Multi-channel implant

Abstract

The invention relates to an implant comprising a plurality of channels (30a, 30b). The implant (1) comprises a body (10), wherein the main cavity (20) of the body (10) is accessible through an inlet opening (25). The body (10) has a plurality of channels (30a, 30b) having a first opening (35) and a second opening (36), the channels being configured to allow fluid to flow from the cavity (20) through the plurality of channels (30a, 30b) to an external environment of the body (10). Furthermore, the invention relates to a kit comprising the implant, and a regeneration medium and / or a specification.

Description

Technical Field

[0001] This invention relates to an implant that can be used at bone defect sites, particularly suitable for segmental bone defects and critical bone defects. Furthermore, this invention also relates to a kit comprising the implant, a regenerative medium, and / or an instruction manual. Background Technology

[0002] Discontinuous bone defects caused by trauma, surgery, or poor fracture healing (i.e., nonunion) usually require surgical treatment. These types of fractures are mostly treated with autologous bone grafts to provide sufficient regenerative capacity or weight-bearing stability.

[0003] Autologous bone material, also known as autologous bone graft or autologous bone, refers to bone tissue taken from a patient's own body for various medical purposes, such as bone grafting or bone reconstruction. This type of bone tissue is usually obtained from other parts of the patient's body, such as the iliac crest, scapula, fibula, or other bones, and then transplanted to the desired site.

[0004] This treatment method, due to the increased complexity and duration of the surgery, leads to a higher frequency and incidence of complications, resulting in longer hospital stays. Hospitals, in turn, incur significantly higher costs due to the increased number of surgeries and longer hospital stays.

[0005] On the other hand, the use of implants to repair tissue defects has been clinically established. However, in many cases, insufficient integration of the implant with surrounding tissues and poor fusion with the vascular system are the reasons for the long-term functional impairment of larger implants. Although bioabsorbable or bioactive coating materials have partially improved these properties through highly porous and biomimetic internal structures, the colonization effect of human cells, especially in biomechanically stable support structures, remains unsatisfactory.

[0006] Bioactive liquids and hydrogels facilitate tissue integration, cell colonization, and vascularization. For tissues with lower mechanical requirements, such as cartilage, implants combining solid and gel-like materials have been developed and successfully applied clinically as hybrid material structures. However, in the field of bone substitutes, connecting bulky, mechanically stable, and highly porous structures that can be uniformly filled with liquid materials remains a significant challenge. To date, bone substitutes developed have focused on mechanical stability and, from the perspective of bone tissue, strive to achieve the highest possible similarity to biological structures (biomimetic).

[0007] In the field of bone substitutes, cell-based implants based on polylactic-co-glycolic acid copolymer (PLGA) and autologous bone cells for use in oral and maxillofacial surgery and dental procedures, especially for filling defects in maxillary sinus lift surgery, have been developed to the market access stage.

[0008] US Patent 11,291,556 B2 discloses an intervertebral bone implant, which may be referred to as a cage-like implant for intervertebral fusion of two vertebrae. This implant is specifically designed for use with a large amount of autologous bone.

[0009] International application WO2007003324A2 relates to artificial bone fragments, methods for their preparation, and their application in surgical procedures. The artificial bone fragments consist of a bioresorbable or biocompatible scaffold structure made of fibrin or hydrogel, osteoblasts, and factors such as growth factors or osteogenic bioactive factors, which are arranged in an interlocking geometry.

[0010] International application WO0159068A2 describes a cell-free graft comprising a viscous, structure-forming matrix having open porosity, made from biologically and pharmaceutically acceptable materials and serum.

[0011] Most other commercially available bone replacement materials are calcium phosphate-based and require normal bone healing function or a suitable bone development microenvironment. Osteocyte colonization is optimal in biopolymers that are as soft as possible and fortified with osteogenic growth factors. Various hydrogel-forming polymers, such as collagen, gelatin, hyaluronic acid derivatives, and alginate, can ensure osteogenic potential.

[0012] However, these soft polymers themselves lack sufficient stability to withstand the loads required for postoperative fracture healing. For such polymers to be successfully applied to fracture healing, they must be fixed to the fracture site and connected to a stable structure to ensure mechanical stability. However, there is currently no readily available technological solution that can achieve both simultaneously.

[0013] In summary, no unified strategy has yet been developed for filling implants with highly viscous materials. Summary of the Invention

[0014] This invention is defined by the appended claims. The following description is subject to these limitations. Any disclosure beyond the scope of the claims is for illustrative and comparative purposes only.

[0015] This invention addresses this problem by providing an implant comprising a body having a main cavity formed therein. The chamber of the main cavity is accessible through an inlet opening that allows fluid communication between the chamber of the main cavity and the surrounding environment of the body. The body also contains a plurality of channels, each having a first opening toward the main cavity and a second opening toward the surrounding environment of the body, and each channel is configured to allow fluid to flow from the main cavity through the channel to the surrounding environment of the body; wherein the cross-sectional area of ​​the first opening of at least one of the plurality of channels is larger than the cross-sectional area of ​​the second opening of the at least one channel; preferably, at least one of the plurality of channels is conical.

[0016] In this invention, the term "implant" should be understood as a scaffold manufactured for the purpose of replacing missing biological structures, supporting damaged biological structures, or enhancing existing biological structures. This implant can be used in conjunction with regenerative media.

[0017] According to a preferred embodiment, the main cavity extends within the body along a first direction X, and a plurality of channels penetrate the body along a second direction Y, wherein the first direction X and the second direction Y are different from each other, and the included angle α between the first direction and the second direction is selected from the range of 60° to 120°; more preferably, α is selected from the range of 75° to 105°; even more preferably, α is selected from the range of 85° to 95° or is 90°. The walls of the main cavity and the walls of at least one, more, or all of the plurality of channels can be composed of continuous walls, or they can be composed of discontinuous walls or fractured walls.

[0018] According to a particularly preferred embodiment, the angle α between the first direction and the second direction is 90°. In this case, the main cavity extends vertically through the body, and multiple channels extend horizontally through the body. In this invention, "horizontal" and "vertical" are terms used to describe two fundamental directions (i.e., the first direction X and the second direction Y) within the implant body. The emphasis is on considering relative orientation, where the horizontal direction is perpendicular to the vertical direction, i.e., the angle α is 90°. According to the above preferred embodiment, the main cavity extends vertically through the body, thereby defining an axis corresponding to the vertical direction. Multiple channels extend horizontally (i.e., in a direction perpendicular to the vertical direction) through the body.

[0019] According to another preferred embodiment, the main cavity is constructed as an elongated central channel that only partially penetrates the body in the first direction X. In this preferred embodiment, the feature that the main cavity only partially penetrates the body means that the channel contains only one main inlet opening through which fluid can be injected, while the other end of the main cavity is closed to ensure that the fluid does not completely pass through the body in the first direction X, but is instead guided to multiple channels preferably oriented in the horizontal direction (i.e., the second direction Y). This allows fluid or substances to be injected into the implant to aid the healing process. Specifically, a regenerative medium can be injected into the main cavity of the implant and then guided and evenly distributed in multiple channels extending outward from the main cavity (i.e., extending in the Y direction).

[0020] This invention provides a mechanically stable structure that can be infused with a viscous substance through a fluid microstructure without significantly reducing its mechanical load-bearing stability. This allows fracture ends to be indirectly connected via a bioregenerative matrix (such as hydrogel) while ensuring the necessary load-bearing stability for adequate bone healing.

[0021] In a non-inventive embodiment, the diameter of at least one of the plurality of channels (preferably each channel) remains constant along a second direction penetrating the body, wherein the at least one of the plurality of channels (preferably each channel) is cylindrical. Preferably, the diameter of each of the plurality of channels is selected from the range of 0.1 mm to 2 mm; more preferably, from the range of 0.1 mm to 1.75 mm; and even more preferably, from the range of 0.2 mm to 1.75 mm.

[0022] The diameter is preferably determined by the viscosity of the liquid. For example, if the viscosity is extremely low, a channel size of less than 1 mm is preferred. With such a small diameter, the liquid can be advantageously held by capillary force. Therefore, those skilled in the art can advantageously adjust the channel diameter according to the viscosity of the medium. For a viscosity range of 1 to 40 mPa·s, the channel diameter is preferably no more than 1 mm, more preferably 0.2 to 1 mm.

[0023] The above implementation can also be described as follows: the diameter of at least one of the plurality of channels remains constant along a second direction from the main cavity through the body to the surrounding environment, such that the inner diameter at the first opening is substantially the same as the outer diameter at the second opening. Preferably, the diameter of each of the plurality of channels remains constant along the second direction Y from the main cavity through the body to the surrounding environment, such that the inner diameter at the first opening is exactly the same as the outer diameter at the second opening. This design can also be described as follows: the plurality of channels have an inner diameter and an outer diameter, and the inner diameter is equal to the outer diameter. The inner diameter (DI) refers to the diameter of the channel in the main cavity. The outer diameter (DO) refers to the diameter of the channel at the outer periphery of the body (i.e., the surrounding environment of the body).

[0024] Due to its large wall thickness and small volume channels, this embodiment with a constant diameter exhibits high mechanical durability. However, although the initial design demonstrates satisfactory mechanical properties, it may not promote uniform fluid distribution throughout the structure, which would necessitate the use of a large amount of filler material or result in some areas remaining unfilled.

[0025] The various embodiments of the present invention overcome these defects, wherein the first opening cross-sectional area of ​​at least one of the plurality of channels is greater than the second opening cross-sectional area of ​​at least one, more or all of the plurality of channels; preferably, at least one, more or all of the plurality of channels are conical.

[0026] For the purposes of this invention, the term "conical" refers to a cross-sectional area at the first opening being larger than that at the second opening. The cross-sectional area (i.e., the cross-sectional area perpendicular to the axis extending along the second direction Y) may decrease continuously or discontinuously along the second direction Y from the first opening to the second opening. Continuous decrease means that the rate of decrease of the cross-sectional area remains constant on average over the entire length between the first and second openings (along the second direction Y from the first opening to the second opening); discontinuous decrease means that the rate of decrease of the cross-sectional area is not constant along the second direction Y from the first opening to the second opening.

[0027] The first opening and the second opening may have regular or irregular cross-sectional shapes independently of each other in a plane perpendicular to the second direction. As long as the cross-sectional area of ​​the first opening is greater than that of the second opening, the cross-sectional shape of the first opening may be the same as or different from that of the second opening. The cross-sectional shape of the first opening and / or the second opening may be circular, elliptical, or polygonal.

[0028] Preferably, the minimum diameter of the cross-sectional area of ​​at least one of the plurality of channels gradually decreases along a second direction Y from the main cavity through the body to the surrounding environment, such that the inner diameter (e.g., the minimum diameter of the cross-sectional area) at the first opening is greater than the outer diameter (e.g., the minimum diameter of the cross-sectional area) at the second opening; more preferably, the diameter of each of the plurality of channels gradually decreases along a second direction from the main cavity through the body to the surrounding environment, such that the inner diameter (DI) at the first opening is greater than the outer diameter (DO) at the second opening (wherein, the inner diameter and outer diameter are preferably calculated based on the minimum inner diameter of the cross-sectional area of ​​the corresponding first opening and / or second opening).

[0029] These embodiments of the present invention minimize the uneven distribution of low-viscosity and high-viscosity liquids in stable, open porous support structures by taking into account the hydrodynamic properties of the liquid and the size of the implant.

[0030] In embodiments of the present invention, at least one of the plurality of channels is preferably conical; more preferably, one or more or all of the plurality of channels are conical.

[0031] In this invention, "cone" refers to a three-dimensional geometric shape similar to a cone. A cone is a solid object with a flat circular or elliptical base and a curved surface that gradually narrows to a point (called the vertex). The base and the vertex are connected by a curved surface (commonly called the lateral surface). The size and proportions of a cone may vary, but all possess this basic conical characteristic. In the implant of this invention, at least one, more, or all of the plurality of channels are preferably conical, wherein the vertex diameter of the at least one, more, or each cone corresponds to the outer diameter (DO) of the channel, and the base diameter corresponds to the inner diameter (DI) of the channel.

[0032] According to a preferred embodiment, the implant is characterized in that: the inner diameter (DI) of at least one, more, or each of the plurality of channels is from 1.25 mm to 4.0 mm; and the outer diameter (DO) of at least one, more, or each of the plurality of channels is from 0.2 mm to 3.0 mm. According to another preferred embodiment, the implant is characterized in that: the inner diameter is from 1.25 mm to 2.55 mm; and the outer diameter is from 0.3 mm to 0.9 mm. According to a more preferred embodiment, the implant is characterized in that: the inner diameter is from 1.5 mm to 3.5 mm; and the outer diameter is from 0.25 mm to 0.75 mm. According to another preferred embodiment, the implant is characterized in that: the inner diameter is from 1.3 mm to 1.5 mm; and the outer diameter is from 0.3 mm to 0.6 mm. According to a particularly preferred embodiment, the implant is characterized in that: the inner diameter is approximately 1.45 mm, and the outer diameter is approximately 0.5 mm.

[0033] The diameter is preferably determined by the viscosity of the liquid. For example, if the viscosity is extremely low, a smaller diameter value is preferred, in which case the liquid can be advantageously held by capillary force. Therefore, those skilled in the art can advantageously adjust the diameter of the channel according to the viscosity of the medium.

[0034] These implementation schemes ensure rapid and uniform infusion while maintaining a high fluid volume within the implant and preserving wall thickness, thereby guaranteeing mechanical strength. The pore size and the degree of pore size reduction are determined and adjusted based on the viscosity and wetting behavior of the liquid relative to the carrier material.

[0035] According to a preferred embodiment, the body of the implant has at least one C n Symmetrical element. One C nAn axis is a symmetry element that characterizes rotational symmetry. Specifically, it represents a rotation that divides 360 degrees into n equal parts, with each part of the rotation called an "n-fold rotation" or "C-axis rotation". n "Rotation". For example, in this context, the C2 axis represents a double rotation, i.e., a 180-degree rotation; the C3 axis represents a triple rotation, i.e., a 120-degree rotation; and the C4 axis represents a quadruple rotation, i.e., a 90-degree rotation. Typically, a C... n An axis describes rotational symmetry through a specific angle (i.e., 360 degrees divided by n). In C n In the axis, "n" can take the value of an integer greater than or equal to 2. This means that n can be any positive integer starting from 2, including C, which represents infinite rotational symmetry. ∞ (C infinity) axis). C n The presence of an axis does not preclude the existence of other symmetry elements, such as additional axes of rotation and / or mirrors. According to a preferred embodiment, the main chamber extends through the body along a first direction X, which is along C... n Axis definition; multiple channels penetrate the body along a second direction Y, which is parallel to C. n Definition of an axis that makes an angle α with the axis.

[0036] According to a preferred embodiment, the implant body is cylindrical. In this embodiment, a main chamber extends through the body along a first direction X, defined along the rotational axis of the cylindrical body; multiple channels extend through the body along a second direction Y, defined along a second axis Y. From the perspective of symmetry elements, the cylindrical body has a C-axis representing infinite rotational symmetry. ∞ The (C infinity) axis. In other words, this indicates that an object or system possesses continuous rotational symmetry, meaning that its appearance remains unchanged after rotating by any angle around a specific axis. ∞ The axis does not have discrete rotation angles, but allows rotation within a continuous range.

[0037] According to a preferred embodiment, the main chamber diameter of the implant is 2 to 4 millimeters.

[0038] According to a preferred embodiment, the implant has a channel density of 1 to 300 channels per square centimeter, preferably 3 to 200 channels per square centimeter, and more preferably 3 to 100 channels per square centimeter.

[0039] According to a preferred embodiment, the plurality of channels are arranged in a regular pattern along an axis extending in the first direction X. Alternatively, the plurality of channels may also be arranged in an irregular pattern within the body along an axis extending in the first direction X.

[0040] The body of the implant of the present invention can have a shape adapted to the intra-body drug delivery site. In other words, the shape of the body depends on the specific application scenario for which the implant is designed. Therefore, for the implant of the present invention, the body can have any shape suitable for the intended application and is not limited to a specific geometric shape. The body of the implant of the present invention can, for example, be conical, cylindrical, or any combination thereof.

[0041] Preferably, the main body is cylindrical, and the plurality of channels are arranged on the external surface of the main body along the circumferential direction of the main body and the vertical direction corresponding to the first direction X.

[0042] The cylinder constituting the cylindrical base in the above embodiment is a three-dimensional geometric object characterized by two parallel and congruent circular bases connected by a curved surface. The term "congruent" means that the two bases are identical in size and shape. This curved surface (often referred to as the lateral surface or lateral surface area) connects the two bases along their circumference. The curved surface of the cylinder encloses the space between the two bases, forming a tubular structure. This curved surface can also be called a circumferential surface. The circumferential direction refers to the circular path around the circumferential surface of the cylinder. The line segment connecting the centers of the two circular bases is called the axis of the cylinder, which corresponds to the first direction X.

[0043] According to a preferred embodiment, the body of the implant includes an inlet opening located at the top of the body, and the main chamber extends through the inlet opening.

[0044] The implant mainly comprises a body, a main chamber, and multiple channels, and its purpose is to provide support and treatment for fractures, segmental bone defects, and borderline bone defects. An inlet opening is incorporated into the design to perform a specific function during the application of the implant.

[0045] Therefore, the implant design includes a mechanism for delivering drugs or therapeutic agents to the fracture site, with the inlet opening being part of this mechanism. It allows the introduction of fluids or substances into the implant to aid the healing process. Preferably, a regenerative medium can be introduced into the implant through the inlet opening.

[0046] The aforementioned inlet opening can be fully integrated into the main body to form a single structure. Alternatively, the inlet opening can be separated from the main body and connected to it.

[0047] According to a preferred embodiment, the diameter of the inlet opening of the implant is smaller than the average diameter of the main chamber. This embodiment ensures the safe introduction of liquids or substances into the implant to aid the healing process, while keeping the implant opening small to avoid unnecessary contamination from the surrounding environment. Specifically, regenerative media can be immersed into the implant through the inlet opening. Subsequently, the regenerative media is introduced into the main chamber through the smaller diameter inlet opening and then flows from the main chamber to multiple channels extending outward from the main chamber (i.e., extending in a second direction).

[0048] The implant described in the above embodiments can be fabricated, for example, using a fused layer modeling / manufacturing (FLM) process. FLM is a commonly used 3D printing technology for manufacturing three-dimensional objects layer by layer. The FLM process may include the following steps.

[0049] Material feeding: The thermoplastic filament is fed into the heating nozzle.

[0050] Heated extrusion: The nozzle melts the filament, making it malleable.

[0051] Layer-by-layer printing: The material is extruded layer by layer according to the computer-generated design.

[0052] Curing: Each layer of material cools and solidifies, and then bonds to the previous layer.

[0053] Support structure: For complex shapes, optional support structures can be added.

[0054] Cooling hardening: The cooling system helps the material solidify and harden.

[0055] Object Removal: After printing is complete, remove the printed object. If further processing is required, it can be performed.

[0056] The filaments used in the implants of this invention (especially those for human use) must meet specific biocompatibility and safety standards to ensure their suitability for medical applications.

[0057] The wires used in implants should be made of biocompatible materials, meaning they will not trigger adverse immune responses or produce toxicity upon contact with human tissues or fluids. Commonly used biocompatible materials include medical-grade metals (such as titanium or stainless steel), non-degradable polymers (such as polyetheretherketone (PEEK) or acrylonitrile-butadiene-styrene copolymer (ABS)), biodegradable polymers (such as polytrimethylene carbonate (PTMC), polycaprolactone (PCL), polylactic acid (PLA), polyglycolic acid (PGA), polylactic-glycolic acid copolymer (PLGA), or polyadipate (AA)), or ceramic materials (such as hydroxyapatite, tricalcium phosphate, or zirconium dioxide). Non-degradable polymers are carefully selected and prepared to ensure biocompatibility and stability in the human body, without degradation or the production of harmful byproducts. This allows them to function long-term in the body without harming the patient's health.

[0058] The implant wire should be able to withstand sterilization processes such as high-pressure steam sterilization or ethylene oxide gas sterilization to ensure that it is free of harmful microorganisms before implantation.

[0059] In addition, the filament material should possess suitable mechanical properties, such as strength, flexibility, and durability, to meet the specific requirements of the implant. These mechanical properties will depend on the type of implant and its intended function.

[0060] Particularly preferred materials include polylactic acid (PLA). PLA offers several advantages for use in implants, one of its main advantages being biocompatibility. PLA is well-tolerated by the human body and generally does not trigger immune responses or adverse reactions. This property is crucial for medical implants because it ensures that the material will not cause harm or complications after implantation.

[0061] Another advantage of PLA is its biodegradability. PLA implants gradually degrade into non-toxic byproducts over time, which are absorbed or metabolized by the body. This property is particularly useful for implants with temporary uses, such as those used for tissue regeneration. As the implant degrades, it makes room for natural tissue growth, thus reducing the need for additional surgery to remove the implant.

[0062] PLA is also a versatile material. It can be molded into various shapes and sizes to match the specific requirements of different implant applications. This flexibility enables customized and highly precise implant design.

[0063] According to another aspect of the invention, the present invention relates to an implant for treating bone defects, particularly by promoting a superior fracture healing process. While the implant is preferably used for treating bone defects, it can also be applied to a variety of situations requiring a combination of mechanical stabilization and additional regenerative potential. In addition to treating bone defects, the implant can also be used to treat one or more of the following conditions.

[0064] (1) Flat tissue replacement implants for large-area traumatic soft tissue injuries.

[0065] (2) Breast tissue implant.

[0066] (3) Catheter implants for peripheral nerve regeneration.

[0067] The fracture healing process is divided into five different stages, which are described in detail below.

[0068] Injury stage: External forces acting on the bone cause damage to the periosteum, cortical bone and bone marrow, which in turn leads to the formation of hematoma in the fracture space.

[0069] Inflammatory phase: Within the fracture hematoma, pluripotent mesenchymal stem cells differentiate into osteoblasts, fibroblasts, and chondrocytes. Cytokines and growth factors secreted into the hematoma are crucial for controlling cell infiltration, angiogenesis, and cell differentiation. Immune cells invade the hematoma, triggering local inflammation and promoting further cell migration through subsequent capillary leakage.

[0070] Granulation tissue formation stage: A network of fibrin and collagen forms within the fracture hematoma. This network is gradually replaced by granulation tissue (callus) containing fibroblasts, more collagen, and capillaries. This process usually occurs about 4 to 6 weeks after the fracture. Osteoclasts break down bone tissue without blood perfusion, while osteoblasts generate new bone under the periosteum.

[0071] Bone callus maturation stage: During this stage, the formed callus mineralizes and transforms into woven bone. The initial structure is influenced by invading capillaries and gradually aligns along the mechanical stress axis. The bone callus maturation stage lasts approximately 3 to 4 months, after which the bone can again withstand physiological loads.

[0072] Remodeling and Reconstruction Phase: Woven bone transforms into lamellar bone. Restoration of the original bone structure involves providing regular nutrition to the bone through the Haversian and Falkmann canal systems. Complete restoration of the original bone structure (including medullary canal formation) is a subsequent process of remodeling, which typically takes 6 to 24 months to complete under normal healing conditions.

[0073] This process demonstrates that a crucial element in fracture healing is the presence of a sufficient hematoma containing essential mesenchymal cells, leukocytes, and necessary anabolic stimulants. In cases of skeletal discontinuity, either the bone defect is too large (typically greater than 1.5 cm), preventing hematoma formation in the defect area; or, due to biological reasons, even after reduction, the biological stimulation within the fracture space is insufficient to achieve bone healing. In both cases, it is necessary to implant a matrix with sufficient load-bearing capacity and regenerative properties into the fracture space.

[0074] Firstly, its application in the field of bone substitute materials is foreseeable. Specifically, this includes the following situations: (1) delayed healing and poor healing (nonunion) after fracture treatment; (2) large-area traumatic bone defects; (3) tumor-related bone defects; (4) congenital bone defects; and (5) revision surgery of implantable prostheses.

[0075] The regenerative capacity of the implant of this invention comes from the soft matrix that fills it, rather than solely from the materials and properties of the hard components.

[0076] According to a preferred embodiment, the main chamber and at least one of the plurality of channels contain a regeneration medium; preferably, the main chamber and each of the plurality of channels contain a regeneration medium.

[0077] According to a preferred embodiment, the regeneration medium comprises or is composed of a hydrogel.

[0078] According to another aspect, the present invention relates to a kit comprising an implant as described above and at least one, more or all of the components for forming a regeneration medium (preferably a hydrogel); and / or an optional instruction manual containing detailed instructions on how to form the regeneration medium and how to inject the regeneration medium into the main chamber and multiple channels of the implant.

[0079] This modular kit is based on a series of scaffolds with different basic shapes, load-bearing capacities, and volumes. These scaffolds are individually sterilized and selected by the surgeon based on intraoperative defect assessment. All corresponding scaffolds are connected to a filling mechanism to allow the addition of a soft matrix within the scaffold during surgery. The core concept of this product is to provide a sufficient number of different fit types for different bone regions and different presentations of bone defects.

[0080] Osteocyte colonization is most effective in biopolymers that are as soft as possible and fortified with osteogenic growth factors. Many hydrogel-forming polymers (such as collagen, gelatin, hyaluronic acid derivatives, and alginate) can ensure osteogenic potential. However, these soft polymers themselves lack sufficient stability to withstand the loads required for postoperative fracture healing. For successful use of such polymers in fracture healing, they must be fixed to the fracture site and connected to a stable structure to ensure mechanical stability. This invention overcomes these problems and allows the use of a variety of hydrogel-forming polymers (such as collagen, gelatin, hyaluronic acid derivatives, and alginate). Therefore, this invention expands the scope of applications.

[0081] Hydrogel-forming polymers (such as collagen, gelatin, hyaluronic acid derivatives, and alginate) are a class of materials with water absorption and retention capabilities that can form gel-like structures. Due to their unique properties, these polymers are commonly used in a variety of biomedical and pharmaceutical applications. The following is a brief description of each polymer.

[0082] Collagen is a naturally occurring protein found in connective tissues, including skin, bones, and tendons. Due to its biocompatibility, it is a widely used polymer in tissue engineering and regenerative medicine that can form hydrogels. Collagen hydrogels can provide a support matrix for cell growth and the repair of damaged tissues.

[0083] Gelatin, derived from collagen, is another biocompatible polymer. It is commonly used in pharmaceutical, food, and medical applications. Gelatin hydrogels can be used in drug delivery systems, wound dressings, and tissue engineering.

[0084] Hyaluronic acid and its derivatives are naturally occurring polysaccharides found in the human body, particularly in joints and skin. Its derivatives can be used to prepare hydrogels with excellent water-retention properties. Hyaluronic acid-based hydrogels have applications in ophthalmology and dermatology, and can also be used as components in dermal fillers.

[0085] Alginates, derived from brown algae, are characterized by good biocompatibility and low toxicity. They are commonly used in the pharmaceutical and food industries. In the field of hydrogels, alginates are frequently used in drug delivery systems, wound dressings, and tissue engineering scaffolds.

[0086] These hydrogel-forming polymers are selected based on their specific properties and intended applications. They can be engineered to achieve a variety of properties, such as different hardness, porosity, and degradation rates, making them versatile materials suitable for a wide range of medical and biotechnology applications.

[0087] Preferably, the functionalized hydrogel is provided in lyophilized form, with the necessary resuspension liquid.

[0088] According to a preferred embodiment, the hydrogel has been functionalized, that is, modified or treated in some way to give it specific properties or functions; depending on the specific intended use, these properties or functions may include biocompatibility, controlled drug release, or tissue regeneration capacity, etc.

[0089] According to a preferred embodiment, the hydrogel has been freeze-dried. Freeze-drying is a common method for preserving substances (especially sensitive biological or chemical materials) by removing moisture from the substance. Here, "freeze-drying" refers to the process by which the hydrogel is treated: in this process, the hydrogel is first frozen and then placed in a vacuum environment; under vacuum conditions, the frozen water is converted directly from ice to vapor without passing through a liquid phase, thus effectively removing moisture. The final product is a dry, powdery substance that is easy to store and resistant to degradation.

[0090] The surgeon's decision to select the implant and appropriate medium can be made preoperatively or intraoperatively, after which the hydrogel is resuspended in a provided liquid by a surgical assistant. After the surgeon has customized the scaffold according to the required defect site, the hydrogel is introduced into the implant through a specialized filling and dispensing mechanism; the hydrogel is then functionalized and cured into a stable form, thus forming a composite system of implant and regenerative medium.

[0091] The surgeon's decision can be made preoperatively or intraoperatively. These two options refer to the timeframe at which the surgeon determines the specific procedures for the surgical plan. If it is a preoperative decision, the surgeon will make the choice before the actual surgery begins: for example, the surgeon may assess the patient's medical history, conduct diagnostic tests, and develop a surgical plan. In this preoperative stage, they may determine various details of the surgery, including the type or material of implant to be used, surgical techniques, and the overall surgical plan.

[0092] Intraoperative decisions involve the surgeon making the decision during the procedure. This can happen when new information or unexpected situations arise after surgery has begun. For example, during surgery, the surgeon may encounter situations that differ from the initial expectations of the preoperative assessment. In such cases, they may need to adjust the surgical approach, decide on the tools or materials to use, or modify the surgical plan in real time to ensure the best possible treatment outcome for the patient.

[0093] According to a preferred embodiment, the specification includes additional information regarding the preparation and / or use of an implant containing a regenerative medium to treat bone defects. Preferably, the kit can be used for the treatment of bone defects because the specification provides detailed instructions on how to form the regenerative medium and how to inject the regenerative medium into the main chamber and multiple channels of the implant, thereby effectively treating bone defects.

[0094] Other preferred embodiments of the invention may be derived from other features mentioned in the dependent claims.

[0095] Unless otherwise stated in the specific circumstances, the various embodiments of the invention mentioned in this application may be advantageously combined with each other. Attached Figure Description

[0096] The features of the present invention will become clear to those skilled in the art through a detailed description of exemplary embodiments in conjunction with the accompanying drawings. Wherein: Figure 1 : An external view not of the first embodiment of the implant of the present invention; Figure 2 : A cross-sectional view not of the first embodiment of the implant of the present invention; Figure 3 : Perspective view not of the second embodiment of the present invention; Figure 4a : A cross-sectional view of the implant of the present invention; Figure 4b : A perspective view of the implant of the present invention; Figure 4c Detailed cross-sectional view of the implant of the present invention; Figure 5 The following figures illustrate the fluid testing results of two implants: one with a design featuring multiple cylindrical channels, and the other with a design featuring multiple conical channels. Figure A shows the percentage of filling at the first leakage for each design; Figure B shows the leakage amount at full filling for each design; and Figure C shows test example images used for quantitative analysis. Figure 6 The following diagram illustrates the fluid testing results of two implants: one with a design featuring multiple cylindrical channels, and the other with a design featuring multiple conical channels. Figure A shows the filling volume of the cylindrical channel design at the first leakage; Figure B shows the leakage volume of the cylindrical channel design at full filling; Figure C shows the filling volume of the conical channel design at the first leakage; and Figure D shows the leakage volume of the conical channel design at full filling. Figure 7 Another embodiment of the implant of the present invention is shown in Figure A, which shows a side view; Figure B shows an isometric view; and Figure C shows a cross-sectional view of the implant. The rate of decrease of the cross-sectional area of ​​the plurality of channels 30b is kept constant on average over the entire length between the first opening 35 and the second opening 36 (along the second direction Y from the first opening 35 to the second opening 36). Figure 8Another embodiment of the implant of the present invention, wherein Figure A shows an isometric view; Figure B shows a cross-sectional view of the implant; wherein for the plurality of channels, the rate of decrease of the cross-sectional area is not constant, but gradually decreases along a second direction Y from the first opening 35 to the second opening 36; Figure 9 Another embodiment of the implant of the present invention, wherein Figure A shows an isometric view; Figure B shows a cross-sectional view of the implant; wherein the walls of the main body and the plurality of channels are discontinuous; Figure 10 :exhibit Figure 9 The enlarged detailed cross-sectional view of the embodiment shows that the cross-sectional areas of the first opening 35, the intermediate opening 37, and the second opening 36 are not only different in size, but also in shape. Detailed Implementation

[0097] Reference will now be made in detail to various embodiments, examples of which are illustrated in the accompanying drawings. The effects, features, and implementation methods of exemplary embodiments will be described in conjunction with the drawings. In the drawings, the same reference numerals denote the same elements, and repeated descriptions are omitted. However, this disclosure may be embodied in many different forms and should not be construed as being limited to the embodiments shown herein. Rather, these embodiments are provided to make this disclosure more comprehensive and complete, and to fully convey the aspects and features of this disclosure to those skilled in the art.

[0098] The implant described in each embodiment is a 2×1 cm long cylinder, which is made using polylactic acid (PLA) filaments through FLM 3D printing technology.

[0099] Figure 1 This is an external view of an implant 1 that is not an exemplary embodiment of the present invention. The implants described in different embodiments have the same appearance.

[0100] The implant 1 is used to treat bone defects and includes a body 10, within which a main chamber 20 extending in a first direction X is provided. In addition, a plurality of channels 30a and 30b are provided, which penetrate the body 10 in a second direction Y and extend outward from the main chamber 20 to the external environment of the body 10.

[0101] The first direction X and the second direction Y are different from each other, and the included angle α between the first direction X and the second direction Y can be selected according to the specific application scenario. This included angle is usually selected in the range of 60° to 120°. In the attached figure, the included angle α is selected as 90°. In this case, the main chamber, which is formed as an elongated main channel, penetrates the main body along the first direction X (which can be described as a vertical direction), while multiple channels penetrate the main body along the second direction Y (which can be described as a horizontal direction).

[0102] The external shape of the implant 1 is adapted to the bone or bone defect site, and its main chamber 20 serves as the starting point of a multi-channel system. This enables the provision of an implant that is large in volume, mechanically stable, and has a porous open structure that can be uniformly filled with a viscous liquid material.

[0103] The main body 10 is, for example, cylindrical or conical, with a diameter of 1 to 4 cm, preferably 3 cm.

[0104] Multiple channels 30a and 30b are arranged along the circumference and vertical direction of the cylindrical body 10.

[0105] The implant 1 has an inlet opening 25 located at the top of the body 10. A main chamber 20 extends through this inlet opening 25. The diameter of the inlet opening 25 is smaller than the diameter of the main chamber 20. This embodiment allows for the safe introduction of fluids or substances into the implant to aid the healing process. Specifically, regenerative media can be injected into the implant through the inlet opening 25. Subsequently, the regenerative media enters the main chamber through the smaller diameter inlet opening 25; from the main chamber, fluid is guided into multiple channels extending outward from the main chamber along a second axis Y.

[0106] Each of the multiple channels 30a, 30b has a first opening facing the main chamber (in Figure 1 (Not visible in the external view shown), and a second opening 36 located on the outer surface of the body 10 and facing the external environment of the body. Channels 30a and 30b are configured to allow fluid from the main chamber 20 to communicate with the external environment of the body 10 through channels 30a and 30b.

[0107] Implant 1 is preferably used to treat bone defects. To achieve this, implant 1 needs to be filled with a regenerative medium. Advantageously, such implants can be used in conjunction with regenerative media of higher viscosity.

[0108] The system can be distributed as a modular kit, which comprises two independent components: an implant 1 and a regeneration medium. Before using the implant 1, the regeneration medium must be filled into the implant 1.

[0109] Figure 2 : Cross-sectional view not of the first embodiment of the implant of the present invention.

[0110] Multiple channels 30a are cylindrical, and their diameter remains constant as they extend outward from the main chamber 20 along the second axis Y through the main body 10. In other words, there are multiple channels 30a that penetrate the main body 10, and their diameter remains constant as they extend outward from the main chamber 20.

[0111] This design can also be described as follows: multiple channels 30a have inner diameters and outer diameters, and the inner diameters are equal to the outer diameters. The inner diameter refers to the diameter of the channel 30a at the main chamber 20, and the outer diameter refers to the diameter of the channel 30a at the outer periphery of the body 10.

[0112] The stent is tubular and bone-shaped, with a removable filler sleeve (i.e., inlet opening 25) at the top. The 3 mm thick walls, combined with a channel 30a only 0.5 mm in diameter, provide it with high mechanical strength. The cylindrical design of channel 30a is optimized for low-viscosity fluids, where an increase in volume does not lead to a strong exponential increase in internal pressure.

[0113] Implant 1 exhibits high mechanical durability due to its thicker walls and smaller volume channels. However, despite the satisfactory mechanical properties exhibited by the initial design, it may not be able to promote uniform fluid dispersion throughout the structure, either requiring a large amount of filler material or resulting in some areas remaining unfilled.

[0114] Figure 3 : Perspective view not of the second embodiment of the present invention.

[0115] As previously stated, although the first embodiment has good mechanical properties, it cannot promote the uniform distribution of fluid within the structure, either requiring a large amount of filler material or leaving unfilled areas.

[0116] In the second embodiment, these problems can be alleviated to some extent by increasing the size of the main chamber 20 and the plurality of channels 30a to reduce fluid resistance during the filling process and ensure a higher fluid volume within the implant. Similar to the first embodiment, the main chamber 20 and the plurality of channels 30a in the second embodiment are cylindrical, and their diameter remains constant as the plurality of channels 30a extend outward from the main chamber 20 through the body 10.

[0117] Specifically, the stent is tubular and bone-shaped, with a removable filler sleeve (i.e., inlet opening 25) at the top. The 3 mm thick wall, combined with multiple 1.5 mm diameter channels 30a, provides moderate mechanical strength while maintaining high fluid capacity. The large-volume, cylindrical drainage channels 30a are optimized for medium to low viscosity fluids.

[0118] However, achieving uniform fluid distribution remains a challenge because fluid resistance increases with distance from the filling point, and fluid may leak out from the outer side near the filling point before all internal areas are fully filled. Furthermore, larger channels 20, 30a significantly reduce the wall stability of the implant, leading to a decrease in its critical high mechanical strength properties.

[0119] Figure 4 shows the implant of the present invention.

[0120] Figure 4a This is a cross-sectional view of the implant 1 of the present invention.

[0121] The implant 1 of the present invention is used to treat bone defects and includes a body 10, wherein the body 10 has a main chamber 20 extending along a first direction X. In addition, it also has a plurality of channels 30a and 30b, which penetrate the body 10 along a second direction Y and extend outward from the main chamber 20 to the external environment of the body 10.

[0122] The first direction X and the second direction Y are different from each other, and the included angle α between the first direction X and the second direction Y can be selected according to the specific application scenario. This included angle is usually selected in the range of 60° to 120°. In the attached figure, the included angle α is selected as 90°. In this case, the main chamber, which is formed as an elongated main channel, penetrates the main body along the first direction X (which can be described as a vertical direction), while multiple channels penetrate the main body along the second direction Y (which can be described as a horizontal direction).

[0123] The external shape of the implant 1 is adapted to the bone or bone defect site, and its main chamber 20 serves as the starting point of a multi-channel system. This enables the provision of an implant that is large in volume, mechanically stable, and has a porous open structure that can be uniformly filled with a viscous liquid material.

[0124] The main body 10 is, for example, cylindrical or conical, with a diameter of 1 to 4 cm, preferably 3 cm.

[0125] Multiple channels 30a and 30b are arranged along the circumference and vertical direction of the cylindrical body 10.

[0126] The implant 1 has an inlet opening 25 located at the top of the body 10. A main chamber 20 extends through this inlet opening 25. The diameter of the inlet opening 25 is smaller than the diameter of the main chamber 20. This embodiment allows for the safe introduction of fluids or substances into the implant to aid the healing process. Specifically, regenerative media can be injected into the implant through the inlet opening 25. Subsequently, the regenerative media enters the main chamber through the smaller diameter inlet opening 25; from the main chamber, fluid is guided into multiple channels extending outward from the main chamber along a second axis Y.

[0127] Each of the multiple channels 30a, 30b has a first opening facing the main chamber (in Figure 1 (Not visible in the external view shown), and a second opening 36 located on the outer surface of the body 10 and facing the external environment of the body. Channels 30a and 30b are configured to allow fluid from the main chamber 20 to communicate with the external environment of the body 10 through channels 30a and 30b.

[0128] Implant 1 is preferably used to treat bone defects. To achieve this, implant 1 needs to be filled with a regenerative medium. Advantageously, such implants can be used in conjunction with regenerative media of higher viscosity.

[0129] The system can be distributed as a modular kit, which comprises two independent components: an implant 1 and a regeneration medium. Before using the implant 1, the regeneration medium must be filled into the implant 1.

[0130] As previously mentioned, the first embodiment, which is not part of this invention, may not promote uniform dispersion of fluid throughout the structure. On the other hand, in the second embodiment, which is not part of this invention, the larger channels 20, 30a significantly reduce the wall stability of the implant, resulting in a decrease in its critical high mechanical strength properties.

[0131] These problems not found in the first and second embodiments of this invention can be addressed by... Figure 4a The implant 1 of the present invention shown provides relief, wherein a plurality of channels 30b are provided through the main body 10, which gradually narrow as they extend from the main chamber 20 in the second direction Y.

[0132] The implant of the present invention minimizes the uneven distribution of low-viscosity and high-viscosity fluids within a stable, porous, open support structure by taking into account the fluid dynamics characteristics of the fluid and the size of the implant 1 of the present invention.

[0133] This ensures rapid and uniform infusion while maintaining wall thickness and mechanical strength, and keeps the implanted body at a high fluid volume.

[0134] Figure 4b A perspective view of the implant of the present invention is shown.

[0135] The stent is shaped like a tubular bone with a removable filling sleeve (i.e., inlet opening 25) at the top. A wall thickness of 3 mm, combined with 96 channels 30b with gradually decreasing diameters, provides high mechanical strength while maintaining high fluid capacity and near-complete distribution. The shape of the channels 30b is optimized for both high-viscosity and low-viscosity fluids, ensuring high capacity without significantly sacrificing mechanical stability.

[0136] The implant 1 of this invention minimizes the uneven distribution of low-viscosity and high-viscosity liquids within a stable, porous, open support structure by considering the hydrodynamic properties of the liquid and the size of the implant. The diameter of channel 30b decreases with increasing distance from the filling point, reaching its minimum at the outlet point. This ensures rapid and uniform infusion while maintaining wall thickness (and thus mechanical strength), and maintains a high fluid volume within the implant. The pore size and the degree of pore size reduction are determined and adjusted based on the viscosity and wetting behavior of the liquid relative to the carrier material.

[0137] Figure 4c is a detailed cross-sectional view of the implant of the present invention. The view clearly shows that the diameter of the multiple channels 30b and the autonomous cavity 10 is gradually set as they extend outward along the Y direction.

[0138] Each of the multiple channels 30a and 30b has a first opening 35 facing the main cavity and a second opening 36 facing the outside of the implant body. The structural design of each channel 30a and 30b allows the fluid self-cavity 20 to flow through the channels 30a and 30b to the external environment of the implant body 10.

[0139] Multiple channels 30b are tapered structures, each having an inner diameter DI and an outer diameter DO. The inner diameter DI is the diameter of the channel 30b at the first opening 35 facing the main cavity 20, and the outer diameter DO is the diameter of the channel 30b at the outer periphery of the implant body 10, with the inner diameter DI being larger than the outer diameter DO. In other words, the multiple transverse channels 30b penetrating the implant body 10 gradually narrow as the main cavity 20 extends along the second direction Y. In a preferred embodiment, the inner diameter DI ranges from 1.25 mm to 1.55 mm, and the outer diameter DO ranges from 0.25 mm to 0.75 mm; a more preferred diameter gradient is narrowing from 1.45 mm to 0.5 mm. The general range for the implant 1 of this invention is: inner diameter can be set to 1.25 mm to 4 mm, and outer diameter can be set to 0.2 mm to 3 mm.

[0140] Fluid testing of the implant of this invention.

[0141] Fluid validation experiments were conducted using a simplified implant design to compare the performance differences between conical and cylindrical fluid channels with repeatable structures. The fillable volumes of the two designs are comparable. All geometries were fabricated using mask stereolithography with transparent PLA UV resin, and were processed strictly according to the manufacturer's specifications.

[0142] A polypropylene glycol-water mixture (viscosity 200 mPa·s) dyed with 1% black ink was injected into two types of printed structures at a constant flow rate of 6 mL / min, and the injection volume was quantified over time. The experiment used "leak-free fill percentage" (fill volume / geometric volume) and "additional volume required for complete fill" (leakage percentage, leakage volume / geometric volume) as evaluation indicators to compare the two channel designs. Each design had four technical replicates. Experimental results are expressed as mean ± standard deviation, and t-tests were used to verify the statistical significance of differences. Figure 5 A, B).

[0143] The fill percentage of the tapered channel design was 89.6%, which is more than 7% higher than that of the cylindrical channel design (82.2%). Figure 5 A, Figure 5 C (top row).

[0144] The leakage volume of a cylindrical channel design when fully filled is 6.5 times that of a conical geometry—the former has a leakage percentage of 21.5%, while the latter has a leakage percentage of 3.2%. Figure 5 B. Figure 5 (C bottom row).

[0145] Both of the above comparison results were statistically significant.

[0146] like Figure 6 As shown in A and 6C, the corresponding cylindrical channel design ( Figure 6 Compared to A), the tapered channel design ( Figure 6 C) It exhibits a significantly higher fill level when the first drop of liquid begins to leak.

[0147] like Figure 6 As shown in B and 6D, the corresponding cylindrical channel design ( Figure 6 Compared to B, where leakage is more pronounced, the tapered channel design (B) is more effective. Figure 6 D) It exhibits significantly lower leakage fill when the channel is fully filled.

[0148] Therefore, the tapered channel design achieves a significantly higher filling degree before the first drop of liquid begins to leak; and when achieving uniform (complete) filling of the geometry, a significantly smaller leakage volume is required.

[0149] Further embodiments of the implant of the present invention.

[0150] Figure 7 Another embodiment of the implant of the present invention is shown, wherein Figure 7 A is a side view; Figure 7 B is an isometric view; Figure 7 C is a cross-sectional view of the implant. Figure 7 The main difference between the embodiment shown in Figure 4 and the embodiment shown in Figure 5 is that the implant body is formed by multiple sets of "V"-shaped spiral structures wound around the main cavity. One set of spiral structures is wound clockwise, and the second set of spiral structures is wound counterclockwise. The spiral structures interweave with each other to form a mesh structure with conical channels 30b. In addition, the cross-sections of the first opening 35 and the second opening 36 are both rhomboid. This rhomboid structure can increase the outer surface area of ​​the implant to achieve more cell surface interactions. In this embodiment of the implant of the present invention, the multiple channels 30b are in a constant tapering shape, that is, the average rate of decrease in the cross-sectional area of ​​the channels remains constant along the entire length from the first opening 35 to the second opening 36 (extending along the second direction Y from the first opening 35 to the second opening 36).

[0151] Figure 8 Another embodiment of the implant of the present invention is shown, wherein Figure 8 A is an isometric view; Figure 8 B is a cross-sectional view of the implant. Figure 8 The illustrated embodiments and Figure 7 The main difference in the illustrated embodiment is that the channel 30b is non-constantly tapering, that is, for the multiple channels 30b, the rate of decrease in their cross-sectional area is not constant, but gradually decreases as they extend along the second direction Y from the first opening 35 to the second opening 36.

[0152] Figure 9 Another embodiment of the implant of the present invention is shown, wherein Figure 9 A is an isometric view; Figure 9 B is a cross-sectional view of the implant. Figure 9 The difference between the embodiment shown in Figure 4 and the embodiment shown in Figure 5 is that the walls of the implant body and the walls of the multiple channels are discontinuous structures, i.e., there are gaps in the walls. The implant body is not an integral structure with embedded channels, but rather an open stent. Among the multiple channels, channel 30b not only has a first opening 35 and a second opening 36, but also one or more intermediate openings 37 can be provided between the first opening 35 and the second opening 36 along the second direction Y. The cross-sectional shapes of the first opening 35, the second opening 36, and each intermediate opening 37 are different, and the cross-sectional area decreases in a decreasing trend—from the first opening 35 with the largest cross-sectional area, to the intermediate opening 37 with the middle cross-sectional area, and then to the second opening 36 with the smallest cross-sectional area.

[0153] Figure 10 It shows Figure 9 The enlarged and more detailed cross-sectional view of the embodiment shown shows that the cross-sections of the first opening 35, the intermediate opening 37, and the second opening 36 are not only different in size, but also different in shape.

[0154] Reference symbol 1. Implant 10 main bodies 20 main chamber 25 entrance openings 30a Multiple channels 30b Multiple Channels 35 First Opening 36 Second opening 37 Opening in the middle DI inner diameter DO outer diameter X First Direction Y second direction α is the angle between the first direction and the second direction.

Claims

1. An implant (1), comprising: One body(10); A main cavity (20) is formed within the body (10), wherein the chamber of the main cavity (20) can be entered through an inlet opening (25), the inlet opening (25) enabling fluid communication between the chamber of the main cavity (20) and the external environment of the body (10); Multiple channels (30a, 30b) are formed within the body (10), each of the multiple channels (30a, 30b) having a first opening (35) facing the main cavity (20) and a second opening (36) facing the external environment of the body (10), and the channels (30a, 30b) are configured to allow the fluid autonomous cavity (20) to flow through the channels (30a, 30b) to the external environment of the body (10); wherein the cross-sectional area of ​​the first opening of at least one of the multiple channels is greater than the cross-sectional area of ​​the second opening of at least one of the multiple channels; preferably, at least one of the multiple channels has a conical structure.

2. The implant (1) according to claim 1, characterized in that, The main cavity (20) extends within the body (10) along a first direction (X); The plurality of channels (30a, 30b) extend through the body (10) along the second direction (Y); wherein, The first direction (X) and the second direction (Y) are different from each other, and the included angle α between the first direction (X) and the second direction (Y) ranges from 60° to 120°; more preferably, the included angle α ranges from 75° to 105°; even more preferably, the included angle α ranges from 85° to 95°; most preferably, the included angle α is 90°.

3. The implant (1) according to any of the preceding claims, characterized in that, The diameter of at least one of the plurality of channels (30b) gradually decreases along the second direction (Y) from the self-cavity (20) through the body (10) toward the external environment, such that the inner diameter (DI) at the first opening (35) is greater than the outer diameter (DO) at the second opening (36).

4. The implant (1) according to any of the preceding claims, characterized in that, At least one of the plurality of channels (30b) has a conical structure.

5. The implant (1) according to any of the preceding claims, characterized in that, The inner diameter (DI) ranges from 1.25 mm to 4 mm; the outer diameter (DO) ranges from 0.2 mm to 3 mm.

6. The implant (1) according to any of the preceding claims, characterized in that, The average diameter of the main cavity (20) ranges from 2 mm to 4 mm; preferably, the diameter of the main cavity (20) remains constant along the first direction (X).

7. The implant (1) according to any of the preceding claims, characterized in that, The plurality of channels (30a, 30b) are arranged in a regular pattern along the axis extending in the first direction (X).

8. The implant (1) according to any of the preceding claims, characterized in that, The body (10) and / or the main cavity (20) are cylindrical in shape.

9. The implant (1) according to any of the preceding claims, characterized in that, The diameter of the inlet opening (25) is smaller than the average diameter of the main cavity (20).

10. The implant (1) according to any of the preceding claims, characterized in that, The main cavity (20) and at least one of the plurality of channels (30a, 30b) contain a regeneration medium; preferably, each of the main cavity (20) and the plurality of channels (30a, 30b) contains a regeneration medium.

11. The implant (1) according to claim 10, characterized in that, The regeneration medium comprises or is composed of hydrogels.

12. A kit, characterized in that, include: The implant (1) according to any one of claims 1 to 11; At least one, more than one or all of the components used to form the regeneration medium, preferably the components used to form the hydrogel; as well as Optionally, a specification containing detailed instructions on how to form the regeneration medium and how to inject the regeneration medium into the main lumen (20) and multiple channels (30a, 30b) of the implant (1).

13. The kit according to claim 12, characterized in that: The specification also contains additional information regarding the preparation of regenerative media and / or the use of implants (1) containing regenerative media for the treatment of bone defects, particularly segmental and critical bone defects.

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