A compostable orthopedic splint assembly for quick application

Abstract

The present invention discloses a compostable orthopedic splint assembly (100) comprising a pre-fabricated shaped component (101) further comprising a hexagonal hole (102) pattern, and a fastener to secure the pre-fabricated component (101) onto the injured part of a user. The splint assembly (100) is constructed based on the principle of thermoforming, wherein the shape of the material is altered upon application of heat through hot water or a heat gun and is molded to the injured part of the user. The hexagonal hole pattern (102) ensures optimum breathability. The pre-fabricated shaped component (101) is constructed from a blend of polylactic acid and an impact modifier, wherein the splint assembly (100) is heated, softened and subsequently molded to the injured part of the user, wherein the splint assembly (100) has the ability to be reheated and remolded multiple times.

Description

TITLE OF THE INVENTIONA compostable orthopedic splint assembly for quick applicationPRIORITY CLAIM:

[0001] This application claims priority from the provisional application numbered 202441048230 filed with Indian Patent Office, Chennai on 24thAugust 2024 entitled “d compostable orthopedic splint assembly for quick application'’'’, the entirety of which is expressly incorporated herein by reference.PREAMBLE TO THE DESCRIPTION:

[0002] The following specification particularly describes the invention, and the manner in which it is to be performed:DESCRIPTION OF THE INVENTIONTechnical field of the invention

[0003] The present invention generally relates to orthopedic splint assemblies, and more particularly to quick application orthopedic splint assemblies using a compostable material.Background of the invention

[0004] Orthopedic splinting is a technique used in orthopedic medicine to immobilize and support injured limbs or joints. Splinting is often employed in the initial management of fractures, sprains, strains, and other musculoskeletal injuries to prevent further damage, reduce pain, and promote healing. Further, splinting creates support, protection and immobilization of an injured or affected limb, at the time of injury, post-operative or in rehabilitation.

[0005] Splints provide support to injured bones, muscles, and ligaments, reducing pain and promoting healing. By stabilizing the injured area, splints help maintainproper alignment, which is crucial for optimal healing of fractures and other injuries. The orthopedic splints are designed in various forms, including pre-formed splints, custom-made splints, and improvised splints made from readily available materials such as cardboard, foam padding, or aluminum strips.

[0006] Splints are constructed from a variety of materials, including plaster of Paris, fiberglass, thermoplastic materials, and metal, where the Plaster of Paris (POP) and fiberglass are commonly used for casting, while thermoplastic materials (such as polyethylene or polypropylene) are often used for removable splints due to their lightweight, moldability, and ease of application, and off-the-shelf splints that are readily available at the pharmacies.

[0007] The Patent Application No. W02023006987A1 entitled "Method and system for manufacturing an orthopaedic splint and orthopaedic splint thereof The invention relates to a method for manufacturing an orthopaedic splint, wherein the splint is made up of two non-identical foam shells made of plastic, the two shells extending substantially longitudinally and being intended to be wrapped around a patient's limb, the shells being connected to one another by a plurality of attachments, wherein the method comprises a subsequent step of thermoforming the two shells during which the two shells are put in place around the patient's limb and at least one portion of at least one of the two shells is heated at a temperature of between 40°C and 70°C in a way that the shape of the portion is modified strictly within the circumferential limits of the two shells.

[0008] The Patent Application No. IN2021050119W entitled “Fabrication of 3D- printed fracture-specific orthopaedic cast' wherein a method of fabricating a personalized orthopaedic cast is disclosed. The method includes 3D scanning of a body part of a user, generating a Computer Aided Design (CAD) of an orthopaedic cast for the scanned body part, and simulating real-life conditions to determine mechanical stability of the modelled cast. The mechanical stability is determined through Finite Element Analysis (FEA). The method includes determining whether the mechanical stability of the modelled cast is acceptable. The method includes finalizing the CAD model when the mechanical stability of the modelled cast isfound to be acceptable. The method includes 3D printing the finalized CAD model to fabricate the personalized orthopedic cast.

[0009] The drawbacks of the existing system includes that the casts made from Plaster of Paris (POP), synthetic casts and slabs include time consuming, requiring reapplication from time to time, extreme discomfort while wearing the splint including rashes, itching, sweating etc., heavy and cumbersome, and not adaptable to readjustment. Further, the thermoplastic splints show several drawbacks including need for measuring a section, cutting it and molding it to the patient followed by fabrication of straps, less durable and limited shelf life of the thermoplastic sheets, restricted mouldability, and are highly expensive.

[0010] In order to overcome the drawbacks of the existing systems, there is a need for a compostable orthopedic splint assembly constructed using a biodegradable resin that can be easily applied to a user, through application of heat.Summary of the Invention

[0011] The present invention overcomes the drawbacks of the existing orthopedic splints to provide a compostable orthopedic splint assembly comprising a prefabricated shaped component constructed from a compostable material containing polylactic acid and an impact modifier. The orthopedic splint assembly further comprises a fastener to secure the pre-fabricated component onto the injured part of the user. The pre-fabricated shaped component comprises a hexagonal hole pattern, wherein the hexagonal holes are located at an angle of 120 degrees, to ensure optimum breathability for the user wearing the splint assembly. The prefabricated shaped component of the splint assembly is constructed using a compostable material, i.e., polylactic acid (PLA) at a concentration of 75% w / w - 98% w / w, and the impact modifier at a concentration of 2% w / w to 30% w / w, wherein the impact modifier is methyl methacrylate-butadiene-styrene core shell modifier (MBS core shell), and ethylene terpolymer.

[0012] Further, the orthopedic splint assembly is constructed based on the principle of thermoforming, wherein the shape of the material is altered upon application of heat and is molded to the injured part of the user. The splint assembly is created inpre-fabricated shapes, wherein the prefabricated shaped component is adaptable to be molded to any size. The orthopedic splint assembly has the ability to be reheated and remolded at least 15 times, according to an embodiment of the invention. The re-moldable property of polylactic acid (PLA) facilitates the pre-fabricated shaped component to be heated between 50° C-80° C in order to be remolded at least one time, thus modifying the splint assembly to fit the user.

[0013] According to the invention, the hexagonal hole pattern facilitates formation of the regular triaxial lattice pattern on the pre-fabricated shaped component, wherein the spacing between the two consecutive hexagons form a 120-degree beam network. The formation of the 120-degree beam network facilitates maintenance of the structural stability of the pre-fabricated shaped component through a network of interconnected beams, further promoting flexibility in molding. Additionally, the use of hexagonal-hole pattern provides flexibility to the lattice, thus enabling the easy flexing of the pre-fabricated shaped component when securing the orthopedic splint assembly to the affected body part of the user. Additionally, the orthopedic splint assembly is ambidextrous in nature, wherein the orthopedic splint assembly is adaptable to be used on both left and right hand of the user. Further, the orthopedic splint assembly is used as a rigid splint or a temporary slab for pre-operative care or post-operative care.

[0014] There are several advantages of the present invention. The orthopedic assembly is lightweight and uses less material for construction. The hexagonal hole pattern facilitates reduction material use and the weight of the assembly, thus enhancing the user comfort. The assembly is constructed from industrially compostable and biocompatible polylactic acid (PLA) with impact modifiers, thus supporting sustainability and environmental safety. Further, the assembly is durable and re-moldable up to 15 times, offering a longer shelf life than traditional thermoplastic splints.

[0015] Additionally, the splint assembly is versatile in nature and is applicable in various healthcare settings, including tertiary care and field hospitals. Further, the assembly is cost-efficient and highly accessible. Further, the assembly is suitablefor various splint types such as cock-up, thumb spica, volar block, ulnar gutter, dorsal block, stack splint, mallet splint, and others.Brief description of the drawings

[0016] The foregoing and other features of embodiments will become more apparent from the following detailed description of embodiments when read in conjunction with the accompanying drawings. In the drawings, like reference numerals refer to like elements.

[0017] Figure 1 illustrates the top view of the orthopedic splint assembly, disclosing cock up splint assembly.

[0018] Figure 2 illustrates the top view of the orthopedic splint assembly, disclosing thumb spica splint assembly.

[0019] Figure 3 illustrates the isometric view of the fastener of the orthopedic splint assembly, according to an embodiment of the invention.

[0020] Figure 4 illustrates the hexagonal pattern in the pre-fabricated component of the orthopedic splint assembly.

[0021] Figure 5 illustrates the tabular representation of the impact of the hexagonal pattern on the weight reduction of the orthopedic splint assembly, according to an embodiment of the invention.

[0022] Figure 6A and Figure 6B illustrates the graphical representation of the strength analysis of the injection molded orthopedic splint assembly, and the thermoplastic splint respectively, according to an embodiment of the invention.

[0023] Figure 7 illustrates a graphical representation of flexural strength of the orthopedic splint assembly.

[0024] Figure 8 illustrates the isometric view of stacked orthopedic splint assembly, according to an embodiment of the invention.

[0025] Figure 9 illustrates the front view of the orthopedic splint assembly, assembled to the hands of a user, according to an embodiment of the invention.Detailed description of the invention:

[0026] Reference will now be made in detail to the description of the present subject matter. Various changes and modifications obvious to one skilled in the art to which the invention pertains are deemed to be within the spirit, scope and contemplation of the invention.

[0027] Referring to drawings and initially to Figures 1 and 2, the top view of the orthopedic splint assembly is disclosed, wherein the orthopedic splint assembly is constructed using a compostable material.

[0028] According to the preferred embodiment of the invention, the orthopedic splint assembly (100) is used in various forms including, but not limited to cock up splint assembly and thumb spica splint assembly. The orthopedic splint assembly (100) comprising a pre-fabricated shaped component (101) of the compostable material and a fastener (not pictured) to secure the pre-fabricated component (101) onto the injured part of the user. The pre-fabricated shapes and the thickness of the orthopedic splint assembly (100) ensures quick and easy molding with maximum strength. According to an embodiment of the invention, the thickness of the prefabricated shaped component (101) is 3 mm. Further, a Velcro strap is used as the fastener to facilitate fastening of the splint assembly (100) to the user.

[0029] Further, the splint assembly (100) is constructed based on the principle of thermoforming, wherein the shape of the material is altered upon application of heat and is molded to the injured part of the user. According to the invention, the application of heat is performed through hot water or a heat gun. The splint assembly (100) is created in pre-fabricated shapes, wherein the prefabricated shaped component (101) is adaptable to be molded to any size. Additionally, the splint assembly (100) comprises a hexagonal hole (102) pattern in order to ensure optimum breathability for the user wearing the splint assembly (100).

[0030] According to the preferred embodiment of the present invention, the prefabricated shaped component of the splint assembly (100) is constructed using a compostable material, i.e., polylactic acid (PLA) at a concentration of 75%-98% w / w, wherein polylactic acid has a molding temperature of 60°C-100°C and possesses the ability to be molded using three-dimensional (3D) printing and / or injection molding. Further, the polylactic acid is combined with an impact modifier at a concentration of 2% to 30% w / w, wherein the impact modifier is methyl methacrylate-butadiene-styrene core shell modifier (MBS core shell), and ethylene terpolymer, according to an embodiment of the invention.

[0031] According to an embodiment of the invention, the blending of polylactic acid (PLA) with the impact modifier such as methyl methacrylate-butadiene- styrene core shell modifier (MBS core shell), and ethylene terpolymer facilitates creation of a tough and durable material, reducing the brittleness of the polylactic acid. The impact modifier, methyl methacrylate-butadiene-styrene core shell modifier (MBS core shell) disperses in the polylactic acid into nanoscale or microscale particles, preventing the crack initiation and propagation in the orthopedic splint assembly (100). The impact modifiers facilitate significant improvement in impact strength of the orthopedic splint assembly (100). Further, due to the presence of the impact modifier with the polylactic acid, the stiffness of the material during application of the orthopedic splint assembly (100) is reduced.

[0032] According to the invention, blending polylactic acid with the impact modifiers such as methyl methacrylate-butadiene-styrene core shell modifier (MBS core shell) and ethylene terpolymer facilitates creation of a composite with improved mechanical toughness. The methyl methacrylate-butadiene-styrene (MBS) particles facilitate absorption of the impact energy of the orthopedic splint assembly (100), and the ethylene terpolymer provides ductility and compatibility, resulting in the durability, processibility and applicability of the polylactic acid (PLA) material.

[0033] The orthopedic splint assembly (100) is constructed using three- dimensional (3D) printing or injection molding, wherein in the three-dimensional (3D) printing process, the filament of polylactic acid with impact modifiers issubjected to a three-dimensional (3D) printer, facilitating creation of the splint assembly (100) based on the design input provided to the three-dimensional (3D) printing machine through the geometric codes (G-Codes). Additionally, in the injection molding process, a specific mold for the specific shape of the splint assembly (100) is created, wherein the polylactic acid pellets are heated, melted, and injected into the mold to create the splint assembly (100).

[0034] Further, the polylactic acid material is a bioplastic, and hence is highly sustainable and industrially compostable. The polylactic acid material has a setting time of 30-60 seconds and has the ability to quickly mold to fit the shape of the injured part of the user. Additionally, the pre-fabricated shaped component (101) of the splint assembly (100) is flat shaped, and upon heating, it softens and subsequently it is molded to the injured part of the user.

[0035] The orthopedic splint assembly (100) has the ability to be reheated and remolded at least 15 times, according to an embodiment of the invention. The remoldable property of polylactic acid (PLA) facilitates the pre-fabricated shaped component (101) to be heated between 50° C-80° C in order to be remolded at least one time, thus modifying the splint assembly to fit the user. According to an embodiment of the invention, the orthopedic splint assembly (100) is used as a slab, wherein it facilitates high support in post-operative slabbing. Further, the splint assembly (100) is radiolucent, wherein the splint assembly is compatible with X- ray scanning, computerized tomography (CT) and magnetic resonance imaging (MRI) scanning procedures without damaging or degrading the material.

[0036] Figure 3 illustrates the isometric view of the fastener of the orthopedic splint assembly, according to an embodiment of the invention. With reference to Figure 3, the fastener (103) comprises a buckle (104), a base (105) from the fastener (103), a loop (106) and a hook (107), wherein the buckle (104) three- dimensional (3D) printed with the poly lactic acid (PLA). The base (105) holds the loop (106) and the buckle (104) together, wherein the hook (107) attaches to the loop (106) facilitating secure attachment, that is detached by pulling the hook (107) and the loop (106) apart in peeling motion.

[0037] Figure 4 illustrates the hexagonal hole pattern in the pre-fabricated component of the orthopedic splint assembly. With reference to Figure 4, the hexagonal hole (102) pattern facilitates formation of the regular lattice pattern on the pre-fabricated shaped component (101), wherein the spacing between the two consecutive hexagons form a 120-degree beam network. The formation of the 120- degree beam network facilitates maintenance of the structural stability of the prefabricated shaped component (101) through a network of interconnected beams, further promoting flexibility in molding. Additionally, the use of hexagonal -hole (102) pattern provides flexibility to the lattice, thus enabling the easy flexing of the pre-fabricated shaped component (101) when securing the orthopedic splint assembly to the affected body part of the user.

[0038] Further, the use of three-dimensional (3D) printing for printing the hexagonal hole (102) pattern lattice structures in the pre-fabricated shaped component (101) provides enhanced structural stability due to their geometric configuration. In comparison to the quadrilateral network, the hexagonal hole (102) pattern features longer filament paths at each junction, facilitating efficient distribution of the forces across the network. Additionally, each hexagonal hole (102) comprises of three stress points experiencing minimal stress, wherein each hexagonal hole (102) connects to three neighboring filaments, reducing the number of stress concentration points relative to quadrilateral configurations.

[0039] Additionally, the hexagonal hole (102) pattern displays triaxial load distribution, that minimizes the localized stress and enhances the overall durability under multiaxial loading conditions, thus rendering the hexagonal hole (102) pattern highly advantageous for the applications requiring high strength-to-weight ratio. Additionally, the material between the hexagonal holes (102) providing structural stability and also promotes molding, as the flexibility of the heated polylactic acid is enhanced through linearized bending stresses.

[0040] The present invention is described in detail through the following examples, which are provided for illustrative purposes only and should not be construed as limiting the scope of the invention in any manner.Example 1: Assessment of the impact of the hexagonal hole pattern on the weight reduction of the orthopedic splint assembly.

[0041] According to an embodiment of the invention, the hexagonal hole (102) pattern in the pre-fabricated shaped component (101) facilitates reduction in the material usage required for production of the orthopedic splint assembly (100). The hexagonal hole (102) pattern further facilitates reduction in the weight of the in the orthopedic splint assembly (100). According to an embodiment of the invention, the pre-fabricated shaped component (101) is three-dimension (3D) printed into cock-up splint, stack splint, ulnar gutter splint, dorsal block splint, volar block splint and thumb spica.

[0042] The cock-up splint is used for immobilization of the wrist while allowing finger movement, wherein the cock-up splint is used in cases of carpal tunnel syndrome, wrist sprains, rheumatoid arthritis, radial nerve palsy etc. Further, the stack splint facilitates immobilization of the distal interphalangeal (DIP) joint, that is specifically used for mallet finger injuries. The ulnar gutter splint facilitates immobilization of the 4thand 5thfingers and ulnar side of the hand, wherein the ulnar gutter splint is used for the affected part in the 4thand 5thmetacarpal s and phalangeal fractures.

[0043] Further, the dorsal block splint assembly prevents extension of the fingers and wrist, and is used for flexor tendon repair. The volar block splint prevents the wrist and finger flexion, and is used for extensor tendon injuries. Further, the thumb spica splint facilitates immobilization of the thumb and the wrist, wherein the thumb spica splint is used for scaphoid fractures, thumb ligament injuries etc.

[0044] With reference to Figure 5, the cock-up splint assembly displayed an average of 18.43% reduction in weight of the splint assembly due to the hexagonal pattern. Further, the stack splint displayed an average of 13.12% reduction in the weight, whereas the ulnar gutter splint displayed an average of 31.17%. Additionally, the dorsal block splint, the bolar block splint and the thumb spica splint displayed average reduction in weight by 27.41%, 43.12% and 21.36% respectively.

[0045] According to the invention, it is determined that the reduction in the material volume required to construct the orthopedic splint assembly (100) results in a thermal response characterized by approximately 25% faster heating during the application. The accelerated thermal conduction facilitates efficient and rapid thermoforming of the orthopedic splint assembly (100) into the desired anatomical shape, as the reduced thermal mass and thickness contribute to the enhanced heat transfer rate.Example 2: Determination of the strength of the orthopedic splint assembly in comparison with a thermoplastic splint.

[0046] The strength of the orthopedic splint assembly (100) was determined by a bending test, wherein the per-fabricated shaped components (101) was subjected to force. Figure 6A and Figure 6B illustrates the graphical representation of the strength analysis of the injection molded orthopedic splint assembly, and the thermoplastic splint respectively, according to an embodiment of the invention.

[0047] With reference to Figure 6A, the injection molded cock-up splint displayed that the material of the pre-fabricated shaped component (101) was elastic and had a distinct upper and lower yield points, wherein the upper yield point was found to be at 130N. Further, with reference to Figure 6B, the graphical representation of an existing custom-made thermoplastic splint displayed disintegration twice due to breakage at the clamp point and further deflection to completely break to thermoplastic splint. It was determined that the upper yield point of the prefabricated shaped component (101) of the orthopedic splint assembly (100) was higher with respect to the thermoplastic splint.Example 3: Determination of the flexural strength of the orthopedic splint assembly.

[0048] In order to determine the flexural strength of the orthopedic splint assembly, the three-dimension (3D) printed splint and injection molded splint samples were prepared, wherein the sample 1, sample 3 and sample 5 were printed using a three- dimensional (3D) printer and the sample 2 and sample 4 were prepared from injection molding. The flexural test or the bending test indicated that the sample 1,sample 3 and sample 5 did not disintegrate into pieces, whereas the injection molded samples 2 and 4 deformation on application of force. With reference to Figure 7, it was determined that the maximum flexural load for the sample 1, sample 3 and sample 5 were 84.0 N, 68.3 N and 80.8 N respectively. Whereas, the flexural load of the sample 2 and sample 4 were determined to be 131 N and 10 IN respectively.

[0049] Further, it was determined that the sample 1 and sample 3 displayed a similar curve, wherein the sample 1 was loaded across a continuous cross section and the sample 3 was loaded at a section of the pre-fabricated shaped component (101) where the fastener (103) created a discontinuity in the cross-section, leading to a lower peak force. Further, the sample 4 displayed a section of the deformation in the pre-fabricated shaped component (101) before the disintegration of the complete splint assembly. The sample 2 exhibited good loading conditions with a distinct failure point. The orthogonal splint assembly (100) displayed increased strength due to the hexagonal hole (102) pattern, wherein post injection molding, the orthogonal splint assembly (100) exhibited more than 5 times the flexural strength with respect to a plaster made from gypsum and fibre glass cast assembly.Example 4: Determination of linearized stress on the hexagonal hole pattern for prediction of deformation during molding.

[0050] According to an embodiment of the invention, the pre-fabricated shaped component (101) containing the hexagonal hole (102) pattern, wherein the prefabricated shaped component (101) is molded into a semi-cylindrical (arch) shape and supported at the bottom, and a force is applied to the center of the 120-degree hexagonal network. It was determined that one of the lobes of the hexagonal network is aligned with the X axis to visualize the stress in that direction, wherein the visualization of the variation of the normal stress in the x direction indicated that the stress is majorly present only in the hexagonal lobe aligned with the x-axis. Further, it was observed that linearization of stress across the orthopedic splint assembly (100) facilitates improved thermoformability, and specifically, the redistribution of mechanical stress from localized concentration points to a more uniform stress gradient enables controlled deformation of the splint material duringthe heating phase. The determination of the linearized stress facilitated in enhanced moldability and improved anatomical conformity upon application, thereby optimizing patient fit and comfort.

[0051] Figure 8 illustrates the isometric view of stacked orthopedic splint assembly, according to an embodiment of the invention. According to an embodiment of the invention, each flat and unshaped pre-fabricated shaped components (101) are stacked above one another, facilitating compact packaging and reduction in the shipping volume by 80% in comparison with the pre-molded products.

[0052] The method of use of the orthopedic splint assembly (100) is disclosed, wherein the flat pre-fabricated shaped component (101) is heated using multiple means including, the hot water bath, a heat gun etc., to a temperature in between 60°C to 100°C. Further, upon rendering the pre-fabricated shaped component (101) soft and malleable, it is molded to the affected part of the user to take its shape, thus providing immobilization, support, and protection to the limb. Subsequently, after molding the splint assembly (100), the fastener (103) is fastened to the injured part of the user. Additionally, in case the orthopedic splint assembly (100) is required to be molded for another injured part of the user, the pre-fabricated shaped component (101) is heated again to a temperature in between 60°C to 100°C, and molded to the required injured part of the user to take its shape.

[0053] Figure 9 illustrates the front view of the orthopedic splint assembly, assembled to the hands of a user, according to an embodiment of the invention. With reference to Figure 9, the orthopedic splint assembly (100) displays ambidextrous design, wherein the orthopedic splint assembly (100) is adaptable to be used on both left and right hand of the user, according to an embodiment of the invention. Further, the orthopedic splint assembly (100) is used as a rigid splint or a temporary slab for pre-operative care or post-operative care. According to an embodiment of the invention, the orthopedic splint assembly (100) comprises embedded alignment channels or tactile ridges facilitating anatomical positioning during molding the orthopedic splint assembly (100) onto the affected part of the body of the user.

[0054] There are several advantages of the present invention, such as reduction of weight and material usage of the orthopedic splint assembly (100) due to the hexagonal hole (102) pattern; a light-weight orthopedic splint assembly (100) due to use of lesser material, resulting in a seamless wearing experience. Further, the integrated edge buffers or smooth rims facilitate reduction in the pressure or irritation at skin contact zones, especially for extended wear. Furthermore, the use of industrially compostable poly lactic acid (PLA) facilitates reduction on the environmental impact and enhanced sustainability.

[0055] Further, the use of polylactic acid material as the material of construction, wherein polylactic acid is biocompatible, lightweight, stronger, washable, breathable and highly comfortable. Further, the splint assembly (100) has the ability to be reheated and remolded up to 15 times, and has a longer shelflife in comparison with the thermoplastic sheets. According to the preferred embodiment of the present invention, the splint assembly (100) is quickly applicable to the user, wherein the application time is under 5 minutes. Further, the splint assembly (100) is sweatproof and washable, wherein the polylactic acid material ensures that the perspiration does not affect the quality of the splint assembly (100). Further, the splint assembly (100) is versatile and can be used in different healthcare settings, including tertiary care hospitals and field hospitals.

[0056] Additionally, the splint assembly (100) is cost-effective, thus making it accessible to a wide range of healthcare facilities and patients. Further, the splint assembly (100) is radiolucent, and thus is compatible with medical imaging procedures, including as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) scans. The splint assembly (100) is highly compatible as some materials or devices interfere with imaging equipment or cause artifacts in the images, potentially compromising the diagnostic accuracy. According to an embodiment of the invention, the orthopedic splint assembly (100) has applications including, but not limited to cock up splint, thumb spica splint, volar block splint, ulnar gutter splint, resting hand splint, dorsal block splint, stack splint, boutonniere splint, mallet splint, and bunion splint etc.Reference Numbers

Claims

ClaimsWe Claim:

1. A compostable orthopedic splint assembly, the assembly (100) comprising: a. a pre-fabricated shaped component (101) constructed using a compostable material, the compostable material comprising a blend of polylactic acid and at least one impact modifier selected from methyl methacrylate-butadiene- styrene (MBS) core-shell modifiers, ethylene terpolymer, or a combination thereof, wherein the pre-fabricated shaped component (101) further comprising a plurality of hexagonal holes (102) on the surface; b. a fastener (103) configured to secure the pre-fabricated shaped component (101) on to the injured body part of a user; wherein, the blend of polylactic acid and at least one impact modifier is thermoformable, whereby the thermoformable material of the pre-fabricated shaped component (101) facilitates molding the orthopedic splint assembly (100) into a desired shape on to the injured body part of the user.

2. The assembly (100) as claimed in claim 1 wherein, the concentration of polylactic acid is in the range of 75% w / w to 98% w / w.

3. The assembly (100) as claimed in claim 1 wherein, the concentration of the impact modifier is in the range of 2% w / w to 30% w / w.

4. The assembly (100) as claimed in claim 1 wherein, the thickness of the prefabricated shaped component (101) is 3mm.

5. The assembly (100) as claimed in claim 1 wherein, the hexagonal hole (102) pattern on the pre-fabricated shaped component (101) further comprises a triaxial beam lattice network, wherein a plurality of hexagonal holes (102) is placed at an angle of 120-degrees.

6. The assembly (100) as claimed in claim 1 wherein, each hexagonal hole (102) comprises three stress points experiencing minimal stress, wherein eachhexagonal hole (102) connects to three neighboring beams, facilitating reduction in the number of stress concentration points.

7. The assembly (100) as claimed in claim 1 wherein, the pre-fabricated shaped component (101) is constructed by processing the blend of polylactic acid and at least one impact modifier through three-dimensional (3D) printing or injection molding.

8. The assembly (100) as claimed in claim 1 wherein, the pre-fabricated shaped component (101) is reheated and remolded up to 15 times at a temperature in a range of 50°C to 80°C.

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