Super-elastic exoskeleton devices for preventing and minimizing joint, tendon, ligament or muscle injury and methods of use thereof

Abstract

A support device for mitigating and preventing injury includes a flexible support material configured to be wrapped around a specified joint, tendon, ligament or muscle of a mammal and a Nitinol element contained in or on the support material, wherein the Nitinol element is configured to transform to an austenitic super-elastic phase by the body temperature of the mammal when the support material is wrapped around the joint, tendon, ligament or muscle, and the Nitinol element is positioned and configured to provide a counter force to the force exerted on the joint when the bending or stretching of the joint, tendon, ligament or muscle exceeds the normal angle of extension of the joint, tendon or muscle. Thus, the device acts dynamically and instantaneously in a super-elastic manner to prevent or minimize acute injury impact and also acts as a continuous support and fatigue reducer to minimize acute and chronic injuries.

Description

Background Technology

[0001] Joint, tendon, ligament, or muscle injuries are very common for athletes, workers, and virtually anyone who engages in physical activity. These injuries can occur at any joint, including the toes, ankles, knees, hips, back, neck, shoulders, elbows, wrists, and fingers, and can be disabling for people (or animals) who suffer a sprain. Such injuries can cause short-term or chronic pain, reduce bodily function, and in extreme cases, render a person or animal completely unable to perform the activities they desire.

[0002] Furthermore, extreme joint instability or hyperextension can lead to devastating traumatic injuries, causing partial or complete tears of ligaments, tendons, and muscles. Common examples include injuries to the Achilles tendon, patellar tendon, anterior cruciate ligament (ACL), medial collateral ligament (MCL), hamstrings, pectoral muscles, and calf muscles. Even if the injury is not severe, repetitive movements during work, sports, or daily activities can lead to cumulative stress and strain, inflammation, pain, and instability of joints, ligaments, tendons, and muscles. This can result in short-term or permanent repetitive motion injuries, leading to reduced physical function or complete loss of mobility.

[0003] Joint sprains can occur in any joint, including the toes, ankles, knees, hips, back, neck, shoulders, elbows, wrists, and fingers, and can disorient an athlete or worker, causing short-term or chronic pain, reduced physical function, or complete loss of mobility. Similarly, animals can also suffer joint injuries that impair their mobility. For horses, this includes ranch horses, racehorses, show jumping horses, barrel racing horses, and rodeo horses. For dogs, this includes racing dogs, sled dogs, and sheepdogs.

[0004] Joint, neck, and back sprains are common in various sports, including but not limited to basketball, football, rugby, baseball, softball, handball, volleyball, lacrosse, rugby, Australian rules, gymnastics, wrestling, weightlifting, running, golf, tennis, pickleball, American squash, track and field, boxing, martial arts, motorsports (cars, motorcycles, water sports), rodeo (bull riding, etc.), water sports (water skiing, jet skiing, diving, etc.), winter sports (skating, ice dancing, ice hockey, skiing, snowboarding, freestyle snowboarding and speed jumping, cross-country skiing, snowmobiling, tobogganing, etc.), and dance (ballet, ballroom dancing, modern dance). In fact, joint, tendon, and muscle injuries occur frequently in almost any sport involving dynamic human movement, including but not limited to running, jumping, weightlifting, sports that cause instability, repetitive motion injuries, or overextension. Similarly, in non-sports professions, joint sprains and chronic injuries can occur due to long-term or excessive use of joints during work, which often leads to repetitive motion injuries.

[0005] Various protective gear, sleeves, or supportive bandages or sports tapes have been attempted to prevent these types of joint, tendon, and muscle injuries, but with limited effectiveness. All these existing devices attempt to provide "restraint" or improve joint stability within the normal range of motion. However, not only are these devices limited in their effectiveness, but they often hinder performance due to their bulkiness.

[0006] For example, traditional woven fiber sports support tape has been used to "wrap" athletes to restrain and prevent ankle twisting or to minimize the severity of injuries and sprains. Despite this protection, ankle sprains are seen in almost every competition, affecting athletes from one team or another. This tape lacks elasticity, failing to restrain the joint or provide stability to prevent overextension beyond its normal range of motion. Furthermore, the tape may loosen during use due to its poor elasticity or deform during application, irreversibly returning to its original pre-deformation position or shape. Moreover, the support it provides is not "instantaneous," but rather arises only after the tape deforms due to foot and ankle movement, subsequently providing restraint.

[0007] In summary, lack of support can lead to instability and acute injuries unrelated to fatigue. Furthermore, lack of support can cause fatigue, stress, and strain, which can result in greater instability and lead to both acute and chronic injuries. Ideally, a device that is both hyperelastic and possesses transient shape memory properties could provide continuous, stable support to reduce fatigue, stress, strain, and both acute and chronic injuries. Summary of the Invention

[0008] In one embodiment, an exoskeleton device and a method of using the same are provided, comprising a flexible support material configured to wrap around or conform to a designated joint of a mammal and a nitinol element contained in or located on the support material, wherein the nitinol element is configured to transform into an austenitic hyperelastic phase by the mammal’s body temperature when the support material wraps around or conforms to the joint, and the nitinol element is positioned and configured to provide a continuous dynamic reaction force to forces applied to the joint when the joint flexes to and exceeds the joint’s normal extension angle.

[0009] In another embodiment of the invention, a method for optimizing the performance of an exoskeleton device is provided to mitigate and / or prevent injury to the user wearing the exoskeleton device. The method includes using a design tool to arrange nitinol elements, including at least one of nitinol wires, nitinol tubes, and nitinol sheets, in a predetermined arrangement in and / or on the exoskeleton device. The design tool is configured to perform at least one of finite element analysis, artificial intelligence analysis, and modeling and simulation analysis to integrate data stored in a database accessible by the design tool regarding at least one of human and / or animal anatomy, kinesiology, and ergonomics.

[0010] This summary introduces only a simplified version of some concepts that will be further described in the detailed embodiments described below. This summary is not intended to define the key or essential features of the claimed invention, nor is it intended to limit the scope of the claimed invention. Furthermore, the claimed invention is not limited to embodiments that address any or all of the deficiencies mentioned in any part of the invention. Attached Figure Description

[0011] The accompanying drawings illustrate one or more embodiments of the invention by way of example and not limitation. In the drawings, the same reference numerals refer to the same or similar elements. Furthermore, it should be understood that the drawings are not necessarily drawn to scale.

[0012] Figure 1 According to one aspect of the invention, an example of an ankle injury is shown, and the device of the invention can be used to alleviate or prevent such injury; Figure 2 It shows Figure 1 The extent of ankle injury is shown. Figure 3 According to one aspect of the invention, it is shown that it can be used to mitigate or prevent, such as Figure 1 A simplified structural diagram of an exoskeleton ankle bandage device for ankle injuries is shown. Figure 4According to one aspect of the invention, an alternative embodiment of a supportive ankle wrap is shown, wherein nitinol wire, tubing, or sheet is sewn into (or located on the outside or inside of) the supportive ankle wrap to reduce or prevent [damage / injury]. Figure 1 The ankle injury shown; Figure 5 According to one aspect of the invention, methods for mitigating or preventing such... Figure 1 A simplified structural diagram of an alternative embodiment of an ankle bandage device for ankle injuries; Figure 6 According to one aspect of the invention, a method for alleviating or preventing symptoms similar to those caused by overstretching is shown. Figure 1 A simplified structural diagram of an embodiment of an exoskeleton wrist device for ankle and wrist injuries is shown. Figure 7 According to one aspect of the invention, an exoskeleton wrist support wrap is shown, wherein nitinol wires, tubes or sheets are sewn into or located on the outer (upper) side of the wrist support wrap to mitigate or prevent wrist injury caused by excessive extension of the wrist in the downward direction (i.e., on the inner (lower) side of the wrist opposite to the outer side where the nitinol wires, tubes or sheets are located). Figure 8 According to one aspect of the invention, an exoskeleton wrist support wrap is shown, wherein nitinol wire, tube or sheet is sewn into or located on the inner (lower) side of the wrist support wrap to mitigate or prevent wrist injury caused by excessive extension of the wrist in the upward direction. Figure 9 According to one aspect of the invention, examples of floral patterns that can be used in nickel-titanium material sheets, particularly for wearable designs, are shown. Detailed Implementation

[0013] In the detailed embodiments described below, numerous specific details are illustrated by way of example in order to provide a full understanding of the relevant technical teachings of the invention. However, it will be apparent that the invention may be practiced without these details. In other instances, well-known methods, procedures, components, and / or circuits are given a relatively general overview rather than a detailed description in order to avoid unnecessarily obscuring aspects of the invention.

[0014] This invention generally relates to the use of hyperelastic and / or shape memory materials to provide or enhance joint stability, restraint, or support to mitigate and / or prevent sports or workplace injuries associated with joint instability, fatigue, repetitive motion injuries, and / or joint hyperextension. These materials can effectively function as protective exoskeletons (e.g., wearable devices, structures, or clothing designed to aid in injury prevention), delivering unprecedented performance leaps for the wearer. It is understood that such protective exoskeletons may take the form of sports support patches, wraps, sheaths, braces, splints, or protective clothing.

[0015] More specifically, this invention employs a nickel-titanium alloy (NiTi), also known as nitinol, to protect joints by providing targeted, continuous dynamic reaction forces against forces applied to joints, ligaments, tendons, and muscles during activity. As discussed below, the relative percentages of Ni and Ti can be adjusted as needed to provide the desired temperature response, thereby ensuring the necessary reaction forces are applied during the user's activity. For example, nitinol 55 (Ni to Ti ratio of 55 / 45) and nitinol 60 (Ni to Ti ratio of 60 / 40) are two such alloys that can be used in this invention. In this respect, the Ni to Ti ratio determines the temperature at which nitinol transforms into its hyperelastic austenitic phase, which is the phase required in this invention to generate the continuous dynamic reaction forces against forces that could lead to damage to ligaments, tendons, and muscles at the joints.

[0016] The nitinol used in this invention possesses unique properties that enable it to generate the desired damage mitigation / prevention reaction force. Specifically, when the temperature is above its phase transformation temperature (in the austenitic phase), nitinol exhibits hyperelasticity and transient properties. In other words, when nitinol is stretched in the austenitic phase at a temperature above its phase transformation temperature, it will immediately attempt to rapidly return to its original position. On the other hand, when nitinol is stretched below its phase transformation temperature (in the martensitic phase), it only exhibits a shape memory effect. In other words, when nitinol is stretched in the martensitic phase at a temperature below its phase transformation temperature, it will remain in the stretched position without generating a hyperelastic reaction support force.

[0017] Furthermore, another important characteristic of nitinol materials for this invention is that nitinol, in its austenitic phase, can withstand unique deformations 10 to 30 times greater than ordinary metals and still rapidly recover its original shape. It is also important to understand that this phase transformation is both bidirectional and reversible, and occurs instantaneously. In this regard, it should be understood that nitinol metal has different elastic moduli and yield strengths in its two different phases: for example, in the martensitic (lower temperature) phase, the elastic modulus ranges from 28 to 40 GPa, and the yield strength ranges from 70 to 140 MPa; while in the austenitic (higher temperature) phase, the elastic modulus ranges from 75 to 83 GPa, and the yield strength ranges from 195 to 690 MPa.

[0018] The temperature at which nickel-titanium alloys transform into their superelastic phase or state is typically around 70°F to 95°F (21°C to 35°C). This temperature range is where shape memory alloys exhibit their unique superelasticity and shape memory properties, allowing them to recover their original shape after deformation. This temperature range is ideal for applications in everyday life for athletes, workers, and the general public.

[0019] In summary, the properties of nitinol allow it to deform freely while providing instantaneous and hyperelastic support and joint stability. In the embodiments of sports support patches incorporating nitinol discussed below, the wrapping technique is identical to that of standard patches. Uniquely, according to the invention, the temperature of the nitinol filaments, tubes, or sheets rises due to heat from the skin during exercise. This temperature rise causes the nitinol fibers, tubes, or sheets to transform from a martensitic shape memory phase to an austenitic hyperelastic phase. As the joint extends (e.g., during ankle rotation), the nitinol deforms but contracts hyperelastically and instantaneously to resist and limit deformation, restoring its original shape memory martensitic morphology. These unique properties provide joint support, restraint, and stability protection far superior to conventional sports support patches, wraps, sheaths, supports, braces, etc., to prevent overstretching and associated tissue damage.

[0020] This technology represents a major breakthrough in joint support and stability, promising to significantly reduce injuries caused by hyperextension. Various types of hyperextension injuries can be addressed in specific applications by designing different patterns of wires or tubes. For example, in addition to preventing Achilles tendon injuries using linear wires or tubes extending along the tendon axis, basketball players can use a "diamond pattern" of nitinol wires or tubes to prevent ankle inversion and eversion sprains, accommodating complex extension movements. Similarly, nitinol sheets can be used to prevent this devastating injury.

[0021] Although this article describes the use of nitinol wires, tubes, or sheets in exoskeleton protective devices, it is important to note that various arrangements of nitinol elements can be used in the same device to tailor the device for specific types of joint, ligament, tendon, and muscle protection. In other words, a single exoskeleton protective device can have a complex combination of nitinol elements. For example, the device may have two or more nitinol wires or tubes with different outer diameters (OD), or wires and sheets with different thicknesses and patterns, or a mixture of two or more of the wires, tubes, and sheets in the same device, or any combination of these forms.

[0022] As will be discussed in detail below, responding to the dynamic plastic deformation of a device through transient and hyperelastic shape memory responses (e.g., hyperelastic deformation and re-deformation) facilitates the prevention of joint / tissue injuries. Key properties for achieving injury prevention are maximizing stability and minimizing fatigue. The device and method described in this invention continuously, dynamically, and transiently respond to plastic deformation, thereby providing unparalleled stability for joints, ligaments, tendons, and muscles. This, in turn, reduces fatigue in the protected joints, which is crucial because fatigue increases the likelihood of injury. The transient and proportional reaction force response during intense plastic deformation mitigates traumatic injuries.

[0023] A typical example of injuries caused by instability and fatigue is that studies show thoroughbred racehorses are prone to fracturing their foreleg bones below the third metatarsal, near the sesamoid bone, with 70% of these fractures occurring in the third and fourth turns and the final straight—precisely when the horse is most fatigued. Only 30% of such injuries occur in the first and second turns and the final straight (at the start of the race). After an injury, this device can help prevent recurrence of similar injuries by providing maximum joint stability and minimal joint fatigue once again.

[0024] As will be understood from the following discussion, the present invention provides an arrangement for optimizing the performance of an exoskeleton device to mitigate and / or prevent injury to the user wearing the exoskeleton device, comprising using a design tool configured to perform at least one of finite element analysis, artificial intelligence analysis, and modeling and simulation analysis to integrate data on at least one of human and / or animal anatomy, kinesiology, and ergonomics stored in a database accessible by the design tool, and arranging nitinol elements, including at least one of nitinol wires, nitinol tubes, and nitinol sheets, in a predetermined arrangement in and / or on the exoskeleton device.

[0025] Figure 1An example of an ankle injury is shown, serving as an example of an injury that the device and method of the present invention can mitigate or prevent. This embodiment is intended to illustrate the use case of the unique mechanism of protection (MOA) of the device and method of the present invention, but as discussed below, the same MOA can be used to protect a variety of joints, and each product application embodiment relies on the same basic principles discussed for this example of an ankle injury.

[0026] Basketball has the highest rate of joint sprains of all competitive sports, with ankle sprains being the most common injury. The high-dynamic running and jumping (in the NBA, the average jump height is 28 inches, with a maximum of 48 inches), shoes designed for grip, and the wide feet of athletes combine to create a perfect synergy for frequent ankle injuries. However, such ankle injuries can also occur in many other sports, especially those involving jumping and hard surfaces, such as tennis, squash, short-handled wallball, and handball.

[0027] Figure 1 The so-called "ankle rollover" shown is the most common cause of ankle sprains. Taking basketball as an example, offensive players often jump to shoot or rebound. When a player lands from a nominal height of 24-48 inches off the ground, they may land on another player's shoe, usually an opposing guard. Due to relative lateral movement during defense, the guard now unintentionally encroaches on the offensive player's landing area. In this situation, one of the offensive player's feet lands on the irregular surface of the defender's shoe. Unlike the adapted and expected flat wooden court surface, the defender's foot causes the offensive player's ankle to roll outwards from inside the shoe, resulting in hyperextension of the ankle. This hyperextension is unpredictable for the landing player, as they expect a flat surface and typically don't look down to anticipate the ankle twist upon landing.

[0028] Figure 1 This illustrates what can happen to a player's ankle during landing, specifically during ankle twisting. Soft tissue damage and ligament tears, particularly during hyperextension upon landing, can occur. For example, Figure 1 This illustrates an ankle twist resulting in a tear of the calcaneofibular ligament and the anterior talofibular ligament. These ankle sprains are graded according to severity, from minor grade 1 to severe grade 3 complete ligament tears, such as... Figure 2 As shown.

[0029] Figure 3A simplified structural schematic diagram of an ankle support device 300 is shown, which has a flexible support material 310 (e.g., a conventional sports support patch) configured to wrap around the ankle joint. Nitinol elements 320 (e.g., filaments or tubes) are integrated and / or woven into (or attached to the upper or lower surface of) the flexible support material 310 to alleviate or prevent [conditions such as] Figure 1 The ankle injury is shown. Velcro™ fasteners 330A and 330B are provided on opposite surfaces of the flexible support material 310 so that the flexible support material can wrap around the ankle joint and be secured to the ankle joint by the Velcro™ fasteners 330A and 330B.

[0030] According to the principles of the invention, the flexible support material 310 should wrap around the ankle joint, such that the nitinol element 320 will at least cover the outer part of the ankle joint (i.e., the portion of the ankle joint that will be stretched during ankle torsion). Thus, when an event such as... Figure 1 During ankle torsion, the nitinol element 320 stretches with the ankle torsion, but then immediately retracts (assuming the nitinol element 320 is in its hyperelastic austenitic phase due to the user's body temperature) to provide a strong protective reaction force against the force of ankle torsion. In other words, when the nitinol element 320 begins to stretch due to ankle torsion, it immediately attempts to retract to its original length, thereby providing the necessary reaction force against the force generated during ankle torsion. This reaction force effectively holds the ankle in its original position to prevent injury due to hyperextension. Depending on the force exerted by ankle torsion and the strength of the reaction force exerted by the retracted nitinol element 320, injury caused by ankle torsion can be prevented or at least minimized. Current conventional ankle taping methods restrict mobility, significantly reducing freedom of movement despite their protective function. On the other hand, the hyperelastic exoskeleton device of the present invention provides continuous dynamic support and instantaneous response to destructive deformation forces, with far less restriction on the user's movement than current conventional devices. It should be noted that the nickel-titanium material can also be integrated into sports support patches, combining the protective properties of the patches with the support, stability, and fatigue resistance derived from instantaneous hyperelasticity.

[0031] As mentioned above, such as Figure 3As shown, the nitinol element 320 should be positioned appropriately within or on the flexible support material 310 to apply a reaction force to forces that could cause injury, such as ankle torsion. The position of the nitinol element 320 within or on the flexible support material 310 will vary depending on the type of joint being protected. For example, the position of the nitinol element 320 used to protect the knee, shoulder, back, neck, etc., can be adjusted to ensure that a reaction force is applied when the relevant joint bends in a direction that could cause joint injury.

[0032] Figure 3 The position of the nitinol element 320 shown is specifically designed to prevent outward rotation of the ankle joint. This is the most common type of ankle injury, and designing protection for this area not only prevents this common injury but also minimizes the cost, manufacturing process, and weight of the ankle support device 300. However, in alternative embodiments, additional elements may be added... Figure 3 The nitinol element 320 shown is spaced apart from other nitinol elements 320 to prevent, for example, inward rotation of the ankle joint. Of course, if desired, the nitinol elements 320 can also be arranged entirely along the length of the flexible support material 310 to provide comprehensive protection for the ankle joint.

[0033] As described above, it is important that the nitinol elements 320 are configured to be in the superelastic austenitic phase during activities requiring user protection. This involves selecting a suitable Ni / Ti metal ratio, the diameter of the nitinol wire / tube, and the arrangement of the nitinol elements 320 within the flexible support material, so that the nitinol elements 320 can be sufficiently heated by the user's body temperature, exceeding their phase transformation temperature, entering the austenitic phase and exhibiting superelasticity. This superelastic property is the basis for the present invention's protective reaction against forces that could cause joint damage, such as ankle torsion.

[0034] The aforementioned ultra-elastic nitinol sports wrapping device 300 is typically worn inside an athlete's sock (e.g., as a wrapping support patch). The sock is optimized to trap heat to help reach and maintain the activation temperature. Once the woven nitinol patch has fully reached its phase transition temperature, it provides the necessary ultra-elastic support. At moments of ankle stress, the nitinol fibers act to prevent excessive ankle movement, potentially reducing the severity of sprains (e.g., as...). Figure 2 As shown in the figure, the severity can be reduced from severe to moderate, from moderate to mild, or even completely prevented.

[0035] Figure 4Another embodiment of a supportive ankle wrap 400 is shown, wherein nitinol wire, tubing, or sheet is sewn into (or located outside or inside) the supportive ankle wrap to alleviate or prevent [conditions such as] Figure 1 The ankle injury is illustrated. The ankle bandage 400 can be a commercially available ankle bandage modified according to the present invention to embed nitinol wire, tube, or sheet therein or thereon, thereby providing a fit... Figure 3 The same protection effect as described above is achieved in the embodiment shown.

[0036] Figure 5 It shows that it can be used to alleviate or prevent such Figure 1 A simplified structural schematic diagram of another alternative embodiment of the ankle bandage 500 for ankle injuries shown. The bandage 500 is similar to... Figure 3 The wrapping device 300 shown is formed from a flexible wrapping material 510 configured to include the ankle joint and Velcro™ Velcro straps 530A and 530B. However, instead of Figure 3 The Nitino element 320 can be a parallel wire or tube. Figure 5 In the illustrated embodiment, a nitinol sheet 520 is used to generate the desired reaction force against ankle torsional forces. This nitinol sheet 520 can be woven into the flexible wrapping material 510 or attached to the inner or outer side of the wrapping material 510. In any case, similar to... Figure 3 The nitinol element 320 shown, and the nitinol sheet 520, need to be located in or above the wrapping material 510, at a position that allows the nitinol sheet 520 to be in the austenitic phase and located outside and above the ankle joint to resist ankle torsion.

[0037] The nitinol sheet 520 can take various forms. For example, the nitinol sheet 520 can be made by weaving multiple nitinol filaments together to form a nitinol metal fabric sheet. Alternatively, the nitinol sheet 520 can simply be a sheet of solid nitinol material. Furthermore, regardless of whether the nitinol sheet 520 is woven or solid, various patterns can be formed therein, such as... Figure 9 As shown. Specifically, as Figure 9 As shown, these shapes may include, but are not limited to, rhombuses, hexagons, pentagons, rectangles, rings, circles, and ellipses. These patterns can be cut entirely through the nitinol sheet 520 or partially through the sheet in an embossed manner. In any case, these patterns (compared to simple "unpatterned" flat sheets) help provide greater flexibility to the nitinol sheet during user movement and also facilitate ventilation to prevent heat buildup beneath the sheet. Furthermore, as shown in Table 1 below, in some applications, using nitinol sheet 520 instead of filaments or tubes provides higher strength and offers higher, faster, and / or more stable heat transfer.

[0038] Whether using Figure 3 The nickel-titanium wire or tube shown is still used Figure 5 The nitinol sheets (or combinations of these nitinol elements) shown can be customized with the properties of the nitinol, as well as the properties of the wires, tubes, or sheets, to provide the desired reaction force for the specific joint being protected. For example, as mentioned above, the nickel / titanium ratio of the nitinol is a crucial factor in determining its phase transformation temperature (i.e., the phase transformation temperature at which nitinol transitions from a martensitic to an austenitic state). The placement of the nitinol wires, tubes, and sheets within the flexible support material is also important for the phase transformation temperature, ensuring that the user's body heat is transferred to the nitinol material to activate it into a hyperelastic austenitic state.

[0039] Similarly, as shown in Table 1 below, the characteristics of the filaments, tubes, and sheets in terms of quantity, size, and thickness are important for determining how much reaction force will be generated in response to forces that may cause joint damage.

[0040] Table 1: Solid wire: available in various sizes and nickel:titanium ratios Hollow tubes: available in various diameters (various outer diameters, inner diameters, and associated wall thicknesses) and nickel:titanium ratios for different performance characteristics and austenite activation temperatures.

[0041] Flat sheet material with or without floral or embossed cut elements Geometric floral patterns include, but are not limited to, various shapes Various sheet thicknesses Nickel:Titanium ratio Patterns can be obtained by laser cutting sheets (an existing process). In some applications, patterned sheets can provide higher strength than wire or tube, as well as higher, faster and / or more stable heat transfer, while providing greater flexibility and deformation capacity than "unpatterned" sheets.

[0042] For example, refer to Figure 3 The quantity and specifications of the nitinol wires or tubes 320 will determine the magnitude of the reaction force generated during joint bending. Similarly, Figure 5The size and thickness of the nitinol sheet 520 will also determine the magnitude of the resulting reaction force. According to various aspects of the invention, these parameters (e.g., the number of wires or tubes, the size of the sheet, the thickness of the wires, tubes, and sheets, the position of the wires, tubes, and sheets, etc.) can be customized to provide the magnitude of the reaction force needed to protect the joint, without being so large as to prevent the joint from bending to the point that the user cannot perform the intended movement. This customization of the nitinol element parameters and position can be performed by measuring the force generated when the joint bends, and then adjusting the parameters and position of the nitinol element (e.g., wires, tubes, or sheets) to provide an appropriate magnitude of reaction force to the measured force, thereby preventing injury to the user while they are active.

[0043] exist Figure 3 and Figure 5 In the diagram, the nitinol element 320 and sheet 520 are shown positioned to allow them to cover the outside of the user's ankle joint when the device is wrapped around it. As mentioned above, it is desirable that the nitinol element 320 and sheet 520 are positioned such that the nitinol is stretched when the joint is flexed. However, according to an alternative embodiment of the invention, additional nitinol elements or sheets may be provided at different locations on the flexible support material to provide protection against other potential injuries. For example, in Figure 3 In this embodiment, the nitinol element 320 is arranged to prevent injuries caused by outward rotation of the ankle joint (which is by far the most common ankle injury). However, the nitinol element 320 can also be positioned to cover other parts of the ankle joint, such as the medial side or top of the ankle joint, which may also be injured if these parts are subjected to unnatural or excessive bending.

[0044] exist Figure 3 as well as Figure 5 In this embodiment, the nitinol element 320 and nitinol sheet 520 are located after the device wraps around the ankle joint, covering the outer portion of the user's ankle. As described above, the nitinol element 320 and nitinol sheet 520 are most preferably located where the nitinol can stretch with the flexing of the joint. However, according to another alternative embodiment of the invention, other nitinol elements or sheets can be placed at different locations on the flexible support material to provide protection against other potential injuries. For example, in Figure 3 In the illustrated embodiment, the nitinol element 320 is arranged to prevent injury caused by outward rotation of the ankle joint (which is by far the most common type of ankle injury). However, the nitinol element 320 may also be positioned to cover other potentially damaged areas of the ankle joint, such as the medial side or top of the ankle joint, to address potential injuries to these areas when subjected to unnatural or excessive flexion.

[0045] The foregoing discussion uses ankle injuries as an exemplary application of the apparatus and method of the present invention. However, as stated above, the present invention also aims to prevent or at least mitigate joint injuries in all types of joints, whether in humans or animals. In each case, the composition of the nitinol, the characteristics of the nitinol elements or sheets, and the location of these elements need to be tailored to the joint in question. For example, the composition, size, and location of nitinol elements or sheets used for finger joint protection will differ from those required for ankle, knee, or shoulder joint protection.

[0046] Figure 6-8 An example of a protective wristband 600 that utilizes the above principle to generate a reaction force to protect the wrist, regardless of whether the wrist is bent upwards or downwards, is shown. For this purpose, the protective wristband 600 includes a flexible support material 610 and Velcro™ Velcro 630A and 630B (similar to...). Figure 3 and Figure 5 (As shown in the embodiment) and a set of nitinol elements 620 and 625. When the flexible support material 610 is wrapped around the user's wrist, the nitinol element 620 is located on the upper (top) side of the wrist that covers it (e.g., the embodiment shown). Figure 7 The nickel-titanium element 625 is located at the position shown, while the nitinol element 625 is located on the lower side (bottom) that covers the wrist (as shown). Figure 8 (as shown in the image) at the location. In this situation, regardless of whether the wrist is excessively bent upwards or downwards, the Nitinol element 620 or 625 (e.g., Nitinol wire or tube) generates a reaction force to protect the wrist joint from injury.

[0047] The foregoing description specifically illustrates the principles of the invention in the context of preventing / reducing ankle and wrist injuries. The following description will provide further details regarding the prevention / reduction of such ankle and wrist injuries in humans, as well as numerous other examples of applications of the apparatus and methods of the invention for other joints in humans and animals.

[0048] The following embodiments can be categorized as devices designed for single use or reusable use. Key application areas of the above-described devices and methods of the present invention include, but are not limited to: Human sports Animal sports Occupational / Physical Labor Activities Human daily activities Functional clothing integration Special protective applications: police officers, firefighters, military personnel, astronauts, pilots, the elderly, the disabled, and those using automobiles, motorcycles, skateboards, skis, snowboards, water skiing, and jet skis. These key areas will be discussed below.

[0049] In the field of human sports, this can include disposable or reusable: sports support patches integrated with and / or woven with nitinol fibers, tubes, or sheets; sports support sleeves integrated with and / or woven with nitinol fibers, tubes, or sheets; and sports support braces and splints integrated with and / or woven with nitinol fibers, tubes, or sheets. The term "human sports" includes, but is not limited to, basketball, football, rugby, baseball, volleyball, lacrosse, rugby, gymnastics, wrestling, weightlifting, running, golf, tennis, picket, squash, track and field events, boxing, martial arts, machine racing (automobiles, motorcycles, jet skis), rodeo (bull riding, etc.), water sports (water skiing, jet skiing, diving, etc.), winter sports (skating, ice dancing, ice hockey, skiing, snowboarding, snowmobiling, sledding), dance (ballet, ballroom dancing, modern dance), hiking, climbing (mountain, rock climbing), etc. The devices and methods of the present invention can help prevent / mitigate some common injuries, including pitcher's elbow and tennis elbow.

[0050] In the field of animal sports, similar sports support patches, sleeves, braces, and splints as those described above for human athletes can be used. Such animal sports include, but are not limited to, racehorses, rodeo horses, draft horses, carriage horses, racing dogs, and sheepdogs. Racehorses are particularly prone to ankle and leg injuries. The impact is severe, as the consequences often necessitate euthanasia. These horses are typically worth millions of dollars due to their competition and breeding value. Solutions for preventing these ankle and leg injuries are essentially similar to the human examples provided in this invention. Nitinol is woven and / or integrated into flexible support patches, sleeves, braces, or splints to provide joint stability and prevent / minimize joint damage and / or fractures.

[0051] In occupational and manual labor activities, similar flexible support patches, sleeves, braces, and splints used for the aforementioned human athletes can also be used. Occupational / manual labor activities include, but are not limited to, manufacturing, agriculture, industry, construction, transportation, and warehousing. By providing a reaction force to pressure-induced joint movements, the device and method of the present invention can counteract the harmful effects of repetitive movements frequently required in occupational and manual labor activities. For example, the stability of the device can reduce fatigue in chronic conditions, such as repetitive wrist injuries caused by the repeated use of tools (tightening screwdrivers, holding pliers, opening and closing scissors, etc.) in industrial work.

[0052] Other non-manufacturing and non-sports professionals are also susceptible to repetitive motion injuries and will benefit from protective devices manufactured using the principles disclosed in this invention. These professions include, but are not limited to, musicians, chefs / cooks, surgeons, dentists, dental hygienists, etc. For example, musicians who play stringed instruments, including guitarists, violinists, viola players, cellists, bassists, etc., frequently suffer from repetitive strain injuries to their elbows, wrists, and fingers. Similarly, chefs and cooks often experience wrist and elbow problems due to cooking techniques such as whipping and mixing. Surgeons, dentists, hygienists, and echocardiologists frequently experience problems with their forearms, wrists, and hands. Surgeons and dentists who use microscopes at work also experience neck, shoulder, and back problems. People who type extensively also frequently suffer from wrist injuries, such as the well-known carpal tunnel syndrome. These are just a few examples among the many fields that can benefit from the devices and methods disclosed in this invention.

[0053] In everyday human activities, flexible support patches, sleeves, braces, and splints similar to those used for human athletes can be used. These activities include household chores and yard work, where joint injuries are common.

[0054] In the field of functional clothing integration, shirts, trousers, underwear, socks, shoes, and gloves are all examples of functional garments that incorporate nitinol fibers, tubes, or sheets, either woven or layered. Integrating nitinol fibers, tubes, or sheets into clothing is highly beneficial for providing all-day support, stability, and protection for chronic pain issues. It is also very helpful in preventing falls, especially in older adults, by providing support at the ankles, knees, and hips to prevent these joints from becoming unstable during walking. Preventing such falls is crucial for preventing hip fractures, as well as back, knee, head, neck, hand, and wrist injuries, which are often caused by these falls. Hip fractures are a well-known cause of premature death within a few years of the injury.

[0055] In the field of specialized protective applications, flexible support patches, sleeves, protective gear, and splints similar to those used for the aforementioned human athletes can be used. These specialized protective applications include, but are not limited to, injury prevention in high-risk activity categories, such as police officers, firefighters, emergency medical personnel, rescue workers, military personnel, astronauts, pilots, ship / maritime personnel, automotive workers, motorcyclists, the elderly, and people with disabilities.

[0056] As described above, the principles of this invention regarding the use of nitinol wires, tubes, and sheets can be applied to traditional sports tape. In this regard, it should be noted that the teachings of this invention can be used without hindering the use of the following three most mainstream and effective sports tape application technologies: Stirrup-style technology : First, apply a stabilizing strap above the inner ankle bone.

[0057] Pass the patch under the arch of the foot, wrap it around the heel, and press it onto the retaining strap.

[0058] Continue wrapping the patch upwards around the ankle in a figure-eight pattern, wrapping both sides and supporting the ankle joint.

[0059] Finally, secure the patch to the outside of the foot with another securing strap.

[0060] Eight-character winding technique : First, apply a support band above the inner ankle bone.

[0061] Cross the patch at the front of the foot and wrap it around the ankle.

[0062] Move the patch diagonally to the back of the heel to form a figure-eight pattern.

[0063] Continue in a figure-eight pattern, alternately wrapping the patch around the front and back of the ankle until the ankle is fully supported.

[0064] Secure the patch to the outside of the foot with a fastening strap.

[0065] Basket weaving technique : First, apply a support band above the inner ankle bone.

[0066] Apply a second fixation band below the outer ankle bone.

[0067] Apply two strips diagonally from the inner fixing strip to the outer fixing strip to form an 'X' shaped pattern.

[0068] Repeat this process, alternating between the inside and outside of the belt to form a basket weave pattern.

[0069] Wrap the patch snugly but not too tightly to provide support without restricting blood circulation. Ensuring the patch adheres well to the skin helps provide effective support during physical activity.

[0070] In addition to using the devices and methods of this invention in conjunction with sports support patches, these devices and methods can also be used in modified joint sleeves with nitinol wires, tubes, or sheets. Conventional pressure-fit joint sleeves can be enhanced by designing nitinol wires, tubes, or sheets with various wire diameters and patterns according to the joint's usage and performance requirements. Conventional pressure-fit joint sleeves are often worn on the knees, elbows, ankles, and fingers to support them, protect joints previously moderately injured, or prevent primary joint hyperextension. These joint sleeves are typically elastic, stretching to conform to an individual's limb structure, and their dimensions are designed to provide an over-fit or slightly compressive fit to the limb structure. These conventional pressure-fit joint sleeves provide only moderate support, but their advantage lies in being lightweight and uncluttered.

[0071] According to the principles of this invention, the design of the pressure joint sleeve is similar to that of conventional sleeves, but incorporates an integrated nitinol wire, tube, or sheet, retaining the advantage of current sleeves being lightweight while providing a superelastic support similar to that described above. This pressure-fitting joint sleeve adheres closely to the skin, and the sleeve material can rapidly raise the temperature of the nitinol wire, tube, or sheet to the austenitic superelastic phase. Therefore, the improved pressure-fitting joint sleeve (with nitinol elements) will provide the reaction force required for preventing / mitigating injury, as described above.

[0072] Similarly, in addition to combining the devices and methods of the present invention with sports support patches, these devices and methods can also be used in modified braces, splints, and casts incorporating nitinol wires, tubes, or sheets. Depending on the joint usage and performance requirements, conventional knee, neck, wrist, or back braces, splints, and casts can be reinforced with structural nitinol elements (designed with various diameters and / or filament patterns) and / or various thicknesses, shapes, and functional mechanisms (hinges, levers, struts, etc.) as described in the present invention. Similarly, for fractures, less bulky, hyperelastic reinforced casts can be used to provide good support during healing. Typically, braces are worn to prevent injury, reduce the likelihood of re-injury, or reduce fatigue or inflammation caused by overuse of joints in daily life, workplace activities, or sports. The integrated nitinol wires and / or structural elements and / or functional mechanisms of the present invention reduce the bulkiness of current braces while providing superior hyperelastic support. The close fit between the protective gear and the human skin helps to raise the temperature of the nickel-titanium element above the phase transformation temperature, allowing it to enter the austenitic phase and thus providing super-elastic support.

[0073] While various embodiments have been described, this description is intended to be exemplary and not restrictive, and it should be understood that many more embodiments and implementations may exist within the scope of these embodiments. Although many possible combinations of features are shown in the drawings and discussed in the specific embodiments, many other combinations of the disclosed features are also possible. Unless specifically limited, any feature of any embodiment may be used in combination with or replaced by any other feature or element in any other embodiment. Therefore, it should be understood that any feature shown and / or discussed in this invention may be implemented together in any suitable combination. Thus, the boundaries of the embodiments of this invention should be defined according to the appended claims and their equivalents. Furthermore, various modifications and variations may be made within the scope of the appended claims.

[0074] While the content and / or other examples considered to be the best mode have been described above, it should be understood that various modifications are possible, and the subject matter disclosed herein can be implemented in various forms and examples. The technical teachings of this invention can be applied to many applications, some of which are described herein only. The appended claims are intended to cover any and all applications, modifications, and variations that fall within the true scope of the technical teachings of this invention.

[0075] Unless otherwise stated, all measurements, numerical values, grades, locations, sizes, dimensions, and other specifications set forth in this specification (including the appended claims) are approximate values, not precise values. They are intended to have a reasonable range consistent with their associated functions and the conventions of the field.

[0076] The scope of protection of this invention is defined solely by the appended claims. In conjunction with this specification and the subsequent examination process, this scope is intended and should be interpreted as broadly as possible according to the ordinary meaning of the terms used in the claims, and covers all structural and functional equivalents. Nevertheless, none of the claims are intended to include, nor should they be interpreted as including, subject matter inconsistent with Articles 101, 102, or 103 of the Patent Act. Any unintentional coverage of such subject matter is hereby waived.

[0077] Except as described above, nothing described or shown is intended or should not be construed as contributing any component, step, feature, purpose, benefit, advantage, or equivalent to the public, whether or not it is defined in the claims.

[0078] It should be understood that, unless otherwise stated, the terms and expressions used herein have their general meanings within their respective fields of exploration and research. For example, first and second relational terms are used only to distinguish one entity or action from another, and do not necessarily require or imply any actual such relationship or order between these entities or actions. The terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those listed but also other elements not expressly listed or inherent to such processes, methods, articles, or apparatus. Unless further defined, an element modified by the indefinite article “a” or “an” does not exclude the possibility of the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0079] This abstract is intended to enable the reader to quickly determine the essence of the invention. It should be understood that this abstract is not intended to interpret or limit the scope or meaning defined by the claims. Furthermore, in the above detailed description, it can be seen that features are combined in various embodiments for the purpose of simplification. This disclosure should not be construed as claiming more features than are expressly recited in each claim. Rather, as reflected in the appended claims, the subject matter of the invention can be implemented with only a portion of all features in a single disclosed example. Therefore, the appended claims are incorporated herein by reference to the detailed description, and each claim may stand alone as a separate claim.

Claims

1. An exoskeleton support device for mitigating and preventing injury, comprising: A flexible support material configured to wrap around a designated joint, tendon, ligament, or muscle of a mammal; as well as Nickel-Titanium elements contained in or located on the support material; The nitinol element is configured such that when the support material is wrapped around the joint, tendon, ligament, or muscle, the nitinol element transforms into an austenitic hyperelastic phase through the body temperature of the mammal; and The nitinol element is positioned and configured to provide a reaction force to the force applied to the joint, tendon, ligament, or muscle when the flexion of the joint, tendon, ligament, or muscle exceeds a preset extension angle of the joint, tendon, ligament, or muscle.

2. The support device according to claim 1, characterized in that: The support material is configured to wrap around the ankle joint of the mammal.

3. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's toe joints.

4. The support device according to claim 1, characterized in that: The support material is configured to wrap around the knee joint of the mammal.

5. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's hip joint.

6. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's back and spine.

7. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's shoulders.

8. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's elbow joint.

9. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the human's wrist joint.

10. The support device according to claim 1, characterized in that: The mammal is a human, and the support material is configured to wrap around the finger joints of the human.

11. The support device according to claim 1, characterized in that: The mammal in question is a horse.

12. The support device according to claim 1, characterized in that: The mammal in question is a canine.

13. The support device according to claim 1, characterized in that: The nitinol element comprises multiple nitinol wires arranged parallel to each other in a certain direction to provide the reaction force.

14. The support device according to claim 1, characterized in that: The nitinol element comprises multiple hollow nitinol tubes arranged parallel to each other in a certain direction to provide the reaction force.

15. The support device according to claim 1, characterized in that: The nitinol element comprises multiple nitinol wires arranged in a grid that intersect each other in a certain direction to provide the reaction force.

16. The support device according to claim 1, characterized in that: The nitinol element comprises multiple hollow nitinol tubes arranged in a grid that intersect each other in a certain direction to provide the reaction force.

17. The support device according to claim 1, characterized in that: The nitinol element includes a pattern in a nitinol sheet, the pattern being arranged such that the nitinol sheet provides the reaction force.

18. The support device according to claim 17, characterized in that: The flower pattern is formed by laser cutting from the nickel-titanium material sheet.

19. The support device according to claim 1, characterized in that: The nitinol element is configured to transform into the austenitic hyperelastic phase by setting the ratio of nickel and titanium in the nitinol, thereby absorbing the body temperature of the mammal.

20. The support device according to claim 1, characterized in that: The nitinol element is configured to provide the reaction force based on the diameter or thickness specification of the nitinol element.

21. The support device according to claim 16, characterized in that: The nitinol element is configured to provide the mesh in a wiring or braiding pattern to provide the reaction force.

22. The support device according to claim 1, characterized in that: The supporting material is clothing.

23. The support device according to claim 1, characterized in that: The preset angle is an angle that exceeds the preset extension angle of the joint.

24. A method for mitigating and / or preventing injury, comprising: Wrap a support material, incorporating or having incorporated Nitinol elements, around a designated joint, tendon, ligament, or muscle of a mammal. and The nitinol element is configured to transform into an austenitic hyperelastic phase by the mammal's body temperature when the support material is wrapped around the joint, tendon, ligament, or muscle. The nitinol element is positioned and configured to provide an instantaneous dynamic reaction force to the force applied to the joint, tendon, ligament, or muscle when the flexion of the joint, tendon, ligament, or muscle exceeds a preset extension angle of the joint, tendon, ligament, or muscle, in order to minimize or prevent injury. The nitinol element is positioned and configured to provide a continuous dynamic support reaction force to the force applied to the joint, tendon, ligament or muscle when the flexion of the joint, tendon, ligament or muscle reaches a preset extension angle of the joint, tendon, ligament or muscle, so as to provide continuous support and reduce fatigue, thereby minimizing acute and chronic injuries.

25. A method for optimizing the performance of an exoskeleton device to mitigate and / or prevent injury to a user wearing the exoskeleton device, the method comprising: Using a design tool, NiTiNo elements comprising at least one of NiTiNo wires, NiTiNo tubes, and NiTiNo sheets are arranged in a predetermined layout within and / or on the exoskeleton device, wherein the design tool is configured to perform at least one of finite element analysis, artificial intelligence analysis, and modeling and simulation analysis to integrate data stored in a database that is accessible by the design tool regarding at least one of human and / or animal anatomy, kinesiology, and ergonomics.

26. The method according to claim 25, characterized in that: The arrangement of the nitinol elements includes selecting a plurality of nitinol elements and the characteristics of the nitinol elements, wherein the characteristics include at least one of the following: element type, diameter, thickness, specifications, quantity, length, shape, nickel:titanium ratio, placement position, and arrangement of the nitinol elements.

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