WO2014087321A2

WO2014087321A2 - Incentive generator

Info

Publication number: WO2014087321A2
Application number: PCT/IB2013/060574
Authority: WO
Inventors: Lucky GUPTA
Original assignee: Gupta Lucky
Priority date: 2012-12-03
Filing date: 2013-12-02
Publication date: 2014-06-12
Also published as: WO2014087321A3

Abstract

The present disclosure relates to an advanced multi-dimensional Wrist/Hand Orthosis (WHO) intended to decrease pain symptoms associated with various wrist injuries/surgery in order to improve wrist joint function, by using a single device that provides recovery, rehabilitation, and return to action. The proposed wrist and hand orthosis apparatus is achieved by using a Peltier heating and cooling technology, a controlled range of motion using an articulating hinge system, and optionally, an immobilization mechanism using a detachable wrist immobilizer and thumb spica. The three key features mentioned above function in complete or selective combination in a single device, providing a multidimensional aspect to the wrist/hand wrap based on the current stage of the user's rehabilitation process, thereby enabling the user to a speedy and efficient recovery.

Description

HAND AND WRIST JOINT ORTHOSIS

COPYRIGHT NOTICE

[0001] Contained herein is material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of the patent disclosure by any person as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all rights to the copyright whatsoever. Copyright © 2012, Dhama Innovations Pvt. Ltd.

BACKGROUND

Field

[0002] The present invention relates to a new and improved orthosis apparatus for the protection of the wrist and hand and for use in effecting and controlling movement of the wrist of a user. More particularly, wrist wrap of the present application is configured to provide instant thermal therapy along with enabling a user with limited manual dexterity to quickly and easily adjust the positioning of the wrist wrap to a maximum comfort and/or optimal treatment orientation.

Description of the Related Art

[0003] Wrist of a human being is formed where two bones of the lower arm, namely the radius and the ulna meet at the hand. The wrist provides a passage to the two major nerves of the hand (the median and ulnar nerves), which run the length of the arm to transmit electrical impulses to and from the brain to create movement and sensation.

[0004] One of the more common afflictions of the wrist is the Carpal Tunnel Syndrome, which causes paresthesia, pain, numbness, and other symptoms in the distribution of the median nerve due to its compression at the wrist in the carpal tunnel. . The carpal tunnel is a bony canal within the palm side aspect of the wrist that allows for the passage of the median nerve to the hand. Pinching or compression of this nerve by the transverse carpal ligament sets into motion a progressively crippling disorder which eventually results in wrist pain, numbness and tingling in the hand, pain consisting of a "pins and needles" feeling at night, and weakness in the grip. The wrist is also subject to cartilage damage (much like the knee), which is often repaired with arthroscopic surgery.

[0005] The wrist joint can suffer damage from high dynamic loading, overloading in/across the wrong motions/axes, and through repeated repetitive motions that commonly develop tendon, muscle and joint related, and even degenerative problems, which can be mitigated by using a suitable articulated joint treatment system. When traumatized, these joints frequently swell and may create further trauma by involving local muscles or tendons.

[0006] Existing in the art are many splint/brace assemblies that are significantly bulky, limit the use of an individual's hands, and are difficult to adjust by the user. For example, a United States Patent No. 2312523 discloses an adjustable tension splint which includes a front hand grip that limits the use of a user's hand and requires loosening and tightening of a plurality of screws in order to adjust tension of the splint. Similarly, the derotation wrist brace disclosed by United States Patent No. 5002044 utilizes a number of pins to limit the range of motion of parallel hinges on the brace. In such devices, it would be substantially difficult for a user to adjust the brace to a more desirable position during use, and use of the hands would be limited. An adjustable wrist splint disclosed in United States Patent No. 4677971 discloses enablement of lateral movement of the wrist is limited with regard to the disposition of the hand relative to the forearm and can not be utilized in a large variety of circumstances. Existing splint/braces are therefore not adapted to enable or facilitate use and/or adjustment by the particular user and are generally directed at fixing the disposition of the wrist relative to the forearm without allowing a user to make quick and easy adjustments of the positioning as needed for their comfort and beneficial treatment. Being rigid, existing orthosis apparatus, including wraps for palm and/or thenar eminence do not allow custom fitting, controlled range of motion (ROM), and adjustability as per individual needs and stage of recovery.

[0007] It would also noted that when a person is wearing a wrist brace post surgery or fracture or sprain, he/she is not expected to move the wrist, and therefore range of motion restriction is required to avoid any additional strain on the wrist. Also, cold therapy/hot therapy/contrast therapy may need to be applied in all these cases, wherein, as the person cannot remove his brace (which would cause strain on the wrist), application of cooling/heating/contrast becomes very difficult.

[0008] Few of the existing solutions also incorporate cooling treatment for acute injuries, especially where swelling is or may become present, providing both short-term pain relief and a reduction of swelling by reducing blood flow to the injured area. For instance, the R.I.C.E. method is commonly used, wherein RICE stands for "Rest, Ice, Compression and Elevation", and in which the ice or 'frozen gel' packs are used to relieve pain, limit swelling, and protect the injured tissues, therefore promoting faster healing. However, the RICE method has historically relied upon the use of either ice or 'frozen gel' to achieve localized cooling, both of which can cause profound skin and/or tissue damage if left in contact with the body for more than about 20 minutes (proper use of this method cycles cooling packs on and off the affected area). This can be problematic in both medical settings (where staff responsibilities may preclude cycling packs on/off at the necessary intervals) and especially at home, wherein adequate training regarding the risks of thermal over-exposure exacerbated by the body's natural tendency towards adaptation (wherein the body becomes less sensitive to temperature sensations) causes the patient to believe the pack doesn't yet need to be removed/cycled. The incidence of RICE method accidents is high enough that numerous class action lawsuits are being developed around failures of this technique.

[0009] Various approaches/equipment's have been devised to provide such localized cooling, ranging from a frozen bag of peas held in place by hand to using various cooling packs. While some existing mechanisms include an outer layer that helps buffer the cold so the user can more comfortably hold the pack against the affected area; others integrate layers to absorb attendant bodily fluids and/or condensate from the cooling bags (which are quite cold). Few other mechanisms also include various attachment means, including straps in different configurations so that the cooling pack can be held against the knee without being manually held in place or means to lash or wrap the cooling bag or container to the joint.

[00010] A common problem amongst such devices is their inability to readily conform to the affected joint, especially during motion. It becomes nearly impossible to use such cooling to reduce swelling while simultaneously operating the joint through range of motion or repetitive exercises. There is therefore a need of a device that provides cooling or heating at strategic/configurable points on the wrist. There is also a need in the art for designs that act as heat exchangers and allow setting of multiple temperature modes to provide instant therapy.

[00011] Existing in the prior art are also solutions such as universal articulated splints, which typically include an elaborate hand splint, wherein each finger on the hand is immobilized such that an individual cannot use their hand if necessary. Various orthopedic support devices are known for supporting a thumb after an injury. Typically, these devices utilize a splint which attempts to immobilize the thumb so that the thumb is placed into a fixed position. These devices, however, have various drawbacks. For example, one type of thumb support device utilizes a soft, fabric material with metal stays sewn into place to provide rigidity. The metal stays, however, are very rigid, and may not conform to a user's hand. Thus, the rigid metal stays may be uncomfortable for a user. Moreover, conventional devices typically employ two rigid metal stays placed on opposite sides of the thumb, and the stays do not completely enclose the thumb. Therefore, the metal stays still allow movement of the thumb, and the thumb is not totally immobilized.

[00012] There is therefore the need for an immobilization device, preferably detachable, for providing selective wrist immobility depending on the patient's stage of recovery. There is further a need for wrist immobilizer and thumb spica that allow efficient/configurable and optimal splinting of the wrist/thumb when additional stability is desired. [00013] It is evident from the aforementioned matters that previous attempts at devices used to heal wrist/hand/finger injuries provide limited relief in the form of stability, flexibility of use, interoperability between hands, range of movement, heating or cooling effect or a combination of the abovementioned or other aspects. Devices providing immobility do not provide an option of limited mobility when required by the patient, or when the patient has moved on to the next stage in the recovery process.

[00014] Applicant's United States Patent No. 8397518 to Dhama Innovations Pvt. Ltd. Titled "Apparel with integral heating and cooling device" relates to a device for heating or cooling a body of a user is provided. The device includes a thermoelectric module, a heat sink thermally coupled to the thermoelectric module, a wetting material in thermal communication with the heat sink, and a controller for cycling the thermoelectric module in accordance with a duty cycle. Another United States Publication No. US20100107657 relates to a system and process for heating and cooling the body or a portion of the body through a thermoelectric unit having a cooling surface and a heating surface, wherein the cooling surface is thermally insulated from the heating surface.

[00015] There is therefore a need to provide a multidimensional device capable of permitting a controlled range of motion, while allowing for strategic cooling and heating, with an option of complete immobilization, if required. Such a device would provide a complete rehabilitative solution for a patient, from the initial stage to the final stage of recovery. There is also a need in the art to provide a single device to heal all kinds of wrist injuries, wherein the device being compatible to be used on the left hand, right hand, palmar side, and dorsal side, in any desired configuration or selection. OBJECTS OF THE PRESENT INVENTION

[00016] It is an object of the present disclosure to allow complete wrist and hand thermal therapy with strategically located cooling/heating points around the wrist area.

[00017] It is an object of the present disclosure to allow controlled range of motion that can be configured and fixed, and then varied at desired intervals and ranges depending on the current stage of the patient's recovery.

[00018] It is an object of the present disclosure to allow an option of complete immobilisation of the hand and/or thumb using an immobilizer that can be detached or attached as per requirement.

[00019] It is an object of the present disclosure to provide a multidimensional wrist/hand orthosis (WHO) in combination of an articulating hinge system and a thermoelectric unit based cooling/heating technology.

[00020] It is an object of the present disclosure to allow customisation for perfect conformance using a custom fitted articulating hinge based on the hand and wrist measurements of the individual, and a customised size of the cooling unit and strap length based on the users measurements.

[00021] It is an object of the present disclosure to provide an open palm design that allows movement and grip.

[00022] It is an object of the present disclosure to provide a single device that can be used on either hand and on both the palmar and/or dorsal side.

[00023] It is an object of the present disclosure to provide a light weight and portable device providing supreme comfort with high grade functional materials. SUMMARY

[00024] The present disclosure relates to a wrist orthosis apparatus/device, wherein the device may be configured to apply instant thermal therapy and provide configurable support and assistance in recuperation of an injured wrist of human body. Although the present application references to interchangeable terms such as wrap, strap, brace, band, it would be appreciated that they all reference to proposed orthosis apparatus or part thereof. Furthermore, although the present disclosure discusses embodiments relating to wrists, scope of the instant disclosure covers all possible and applicable body parts where the proposed device can be implemented such as palm, hand, or any other part. In an embodiment, the proposed hand and wrist orthosis relates to a support to be fitted around an injured wrist of a human hand, allowing it to move in a controlled range of motion. The apparatus may be configured to allow cooling and heating at strategic points on the wrist and hand, along with holding the joint with an attempt to decrease pain symptoms associated with various wrist injuries/surgery in order to improve wrist joint function.

[00025] According to one embodiment of the present application, the proposed wrist orthosis treatment apparatus creates an effective and quick impact on injury, by applying cooling and/or heating thermal therapy. The main body of the wrist wrap is made up of a thermoelectric unit, which provides instant application of hot, cold and contrast therapy. Based on the type of injury, it is adjustable for different therapies including ice therapy, heat therapy, contrast therapy, and moist heat therapy. This mechanism provides cooling/heating to not only the wrist but also the palm and forearm.

[00026] Another embodiment of the present application may comprise one or more sections that are capable of controlling range of motion of an injured wrist with an articulating hinge system, wherein the proposed hinge system manages movement of the wrist depending on the status of injury. The articulating hinge system may be adjustable from full extension to up to 50° flexion or more in configurable increments based on individual's need and stage of recovery. Once the hinge system is adjusted to a desired angle it can be fixed to a static position by means of adjustment screws and stopping means.

[00027] According to one embodiment, hand and wrist orthosis apparatus/device of the instant disclosure may incorporate a detachable wrist immobilizer and a detachable thumb immobilizer, which allow splinting of the wrist and/or thumb respectively when additional stability is needed and can be removed conveniently to allow mobility.

[00028] In yet another embodiment, the wrist orthosis apparatus/device provides a bidirectional slot indexing mechanism that is operatively coupled with the hinge system, wherein the indexing mechanism is placed on both sides of the orthosis apparatus to make the main body of the wrist wrap usable on both right and left hand by simply removing and reattaching the hinge on either side. Also this design feature allows the user to use the wrist wrap on the dorsal and/or palmar side of the hand without hampering the functioning of the hinge and of the wrist orthosis apparatus/device.

[00029] Other features of embodiments of the present disclosure will be apparent from accompanying drawings and from detailed description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

[00030] In the Figures, similar components and/or features may have the same reference label. Further, various components of the same type may be distinguished by following the reference label with a second label that distinguishes among the similar components. If only the first reference label is used in the specification, the description is applicable to any one of the similar components having the same first reference label irrespective of the second reference label.

[00031] FIG. 1 illustrates areas where thermal therapy is applied when the main body and thenar eminence wrap are part of the wrist/hand orthosis in accordance with an embodiment of the present application.

[00032] FIG. 2 illustrates areas where thermal therapy is applied by main body wrap in accordance with an embodiment of the present application.

[00033] FIG. 3 illustrates areas where thermal therapy is applied by thenar eminence wrap in accordance with an embodiment of the present application.

[00034] FIGs. 4(A) to 4(G) illustrate configuration and structure of an articulating hinge system as apart of the wrist/hand orthosis in accordance with an embodiment of the present application.

[00035] FIG. 5 illustrates a bidirectional hinge slot design on main body of hand/wrist orthosis apparatus in accordance with an embodiment of the present application.

[00036] FIG. 6(A) illustrates use of hand/wrist orthosis on right hand in accordance with an embodiment of the present application.

[00037] FIG. 6(B) illustrates use of hand/wrist orthosis on left hand in accordance with an embodiment of the present application.

[00038] FIG. 6(C) illustrates use of the hand/wrist orthosis on palmar surface in accordance with an embodiment of the present application.

[00039] FIG. 6(D) illustrates use of hand/wrist orthosis on the dorsal surface in accordance with an embodiment of the present application. [00040] FIG. 7 illustrates customisation aspect of the hand/wrist orthosis in accordance with an embodiment of the present application.

[00041] FIG. 8(A) illustrates an open palm design of the hand/wrist orthosis in accordance with an embodiment of the present application.

[00042] FIG. 8(B) illustrates another open palm design of the hand/wrist orthosis in accordance with an embodiment of the present application.

[00043] FIGs. 9(a), 9(b), and 9(c) illustrate functioning and incorporation of an immobilizer in accordance with an embodiment of the present application.

[00044] FIGs. 10(a), 10(b), 10(c), 10(d), and 10(e) illustrate exemplary representations of a detachable thumb immobiliser in accordance with an embodiment of the present application.

[00045] FIGs. 11(a), 1 1(b), 1 1(c), 11(d), 11(e), and 11(f) illustrate different utility scenarios of the wrist/hand orthosis appartus along with illustrating the multidimensional aspect of the proposed device and structure thereof in accordance with an embodiment of the present application.

[00046] FIG. 12 illustrates, in an exemplary embodiment, different components of the proposed wrist/hand joint orthosis apparatus individually.

DETAILED DESCRIPTION

[00047] Although the following detailed description contains many specifics for the purposes of illustration, anyone of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention. Accordingly, the following preferred embodiments of the invention are set forth without any loss of generality to, and without imposing limitations upon, the claimed invention.

[00048] Illustrated through FIGs. 1-12 of the present application is a multidimensional hand and wrist orthosis apparatus used to effectively heal any kind of wrist injury through the entire recovery cycle of the patient. The device consists of various detachable parts, which can be configured and operatively coupled to each other to suit a patient's current requirement and can also be customised to a particular shape or size.

[00049] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details. If the specification states a component or feature "may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[00050] Various embodiments of the present invention will be disclosed, illustrating in numerous ways, but not limiting the multidimensional aspect of the present invention. FIG. 1 of the present application represents a hand and wrist orthosis apparatus that utilises a thermoelectric unit based cooling and/or heating technique along with other multidimensional design parameters to help effectively heal the wrist/hand injury, descrease pain symptoms, and improve wrist-joint function..

[00051] Although not shown, according to one embodiment of the present disclosure, cooling and/or heating technique of the proposed orthosis apparatus comprises a thermoelectric unit having a cooling surface and a heating surface, wherein the cooling surface is thermally insulated from the heating surface. Such a peltier technique based cooling/heating apparatus can further comprise a heat sink that is thermally coupled with the thermoelectric unit and is configured to remove heat from hot side of the thermoelectric unit in cooling applications. The proposed cooling/heating apparatus can further include a wicking material that is operatively coupled with the heat sink, wherein the wicking material may be substantially saturated with water to dissipate energy. The cooling/heating apparatus of the hand and wrist orthosis apparatus may further include a breathable layer that is disposed on the wicking material to allow evaporation of water to the environment by forming a thin layer based on the combination of different materials (Cotton, Tissue paper, treated Aluminum mesh). Furthermore, a phase change material may be disposed between the body and the cold side of the thermoelectric unit for storage of cold energy to increase the system functioning time. The system may include a unit that can be filled so as to allow a user to resaturate the wicking material with the water. A battery unit or any other power source may power the thermoelectric unit to operate and control the temperature conditions, wherein the battery unit can be configured to provide variable temperature control and can be attached to any desired body part or apparel thereon. [00052] According to one embodiment, FIG. 1 , by means of representation 100, illustrates main body of the wrap 102 and optionally in a palm wrap, in the form of a thenar eminence wrap 104. The peltier cooling and heating technique is implemented within the main body 102 and/or the thenar eminence wrap 104 (not shown) by means of the above described architecture.

[00053] In an implementation as shown in FIG. 1, if an injury requires thermal therapy on the wrist and/or the palm, a complete wrist cooling solution 100 may be configured and implemented. In another implementation, any or both of the main body wrap 102 and the thenar eminence wrap 104 can also be configured to work without the hearting/cooling apparatus thereby functioning based on the proposed and inventive hinge system that provides adjustability, flexible positioning, and configuration of the wrist position and allowable movement. The thenar eminence wrap 104 may be a detachable and an optional device used in cases as shown in FIG. 1 and FIG. 3, where simultaneous thermal therapy to the wrist and palm may be needed for speedy and efficient rehabilitation.

[00054] FIG. 2 illustrates a wrist wrap 200 that is configured to heal wrist injuries and require thermal effect to be applied on the wrist only. The wrist wrap of FIG. 2 is also interchangeably referred to as main body wrap 102 in the present application. In an embodiment, the wrist wrap is configured to allow movement and gripping, facilitating the patient to comfortably proceed with permissible regular activity depending on the stage of recovery of the rehabilitation process. As can be seen in FIG. 2, the main body wrap 200 can be configured without the thenar eminence wrap/palm wrap 104. Although not illustrated in FIG. 2, the main body wrap 200 can be configured to include the cooling unit as described above along with a base stabilizer that can help stabilize the orthosis apparatus. By means of an external battery charger that is operatively coupled with the the main body wrap 200 (to control the thermoelectric unit configured therein), the apparatus 200 can be enabled to provide instant application of hot, cold and contrast therapy, anytime and anywhere. Using the peltier based thermoelectric unit allows the temperature to vary within a range of 30°F to 160°F.

[00055] The proposed apparatus of FIG. 1 and FIG. 2 utilizes an indigenous combination of ice therapy, heat therapy, contrast therapy and moist heat therapy. Combinations of the abovementioned therapies are selectively used based on the type, severity and intensity of the injury, and generally know longevity of the healing process, as advised by a medical professional. Furthermore, the proposed device removes the above mentioned problem of not being able to apply cooling/heating while the brace is on as the instant device provides cooling/heating/contrast therapy on demand without even touching or moving the brace. Temperature adjust is enabled immediately (within seconds) by thermoelectric unit and the user has complete control over the temperature thereby reducing the chance of cold or hot injury.

[00056] FIG. 3 illustrates an exemplary palm wrap 300, also referred to as thenar eminence wrap/strap 300 hereinafter. According to one embodiment, the thenar eminence wrap/strap 300 can be configured with or without the cooling/thermoelectric unit and therefore, in one implementation, the thenar eminence wrap 300 can simply be used to support the main body wrap/wrist wrap of the present application and not have the cooling mechanism for healing of the palm region. [00057] FIG. 4 illustrates a hinge system that can be operatively coupled with the peltier based cooling/heating mechanism and configured to allow varied ranges of motion from say 0 degrees to 50 degrees or more, for instance. Although the present application shows the use of the hinge system with respect to the main body wrap/wrist wrap, the mechanism and technology therein can be implemented/designed for any other appicable body part and any such implementation is completely within the scope of the present application. FIG. 4(a) illustrates varying possible ranges of wrist motion through representation 402, which is brought about by the articulating hinge system 410, the exemplary structure of which is depicted in FIG. 4(b) and FIG. 4(c). As can be seen in FIG. 4(a), the representation 402 shows possible changes in angles of the wrist from 0 degrees upto 60 degrees at varying intervals such as 20 degrees and 40 degrees.

[00058] Typically, once a person suffers from a wrist injury, restricted or complete immobility is suggested depending on the injury type. While the patient takes the necessary precautions during his/her rehabilitation process anticipating a speedy recovery, the extent of restriction of movement is gradually reduced as time passes, considering the gradual healing of the joint. This enables the patient to resume with regular active movements during the course of his/her recovery process.

[00059] Hinge system 410 as shown in FIG. 4(b) provides an efficient and customizable rehabilitative solution by enabling implementation of an articulating hinge mechanism, which is a detachable device and forms an integral part of the proposed hand and wrist joint orthosis. The hinge system 410 can be configured to adjust and allow controlled range of motion (ROM) based on the patient's need and stage of recovery, wherein the range of motion can be controlled and subsequently fixed till the wrist joint further heals, upon which the range of motion is further increased to suit the patients current requirements, allowing him/her to resume regular activity with in the permissible range of motion, without hampering the process in any way. FIG. 4(b) depicts side view of the hinge system 410 illustrating its design and utility features. The hinge system 410 may include a contoured hinge leg 412 operative ly coupled with a plurality of adjustment screws such as screws 414a and 414b (collectively referred to as adjustment screws 414) and one or more stopping means such as sliders such as 416a and 416b, collectively referred to as sliders 416. It would be appreciated that instead of two adjustment screws 414, there can any of them, as is also the case with the stopping means 416. According to one embodiment, each stopping means 416 comprises a slider with a stopper, wherein once the adjustment screws 414 are positioned at their desired location and orientation, the stopping means 416 can be used to fix to the respective adjustment screw 414 and stop any further movement of the screw 414. Any other stopping or adjustment means can also be incorporated in accordance with an embodiment the present application.

[00060] According to one embodiment, the hinge leg 412, adjustment screws 414, and the stopping means 416 can be configured and fixed onto the main body 418 of the hinge system 410 by means of a plurality of slots on the main body 418. Such slots can be fixed on to the orthosis apparatus and used for adjustment of the hinge system 410 by means of screws such as slot pan head screws 419a and 419b which would be explained subsequently in the disclosure. In an implementatino, the contoured hinge leg 412 enables adjustment of allowable range of motion. The adjustment screws 414 can be adjusted to control the degree of extension of the hinge leg 412, allowing it to sit perfectly and match with the outer palm surface. [00061] FIG. 4(c) depicts the top view 420 of the hinge system. The hinge system of FIG. 4(c) illustrates two slot pan head screws 422 that are configured to fit into a slot 424 and enable adjustment of the length of the hinge system 420 based on the length of the hand and the wrist. In order to enable controlled and accurate anatominal range of motion, the hinge should essentially lie adjacent to the radio carpal joint, which varies in position for each individual, depending on the size of the forewarm and the palm. Screws 422 can aso be used to adjust and customize the size of the strap/wrap length for a particular individual based on his/her measurements. FIG. 7 shows the actual use of the screws 422 for adjusting the length. FIG. 4(c) further illustrates a dial 426 that includes one or more adjustment screws 414 and is operatively coupled with the hinge leg 412. According to one embodiment, adjustment screws 414, as shown in FIG. 4(c), can be positioned together and implement a situation wherein the hinge leg 412 is at 0 degrees and therefore does not allow any movement of wrist. Movement of the adjustment screws 414 away from the initial position as shown in FIG. 4(d) allows increase in range of motion and therefore more flexbility and extensibility. Actual configuration of the hinge system can be seen in FIG. 7, which clearly shows the dial 426 comprising the adjustment screws 414. According to one embodiment, hinge system 420 of the present application can be fixed on either side of the main body of the hand and wrist joint orthosis. The slot screws 422 can be configured with one or more stoppers that can fix the screws 422 to the main body 418 of the hinge system 420.

[00062] FIG. 4(d) illustrates another view 430 of the hinge system. The representation 430 shows calibration of the adjustment screws, wherein such calibration defines the extent to which the hinge leg allows the range of motion of the wrist joint. As described above, movement of the adjustment screws 414 away from the center alignment allows loosening of the hinge leg, thereby allowing further extension of the hand wrist. According to one emboidment, a velcro hook 432 can be incorporated on the inner/rear/back side of the contoured hinge leg 412 and fastened onto the hand to eliminate the chances of unwanted hinge movement and to enhance hinge stability. According to another embodiment, serrations can be formed on the slots formed for the adjustment screws 414 so as to allow the stopping means such as slider to fit in. FIG. 4(e) shows the rear/back view 440 of the hinge system more clearly illustrating the velcro arrangement 432 on the hinge leg.

[00063] FIG. 4(f) and FIG. 4(g) illustrate a representation 450 showing adjustment, control, and configuration arragement of the range of motion (ROM) based on the calibration of adjustment screws 414 and the hinge arrow pointer 452. As can be seen, the hinge apparatus 450 comprises a dial guage 454 and slots/holes 456 in which the adjustment screws 414 are configured. According to one embodiment, the hinge arrow pointer 452 can be configured to point to and indicate the degrees till which the extension of wrist is to be allowed, say 30". Once the arrow is pointed and marked to the desired level, the adjustment screw(s) 414 can be moved and placed accordingly in the slots/holes 456. In an instance, as there are two slots 456a and 456b shown in FIG. 4(f), one slot would, at any given time, include/show the arrow pointer 452, which is 456a in the present illustration. In such a case, the adjustment screw 414 of the other slot 456b can be adjusted such that the hinge leg is appropriately configured. In case the adjustment screw 414 is to be marked 20° greater than the hole to which the arrow 452 points, and if the arrow, for instance, points at 30 on the gauge 454, the adjustment screw 414 should be placed at 50° on the gauge, as shown in FIG. 4(f).

[00064] FIG. 4(g) illustrates a representation 460 showing calibration and configuration of the adjustment screw(s) with respect to the arrow pointer of FIG. 4(g). As mentioned above, the hinge system of the proposed application can be implemented on any of the hands and length of the same can be adjusted using the slots of FIG. 4(c). FIG. 4(h), on the other hand, illustrates the top view representation 470 of the hinge arrow pointer 452 in accordance with an embodiment of the present application. As other elements of the hinge system have already been explained in detailed, the same not being repeated again.

[00065] FIG. 5 illustrates a bidirectional hinge slot indexing design 500 in accordnace with an embodiment of the present application. In one embodiment, hinge slots 502 and 504 can be placed on both sides of the main body 506 (correspoding to 102 of FIG. 1) of the wrist/hand orthosis design 500. The proposed hinge system may be a detachable device and can be attached onto the right hinge slot of the main body 504 or on the left hinge slot of the main body 502 by detaching and then re-attaching the hinge system by means of operationally coupling the hinge slot 502/504 with the slot 508 on the main body of the hinge system 510, wherein the slot pan head screws 512 can be configured to couple the slot 508 of hinge main body and hinge slot 502/504 on the orthosis main body 506 by means of stoppers. The convenience of coupling and decoupling the hinge system 510 with the main body orthosis 506 allows the hinge system 510 to be fixed at any hand of the user. FIG. 5(b) again shows separate parts of the hinge system, wherein hinge leg 552 is operatively coupled with the hinge main body 554 by means of adjustment screws 556 and stopping means. Length of the hinge system can be adjusted based on the dimensions of the hand/wrist/forearm by means of screws 512 and stopping means 558.

[00066] FIG. 6(a) and FIG. 6(b) illustrate representations 600 and 620 showing use of the bidirectional hand and wrist orthosis design having the proposed inventive hinge slot on the right as well as the left hand. FIG. 6(c) and FIG. 6(d), on the other hand, illustrate representations 640 and 660 showing use of the proposed hand and wrist orthosis design having the inventive hinge slot on the palmer surface as well as the dorsal surface of the hand without hampering the functioning of the hinge or the orthosis device in any manner.

[00067] FIG. 7 illustrates use of slot pan head screws 702 for adjustment of the length of the hinge system in accordance with an embodiment of the present application. According to one embodiment, the proposed wrist/hand orthosis can be custom fitted for perfect conformance according to the measurements of each individual. For accurate anatomical range of motion, the hinge may be configured to lie adjacent to the radio carpal joint, which varies in position for each individual depending upon the size of the forearm and the palm. The articulating hinge can be custom fitted based on the hand and wrist measurements of each individual by means of the slot pan head screws 702, which moves laterally on the frame of the hinge body as depicted in FIG. 7 to vary the length of the hinge system. Additionally, the size of the cooling unit and the strap length can be customized to a particular individual based upon his/her measurements.

[00068] FIGs. 8(a) and 8(b) illustrate exemplary representations 800 and 850 respectively, wherein the representation 800 shows the open palm design of the proposed orthosis having palm wrap 802 and main body wrap 804, allowing free movement within permissible range of motion (ROM) and providing grip to efficiently perform regular activities. Representation 850 shows varying ways in which the wrist joint can move or made to move using the proposed orthosis apparatus and controlled ROM by means of the hinge system.

[00069] FIGs. 9(a), 9(b), and 9(c), through corresponding representations 900, 930, and 960, illustrate functioning and incorporation of an immobilizer 902, which is a detachable device and used generally but not essentially at the initial stages of the recovery process when complete stability, and hence complete immobilisation, is recommended. Once a user/patient reaches the next stage of the recovery process and limited mobility would not further aggravate the injury, immobilizer 902 can be detached, removed and and the hinge system can be attached onto the orthosis apparatus to control wrist motion. According to one embodiment, the immobilizer 902 can be used along with the hinge system as well. The immobilizer 902 can be operatively coupled with the main body wrap as disclosed in FIGs. 1 and 2 to ensure controlled heating/cooling as well as controlled motion. Immobilizer 902 can therefore allow splinting of the wrist when additional stability is needed and can be removed conveniently to allow mobililty. According to one embodiment, the detachable immobilizer 902 can be placed on the dorsal surface of the hand, at the base of the fingers, near the knuckles/metacarpal phalangeal joints, or any other appropriate position, allowing desired positioning of the base stabilizer with the cooling unit at the correct position on the wrist. The detachable immobiliser 902 can also be fixed onto the wrist/hand orthosis using straps 962, strapped onto the main body as shown in FIG. 9(c). [00070] FIGs. 10(a), 10(b), 10(c), 10(d), and 10(e) illustrate exemplary representations of a detachable thumb immobiliser 1002, also interchangeably referred to as thumb spica hereinafter. In situations when the thumb requires additional stability, the detachable thumb immobilizer (Spica) 1002 can be configured to allow splinting of the thumb and can be removed conveniently to allow mobility. According to one embodiment, the detachable thumb spica 1002 can be fixed onto the thenar eminence wrap (also interchangeably referred to as palm wrap) using one or more straps 1032 and 1034 as shown in the FIG. 10(b) and FIG. 10(d). Such thenar eminence wrap can be configured with the cooling/heating apparatus (as shown in FIG. 10(a) or without the apparatus by simply having a wrap (as shown in FIG. 10(c)). According to another embodiment, the detachable thumb spica 1002 can be fixed directly to the wrist wrap (main body wrap) so that it can be conveniently removed or detached and then reattached when desired.

[00071] FIGs. 11(a), 1 1(b), 1 1(c), 11(d), 11(e), and 11(f) illustrate different utility scenarios of the wrist/hand orthosis appartus along with illustrating the multidimensional aspect of the proposed device and structure thereof. It would be appreciated that the proposed design configuration are completely exemplary in nature and the utility scenarios of FIG. 11 are not limiting in any manner. FIG. 11(a) , through representation 1100, depicts the scenario of complete immobilisation using the detachable immobiliser coupled with the main body of the wrist/hand orthosis (also referred to wrist wrap in the above and below disclosure). FIG. 11(b), through representation 11 10, on the other hand, depicts use of the wrist wrap that incorporates the controlled range of motion (ROM) using the articulating hinge system of the instant disclosure. FIG. 1 1(b) further illustrates use of the palm wrap without the cooling/heating apparatus.

[00072] FIG. 11(c), through representation 1 120, illustrates use of wrist wrap incorporating the controlled range of wrist motion using the hinge system, along with the detachable thumb spica that is used to completely immobilize the thumb and is coupled with the main body and/or the palm wrap. FIG. 11(d), through representation 1 130, illustrates main body wrap for providing controlled ROM and thermal therapy to the wrist joint, and further illustrates the thenar eminence wrap that enables thermal therapy to be applied to the palm. FIG. 11(e), through representation 1140, illustrates a combination of wrist wrap, thenar eminence wrap, and a detachable thumb spica. FIG. 11(f), on the other hand, through representation 1150, illustrates varied positioning of the wrist wrap depending on the injured position of the body/wrist/fo rearm.

[00073] FIG. 12 illustrates, in an exemplary embodiment, different components of the proposed wrist/hand joint orthosis apparatus individually. Such components can be used in varied combinations to customize the device, providing it with various strapping options and flexible positioning of cooling/heating points for multiple application areas and thereby imparting the device with an ability to treat any kind of wrist injury over the span of the complete rehabilitation process, leading to a speedy and efficient recovery.

[00074] According to another embodiment of the present disclosure, a tension providing unit can be added to tackle muscle atrophy in the wrist region. Such a unit, in one aspect, can be adjusted to prevent muscle atrophy and can, in another aspect, be made as a dynamic split by incorporation of a torsion joint (where the joint can be spring loaded). [00075] It would be appreciated that each compenent of the proposed device can be combined with another to provide the desired functionality and customization. For instance, the proposed device, at one hand, can be configured to provide thumb cooling/heating and/or wrist cooling/heating, while, on the other hand, can be used for thumb arthritis, thumb fracture, among other thumb related diseases along with wrist ailments.

[00076] As all the componenets, structures, and functionality thereof have already been explained in detailed above, the same is not being repeated herein again. Components such as water feeder bottle and moist heat pad are additional componenets, which can be added on need basis. It would be appreciated that the above mentioned componenets are completely exemplary and any other component that is structurally required to support or enhance the basic structure of the instant disclosure is completely covered within the scope of the invention. Furthermore, other changes such as change of material to extremely light-weight EVA sheet can be used for structural stability and heat insulation. Furthermore, moisture managing poly-fleece can be used for better comfort. Furthermore, soft foam fused velcro fabric can be used instead of usual Velcro tape for higher breathability and cushioning. Furthermore, latex free PVC frames can be used around the cooling points for additional cushioning.

[00077] While embodiments of the present invention have been illustrated and described, it will be clear that the invention is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the spirit and scope of the invention, as described in the claim. ADVANTAGES OF THE PRESENT INVENTION

[00078] The present disclosure allows complete wrist and hand thermal therapy with strategically located cooling/heating points around the wrist area.

[00079] The present disclosure allows controlled range of motion that can be configured and fixed, and then varied at desired intervals and ranges depending on the current stage of the patient's recovery.

[00080] The present disclosure allows an option of complete immobilisation of the hand and/or thumb using an immobilizer that can be detached or attached as per requirement.

[00081] The present disclosure provides a multidimensional wrist/hand orthosis (WHO) in combination of an articulating hinge system and a thermoelectric unit based cooling/heating technology.

[00082] The present disclosure allows customisation for perfect conformance using a custom fitted articulating hinge based on the hand and wrist measurements of the individual, and a customised size of the cooling unit and strap length based on the users measurements.

[00083] The present disclosure provides an open palm design that allows movement and grip.

[00084] The present disclosure provides a single device that can be used on either hand and on both the palmar and/or dorsal side.

[00085] The present disclosure provides a light weight and portable device providing supreme comfort with high grade functional materials.

Claims

CLAIMS We Claim:

1. A hand and wrist orthosis comprising:

a thermoelectric cooling and/or heating unit configured to enable controllable cooling and heating of said hand and wrist orthosis; and

a hinge system operatively coupled with said thermoelectric cooling and/or heating unit and configured to enable change and control of range of motion of said hand and wrist orthosis.

2. The hand and wrist orthosis of claim 1, wherein said thermoelectric cooling and/or heating unit is operatively coupled with an electronic interface to supply and/or remove heat to said unit.

3. The hand and wrist orthosis of claim 1, wherein said thermoelectric cooling and/or heating unit is powered by a battery unit, and wherein said unit comprises a cooling surface and a heating surface, wherein said cooling surface is insulated from said heating surface.

4. The hand and wrist orthosis of claim 3, wherein said thermoelectric cooling and/or heating unit is operatively coupled with a heat sink, further wherein a wicking material is operatively coupled to said heat sink to allow evaporation of water to environment.

5. The hand and wrist orthosis of claim 3, wherein said thermoelectric cooling and/or heating unit is equipped with multiple temperature modes that enable instant therapy, wherein said instant therapy comprises one or a combination or a combination of ice therapy, heat therapy, contrast therapy, and moist heat therapy.

6. The hand and wrist orthosis of claim 1, wherein said hinge system comprises a contoured hinge leg operatively coupled with a plurality of adjustment screws and a stopping means, wherein said contoured hinge leg enables adjustment of allowable range of motion, and wherein said plurality of adjustment screws control degree of extension of said hinge leg by means of said stopping means.

7. The hand and wrist orthosis of claim 6, wherein said range of motion based on said plurality of adjustment screws and arrow pointer, wherein calibration of said plurality of adjustment screws with respect to said arrow pointer allows configuration of said range of motion.

8. The hand and wrist orthosis of claim 7, wherein loosening of said plurality of adjustment screws allows further extension of the contoured hinge leg.

9. The hand and wrist orthosis of claim 6, wherein said hinge system allows extension up to 50° flexion.

10. The hand and wrist orthosis of claim 6, wherein said stopping means comprises a slider with a stopper that locks said plurality of adjustment screws.

11. The hand and wrist orthosis of claim 6, wherein said hinge leg sits on outer palm surface.

12. The hand and wrist orthosis of claim 6, wherein a velcro hook is configured on said hinge leg to eliminate chances of unwanted hinge movement.

13. The hand and wrist orthosis of claim 6, wherein said hinge system comprises one or more slots, wherein said one or more slots are operatively coupled with a plurality of slot screws, wherein said slot screws enable adjustment in length of said hinge system based on size of forearm and palm.

14. The hand and wrist orthosis of claim 13, wherein said one or more slots are positioned on both sides of said hand and wrist orthosis to enable positioning of said hinge system on any or both hands.

15. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus is positioned on palmer surface of said hand.

16. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus is positioned on dorsal surface of said hand.

17. The hand and wrist orthosis of claim 1, further comprising a detachable immobilizer,

wherein said detachable immobilizer allows splinting of the wrist.

18. The hand and wrist orthosis of claim 1, wherein said detachable immobilizer is placed at one or a combination of dorsal surface of said hand, base of finger(s), near knuckles/metacarpal phalangeal joints.

19. The hand and wrist orthosis of claim 1, further comprising a detachable thumb immobilizer allows splinting of the thumb when additional stability is needed.

20. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus comprises a base stabilizer to support said thermoelectric cooling and/or heating unit.

21. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus is a palm wrap.

22. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus is a thenar eminence wrap.

23. The hand and wrist orthosis of claim 1, wherein said orthosis apparatus is a wrist wrap.

24. A hand and wrist orthosis comprising:

a thermoelectric cooling and/or heating unit configured to enable controllable cooling and heating of said hand and wrist orthosis.

25. A hand and wrist orthosis comprising:

a thermoelectric cooling and/or heating unit configured to enable controllable cooling and heating of said hand and wrist orthosis; and a hinge system operatively coupled with said thermoelectric cooling and/or heating unit and configured to enable change and control of range of motion of said hand and wrist orthosis, wherein said hinge system comprises a contoured hinge leg operatively coupled with a plurality of adjustment screws and a stopping means, and wherein said contoured hinge leg enables adjustment of allowable range of motion by means of said plurality of adjustment screws and stopping means.

The hand and wrist orthosis of claim 25, wherein said plurality of adjustment screws control degree of extension of said hinge leg by means of said stopping means.