Intervertebral fusion prosthesis

Abstract

The application provides an intervertebral fusion prosthesis, which comprises a prosthesis body having a receiving cavity; two prosthesis end plates respectively located at two ends of the prosthesis body, a surface of the prosthesis end plate away from the prosthesis body having a first porous structure, and the prosthesis end plate being made of a degradable material; two built-in support bodies movably arranged in the receiving cavity, the two built-in support bodies being connected with the two prosthesis end plates in a one-to-one correspondence, and a surface of the built-in support body having a second porous structure; and an elastic intermediate body arranged in the receiving cavity and located between the two built-in support bodies, the elastic intermediate body being connected with the built-in support bodies so as to make the two built-in support bodies move away from each other. Through the technical scheme provided in the application, the problem that the intervertebral fusion prosthesis in the related art cannot simultaneously solve the problems of poor elastic modulus matching and poor bone integration effect can be solved.

Description

Technical Field

[0001] This invention relates to the field of prosthesis technology, and more specifically, to an interbody fusion prosthesis. Background Technology

[0002] In the field of spinal surgery, interbody fusion is a common surgical procedure used to treat various conditions such as intervertebral disc degeneration, spondylolisthesis, and spinal fractures. To achieve intervertebral fusion, a fusion prosthesis is typically implanted to replace the damaged intervertebral disc and maintain the height of the intervertebral space, promoting bone fusion between the vertebral bodies above and below the disc. Currently, the mainstream materials for intervertebral fusion prostheses on the market mainly include titanium alloys, tantalum metal, and PEEK (polyether ether ketone), which are widely used due to their high strength and corrosion resistance.

[0003] However, traditional titanium alloy and tantalum prostheses suffer from insufficient bioactivity. These materials themselves lack the ability to promote bone regeneration, resulting in an inability to form an effective biological bond with human bone tissue after implantation, affecting the effectiveness and speed of bone fusion. Furthermore, the high elastic modulus of titanium alloys and tantalum far exceeds that of human bone tissue. This mismatch leads to uneven stress distribution on the vertebral body post-surgery, especially in patients with osteoporosis. This can easily cause stress shielding, where the prosthesis bears most of the load after implantation, while the stress on the surrounding bone tissue is reduced. This can potentially lead to bone atrophy, decreased long-term prosthesis stability, and even prosthesis subsidence or displacement.

[0004] On the other hand, while PEEK prostheses possess good biocompatibility and a low elastic modulus, making them closer to human bone tissue, they have significant limitations in promoting osseointegration. PEEK is a bioinert material and cannot actively promote bone growth and fusion; therefore, after implantation, its osseointegration with the vertebral body is weak, affecting the prosthesis's fixation effectiveness. Furthermore, the smooth surface of PEEK material results in poor physical stability in the initial implantation stage, which also limits its application in interbody fusion surgery.

[0005] In summary, among the relevant technologies, neither high-strength metal materials nor bio-inert PEEK materials can simultaneously solve the problems of poor elastic modulus matching and poor osseointegration. Summary of the Invention

[0006] This invention provides an interbody fusion prosthesis to solve the problem that interbody fusion prostheses in related technologies cannot simultaneously address the issues of poor elastic modulus matching and poor osseointegration.

[0007] This invention provides an interbody fusion prosthesis, comprising: a prosthesis body having a receiving cavity; two prosthesis endplates located at opposite ends of the prosthesis body, the surfaces of the endplates away from the prosthesis body having a first porous structure, the endplates being made of a biodegradable material; two internal supports movably disposed within the receiving cavity, the two internal supports being connected to the two prosthesis endplates one-to-one, the surfaces of the internal supports having a second porous structure; and an elastic intermediate body disposed within the receiving cavity and located between the two internal supports, the elastic intermediate body being connected to the internal supports to keep the two internal supports away from each other.

[0008] Furthermore, there are bone-filled gaps between the elastic intermediate and the surfaces of the two built-in supports.

[0009] Furthermore, the elastic intermediate includes a substrate and an elastic mechanism. There is a bone-filling gap between the surface of the substrate and the two built-in supports. The elastic mechanism is located within the bone-filling gap. One end of the elastic mechanism is connected to the substrate, and the other end of the elastic mechanism is connected to the corresponding built-in support.

[0010] Furthermore, the prosthetic endplate is provided with a connecting post, the built-in support is provided with a first connecting through hole, the substrate is provided with a second connecting through hole corresponding to the first connecting through hole, and the connecting post passes through the first connecting through hole and the second connecting through hole.

[0011] Furthermore, the connecting column is equipped with bone graft holes.

[0012] Furthermore, the end of the built-in support facing closer to the substrate is provided with a first implantation hole for implanting a biodegradable material; and / or, the substrate is provided with a second implantation hole for implanting a biodegradable material.

[0013] Furthermore, the substrate surface is provided with a plurality of strip-shaped flow channels, the plurality of strip-shaped flow channels penetrate the sidewall of the substrate in a first direction, and the plurality of strip-shaped flow channels are spaced apart in a second direction perpendicular to the first direction; and / or, the substrate is provided with a plurality of hole-shaped flow channels, the plurality of hole-shaped flow channels are spaced apart along the circumference of the substrate.

[0014] Furthermore, the end of the built-in support facing the corresponding prosthetic endplate is provided with a riveting protrusion, and the prosthetic endplate is provided with a riveting hole, with the riveting protrusion inserted into the riveting hole.

[0015] Furthermore, a bone extension hole is provided at the end of the riveting protrusion away from the built-in support; and / or, multiple riveting protrusions are provided on the built-in support, the multiple riveting protrusions are arranged at intervals along the circumference of the built-in support, and multiple riveting holes are provided on the prosthesis endplate, the multiple riveting holes being provided one-to-one with the multiple riveting protrusions.

[0016] Furthermore, the prosthesis body includes a frame and multiple porous layers. The frame has multiple spaced-apart mounting ports, and the multiple porous layers are installed one-to-one within the multiple mounting ports. The frame and the multiple porous layers together form a receiving cavity. And / or, both the prosthesis body and the built-in support are anodized. And / or, the interbody fusion prosthesis also includes a fixation element, which includes a fixation plate and fixation pins disposed on the fixation plate. The fixation pins have a third implantation hole for implanting biodegradable materials. The fixation element is anodized.

[0017] The interbody fusion prosthesis of this invention comprises a prosthesis body, two prosthetic endplates, two internal supports, and an elastic intermediate. Utilizing the properties of the biodegradable material and the dynamic adjustment capability of the elastic intermediate, it achieves the dual objectives of adaptive height compensation and bone tissue growth after prosthesis implantation. As the prosthetic endplates begin to degrade, the elastic intermediate gradually expands the two internal supports to compensate for the height loss caused by endplate degradation, thereby maintaining intervertebral disc stability, reducing prosthesis subsidence, and improving surgical success rate.

[0018] Furthermore, because the surface of the prosthesis endplate furthest from the prosthesis body has a first porous structure, and the surface of the internal support has a second porous structure, the combination of the first and second porous structures can improve the osseointegration effect of the interbody fusion prosthesis. Additionally, since the two internal supports are movably disposed within the receiving cavity, the elastic intermediate and the two internal supports can improve the elastic modulus matching effect. In summary, this interbody fusion prosthesis can simultaneously solve the problems of poor elastic modulus matching and poor osseointegration. Attached Figure Description

[0019] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings:

[0020] Figure 1 A schematic diagram of the structure of an interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0021] Figure 2 A cross-sectional view of an interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0022] Figure 3 A schematic diagram of the structure of the prosthesis body of the interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0023] Figure 4 A schematic diagram of the prosthetic endplate of an interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0024] Figure 5This diagram shows a structural schematic of the prosthetic endplate of the interbody fusion prosthesis provided according to an embodiment of the present invention from another perspective;

[0025] Figure 6 A schematic diagram of the internal support structure of the interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0026] Figure 7 It shows Figure 6 A schematic diagram of the riveting protrusion in the diagram;

[0027] Figure 8 This diagram shows a structural schematic of the internal support of the interbody fusion prosthesis provided according to an embodiment of the present invention from another perspective;

[0028] Figure 9 A schematic diagram of the structure of the elastic intermediate of the interbody fusion prosthesis provided according to an embodiment of the present invention is shown;

[0029] Figure 10 A schematic diagram of the fixation component of an interbody fusion prosthesis provided according to an embodiment of the present invention is shown.

[0030] The above figures include the following reference numerals:

[0031] 10. Prosthesis body; 11. Receptive cavity; 12. Frame; 13. Porous layer;

[0032] 20. Prosthetic endplate; 21. Connecting post; 211. Bone graft hole; 22. Riveting hole;

[0033] 30. Built-in support; 31. First connecting through hole; 32. First implantation hole; 33. Riveting protrusion; 331. Bone growth inlet hole; 34. Elastic mechanism connecting hole;

[0034] 40. Elastic intermediate; 41. Substrate; 411. Second connecting through hole; 412. Second implantation hole; 413. Strip-shaped flow channel; 414. Hole-shaped flow channel; 42. Elastic mechanism;

[0035] 50. Bone filling interval;

[0036] 60. Fixing component; 61. Fixing plate; 62. Fixing pin; 621. Third implantation hole. Detailed Implementation

[0037] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the present invention or its application or use. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0038] like Figures 1 to 10 As shown, this embodiment of the invention provides an interbody fusion prosthesis, which includes a prosthesis body 10, two prosthesis endplates 20, two internal supports 30, and an elastic intermediate body 40. The prosthesis body 10 has a receiving cavity 11. The two prosthesis endplates 20 are located at opposite ends of the prosthesis body 10, and the surfaces of the prosthesis endplates 20 away from the prosthesis body 10 have a first porous structure. The prosthesis endplates 20 are made of a biodegradable material. The two internal supports 30 are movably disposed within the receiving cavity 11, and are connected one-to-one with the two prosthesis endplates 20. The surfaces of the internal supports 30 have a second porous structure. The elastic intermediate body 40 is disposed within the receiving cavity 11 and located between the two internal supports 30. The elastic intermediate body 40 is connected to the internal supports 30 so that the two internal supports 30 are spaced apart.

[0039] The interbody fusion prosthesis provided in this embodiment utilizes the properties of biodegradable materials and the dynamic adjustment capability of the elastic intermediate 40 to achieve the dual objectives of adaptive height compensation and bone tissue growth after prosthesis implantation. When the prosthesis endplate 20 begins to degrade, the elastic intermediate 40 gradually expands the two internal supports 30 to compensate for the height loss caused by the degradation of the prosthesis endplate, thereby maintaining the stability of the intervertebral space, reducing prosthesis subsidence, and improving the success rate of the surgery.

[0040] Furthermore, since the surface of the prosthesis endplate 20 furthest from the prosthesis body 10 has a first porous structure, and the surface of the internal support 30 has a second porous structure, the combination of the first and second porous structures can improve the osseointegration effect of the interbody fusion prosthesis. Additionally, since the two internal supports 30 are movably disposed within the receiving cavity, the elastic intermediate 40 and the two internal supports 30 can improve the elastic modulus matching effect. In summary, this interbody fusion prosthesis can simultaneously solve the problems of poor elastic modulus matching and poor osseointegration.

[0041] In this embodiment, both the first porous structure and the second porous structure are bone-like trabecular structures.

[0042] Specifically, the built-in support 30 is entirely composed of bone-like trabecular structures. The built-in support 30 is manufactured from orthopedic implant materials such as titanium and titanium alloys, and tantalum metal.

[0043] The prosthetic endplate is made of biodegradable metallic materials, such as magnesium and magnesium alloys.

[0044] In some embodiments, the surface of the prosthetic endplate 20 is provided with a coating to alter the degradation rate of the prosthetic endplate 20, thereby matching the rate of intervertebral fusion in the human body. By providing the coating, the degradation rate of the prosthetic endplate 20 can be adapted to individuals with different physical conditions (e.g., different age groups).

[0045] Specifically, the coatings include, but are not limited to, polymer coatings, oxide coatings, calcium phosphate coatings, and drug-release coatings. 1) Polymer coatings include coatings formed from biodegradable polymers such as polylactic acid (PLA), polycaprolactone (PCL), and polyhydroxybutyrate (PHB). These materials can delay direct contact between the metal surface and body fluids, thereby controlling the degradation rate. Through their slow degradation characteristics, polymer coatings gradually expose the metal matrix of the prosthetic endplate, thus controlling the degradation rate of the metal and ensuring it matches the process of intervertebral fusion. 2) Oxide coatings include magnesium oxide or magnesium hydroxide coatings formed through anodizing. This coating forms on the surface of magnesium alloys and slows down the degradation rate of the magnesium alloy. The oxide coating acts as a barrier to reduce direct reaction between the metal and body fluids, while magnesium oxide is a biocompatible material, and its degradation products can further promote bone tissue growth. 3) Calcium phosphate coatings include calcium phosphate-based bioactive coatings such as hydroxyapatite (HA) and tricalcium phosphate (TCP). Calcium phosphate coatings not only possess excellent biocompatibility and osteogenic properties, but also exhibit slow degradation. The degradation rate can be adjusted based on the coating thickness and composition, allowing for synchronized degradation of the prosthesis endplate with bone fusion. 4) Drug-release coatings are polymer coatings containing growth factors such as bone morphogenetic proteins (BMPs), antibacterial drugs, or anti-inflammatory drugs. These coatings control metal degradation while simultaneously releasing drugs to promote bone tissue growth, prevent infection, or reduce postoperative inflammation, further optimizing the biomedical performance of the implant.

[0046] In general, by selecting appropriate coating materials and techniques, the degradation rate of the prosthetic endplate can be adjusted to meet the needs of patients of different ages and health conditions, as well as the dynamic process of interbody fusion.

[0047] In some embodiments, the interbody fusion prosthesis includes a control unit, a drive unit, and a detection unit capable of real-time monitoring of the degradation degree of the prosthesis endplate. The control unit is signal-connected to both the drive unit and the detection unit. The control unit controls the operation of the drive unit based on parameters detected by the detection unit. The drive unit precisely controls the compensation action of the elastic intermediate, ensuring that the fine-tuning of the intervertebral disc height meets the patient's actual needs and improving the personalization of prosthesis implantation. For example, the drive unit is an electric push rod, with both ends connected to two built-in supports 30. The extension or retraction of the electric push rod precisely controls the compensation action of the elastic intermediate.

[0048] It should be noted that the elastic intermediate 40 can be designed in various structural forms to provide appropriate elastic support while allowing for the ingrowth of biomaterials and the growth of bone tissue. The elastic intermediate 40 can be entirely elastic or only partially elastic. Examples of specific structures are as follows:

[0049] (1) Helical spring structure: Similar to common mechanical springs, the elastic intermediate can be designed as a helical spring made of metal or polymer materials and embedded in the holes inside the prosthesis. This structure can provide uniform elastic support while allowing biomaterial to fill the gaps in the helical structure.

[0050] (2) Mesh elastic structure: A mesh structure made of elastic metal or polymer materials, such as titanium alloy mesh or PEEK mesh similar to spring steel. The mesh can serve as a channel for the implantation of biomaterials, while the mesh structure itself provides elastic recovery force to compensate for the height loss after the prosthesis endplate degrades.

[0051] (3) Corrugated structure: The elastic intermediate can be designed as a corrugated shape made of elastic material, such as silicone or specific engineering plastics. The corrugated tube has good deformability and can adapt to the degradation process of the prosthesis endplate, maintaining the prosthesis height through stretching and compression.

[0052] (4) Elastic foam structure: Foam materials with high elastic recovery rate (such as polyurethane foam) are used, and the interior can have an open or closed pore structure. These pores not only allow the permeation of biomaterials, but also expand after the prosthesis endplate degrades, maintaining the stability and height of the prosthesis.

[0053] like Figure 2 As shown, in this embodiment, bone-filling gaps 50 are provided between the surfaces of the elastic intermediate 40 and the two built-in supports 30. The presence of the bone-filling gaps 50 is to provide additional space for implantation of bone-filling material, thereby further improving bone ingrowth and osseointegration, and enhancing the biocompatibility and long-term stability of the prosthesis.

[0054] like Figure 2 and Figure 9 As shown, in this embodiment, the elastic intermediate 40 includes a base plate 41 and an elastic mechanism 42. The base plate 41 and the surfaces of the two built-in supports 30 each have bone-filling gaps 50. The elastic mechanism 42 is located within the bone-filling gaps 50, with one end connected to the base plate 41 and the other end connected to the corresponding built-in support 30. The ingenious aspect of this structure is that the elastic mechanism 42 can automatically unfold during the degradation of the prosthesis endplate 20, compensating for height loss without interfering with the implantation of the bone-filling material. The base plate 41, acting as a support platform, ensures the stability and positioning accuracy of the elastic mechanism 42, while the dynamic characteristics of the elastic mechanism 42 guarantee the adaptability of the prosthesis at different stages. This design significantly improves the accuracy and success rate of interbody fusion surgery. The adaptive compensation mechanism of the elastic mechanism 42 can better adapt to individual differences and reduce the occurrence of complications.

[0055] It should be noted that the elastic mechanism 42 plays a crucial role in the design of interbody fusion prostheses, especially in compensating for height changes caused by endplate degradation and maintaining intervertebral disc stability. Below are some examples of specific structures:

[0056] (1) Spring structure: A helical spring is provided between the built-in support 30 and the base plate 41.

[0057] (2) Bellows-type elastic support: Similar to the bellows compensator in the hydraulic system, it is made of medical-grade metal or polymer material (such as PEEK) into a bellows-shaped elastic support and placed around the connecting through hole.

[0058] (3) Elastic polymer skeleton: Construct a three-dimensional skeleton composed of medical-grade elastic polymer (such as polyester or polyurethane), with micropores on the skeleton, which can be implanted between the prosthesis endplate and the substrate.

[0059] In this embodiment, the elastic mechanism 42 is a helical spring, which has the advantages of simple structure and low cost.

[0060] Specifically, the prosthesis endplate 20 is provided with a connecting post 21, the internal support 30 is provided with a first connecting through hole 31, and the base plate 41 is provided with a second connecting through hole 411 corresponding to the first connecting through hole 31. The connecting post 21 passes through the first connecting through hole 31 and the second connecting through hole 411. With the above structure, the connecting post 21 will also degrade after implantation, thereby promoting bone formation from within the prosthesis.

[0061] Furthermore, the connection column 21 ensures the positioning accuracy and stability between the prosthesis endplate 20, the built-in support 30, and the base plate 41, maintaining structural integrity even under the complex loads of the spine. The alignment and insertion process of the first connecting through hole 31 and the second connecting through hole 411 not only simplifies the assembly process of the prosthesis but also ensures precise docking between components, improving the overall stability of the prosthesis.

[0062] In this embodiment, both the substrate 41 and the built-in support 30 are provided with elastic mechanism connection holes 34, and the two ends of the elastic mechanism 42 are respectively inserted into the elastic mechanism connection holes of the substrate 41 and the built-in support 30.

[0063] like Figure 5 As shown, in this embodiment, the connecting column 21 is provided with a bone graft hole 211. The bone graft hole 211 is designed to promote bone tissue growth. By implanting bone filling material into the bone graft hole 211, the osseointegration process can be accelerated, and the biocompatibility between the prosthesis and the vertebral body can be enhanced.

[0064] like Figure 8 As shown, in this embodiment, the end of the built-in support 30 facing near the substrate 41 is provided with a first implantation hole 32 for implanting biodegradable materials, and the substrate 41 is provided with a second implantation hole 412 for implanting biodegradable materials. The provision of the first implantation hole 32 and the second implantation hole 412 provides a pathway for bone formation within the prosthesis. By implanting biodegradable materials such as magnesium and magnesium alloys, bone tissue growth can be further promoted, improving osseointegration. The advantage of this design is that even after the prosthesis endplate 20 degrades, bone formation can continue within the prosthesis through the biodegradable materials implanted in the implantation holes, thereby maintaining the stability of the intervertebral space and the bioactivity of the prosthesis, and extending the effective service life of the prosthesis.

[0065] like Figure 9 As shown, in this embodiment, the surface of the substrate 41 is provided with a plurality of strip-shaped flow channels 413. The plurality of strip-shaped flow channels 413 penetrate the sidewall of the substrate 41 in a first direction, and are spaced apart in a second direction perpendicular to the first direction. The substrate 41 is also provided with a plurality of perforated flow channels 414, which are spaced apart along the circumference of the substrate 41. The strip-shaped flow channels 413 and the perforated flow channels 414 are designed to increase the surface roughness of the substrate 41 and improve hydrophilicity, thereby promoting the attachment and growth of bone tissue.

[0066] Specifically, both the strip-shaped flow channel 413 and the aperture-shaped flow channel 414 are processed by laser etching technology. The application of laser etching technology ensures the precision and uniformity of the flow channels, providing an ideal microenvironment for the growth of bone cells.

[0067] This design is particularly suitable for situations requiring accelerated osseointegration, such as interbody fusion surgery for elderly or osteoporotic patients. During the postoperative recovery period, bone cells can rapidly attach and grow along the guidance of the flow channel, shortening the fusion time between bone tissue and the prosthesis and improving the overall surgical outcome.

[0068] In this embodiment, the substrate 41 is made of PEEK.

[0069] like Figure 6 As shown, in this embodiment, the end of the built-in support 30 facing the corresponding prosthetic endplate 20 is provided with a riveting protrusion 33, and the prosthetic endplate 20 is provided with a riveting hole 22, into which the riveting protrusion 33 is inserted. The cooperation between the riveting protrusion 33 and the riveting hole 22 ensures a stable connection between the prosthetic endplate 20 and the built-in support 30, maintaining the integrity of the structure even under dynamic loads on the spine.

[0070] Furthermore, as the prosthesis endplate 20 degrades, the riveting protrusion 33 will directly contact the vertebral body, playing an anchoring role, preventing the prosthesis from shifting or falling off, and improving the long-term stability of the prosthesis.

[0071] like Figure 7 As shown, in this embodiment, a bone growth port 331 is provided at the end of the riveting protrusion 33 that is away from the built-in support 30. The design of the bone growth port 331 provides a growth channel for bone tissue, allowing bone cells to grow from the vertebral body into the prosthesis, strengthening the integration of bone tissue and prosthesis, and improving the fusion rate of the surgery.

[0072] In this embodiment, the built-in support 30 is provided with multiple riveting protrusions 33, which are arranged at intervals along the circumference of the built-in support 30. The prosthesis endplate 20 is provided with multiple riveting holes 22, which are arranged one-to-one with the multiple riveting protrusions 33. The arrangement of multiple riveting protrusions 33 and multiple riveting holes 22 increases the number of connection points of the prosthesis, improves the reliability and stability of the connection, and can maintain the position of the prosthesis even under extreme conditions. Furthermore, after surgical implantation, bone tissue will gradually grow into the multiple bone ingrowth holes 331, forming a stable biological connection, reducing the risk of prosthesis displacement, and providing patients with more durable vertebral support and a better postoperative experience.

[0073] like Figure 3 As shown, in this embodiment, the prosthesis body 10 includes a frame 12 and multiple porous layers 13. The frame 12 has multiple spaced mounting openings, and the multiple porous layers 13 are installed one-to-one within the multiple mounting openings. The frame 12 and the multiple porous layers 13 together form a receiving cavity 11. The combination of the frame 12 and the porous layers 13 ensures the structural strength of the prosthesis body 10 while providing the porous structure required for bone tissue growth, achieving a balance between mechanical support and bioactivity.

[0074] In this embodiment, both the prosthesis body 10 and the built-in support 30 are anodized. Anodizing not only improves the corrosion resistance of the material, but also allows the introduction of ions such as Ca, Mn, Cu, Ag, Zn, and P, further enhancing the bioactivity and antibacterial properties of the prosthesis and creating a healthier rehabilitation environment for patients.

[0075] Specifically, the porous layer 13 has a trabecular bone structure. The prosthesis body 10 is made of orthopedic implant materials such as titanium and titanium alloys or tantalum metal. The solid structure increases the strength of the prosthesis, while the trabecular bone structure enhances bone ingrowth. Simultaneously, the prosthesis body undergoes anodizing treatment to enhance corrosion resistance.

[0076] It should be noted that because both the prosthesis body and the internal support structure have a trabecular bone structure, the elastic modulus of the prosthesis can be significantly reduced. Furthermore, the prosthesis endplate is made of biodegradable materials such as magnesium and magnesium alloys, and the matrix is ​​made of PEEK, both materials having even lower elastic moduli. Thus, through the selection of these structural materials, the overall elastic modulus of the prosthesis is significantly reduced, allowing its elastic modulus to match that of the human vertebral bone tissue, reducing prosthesis subsidence, and improving the clinical application effect of the prosthesis.

[0077] like Figure 10 As shown, in this embodiment, the interbody fusion prosthesis also includes a fixation member 60, which includes a fixation plate 61 and fixation pins 62 disposed on the fixation plate 61. The fixation pins 62 have a third implantation hole 621 for implanting biodegradable materials. The design of the fixation member 60, especially the third implantation hole 621 in the fixation pins 62, allows for the implantation of biodegradable materials inside the fixation pins 62, thereby strengthening the bond between the fixation pins 62 and the vertebral body and improving the stability of the entire system.

[0078] Among them, the fastener 60 is an anodized part. Anodizing not only improves the corrosion resistance of the material, but also allows the introduction of ions such as Ca, Mn, Cu, Ag, Zn, and P, further enhancing the bioactivity and antibacterial properties of the prosthesis and creating a healthier rehabilitation environment for patients.

[0079] Specifically, the built-in support 30 is also anodized to enhance its corrosion resistance.

[0080] In this embodiment, the fastener 60 is made of titanium alloy.

[0081] The interbody fusion prosthesis provided in this embodiment has the following beneficial effects:

[0082] (1) Bidirectional Osteogenesis: The prosthesis design can promote bone tissue growth from both the outside and the inside. Externally, the prosthesis endplate 20 is made of biodegradable metal materials (such as magnesium and magnesium alloys), which promotes the integration of surrounding bone tissue during the degradation process in vivo; internally, the implantation holes of the built-in support 30 and the elastic intermediate 40 can be implanted with biodegradable materials to promote internal bone growth, thereby significantly improving the speed and quality of bone integration.

[0083] (2) Enhanced stability: The porous structure of the built-in support 30 allows bone tissue to grow in, enhancing the bonding force between the bone and the prosthesis. At the same time, the degradation of the prosthesis endplate 20 allows the riveting protrusion 33 to come into direct contact with the vertebral bone tissue, playing an anchoring role, preventing prosthesis displacement and detachment, and ensuring long-term stability.

[0084] (3) Reduce elastic modulus and stress shielding: By using materials with low elastic modulus (such as magnesium alloys and PEEK) and structural designs (such as bone-like trabecular structures), the overall elastic modulus of the prosthesis is significantly reduced, making it closer to the elastic modulus of human vertebral bone tissue, thereby reducing stress shielding, avoiding prosthesis sinking, and improving clinical application results.

[0085] (4) Adjustable intervertebral space height: The built-in support 30 and elastic intermediate 40 structure inside the prosthesis body 10 can automatically compensate for the prosthesis height after the prosthesis endplate 20 degrades, maintain the stability of the intervertebral space, and reduce the risk of postoperative intervertebral space height loss.

[0086] (5) Improve biocompatibility and antibacterial properties: Anodizing not only enhances the corrosion resistance of the prosthesis, but also introduces ions such as Ca, Mn, Cu, Ag, Zn and P on the surface. These ions help promote bone growth and have antibacterial function, further improving the biocompatibility and safety of the prosthesis.

[0087] In summary, the interbody fusion prosthesis provided in this embodiment significantly improves the osseointegration effect, stability, and biocompatibility of the implant through its unique material combination, structural design, and implant hole layout, while reducing the risk of postoperative complications and enhancing the clinical application effect of medical implants.

[0088] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0089] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps described in these embodiments do not limit the scope of the invention. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as exemplary only and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0090] In the description of this invention, it should be understood that "a plurality of" means two or more. Directional terms such as "front, back, up, down, left, right," "horizontal, vertical, perpendicular, horizontal," and "top, bottom" indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. These terms are used solely for the convenience of describing the invention and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this invention. The directional terms "inner" and "outer" refer to the inner or outer contours relative to the outline of each component itself.

[0091] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.

[0092] Furthermore, it should be noted that the use of terms such as "first" and "second" to define components is merely for the purpose of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore should not be construed as limiting the scope of protection of this invention.

[0093] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An interbody fusion prosthesis, characterized in that, The interbody fusion prosthesis includes: The prosthesis body (10) has a receiving cavity (11); Two prosthetic endplates (20) are located at both ends of the prosthetic body (10), and the surface of the prosthetic endplate (20) away from the prosthetic body (10) has a first porous structure. The prosthetic endplate (20) is made of a biodegradable material. Two built-in supports (30) are movably disposed in the receiving cavity (11), and the two built-in supports (30) are connected one-to-one with the two prosthetic endplates (20). The surface of the built-in supports (30) has a second porous structure. An elastic intermediate (40) is disposed within the receiving cavity (11) and located between the two built-in supports (30), the elastic intermediate (40) being connected to the built-in supports (30) so that the two built-in supports (30) are far apart from each other; The elastic intermediate (40) includes a substrate (41) and an elastic mechanism (42). The substrate (41) has a bone-filling space (50) between its surface and the surfaces of the two built-in supports (30). The elastic mechanism (42) is located within the bone-filling space (50). One end of the elastic mechanism (42) is connected to the substrate (41), and the other end of the elastic mechanism (42) is connected to the corresponding built-in support (30). The prosthetic endplate (20) is provided with a connecting post (21), the built-in support (30) is provided with a first connecting through hole (31), the substrate (41) is provided with a second connecting through hole (411) corresponding to the first connecting through hole (31), and the connecting post (21) passes through the first connecting through hole (31) and the second connecting through hole (411).

2. The interbody fusion prosthesis according to claim 1, characterized in that, The connecting column (21) is provided with a bone graft hole (211).

3. The interbody fusion prosthesis according to claim 1, characterized in that, The built-in support (30) has a first implantation hole (32) at one end facing closer to the substrate (41) for implanting a biodegradable material; and / or, The substrate (41) is provided with a second implantation hole (412) for implanting biodegradable materials.

4. The interbody fusion prosthesis according to claim 1, characterized in that, The surface of the substrate (41) is provided with a plurality of strip-shaped flow channels (413), the plurality of strip-shaped flow channels (413) penetrating the sidewall of the substrate (41) in a first direction, and the plurality of strip-shaped flow channels (413) being spaced apart in a second direction perpendicular to the first direction; and / or, The substrate (41) is provided with a plurality of perforated flow channels (414), and the plurality of perforated flow channels (414) are arranged at intervals along the circumference of the substrate (41).

5. The interbody fusion prosthesis according to any one of claims 1 to 4, characterized in that, The built-in support (30) has a riveting protrusion (33) at one end of the prosthetic endplate (20) facing the same direction. The prosthetic endplate (20) has a riveting hole (22), and the riveting protrusion (33) is inserted into the riveting hole (22).

6. The interbody fusion prosthesis according to claim 5, characterized in that, The end of the riveting protrusion (33) away from the built-in support (30) is provided with a bone elongation inlet (331); and / or, The built-in support (30) is provided with a plurality of riveting protrusions (33), which are arranged at intervals along the circumference of the built-in support (30). The prosthetic endplate (20) is provided with a plurality of riveting holes (22), which correspond one-to-one with the plurality of riveting protrusions (33).

7. The interbody fusion prosthesis according to any one of claims 1 to 4, characterized in that, The prosthesis body (10) includes a frame (12) and multiple porous layers (13). The frame (12) has multiple spaced mounting openings, and the multiple porous layers (13) are installed one-to-one within the multiple mounting openings. The frame (12) and the multiple porous layers (13) together form the receiving cavity (11); and / or, Both the prosthesis body (10) and the built-in support (30) are anodized; and / or, The interbody fusion prosthesis also includes a fixation member (60), which includes a fixation plate (61) and a fixation pin (62) disposed on the fixation plate (61). The fixation pin (62) has a third implantation hole (621) for implanting a biodegradable material. The fixation member (60) is an anodized part.

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