Modular bone implant device

Abstract

The present disclosure describes a modular bone implant device, which is artificial bone material for repairing bone defects, comprising a plurality of assembled filling units, each filling unit having a hole and an interlocking mechanism for mutual assembly, after the plurality of filling units are assembled by the interlocking mechanism, each hole forms an internal passage through the bone implant device in at least one direction, the filling units are made of degradable biological material, and the elastic modulus of the filling units is always not less than the elastic modulus of the host bone during the repair period, and the ratio of the two decreases over time. Thus, a modular bone implant device with good structural stiffness, flexible assembly and degradation absorption can be provided.

Description

Technical Field

[0001] This disclosure generally relates to the biomedical engineering industry, and specifically to a modular bone implant device. Background Technology

[0002] In orthopedic surgery, bone repair materials are routinely used to fill bone defects caused by trauma, pathological bone lesions, or surgical resection. The core function of these materials is to provide a scaffold or carrier for osteogenic tissue regeneration, thereby promoting bone healing and restoring the mechanical properties and load-bearing function of the bone structure. Currently, materials available for bone defect repair mainly include: autologous bone, allogeneic bone, xenogeneic bone, metal implants, and synthetic biomaterials.

[0003] Synthetic biomaterials have gained widespread use due to their advantages such as controllable morphology, stable source, and avoidance of secondary surgical damage. Their conventional structural forms can include granular, monolithic, prefabricated structures, and porous scaffold structures. Prefabricated structures are typically created by three-dimensional reconstruction of bone defects using computed tomography (CT) images, followed by personalized fabrication using additive manufacturing (3D printing) technology. These prefabricated structures can adapt well to various bone defect morphologies and possess basic initial mechanical strength, providing a certain degree of mechanical support for the bone repair process.

[0004] However, prefabricated structures still have significant limitations in practical applications. On the one hand, the preparation cycle of such individualized prefabricated structures is relatively long. The preparation process requires device manufacturers to complete patient image data processing, personalized structural design, additive manufacturing, and terminal sterilization in sequence, resulting in poor clinical timeliness and making it difficult to meet the needs of emergency or time-sensitive surgeries. On the other hand, when prefabricated structures are implanted into weight-bearing bone sites (such as the femur and tibia) or other structurally critical bone defects, the prefabricated structures usually cannot provide sufficient temporary mechanical support in the early stages of bone healing, which may lead to the risk of implant breakage, displacement, or repair failure during the healing process. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned situation and aims to provide a modular bone implant device with good structural rigidity, flexible assembly and biodegradability.

[0006] Therefore, this disclosure provides a modular bone implant device, which is an artificial bone material for repairing bone defects. The bone implant device includes a plurality of interconnected filling units. Each filling unit has a channel and an interlocking mechanism for interconnection. After the plurality of filling units are assembled through the interlocking mechanism, each channel forms an internal channel penetrating the bone implant device in at least one direction. The filling units are made of biodegradable biomaterials. The elastic modulus of the filling units is always not lower than the elastic modulus of the host bone during the repair period, and the ratio between the two decreases over time.

[0007] In this disclosure, the filling units are modularly designed and can be easily assembled together to form a bone implant device via an interlocking mechanism. By splicing multiple independent filling units together, the overall shape and volume of the bone implant device can be flexibly adjusted as needed, thereby adapting to different bone defect contours without the need for customized production of the bone implant device. In addition, the interlocking mechanism can improve the overall structural stability of the assembled multiple filling units, thereby suppressing the displacement of the filling units. Furthermore, the channels of each filling unit are interconnected after assembly, forming an internal channel penetrating the bone implant device in at least one direction, thereby creating a continuous fluid flow path, which is beneficial for eliminating blood stasis and promoting the migration of functional cells (such as osteoblasts and stem cells) to the bone defect area to promote bone healing. In addition, since the elastic modulus of the filling units is always not lower than the elastic modulus of the host bone during the repair period, After the bone implant is placed in the defect area of ​​the host bone, it can ensure that the implant bears most of the mechanical load in the early stage when the bone is most vulnerable during healing, thus providing a stable mechanical environment for the initial formation of new bone. Furthermore, while the elastic modulus of the host bone remains unchanged, as the bone itself recovers its strength, the stiffness of the implant decreases due to material degradation, thereby gradually and smoothly transferring the mechanical load from the implant to the new bone, suppressing the stress shielding effect caused by the long-term excessive stiffness of traditional metal implants. In addition, the filling unit is made of biodegradable biomaterials, so that after the implant has fulfilled its mechanical support mission, it is gradually degraded during the regeneration cycle of the host bone, and the degradation products are absorbed by the human body. At the same time, the new bone can grow in along the internal channels of the implant and gradually replace the degraded material, ultimately achieving bone repair at the defect site and suppressing the long-term retention of foreign bodies.

[0008] Additionally, in the bone implant device disclosed herein, optionally, the interlocking mechanism is formed on the surface of the filling unit, and the channel penetrates through the interlocking mechanism. In this case, when multiple filling units are assembled, the channel can be connected to the assembly gap of the interlocking mechanism, thereby constructing a global fluid circulation channel network from the surface to the interior and then to the assembly gap on the bone implant device, further improving the efficiency of bone cell migration and nutrient exchange; furthermore, when multiple filling units are assembled through the interlocking mechanism, it is easy to align and connect the various channels to form internal channels, thereby helping to eliminate the risk of internal channel blockage caused by assembly angle or position deviation.

[0009] Additionally, in the bone implant device disclosed herein, optionally, the filling unit has at least two opposing surfaces, and the number of channels is plurality of multiple channels, with at least two channels penetrating the two opposing surfaces of the filling unit and the interlocking mechanism. An indicator groove is formed on either of the two opposing surfaces of the filling unit, the extending direction of which is perpendicular to the line connecting the openings formed by the two channels on that surface. In this configuration, a specific and fixed positional relationship can be established between the indicator groove, the channels, and the interlocking mechanism, thereby introducing an orientation recognition and error-proofing assembly mechanism for the filling unit. When assembling the individual filling units, they can be spliced ​​in the correct orientation using the indicator groove, preventing channel misalignment or interlocking failure due to incorrect orientation of the filling units.

[0010] Additionally, in the bone implant device disclosed herein, optionally, after the assembly of the plurality of filling units is completed, the orientation and extension direction of each of the indicator grooves are consistent. In this case, it is easy to confirm that the plurality of filling units are assembled in a uniform direction (or posture), which helps to maintain the consistency of the anisotropic mechanical properties of the bone implant device.

[0011] Furthermore, in the bone implant device disclosed herein, optionally, the number of internal channels is multiple, and the bone implant device further includes at least one fixation device configured to be inserted into at least one of the internal channels to structurally reinforce the bone implant device. In this case, the initial structural stiffness and stability of the entire bone implant device can be conveniently improved according to the needs of the application scenario, thereby increasing the flexibility of the bone implant device application.

[0012] Additionally, in the bone implant device disclosed herein, optionally, the interlocking mechanism includes a protruding ridge and an elongated groove configured to mate with the protruding ridge, wherein the filling unit is a polyhedral structure, at least one surface of the polyhedral structure has the protruding ridge and at least another surface has the elongated groove. In this case, the interlocking mechanism provides a surface-contact interlocking method with strong shear resistance and good guidance for the assembly of adjacent filling units, and the mechanical load is transferred through a larger contact surface, thereby improving the overall structural strength of the bone implant device.

[0013] Furthermore, in the bone implant device disclosed herein, optionally, the polyhedral structure is a hexahedral structure, having a first vertex and a second vertex spatially opposite the first vertex. Each of the three adjacent surfaces intersecting the first vertex has a protruding ridge, and each of the three adjacent surfaces intersecting the second vertex has a long groove. In this case, by centrally arranging the interlocking structures on the relevant surfaces of the two spatially opposite vertices, a single filling unit can connect with adjacent filling units in the front-back, left-right, and up-down dimensions, thereby enabling the filling unit to have three-dimensional spatial expansion and assembly capabilities, thus improving the flexibility of the bone implant device in adapting to bone defect areas of different shapes.

[0014] Furthermore, in the bone implant device disclosed herein, optionally, adjacent filling units are effectively assembled in a staggered assembly manner. This staggered assembly means that when adjacent filling units are assembled via the interlocking mechanism, the edges of the adjacent filling units are not aligned, but at least one pair of channels in the adjacent filling units are coaxially aligned. In this case, even if adjacent filling units are assembled in a staggered manner (e.g., halfway through assembly), at least one pair of channels in the adjacent filling units can remain continuous, thereby providing an assembly method with high fault tolerance and ease of operation.

[0015] Additionally, in the bone implant device disclosed herein, optionally, the repair period is from week 1 to week 24 after the bone implant device is implanted into the host. The ratio of the elastic modulus of the filling unit to the elastic modulus of the host bone is greater than 2 in week 1 and less than or equal to 1.2 in week 24. In this case, in the early repair stage (week 1), the elastic modulus of the filling unit is greater than twice the elastic modulus of the host bone, enabling the bone implant device to provide strong mechanical support to the host bone. As time progresses, in the late repair stage (week 24), the elastic modulus of the filling unit is greater than the elastic modulus of the host bone but less than or equal to 1.2 times the elastic modulus of the host bone, causing the elastic modulus of the bone implant device to gradually approach that of the host bone. This allows the mechanical load to be gradually and smoothly transferred from the bone implant device to the newly formed bone, suppressing the stress shielding effect caused by excessive stiffness in traditional metal implants over a long period of time.

[0016] Additionally, in the bone implant device disclosed herein, optionally, the filling unit includes particulate matter, a buffer layer, and a matrix. The buffer layer encapsulates the particulate matter, and the matrix encapsulates the buffer layer. The buffer layer has a first glass transition temperature, which is not higher than normal human body temperature. The matrix has a second glass transition temperature, which is greater than the first glass transition temperature. In this case, because a buffer layer exists between the particulate matter and the matrix, and the glass transition temperature of the buffer layer is not higher than normal human body temperature, when the filling unit is applied to orthopedic clinical treatment, the buffer layer can remain in a rubbery state within the human body. The rubbery buffer layer can release stress concentration caused by the particulate matter and alleviate microcracks, improving the toughness of the composite material. Furthermore, the particulate matter can also suppress the drastic deformation of the rubbery buffer layer under certain stress, thereby suppressing the decrease in composite material strength caused by the addition of the rubbery buffer layer material.

[0017] According to this disclosure, a modular bone implant device with good structural rigidity, flexible assembly, and biodegradability can be provided. Attached Figure Description

[0018] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings.

[0019] Figure 1 This is a schematic diagram illustrating an application scenario of the bone implant device involved in the examples of this disclosure.

[0020] Figure 2 This is a schematic diagram illustrating a first embodiment of the bone implant device according to the examples of this disclosure.

[0021] Figure 3 This is a schematic diagram illustrating a second embodiment of the bone implant device involved in the examples of this disclosure.

[0022] Figure 4 This is a schematic diagram illustrating a third embodiment of the bone implant device involved in the examples of this disclosure.

[0023] Figure 5 This is a schematic diagram showing the overall structure of the first embodiment of the filling unit involved in the examples of this disclosure.

[0024] Figure 6 This is a schematic diagram showing the overall structure of a second embodiment of the filling unit involved in the examples of this disclosure.

[0025] Figure 7 This diagram illustrates the change in elastic modulus of the filling unit and host bone during the repair period, as described in the examples of this disclosure.

[0026] Figure 8 This is a schematic diagram illustrating the constituent materials of the filling unit involved in the example of this disclosure.

[0027] Explanation of reference numerals in the attached figures: A…host skeleton, 1…bone implant device, 10…filling unit, 12…channel, 14…interlocking mechanism, 142…protrusion, 144…long slot, 16…indicator slot, 20…internal channel, 30…fixation device, 102…particulate matter, 104…buffer layer, 106…matrix, P1…first vertex, P2…second vertex. Detailed Implementation

[0028] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this disclosure, and not all embodiments. Based on the embodiments of this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0029] It should be noted that the terms "first," "second," "third," and "fourth," etc., in this disclosure, claims, and the aforementioned drawings are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices. In the following description, the same reference numerals are used for the same parts, and repeated descriptions are omitted. Additionally, the drawings are merely schematic diagrams, and the scale of the dimensions of the parts or the shape of the parts may differ from the actual figures.

[0030] First, let me introduce the relevant terminology used in this disclosure.

[0031] "Elastic modulus" is a physical quantity (usually measured in megapascals) that characterizes a material's ability to resist elastic deformation and reflects the material's stiffness during elastic deformation.

[0032] "Stress shielding" refers to the phenomenon in orthopedic implantation scenarios where the elastic modulus of the implant and the host bone do not match, causing the implant to bear most of the physiological and mechanical load of the bone defect area, resulting in insufficient stress on the host bone in the long term, thus leading to bone loss and bone atrophy.

[0033] The modular bone implant device disclosed herein is assembled from multiple filler units. Each filler unit is a modular, independently designed unit that can be easily assembled with other units via an interlocking mechanism. The channels of each filler unit are interconnected after assembly, forming an internal channel penetrating the bone implant device in at least one direction. Furthermore, the filler units are made of biodegradable biomaterials, and their elastic modulus remains no less than that of the host bone during the repair period. Therefore, a bone implant device with good structural rigidity, flexible assembly, and biodegradability can be provided.

[0034] In some examples, the modular bone implantation device described in this disclosure may be referred to simply as a bone implantation device or implantation device, and sometimes as a bone repair material or bone filler.

[0035] The bone implant device 1 involved in this disclosure will now be described in conjunction with the accompanying drawings.

[0036] Figure 1 This is a schematic diagram illustrating an application scenario of the bone implant device 1 involved in the example of this disclosure. Figure 2 This is a schematic diagram illustrating a first embodiment of the bone implant device 1 according to the examples of this disclosure. Figure 3 This is a schematic diagram illustrating a second embodiment of the bone implant device 1 according to the examples of this disclosure. Figure 4 This is a schematic diagram illustrating a third embodiment of the bone implant device 1 according to the examples of this disclosure.

[0037] In some examples, the bone implant device 1 can be an artificial bone material used to repair bone defects. See specifically... Figure 1 The bone implant device 1 can be a functional implant designed for bone defect repair. It can be constructed to provide temporary mechanical support and maintain the spatial morphology of the defect while creating a suitable biological environment for bone tissue regeneration of the host skeleton A through its own structural strength and material properties.

[0038] See in some examples Figures 2 to 4 The bone implant device 1 may include at least one filling unit 10. The filling unit 10 can be used to fill, repair, and support areas of bone defects.

[0039] See in some examples Figures 2 to 4The bone implant device 1 may include multiple filling units 10, which can be assembled with each other (i.e., adjacent filling units 10 can be spliced ​​together). In other words, the assembly of multiple filling units 10 can constitute the bone implant device 1 to fill, repair, and support bone defect areas. In this case, by splicing multiple independent filling units 10 together, the overall shape and volume of the bone implant device 1 can be flexibly adjusted as needed, thereby adapting to different bone defect contours without the need for customized production of the bone implant device 1.

[0040] Figure 5 This is a schematic diagram showing the overall structure of the first embodiment of the filling unit 10 involved in the example of this disclosure. Figure 6 This is a schematic diagram showing the overall structure of a second embodiment of the filling unit 10 involved in the examples of this disclosure.

[0041] See in some examples Figure 5 or Figure 6 Each filling unit 10 may have an interlocking mechanism 14, which can be used for the mutual assembly of adjacent filling units 10. Furthermore, the interlocking mechanism 14 can also be used to enhance the robustness of the assembly of adjacent filling units 10.

[0042] In some examples, multiple filling units 10 can be assembled with each other via an interlocking mechanism 14. In this case, since the filling units 10 are modular and independently designed, multiple filling units 10 can be conveniently assembled with each other via the interlocking mechanism 14 to form a bone implant device 1. Furthermore, the interlocking mechanism 14 can improve the overall structural stability of the assembled multiple filling units 10, thereby preventing displacement of the filling units 10.

[0043] For example, see Figure 2 Each filling unit 10 can be assembled by cooperating with the interlocking mechanism 14 of another filling unit 10 through its own interlocking mechanism 14.

[0044] See in some examples Figure 5 or Figure 6 Each filling unit 10 may have a channel 12. In some examples, the channel 12 may be used for the flow of bodily fluids. In other examples, the channel 12 may be used for filling bone repair material.

[0045] In some examples, the channel 12 may penetrate the interior of the filling unit 10. For example, the channel 12 may penetrate two opposite surfaces of the filling unit 10.

[0046] See in some examples Figure 5 For each filling unit 10, the number of channels 12 can be multiple ( Figure 5Six of the channels are schematically marked (12).

[0047] In some examples, at least two channels 12 are interconnected inside the filling unit 10. In this case, it is possible to facilitate sufficient and efficient circulation of body fluid inside the filling unit 10, and to increase the contact area between the body fluid and the filling unit 10.

[0048] In some examples, multiple channels 12 may penetrate at least two opposing surfaces of the filling unit 10. See also [reference needed] for some examples. Figure 5 The filling unit 10 can be a polyhedral structure, and each surface of the filling unit 10 can have at least one channel 12 distributed thereon.

[0049] See in some examples Figure 6 The plurality of channels 12 distributed on each surface of the filling unit 10 can be symmetrical about the central axis of the filling unit 10. Figure 5 The diagram schematically shows two channels 12 symmetrically distributed around the central axis of the filling unit 10.

[0050] In some examples, the multiple channels 12 can be an array of through holes arranged in an orderly manner. That is, the multiple channels 12 distributed on the surface of the filling unit 10 can be an array of through holes.

[0051] For example, the multiple channels 12 can be an array of through holes arranged in an orderly manner along a predetermined direction on the surface of the filling unit 10. This facilitates the construction of a regular fluid circulation path, which helps promote the directional migration of bone cells and the uniform delivery of nutrients. Alternatively, the multiple channels 12 can be arranged in an array on the surface of the filling unit 10. This layout not only ensures the uniform distribution of internal stress in the bone implant device 1 but also helps improve the consistency of bone tissue ingrowth.

[0052] See in some examples Figures 2 to 4 After multiple filling units 10 are assembled by interlocking mechanism 14, each channel 12 can be aligned to form a channel (i.e., internal channel 20).

[0053] See in some examples Figures 2 to 4 After the multiple filling units 10 are assembled by the interlocking mechanism 14, each channel 12 can form an internal channel 20 penetrating the bone implant device 1 in at least one direction. In this case, the channels 12 of each filling unit 10 are interconnected after assembly, and an internal channel 20 penetrating the bone implant device 1 can be formed in at least one direction, thereby creating a continuous fluid flow path and promoting bone tissue regeneration.

[0054] Specifically, since at least two opposing surfaces of the filling unit 10 are provided with channels 12, when multiple filling units 10 are assembled through the cooperation between interlocking mechanisms 14, the channels 12 of each filling unit 10 can be aligned and interconnected in multiple directions, thereby forming a three-dimensional interconnected fluid channel inside the bone implant device 1.

[0055] In some examples, the alignment (or alignment) of the channels 12 of adjacent filling units 10 can be used as a criterion for determining whether adjacent filling units 10 have completed assembly. In other words, when the channels 12 of adjacent filling units 10 are coaxially aligned and there is no obvious misalignment, it can be determined that the adjacent filling units 10 have completed effective assembly, thereby ensuring the smooth circulation of subsequent body fluids (such as blood).

[0056] Additionally, in some examples, see Figure 4 Adjacent filling units 10 can also be assembled effectively in a staggered manner. In this case, even if adjacent filling units 10 are assembled in a staggered manner (e.g., assembled to halfway), at least one pair of channels of adjacent filling units 10 can remain connected, thereby providing an assembly method with high fault tolerance and simple operation.

[0057] In some examples, misaligned assembly may refer to the following: when adjacent filling units 10 are assembled by interlocking mechanism 14 (e.g., by embedding ridge 142 into long slot 144), the edges of adjacent filling units 10 are not aligned, but at least one pair of channels 12 in adjacent filling units 10 are coaxially aligned.

[0058] In some examples, the internal channel 20 can be a fluid channel. That is, the internal channel 20 can be used for the circulation of bodily fluids. In this case, blood can circulate within the bone implant device 1, thereby accelerating bone recovery and regeneration. In some examples, the internal channel 20 can be a continuous cylindrical channel. For example, the internal channel 20 can be cylindrical or prismatic.

[0059] In some examples, after the bone implant device 1 is implanted into the bone defect area, the internal channel 20 can have at least one of the following functions: it can drain blood from the defect area, reducing adverse events such as infection caused by blood stasis; it can promote blood flow in the defect area, providing sufficient blood supply for bone repair, transporting nutrients required for bone repair and removing metabolic waste through the blood, thereby promoting bone regeneration; it can increase the contact area between the bone implant device 1 and the blood; it can provide a physical channel for cell migration (that is, functional cells in the blood (such as bone cells) can be directly colonized inside the bone implant device 1 and at the interface of the bone defect through the internal channel 20, thereby promoting bone tissue regeneration).

[0060] In some examples, the internal channel 20 can also be used to fill bone repair materials (such as bone cement or osteogenic drugs).

[0061] See in some examples Figures 2 to 4 For the bone implant device 1, the channels 12 of each filling unit 10 can form an internal channel network penetrating the bone implant device 1 in multiple directions. That is, there can be multiple internal channels 20, and these multiple internal channels 20 can extend in different directions. In some examples, at least two internal channels 20 can be interconnected. In this case, it is possible to facilitate the flow of body fluid in multiple directions within the bone implant device 1 and to promote sufficient and efficient circulation of body fluid within the bone implant device 1. It can also increase the contact area between body fluid and the bone implant device 1, promoting osteogenic healing at the bone defect site. In addition, when some internal channels 20 are blocked, body fluid can also flow through other interconnected paths.

[0062] In some examples, at least two channels 12 are interconnected within the filling unit 10, which allows at least two internal channels 20 to be interconnected. Thus, the interconnection of adjacent channels 12 facilitates the interconnection of internal channels 20 within the bone implant device 1.

[0063] In some examples, a portion of the internal channel 20 can be used for the circulation of body fluids, while another portion of the internal channel 20 can be used to fill other medical devices or medical materials.

[0064] Additionally, in some examples, at least two internal channels 20 may not be interconnected. In this case, some internal channels 20 can be filled with other medical devices or materials to improve the overall structural strength of the bone implant device 1 or promote bone repair efficiency, while other internal channels 20 remain for the flow of bodily fluids to ensure the fluid conduction performance of the bone implant device 1. Furthermore, even if one or more internal channels 20 are blocked, fluid can still be conducted through the other internal channels 20.

[0065] In some examples, the fact that at least two channels 12 are not connected within the filling unit 10 can also prevent at least two internal channels 20 from being connected. This allows for the creation of at least one independent internal channel 20 whose function is unaffected by other connected internal channels 20.

[0066] For example, see Figure 4 The filling unit 10 may have at least two non-communicating channels 12. When adjacent filling units 10 are assembled, at least one independent internal channel 20 can be obtained inside the bone implant device 1.

[0067] See in some examples Figure 3The bone implant device 1 may also include at least one fixation device 30, which can be used to insert into the internal channel 20.

[0068] See in some examples Figure 3 The fixation device 30 can be configured to insert at least one internal channel 20 to structurally reinforce the bone implant device 1. In this case, the initial structural stiffness and stability of the entire bone implant device 1 can be easily improved according to the needs of the application scenario, thereby increasing the flexibility of the application of the bone implant device 1.

[0069] In some examples, the fixing device 30 can form an interference fit with the internal channel 20. That is, after the fixing device 30 is inserted into the internal channel 20, it can form an interference fit with the internal channel 20 to establish a stable mechanical connection between the fixing device 30 and the internal channel 20.

[0070] In some examples, the material of the fixation device 30 may be the same as the material of the filling unit 10. In other examples, the material of the fixation device 30 may be different from the material of the filling unit 10.

[0071] In some examples, the fixation device 30 may be a bone rod (e.g., an absorbable bone rod). However, this disclosure is not limited to this, and in other examples, the fixation device 30 may also be a synthetic material, autologous bone, allogeneic bone, xenogeneic bone, or a high-strength metal rod (e.g., a titanium alloy guidewire).

[0072] See in some examples Figure 5 or Figure 6 The interlocking mechanism 14 can be formed on the surface of the filling unit 10, and the channel 12 can pass through the interlocking mechanism 14. In this case, when multiple filling units 10 are assembled, the channel 12 can be connected to the assembly gap of the interlocking mechanism 14, thereby constructing a global fluid circulation channel network from the surface to the interior and then to the assembly gap on the bone implant device 1, further improving the efficiency of bone cell migration and nutrient exchange.

[0073] See in some examples Figure 5 or Figure 6 The channel 12 can pass through the interlocking mechanism 14 so that the channel 12 is located in the interlocking mechanism 14, thereby establishing a fixed positional relationship between the channel 12 and the interlocking mechanism 14. In this case, when multiple filling units 10 are assembled through the interlocking mechanism 14, it is easy to align and connect the various channels 12 to form an internal channel 20, thereby helping to eliminate the risk of blockage of the internal channel 20 due to assembly angle or position deviation.

[0074] As described above, the filling unit 10 may have multiple channels 12. In some examples, at least one channel 12 may extend through the interlocking mechanism 14 (see...). Figure 6 ).

[0075] In some examples, the channel 12 may not pass through the center of the filling unit 10. In this case, after multiple filling units 10 are assembled to form the bone implant device 1, the influence of the internal channel 20 formed by the channel 12 on the overall strength of the bone implant device 1 can be reduced, which helps to maintain the overall strength of the bone implant device 1.

[0076] See in some examples Figure 5 or Figure 6 The filling unit 10 can be a polyhedral structure, and the surface of the polyhedral structure can be provided with protruding ridges 142 and elongated grooves 144. The protruding ridges 142 and elongated grooves 144 can cooperate with each other (that is, the elongated grooves 144 are configured to cooperate with the protruding ridges 142).

[0077] See in some examples Figure 6 At least one surface of the polyhedral structure may be provided with a protruding ridge 142 and at least one other surface may be provided with a long groove 144. In other words, at least one protruding ridge 142 and at least one long groove 144 may be formed on different surfaces of the polyhedral structure. In this case, adjacent filling units 10 can be assembled in multiple orientations, thereby improving the flexibility of assembling adjacent filling units 10.

[0078] See in some examples Figure 2 The protruding ridge 142 can be interference-fitted with the elongated slot 144. For example, the protruding ridge 142 can be interference-fitted with the elongated slot 144 by embedding it into the slot. In this case, the assembly between adjacent filling units 10 can form a surface contact interlocking method with strong shear resistance and good guidance, thereby improving the robustness of the assembly.

[0079] In some examples, the interference fit between the protruding ridge 142 and the long groove 144 can mean that the cross-sectional shape of the protruding ridge 142 matches the cavity shape of the long groove 144. After the two are fitted together, the relative displacement can be restricted, thereby realizing the mechanical interlocking of adjacent filling units 10.

[0080] See in some examples Figure 2 The interlocking mechanism 14 may include a protruding ridge 142 and a long groove 144. That is, the cooperation of the protruding ridge 142 and the long groove 144 can form the interlocking mechanism 14 of the filling unit 10. Adjacent filling units 10 can be interlocked to complete assembly through the interference fit of the protruding ridge 142 and the long groove 144. In this case, the interlocking mechanism 14 can provide a surface contact interlocking method with strong shear resistance and good guidance for the assembly between adjacent filling units 10. By transmitting mechanical loads through a larger contact surface, the overall structural strength of the bone implant device 1 can be improved.

[0081] See in some examples Figure 2 Adjacent filling units 10 can be stably and precisely assembled by inserting the protrusion 142 into the long slot 144 and sliding in the long slot 144 until their channels 12 are aligned.

[0082] See in some examples Figure 5 or Figure 6 The polyhedral structure can be a hexahedral structure (that is, the filling unit 10 can be a hexahedral structure). In some examples, at least one protruding ridge 142 and at least one elongated groove 144 can be respectively provided on two opposite surfaces of the hexahedral structure.

[0083] In some examples, the two opposite surfaces of the hexahedral structure are provided with the same number of protrusions 142 and slots 144 (in Figure 5 In the example shown, each of the two opposing surfaces is provided with a protruding ridge 142 and a long groove 144. This improves the assembly flexibility and stability of adjacent filling units 10.

[0084] For example, in any set of opposite surfaces of a hexahedral structure, one surface may have 1 to 3 protruding ridges 142, and the other opposite surface may have 1 to 3 long grooves 144, and the spacing between the protruding ridges 142 is the same as the spacing between the long grooves 144.

[0085] See in some examples Figure 5 A hexahedral structure can have a first vertex P1 and a second vertex P2. The second vertex P2 can be spatially opposite to the first vertex P1 (that is, the first vertex P1 and the second vertex P2 are spatially opposite vertices).

[0086] In some examples, the three adjacent surfaces intersecting at the first vertex P1 may each have a protruding ridge 142, and the three adjacent surfaces intersecting at the second vertex P2 may each have a long groove 144. In this case, by arranging the interlocking structures centrally on the relevant surfaces of two spatially opposite vertices, a single filling unit 10 can be connected to adjacent filling units 10 in the front-back, left-right, and up-down dimensions, thereby enabling the filling unit 10 to have a three-dimensional spatial expansion assembly capability, which in turn improves the flexibility of the bone implant device 1 in adapting to bone defect areas of different shapes.

[0087] For example, see Figure 5For the filling unit 10 with a hexahedral structure, the three adjacent surfaces intersecting at the first vertex P1 are the first surface, the second surface, and the third surface, respectively; in addition, the three adjacent surfaces intersecting at the second vertex P2 are the fourth surface, the fifth surface, and the sixth surface, respectively; wherein, the first surface is opposite to the fourth surface, the second surface is opposite to the fifth surface, and the third surface is opposite to the sixth surface; assuming that the first surface has at least one first protrusion 142a, then the fourth surface may have the same number of first long slots 144a; in addition, assuming that the second surface has at least one second protrusion 142b, then the fifth surface may have the same number of second long slots 144b; in addition, assuming that the third surface has at least one third protrusion 142c, then the sixth surface may have the same number of third long slots 144c.

[0088] See in some examples Figure 5 or Figure 6 The protruding ridges 142 and the elongated grooves 144 on the two opposing surfaces of the filling unit 10 extend in the same direction and are parallel to each other. In this case, the parallel arrangement of the protruding ridges 142 and the elongated grooves 144 facilitates the linear guided assembly (or splicing) of adjacent filling units 10, thereby improving the positioning accuracy and shear resistance of the assembly.

[0089] In some examples, the edges of the filling unit 10 can be rounded, and the corners of the filling unit 10 can be rounded. In this case, the circumferential corners of the filling unit 10 can form a smooth surface with a preset radius of curvature, eliminating protrusions or sharp structures such as sharp corners and burrs. This can eliminate problems such as sharp corners of the filling unit 10 scratching or puncturing bone tissue or muscle, and reduce the risk of tissue damage during surgical procedures.

[0090] For example, see Figure 6 For the filling unit 10 with a hexahedral structure, the connection between adjacent surfaces can be made by rounded transition, and the corners of the hexahedral structure can be rounded.

[0091] In some examples, the cross-section of the protruding rib 142 can be trapezoidal. That is, the protruding rib 142 can have a trapezoidal structure with its base facing outward and its top facing inward. In this case, the protruding rib 142 and the elongated groove 144 can form a dovetail tenon-and-mortise fit. Thus, the shape of the protruding rib 142 itself can achieve self-locking in the longitudinal direction, thereby improving the stability of the assembly between adjacent filling units 10.

[0092] In some examples, the edges of the interlocking mechanism 14 can be rounded, and the corners of the interlocking mechanism 14 can be rounded. This makes the assembly of adjacent filling units 10 smoother and easier. For example, see... Figure 6The edge of the protruding ridge 142 can be rounded, and the corners of the protruding ridge 142 can be rounded.

[0093] As described above, at least one channel 12 may penetrate the interlocking mechanism 14. In some examples, the channel 12 penetrating the interlocking mechanism 14 may mean that the channel 12 penetrates the protrusion 142 and the elongated slot 144 on the filling unit 10. Specifically, see Figure 5 or Figure 6 At least one channel 12 can extend from a protrusion 142 (or groove 144) on any surface of the filling unit 10 to a groove 144 (or protrusion 142) on another opposite surface. In this case, the channel 12 can be connected to the assembly gap of the protrusion 142 and the groove 144, thereby constructing a global fluid circulation channel network from the surface to the interior and then to the assembly gap, eliminating dead zones in fluid circulation at the interlocking mechanism 14.

[0094] In some examples, multiple channels 12 may pass through the ridge 142 and the long groove 144 and be arranged along the length of the ridge 142 or the long groove 144.

[0095] For example, see Figure 5 or Figure 6 The filling unit 10 has a hexahedral structure, and each surface can have two channels 12. For a surface with at least one protrusion 142, the two channels 12 can be arranged along the length of the protrusion 142. In addition, on another opposite surface with at least one long groove 144, the two channels 12 can be arranged along the length of the long groove 144.

[0096] As described above, the filling unit 10 may have at least two opposing surfaces, and at least two channels 12 may penetrate the two opposing surfaces of the filling unit 10 and the interlocking mechanism 14.

[0097] See in some examples Figure 5 or Figure 6 An indicator groove 16 can be formed on either of the two opposing surfaces of the filling unit 10. The indicator groove 16 can be used to indicate the spatial orientation (i.e., attitude) of the filling unit 10.

[0098] See in some examples Figure 5 or Figure 6The channel 12 can be located in the interlocking mechanism 14, and the indicator groove 16 can also be located in the interlocking mechanism 14, with a fixed positional relationship to the channel 12. In this case, the indicator groove 16 can simultaneously establish a fixed positional relationship with the channel 12 and the interlocking mechanism 14. When the spatial orientation of the filling unit 10 is obtained through the indicator groove 16, the spatial orientation of the channel 12 and the interlocking mechanism 14 can be obtained simultaneously. In addition, since the channel 12 and the indicator groove 16 are both located in the interlocking mechanism 14, when multiple filling units 10 are assembled, the channel 12 and the indicator groove 16 can be connected to the assembly gap of the interlocking mechanism 14. This allows for a better construction of a global fluid circulation channel network from the surface to the interior and then to the assembly gap on the bone implant device 1, further improving the efficiency of bone cell migration and nutrient exchange.

[0099] In some examples, the indicator slots 16 and filling units 10 may have a one-to-one correspondence. That is, each filling unit 10 may have one indicator slot 16. For example, for a filling unit 10 with two opposing surfaces, either of the two opposing surfaces may have an indicator slot 16 formed therein.

[0100] See in some examples Figure 5 or Figure 6 The extending direction of the indicator groove 16 can be perpendicular to the line connecting the openings formed by the two channels 12 on the surface of the filling unit 10. Specifically, at least two channels 12 can be located in the interlocking mechanism 14, and the extending direction of the indicator groove 16 can be perpendicular to the line connecting the openings formed by the two channels 12 on the surface of the filling unit 10. In this case, a specific and fixed positional relationship can be established between the indicator groove 16, the channels 12, and the interlocking mechanism 14, thereby introducing an orientation recognition and error-proof assembly mechanism for the filling unit 10. When assembling each filling unit 10, it can be spliced ​​in the correct orientation through the indicator groove 16, preventing the channels 12 from misaligning or the interlock from failing due to incorrect orientation of the filling unit 10.

[0101] See in some examples Figure 2 or Figure 3 After the multiple filling units 10 are assembled, the orientation and extension direction of each indicator groove 16 are consistent. In other words, when the orientation and extension direction of each indicator groove 16 are consistent, it can be confirmed that the multiple filling units 10 have been effectively assembled. In this case, it is easy to confirm that the multiple filling units 10 are assembled in a uniform direction (or posture), which helps to maintain the consistency of the anisotropic mechanical properties of the bone implant device 1.

[0102] For example, see Figure 2 or Figure 3For the filling unit 10 with a hexahedral structure, since the indicator groove 16 is located between the two channels 12 on the protrusion 142 and the extension direction of the indicator groove 16 is perpendicular to the line connecting the two channels 12, the indicator groove 16 can be used to indicate the spatial orientation (i.e., X, Y, and Z directions) of the filling unit 10 in three-dimensional space. In this case, it is only necessary to confirm that the orientation and extension direction of the indicator grooves 16 of each filling unit 10 are consistent to confirm that the multiple filling units 10 are assembled in the correct posture, so that the orientation of each protrusion 142 is consistent and the orientation of each long groove 144 is consistent. Thus, it is possible to suppress the misalignment of the protrusion 142 and the long groove 144 caused by the random assembly of each filling unit 10.

[0103] In some examples, the filler unit 10, which has a hexahedral structure, can be a cube, and the side length of the cube can be from 8 mm to 12 mm. In this case, since the cube is a geometry that is easy to standardize and stack in space, the side length of the cube in the range of 8 mm to 12 mm facilitates the hand-held operation and precise assembly of the filler unit 10, and can adapt to most bone defect morphologies. This improves the flexibility of modular assembly of the filler unit 10 while ensuring its structural strength. For example, the side length of the cube can be 8 mm, 9 mm, 10 mm, 11 mm, or 12 mm.

[0104] In some examples, the pore size of channel 12 can be from 1 mm to 3 mm. This pore size range is ideal for promoting bone tissue ingrowth and vascularization. A pore size smaller than 1 mm may limit cell migration and blood vessel formation; a pore size larger than 3 mm may reduce the overall mechanical strength of the filling unit 10 structure and is not conducive to serving as a cell attachment scaffold. For example, the pore size of the channel can be 1 mm, 1.5 mm, 2 mm, 2.5 mm, or 3 mm.

[0105] Figure 7 This is a diagram showing the change in elastic modulus of the filling unit 10 and the host bone A involved in the example of this disclosure during the repair period. Figure 8 This is a schematic diagram showing the compositional materials of the filling unit 10 involved in the example of this disclosure.

[0106] In some examples, the filling unit 10 can be made of biodegradable biomaterials. This allows the bone implant device 1 to be degraded and absorbed within the host body without the need for a second surgical removal.

[0107] In some examples, the filling unit 10 may include a calcium phosphate compound, a calcium silicate-based bioactive ceramic, a polymer, or a composite thereof. The calcium phosphate compound may include at least one of hydroxyapatite and tricalcium β-phosphate. Additionally, the calcium silicate-based bioactive ceramic may include at least one of calcium silicate and a calcium oxide-silica composite. Furthermore, the polymer may include at least one of polylactic acid (PLA), polyglycolic acid (PGA), and copolymers thereof (PLGA).

[0108] It should be noted that the above materials have good biocompatibility and are all biodegradable. Furthermore, the calcium and phosphorus components in the materials are beneficial for participating in the mineralization process of new bone and promoting the formation of new bone.

[0109] In some examples, the elastic modulus of the filling unit 10 remains no less than that of the host bone A during the repair period, and the ratio between the two decreases over time. In this case, since the elastic modulus of the filling unit 10 remains no less than that of the host bone A during the repair period, after the bone implant 1 is implanted into the defect area of ​​the host bone A, it can ensure that the implant bears most of the mechanical load in the early stage when the bone is most vulnerable during healing, thereby providing a stable mechanical environment for the initial formation of new bone. Furthermore, while the elastic modulus of the host bone A remains unchanged, as the bone itself recovers its strength, the stiffness of the implant decreases due to material degradation, thereby gradually and smoothly transferring the mechanical load from the implant to the new bone, suppressing the stress shielding effect caused by excessive stiffness in traditional metal implants over a long period of time.

[0110] Specifically, during the repair period, the elastic modulus of the filling unit 10 can always be no less than the elastic modulus of the host bone A. When the elastic modulus of the host bone A remains unchanged, the stiffness of the filling unit 10 decreases due to the degradation of the material over time. As a result, the ratio of the elastic modulus of the filling unit 10 to the elastic modulus of the host bone A (also referred to as the ratio) changes dynamically from large to small over time.

[0111] In some examples, the recovery period may refer to the period from week 1 to week 24 after the bone implant device 1 is implanted in the host. In other examples, the recovery period may refer to the period from 0 to 6 months after the bone implant device 1 is implanted in the host.

[0112] In some examples, the elastic modulus of the filler element 10 can be from 150 MPa to 500 MPa. For example, the elastic modulus of the filler element 10 can be 150 MPa, 200 MPa, 250 MPa, 300 MPa, 350 MPa, 400 MPa, 450 MPa or 500 MPa.

[0113] See Figure 7In some examples, the elastic modulus of the filling unit 10 may always be no less than the elastic modulus of the host bone A (e.g., cortical bone) during the repair period (e.g., 0 to 6 months).

[0114] exist Figure 7 In the diagram, the vertical axis represents bending strength (MPa), reflecting the material's mechanical properties against bending; the horizontal axis represents time (0-6 months, representing months), representing the repair period, corresponding to the core stage of bone healing.

[0115] In some examples, the ratio of the elastic modulus of the filler unit 10 to that of the host bone A can be greater than 2.0 in week 1 and decrease monotonically over time until it is less than or equal to 1.2 in week 24. In this case, the elastic modulus of the filler unit 10 is greater than twice the elastic modulus of the host bone A in the early stage of repair (week 1), enabling the bone implant device 1 to provide strong mechanical support for the host bone A. As time progresses, in the late stage of repair (week 24), the elastic modulus of the filler unit 10 is greater than the elastic modulus of the host bone A but less than or equal to 1.2 times the elastic modulus of the host bone A, allowing the elastic modulus of the bone implant device 1 to gradually approach that of the host bone A. This enables the mechanical load to be transferred gradually and smoothly from the bone implant device 1 to the newly formed bone, suppressing the stress shielding effect caused by excessive stiffness in traditional metal implants over a long period of time.

[0116] The filler unit 10 (or bone implant device 1) disclosed herein exhibits the highest initial flexural strength (approximately 310 MPa) during the initial repair phase (i.e., week 1), which gradually decreases over time, maintaining a high strength of approximately 150 MPa until nearly 6 months (i.e., week 24), consistently ranking at the top of the graph. Furthermore, the host bone A, using human cortical bone as a reference standard, maintains a flexural strength of 150 MPa, placing it in the middle range. Additionally, the ordinary material exhibits the lowest strength and is used to compare the filler unit 10 and cortical bone.

[0117] In the early stages of the repair process, the flexural strength of the filling unit 10 (or bone implant device 1) disclosed herein is at its maximum (greater than twice the flexural strength of the host bone A). Under these conditions, the bone implant device 1 can replace the bone in bearing most of the mechanical load, creating a stable mechanical environment for the healing of the damaged bone. In contrast, the flexural strength of ordinary materials is insufficient to provide adequate support and protection. Furthermore, as time progresses (entering the middle and late stages of the repair process), the bone gradually heals. At this point, the flexural strength of the bone implant device 1 gradually decreases due to material degradation, thereby gradually transferring the mechanical load to the newly formed bone, stimulating its growth and strengthening, and suppressing the stress shielding effect.

[0118] exist Figure 7In the example shown, the flexural strength of the bone implant 1 is consistently no less than that of the host bone A throughout the entire repair period, and the difference between the two gradually narrows in the later stages. In this case, the bone implant 1 can provide full support and protection for the healing of the damaged bone while suppressing the long-term stress shielding effect, thus verifying the precise matching relationship between the flexural strength and degradation absorption rate of the filling unit 10.

[0119] In some examples, the filling unit 10 can be made of a biodegradable material. In other words, the filling unit 10 can be made of a biodegradable material. In this case, after the bone implant device 1 has fulfilled its mechanical support function, it is gradually degraded during the regeneration cycle of the host bone A, and the degradation products are absorbed by the human body. At the same time, new bone can grow in along the internal channel 20 of the bone implant device 1 and gradually replace the degraded material, ultimately achieving bone repair at the defect site and preventing long-term foreign body retention.

[0120] Furthermore, in this disclosure, as the strength of the host bone A gradually recovers, and the stiffness of the bone implant device 1 decreases due to material degradation, the difference between the elastic modulus of the bone implant device 1 and the elastic modulus of the host bone A gradually narrows, so that the mechanical load is gradually and smoothly transferred from the bone implant device 1 to the new bone. In addition, the gradual transfer of mechanical load can apply stress stimulation to the host bone A, and the stress stimulation can promote bone cell growth, accelerate callus maturation and shaping, thereby making the healed bone of higher quality and closer to the original bone.

[0121] In some examples, the filling unit 10 may include a calcium phosphate compound, a polymer, or a complex thereof. In some examples, the filling unit 10 may include hydroxyapatite, a polymer, or a hydroxyapatite-polymer complex. In this case, the osteoconductivity, osteogenic affinity, high structural stiffness, and high structural strength of hydroxyapatite can be utilized to improve the supporting performance of the filling unit 10 and promote bone defect repair; and the good toughness and adjustable degradation rate of the polymer can be utilized to further improve the supporting performance of the filling unit 10 and promote bone defect repair.

[0122] In some examples, the calcium phosphate compound may be selected from hydroxyapatite, calcium polyphosphate, and tricalcium phosphate. The polymer may include a polymer of a monomer selected from lactide, caprolactone, p-dioxanone, and glycolide.

[0123] In some examples, the filling unit 10 can form micropores during degradation. For instance, the filling unit 10 comprises a hydroxyapatite composite polylactic acid material, which can form numerous micropores during degradation, facilitating osteoblast growth (or ingrowth). In this case, while maintaining the unit volume of the filling unit 10, the surface area of ​​the filling unit 10 can be increased, thereby facilitating the full encapsulation of the filling unit 10 by blood, and thus accelerating the degradation and absorption of the filling unit 10.

[0124] In some examples, the degradation time of the filler unit 10 can be 6 to 30 months. For example, the degradation time of the filler unit 10 can be 6 months, 12 months, 18 months, 24 months, or 30 months. In practical applications, if the degradation time of the filler unit 10 is too long, it can easily lead to stress shielding effects; on the other hand, if the degradation time is too short, the structural strength of the filler unit 10 cannot be guaranteed, prematurely weakening the mechanical strength of the bone implant device 1, which is not conducive to providing stable temporary mechanical support during the bone regeneration cycle. In some examples, the filler unit 10 maintains its structural strength (e.g., flexural strength) for about 6 months, while the complete degradation of the filler unit 10 requires 6 to 30 months.

[0125] See in some examples Figure 8 The filling unit 10 may include particulate matter 102, a buffer layer 104, and a matrix 106. The buffer layer 104 may cover the surface of the particulate matter 102, and the matrix 106 may be formed on the outer surface of the buffer layer 104. In other words, the buffer layer 104 may encapsulate the particulate matter 102, and the matrix 106 may encapsulate the buffer layer 104. In this case, a buffering mechanism can be introduced between the particulate matter 102 and the matrix 106, thereby enhancing the interfacial forces between the particulate matter 102 and the matrix 106, improving the dispersion uniformity of the particulate matter 102 in the matrix 106, and also improving the mechanical strength and toughness of the filling unit 10.

[0126] In some examples, a buffer layer 104 may be formed between the particulate matter 102 and the matrix 106. That is, the buffer layer 104 may be located between the particulate matter 102 and the matrix 106 (see [reference]). Figure 8 ).

[0127] See in some examples Figure 8 The particulate matter 102 and the buffer layer 104 can be uniformly dispersed in the matrix 106 as a whole.

[0128] In some examples, particulate matter 102 may contain calcium and phosphorus compounds. In this case, it helps to enhance the bioactivity of filling unit 10 and promote its repair effect on the host bone A tissue.

[0129] In some examples, particulate matter 102 may contain one or more selected from hydroxyapatite, calcium polyphosphate, and tricalcium phosphate.

[0130] In some examples, particulate matter 102 can have a Young's modulus greater than 2 × 10⁻⁶. 11 Pa rigid particles. This effectively improves the mechanical strength of the filling unit 10.

[0131] In some examples, the particle size of particulate 102 can be from 5 nm to 150 μm. For example, the particle size of particulate 102 can be 5 nm, 10 nm, 50 nm, 100 nm, 500 nm, 1 μm, 5 μm, 10 μm, 50 μm, or 150 μm. In this case, it is beneficial to ensure that particulate 102 has good dispersibility in matrix 106 and to ensure the mechanical strength of filling unit 10.

[0132] In some examples, the mass percentage of particulate matter 102 in the filling unit 10 can be 1 wt% to 10 wt% (that is, the proportion of particulate matter 102 to the total mass of the filling unit 10 can be 1% to 10%). In this case, the mechanical strength of the filling unit 10 can be effectively improved while minimizing the impact on the toughness of the filling unit 10, thus achieving a good balance between the mechanical strength and toughness of the filling unit 10. For example, the mass percentage of particulate matter 102 can be 1 wt%, 3 wt%, 5 wt%, 8 wt%, or 10 wt%.

[0133] In some examples, the buffer layer 104 may have a first glass transition temperature. This first glass transition temperature may not exceed normal human body temperature (e.g., 36.5~37.7°C). In this case, when the filling unit 10 is implanted into the human body, because the first glass transition temperature of the buffer layer 104 is not higher than normal human body temperature, the buffer layer 104 can remain in a rubbery state. The rubbery buffer layer 104 can release stress concentration caused by the particles 102, thereby improving the toughness of the filling unit 10. Furthermore, the particles 102 can stabilize the rubbery buffer layer 104 under certain stress, thereby suppressing the decrease in the mechanical strength of the filling unit 10.

[0134] In some examples, the buffer layer 104 may be made of a polymer material. In some examples, the buffer layer 104 may comprise a homopolymer of a monomer selected from lactide, caprolactone, p-dioxanone, and glycolide.

[0135] In some examples, the buffer layer 104 may also comprise a binary or block copolymer selected from lactide, caprolactone, p-dioxanone, and glycolide. This allows the buffer layer 104 to form a biodegradable and absorbable polymer material.

[0136] In some examples, the molecular weight of buffer layer 104 can be from 3000 g / mol to 5000 g / mol. For example, the molecular weight of buffer layer 104 can be 3000 g / mol, 3250 g / mol, 3500 g / mol, 3750 g / mol, 4000 g / mol, 4250 g / mol, 4500 g / mol, 4750 g / mol, or 5000 g / mol. Here, molecular weight can refer to weight-average molecular weight (Mw).

[0137] In some examples, the mass percentage of the buffer layer 104 in the filling unit 10 can be 0.5 wt% to 10 wt% (that is, the proportion of the buffer layer 104 to the total mass of the filling unit 10 can be 0.5% to 10%). In this case, the toughness of the filling unit 10 can be effectively improved while minimizing the impact on the mechanical strength of the filling unit 10, thus achieving a good balance between the toughness and mechanical strength of the filling unit 10. For example, the mass percentage of the buffer layer 104 can be 0.5 wt%, 1 wt%, 3 wt%, 5 wt%, 8 wt%, or 10 wt%. In some examples, the buffer layer 104 and the particulate matter 102 can be covalently bonded. In this case, a strong interfacial force is formed between the particulate matter 102 and the buffer layer 104, thereby improving the bonding force between them.

[0138] As described above, a matrix 106 may be formed on the outer surface of the buffer layer 104. In some examples, the matrix 106 may have a second glass transition temperature.

[0139] In some examples, the second glass transition temperature can be greater than the first glass transition temperature of the buffer layer 104. In this case, under the same temperature conditions, the matrix 106 can maintain better mechanical strength than the buffer layer 104, thereby enhancing the mechanical properties (e.g., material stiffness) of the filler unit 10. In some examples, the second glass transition temperature can be greater than normal human body temperature (e.g., 36.5~37.7°C). For example, the second glass transition temperature can be 40°C, 45°C, 50°C, 55°C, or 60°C.

[0140] For example, when the filling unit 10 is implanted into the human body, the matrix 106 can still remain in a glassy state, thereby ensuring that the bone implant device 1 has sufficient mechanical strength.

[0141] In some examples, matrix 106 may comprise a homopolymer of a monomer selected from lactide, caprolactone, p-dioxanone, and glycolide.

[0142] Additionally, in some examples, matrix 106 may also comprise a binary or block copolymer selected from lactide, caprolactone, p-dioxanone, and glycolide. In this case, matrix 106 can be formed into an absorbable polymer material, thereby facilitating the degradation and absorption of filler unit 10 within the human body.

[0143] In some examples, the molecular weight of matrix 106 can be from 250,000 g / mol to 450,000 g / mol. For example, the molecular weight of matrix 106 can be 250,000 g / mol, 275,000 g / mol, 300,000 g / mol, 325,000 g / mol, 350,000 g / mol, 375,000 g / mol, 400,000 g / mol, 425,000 g / mol, or 450,000 g / mol. Here, molecular weight can refer to weight-average molecular weight (Mw).

[0144] In some examples, the mass percentage of matrix 106 in filling unit 10 can be 80 wt% to 98 wt% (that is, the proportion of matrix 106 to the total mass of filling unit 10 can be 80% to 98%).

[0145] In some examples, the buffer layer 104 can be covalently bonded to the matrix 106. This allows for the formation of strong interfacial forces between the buffer layer 104 and the matrix 106, thereby improving the bonding strength between them.

[0146] This disclosure also provides a specific method for preparing the material of the filling unit 10, comprising: preparing 0.5 g of hydroxyapatite particles (average particle size 5 nm), 0.06 g of L-lactide monomer, and 0.06 g of caprolactone monomer; mixing the three evenly; adding 40 μL of stannous octoate catalyst; and then stirring and reacting for 2 hours under nitrogen protection at a reaction temperature of 180 °C to obtain a particle-buffer layer. Then, 10 g of L-lactide is added to the reaction system, and the reaction continues at 180 °C for 2 hours. After the reaction is complete, the reaction product mixture is dissolved in chloroform, precipitated in methanol, and washed three times with methanol to obtain a particle-buffer layer-matrix. The elastic modulus of the product is then tested, and the test results are shown below. Figure 7 .

[0147] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. A modular bone implant device, an artificial bone material for repairing bone defects, characterized in that, The bone implant device includes multiple interconnected filling units, each filling unit having a channel and an interlocking mechanism for interconnection. After the multiple filling units are assembled via the interlocking mechanism, each of the channels forms an internal passage through the bone implant device in at least one direction. The filling unit is made of biodegradable biomaterial, and the elastic modulus of the filling unit is always no less than that of the host bone during the repair period, and the ratio between the two decreases over time.

2. The bone implant device according to claim 1, characterized in that, The interlocking mechanism is formed on the surface of the filling unit, and the channel passes through the interlocking mechanism.

3. The bone implant device according to claim 2, characterized in that, The filling unit has at least two opposing surfaces, and the number of channels is plurality of, with at least two channels penetrating both opposing surfaces of the filling unit and the interlocking mechanism. An indicator groove is formed on either of the two opposing surfaces of the filling unit, the direction of which the indicator groove extends perpendicular to the line connecting the openings formed on the two channels on the surface.

4. The bone implant device according to claim 3, characterized in that, After the multiple filling units are assembled, the orientation and extension direction of each of the indicator slots are consistent.

5. The bone implant device according to claim 1, characterized in that, The number of internal channels is multiple, and the bone implant device further includes at least one fixation device configured to be inserted into at least one of the internal channels to structurally reinforce the bone implant device.

6. The bone implant device according to claim 1, characterized in that, The interlocking mechanism includes a protruding ridge and an elongated slot configured to mate with the protruding ridge. The filling unit is a polyhedral structure, with at least one surface of the polyhedral structure having the protruding ridge and at least one other surface having the elongated groove.

7. The bone implant device according to claim 6, characterized in that, The polyhedral structure is a hexahedral structure, which has a first vertex and a second vertex spatially opposite the first vertex. The three adjacent surfaces intersecting at the first vertex are each provided with the convex ridge, and the three adjacent surfaces intersecting at the second vertex are each provided with the elongated groove.

8. The bone implant device according to claim 1, characterized in that, The adjacent filling units are effectively assembled in a staggered assembly manner, wherein the staggered assembly means that when the adjacent filling units are assembled by the interlocking mechanism, the edges of the adjacent filling units are not aligned, but at least one pair of the channels in the adjacent filling units are coaxially aligned.

9. The bone implant device according to claim 1, characterized in that, The repair period is from week 1 to week 24 after the bone implant device is implanted into the host. The ratio of the elastic modulus of the filling unit to the elastic modulus of the host bone is greater than 2 in week 1 and less than or equal to 1.2 in week 24.

10. The bone implant device according to any one of claims 1 to 9, characterized in that, The filling unit includes particulate matter, a buffer layer, and a matrix. The buffer layer encapsulates the particulate matter, and the matrix encapsulates the buffer layer. The buffer layer has a first glass transition temperature, which is not higher than normal human body temperature. The matrix has a second glass transition temperature, which is greater than the first glass transition temperature.

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