WO2016069713A1

WO2016069713A1 - Orthosis for range of motion

Info

Publication number: WO2016069713A1
Application number: PCT/US2015/057749
Authority: WO
Inventors: Glen A. Phillips; Boris Bonutti; Peter M. Bonutti; Joseph MATHEWSON
Original assignee: Bonutti Research, Inc.
Priority date: 2014-10-29
Filing date: 2015-10-28
Publication date: 2016-05-06
Also published as: CN107106314A; CN110448434A; CN107106314B; CN110448434B

Abstract

An orthosis for increasing range of motion of a body joint includes first and second dynamic force mechanisms for simultaneously applying a dynamic force to body portions on opposite sides of a body joint. This or another orthosis includes first and second linkage mechanisms which transmit force from an actuator mechanism to the dynamic force mechanisms and/or respective first and second cuffs to impart movement of the first and second cuffs relative to one another.

Description

ORTHOSIS FOR RANGE OF MOTION

FIELD OF THE DISCLOSURE

[0001] The present disclosure generally relates to an orthosis for treating a joint of a subject, and in particular, and orthosis for increasing range of motion of the joint of the subject.

BACKGROUND OF THE DISCLOSURE

[0002] In a joint of a body, its range of motion depends upon the anatomy and condition of that joint and on the particular genetics of each individual. Many joints primarily move either in flexion or extension, although some joints also are capable of rotational movement in varying degrees. Flexion is to bend the joint and extension is to straighten the joint; however, in the orthopedic convention some joints only flex. Some joints, such as the knee, may exhibit a slight internal or external rotation during flexion or extension. Other joints, such as the elbow or shoulder, not only flex and extend but also exhibit more rotational range of motion, which allows them to move in multiple planes. The elbow joint, for instance, is capable of supination and pronation, which is rotation of the hand about the longitudinal axis of the forearm placing the palm up or the palm down. Likewise, the shoulder is capable of a combination of movements, such as abduction, internal rotation, external rotation, flexion and extension.

[0003] When a joint is injured, either by trauma or by surgery, scar tissue can form or tissue can contract and consequently limit the range of motion of the joint. For example, adhesions can form between tissues and the muscle can contract itself with permanent muscle contracture or tissue hypertrophy such as capsular tissue or skin tissue. Lost range of motion may also result from trauma such as excessive temperature (e.g., thermal or chemical burns) or surgical trauma so that tissue planes which normally glide across each other may become adhered together to markedly restrict motion. The adhered tissues may result from chemical bonds, tissue hypertrophy, proteins such as Actin or Myosin in the tissue, or simply from bleeding and immobilization. It is often possible to mediate, and possibly even correct this condition by use of a range-of-motion (ROM) orthosis.

[0004] ROM orthoses are used during physical rehabilitative therapy to increase the range-of-motion of a body joint. Additionally, they also may be used for tissue transport, bone lengthening, stretching of skin or other tissue, tissue fascia, and the like. When used to treat a joint, the device typically is attached on body portions on opposite sides of the joint so that is can apply a force to move the joint in opposition to the contraction. [0005] A number of different configurations and protocols may be used to increase the range of motion of a joint. For example, stress relaxation techniques may be used to apply variable forces to the joint or tissue while in a constant position. "Stress relaxation" is the reduction of forces, over time, in a material that is stretched and held at a constant length.

Relaxation occurs because of the realignment of fibers and elongation of the material when the tissue is held at a fixed position over time. Treatment methods that use stress relaxation are serial casting and static splinting. One example of devices utilizing stress relaxation is the JAS EZ orthosis, Joint Active Systems, Inc., Effingham, IL.

[0006] Sequential application of stress relaxation techniques, also known as Static Progressive Stretch ("SPS") uses the biomechanical principles of stress relaxation to restore range of motion (ROM) in joint contractures. SPS is the incremental application of stress relaxation—stretch to position to allow tissue forces to drop as tissues stretch, and then stretching the tissue further by moving the device to a new position— repeated application of constant displacement with variable force. In an SPS protocol, the patient is fitted with an orthosis about the joint. The orthosis is operated to stretch the joint until there is tissue/muscle resistance. The orthosis maintains the joint in this position for a set time period, for example five minutes, allowing for stress relaxation. The orthosis is then operated to incrementally increase the stretch in the tissue and again held in position for the set time period. The process of incrementally increasing the stretch in the tissue is continued, with the pattern being repeated for a maximum total session time, for example 30 minutes. The protocol can be progressed by increasing the time period, total treatment time, or with the addition of sessions per day. Additionally, the applied force may also be increased.

[0007] Another treatment protocol uses principles of creep to constantly apply a force over variable displacement. In other words, techniques and devices utilizing principles of creep involve continued deformation with the application of a fixed load. For tissue, the deformation and elongation are continuous but slow (requiring hours to days to obtain plastic deformation), and the material is kept under a constant state of stress. Treatment methods such as traction therapy and dynamic splinting are based on the properties of creep.

SUMMARY OF THE DISCLOSURE

[0008] In one aspect, an orthosis for increasing range of motion of a body joint, the orthosis generally comprises a first body portion securement member configured for securement to a first body portion associated with a body joint, and a second body portion securement member configured for securement to a second body portion associated with the body joint. First and second dynamic force mechanisms are operatively connected to the respective first and second body portion securement members and configured to simultaneously apply dynamic forces to the respective first and second body portions.

[0009] In another aspect, an orthosis for increasing range of motion of a body joint generally comprises a first body portion securement member configured for securement to a first body portion associated with a body joint, a second body portion securement member configured for securement to a second body portion associated with the body joint, and an actuator mechanism. First and second linkage mechanisms operatively connect the respective first and second body portion securement members to the actuator mechanism and are configured to transmit force from the actuator mechanism to the respective first and second body portion securement members to impart movement of the first and second body portion securement members relative to one another. The first and second linkage mechanisms include respective first and second bell crank links.

[0010] Other features will be in part apparent and in part pointed out hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is a perspective of one embodiment of an orthosis for use in treating a body joint in extension;

[0012] FIG. 2 is a front elevation of the orthosis, including first and second cuffs, being driven in a flexion direction;

[0013] FIG. 3 is a partial exploded view of an actuator mechansim and a portion of a linkage mechanism of the orthosis;

[0014] FIG. 4 is an exploded view of a transmission assembly of the actuator mechanism and the portion of the linkage mechanism;

[0015] FIG. 5 is a top plan of the transmission assembly of the actuator mechanism and the portion of the linkage mechanism;

[0016] FIG. 6 is an exploded view of the orthosis showing the linkage mechanisms and dynamic force mechanisms exploded from the actuator mechanism;

[0017] FIG. 7 is an exploded view of the orthosis showing bell crank links exploded from remainders of the linkage mechanisms;

[0018] FIG. 8 is an exploded view of a drive assembly of the actuator mechanism; [0019] FIG. 9 is an enlarged top plan view of a clutch mechanism of the drive assembly, a portion of which being in section;

[0020] FIG. 10 is an exploded view of the orthosis showing the dynamic force mechanisms exploded from the respective linkage mechanisms;

[0021] FIG. 11 is a front elevation of the orthosis, including first and second cuffs, being driven in an extension direction;

[0022] FIG. 12 is similar to FIG. 11, with springs of the dynamic force mechanisms being loaded by pivoting of the bell crank links;

[0023] FIG. 13 is another embodiment of the orthosis for use in treating a body joint in flexion;

[0024] FIG. 14 is a front elevation of the orthosis, including first and second cuffs, being driven in an extension direction;

[0025] FIG. 15 is a front elevation of the orthosis, including first and second cuffs, being driven in an flexion direction;

[0026] FIG. 16 is similar to FIG. 15, with springs of the dynamic force mechanisms being loaded by pivoting of the bell crank links;

[0027] FIG. 17 is an enlarged top plan view of a clutch mechanism of the orthosis, a portion of which being in section;

[0028] FIG. 18 is a perspective of another embodiment of an orthosis for use in treating a body joint in extension;

[0029] FIG. 19 is a front elevation of the orthosis, including first and second cuffs, being driven in a flexion direction;

[0030] FIG. 20 is an exploded view of the orthosis showing the linkage mechanisms and dynamic force mechanisms exploded from the actuator mechanism;

[0031] FIG. 21 is an exploded view of the orthosis showing bell crank links exploded from remainders of the linkage mechanisms;

[0032] FIG. 22 is a perspective the second dynamic force mechanism;

[0033] FIG. 23 is a right elevational view of the second dynamic force mechanism;

[0034] FIG, 24 is an exploded view of the second dynamic force mechanism;

[0035] FIG. 25 is a front elevation of the orthosis, including first and second cuffs, being driven in an extension direction;

[0036] FIG. 26 is similar to FIG. 11, with springs of the dynamic force mechanisms being loaded by pivoting of the bell crank links; [0037] FIG. 27 is a perspective of another embodiment of an orthosis for use in treating a body joint in flexion;

[0038] FIG. 28 is a front elevation of the orthosis, including first and second cuffs, being driven in an extension direction;

[0039] FIG. 29 is a perspective the second dynamic force mechanism;

[0040] FIG. 30 is a right elevational view of the second dynamic force mechanism;

[0041] FIG. 31 is an exploded view of the second dynamic force mechanism;

[0042] FIG. 32 is a front elevation of the orthosis, including first and second cuffs, being driven in a flexion direction;

[0043] FIG. 33 is similar to FIG. 11, with springs of the dynamic force mechanisms being loaded by pivoting of the bell crank links; and

[0044] FIG. 34 is an enlarged top plan view of another embodiment of a clutch mechanism of the drive assembly, a portion of which being in section.

[0045] Corresponding reference characters indicate corresponding parts throughout the drawings.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0046] Referring to FIGS. 1 and 2, an orthosis for treating a joint of a subject is generally indicated at reference numeral 10. The general structure of the orthosis illustrated in FIGS. 1 and 2 is suitable for treating hinge joints (e.g., knee joint, elbow joint, and ankle joint) or ellipsoidal joints (e.g., wrist joint, finger joints, and toe joints) of the body. In particular, the configuration of the orthosis 10 illustrated in FIGS. 1 and 2 is suitable for increasing range of motion of a body joint in extension, although as shown in FIGS. 13-16 and explained in more detail below, in other configurations the orthosis is suitable for increasing range of motion of a body joint in flexion. Moreover, another embodiment suitable for increasing range of motion of a body joint in extension is illustrated in FIGS. 18-26, and another embodiment suitable for increasing range of motion of a body joint in flexion is illustrated in FIGS. 26-33. These additional embodiments are explained in more detail below. Various teachings of the orthosis set forth herein are also suitable for orthoses for treating other joints, including but not limited to the shoulder joint, and the radioulnar joint. Thus, in other embodiments the teachings of the illustrated orthosis may be suitable for increasing range of motion of a body joint in adduction and/or abduction (e.g., the shoulder joint) or in pronation and/or supination (e.g., the radioulnar joint), among other joints. The illustrated embodiments are suitable for applying a dynamic stretch or load to a joint. It is understood that the embodiments may be modified to apply a static stretch or load to a joint, such as by omitting the dynamic force mechanisms, which are described below.

[0047] Referring to FIGS. 1 and 2, the illustrated orthosis 10 is a dynamic stretch orthosis comprising first and second dynamic force mechanisms, generally indicated at 12, 14, respectively, for applying a dynamic stretch to respective first and second body portions on opposite sides of a body joint. An actuator mechanism, generally indicated at 16, is operative ly connected to first and second linkage mechanism, generally indicated at 20, 22, respectively, for transmitting force to respective first and second dynamic mechanisms 12, 14 and loading the dynamic force mechanism during use, as will be explained in more detail below. As shown in FIG. 2, first and second cuffs, generally indicated at 24, 26, respectively (broadly, body portion securement members), are secured to the respective first and second dynamic mechanisms for coupling the body portions to the first and second dynamic mechanisms. Each cuff 24, 26 may include a plastic shell 30, an inner liner 32 comprising a soft, pliable material, at least one strap 34 and associated ring 36 secured to the plastic shell for fastening the body portion to the cuff. The strap(s) may include a hook-and-loop fastener as is generally known in the art. Other ways of attaching the cuffs 24, 26 to the desired body portions of opposite sides of a joint do not depart from the scope of the present invention.

[0048] In one non-limiting example, the first cuff 24 may be configured for coupling to an upper leg portion of a subject, and the second cuff 26 may be configured for coupling to a lower leg portion of the subject to treat a knee joint of the subject. In another non-limiting example, the first cuff 24 may be configured for coupling to an upper arm portion of a subject, and the second cuff 26 may be configured for coupling to a lower arm portion of the subject to treat an elbow joint of the subject. In yet another non-limiting example, the first cuff 24 may be configured for coupling to a lower arm portion of a subject, and the second cuff 26 may be configured for coupling to a hand portion of the subject for treating a wrist joint of the subject. In another non-limiting example, the first cuff 24 may be configured for coupling to a lower leg portion of a subject, and the second cuff 26 may be configured for coupling to a foot portion of the subject for treating an ankle joint of the subject. It is understood that the first and second cuffs 24, 26 may be configured for coupling to other body portions for treating other joints of the subject without departing from the scope of the present invention.

[0049] In one or more embodiments, one or more of the cuffs 24, 26 may be further configured to apply a compressive force to the corresponding body portion to increase blood flow in the body portion and/or inhibit thrombosis. In one example, the one or more cuffs 24, 26 may be configured to apply sequential compression therapy to the corresponding body portion. The one or more cuffs 24, 26 may comprise a sleeve including one or more inflatable bladders. The one or more inflatable bladders may be configured to be in fluid communication with a source of pressurized fluid (e.g., air) for delivering pressurized fluid to inflate the one or more bladders. The one or more cuffs may be configured to apply compression to the corresponding body portion in other ways.

[0050] As will be understood through the following disclosure, the orthosis 10 (and the other orthosis embodiments disclosed herein) may be used as a combination dynamic and static- progressive stretch orthosis. It is understood that in other embodiments the dynamic force mechanisms may be omitted without departing from the scope of the present invention, thereby making the orthosis 10 suitable as a static stretch or static progressive stretch orthosis by utilizing the actuator mechanism 16 and/or linkage mechanism of the illustrated orthosis. In addition, it is understood that that in other embodiments the orthosis 10 may include the illustrated dynamic force mechanisms, while omitting the illustrated actuator mechanism and/or linkage mechanism.

[0051] Referring to FIGS. 3-5, the actuator mechanism 16 includes a drive assembly, generally indicated at 38, and a transmission assembly (e.g., a gear box), generally indicated at 40, operatively connected to the drive assembly. The transmission assembly 40 is contained within a transmission housing 42, and a portion of the drive assembly 38 extends outside the transmission housing. The drive assembly 38 includes a rotatable input shaft 46, a knob 48 accessible outside the transmission housing 42, and a clutch mechanism, generally indicated at 54, which operatively connects the knob to the input shaft to transmit torque from the knob to the input shaft. (More details of the clutch mechanism 54 are shown in FIGS. 8 and 9 and disclosed below herein.) The knob 48 and input shaft 46 are rotatable about a common input axis Al (FIG. 1). The knob 48 is configured to be grasped by a user (e.g., the subject) and rotated about the input axis to impart rotation of the input shaft 46 about the input axis. It is understood that the input shaft 46 may be operatively connected to a prime mover, such as a motor or engine, for rotating the input shaft, rather than a knob 48 or other components for manual operation of the orthosis 10. The drive assembly 38 may be of other configurations without departing from the scope of the present invention.

[0052] Referring still to FIGS. 3-5, the transmission assembly 40 includes an input gear 56 connected to the input shaft 46, a reduction gear 58, an output shaft 60, and an output gear 62. The input gear 56 is rotatable about the input axis, while each of the reduction gear 58, the output shaft 60, and the output gear 62 are rotatable about a common output axis A2 (FIG. 4). In the illustrated embodiment, the output axis is generally parallel to the input axis, although the axes may be in other orientations relative to one another. The input gear 56 is connected to an end of the input shaft 46 and rotates with the input shaft about the input axis. In turn, the input gear 56 is operatively connected to (i.e., in meshing engagement with) the reduction gear 58 for driving rotation of the reduction gear about the output axis. One end of the output shaft 60 is secured to the reduction gear 58 and the other end is secured to the output gear 62 so that rotation of the reduction gear 58 about the output axis imparts axial rotation of the output shaft, which in turn imparts axial rotation of the output gear. The reduction gear 58 is configured to reduce the rotational speed transmitted from the input gear 56 to the output gear 62, while at the same time increasing the torque transmitted from the input gear to the output gear. In the illustrated embodiment, the reduction gear 58 has a larger diameter (and more teeth) than the input gear 56, thus making a simple, single-stage gear reduction system. It is understood that the transmission mechanism may be of other configurations or the transmission mechanism may be omitted from the orthosis 10 without departing from the scope of the present invention.

[0053] Referring to FIGS. 6 and 7, each of the first and second linkage mechanisms 20, 22 includes a sliding link 72, a yoke link 74, a bell crank link, generally indicated at 76, and a fixed link 78. The first and second linkage mechanisms 20, 22 may be of similar construction, although dimensions of the components of the respective linkage mechanisms may be slightly different depending on the body joint to be treated. As shown in FIGS. 3-5, in the illustrated embodiment, the sliding link of each of the first and second linkage mechanisms 20, 22 is operatively connected to the output gear 62 of the transmission assembly 40. In particular, each of the first and second sliding links 72 are in meshing engagement with the output gear 62 to form a dual rack and pinion mechanism, whereby the sliding links are configured as racks and the output gear is configured as a pinion. The sliding links 72 are slidably received in the transmission housing 42 such that linear sets of teeth 82 extending along the respective sliding links are in opposing relationship and the output gear 62 (i.e., the pinion) is disposed between the linear sets of teeth. Rotation of the output gear 62 (i.e., the pinion) about the output axis, as driven by rotation of the knob 48, imparts linear movement of the first and second sliding links 72 in opposite directions. In particular, as shown in FIG. 2, rotation of the knob 48 in a first direction (e.g., clockwise) about the input axis (as indicated by arrow Rl) moves the sliding links along linear paths in opposite first directions, as indicated by arrows Dl, and as shown in FIG. 11, rotation of the knob in a second direction (e.g., counterclockwise) about the input axis (as indicated by arrow R2) moves the sliding links along linear paths in opposite second directions, as indicated by arrows D2. Accordingly, the illustrated actuator mechanism 16 is configured as a linear actuator mechanism which converts rotational movement (e.g., rotation of the knob 48) into linear movement of the first and second sliding links 72. The sliding links 72 extend out of opposite ends of the transmission housing 42 through respective first and second openings, 86, 88.

[0054] The first and second yoke links 74 are secured to ends of the respective first and second sliding links 72 that are outside the transmission housing 42. In the illustrated embodiment, the yoke links 74 are fastened (e.g., bolted) to the respective first and second sliding links 72, although it is understood that the yoke links may be integrally formed with the first and second sliding links. By making the yoke links 74 separate from the sliding links 72, yoke links with different sizes/configurations can be interchangeable on the orthosis 10 to accommodate different body joint sizes and/or different body joints. Each of the yoke links 74 define a slot-shaped opening 90 having a length extending generally transverse (e.g., orthogonal) to the lengths and linear paths of the respective first and second sliding linkages.

[0055] Referring still to FIGS. 6 and 7, the first and second bell crank links 76 of the respective first and second linkage mechanisms 20, 22 are generally L-shaped, each having a first crank arm 94 (or first pair of arms) operatively (i.e., slidingly) connected to the

corresponding yoke link, and a second crank arm 96 (or second pair of arms) extending outward from the first crank arm in a direction generally transverse to a length of the first crank arm. Yoke pins 97 are received in the slot-shaped openings 90 of the corresponding yoke links 74 slidably to secure terminal ends of the first crank arms 94 to the yoke links, thereby allowing sliding movement of the first crank arms relative to the corresponding yoke links. The first and second bell crank links 76 are rotatably (e.g., pivotably) attached to terminal ends of the respective first and second fixed links 78 generally adjacent junctions of the first and second crank arms 94, 96. In particular, fixed link pins 98 pivotably connect the first and second bell cranks 76 to the respective first and second fixed links 78 so that the bell crank links 76 are rotatable about pivot axes PA1 (FIGS. 2 and 11). The other ends of the fixed links 78 are fixedly secured to an underside of the transmission housing 42, such as by fasteners 100 (e.g., screws). In the illustrated embodiment, the locations of the fixed links 78 on the transmission housing 42 are adjustable to change a distance d (FIG. 2) between the pivot axes of the first and second bell crank links 76 to accommodate joints and body portions of different sizes and/or different joints.

[0056] In operation, rotation of the knob 48 imparts rotation of the input shaft 46 and the input gear 56 about the input axis. Rotation of the input gear 56 imparts rotation to the reduction gear 58, thus imparting rotation to the output gear 62 (i.e., the pinion). Rotation of the pinion in turn imparts linear movement of the first and second sliding links 72. Referring to FIG. 2, rotation of the knob 48 in the first direction (e.g., the clockwise direction as viewed in FIG. 2) imparts linear movement of the first and second sliding links 72 such that the yoke links 74 move away from one another to increase the distance between the yoke links. Moving the yoke links 74 away from one another imparts rotation of the first and second bell cranks 76 about the pivot axes in a flexion direction, as shown by arrows R4 (broadly, a first direction), such that the second crank arms 96 pivot toward one another, and the first crank arms 94 slide along the slot- shaped openings 90 as shown by arrows D4. As the second crank arms 96 pivot toward one another in the flexion direction, an included angle a between axes of the cuffs 24, 26 (and the second crank arms) decreases. Referring to FIG. 11, in the illustrated embodiment, rotation of the knob 48 in the second direction (e.g., the counterclockwise direction, as viewed in FIG. 11) imparts linear movement of the first and second sliding links 72 such that the yoke links 74 move toward one another to decrease the distance between the yoke links. As shown in FIG. 11, moving the yoke links 74 toward one another imparts rotation of the first and second bell cranks 76 about the pivot axes in an extension direction, as shown by arrows R3 (broadly, a second direction), such that the second crank arms 96 pivot away from one another, and the first crank arms 94 slide along the slot-shaped openings 90 as shown by arrows D3. As the second crank arms 96 pivot away from one another in the extension direction, the included angle a between axes of the cuffs 24, 26 (and the second crank arms) increases. Accordingly, the actuator mechanism 16 and the linkage mechanism are used to adjust an angular position of the first and second cuffs 24, 26 relative to one another to facilitate extension and flexion of the body joint. As can also be seen from FIGS. 2 and 11, the intersection of the axes of the cuffs 24, 26 (i.e., the effective pivot point of the cuffs) moves as the cuffs are pivoted about the pivot axes PA1.

[0057] Referring to FIGS. 10 and 11, the first and second dynamic force mechanisms 12, 14 are operatively connected to the respective first and second bell cranks 76. In the illustrated embodiment, the dynamic force mechanisms are generally configured as levers, each comprising a lever arm 104 pivotably connected to the corresponding one of the bell cranks 76 by a lever pivot pin 106 functioning as a fulcrum. Force elements 108 apply forces to the respective lever arms 104 to pivot the lever arms about pivot axes PA2 and relative to the respective bell cranks 76 (more specifically, the second crank arms 96 of the bell cranks). In the illustrated

embodiment, the force elements 108 are springs (e.g., compression springs) mounted on corresponding spring mounts 110 secured to the corresponding lever arms 104. The illustrated spring mounts 110 comprise shafts 112 having first ends secured to the respective levers arms, and heads 114 spaced at a second end of the shaft spaced apart from the lever arms 104. The shafts 112 of the spring mounts 110 extend through slot- shaped openings 116 in second crank arms 96 of the first and second bell cranks 76. In the illustrated embodiment, the springs 108 are received on the shafts 112 of the mounts and captured between the respective heads 114 of the spring mounts 110 and the respective second crank arms of the bell cranks 76. The spring mounts 110 may comprise bolts in one embodiment. As shown in FIG. 11, through this configuration, the lever arms 104 are biased in a biased direction, as indicated by arrows R5, away from one another and toward the respective second crank arms 96, such that the lever arms are in collapsed positions relative to the respective second crank arms. In the illustrated embodiment, the lever arms 104 nest with the respective second crank arms 96 to allow the lever arms to be generally parallel to the second crank arms in the collapsed positions. As shown in FIG. 12, from the collapsed positions, the lever arms 104 are pivotable against the force of the spring 108 in a load direction, as indicated by arrows R6, about the pivot axes toward one another and away from the corresponding second crank arms 96 toward extended positions. Pivoting of the lever arms 104 about the pivot axes adjusts the included angle between the cuffs 24, 26 (and the lever arms 104), independent of movement of the linkage mechanism and the actuator mechanism 16, and loads the springs 108 to apply a dynamic force to the body joint as indicated by spring forces Fl in FIG. 12. Thus, pivoting of the lever arms 104 also adjusts the angular position of the first and second cuffs 24, 26 relative to one another to facilitate extension and flexion of the body joint, independent of movement of the linkage mechanism and the actuator mechanism 16.

[0058] The illustrated orthosis 10 further includes an anti-back off mechanism for inhibiting the movement of the bell cranks 76 in at least one of the extension direction and the flexion direction independent of the drive assembly 38. In other words, the anti-back off mechanism inhibits the bell cranks 76 from rotating about the respective pivots axes PA1 in at least one of the extension direction and the flexion direction without operating the drive assembly 38. As set forth above, the embodiment illustrated in FIGS. 1-12 is configured to increase range of motion of a body joint in extension. For reasons explained in more detail below when discussion the use of the illustrated orthosis 10, the anti-back off mechanism of this embodiment is configured to inhibit rotation of the bell cranks 76 in at least the fiexion direction independent of the drive so that the positions of the bell cranks in extension are maintained against a force imposed by the body joint biasing the bell cranks in the flexion direction when the body portions are secured to the cuffs 24, 26. In addition, the illustrated anti-back off mechanism is configured to allow rotation of the bell cranks 76 in the extension direction independent of the drive. As explained in more detail below, this allows the positions of the bell cranks 76 (and the cuffs 24, 26) in extension to be quickly set without operating the drive. In one or more embodiments disclosed herein, the anti-back off mechanism may be configured to inhibit rotation of the bell cranks 76 in both directions (i.e., both flexion and extension). An example of such a configuration is illustrated in FIG. 34 and explained below, with the understanding that this configuration may be incorporated in the device of FIGS. 1-12 and other embodiments disclosed herein.

[0059] In the illustrated embodiment, the anti-back off mechanism is integrated with the drive assembly 38, although in other embodiments the anti-back off mechanism may be integrated or associated with other components of the orthosis 10, including but not limited to the transmission mechanism and/or the linkage mechanism. The illustrated anti-back off mechanism comprises the clutch mechanism 54. Referring to FIGS. 8 and 9, the clutch mechanism 54 is a unidirectional clutch mechanism (broadly, a one-way anti-rotation device), interconnecting the knob 48, via a knob shaft 122, to the input shaft 46. The unidirectional clutch mechanism 54 is contained within a clutch housing 123 connected to the transmission housing 42. The clutch mechanism 54 includes a hub 124 secured to the knob shaft 122, an outer race 126 fixedly secured to the transmission housing 42, an inner race 128 (e.g., two inner race pieces) disposed in the outer race and fixedly connected to the input shaft 46, and rollers 130 (e.g., cylinders) between the inner and outer races. The inner race 128 is rotatable within the outer race 126 about the input axis. The hub 124 includes fingers 132 (e.g., three fingers) spaced apart about the input axis for connecting the hub to the inner race 128. The inner race 128 includes radially extending stops 136 (e.g., three stops) spaced apart about the input axis. Disposed between adjacent stops 136 are first and second roller notches 138 adjacent the respective stops, and a finger notch 140 adjacent intermediate the roller notches 138. A rib on each of the hub fingers 132 is slidably received in a corresponding one of the finger notches 140 to connect the hub to the inner race 128. The rollers 130 are received in one of the first and second roller notches 138. [0060] In operation, the unidirectional clutch allows transmission of torque from the knob 48 to the input shaft 46 when the knob is rotated in either direction. As torque is applied to the hub 124 by rotating the knob 48, the hub fingers 132 transmit the torque to the inner race 128. In the illustrated embodiment, where the rollers 130 are received in the first roller notches 138, torque applied to the hub 124 in a first direction (e.g., the counterclockwise direction) imparts rotation to the inner race 128, whereby the stops 136 move toward and engage the rollers 130 to move the rollers along the inner wall of the outer race 126 and rotate the inner race and the input shaft 46 about the rotational axis. Torque applied to the hub 124 in the second direction (e.g., the clockwise direction) causes the hub fingers 132 to move toward the rollers 130 to move the rollers along the inner wall of the outer race 126 and rotate the inner race 128 and the input shaft 46 about the rotational axis. Thus, rotation of the knob 48 in either direction imparts rotation of the input shaft 46 about the rotational axis via the unidirectional clutch.

[0061] The unidirectional clutch also allows transmission of torque from the input shaft 46 to the knob 48 in one direction, thereby allowing the crank arms to pivot about the pivot axes in one direction without operating the knob, and inhibits transmission of torque from the input shaft to the knob in the opposite direction, thereby inhibiting pivoting of the crank arms about the pivot axes in the opposite direction without operating the knob. When torque is applied to the input shaft 46 from the linkage mechanism (e.g., torque is applied to the input shaft without operating the knob 48), the input shaft transmits torque to the inner race 128. In the illustrated embodiment, where the rollers 130 are received in the first roller notches 138, as illustrated, torque applied to the input shaft 46 in a first direction (e.g., the counterclockwise direction) imparts rotation to the inner race 128, whereby the stops 136 move toward and engage the rollers to move the rollers along the inner wall of the outer race 126 and rotate the inner race and the knob 48 about the rotational axis. Torque applied to the input shaft 46 in the second direction (e.g., the clockwise direction) causes the inner race 128 to move relative to the outer race 126 and independent of the rollers 130. As the inner race 128 moves independent of the rollers 130, the notched portions of the inner race engage the rollers 130 and push the rollers against the inner wall of the outer race 126 creating interference between the rollers and the outer race, thereby inhibiting relative movement between the inner and outer races 126, 128. Thus, torque applied to the input shaft 46 in one direction via the linkage mechanism imparts rotation of the inner race 128 relative to the outer race 126, thereby allowing the cuffs 24, 26 to be moved in one direction without operating the knob 48, while torque applied to the input shaft in the opposite direction via the linkage mechanism is does not impart rotation of the inner race 128 relative to the outer race, thereby inhibiting movement of the bell cranks 76 (and thus the cuffs) in the opposite direction without operating the knob.

[0062] As disclosed above, the configuration of the orthosis 10 illustrated in FIGS. 1-12 is suitable for increasing range of motion of a body joint in extension. In an exemplary method of use, a first body portion is secured to the first cuff 24 and a second body portion on an opposite side of a joint, for example, is secured to the second cuff. As a non-limiting example, in the embodiment illustrated in FIG. 1, an upper leg or upper arm portion can be secured to the first cuff 24 and a lower leg or lower arm portion can be secured to the second cuff for treating a knee or elbow joint in extension. In the illustrated embodiment, the body portions are secured to the cuffs 24, 26 using the straps and the hook and loop fasteners on the straps. With the body portions secured to the respective cuffs 24, 26, the subject extends the body joint to a desired, initial position in extension, such as a position recommended by a healthcare professional and/or to a maximum initial position in extension to which the subject can move the body joint. As set forth above, the unidirectional clutch allows the bell cranks 76 to rotate in the extension direction without operating the knob 48 so that extension of the body joint causes the bell cranks to rotate in the extension direction R3 to an initial angular position. Moreover, the

unidirectional clutch inhibits the bell cranks 76 from rotating in the flexion direction R4 without operating the knob 48 (i.e., the unidirectional clutch inhibits the bell cranks from "backing off in the flexion position). In another example, the desired initial rotational position of the bell cranks 76 may be set before donning the orthosis 10 by applying force to the bell cranks using one's hands, for example. With the bell cranks 76 in the desired initial angular position, the cuffs 24, 26 may be secured to the respective body portions to position the body joint in the desired, initial position in extension.

[0063] With the body portions secured to the orthosis 10 and the body joint in the desired, initial position in extension, the knob 48 is rotated to impart rotation of the bell cranks 76 in the extension direction. At some point in the range of motion in extension of the body joint (e.g., at the initial extension position of the body joint), rotation of the bell cranks 76 in the extension direction does not impart further extension of the body joint because the stiffness of the body joint overcomes the biasing force of the springs 108. Accordingly, further rotation of the bell cranks 76 in the extension direction moves the second crank arms 96 of the bell cranks away from the lever arms 104 and the cuffs 24, 26 secured to the lever arms (e.g., relative pivoting of the lever arms and cuffs in the direction R6), as the lever arms and the cuffs stay with the body portions. As the second crank arms 96 of the bell cranks 76 pivot away from the lever arms 104 in the direction R6 about the pivot axes PA2, the springs 108to elastically deform (e.g., compress) on the spring mounts 110, as shown in FIG. 12. Elastic deformation of the springs 108 produces a dynamic force on the lever arms 104 biasing the lever arms toward the corresponding second crank arms 96 of the bell cranks 76 (as indicated by force Fl), which in turn, produces a biasing force of the spring 108 on the body portions in the extension direction R5. Further pivoting of the bell cranks 76 by turning the knob 48 increases the angular distance between the second cranks arms and the corresponding lever arms 104, thereby increasing the dynamic force of the spring 108 imparted on the body portions in the extension direction. The bell cranks 76 are pivoted to a suitable treatment position in which the biasing forces of the springs 108 are constantly applied to both sides of the body joint in the extension direction. The application of this biasing force utilizes the principles of creep to continuously stretch the joint tissue during a set time period (e.g., 4-8 hours), thereby maintaining, decreasing, or preventing a relaxation of the tissue.

[0064] As set forth above, in other embodiments the orthosis may be configured for increasing range of motion of a body joint in flexion. Referring to FIGS. 13-17, such an orthosis embodiment for increasing range of motion of a body joint in flexion is generally indicated at reference numeral 210. Except as disclosed herein below, the orthosis 210 is substantially identical to the orthosis 10, including identical components indicated by corresponding reference numerals.

[0065] Because orthosis 210 is configured for increasing range of motion of a body joint in flexion, the bell crank links 276 are different than the bell crank links 76 of the first embodiment in that the included angle between the first and second crank arms 294, 296 is greater than the included angle between the first and second crank arms 94, 96 of the first orthosis 10. This allows greater range of motion in flexion.

[0066] Because orthosis 210 is configured for increasing range of motion of a body joint in flexion, the unidirectional clutch mechanism 254 is also configured differently than the clutch mechanism 54 of the first orthosis 10 so that the present clutch mechanism is configured to inhibit rotation of the bell cranks 76 in at least the extension direction independent of the drive so that the positions of the bell cranks in flexion are maintained against a force imposed by the body joint biasing the bell cranks in the extension direction when the body portions are secured to the cuffs 224, 226. As shown in FIG. 17, the clutch mechanism 254 is substantially similar to the clutch mechanism 54 of the first orthosis 10 other than the locations of the rollers 130. In the present embodiment, the rollers 130 are received in the second notch portions of the inner race 128 so that torque applied to the input shaft 46 in a first direction (e.g., the clockwise direction) imparts rotation to the inner race, whereby the stops 136 move toward and engage the rollers to move the rollers along the inner wall of the outer race 126 and rotate the inner race and the knob 48 about the rotational axis. Torque applied to the input shaft 46 in the second direction (e.g., the counterclockwise direction) causes the inner race 128 to move relative to the outer race 126 and independent of the rollers 130. As the inner race 128 moves independent of the rollers 130, the notched portions of the inner race 128 engage the rollers and push the rollers against the inner wall of the outer race 126 creating interference between the rollers and the outer race, thereby inhibiting relative movement between the inner and outer races. Thus, torque applied to the input shaft 46 in one direction via the linkage mechanism imparts rotation of the inner race 128 relative to the outer race 126, thereby allowing the bell crank links 276 to be moved in one direction (e.g., extension direction R3) without operating the knob 48, while torque applied to the input shaft in the opposite direction via the linkage mechanism (e.g., flexion direction R4) is does not impart rotation of the inner race 128 relative to the outer race, thereby inhibiting movement of the bell cranks 76 in the opposite direction without operating the knob. As described above, in one or more embodiments disclosed herein, the anti-back off mechanism may be configured to inhibit rotation of the bell cranks 76 in both directions (i.e., both flexion and extension). An example of such an embodiment of the anti-back off mechanism is generally indicated at reference numeral 354 in FIG. 34. The anti-back off mechanism is similar to the anti-back mechanisms 54, 254, with like components being indicated with corresponding reference numerals. The main difference is the rollers 130 are received in both the first and the second notch portions of the inner race 128 so that torque applied to the input shaft 46 in either the first direction (e.g., the clockwise direction) or the second direction (e.g., the counterclockwise direction) causes the inner race to move relative to the outer race 126 and independent of the rollers 130. As the inner race 128 moves independent of the rollers 130, the notched portions of the inner race engage the rollers and push the rollers against the inner wall of the outer race 126 creating interference between the rollers and the outer race, thereby inhibiting relative movement between the inner and outer races. Thus, the knob 48 must be operated to rotate bell crank links 276 in either direction. This embodiment may be incorporated in the device of FIGS. 1-12 and the device of FIGS. 13-17 and other embodiments disclosed herein.

[0067] Because orthosis 210 is configured for increasing range of motion of a body joint in flexion, the first and second dynamic force mechanisms 212, 214 are configured such that the force elements 108 (e.g., compression springs) apply forces to the respective lever arms 104 to pivot the lever arms about pivot axes PA2 and relative to the respective bell cranks 276 (more specifically, the second crank arms of the bell cranks) in a biased direction R6 to an extended position, unlike the first and second dynamic force mechanisms 12, 14 of the first orthosis 10. The springs are received on the shafts 112 of the mounts and captured between the respective lever arms 104 and the respective second crank arms of the bell cranks 276. As shown in FIG. 16, from the extended positions, the lever arms 104 are pivotable against the force of the spring in a load direction, as indicated by arrows R5, about the pivot axes away from one another and toward the corresponding second crank arms to collapsed positions. Pivoting of the lever arms 104 about the pivot axes adjusts the included angle between the cuffs 224, 226 (and the lever arms), independent of movement of the linkage mechanism and the actuator mechanism, and loads the springs to apply a dynamic force to the body joint as indicated by spring forces F2 in FIG. 16. Thus, pivoting of the lever arms 104 also adjusts the angular position of the first and second cuffs 224, 226 relative to one another to facilitate extension and flexion of the body joint, independent of movement of the linkage mechanism and the actuator mechanism 216.

[0068] The orthosis 210 for increasing range of motion in flexion is used in a manner similar to the orthosis 10, other than the loading of the spring of the first and second dynamic force mechanisms 212, 214 is created in when pivoting the bell crank links 276 in the flexion direction. The bell crank links 276 are pivoted to a suitable treatment position in which the biasing forces of the springs are constantly applied to both sides of the body joint in the flexion direction. The application of this biasing force utilizes the principles of creep to continuously stretch the joint tissue during a set time period (e.g., 4-8 hours), thereby maintaining, decreasing, or preventing a relaxation of the tissue.

[0069] Referring to FIGS. 18 and 19, another embodiment of an orthosis for increasing range of motion of a body joint in extension is generally indicated at reference numeral 310. Unless specified below, this embodiment has identical or substantially similar components as the first embodiment disclosed in FIGS. 1-12. For example, components of the orthosis 310 that are identical to or substantially the same as the corresponding components of the first orthosis 10 include, but are not limited to, the actuator mechanism, generally indicated at 316, including the drive assembly 338 thereof, generally indicated at 338, and transmission assembly 340 thereof (not visible); and the first and second cuffs, generally indicated at 324, 326, respectively. As explained in more detail below, the main difference between the present orthosis 310 and the first orthosis 10 is that the force elements 408 of the first and second dynamic force mechanism 312, 314, respectively, of the present orthosis are different than the force elements 108 of the first orthosis. In particular and as explained below, the force elements 408 of the present orthosis 310 are configured to apply torque, rather than a linear force applied by the force elements 108 of the first orthosis. In the illustrated embodiment, each force element 408 comprises a torsion spring, although the force element 408 may be of other types for applying torque. Because the present orthosis 310 uses torsional force elements 408— rather than linear force elements 108 of the first orthosis 10— the first and second linkage mechanisms 320, 322, respectively, and the first and second dynamic force mechanism 312, 314, respectively, are different than the corresponding components of the first orthosis. These differences are described herein below.

[0070] Referring to FIG. 20, each of the first and second linkage mechanisms 320, 322 includes a sliding link 372, which may be identical or substantially similar to the sliding link 72; a yoke link 374, which may be identical or substantially similar to the yoke link 74; a bell crank link, generally indicated at 376, which is different than the bell crank link 76; and a fixed link 378, which may be identical or substantially similar to the fixed link 78. The first and second bell crank links 376 of the respective first and second linkage mechanisms 320, 322 are generally L-shaped, each having a first crank arm 394 (or first pair of arms) operatively (i.e., slidingly) connected to the corresponding yoke link, and a second crank arm 396 (or second pair of arms) extending outward from the first crank arm in a direction generally transverse to a length of the first crank arm. Referring to FIG. 20, yoke pins 397 are received in the slot-shaped openings 390 of the corresponding yoke links 374 to slidably secure terminal ends of the first crank arms 394 to the yoke links, thereby allowing sliding movement of the bell crank links 376 relative to the corresponding yoke links. As with the first orthosis 10, the first and second bell crank links 376 are rotatably (e.g., pivotably) attached to terminal ends of the respective first and second fixed links 378 generally adjacent junctions of the first and second crank arms 394, 396. In particular, fixed link pins 398 pivotably connect the first and second bell cranks 376 to the respective first and second fixed links 378 so that the bell crank links are rotatable about the pivot axes PA1 (FIG. 19). Rotation of the knob 348 (e.g., operation of the actuator assembly 316) imparts rotation of the first and second bell crank links 376 about the pivot axes PA1 to adjust an angular position of the first and second cuffs 324, 326 relative to one another to facilitate extension and flexion of the body joint in substantially the same way as described above with respect to orthosis 10. [0071] Referring to FIGS. 21 and 22, the first and second dynamic force mechanisms 312, 314 are operatively connected to the respective first and second bell cranks 376. In the illustrated embodiment, the dynamic force mechanisms 312, 314 include levers, generally indicated at 400, each comprising a first lever arm 404a to which the corresponding cuff 324,

326 is secured, and a second lever arm 404b extending transversely (e.g., orthogonally) relative to the first arm portion. Each lever 400 is pivotably connected to the corresponding one of the bell crank links 376 by a lever pivot pin 406 (functioning as a fulcrum) located generally at the junction of the first and second arm portions 404a, 404b. The levers 400 can be considered bell cranks also.

[0072] The force elements 408 apply forces to the respective levers 400 to pivot the levers about pivot axes PA2 and relative to the respective bell crank links 376 (more

specifically, the second crank arms 396 of the bell cranks). In the illustrated embodiment, the force elements 408 are springs (e.g., torsion springs) mounted on corresponding bell crank links 376. In particular, each force element 408 is received on a spring spool or mount 325, and the spring spool is secured to the corresponding bell crank link 376 by passing the lever pivot pin 406 through the spool. A first spring arm 408a (FIGS. 22-24) of each spring 408 engages a floor

327 of the corresponding bell crank link 376, and a second spring arm 408b of each spring engages the second lever arm 404b. More specifically, the second spring arm 408b engages a rod 331 or other structure of the second lever arm 404b for transmitting torque to the second lever arm as the torsion spring 408 is elastically deformed (e.g., upon torqueing or twisting of the spring). As shown in FIG. 25, through this configuration, the first lever arms 404a are biased in a biased direction, as indicated by arrows R5, away from one another and toward the respective second crank arm links 376, such that the first lever arms are in collapsed positions relative to the respective second crank arms 396. In the illustrated embodiment, the first lever arms 404a nest with the respective second crank arms 396 to allow the first lever arms to be generally parallel to the second crank arms in the collapsed positions. As shown in FIG. 26, from the collapsed positions, the first lever arms 404a are pivotable against the second spring arm 408a and against the biasing force or torque of the spring 408 in a load direction, as indicated by arrows R6, about the pivot axes PA2 toward one another and away from the corresponding second crank arms toward extended positions. Pivoting of the first lever arms 404a about the pivot axes PA2 adjusts the included angle between the cuffs 324, 326 (and the first lever arms) independent of movement of the linkage mechanisms 320, 322 and the actuator mechanism 316, and loads the torsion springs 408 to apply a dynamic force to the body joint in the direction R5 as shown in FIG. 25. Thus, pivoting of the levers 404 also adjusts the angular position of the first and second cuffs 324, 326 relative to one another to facilitate extension and flexion of the body joint, independent of movement of the linkage mechanism and the actuator mechanism 316.

[0073] As disclosed above, the configuration of the orthosis 310 is suitable for increasing range of motion of a body joint in extension. The method of operation is substantially similar as the method set forth above with respect to the orthosis 10, and reference is made to the above description for additional details. With the body portions secured to the orthosis 310 and the body joint in the desired, initial position in extension (such as set forth above with respect to the operation of the first orthosis 10), the knob 348 is rotated to impart rotation of the bell crank links 376 in the extension direction. At some point in the range of motion in extension of the body joint (e.g., at the initial extension position of the body joint), rotation of the bell crank links 376 in the extension direction does not impart further extension of the body joint because the stiffness of the body joint overcomes the biasing force of the springs 408. Accordingly, further rotation of the bell crank links 376 in the extension direction moves the second crank arms 396 of the bell crank links away from the first lever arms and the cuffs 324, 326 secured to the first lever arms 404a (e.g., relative pivoting of the lever arms and cuffs in the direction R6), as the lever arms and the cuffs stay with the body portions. As the second crank arms 396 of the bell crank links 376 pivot away from the first lever arms 404a in the direction R6 about the pivot axes PA2, the rods 331of the second lever arms 404b push against the second spring arms 408b and the springs elastically deform (e.g., torque or twist) on the spring spools 325, as shown in FIG. 26. Elastic deformation of the springs 408 produces a dynamic force, more specifically dynamic torque, on the second lever arms 404b biasing the first lever arms 404a toward the corresponding second crank arms 396 of the bell crank links 376, which in turn, produces a biasing torque of the spring on the body portions in the extension direction R5. Further pivoting of the bell crank links 376 by turning the knob 348 increases the angular distance between the second cranks arms 396 and the corresponding first lever arm portions 404a, thereby increasing the dynamic torques of the springs 408 imparted on the body portions in the extension direction. The bell crank links 376 are pivoted to a suitable treatment position in which the biasing torques of the springs 408 are constantly applied to both sides of the body joint in the extension direction. The application of this biasing torque utilizes the principles of creep to continuously stretch the joint tissue during a set time period (e.g., 4-8 hours), thereby maintaining, decreasing, or preventing a relaxation of the tissue. [0074] Referring to FIGS. 27-33, another orthosis embodiment for increasing range of motion of a body joint in flexion is generally indicated at reference numeral 410. Except as disclosed herein below, the orthosis 410 is identical or substantially the same as the orthosis 310, except that the orthosis is configured for increasing range of motion of a body joint in flexion, and therefore, some components are slightly different, as described below. In addition, the actuator mechanism 416 is substantially identical to the actuator mechanism 216 of the second embodiment 210.

[0075] Because orthosis 410 is configured for increasing range of motion of a body joint in flexion, the bell crank links 476 are different than the bell crank links 76 of the first embodiment in that the included angle between the first and second crank arms 494, 496 is greater than the included angle between the first and second crank arms 394, 396 of the similar orthosis 310. This allows greater range of motion in flexion.

[0076] Because orthosis 210 is configured for increasing range of motion of a body joint in flexion, the first and second dynamic force mechanisms 412, 414 are configured such that the force elements 508 (e.g., torsion springs) apply torques to the respective lever arms 504 to pivot the lever arms about pivot axes PA2 and relative to the respective bell crank links 476 (more specifically, the second crank arms of the bell crank links) in a biased direction R6 to an extended position, unlike the first and second dynamic force mechanisms 312, 314 of the similar orthosis 310. To this end, each spring 508 is mounted on the corresponding bell crank link 476 using the spring spool 425 and the lever pivot pin 506, similar to the other orthosis 310. The first spring arm 508a engages a floor 429 of the corresponding lever arm 504 and the second spring arm 508b engages the second crank arm 496 of the corresponding bell crank link 476. In particular, the first spring arm 508a extends through an opening in the floor 427 of the second crank arm 496 and engages the floor 429 of the lever arm 504 to apply a spring force to the lever arm. The second spring arm 508b engages a rod 431 of the second crank arm 496.

[0077] As shown in FIG. 33, from the extended positions, the lever arms 504 are pivotable against the force of the spring 508 in a load direction, as indicated by arrows R5, about the pivot axes PA2 away from one another and toward the corresponding second crank arms to collapsed positions. Pivoting of the lever arms 504 about the pivot axes PA2 adjusts the included angle between the cuffs 424, 426 (and the lever arms), independent of movement of the linkage mechanism and the actuator mechanism 416, and loads the springs to apply a dynamic torque to the body joint in the direction R6. Thus, pivoting of the lever arms 504 also adjusts the angular position of the first and second cuffs 424, 426 relative to one another to facilitate extension and flexion of the body joint, independent of movement of the linkage mechanism and the actuator mechanism 416.

[0078] The orthosis 410 for increasing range of motion in flexion is used in a manner similar to the orthosis 310, other than the loading of the spring of the first and second dynamic force mechanisms 412, 414 is created in when pivoting the bell crank links 476 in the flexion direction. The bell crank links 476 are pivoted to a suitable treatment position in which the biasing forces of the springs are constantly applied to both sides of the body joint in the flexion direction. The application of this biasing force utilizes the principles of creep to continuously stretch the joint tissue during a set time period (e.g., 4-8 hours), thereby maintaining, decreasing, or preventing a relaxation of the tissue.

[0079] When introducing elements of the present invention or the preferred

embodiment(s) thereof, the articles "a", "an", "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising", "including" and "having" are intended to be inclusive and mean that there may be additional elements other than the listed elements.

[0080] In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained.

[0081] As various changes could be made in the above constructions, products, and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

Claims

WHAT IS CLAIMED IS:

1. An orthosis for increasing range of motion of a body joint, the orthosis comprising: a first body portion securement member configured for securement to a first body portion associated with a body joint;

a second body portion securement member configured for securement to a second body portion associated with the body joint;

first and second dynamic force mechanisms operatively connected to the respective first and second body portion securement members and configured to simultaneously apply dynamic forces to the respective first and second body portions.

2. The orthosis set forth in claim 1, further comprising an actuator mechanism operatively connected to the first and second dynamic force mechanisms and configured to selectively transmit an applied force to the first and second dynamic force mechanisms.

3. The orthosis set forth in claim 2, wherein the actuator mechanism includes a drive assembly and a transmission assembly operatively connected to the drive assembly.

4. The orthosis set forth in claim 3, wherein the drive assembly includes an input shaft, and the transmission assembly includes a gear box, wherein the input shaft is operatively connected to the gear box.

5. The orthosis set forth in claim 4, wherein the gear box includes in input gear operatively connected to the input shaft, a reduction gear in meshing engagement with the input gear, and an output gear operatively connected to the reduction gear.

6. The orthosis set forth in claim 2, further comprising first and second linkage mechanisms operatively coupling the first and second dynamic force mechanisms to the actuator mechanism to transmit the applied force from the actuator mechanism to the first and second dynamic force mechanisms.

7. The orthosis set forth in claim 6, wherein the first and second linkage mechanisms include respective first and second sliding links operatively connected to the actuator mechanism, wherein operation of the actuator mechanism imparts linear movement of the first and second sliding links in opposite directions.

8. The orthosis set forth in claim 7, wherein the first and second linkage mechanisms include respective first and second bell crank links operatively connecting the first and second sliding links to the respective first and second dynamic force mechanisms.

9. The orthosis set forth in claim 8, wherein the first and second dynamic force mechanisms include respective first and second lever arms pivotably connected to the respective first and second bell crank links for rotation about respective first and second pivot axes.

10. The orthosis set forth in claim 9, wherein the first and second dynamic force mechanisms include respective first and second springs biasing the first and second lever arms either toward or away from the respective first and second bell crank links about the respective first and second pivot axes.

11. The orthosis set forth in claim 10, wherein the first and second lever arms include respective first and second bell cranks.

12. The orthosis set forth in claim 9, wherein the first and second linkage mechanisms include respective first and second yoke links fixedly connected to the respective first and second sliding links, wherein the first and second bell crank links are connected to the respective first and second yoke links.

13. The orthosis set forth in claim 12, wherein the first and second linkage mechanisms include respective first and second fixed links fixedly connected to the actuator mechanism, wherein the first and second bell crank links are pivotably secured to the respective first and second fixed links.

14. The orthosis set forth in claim 6, wherein the first and second linkage mechanisms include respective first and second bell crank links operatively connecting the respective first and second dynamic force mechanisms to the actuator mechanism.

15. The orthosis set forth in claim 14, wherein the first and second dynamic force mechanisms include respective first and second lever arms pivotably connected to the respective first and second bell crank links for rotation about respective first and second pivot axes.

16. The orthosis set forth in claim 15, wherein the first and second dynamic force mechanisms include respective first and second springs biasing the first and second lever arms either toward or away from the respective first and second bell crank links about the respective first and second pivot axes.

17. The orthosis set forth in claim 16, wherein the first and second lever arms include respective first and second bell cranks.

18. An orthosis for increasing range of motion of a body joint, the orthosis comprising: a first body portion securement member configured for securement to a first body portion associated with a body joint;

an actuator mechanism;

first and second linkage mechanisms operatively connecting the respective first and second body portion securement members to the actuator mechanism and being configured to transmit force from the actuator mechanism to the respective first and second body portion securement members to impart movement of the first and second body portion securement members relative to one another,

wherein the first and second linkage mechanisms include respective first and second bell crank links.

19. The orthosis set forth in claim 18, wherein the first and second linkage mechanisms include respective first and second sliding links operatively connected to the actuator mechanism, wherein operation of the actuator mechanism imparts linear movement of the first and second sliding links in opposite directions.

20. The orthosis set forth in claim 19, wherein the first and second linkage mechanisms include respective first and second yoke links fixedly connected to the respective first and second sliding links, wherein the first and second bell crank links are operatively connected to the respective first and second yoke links.