is less than the pitch 268 between adjacent teeth at the center of the lead screw 262. Thus, an arm actuator block engaging the lead screw 262 will gain less axial motion at the extremes of motion, per revolution of the lead screw, than in the middle of the range of motion.

As noted above, because of the mechanical advantage provided by the drive mechanism and by the tower, an orthosis constructed in accordance with the present invention is lightweight and easily usable by the patient alone. If the orthosis is used on an elbow joint, the patient can use the orthosis while seated upright, with his arm on a suitable rest such as on a table, for example. If the orthosis is used for CPM on a knee joint, that is, cycling between flexion and extension, the patient can use it while seated in a chair. Such use of the orthosis of the present invention is highly preferable to the typical knee therapy which requires that the patient be lying in bed.

When the orthosis is used on a knee with a seated patient, it is desirable to provide, under the patient's foot, a device such as the foot support 270 illustrated in FIGS. 19-20. FIG. 19 illustrates an orthosis 10 as illustrated in FIGS. 1-5. The orthosis 10 is in position to flex and extend a knee joint 272. The knee joint is located between an upper leg 274 and a lower leg 276. A cuff 278 is attached to the upper leg 274. A cuff 279 is attached to the lower leg 276.

The foot support 270 includes a footrest 280. A heel cup 282 is fixed on the foot rest 280. An adjustable strap 284 secures the patient's foot 286 on the foot rest 280. The foot rest 280 is pivotally mounted at 268 to a frame 290. A plurality of rollers 292 are attached to the frame 290. The rollers 292 are rollable on the floor (not shown) underneath the patient. The foot support 270 allows the patient's foot 286 to move back and forth along the floor with minimal resistance. This permits the orthosis 10 to flex and extend the knee joint 272 easily. Thus, the patient can conveniently use the orthosis 10 on his knee joint while in any position such as a comfortable seated position, as compared to the difficulty and inconvenience of therapy while lying in a bed. Of course, the present orthosis can also be used while the patient is lying in bed.

It should also be noted that the orthoses of the present invention are suitable to hyperextend a joint, so that a slight overcorrection may be obtained if needed. Preferably, the orthosis is constructed so that the joint may be hyperextended by 5.degree. to 7.degree.. This provides the fullest range of motion desired. This can be accomplished by construction of the pivotal connection between the tower and the cuff arms to allow for such hyperextension.

The lever arms of the various of orthoses illustrated are rigid members made of, for example, a metal such as aluminum or stainless steel so as to be able to transmit the necessary forces. It should be understood that any material of sufficient rigidity can be used, including a polymeric or composite material.

It is apparent that the orthosis of the present invention can apply much greater forces, safely through any range of motion, as compared to a spring-driven orthosis such as in the prior art. It is further apparent that the orthosis of the present invention attempts to limit compression of a joint through the joint's entire range of motion.

Further, it can be seen that the orthosis of the present invention is usable with the patient seated or in a lying position as opposed to a prior art device which can be used solely while lying in bed, and is thus more comfortable. The orthosis is light weight and portable, because of the mechanical advantage of the drive mechanism and the small power source needed. The orthosis provides both a manual stretching device and an electric CPM device with a manual override. The orthosis can be used to stretch tissue to increase range of motion, or to cycle through the range of motion to maintain it, or both. The orthosis can, when properly dimensioned, be used on any joint. It can also be used for motion other than flexion and extension, such as rotation, pronation, supination, etc., when suitably modified while incorporating the same operating principles.

From the above description of the invention, those skilled in fine art will perceive improvements, changes and modifications in the invention. Such improvements, changes and modifications within the skill of the art are intended to be covered by the appended claims.