WO2016154292A1

WO2016154292A1 - Medical splinting or bracing device having vibratory capabilities and a method for incorporating vibratory therapy functionalities into a medical splinting or bracing device

Info

Publication number: WO2016154292A1
Application number: PCT/US2016/023750
Authority: WO
Inventors: Garrett NAZE; Bryan SCHWEBKE
Original assignee: Naze Garrett; Schwebke Bryan
Priority date: 2015-03-23
Filing date: 2016-03-23
Publication date: 2016-09-29

Abstract

A therapy device combines splinting and bracing modalities with a vibration modality. Splints and braces of various types incorporate a vibration unit having a vibration motor such that the vibration motor can be mounted to a splint or brace in such a way to generate and impart pressure waves for therapeutic use. Multiple vibration units can be used with a single splint or brace and can be mounted onto the splint or brace or embedded within the splint or brace. The splint or brace comprises a proximal portion disposed at a limb portion above a joint, a medial portion disposed at and about the limb joint and a distal portion disposed at the limb portion below the joint.

Description

PATENT COOPERATION TREATY APPLICATION SPECIFICATION

MEDICAL SPLINTING OR BRACING DEVICE HAVING VIBRATORY CAPABILITIES AND A METHOD FOR INCORPORATING VIBRATORY THERAPY FUNCTIONALITIES INTO A MEDICAL SPLINTING OR BRACING DEVICE

This application claims the benefit and priority of United States Provisional Patent Application No. 62/136,732 filed March 23, 2015. FIELD OF THE INVENTION [0001] The present invention relates generally to medical splinting and bracing devices and to methods for using such splinting and bracing devices with patients. It also relates generally to other devices and methods for supporting patients' arms, shoulders, knees and feet, including dynamic splints, static splints, casts, traction devices, post-surgical braces, extension boards, arm slings, protective walking boots and other recuperative medical splints and braces (collectively, "splinting and bracing devices," the splinting and bracing devices comprising a "splint or brace"). [0002] The present invention also generally relates to the creation of pressure waves via a vibration motor. Further, the present invention also relates generally to vibration therapy of the type that uses mechanical vibration to improve muscle tone in individuals and/or to treat certain health problems. More particularly, the present invention relates to the incorporation of a vibration functionality into such splinting and bracing devices for the purpose of improving and accelerating the healing process in patients. BACKGROUND OF THE INVENTION

[0003] Splinting and bracing devices are well known in the medical and postsurgical arts. In the experience of these inventors, such splinting and bracing devices are typically used for one of two reasons. One reason is to stabilize a joint or other tissue. This is considered "static" splinting, for example. The other reason is to stretch a joint or tissue. This is considered "dynamic" splinting. In short, and when used with a human hand, wrist and forearm, for example, the static splint is designed to support the hand and the dynamic splint is designed to mobilize the hand. In the experience of these inventors, "static progressive" splints are also used to apply a constant force (applied using hook and loop structures, such as VELCRO® (VELCRO is a registered mark of Velcro Industries B.V.)) that can be adjusted. This is not the same type of structure used in dynamic splints which apply an elastic force, but is a type of splinting that is included in devices and methodology of the present invention.

[0004] Relative to the present invention, it is known that striated skeletal muscle responds to passive overstretch through a process called sarcomerogenesis, which is the creation and serial deposition of new sarcomere units. Sarcomeres are characterized through a parallel arrangement of thick filaments of myosin that slide along thin filaments of actin. In a relaxed muscle, actin and myosin filaments lie side- by-side. During contraction, the actin and myosin filaments interact. The actins are pulled toward the center of each myosin filament. As a result, the sarcomeres shorten. In the fully contracted muscle, the ends of the actin myofilaments overlap. Further, movement of tropomyosin uncovers myosin binding sites on the actin, allowing myosin heads to bind and form cross-bridges. These cross-bridges play an important role in muscle contraction. Indeed, sarcomerogenesis is critical to muscle function in that it gradually re-positions muscle back into its optimal operating regime.

[0005] It is also known that the connective tissues in and around the human muscle comprise collagen and the way that collagen behaves is called "viscoelasticity" - viscoelastic tissues comprising viscous and elastic properties. A viscous tissue will deform and stay deformed permanently whereas an elastic tissue will return to its original length (eventually) when force is removed from the tissue. Certain physical properties of viscoelastic tissues describe how the tissues elongate with stretching and include the creep principle, load relaxation and hysteresis. The "creep principle" describes the ability of a tissue to elongate over time when a constant load is applied to it; load relaxation describes how less force is required to maintain a tissue at a set length over time; and hysteresis describes the amount of lengthening a tissue will maintain after a cycle of stretching and then relaxation.

[0006] For example, a therapeutic wrist brace can be configured to dynamically improve the range of motion and flexibility of a patient's wrist where that patient is being treated, pre-operatively or post-operatively, for carpel tunnel syndrome. This is accomplished by stabilizing the patient's forearm and then flexing or stretching the corresponding hand upwardly and/or downwardly in accordance with a therapy program. This type of treatment is beneficial to the patient in view of the dynamic principles mentioned above. Other principles at work is this area of therapeutic medicine include total end range time, or "TERT," which claims that the amount of increase in the "passive" range of motion of a stiff joint is proportional to the amount of time the joint is held at its end range, or TERT. Another principle is Wolff's law according to which biologic systems such as hard and soft tissues become distorted in direct correlation to the amount of stress imposed upon them. Other principles in the areas of physical rehabilitation and sports training include "specific adaptation to imposed demands" or "SAID" which asserts that the human body adapts to imposed demands related to speed, force and time; osteoclasts or bone stimulation; a- motorneurons, or alpha motor neurons, together with the muscle fibers they innervate is a motor unit; muscle spindles which are sensory receptors within a muscle that primarily detect changes in the length of the muscle; H-reflex (or Hoffmann's reflex) is a reflectory reaction of muscles in response to electrical stimulate of sensory fibers; among others.

[0007] As a general proposition, mechanical vibration is a known physical phenomenon whereby oscillations are created within a structure. The oscillations can be periodic or non-periodic, the latter being induced typically by random physical events. On the other hand, "periodic oscillations" can be induced in a controlled fashion for the purpose of moving an object about an equilibrium point at a desired or required frequency and to a desired or required extent. It is well known in the mechanical arts that "forced periodic oscillations" or vibration can be created via an electro-mechanical device. Typically, a vibration motor having a constant voltage applied across the motor can be used to create such forced vibration. As to the vibration functionality itself, and as alluded to above, this is most typically provided by an "electro-mechanical unit" which creates periodic oscillation, resonance or "pressure waves," the pressure waves then being propagated into nearby structures. The unit can comprise a control element that is electrically coupled to a direct current ("DC") motor and a DC power source. The DC motor comprises a shaft and, when the DC motor is actuated, the shaft rotates. An unbalanced weight is attached to the end of the rotating shaft. Actuation of the motor produces varying levels of vibration, depending on the size of the motor, the speed of the motor and the size of the unbalanced weight. Alternatively, the shaft of the DC motor can be coupled with a gear, the gear having the unbalanced weight mechanically attached to it. In either case, this creates a "wobble" effect and the pressure wave of the type described above. Typically, at about 100 to 150 revolutions per minute ("RPM"), an off-center mounting of most any weight can produce a relatively strong vibration. The control element uses a DC electrical power source in the form of batteries, which makes the electro-mechanical unit highly portable. It should be noted that this type of vibration-generating mechanism is well known in vibrating cell phones, pagers and other applications where a vibration is required or desired. However, other dynamic vibrating-generating devices that are known (such as energy cells or the like) or yet to be known could be used to the same end.

[0008] In the medical arts, it is also well known that the use of mechanical vibration of muscle and other tissues can improve and promote healing of those tissues. Some vibrations can be induced by direct subdural electrical stimulation. On the other hand, and as it relates to the type of mechanically-induced vibration as alluded to above, the electro-mechanical unit which creates periodic oscillation, resonance or pressure waves, the pressure waves are propagated into nearby tissue. Vibration, as a medical treatment modality, however, has typically been used in "whole body vibration" (or "WBV") settings. That is, vibration can be artificially produced when a person stands on a vibration platform that generates vertical sinusoidal vibration at a vibrational frequency in the range of 35 to 50 hertz. The hertz, symbolized by the notation "Hz", is equivalent to cycles per second. The mechanical stimulation is transmitted to tendons which, in turn, leads to activation of the a-motorneurons and initiates muscle contractions. The WBV methodology also provides a flexibility effect. That is, such effect involves neural circulatory and thermoregulatory factors. It is well known that the pain threshold serves as a natural barrier for a stretching exercise. This is believed to be a result of WBV producing certain analgesic effects during and after vibration application to muscles. This effect is exploited during WBV stretching. It has also been noted that vibration applied to muscles enhances blood circulation. Increased blood flow also evokes a thermal effect, which can be augmented by heat generation caused by the vibration of muscle fibers as well as to vasodilation of cutaneous and deep blood vessels. Heat-related facilitation of flexibility is well known and widely used. One of the problems with using such a WBV device, however, is that it is typically relatively heavy (in the range of 150 lbs. and up) and, accordingly, not practically portable. For example, U.S. Pat. No. 7,922,622 (the '622 patent) to Holle is drawn to a biomechanical stimulation (or "BMS") device which is based on mechanical influences on the body using vibrations at a respective particular frequency and with a particular amplitude which are intended to act on tensed or stretched muscles along the muscle fiber. The device of the '622 patent is marketed under the name SWISSWING™ (SWISSWING is mark of Swiss Therapeutic Training Products) - a stationary device, and intentionally so.

[0009] In the view of these inventors, splinting and bracing devices, and vibration, have been used separately, but not together. If used together, the combination of a splinting or bracing device with a vibration functionality would improve a patient's range of motion and flexibility, decrease muscle guarding, improve and promote healing, provide proprioceptive input and prevent muscle atrophy, among other things. In short, combining the concept of a splinting and bracing modality with a vibration modality increases the efficacy of both.

[0010] Other benefits of this combination are that it improves the portability of vibration intervention, decreases the cost of using separate devices, decreases postsurgical complications, decreases the cost of physical therapy or surgical intervention that is secondary to post-surgical complications, and avoids invasive procedures that are secondary to post-surgical complications, among other things.

[0011] In the view of these inventors, what is needed is a splinting or bracing device (or a number of such devices) that can incorporate vibration functionality directly into the splinting or bracing device to increase efficacy and accomplish the other patient benefits, as stated above. Alternative embodiments could be presented and used to treat virtually any portion of a patient's body that would benefit by such treatment. Further, it is to be understood that the means for creating the vibration functionality can be incorporated into splinting and bracing devices by original equipment manufacturers ("OEM") during the device manufacturing process. It is also to be understood that, alternatively, the vibration functionality can be added to an OEM device as an aftermarket retrofit. Both concepts are included within the scope of the present invention.

SUMMARY OF THE INVENTION

[0012] In view of the foregoing, a number of splinting or bracing devices that incorporate electro-mechanical or other vibration-generating functionality have been devised by these inventors. In one embodiment, for example, a dynamic hand splint structure has been conceived with this vibration functionality. The hand split comprises a static portion that is secured to a patient's forearm, extending up to, but slightly short of, the patient's wrist. Extending distally from the static portion is a dynamic extension with can be set at any number of angles relative to the "joint line" of the patient's wrist relative to the patient's forearm so as to impose a stretching force to the wrist within a desired range of motion. In the preferred embodiment, a plurality of vibration elements could be placed along the sides of the static portion of the structure to impart vibration to the patient's forearm and wrist. This is but one example of a device that is constructed in accordance with the present invention. In alternative embodiments of both static and dynamic devices, other configurations for such splinting or bracing devices, all of which incorporate vibration, are disclosed and included within the scope of the present invention.

[0013] The foregoing and other features of the present invention will be apparent from the detailed description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 is a perspective view of a vibration motor of the type that could be used in the device of the present invention.

[0015] FIG. 2 is a schematic circuit diagram of a first preferred embodiment of a vibration unit in accordance with the present invention.

[0016] FIG. 2A is a schematic circuit diagram of a second preferred embodiment of a vibration unit where the vibration motor is remote from the vibration unit. [0017] FIG. 3 is a front elevation view of an arm sling of the type that would incorporate at least one of the first preferred embodiment of the vibration unit.

[0018] FIG. 4 is a greatly enlarged cross section view of the arm sling and vibration unit taken along line 4-4 of FIG. 3, the vibration unit being shown disposed at the outer surface of the arm sling.

[0019] FIG. 5 is a rear elevation view of the arm sling shown in FIG. 3.

[0020] FIG. 6 is a front elevation view of the arm sling shown in FIG. 3 wherein the second preferred embodiment of the vibration unit is used.

[0021] FIG. 7 is a greatly enlarged cross section view of the arm sling and vibration unit taken along line 7-7 of FIG. 6, the vibration motor is embedded within the arm sling.

[0022] FIG. 8 is a view similar to that shown in FIG. 7, the vibration unit being shown disposed at the inner surface of the arm sling.

[0023] FIG. 9 is a front elevation view of another type of arm brace that would incorporate at least one vibration unit in accordance with the present invention.

[0024] FIG. 10 is a front elevation view of another type of arm brace that would incorporate at least one vibration unit in accordance with the present invention.

[0025] FIG. 1 1 is a side elevation view of a wrist brace of the type that would incorporate at least one vibration unit in accordance with the present invention.

[0026] FIG. 12 is top plan view of a much simplified wrist brace of the type that would incorporate at least one vibration unit in accordance with the present invention.

[0027] FIG. 13 is side elevation view of a leg brace of the type that would incorporate at least one vibration unit in accordance with the present invention. [0028] FIG. 14 is a perspective view of a boot of the type that would incorporate at least one vibration unit in accordance with the present invention.

[0029] FIG. 15 is a perspective view of an ankle brace of the type that would incorporate at least one vibration unit in accordance with the present invention.

[0030] FIG. 16 is a side elevation view of a full leg brace of the type that would incorporate at least one vibration unit in accordance with the present invention.

[0031] FIG. 17 is a side elevation view of another full leg brace of the type that would incorporate at least one vibration unit in accordance with the present invention.

DETAILED DESCRIPTION

[0032] Referring now to the drawings in detail wherein like numbers represent like elements throughout, it is to be understood that the placement of vibration units is not limited specifically to those points shown on the splinting or bracing devices that are illustrated in the drawings. Other locations can be utilized, and each for a different purpose. The splinting and bracing devices can also be configured to receive a vibration unit at various points within the splinting and bracing devices such as where the unit is embedded or integrally disposed within the splinting or bracing device. The vibration unit can also be positioned within the splinting or bracing device such that the vibration unit is disposed immediately adjacent the user's skin.

[0033] That said, placement of the vibration unit can be on an outer surface of the splint or brace, an inner surface of the splint or brace, and within the splint or brace - the splint or brace having (i) a proximal portion disposed at the limb portion above the joint; (ii) a medial portion disposed at and about the limb joint; and (iii) a distal portion disposed at the limb portion below the joint. [0034] Alternatively, primary options for vibration unit placement include, but are not limited to, (a) the joint line; (b) points that are proximal or distal to the joint line along the rigid structure of the splinting or bracing device; and (c) points that are anterior or posterior over the muscle belly of the muscles superior or inferior to the joint line.

[0035] It is also to be understood that the methodology of the present invention also introduces a temporal component. That is, each splinting and bracing device preferably includes a self-contained DC electrical power supply, a controller and an electro-mechanical vibration-generating unit. In alternative embodiments, the splinting or bracing device may comprise an electrical connection to an alternating current ("AC") supply and a transformer so as to convert the AC to DC. This would be an alternative, but not necessarily a desired one as this would essentially eliminate portability of the splinting or bracing device. However, the AC and transformer could also be used to charge the DC power supply.

[0036] It is also to be understood that the controller may include means for operating the vibration-generating unit such that it has a pre-programmed amount of time for a given session of flexion and extension of a joint, as well as a number of times that each session is conducted in the course of a day, all for optimized use and application of the vibratory component. The vibration will also comprise a vibrational frequency, which typically ranges (in optimized application) from as low as 5 Hz up to a high of about 90 Hz. Other frequencies are within the scope of the present invention, however. Further, the frequency is variable so that frequency optimization is realized in each splinting or bracing device. [0037] Referring now to FIG. 1 , it illustrates a DC vibration motor 1 that comprises an electrical input 2 and an electrical output 3. When a voltage is applied across the motor leads 2, 3, the vibration motor 1 vibrates or oscillates in accordance with known electromechanical principles. Referring to FIG. 2, it illustrates a simplified circuit of a first preferred embodiment of a vibration unit, generally identified 10, constructed in accordance with the present invention. In addition to the DC vibration motor 1 , the vibration unit 10 comprises a DC power supply 4 and an on/off switch 5. Referring to FIG. 2A, it illustrates a second preferred embodiment of a vibration unit 20 that comprises the same elements as the first preferred embodiment of the vibration unit 10 but moves the DC vibration motor 1 to a point that is remote to the other elements of this second preferred embodiment. Electrically, it is also possible to use an AC power supply (not shown) together with an AC to DC transformer (also not shown). The AC power supply could be used as a power supply for the vibration unit 10, 20 itself, but would obviously compromise mobility of the splinting or bracing device with which the vibration units 10, 20 would be used. Lastly, it would also be possible to utilize a vibration unit 10, 20 having multiple vibration motors 1 drawing from it. However, power usage with such a configuration could compromise vibration functionality and/or reduce the amount of time that a motor 1 in a series of motors 1 could be used due to the rapid depletion of electrical energy from the DC power supply 4. Accordingly, the present invention concentrates on each vibration unit 10, 20 standing as a non-networked device.

[0038] It is also possible to utilize a controller or timer (also not shown) in place of the on/off switch 5. The controller or timer would serve to start and stop vibration cycles in accordance with a preprogrammed scheme so as to optimize vibratory therapy via the splinting or bracing device with which the vibration unit 10, 20 is used.

[0039] It is also to be understood that the vibration motor 1 can be placed at a first position on a brace or splint device and the other elements, namely, the alternative embodiment of the vibration unit 20, being placed at a second position, the motor 1 and the other elements being connected via the input and output lead wires 2, 3, respectively. However, placement is a design expediency and depends on the vibration unit 10, 20 used. The first preferred embodiment of the vibration unit 10 is fairly limited to attachment and use on the outer surface of the brace or split. On the other hand, the second preferred embodiment of the vibration unit 20 is a particularly necessary one where the vibration motor 1 is embedded within the splint or brace or is placed on to an inner surface of the brace or splint, both of which render the vibration motor 1 generally inaccessible by the user. In this way, the controller 5 can be available to the user. Also, the DC power supply 4, typically in the form of one or more batteries, could be easily accessed and replaced as needed. These placements will be apparent later in this detailed description.

[0040] Referring now to FIG. 4, it illustrates a "shoulder" or "sling" embodiment of a splinting or bracing device, generally identified 30. As a preliminary matter, the shoulder splinting device 30 could be one of many that are commercially available - incorporated as an OEM element or as a retrofit to an existing device 30. By way of example only, the device 30 could be a dynamic sport-stirrup bracing device that is branded as a DONJOY® product (DONJOY is a registered mark of DJO, LLC and DJ Orthopedics Development Corporation). By way of other examples, the "quick-fit" shoulder immobilizer splinting device 30 could be a device branded as an AIRCAST® product (AIRCAST is a registered mark of DJO, LLC); a static arm immobilizer splinting device that is also branded as an AIRCAST® product; a dynamic sport-stirrup bracing device that is branded as a DONJOY® product; a dynamic elbow splinting device that is branded as a PRO-GLIDE™ product (PRO-GLIDE is a mark of DeRoyal Industries, Inc.); a dynamic elbow bracing device that is branded as a STATIC-PRO® product (STATIC-PRO is a registered mark of DeRoyal Industries, Inc.); a dynamic elbow splinting device that is branded as a DEROM® product (DEROM is a registered mark of DeRoyal Industries, Inc.); among others. The splinting device 30 that is shown in FIGS. 3 and 4 is representative of each.

[0041] This embodiment can also be referred to herein as a "quick-fit" shoulder immobilizer splinting or bracing device 30 (alternatively referred to as a "splint or brace device" throughout) that is constructed in accordance with the present invention. As to this FIG. 3, and as to all of the alternative embodiments discussed below, it is to be understood that the vibration motor 1 itself, its wiring 2, 3, its power supply 4 and its controller 5 are not shown but are incorporated into the first preferred embodiment of the vibration unit 10. The vibration unit 10 itself is shown placed or positioned at a point along the exterior or outer surface 31 of the splint or brace device 30. See FIG. 4.

[0042] The splint or brace device 30 comprises a sling-like splint or brace structure 32 having a proximal upper arm portion 34 and a distal forearm and wrist portion 36. A medial portion effectively covers the user's elbow (not shown). The device 30 holds the user's arm A in place by use of a support strap 38. As shown in FIG. 5, the splint or brace structure 32 further comprises a rearward facing surface 37. As shown in these drawings, a vibration unit 10 is preferably positioned at the upper arm portion 34, 37 facing forward or rearward, respectively, or at the forearm and wrist portion 36. Most significantly, the vibration unit 10 is mounted or attached to the outer surface 31 of the body 33 of the splint or brace structure 32, the body 33 of the splint or brace structure 32 further comprising an interior or inner surface 35.

[0043] As will be apparent in later embodiments of splint or brace devices that the vibration unit 10 will be surface-mounted as well. This is particularly true where the vibration unit 10 is a retrofit of an existing splint or brace device. In other embodiments, however, the second preferred embodiment of the vibration unit 20 will be also surface mounted, with the vibration motor 1 itself being mounted to the interior or inner surface 35 of the splint or brace device 30 or embedded within the splint or brace device 30. This is the construct illustrated in FIGS. 6-8. Specifically, the second preferred embodiment of the vibration unit 20 is mounted or attached to the outer surface 31 of the body 33 of the splint or brace structure 32 where, again, the body 33 of the splint or brace structure 32 further comprises an interior or inner surface 35. As shown, the vibration motor 1 can be embedded within the body 33 of the splint or brace structure 32, as per FIG. 7, or mounted at a point along the inner surface 35, as per FIG. 8.

[0044] It should be noted here that, in the remaining drawings, reference will be made to both embodiments of the vibration unit 10, 20 which is illustrated by a position that is shown in phantom view and identified by the element number 100. This indicates that either embodiment can be used within the scope of the present invention and that either embodiment functions as previously described. [0045] Referring to FIG. 9, it illustrates a dynamic "elbow" bracing device, generally identified 40. This splint or brace structure comprises a proximal upper arm portion 44 and a distal forearm portion 46. A support strap 48 is also shown. The upper arm portion 44 and the forearm portion 46 are rotatable relative to one another about a fixable and/or rotatable medial portion 42, which is a hinge. Using this hinge 42 construct, the users arm A can be set in virtually any angular position that is desired or required. As shown, the vibration units 100 can be positioned at the upper arm portion 44 or at the hinge 42, although positioning is not a limitation of the present invention. The vibration units 100 can be placed at any point along the bracing device 40 as may be desired or required. This bracing device 40 can be of a type that is branded as an AIRCAST® product or as a DONJOY® product of current manufacture. The bracing device 40 can also be a dynamic elbow pronation and supination splinting device that is currently branded as a STATIC-PRO® product.

[0046] Referring to FIG. 10, it illustrates a structure that is similar to that shown in

FIG. 9 but without any support strap and with arm support structure that is intended to be more movable than held in a "fixed" position. In this way, the device is movable from the joint line, which is established by an axial line extending downwardly from the user's upper arm and which would be at 0°, to a flexed angle of about 150° from that joint line. This dynamic bracing device 50 comprises a bracing structure having a rotatable but fixable medial or elbow portion 52, which is a hinge, proximal upper arm portion 54 and a distal forearm portion 56. As shown in FIG. 10, a vibration unit 100 is preferably positioned at the medial upper arm portion 54 and/or at the hinge 52. However, other positions are likewise possible and also within the scope of this invention, for the reasons stated above. The vibration units 100 would lay along the joint line as flexed to the degree stated above. That is, the vibration units 100 would lay at points that are proximal or distal to the joint line along the rigid structure of the splinting or bracing device.

[0047] Referring to FIG. 1 1 , it illustrates a "wrist" bracing device, generally identified 60. Here again, the bracing device 60 comprises two placement options for the vibration unit 100, as shown, but the invention is not limited to those two placement options. This bracing device is of a type of current manufacture, such as an AIRCAST® product. Other like dynamic sport-stirrup bracing devices are branded as a DONJOY® product or a dynamic wrist bracing device that is branded as an EXOS® product (EXOS is a registered mark of Exos Corporation). Other dynamic wrist splinting devices are branded as a PRO-GLIDE™ product, a STATIC-PRO® product and a DEROM® product. As shown, the bracing device 60 comprises a proximal forearm portion 64 and a distal hand and wrist portion 66. The hand and wrist portion 66 is angularly rotatable relative to the forearm portion 64 via a fixable and/or rotatable hinge 62, which is a medial portion. Using this hinge 62 construct, the users hand H and wrist W can be set in virtually any angular position relative to the forearm portion 66 that is desired or required. As shown, the vibration units 100 can be positioned at the forearm portion 64 or at the hinge 62, although positioning is not a limitation of the present invention, as previously stated. The vibration units 100 can be placed at any point along the bracing device 60 as may be desired or required. Further, the forearm portion 64 establishes the joint line at 0° and the wrist portion 66 can be rotated about the hinge 62 by about 70° upwardly and by about 80° downwardly. The vibration units 100 would lay along the joint line for the user's wrist as flexed to the degree stated above. Again, this would be along points that are proximal or distal to the joint line along the rigid structure of the splinting or bracing device when the limb is flexed.

[0048] FIG. 12 illustrates another wrist bracing device, generally identified 70, that is in the form of a sleeve 72. The sleeve 72 comprises a proximal arm and/or wrist portion 74 and a distal hand and/or wrist portion 76. Essentially, the two portions 74, 76 extend between the user's forearm A and the user's hand H. As shown, two placement options for the vibration units 100 are illustrated, but such positioning is not limited.

[0049] Referring to FIG. 3, it illustrates a dynamic "knee" embodiment of a splint or brace device, generally identified 80. Dynamic knee bracing devices that are constructed in similar fashion include those branded as DONJOY® products, DEROM® products, PRO-GLIDE™ products and a dynamic knee splinting device that is branded as a STATIC-PRO® product wherein the device is movable from the joint line, which would be at about 10°, to a flexed angle of about 135° from the joint line. The splint or brace device 80 comprises a proximal portion 84 above the user's knee, a distal portion 86 below the user's knee and a medial portion or hinge 82 at the user's knee. As shown, a vibration device 100 is disposed at the hinge 82, but the invention is not so limited. This particular splint or brace device 80 comprises many other types of embodiments, some of which resemble the arm brace devices of the type shown in FIGS. 9 and 10, wherein the device 80 further comprises connective elements 88 as shown in FIG. 13. The vibration devices 100 would lay along the joint line as flexed to the degree stated above. [0050] Referring to FIG. 14, it illustrates a "boot" embodiment of a splint or brace device, generally identified 90. One such boot is a dorsal night splinting device that is constructed such that it can comprise two placement options for the vibration unit 100, as shown, and is of a type that is known in the art and is branded as an AIRCAST® product. A dynamic sport-stirrup bracing device that is constructed in accordance with the present invention is branded as a DONJOY® product and a dynamic ankle splinting device that comprises two placement options for the vibration unit 100 and branded as a DEROM® product. The boot structure 92 comprises a leg portion 94 that is integrally formed with a foot portion 96. This boot structure 92 is not limited to the placement options shown. In this construct, the medial portion of the boot structure 92 covers the user's ankle (not shown).

[0051] Referring to FIG. 15, it illustrates an "ankle" embodiment of a splint or brace device, generally identified 190. The dynamic sport-stirrup bracing device comprises two placement options for the vibration unit 100, as shown, and is of a type branded in the market as an AIRCAST® product. The device 190 comprises a proximal upper portion 194, a medial portion 192 and a distal portion 196, the device 190 extending between the user's leg L and foot F. Here again, placement of the vibration unit 100 is not limited to the positions shown in FIG. 15.

[0052] Referring to FIGS. 16 and 1 1 , they illustrate a "leg" embodiment of a splint or brace device, generally identified 170 and 180, respectively. The static knee immobilizer splinting devices 170, 180 that are shown is constructed in accordance with the present invention and each comprises two placement options for the vibration unit 100, as shown - one of which is branded in the market as an AIRCAST® product. The first splint or brace leg device 170 comprises a support element 172 that extends between a proximal portion 174 and a distal portion 176, along the user's leg L when the leg L is in a generally vertical position. Other support elements are shown but are not specifically identified. Placement positions for the vibration units 100, as with the foregoing splint or brace devices, are not limited with respect to this leg splint or brace 170. The leg splint or brace device 180 likewise comprises a structure that also has a proximal portion 184 and a distal portion 186. Positioned between those portions 184, 186 are straps 182. Positioned within those portions 184, 186 are the vibration units 100, which can be place anywhere within the device 180 as may be desired or required. The medial portion of each construct is the user's knee, which is effectively immobilized by the devices 170, 180.

[0053] As mentioned at the outset, it is to be understood that the means for creating the vibration functionality can be incorporated into splinting and bracing devices by OEMs and, alternatively, the vibration functionality can be added to an OEM device as an aftermarket retrofit. Both concepts are included within the scope of the present invention.

[0054] Based on the foregoing, it will be seen that there has been provided a new and useful splinting or bracing device that incorporates electro-mechanical or other vibration-generating functionality. Splinting and bracing devices, and vibration, have been used separately, but not together. When used together, the combination of a splinting or bracing device with a vibration functionality improves a patient's range of motion and flexibility, decreases muscle guarding, improves and promotes healing, provides proprioceptive input and prevents muscle atrophy, among other things. In short, the novel combination of a splinting and bracing modality with a vibration modality increases the efficacy of both.

Claims

The details of the invention having been disclosed in accordance with the foregoing, I claim:

1 . A medical splinting or bracing device for use with a human limb of a user, the limb comprising a joint, a limb portion above the joint and a limb portion below the joint, the splinting or bracing device comprising:

a splint or brace comprising an outer surface, the splint or brace further comprising proximal portion disposed at the limb portion above the joint, a medial portion disposed at and about the limb joint and a distal portion disposed at the limb portion below the joint;

a vibration unit mounted to the outer surface of the splint or brace to apply vibration at the proximal portion, the medial portion or the distal portion of the splint or brace and along the limb.

2. The device of claim 1 wherein the vibration unit comprises a vibration motor.

3. The device of claim 2 wherein the splint or brace further comprises a body and the vibration motor is embedded within the splint or brace body.

4. The device of claim 2 wherein the splint or brace further comprises an inner surface and the vibration motor is mounted to the inner surface of the splint or brace.

5. A medical splinting or bracing device for use with a human limb of a user, the limb comprising a joint, a limb portion above the joint and a limb portion below the joint, the splinting or bracing device comprising: a splint or brace comprising an inner surface and an outer surface, the splint or brace further comprising proximal portion disposed at the limb portion above the joint, a medial portion disposed at and about the limb joint and a distal portion disposed at the limb portion below the joint;

a vibration unit to apply vibration along the limb; and

means for mounting the vibration unit alternatively to the inner surface of the splint or brace, to the outer surface of the splint or brace, or integrally within the splint or brace.

6. The device of claim 1 wherein the vibration unit comprises a vibration motor.

7. The device of claim 6 wherein the vibration unit is mounted to the outer surface of the splint or brace and the vibration motor is mounted integrally within the splint or brace body.

8. The device of claim 6 wherein the vibration unit is mounted to the outer surface of the splint or brace and the vibration motor is mounted to the inner surface of the splint or brace.

9. The device of claim 6 wherein the vibration unit is disposed at one position consisting of at least one from a group consisting of:

the limb portion above the joint;

the medial portion disposed at and about the limb joint; and

the limb portion below the joint.

10. The device of claim 9 comprising at least two vibration units.

1 1 . The device of claim 10 wherein the vibration units are disposed at positions consisting of at least two positions from a group consisting of:

the limb portion above the joint;

the medial portion disposed at and about the limb joint; and the limb portion below the joint.

12. A medical splinting or bracing device for use with a human limb of a user, the limb comprising a joint line, points that are proximal or distal to the joint line, and points that are anterior or posterior over the muscle belly of the muscles superior or inferior to the joint line, the splinting or bracing device comprising:

a splint or brace comprising an inner surface and an outer surface;

a vibration unit comprising a vibration motor to apply vibration along the limb; and

means for mounting the vibration motor alternatively to the inner surface of the splint or brace, to the outer surface of the splint or brace, or integrally within the splint or brace.

13. The device of claim 12 wherein the vibration unit is disposed at one position from a group consisting of:

points that are proximal to the joint line;

points that are distal to the joint line; and

points that are anterior or posterior over the muscle belly of the muscles superior or inferior to the joint line.

14. The device of claim 13 comprising at least two vibration units.

15. The device of claim 14 wherein the vibration units are disposed at positions consisting of at least two positions from a group consisting of:

points that are proximal to the joint line;

points that are distal to the joint line; and

16. A method for incorporating vibratory functionalities into a medical splinting or bracing device for use with a human limb of a user, the limb comprising a joint, a limb portion above the joint and a limb portion below the joint, the method comprising the steps of:

providing a splinting or bracing device;

providing a vibration unit having a vibration motor;

mounting the vibration unit to the splinting or bracing device; actuating the vibration motor to apply pressure waves to the limb of the user.

7. The method of claim 16 wherein the splinting or bracing device comprises a body and further comprising the step of mounting the vibration motor within the body of the splinting or bracing device.

8. The method of claim 16 wherein the splinting or bracing device comprises an inner surface and further comprising the step of mounting the vibration motor to the inner surface of the splinting or bracing device.

19. The method of claim 16 wherein the step of providing a vibration unit further comprises providing a plurality of vibration units.