Orthotic device

Abstract

The present invention relates to orthotic devices, such as ankle foot orthoses (AFOs), as well as to methods of manufacturing orthotic devices.

Description

[0001] Orthotic Device

[0002] The present invention relates to orthotic devices, such as ankle foot orthoses (AFOs), as well as to methods of manufacturing orthotic devices.

[0003] Gait abnormalities caused by lower limb neuromuscular deficiencies can detrimentally affect a person's safety and efficiency in walking. Orthotic devices, such as Ankle Foot Orthoses (AFOs), are externally applied devices that provide a force pattern to resist unwanted movements and guide the limb into a more functional gait pattern. Having a device that fits the unique shape of a human's limb is fundamental for efficient force transfer and basic comfort. The lighter, stronger, and more tuned (being aligned correctly and stiff or rigid based on requirements) an AFO is to the user's biomechanical needs, the better the expected outcome. For these reasons, being able to use high end structural materials in any morphology dictated by the needs of a wearer is a design goal for orthotics.

[0004] Traditional technologies used to produce custom AFOs usually involve a physical shape capture of a limb using casting materials, such as gypsum and fiberglass wraps. These anatomical shapes do not suit the orthotic product immediately, and a process of shape modification is required. Traditionally, this is performed by a skilled operator. A starting anatomical shape is shaved, added to, and manipulated to be the desired shape of the finished orthotic device.

[0005] A series of emerging technologies are creating different pathways to achieve similar or advanced results in AFO manufacture. Digital design takes the physical modeling process and makes it possible on a computer with computer aided design (CAD). Anatomical shapes can be digitized with optical or other scanning technologies. This gives the ability for a range of different CAD software to be used to manipulate the shape. The advantages of this are speed in production, consistency, and unit cost.

[0006] Once a competent digital file is produced, the production of an AFO component can be facilitated with the use of subtractive (milling) or additive (3D printing) technologies. The difference between these production technologies is that subtractive milling sees the production of positive shapes for the use of production techniques like traditional technologies, whereas additive production can produce a final useable component. The 3D printing, additive manufacturing platform allowed by digital techniques produces plastic and other parts adequate for a functional orthotic device. However, a current limitation in this technology is seen in the restriction of material types that can be printed.There have also been recent advances in composite technology used in AFO manufacture, particularly involving processing changes. Although the base fibers in the composite remain consistent, some of the resin structures being developed can be described as equally robust, but the curing methodologies have changed to have a quicker cycle time with less consumables required.

[0007] Although emerging technologies are showing remarkable progress, there are still some limitations to overcome. These limitations are highlighted by comparison of the technologies. The use of digital modelling technologies is far more productive in the hands of a highly skilled operative when compared to an operative of similarly high skill using traditional techniques. However, additive manufacturing is limited by the 3D printing materials possible. Although the list of printable materials is growing, the available materials relevant to orthotic intervention, such as AFOs, are plastics.

[0008] Furthermore, because of the layering technique of most printing technologies, there is an anisotropic effect in printed components with an inability to strengthen the Z axis in most techniques. In contrast, composite materials are the highest performing material in structural measures. Composites have an ability to be strong over long lever arms and can hold memory (deflection return). However, the processing ability for custom one-off shapes in composites is far more challenging and costly than that compared to producing components using digital and additive approaches.

[0009] To overcome these problems, some current orthotic devices are combining composite parts with 3D-printed components. However, these known orthotic devices often utilise rigid connections or permanent adhesives between the components that make disassembly and adjustments challenging. As such, traditional connections between components in orthotic applications, such as AFOs, often lack flexibility for modular adjustments and may even require destructive processes for component removal. Modular designs require a solution that can securely hold components together while allowing for easy assembly, adjustments or replacements.

[0010] Accordingly, in a first aspect of the invention, there is provided an orthotic device comprising a composite component, at least one additive component, and an adhesive tape, wherein the composite component and the at least one additive component are attached together by the adhesive tape.

[0011] Advantageously, the use of an adhesive tape, which may be reversible, in orthotic devices of the invention addresses the above challenges, enabling modularconstruction and customisation of orthotic devices while maintaining structural integrity. With high initial tack, environmental resilience, and compatibility with multiple substrates, the adhesive tape offers an effective solution for modern orthotic device construction. A primary technical challenge is bonding the high-stress composite components (e.g., the strut) with the modular fitting components (e.g., the calf cuff and footplate). This invention uses an adhesive tape designed for orthotic applications, which provides strong, reversible bonding. Key properties of the adhesive tape include durability under flexion. In particular, the adhesive's thickness and shear tolerance allow it to flex and bend with the composite components, maintaining adhesion even under dynamic loading, joint movements and high-stress conditions. Furthermore, the adhesive tape bonding the composite component to the additive component is capable of closed chain kinetic load bearing. As such, the adhesive is a necessary structural component transmitting closed chain biomechanical forces.

[0012] In contrast, bolted fixations used in prior art orthotic devices, require significant engineering and often lead to the modular components being made more complex or the composite part being simplified. Additionally, prior art orthotic devices rely on geometry, mechanical fasteners, or thermoset bonded constructions, and do not address adhesive load transfer under cyclic loading conditions. However, the use of an adhesive tape ensures that the strut can still provide the primary structural integrity of the design, thus allowing the addition of the components to be less onerous and achievable with an adhesive film that maintains reliable bonding. Furthermore, the adhesive interface itself forms part of the load path and enables closed chain force transmission between separable structural components.

[0013] It will be appreciated that the adhesive tape comprises a tacky bonding surface which allows attachment of the composite component to the at least one additive component.

[0014] In some embodiments, the adhesive tape comprises acrylic, and so may be an acrylic adhesive tape.

[0015] In some embodiments, the adhesive tape may comprise at least 80%, at least 85%, at least 90%, or at least 95% acrylic. In other embodiments, the adhesive tape may comprise at least 96%, at least 97%, at least 98%, or at least 99% acrylic. In some embodiments, the adhesive tape is pure acrylic adhesive tape. In other words, the adhesive tape may comprise 100% acrylic.In some embodiments, the adhesive tape is substantially translucent or clear. In other embodiments, the tape may be substantially opaque, for example it may be black.

[0016] In some embodiments, the adhesive tape may be adhesive foam tape. This means that the tape is made from a foam material and comprises spongey, easy-to-shape properties. Advantageously, therefore, the tape comprises flexible properties, and can adhere to uneven or textured surfaces. Accordingly, in some embodiments, the adhesive tape comprises a substrate (e.g., a foam) and first and second sides, wherein one or both sides comprise adhesive thereon.

[0017] In some embodiments, the adhesive tape maintains a substantially viscous nature (i.e., is slow to, or never, cure). Thus, the tape may be substantially viscous or sticky. Advantageously, this stickiness allows flexibility in the join, but also the potential for re-bonding to either the composite component and / or the at least one additive component, if a release occurs. Additionally, the viscous nature of the tape means that time and pressure contribute to a good bond between the composite component and the at least one additive component, and therefore, the bond improves therebetween the more the product is used.

[0018] Typically, the adhesive tape maintains a viscoelastic bond with the additive (i.e. 3D-printed) component, meaning it is both viscous and elastic. This means the tacky surface of the tape can flow slightly into surface irregularities in the additive component to increase the contact area between the tape and the additive component. Accordingly, in some embodiments, the adhesive tape may be substantially elastic.

[0019] Higher energy surfaces are more readily wetted by the adhesive, meaning surfaces, such as smooth composite (as opposed to peel ply composites) have larger surface area for the adhesive to bond to. The same comparison could be made with additive (3D printed) parts. If a relatively rough surface nylon produced by a 3D printer is used, it will not bond as well as if it was first treated with a vapour smoothing method beforehand. Accordingly, in some embodiments, the at least one additive component may be prior treated to smooth its surface before the adhesive tape is attached thereto. For example, in an embodiment, the at least one additive component may be prior treated with a vapour smoothing method before the adhesive tape is attached thereto.There is some chemical bonding between the adhesive and the composite component and / or the at least one additive component of the orthotic device in the form of Van der Waals forces and the bond can be improved with both pressure and contact time.

[0020] In some embodiments, the adhesive tape is double-sided. The tape may comprise double-sided adhesion. In other words, the adhesive (tacky) bonding surface is present on both sides of the adhesive tape. Accordingly, the tape may comprise first and second sides, wherein one or both sides comprise adhesive thereon.

[0021] In some embodiments, the adhesive tape is a pressure-sensitive adhesive. In other words, the adhesive tape requires pressure to be applied for adhesion to take place between the composite component and the at least one additive component.

[0022] Advantageously, the thickness of the adhesive tape tolerates shear forces between the composite and additive parts. Accordingly, in some embodiments, the adhesive tape comprises a thickness of between 0.3 mm and 5 mm, between 0.4 mm and 4.5 mm, between 0.5 mm and 4 mm, between 0.6 mm and 3.5 mm, between 0.7 mm and 3 mm, between 0.8 mm and 2.5 mm, between 0.9 mm and 2 mm, or between 1 mm and < 1.5 mm.

[0023] In some embodiments, the adhesive tape comprises a thickness of between 0.3 mm and 5 mm, between 0.3 mm and 4.5 mm, between 0.3 mm and 4 mm, between 0.3 mm and 3.5 mm, between 0.3 mm and 3 mm, between 0.3 mm and 2.5 mm, between 0.3 mm and 2 mm, or between 0.3 mm and < 1.5 mm.

[0024] In some embodiments, the adhesive tape comprises a thickness of between 0.3 mm and 5 mm, between 0.4 mm and 5 mm, between 0.5 mm and 5 mm, between 0.6 mm and 5 mm, between 0.7 mm and 5 mm, between 0.8 mm and 5 mm, between 0.9 mm and 5 mm, or between 1 mm and 5 mm.

[0025] In some embodiments, the adhesive tape comprises a thickness of at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, or at least 0.9 mm. In some embodiments, the adhesive tape comprises a thickness of at least 1.0 mm, at least 1.1 mm, at least 1.2 mm, at least 1.3 mm, at least 1.4 mm, or at least 1.5 mm.

[0026] In some embodiments, the adhesive tape comprises a thickness of less than 5 mm, less than 4.5 mm, less than 4 mm, less than 3.5 mm, or less than 3 mm. In someembodiments, the adhesive tape comprises a thickness of less than 2.5 mm, less than 2 mm, or less than 1.5 mm.

[0027] In some embodiments, the adhesive tape comprises a thickness of about 1.5 mm. Advantageously, this thickness of the adhesive tape is thick enough to bond well and tolerate torsional and shear loads, while being thin enough as to not interfere with fitting in shoes or compromise the aesthetics of the orthotic device.

[0028] In some embodiments, the adhesive tape is stable over temperature ranges from -40°C to over 100°C. Advantageously, this helps to ensure consistent adhesion in various conditions.

[0029] In some embodiments, the adhesive tape is resistant to solvents and plasticisers. Advantageously, therefore, the adhesive tape is designed to withstand degradation form environmental factors, ensuring durability in real-world use.

[0030] In some embodiments, the adhesive tape is semi-permanent. In some embodiments, the adhesive tape is reversible. Therefore, the component and additive parts of the orthotic device can be disengaged using physical force, or a heat or chemical process to replace the additive shells and / or the strut without damaging the parts.

[0031] Accordingly, in some embodiments, the composite component and the at least one additive component can be disengaged using physical force, heat and / or a chemical process.

[0032] In some embodiments, the composite component and the at least one additive component can be disengaged using physical force. Advantageously, the adhesive tape has a balance of being strong enough for normal use, but weak enough for deliberate de-bonding using force, e.g. by the subject.

[0033] In some embodiments, the composite component and the at least one additive component can be disengaged using heat. This is because the tape disintegrates at heat above 100°C, making it easier to lift off, whereas, the composite component (i.e. strut) can easily withstand heat of 250-300°C, and the additive parts can withstand 150 - 175°C. Advantageously, therefore, this means all of the device can be heated in the oven and demould the parts in a hot condition without harming the original components.Accordingly, in some embodiments, the composite component and the at least one additive component may be disengaged from each other using a heat of at least 100°C, at least 110°C, at least 120°C, at least 130°C, or at least 140°C.

[0034] Advantageously, the adhesive tape forms part of the load path and enables closed chain force transmission between the separate structural components.

[0035] Accordingly, in some embodiments, the adhesive tape is capable of closed chain kinetic load bearing. In some embodiments, the adhesive tape transmits closed chain biomechanical forces.

[0036] The orthotic device may be an upper-limb orthosis, a lower-limb orthosis or a spinal orthosis. The upper limb orthosis may be selected from a group consisting of: a clavicular and shoulder orthosis, an arm orthosis, an elbow orthosis, a forearm-wrist orthosis, a forearm-wrist-thumb orthosis, a forearm-wrist-hand orthosis, a hand orthosis, an upper-extremity orthosis, a wrist hand orthosis (WHO), a finger orthosis (FO), a protective cranial orthosis, and a prosthetic socket for an upper limb. The lower limb orthosis may be selected from a group consisting of: a foot orthosis, an ankle-foot orthosis (AFO), a knee-ankle-foot orthosis (KAFO), a knee orthosis (KO), a hip-knee-ankle-foot orthosis (HKAFO), and a prosthetic socket for a lower limb. The spinal orthosis may be selected from a group consisting of: a cervical spinal orthosis (CO), a thoracic lumbar spinal orthosis (TLSO), and a lumbar orthosis (LO).

[0037] In some embodiments, the orthotic device is a foot orthosis, an ankle-foot orthosis (AFO), a knee-ankle-foot orthosis (KAFO) or a hip-knee-ankle-foot orthosis (HKAFO).

[0038] In a typical embodiment, the orthotic device is an ankle-foot orthosis (AFO).

[0039] The composite component (e.g., a strut) is intended to tolerate the biomechanical loads required to compensate for the biomechanical deficit in a subject of the orthotic device. The additive components (i.e. shells) are intended to hold the subject's limb in position and suspend the limb onto the supportive composite component.

[0040] Accordingly, in one embodiment, the composite component is a component of the orthotic device that tolerates a subject's biomechanical load. In one embodiment, the at least one additive component is a component which supports a subject's limb in place, and / or suspends the subject's limb onto the supportive composite component.It will be appreciated that a composite component is one which comprises composite fibres, such as carbon and high tenacity polyesters. In some embodiments, the composite component comprises carbon fibres, fibreglass, aramid fibres, flax fibres, basalt fibres, dyneema fibres, polyester fibres, or any combination thereof. In some embodiments, the composite component comprises epoxy-based resin systems.

[0041] Typically, the composite component comprises carbon fibres.

[0042] The composite component may be selected from a group consisting of: a strut (e.g., for an AFO), a framework for stiffening a device (e.g., for a spinal orthosis), a protection component (e.g., a shell in a helmet), and a connection point which may be load bearing (e.g., a strut in AFO) or low load bearing (e.g., connections in an upper limb device).

[0043] It will be appreciated that an additive component is one which may be manufactured using a 3D-printing technique, based on individual scans for each subject.

[0044] In some embodiments, the at least one additive component comprises nylon, polypropylene, Acrylonitrile Butadiene Styrene (ABS), Thermoplastic Polyurethane (TPU), Polyether Ether Ketone (PEEK), Polyetherimide (PEI) (such as Ultem), or any combination thereof.

[0045] In some embodiments, the nylon may comprise nylon PA12. Accordingly, in some embodiments, the nylon comprises the formula (I):

[0046]

[0047] In some embodiments, the nylon may comprise nylon PA11. Accordingly, in some embodiments, the nylon comprises the formula (II):

[0048]

[0049] (II).Typically, the at least one additive component comprises nylon comprising the formula (I).

[0050] The polypropylene may comprise the formula (C3He)n. The Acrylonitrile Butadiene Styrene (ABS) may comprise the formula (CsHs-C^e-CaHaN)^ The Polyether Ether Ketone (PEEK) may comprise the formula (Ci9Hi2O3)n. The Polyetherimide (PEI) may comprise the formula (C37H240eN2)n.

[0051] The materials of the additive components may be reinforced versions. Accordingly, in some embodiments, the at least one additive component comprises a reinforced material. In some embodiments, the at least one additive component comprises a glass reinforced material or a continuous fibre reinforced material.

[0052] The at least one additive component may be selected from a group consisting of: a footplate, a calf abutment member, an anterior shell (e.g., on an AFO), a thigh shell (e.g., on a KAFO), an extension that compliments force patterns (e.g., varus or valgus flanges), a prosthetic socket, an upper limb shell, and a spinal shell or spinal segment.

[0053] In some embodiments, the at least one additive component comprises a recess in which the adhesive tape is applied. Accordingly, in some embodiments, the calf abutment member and / or the footplate comprises a recess in which the adhesive tape is applied.

[0054] In some embodiments, the recess comprises a depth which allows for a flush surface when combining the adhesive tape thickness and the expected strut thickness.

[0055] Considering that the adhesive benefits from pressure and contact time, it is useful to consider the biomechanical forces likely to be applied to the device in deciding the location of the adhesive placement.

[0056] In some embodiments, the recess is located on the side of the at least one additive component that best respects the expected force pattern of the orthotic device (encouraging bonding) and that is least clinically risky in the unlikely event of debonding. In the case of a leg brace (AFO), for example, this would mean that the composite strut would be against the anatomy of the posterior calf and the additive part would wrap around the outer side with the adhesive between. However, the opposite would occur at the foot as the additive component would be in contact with the plantar surface of the foot and the adhesive would be recessed in the underside ofthe additive shell allowing adhesion of the composite strut. For example, during the most highly pressurised phase of the gait cycle when the leg moves forward with the foot on the ground, both adhesion points at calf and foot are being forced together.

[0057] In some embodiments, when the orthotic device is an AFO, the adhesive tape is applied under the additive footplate. Accordingly, in an embodiment in which the orthotic device is an AFO, the recess is positioned under the additive footplate. This is because it is away from the plantar surface of the foot.

[0058] In other embodiments, when the orthotic device is an AFO, the adhesive tape is applied to the calf cuff under the shell 'skin' side. It will be appreciated that 'skin' side means the side of the calf cuff that rests against the patient's skin. Accordingly, in some embodiments, when the orthotic device is an AFO, the recess on the calf cuff is positioned under the shell 'skin' side. The reason for this is that most of the force during the gait cycle pushes the bond together.

[0059] Typically, when the orthotic device is an ankle-foot orthosis (AFO), the composite component is a strut, and the at least one additive component is a footplate, a calf abutment member and / or an anterior calf section.

[0060] In some embodiments, the footplate is configured to extend beneath the sole of a foot of a subject. Typically, the footplate comprises a front which extends beneath the toes of the subject, a back which extends beneath the heel of the subject, and two sides which extend between the front and the back.

[0061] In some embodiments, the footplate may be an additive-produced nylon footplate. In some embodiments, the footplate may be an additive-produced nylon PA12, PA11 or TPU footplate.

[0062] In some embodiments, the calf abutment member is for abutting the calf of a subject. In one embodiment, the calf abutment member is configured to extend around the back of the subject's leg. In another embodiment, the calf abutment member is configured to extend around the front of the subject's leg. In other words, the calf abutment member extends around the subject's shin. In this embodiment, the calf abutment member may be a tibia shell (or an anterior shell).In some embodiments, the calf abutment member may be an additive-produced nylon calf abutment member. In some embodiments, the calf abutment member may be an additive-produced nylon PA12, PA11 or TPU calf abutment member.

[0063] In some embodiments, the anterior calf section is for abutting the anterior section of a subject's calf. In some embodiments, the anterior calf section may be an additive-produced nylon anterior calf section. In some embodiments, the anterior calf section may be an additive-produced nylon PA12, PA11 or TPU anterior calf section.

[0064] Typically, the strut extends vertically up the leg and changes direction so that it comes to the underside of the foot. The strut may extend down the medial aspect of the limb, straight down the posterior bisection, or originate from the anterior shin and curve around to insert posterior into the foot. Alternatively, the strut may originate from the anterior shin. Alternatively, the strut may originate form the calf and extend down around the lateral posterior lateral malleoli and into the plantar surface of the foot.

[0065] In some embodiments, the strut extends between the footplate and the calf abutment member. In one embodiment, the strut is connected to the footplate at a location which is configured to be posterior ( / .e. behind) to the ankle axis of a subject wearing the orthosis. In one embodiment, the strut is connected to the calf abutment member at a location which is configured to be posterior ( / .e. behind) to the knee of a subject wearing the orthosis.

[0066] In another embodiment, the strut is connected to the footplate at a location which is configured to be along one of the two sides of the footplate. In some embodiments, the strut is connected to the footplate at a location which is configured to be along the outer side of the footplate (i.e., when worn by the patient, the outer side of the footplate is the side which would be furthest away from the patient's other foot). In one embodiment, the strut is connected to the calf abutment member at a location which is configured to be anterior (J.e. in front) to the knee of a subject wearing the orthosis.

[0067] In one embodiment, the strut is configured to extend over the back of a leg of the subject. In another embodiment, the strut is configured to extend over the front of the leg of the subject. In another embodiment, the strut is configured to extend over the side and / or front of the leg of the subject.In some embodiments, the strut component comprises carbon fibres, fibreglass, aramid fibres, flax fibres, basalt fibres, dyneema fibres, or any combination thereof. In some embodiments, the strut component comprises epoxy-based resin systems.

[0068] Typically, the strut component comprises carbon fibres.

[0069] In some embodiments, the orthotic device comprises a releasable fastener for fastening the orthosis to a subject (e.g., for fastening the calf abutment member to a leg of the subject). The releasable fastener may comprise a strap or anchor for fastening the orthotic device to a subject. For example, the releasable fastener may comprise a strap for connecting opposite ends of the calf abutment member. Thus, the calf abutment member and the strap may be configured to encircle the calf of the subject, and tightening the strap may fasten the orthosis. The strap may be held in position by means of a Velcro fastener or a hook fastener.

[0070] The adhesive tape enables secure, adjustable assembly of orthotic components, allowing for efficient configuration by orthotists. Its instant adhesion and absence of curing requirements streamline orthotic construction. Additionally, the PSA supports reusability by allowing easy removal and replacement of parts, promoting sustainable practices.

[0071] Accordingly, in a second aspect of the invention, there is provided use of an adhesive tape for assembling an orthotic device comprising a composite component and at least one additive component, wherein the adhesive tape is used to attach the composite component to the at least one additive component.

[0072] In a third aspect of the invention, there is provided a method for assembling an orthotic device comprising a composite component and at least one additive component, the method comprising attaching the composite component to the at least one additive component using an adhesive tape.

[0073] In some embodiments, the use according to the second aspect and the method according to the third aspect are for manufacturing an orthotic device according to the first aspect. It will be appreciated, therefore, that the orthotic device and the adhesive tape of the second and third aspects, may be as defined for the first aspect.

[0074] In some embodiments, the at least one additive component comprises a recess in which the adhesive tape is applied. Accordingly, in some embodiments, the methodcomprises cleaning the recess of the at least one additive component before the adhesive tape is applied thereto, for example with an alcohol-based cleaning solution.

[0075] In some embodiments, the method further comprises applying the adhesive tape to the recess in the at least one additive component.

[0076] In some embodiments, when the orthotic device is an AFO, the method comprises applying the adhesive tape to a surface under the additive footplate. In some embodiments, when the orthotic device is an AFO, the method comprises applying the adhesive tape to a surface of the calf cuff under the shell 'skin' side.

[0077] In some embodiments, the method according to the third aspect further comprises applying pressure to attach the composite component to the at least one additive component using the adhesive tape.

[0078] In some embodiments, the method according to the third aspect further comprises attaching a releasable fastener to the at least one additive component of the orthotic device.

[0079] It will be appreciated that the orthotic device according to the first aspect, will be fitted to and worn by a subject. In one embodiment, therefore, the method according to the third aspect further comprises attaching the orthotic device to a subject.

[0080] In a fourth aspect of the invention, there is provided a method for fitting the orthotic device according to the first aspect to a subject, the method comprising securing the orthotic device to the subject with a releasable fastener.

[0081] In a fifth aspect of the invention, there is provided a method of treating, preventing or ameliorating an orthotic condition in a subject, the method comprising fitting the orthotic device according to the first aspect to the subject.

[0082] In some embodiments, the method according to the fifth aspect comprises securing the orthotic device to the subject with a releasable fastener.

[0083] The orthotic condition may be selected from a group consisting of: gait abnormalities; lower or upper limb neuromuscular deficiencies; and injury.All of the features described herein (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined with any of the above aspects in any combination, except combinations where at least some of such features and / or steps are mutually exclusive.

[0084] For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example, to the accompanying Figures, in which:-

[0085] Figure 1 shows one embodiment of an orthotic device (an ankle foot orthosis (AFO)) according to the invention, comprising a composite component (the strut 1), and additive components (the calf abutment member or anterior calf section 3, and the footplate 2).

[0086] Figure 2 shows one embodiment of the composite component (the strut 1) of the orthotic device only.

[0087] Figure 3 shows the digital representation of the wearer anatomy which is required to produce the additive components of the orthotic device. The anatomical shape (yellow, 4) is insufficient for a final product, and it needs to be digitally modified using a series of standard operating procedures and some interpretation to change the anatomical shape into an appropriate shape for an AFO (peach, 5).

[0088] Figure 4 shows how the digital representation of Figure 3 is then digitally separated into three separate sections: the calf shell 6, the strut tool 8, and the foot shell 7. The three parts, the strut, calf and the foot shell, are then printed using additive technology. The calf and foot shell are printed as definitive components ready for supply to client. The strut component is not definitive, and it is used as a tool for composite manufacturing.

[0089] Figure 5 (A-D) shows the process by which the adhesive tape 9 is used to attach the additive components to the composite component of an orthotic device (an AFO). A) The adhesive tape is applied to the additive components, i.e., the calf cuff 3 and the footplate 2, of the orthotic device. B) The calf cuff 3 is attached to the composite component, i.e., the strut 1, via the adhesive tape. C) The footplate 2 is attached to the strut 1 via the adhesive tape. D) The releasable fastener, i.e., the strap 10, is attached to the calf cuff 3, for fastening the orthosis to a subject.Examples

[0090] The inventors set out to test the use of a reversible adhesive tape in orthotic devices, in order to enable modular construction and customisation in orthotic devices while maintaining structural integrity.

[0091] Construction

[0092] Figure 1 illustrates an exemplary embodiment of an AFO according to the invention, comprising a strut 1 (the composite component), a footplate 2, and a calf-abutment member or anterior calf section 3 (the additive components). Figure 2 illustrates an exemplary embodiment of the composite component (the strut) of the orthotic device only.

[0093] The strut 1 can be made with a combination of different composite materials, such as carbon, glass, aramid, flax, basalt, or dyneema. Epoxy based resin systems may also be used as the strength of epoxy can be superior. This combination allows tuning of stiffness and strength to the biomechanical requirements. The additive components (e.g., the footplate 2 and calf-abutment member 3) may be made of a nylon material.

[0094] The strut 1 is intended to be shaped in a geometric way to improve the yield of material, decreasing cost and easing lamination production skill. However, it is intended to be structured in a way that tolerates the entire biomechanical load of closed and open chain kinematics in gait. Its design mimics the force lines in closed chain kinematics. For example, the strut 1 cannot originate at the calf and insert as the posterior heel, because as the body rolls over the foot, the additive foot shell will need to be primarily responsible for biomechanical load. The minimum requirement for the strut 1 is that it extends vertically up the leg and changes direction so that it comes to the underside of the foot (possibly not the full underside of the foot - heel to toes, but up to the metatarsal heads or midfoot).

[0095] The composite strut 1 is intended to tolerate the biomechanical loads required to compensate for the biomechanical deficit. The additive shells (e.g., the footplate 2 and calf-abutment member 3) are intended to hold the limb in position and suspend the limb onto the supportive composite strut. The strut 1 could be made with other pathways, such as mirrored to come down the medial aspect of the limb, straight down the posterior bisection or originating from the anterior shin and curved around to insert posterior into the foot. The additive shells (e.g., the footplate 2 and calfabutment member 3) are made with allowances / recesses for the strut. These recesses can be on the anatomical or non-anatomical side of the shell.The strut 1 and the shells (e.g., the footplate 2 and calf-abutment member 3) are joined with adhesive film, such as an acrylic foam adhesive film. The film has some thickness, for example between 0.5mm to 3mm, as this thickness is required to tolerate the shear forces between the parts. The adhesive film is intended to be semipermanent, with the potential ability to disengage using a heat or chemical process to replace the additive shells and / or strut without damaging the parts. Mountings such as strap loops or anchors for fastening dials can be incorporated into the additive shells.

[0096] Manufacturing Method

[0097] Digital Design

[0098] The production of the orthotic device according to the invention starts with a digital representation of the wearer anatomy, as shown in Figure 3. The anatomical shape (yellow, 4) is insufficient for a final product, and it needs to be digitally modified using a series of standard operating procedures and some interpretation to change the anatomical shape into an appropriate shape for an AFO (peach, 5).

[0099] The corrected model is then digitally separated into three separate sections, as shown in Figure 4.

[0100] 1. Calf shell (6)

[0101] 2. Strut tool (8)

[0102] 3. Foot shell (7)

[0103] (Potential accessory parts such as anterior shin or foot inlays can be also be produced.)

[0104] This is produced using software which requires a technician to identify anatomical and product landmarks, but it is otherwise programmed to be automatic and repeatable.

[0105] Additive Manufacture

[0106] The three parts, strut 8, calf 6 and the foot shell 7, are then printed using additive technology, such as HP multijet fusion. The calf and foot shell are printed as definitive components ready for supply to client. The strut component is not definitive, and is a tool to be used for composite manufacturing.

[0107] Assembly

[0108] Figure 5 (A-D) shows an example of the adhesive tape 9 being applied to the additive components of an orthotic device (an AFO), such that they can be attached to the composite component.The recess in the calf and foot shell is first cleaned with an alcohol-based cleaning solution. The recess in the calf and foot shell has an acrylic based adhesive film applied. The composite strut is then positioned to fit congruently within these matched segments. Pressure is applied to consolidate the bond. Necessary straps and suspension mechanism to hold the orthotic device onto the limb are applied to the shells.

[0109] After this, the adhesive tape 9 is applied to the additive components, i.e., the calf cuff 3 and the footplate 2, of the orthotic device (A). Then, the calf cuff 3 is attached to the composite component, i.e., the strut 1, via the adhesive tape (B). The footplate 2 is then attached to the strut 1 via the adhesive tape (C). Finally, the releasable fastener, i.e., the strap 10, is attached to the calf cuff 3, for fastening the orthosis to a subject (D).

[0110] Example AFO

[0111] The AFO may be a custom produced device, consisting of:

[0112] An additive produced nylon PA12, PA11 or TPU foot section - or combination. An additive produced nylon PA12, PA11 or TPU calf section - or combination. Potentially an additive produced PA12, PA11 or TPU anterior calf section.

[0113] (Bivalve onto posterior or independent)

[0114] Composite fiber strut that originates from the calf down around the lateral posterior lateral malleoli and into the plantar surface of the foot.

[0115] Conclusions

[0116] The inventor has demonstrated that the use of a reversible adhesive tape in orthotic devices advantageously enables modular construction and customisation, while maintaining structural integrity. With high initial tack, environmental resilience, and compatibility with multiple substrates, it offers an effective solution for modern orthotic device construction. Key properties of the adhesive tape include durability under flexion. In particular, the adhesive's thickness and shear tolerance allow it to flex and bend with the composite components, maintaining adhesion even under dynamic loading, joint movements and high-stress conditions.

Claims

Claims1. An orthotic device comprising a composite component, at least one additive component, and an adhesive tape, wherein the composite component and the at least one additive component are attached together by the adhesive tape.

2. The orthotic device according to claim 1, wherein the adhesive tape is an acrylic adhesive tape.

3. The orthotic device according to claim 1 or claim 2, wherein the adhesive tape is double-sided.

4. The orthotic device according to any preceding claim, wherein the adhesive tape comprises a thickness of between 0.3 mm and 5 mm, between 0.4 mm and 4.5 mm, between 0.5 mm and 4 mm, between 0.6 mm and 3.5 mm, between 0.7 mm and 3 mm, between 0.8 mm and 2.5 mm, between 0.9 mm and 2 mm, or between 1 mm and < 1.5 mm.

5. The orthotic device according to any preceding claim, wherein the adhesive tape comprises a thickness of at least 0.3 mm, at least 0.4 mm, at least 0.5 mm, at least 0.6 mm, at least 0.7 mm, at least 0.8 mm, or at least 0.9 mm.

6. The orthotic device according to any preceding claim, wherein the adhesive tape comprises a thickness of at least 1.0 mm, at least 1.1 mm, at least 1.2 mm, at least 1.3 mm, at least 1.4 mm, or at least 1.5 mm.

7. The orthotic device according to any preceding claim, wherein the adhesive tape comprises a thickness of less than 5 mm, less than 4.5 mm, less than 4 mm, less than 3.5 mm, or less than 3 mm.

8. The orthotic device according to any preceding claim, wherein the adhesive tape comprises a thickness of about 1.5 mm.

9. The orthotic device according to any preceding claim, wherein the adhesive tape is semi-permanent.

10. The orthotic device according to any preceding claim, wherein the composite component and the at least one additive component can be disengaged using physical force, heat and / or a chemical process.

11. The orthotic device according to any preceding claim, wherein the composite component and the at least one additive component can be disengaged using a heat of at least 100°C, at least 110°C, at least 120°C, at least 130°C, or at least 140°C.

12. The orthotic device according to any preceding claim, wherein the orthotic device is an upper-limb orthosis, a lower-limb orthosis, or a spinal orthosis, optionally wherein:(i) the upper limb orthosis is selected from the group consisting of: a clavicular and shoulder orthosis, an arm orthosis, an elbow orthosis, a forearm-wrist orthosis, a forearm-wrist-thumb orthosis, a forearm-wrist-hand orthosis, a hand orthosis, an upper-extremity orthosis, a wrist hand orthosis (WHO), a finger orthosis (FO), a protective cranial orthosis, and a prosthetic socket for an upper limb;(ii) the lower limb orthosis is selected from the group consisting of: a foot orthosis, an ankle-foot orthosis (AFO), a knee-ankle-foot orthosis (KAFO), a knee orthosis (KO), a hip-knee-ankle-foot orthosis (HKAFO), and a prosthetic socket for a lower limb; and / or(iii) the spinal orthosis is selected from the group consisting of: a cervical spinal orthosis (CO), a thoracic lumbar spinal orthosis (TLSO), and a lumbar orthosis (LO).

13. The orthotic device according to any preceding claim, wherein the orthotic device is an ankle-foot orthosis (AFO).

14. The orthotic device according to any preceding claim, wherein the composite component comprises carbon fibres, fibreglass, aramid fibres, flax fibres, basalt fibres, dyneema fibres, polyester fibres, or any combination thereof.

15. The orthotic device according to any preceding claim, wherein the composite component is selected from the group consisting of: a strut, a framework for stiffening a device, a protection component, and a connection point which may be load bearing or low load bearing.

16. The orthotic device according to any preceding claim, wherein the at least one additive component comprises nylon, polypropylene, Acrylonitrile Butadiene Styrene(ABS), Thermoplastic Polyurethane (TPU), Polyether Ether Ketone (PEEK), Polyetherimide (PEI), or any combination thereof.

17. The orthotic device according to any preceding claim, wherein the at least one additive component is selected from the group consisting of: a footplate, a calf abutment member, an anterior shell, a thigh shell, an extension that compliments force patterns, a varus or valgus flange, a prosthetic socket, an upper limb shell, and a spinal shell or spinal segment.

18. The orthotic device according to any preceding claim, wherein the at least one additive component comprises a recess in which the adhesive tape is applied.

19. The orthotic device according to any preceding claim, wherein the orthotic device is an ankle-foot orthosis (AFO), the composite component is a strut, and the at least one additive component is a footplate, a calf abutment member and / or an anterior calf section.

20. Use of an adhesive tape for assembling an orthotic device comprising a composite component and at least one additive component, wherein the adhesive tape is used to attach the composite component to the at least one additive component.

21. A method for assembling an orthotic device comprising a composite component and at least one additive component, the method comprising attaching the composite component to the at least one additive component using an adhesive tape.

22. A method for fitting the orthotic device according to any one of claims 1 to 19 to a subject, the method comprising securing the orthotic device to the subject with a releasable fastener.

23. A method of treating, preventing or ameliorating an orthotic condition in a subject, the method comprising fitting the orthotic device according to any one of claims 1 to 19 to the subject.

24. The method according to claim 24, wherein the orthotic condition is selected from a group consisting of: gait abnormalities; lower or upper limb neuromuscular deficiencies; and injury.

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