Patent Grant
7101347
This invention relates to therapeutic mobilization and splinting devices and in particular a combination pro/supination and flexion device.
In recent years it has become evident that the rehabilitation and treatment of injured joints and surrounding soft tissue can be expedited by use of continuous passive motion (CPM) static and dynamic serial splinting of the involved joint and surrounding soft tissue. CPM and splinting entails moving the joint via its related limbs through a passive controlled range of motion without requiring any muscle coordination. Active motion is also beneficial to the injured joint, however muscle fatigue limits the length of time the patient can maintain motion or positioning, therefore a device that provides continues passive motion to the joint is essential to maximize rehabilitation results. Numerous studies have proven the clinical efficacy of CPM or splinting to accelerate healing and maintain a range of motion. Static Progressive Splinting (SPS) and Dynamic Splinting (DS) are accepted and effective treatment modalities for the management and modelling of soft tissue surrounding articulations. Both SPS and DS have been proven efficacious and are supported by clinical studies. CPM, SPS and DS are integral components of a successful therapy protocol.
The successful rehabilitation of elbow and forearm injuries is complex, time consuming and often challenging due to the mobility, complex geometry and high stresses in and around the joint.
The therapeutic mobilization device of the present invention includes a flexion assembly, a pro/supination assembly and a valgus carrying angle compensation device. The flexion assembly has an arm attachment assembly and an elbow actuator and the elbow actuator defines and axes of rotation. The pro/supination assembly is attached to flexion assembly and has a distal forearm attachment assembly and a pro/supination actuator operably connected thereto. The valgus carrying angle compensation device is operably attached to the flexion assembly and the pro/supination assembly.
In another aspect of the present invention the therapeutic mobilization device includes an arm attachment assembly, a distal forearm attachment assembly, and elbow actuator and a valgus carrying angle compensation device. The compensation device is connected between the arm attachment assembly and the distal forearm attachment assembly. The elbow actuator is operably connected to the arm attachment assembly and the distal forearm attachment assembly whereby movement of the actuator causes the user's elbow to move through flexion.
In a further aspect of the invention the therapeutic mobilization device includes an arm attachment assembly, a distal forearm attachment assembly and an elbow actuator. The distal forearm attachment assembly includes a housing shaft and an adjustable clamping mechanism slidably mounted on the housing shaft. The elbow actuator is operably connected to the arm attachment assembly and the housing ring whereby movement of the actuator causes the user's elbow to move through flexion and the adjustable clamping mechanism is free to move along the housing shaft.
In a still further aspect of the invention a therapeutic mobilization device includes a pro/supination actuator and a pro/supination assembly. The pro/supination assembly includes a pro/supination housing, an attachment ring rotatably attached to the housing and a distal forearm attachment assembly attached thereto. A belt is attached to the attachment ring and to the pro/supination actuator whereby actuation of the pro/supination actuator causes the belt to move the attachment ring in pronation and supination.
It is an object of the present invention to provide continuous passive motion and/or electronically controlled progressive splinting device. The device will have two operating modes. The first and default-operating mode may be CPM. CPM typically involves defining a range of motion (ROM) within which a device operates. A pause can be added at the end of the direction of travel prior to the device returning to the other programmed extreme of motion. This operational mode promotes the maintenance of a joint's ROM. CPM devices are typically configured with a Reverse On Load (ROL) safety feature. The ROL is the level of force or resistance required to reverse the direction of travel or rotation of a CPM device.
The device may be suitable for bed, chair and ambulatory use configurations. The device may be symmetrical and ambidextrous. The device provides a full range of variable elbow flexion. The device also provides a full range of variable pronation and supination motion for the forearm. These motions are available in a synchronized motion, independently or in a serial motion. If pro/supination serial motion is chosen, preferably pro/supination will occur at 90 degrees of elbow flexion or as close thereto as possible. This is to limit stress on the joints. Preferably the device is controlled by a hand-held user interface which allows the operator to adjust the speed of travel (CPM mode only), range of motion, pause time at end of cycle and reverse on load. Preferably the device includes a means to electronically lock the patient settings while still allowing the patient to adjust the speed.
The orthosis of the device is configured to provide anatomical elbow flexion and forearm pro/supination. The orthosis also compensates for the valgus carrying angle. The valgus carrying angle is the result of the lateral migration of the distal radius and ulna relative to the distal humerus as the forearm pro/supinates. The orthosis may also compensates for the anthropometric variances between patients. This is achieved by accommodating differences in arm circumference, length and anatomical axis relative to the exterior surfaces of the arm. The device integrates a novel arrangement of strain gauges to monitor the amount of force in flexion and torque in pro/supination the device is delivering to the involved limb.
The invention relates to continuous passive motion (CPM) and progressive splinting devices for the synovial joints and surrounding soft tissue of the human body. The device forming the present invention comprises proximal and distal humerus supports. The humerus supports are allowed to move telescopically relative to each other, where the distal humerus support is suitably fixed to the chassis of the device. The device also comprises a distal radius and ulna support. The radius and ulna supports move in rotation relative to the humerus supports to provide pro/supination. The distal radius and ulna support also moves in a planer motion relative to the humerus supports to provide elbow flexion. The device includes two microprocessor controlled electric actuators. The actuators are located at the elbow and distal forearm. The actuators are suitably fixed to the orthosis and provide rotational motion concentric with the elbow and forearm's anatomic axis. The elbow actuator is a simple pivot actuator whereby a mechanical pivot is concentric with the device's elbow anatomical axis.
In typical CPM mode the ROM is defined and the device operates through a consistent defined range. An alternate configuration of elbow anatomical axis compensation includes two semicircular shapes slidably mounted to each other. This configuration can achieve similar results in providing one adjustment to compensate for circumference and position of the elbow's anatomic axis relative to the upper arm.
Further features of the invention will be described or will become apparent in the course of the following detailed description.
The invention will now be described by way of example only, with reference to the accompanying drawings, in which:
Referring to
The upper arm or humerus support 22 includes a lower or distal humerus cuff 28 and an upper or proximal humerus cuff 30. Cuff 30 is slidably mounted along cuff support 32. A lower cuff strap 34 (shown in
The elbow assembly 24, as shown in
The elbow assembly 24 is arranged such that it can easily be adjusted to accommodate patients with different sized elbows and different position of the elbow axis or rotation relative to the humerus support 22. As the first and second elbow actuators 40 and 42 slidably move along top 44 and bottom 46 orthosis rods away from each back portion 50 thereof the distance of the elbow axis 56 relative to humerus support 22 proportionately increases and the distance between the first 40 and second 42 elbow actuators increases. Accordingly by adjusting the barrel nut assembly 48 the patient or health care assistant uses one motion and adjustment to accommodate differences in upper arm circumferences and differences in position of the arm elbow anatomic axis relative to the posterior surface of the arm.
The first 40 and second 42 actuators have corresponding first 60 and second 62 rotating shafts respectively. Rotating shafts 60 and 62 rotate in a concentric fashion with the elbow axis 56. First 64 and second 66 drive stays are connected at one end to first 60 and second 62 rotating shafts respectively. At the other end first 64 and second 66 drive stays are connected to valgus pivot 68. Pro-supination assembly 26 is attached to valgus pivot 68.
Pro-supination assembly 26 includes a pro/supination housing 70, housing shaft 72, a ring assembly 74 and a ulna clamping device 76. Housing shaft 72 includes a pair of parallel rods 73. Pro/supination housing 70 is slidably mounted to parallel rods 73 so that it can easily move along the rods during use. Rods 73 include a bent portion 75 at the distal end thereof which limits movement of the pro/supination housing 70. At the other end rods 73 are attached to valgus pivot 68.
Ring assembly 74 has a variable ulna clamp 76 on the inside thereof, as best seen in
Ring assembly 74 is slidably mounted in pro/supination housing 70. An external belt 84 moves the ring in a rotational fashion relative to pro/supination housing 70. Referring to
As shown in
A mounting feature on the orthosis allows the device to be secured to a bed, chair or ambulatory feature. As shown in
The anatomical features are to compensate and align the orthosis' actuators with the anatomic axis of the elbow and forearm. These features serve to minimize stress on the joint and surrounding soft tissue as the device moves through its range of motion.
Device 10 includes a patient controller 104. Device 10 is electrically connected to the patient controller 104 by cord set 106. Switch 108 on patient controller 104 turns the device 10 off and on. Patient controller 104 is connected to power supply 112 via cable 110. Patient controller 104 contains rechargeable batteries and can supply power to device 10 with or without being connected to a wall outlet.
With all of the therapeutic motion and splint devices it is important to align the device appropriately.
Referring to
The mobilization device 120 includes an upper arm or humerus support 22, an elbow or flexion actuator assembly 122 and a wrist or pro/supination assembly 26.
The upper arm or humerus support 22 includes a lower or distal humerus cuff 28 and an upper or proximal humerus cuff 30. Proximal humerus cuff 30 is slidably mounted with respect to humerus support 22 via two parallel rods 32 and secured in position by lock knobs 124. A distal cuff strap 36 is attached to the distal humerus cuff 28 and a proximal cuff humerus strap 34 is attached to the proximal humerus cuff 30. Straps 34 and 36 use hook and loop type fastener in conjunction with buckles 126 and 128 to allow for easy attachment and adjustment. The distance between the distal humerus cuff 28 and the proximal humerus cuff 30 can be adjusted to ensure that mobilization device 120 is securely attached to the patient.
An L-shaped member 146 attaches humerus support 22 to elbow actuator assembly 122. The orientation of the humerus support 22 can be changed by depressing a button 148 that engages one of a pair of aperture 150 and then rotating humerus support 22 until it engages the other of aperture 150. A mounting post 152 is adapted to engage mounting receptacle 111. Mounting post 152 includes a quick release button 154 for disengaging device 120 from stand 100. Elbow actuator assembly 122 is mounted on L-shaped member 146 with a mount 156. Mount 156 includes electronic switches 158.
The elbow actuator assembly 122 includes an orthosis stay 130 and is pivotally connected to actuator 122 at 132 and pivots around the elbow flexion rotational axis 134 as best seen in
Pro/supination assembly 26 includes a pro/supination housing 70, a ring assembly 74, a variable distal forearm clamping device 76 and pair of parallel rods 73. Pro/supination actuator housing 70 is slidably mounted to parallel rods 73 and is limited in distal sliding range by end stop 136. An elastomeric tether 138 is attached between end stop 136 and pro/supination assembly 26. Elastomeric tether 138 compensates for the weight of the pro/supination assembly 26 and reduces the stress on the users elbow that would be exerted on the patient from the pro/supination assembly.
Ring assembly 74 has a variable distal forearm clamp 76 on the inside thereof, as best seen in
Ring assembly 74 is slidably mounted in pro/supination actuator housing 70. An external belt 84 moves the ring in a rotational fashion relative to pro/supination actuator housing 70. The pro/supination axis 82 is arranged such that it is concentric with the anatomic axis of the patient's forearm when positioned in the device 120. The pro/supination housing 70 is slidably mounted in a radial fashion relative to the valgus pivot axis 83, 134. The forearm clamp assembly 76 and softgoods 80 secure the patient's distal radius and ulna to effectively transfer flexion and pro/supination from the humerus to the forearm. Preferably the forearm clamp assembly 76 and softgoods 80 are secured against the patient's distal ulna and radius. However it will be appreciated by those skilled in the art that ulna clamps 76 could be secured to the patient anywhere along the ulna.
Mobilization device 120 may be mounted on a stand 100 and the height is adjustable with adjusting knob 102. Mobilization device 120 includes a patient controller 104. Device 120 is electrically connected to the patient controller 104 by cord set 106. Switch 108 on patient controller 104 turns the device 120 off and on. Patient controller 104 is connected to power supply 112 via cable 110. Patient controller 104 contains rechargeable batteries and can supply power to device 120 with or without being connected to a wall outlet.
Valgus pivot 68 compensates for the variations in carrying angle. The carrying angle is compensated for in a valgus pivot 68 located between the elbow actuator's 122, orthosis stay 130, and the pro/supination assembly slidably mounted on rods 73. The valgus pivot 68 compensates for misalignment of the patient in the device when it is first attached and during treatment. It minimizes the stresses that are caused by misalignment of the device. The sliding of the pro/supination assembly helps to compensate for the distraction and compression forces during use.
The mobilization device 120 is arranged such that only one adjustment is required to accommodate a range of patients with different sized arms and forearms. Only the proximal humerus cuff 30 is adjusted between patient sizes to accommodate differences in upper arm circumferences and differences in position of the arm's elbow anatomic axis relative to the posterior surface of the arm. This is accomplished by the pro/supination assembly 26 being slidably mounted along rods 73 and having a pivot at the ulna clamping device 76. The anatomical features are to compensate for and align the orthosis' actuators with the anatomic axis of the elbow and forearm and these features serve to minimise stress on the joint and surrounding soft tissue as the device moves through its range of motion.
Mobilization device 120 is designed to easily be adjusted. The device 120 is asymmetrical with the flexion actuator assembly 122 being positioned on the lateral side of the treated arm to minimise abduction while being treated and improve patient comfort. The device 120 can be converted to treat the left and right arm by unlocking and pivoting three components once it is removed from stand 100. To convert the device from left to right the user unlocks and pivots the humerus support 22, the flexion/elbow actuator assembly 122 and valgus pivot 68.
In use mobilization devices 10 and 120 are suitable for bed, chair and ambulatory use configurations. The devices 10 and 120 are symmetrical and ambidextrous. Each device 10, 120 offers a full range of variable elbow flexion. Each device 10, 120 also offer a full range of variable pronation and supination motion for the forearm. These motions are available in a synchronized motion, independently or in a serial motion. If pro/supination is programmed in a serial motion, preferably pro/supination will occur at 90 degrees of elbow flexion or as close thereto as possible. This is to limit stress on the joints. The device may be controlled by a hand held user interface allowing the operator to adjust the speed of travel (CPM mode only), range of motion, pause time at end of cycle and reverse on load. The device may have a means to electronically lock the patient settings while still allowing the patient to adjust the speed. The orthosis of the device is configured to provide anatomical elbow flexion and forearm pro/supination. The orthosis also compensates for the valgus carrying angle. The valgus carrying angle is the result of the lateral migration of the distal radius and ulna relative to the distal humerus as the forearm supinates. The orthosis also compensates for the anthropometric variances between patients. This is achieved by accommodating differences in arm circumference, length and anatomical axis relative to the exterior surfaces of the arm. The device integrates a novel arrangement of strain gauges to monitor the amount of force in flexion and torque in pro/supination the device is delivering to the involved limb. The anatomical features are to compensate for and align the orthosis' actuators with the anatomic axis of the elbow and forearm. These features serve to minimize stress on the joint and surrounding soft tissue as the device is moved or is positioned through its range of motion.
Referring to
Similarly it will be appreciated by those skilled in the art that elements of the present invention could be used for a pro/supination only device wherein the flexion actuator was not used or not included in the device at all. As shown in
Ring assembly 74 has a variable ulna clamp 76 on the inside thereof. Padding and soft goods 80 are attached to screw clamps for comfort. The center of ring assembly 74 is concentric with pro/supination axis 82. Ring assembly 74 is slidably mounted in pro/supination housing 70. An external belt 84 moves the ring in a rotational fashion relative to pro/supination housing 70.
The upper arm support 22 includes a lower or distal humerus cuff 28 and an upper or proximal humerus cuff 30. Cuff 30 is slidably mounted along cuff support 32. A lower cuff strap 34 is attached to the lower humerus cuff 28 and an upper cuff humerus strap 36 is attached to the proximal humerus cuff 30. An L-shaped orthosis stay 130 is pivotally connected at one end thereof to an elongate connector 172 and at the other end thereof it is connected to the vulgas pivot 68. The elongate connector 172 is also attached to the upper arm support 22.
It will be appreciated that the above description related to the invention by way of example only. Many variations on the invention will be obvious to those skilled in the art and such obvious variations are within the scope of the invention as described herein whether or not expressly described.
This patent application is a continuation application of U.S. patent application, Ser. No. 09/689,812 filed on Oct. 13, 2000 now abandoned entitled COMBINATION PRO/SUPINATION AND FLEXION THERAPEUTIC DEVICES with the same inventors, which is related to U.S. Provisional Patent Application, Ser. No. 60/189,051 filed on Mar. 14, 2000 entitled A COMBINATION PRO/SUPINATION AND FLEXION THERAPEUTIC MOBILIZATION DEVICE.
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| Number | Date | Country | |
|---|---|---|---|
| 20040082885 A1 | Apr 2004 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60189051 | Mar 2000 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09689812 | Oct 2000 | US |
| Child | 10436465 | US |
