The present invention relates generally to passive range of motion devices; specifically, to devices providing passive range of motion therapy to a joint.
Surgical procedures on the hip joint are commonly performed in the United States. For example, total hip replacements during the decade between 2000 and 2010 rose from 142 to 257 per 100,000 persons in the general population. Additionally, the use of hip arthroscopy is becoming more popular among orthopedic surgeons, with a quoted incidence in orthopedic surgical procedures of 4 cases per 10,000 orthopedic procedures.
It is well-established that movement following surgery on the hip joint is beneficial. Physical therapy utilizing passive range of motion joint therapy decreases pain, reduces swelling through stimulation of venous and lymphatic drainage, preserves and restores normal range of joint motion, speeds and enhances healing, and strengthens surrounding muscles, ligaments, and connective tissues. Early range of motion (“ROM”) therapy is commonly used to prevent formation of intra-articular adhesions.
Although machines are available to perform passive ROM (“PROM”) therapy on postoperative patients, the motion provided by these machines is generally limited to a single plane. PROM therapy to a hip joint is delivered in the sagittal plane. For example, currently available devices move the patient's leg up-and-down off the bed. Because the hip joint of a patient reclining in a bed is in a position approximately neutral with respect to flexion-extension, use of currently available PROM devices typically results in the hip joint being moved between a neutral position and a partially flexed position. This fails to adduct or abduct the hip joint, because the passive motion is limited to a single two-dimensional plane. There is no multi-planar joint movement. It is likely that passive motion in three dimensions greatly increases the benefits of early motion after hip joint surgery, over simple two-dimensional motion in the sagittal plane alone.
Accordingly, a passive PROM device that generates multi-planar motion of the hip joint is needed for optimal post-operative rehabilitation therapy of hip surgery patients.
The present invention relates generally to passive range of motion devices; specifically, to devices providing passive range of motion therapy to a hip joint.
Disclosed is a passive range of motion device comprising a base; a pivoting member rotationally coupled to the base; a limb support having a first end and a second end, the first end of the limb support hingedly coupled to the pivoting member; an offset member coupled to the second end of the limb support, wherein rotation of the offset member causes the second end to move in a circular motion; and a drive motor coupled to the offset member.
In some embodiments, activation of the drive motor causes the second end of the limb support to move along a circular path. In some embodiments, the passive range of motion device comprises one or more securing straps coupled to the limb support. In some embodiments, the passive range of motion device comprises an offset adjustor. In some embodiments, the passive range of motion device comprises a height adjustor. In some embodiments, the passive range of motion device comprises a rotary-to-linear motion device.
In some embodiments, the passive range of motion device may be controlled by controller that may be coupled to the device or may be a remote control, such as a handheld remote-control device, or a computing device, including any stationary or mobile computing device, such as a smartphone, a tablet, or the like. The controller is communicatively and operatively coupled to the device, whether wired or by a wireless signal, such as Bluetooth, or an internet connection, to remotely cause changes in the operation of an element, or combination of elements, of the device.
In some embodiments, the passive range of motion device comprises various sensors coupled to elements of the device for sensing position, orientation, motion, angle, speed, and/or frequency of motions, and the like, of various elements of the device. Further, some embodiments may comprise a processing unit communicatively coupled to the various sensors and to the controller, the processing unit further comprising a processor and a memory. The processor may be programmed or pre-programmed to control the various elements of the device in response to signals from any of the various sensors as well as input by a user to the controller.
Some embodiments may comprise a processing unit communicatively coupled to the various sensors and to the controller, the processing unit further comprising a processor and a memory. The processor may be programmed or pre-programmed to receive signals from the various sensors, the signals containing information about the various elements of the device. The processor may process these signals and store and/or retrieve such information to or from the memory. The processor may also send such information to the controller for display on the controller. The processor may further be communicatively coupled to the drive motors and/or actuators of the various elements of the device, such that the drive motors and/or actuators may be controlled by the processor, in response to user input to the controller
The processing unit may be configured to store user information on the memory and information regarding the status of the at least one controllable element of the device, as that information is received by the processing unit from a sensor coupled to the at least one controllable element. The information may be stored on the memory 14 in association with the user profile of the user that was using the device when the information was received by the processing unit. Such information may be stored to create a usage record for the user. The user may make adjustments to the status of the at least one controllable element by input to the controller. For example, without limitation, a user may use the device at one location and a physical therapist overseeing treatment of the user may access the usage record of a user remotely and make adjustments to the device to change the status of the at least one controllable element.
In some embodiments, user information and user records, including the status of at least one controllable element of the device may be stored remotely on, and/or retrieved from, a controller, or a server that is communicatively coupled to and accessible by the controller.
A method of using a passive range of motion device is also disclosed.
The foregoing and other features and advantages of the present invention will be apparent to those of ordinary skill in the art from the following more particular description of the invention and its embodiments, and as illustrated in the accompanying drawing figures.
As discussed above, this disclosure relates generally to passive range of motion devices; specifically, to devices providing passive range of motion therapy to a joint, such as a hip joint.
Conventional passive ROM machines used for rehabilitation therapy after hip surgery are generally limited to providing motion in the sagittal plane.
The passive range of motion device of the present invention may be used for passive rotation of the hip joint, the shoulder joint, or other joints, depending upon the characteristics of the joint targeted for PROM therapy and the embodiment of the invention. Unless otherwise stated, however, it should be assumed that anatomic relational terms are used as they apply to the hip joint. For example, flexion, extension, adduction, abduction, and rotation mean flexion, extension, adduction, abduction, and/or rotation of the hip joint.
For the purposes of this disclosure, anatomic relational terms describing motion of a joint have the commonly accepted meanings used in the medical literature. Moreover, those of skill in the medical, physical therapy, and medical device arts will be familiar with such terms. Accordingly, “Medial” means the side or aspect of an anatomic structure nearest the midline of a human body. “Lateral” means the side or aspect of an anatomic structure furthest from the midline of a human body and is the opposite aspect of a structure as its medial aspect. “Proximal” means closer to the head than an additional region of the structure being discussed. In the lower extremity, for example, the hip joint is proximal to the knee joint. “Distal” means further from the heart than other regions of the structure being discussed; i.e., the foot is distal to the knee joint. “Dorsal” means back or behind; i.e., the hamstrings are on the dorsal aspect of the leg. “Ventral” means front; i.e., the front of the thigh is the ventral aspect of the thigh. The “sagittal plane” means the imaginary anatomic plane running through the center of the body which divides the human body, or a structure of the body, into a left side and a right side.
The disclosed PROM device is configured to deliver passive motion to a joint, such as a hip joint. A user of the disclosed PROM device positions an extremity, such as a patient's leg, onto a limb support. Embodiments of the PROM device then moves the distal end of the limb support in a circular motion, wherein the patient's joint disposed near a proximal end of the limb support is passively rotated. A drive motor operationally coupled to the limb support at or near the distal end causes the circular motion through an offset member such as crank arm, for example.
A length of the offset member is adjustable, in some embodiments, wherein a diameter of the circular motion may be chosen and set by the user, according to therapeutic goals, characteristics of the joint receiving PROM therapy, and similar anatomic and clinical considerations. The height of the distal end above the base is also adjustable, in some embodiments, to allow for both adequate clearance off the base for the circular motion of the distal end and to adjust a maximum degree of flexion of the hip joint, for example, during a cycle of the circular motion.
Pivoting member 103 is coupled between base 101 and limb support 102 at joint 104. Pivoting member 103 is hingedly connected to a first end 112 of limb support 102 by a joint 105, such as, but not limited to a hinge joint. Pivoting member 103 and joint 105 are configured to moveably couple limb support 102 to base 101 such that limb support 102 moves respective to base 101: 1) up-and-down in an arcuate motion at joint 105; and 2) 360-degree rotational motion at joint 104 about an axis of joint 104 extending perpendicular to base 101. As shown in
In some embodiments, pivoting member 103 is a structure with a substantially planar bottom surface that rotatably slides across an opposing substantially planar top surface of base 101, such as the embodiment shown by
Joint 105 may couple limb support 102 to pivoting member 103 along a fixed axis, wherein components of the joint 105 may rotate around the fixed axis, and the joint 105 may be a hinge, such as, but not limited to a butt hinge, a flush hinge, a piano hinge, a mortise hinge, a barrel hinge, or other types of hinge joints known in the mechanical arts. The particular type of hinge used to form joint 105 depends upon the configuration of pivoting member 103 and limb support 102 present in the particular embodiment of the invention.
Elements of PROM device 100 that generate and are configured for adjusting the rotational motion of limb support 102 are operatively coupled to a second end 113, in some embodiments. As also shown by
A height adjustor 108 operates to set and adjust a median height of second end 113 during operation of PROM device 100. Height adjustor 108 is coupled to base 101 and rotationally coupled, in some embodiments, to offset member 106, wherein offset member may rotate with respect to height adjustor 108. In some embodiments, height adjustor 108 is coupled to base 101. Height adjustor 108 is configured to determine and adjust a median height of second end 113 above base 100, in some embodiments. In some embodiments with a shorter base 101 wherein base 101 does not extend beneath second end 113, height adjustor 108 is configured to determine and adjust a median height of second end above the bed or other surface whereupon the patient is positioned.
The median height of second end 113 above base 101, or the surface of a structure, such as a bed, supporting the patient, determines the minimum amount of hip flexion. Increasing the median height of second end 113 via height adjustor 108 changes the overall position of the patient's extremity during the PROM therapy. For example, increasing the median height causes the PROM therapy to be delivered at a higher degree of hip (or shoulder) flexion and decreasing the median height delivers therapy as a lesser degree of flexion. Various mechanical structures which allow for height adjustment, including but not limited to the scissors mechanism shown by
A drive motor 120 is operatively coupled to offset member 106, offset adjustor 107, height adjustor 108, or any combination of offset member 106, offset adjustor 107, and height adjustor 108, in some embodiments. The drive motor 120 causes rotation of offset member 106 around central axis 111, either directly or through a mechanical or electromechanical linkage. In some embodiments, multiple drive motors 120 may be employed, wherein a drive motor 120 couples to each the offset member 106, offset adjustor 107 and height adjustor 108, respectively, wherein the motors 120 operate independently to adjust and operate PROM device 100.
Limb support 102 is configured to removably couple to the patient's leg, arm or other body part coupled to and distal to the joint receiving PROM therapy. Limb support 102 may be formed as an elongated structure with a top surface and a bottom surface. The top surface may bear attachment members 116, such as straps, for example, to removably secure device 100 to a user's extremity during PROM therapy.
Some applications of hip PROM therapy require combining knee flexion with hip flexion. Knee flexion releases tension on hip extensor muscles, including the biceps femoris, semimembranosis, and semitendinosis. Releasing tension on hip extensors allows for increased hip flexion. In some patients, simultaneous knee flexion is required to achieve hip flexion greater than ninety (90) degrees. Accordingly, as shown in
In some embodiments, the first and second sections 122 and 124 of limb support 102 are fixed at a set knee flexion angle. In some embodiments, the knee flexion angle is dynamic through a range of knee flexion angles as second end 113 of limb support 102 traces a circular path around axis 111.
In some embodiments, a passive range of motion device 100 may further comprise a rotary-to-linear motion device 130 operatively coupled between offset member 106 and second end 113 of limb support 102. The rotary-to-linear motion device 130 may comprise a mechanism 132 for converting rotary motion to linear oscillating motion, and an oscillating arm 134 extending therefrom. The oscillating arm 134 may be comprised of two components 136 and 138 that are slidingly coupled together, such that the overall length of the oscillating arm 134 may be varied as the two components 136 and 138 slide relative to each other. The oscillating arm 134 swings back and forth, in pendular motion, in response to rotary motion input, such as by a motor drive, by operation of the rotary-to-linear device 130. In some embodiments, rotary motion input to the rotary-to-linear device 130 is by a separate drive motor 120 mounted to the device 130. The oscillating arm 134, being coupled to the second end 113 of limb support 102, causes the second end 113 to oscillate in concert with the oscillating arm 134. Thereby, the second end 113 of limb support may oscillate in a linear fashion up and down, side to side, or diagonally, at any angle corresponding to the angle of rotation of the offset member 106. The sliding mechanism of the two-part oscillating arm 134, as described above, allows for the oscillating arm 134 to extend and retract, as the arm 134 pendulates in an arc about the rotary-to-linear device 130, and the limb support 102 pendulates in an opposing arc about the joint 104.
In some embodiments, the rotary-to-linear motion device 130 may be an adjustable rotary-to-linear motion device 130, as shown in
In operation, an adjustable rotary-to-linear motion device 130 may be adjusted such that the magnitude of the oscillating motion of the oscillating arm 134, and, therefore, the second end 113 of limb support 102, is greater than zero. Further, the offset adjuster 107 may be rotated to an angle corresponding to pendular motion of the oscillating arm in a horizontal plane, for adduction and abduction of a user's hip joint, for example. Alternatively, the offset adjuster 107 may be rotated to an angle corresponding to pendular motion of the oscillating arm in a vertical plane, for flexion and extension of the user's hip joint. Similarly, the offset adjuster 107 may be rotated to any angle corresponding to pendular motion of the oscillating arm in any diagonal plane between the horizontal plane and the vertical plane, to achieve various combinations of adduction, abduction, flexion, and extension of the user's hip joint. The degree of adduction, abduction, flexion, and/or extension of the user's hip joint may be controlled by adjustment of the adjustable rotary-to-linear motion device 130. Similar corresponding adjustments may be made to control motions of other embodiments of a passive range of motion device configured for use with a user's shoulder joint, or other joint, rather than a hip joint.
In some embodiments, the offset member 106, and the drive motor 120 coupled thereto, may be mounted to a framework such that the offset member 106 and the drive motor 120 may be rotated 90 degrees to allow for rotation of the offset member 106 in a circular path in a horizontal plane in response to operation of the drive motor 120. This motion can only be performed when height adjustor 108 has been slid along tracks 128 such that hinge 126 is elevated above the base 101, thereby allowing the second end 113 of limb support 102 to move in a horizontal circular path. Accordingly, rotation of the offset member 106 and the drive motor 120 is not limited to a 90-degree rotation. Offset member 106 and drive motor 120 may be rotated to an angle that is less than 90 degrees or more than 90 degrees, such that the resulting circular path of the second end 113 of limb support 102 is other than horizontal.
An advantage of some embodiments of the present invention is that elements of the device may be used in combination to achieve compound motions. For example, one desirable compound motion is achieved by using height adjustor 108 to raise the second end 113 of limb support 102 to a height equal to the length of the first section 122 and sliding height adjustor 108 along tracks 128 to raise hinge 126 until the first section 122 is vertical. In this position, when a user's leg is strapped to the limb support 102, the upper leg, or thigh portion, of the user is vertical and the lower leg, or shin portion, of the user is horizontal. Then, the rotary-to-linear motion device 130 may be used to pendulate the second end 113 of limb support 102 in a side-to-side arcuate motion about the hinge 126. Simultaneously, the height adjustor 108 may be slid forward and backward along tracks 128 in a synchronous motion with the motion of the rotary-to-linear motion device 130 to achieve motion of the second end 113 of limb support 102 along a horizontal circular path.
In some embodiments, device 100 may be controlled by controller that may be coupled to the device 100 or may be a remote control (not shown), such as a handheld remote-control device, or a computing device, including any stationary or mobile computing device, such as a smartphone, a tablet, or the like. The controller is communicatively and operatively coupled to the device 100, whether wired or by a wireless signal, such as Bluetooth, or an internet connection, to remotely cause changes in the operation of an element, or combination of elements, of device 100. Operation of elements caused to change in response to a signal from the controller, in some embodiments, may include the drive motor 120, offset member 106, offset adjustor 107, height adjustor 108, and rotary-to-linear motion device 130, for example. The remote control may operate to adjust one or more operational parameters of PROM device 100, in any number or combination, such as the height of second end 113, the rotational frequency of second end 113, or to cause offset adjustor 107 to change the radius of the circular path, for example, in response to user input to the remote control.
As shown in
As shown in
In some embodiments, the processing unit 140 may be configured to store user information on the memory 144. For example, in operation, a user may create a user profile, including a user name, a password, and/or other user-identifying information. Without limitation, the processing unit 140 may be programmed to store, on the memory 144, one or more pieces of information regarding the status of the at least one controllable element of the device 100 while the device 100 is in use by a user, as that information is received by the processing unit 140 from a sensor 146 coupled to the at least one controllable element. The information may be stored on the memory 144 in association with the user profile of the user that was using the device 100 when the information was received by the processing unit 140. For example, when a user uses the device 100, information may be stored to the memory 144 regarding the maximum flexion/extension angle of the limb support 102, the angle of the plane of circular motion of the second end 113 of the limb support 102, the height of the second end 113 of the limb support 102, the amount of time the user used the device 100, the number of repetitions of any particular motion of the device 100, and the like. Such information may be stored to create a usage record for the user. The processing unit 140 may be programmed to retrieve the usage record, and/or any other information stored on the memory 144, for display on the controller 148 for a user to view. The user may then make adjustments to the status of the at least one controllable element by input to the controller 148. For example, without limitation, a user may use the device 100 at one location and a physical therapist overseeing treatment of the user may access the usage record of a user remotely and make adjustments to the device 100 to change the status of the at least one controllable element. For example, the physical therapist may remotely increase the length of the offset member 106 to increase the radius of a circular path during the user's next use of the device 100 in order to increase abduction/adduction and flexion/extension motion of the user's leg as part of a progressive treatment/therapy program for the user. In some embodiments, the physical therapist may monitor such information in real time while the user is using the device 100.
In some embodiments, user information and user records, including the status of at least one controllable element of the device 100 may be stored remotely on, and/or retrieved from, a controller 148, or a server that is communicatively coupled to and accessible by the controller 148.
Embodiments of a method of use of a passive range of motion device may comprise: mounting a limb of a user to the limb support; and operating the passive range of motion device to effect motion of the second end of the limb support in one of a circular path, a pendulating arcuate motion about the first end of the limb support, or a combination thereof. Other embodiments of a method of use of a passive range of motion device, as shown in
The components defining any passive range of motion device 100 may be formed of any of many different types of materials or combinations thereof that can readily be formed into shaped objects provided that the components selected are consistent with the intended operation of the passive range of motion device 100. For example, the components may be formed of: rubbers (synthetic and/or natural) and/or other like materials; glasses (such as fiberglass) carbon-fiber, aramid-fiber, any combination thereof, and/or other like materials; polymers such as thermoplastics (such as ABS, Fluoropolymers, Polyacetal, Polyamide; Polycarbonate, Polyethylene, Polysulfone, and/or the like), thermosets (such as Epoxy, Phenolic Resin, Polyimide, Polyurethane, Silicone, and/or the like), any combination thereof, and/or other like materials; composites and/or other like materials; metals, such as zinc, magnesium, titanium, copper, iron, steel, carbon steel, alloy steel, tool steel, stainless steel, aluminum, any combination thereof, and/or other like materials; alloys, such as aluminum alloy, titanium alloy, magnesium alloy, copper alloy, any combination thereof, and/or other like materials; any other suitable material; and/or any combination thereof.
Furthermore, the components defining any passive range of motion device 100 may be purchased pre-manufactured or manufactured separately and then assembled together. However, any of or all the components may be manufactured simultaneously and integrally joined with one another. Manufacture of these components separately or simultaneously may involve extrusion, pultrusion, vacuum forming, injection molding, blow molding, resin transfer molding, casting, forging, cold rolling, milling, drilling, reaming, turning, grinding, stamping, cutting, bending, welding, soldering, hardening, riveting, punching, plating, and/or the like. If any of the components are manufactured separately, they may then be coupled with one another in any manner, such as with adhesive, a weld, annealing, a fastener (e.g. a bolt, a nut, a screw, a nail, a rivet, a pin, and/or the like), wiring, any combination thereof, and/or the like for example, depending on, among other considerations, the particular material forming the components. Other possible steps might include sand blasting, polishing, powder coating, zinc plating, anodizing, hard anodizing, and/or painting the components for example.
The embodiments and examples set forth herein were presented to best explain the present invention and its practical application and to thereby enable those of ordinary skill in the art to make and use the invention. However, those of ordinary skill in the art will recognize that the foregoing description and examples have been presented for the purposes of illustration and example only. The description as set forth is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible considering the teachings herein without departing from the spirit and scope of the forthcoming claims.
This application claims priority to U.S. Provisional Patent Application to Pavel Ivanov entitled “PASSIVE RANGE OF MOTION DEVICE,” Ser. No. 62/670,532, filed May 11, 2018, the disclosures of which are hereby incorporated entirely herein by reference.
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