Intervertebral fusion prosthesis
By designing an intervertebral fusion prosthesis containing a degradable endplate and a built-in support, the dynamic adjustment of the porous structure and elastic intermediates is used to solve the problem of poor elastic modulus matching and bone integration effect of the intervertebral fusion prosthesis, the adaptive high compensation of the prosthesis and bone tissue growth are achieved, and the success rate and stability of the surgical procedure are improved.
Patent Information
- Application Number
- CN202510899882.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-07-01
- Publication Date
- 2025-08-01
- Estimated Expiration
- 2045-07-01
AI Technical Summary
The existing intervertebral fusion prosthesis has shortcomings in elastic modulus matching and osseous integration effects, resulting in poor bone fusion effect after implantation and prosthesis stability problems.
The design consisting of prosthetic body, degradable end plate, built-in support and elastic intermediate is adopted, and the degradable material and porous structure are used, combined with the dynamic adjustment ability of the elastic intermediate, to achieve adaptive height compensation and bone tissue growth, and improve bone integration effect and elastic modulus matching.
It improves the bone integration effect and stability of intervertebral fusion prosthesis, reduces prosthesis subtraction, enhances the binding force between the prosthesis and bone tissue, reduces the risk of postoperative complications, and improves the success rate of surgery.
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Figure CN120392387A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of prostheses, and more particularly, to an intervertebral fusion prosthesis. Background Art
[0002] In the field of spinal surgery, intervertebral fusion is a common surgical method for treating various diseases such as intervertebral disc degeneration, spondylolisthesis, and spinal fractures. To achieve intervertebral fusion, it is usually necessary to implant an intervertebral fusion prosthesis to replace the damaged intervertebral disc and maintain the height of the intervertebral space, promoting bone fusion between the upper and lower vertebral bodies of the intervertebral disc. Currently, the mainstream materials for intervertebral fusion prostheses on the market mainly include titanium alloy, tantalum metal, and PEEK (polyether ether ketone). These materials are widely used due to their high strength and corrosion resistance.
[0003] However, traditional titanium alloy and tantalum metal prostheses have the problem of insufficient bioactivity. These materials themselves do not have the ability to promote bone tissue formation, resulting in an ineffective biological bond with human bone tissue after implantation, affecting the effect and speed of bone fusion. In addition, the high elastic modulus of titanium alloy and tantalum metal far exceeds that of human bone tissue. This mismatch leads to uneven stress distribution on the vertebral body after surgery. Especially in patients with osteoporosis, stress shielding is likely to occur, that is, the prosthesis bears most of the load after implantation, while the stress on the surrounding bone tissue decreases, which may lead to bone tissue atrophy, reducing the long-term stability of the prosthesis and even causing prosthesis subsidence or displacement.
[0004] On the other hand, although PEEK-based prostheses have good biocompatibility and a lower elastic modulus, being closer to human bone tissue, they have obvious limitations in promoting bone integration. PEEK is a bio-inert material and cannot actively promote bone tissue growth and fusion. Therefore, after implantation, the degree of bone integration between it and the vertebral body is weak, affecting the fixation effect of the prosthesis. In addition, the surface of the PEEK material is smooth, and its physical stability in the initial stage of implantation is poor, which also limits its application in intervertebral fusion surgery.
[0005] Generally speaking, in the related art, whether using high-strength metal materials or bio-inert PEEK materials, the problems of poor elastic modulus matching and poor bone integration effect cannot be solved simultaneously. Summary of the Invention
[0006] The present invention provides an intervertebral fusion prosthesis to solve the problems in the related art that the intervertebral fusion prosthesis cannot simultaneously solve the problems of poor elastic modulus matching and poor bone integration effect.
[0007] The present invention provides an intervertebral fusion prosthesis, which includes: a prosthesis body having a receiving cavity; two prosthesis end plates respectively located at both ends of the prosthesis body, the surface of the prosthesis end plate away from the prosthesis body has a first porous structure, and the prosthesis end plate is made of a degradable material; two built-in supports movably arranged in the receiving cavity, the two built-in supports are respectively connected to the two prosthesis end plates in a one-to-one correspondence, and the surface of the built-in support has a second porous structure; an elastic intermediate body arranged in the receiving cavity and located between the two built-in supports, and the elastic intermediate body is connected to the built-in supports to move the two built-in supports away from each other.
[0008] Further, there is a bone filling interval between the elastic intermediate body and the surfaces of the two built-in supports.
[0009] Further, the elastic intermediate body includes a substrate and an elastic mechanism. There is a bone filling interval between the substrate and the surfaces of the two built-in supports, the elastic mechanism is located in the bone filling interval, 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] Further, the prosthesis end plate is provided with connecting columns, the built-in support is provided with first connecting through holes, the substrate is provided with second connecting through holes corresponding to the first connecting through holes, and the connecting columns pass through the first connecting through holes and the second connecting through holes.
[0011] Further, the connecting columns are provided with bone grafting holes.
[0012] Further, the end of the built-in support facing the substrate is provided with a first implantation hole for implanting a degradable material; and / or, the substrate is provided with a second implantation hole for implanting a degradable material.
[0013] Further, the surface of the substrate is provided with a plurality of strip-shaped flow channels, the plurality of strip-shaped flow channels penetrate the side wall of the substrate in a first direction, and the plurality of strip-shaped flow channels are arranged at intervals in a second direction perpendicular to the first direction; and / or, the substrate is provided with a plurality of hole-shaped flow channels penetrating therethrough, and the plurality of hole-shaped flow channels are arranged at intervals along the circumferential direction of the substrate.
[0014] Further, the end of the built-in support facing the corresponding prosthesis end plate is provided with a riveting protrusion, the prosthesis end plate is provided with a riveting hole, and the riveting protrusion is inserted into the riveting hole.
[0015] Further, the end of the riveting protrusion away from the built-in support is provided with a bone ingrowth hole; and / or, the built-in support is provided with a plurality of riveting protrusions, the plurality of riveting protrusions are arranged at intervals along the circumferential direction of the built-in support, the prosthesis end plate is provided with a plurality of riveting holes, and the plurality of riveting holes are arranged in a one-to-one correspondence with the plurality of riveting protrusions.
[0016] Furthermore, the prosthesis body includes a frame and multiple porous layers, the frame has multiple installation openings arranged at intervals, the multiple porous layers are installed in the multiple installation openings in a one-to-one correspondence, and the frame and the multiple porous layers together form a accommodating cavity; and / or, the prosthesis body and the built-in support body are both anodized parts; and / or, the intervertebral fusion prosthesis also includes a fixing part, the fixing part includes a fixing plate and a fixing nail arranged on the fixing plate, the fixing nail has a third implantation hole for implanting a degradable material, and the fixing part is an anodized part.
[0017] Utilizing the technical solution of the present invention, the intervertebral fusion prosthesis comprises a prosthesis body, two prosthetic endplates, two internal supports, and an elastic intermediate. By leveraging the properties of the degradable material and the dynamic adjustment capabilities of the elastic intermediate, the prosthesis achieves the dual goals of adaptive height compensation and bone tissue growth after implantation. When the prosthetic endplates begin to degrade, the elastic intermediate gradually spreads the two internal supports apart to compensate for the height loss caused by the degradation of the prosthetic endplates, thereby maintaining intervertebral space stability, reducing prosthetic subsidence, and improving the success rate of the procedure.
[0018] Furthermore, because the surface of the prosthetic endplate facing away from the prosthesis body has a first porous structure, and the surface of the internal support body has a second porous structure, the combination of the first and second porous structures can enhance the osseointegration of the intervertebral fusion prosthesis. Furthermore, because the two internal support bodies are movably disposed within the accommodating cavity, the elastic intermediate body and the two internal support bodies can enhance elastic modulus matching. In summary, this intervertebral fusion prosthesis can simultaneously address the issues of poor elastic modulus matching and poor osseointegration. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. In the accompanying drawings:
[0020] Figure 1 A schematic structural diagram of an intervertebral fusion prosthesis provided according to an embodiment of the present invention is shown;
[0021] Figure 2 A cross-sectional view of an intervertebral fusion prosthesis provided according to an embodiment of the present invention is shown;
[0022] Figure 3 A schematic structural diagram of a prosthesis body of an intervertebral fusion prosthesis provided according to an embodiment of the present invention is shown;
[0023] Figure 4 A schematic structural diagram of a prosthetic end plate of an intervertebral fusion prosthesis provided according to an embodiment of the present invention is shown;
[0024] Figure 5Shows a schematic structural view of another perspective of the prosthesis end plate of the intervertebral fusion prosthesis provided according to an embodiment of the present invention;
[0025] Figure 6 Shows a schematic structural view of the built-in support of the intervertebral fusion prosthesis provided according to an embodiment of the present invention;
[0026] Figure 7 Shows Figure 6 a schematic structural view of the riveting protrusion in
[0027] Figure 8 Shows a schematic structural view of another perspective of the built-in support of the intervertebral fusion prosthesis provided according to an embodiment of the present invention;
[0028] Figure 9 Shows a schematic structural view of the elastic intermediate body of the intervertebral fusion prosthesis provided according to an embodiment of the present invention;
[0029] Figure 10 Shows a schematic structural view of the fixing member of the intervertebral fusion prosthesis provided according to an embodiment of the present invention.
[0030] Among them, the above-mentioned drawings include the following reference numerals:
[0031] 10. Prosthesis body; 11. Accommodation cavity; 12. Frame; 13. Porous layer;
[0032] 20. Prosthesis end plate; 21. Connecting column; 211. Bone grafting hole; 22. Riveting hole;
[0033] 30. Built-in support; 31. First connection through hole; 32. First implantation hole; 33. Riveting protrusion; 331. Bone ingrowth hole; 34. Elastic mechanism connection hole;
[0034] 40. Elastic intermediate body; 41. Substrate; 411. Second connection through hole; 412. Second implantation hole; 413. Strip-shaped flow channel; 414. Hole-shaped flow channel; 42. Elastic mechanism;
[0035] 50. Bone filling spacer;
[0036] 60. Fixing member; 61. Fixing plate; 62. Fixing nail; 621. Third implantation hole. Detailed implementation manners
[0037] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. The following description of at least one exemplary embodiment is actually illustrative only and in no way limits the present invention and its application or use. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.
[0038] As Figures 1 to 10 shown, the embodiment of the present invention provides an intervertebral fusion prosthesis, which includes a prosthesis body 10, two prosthesis end plates 20, two built-in supports 30, and an elastic intermediate body 40. The prosthesis body 10 has a receiving cavity 11. The two prosthesis end plates 20 are respectively located at both ends of the prosthesis body 10. The surface of the prosthesis end plate 20 away from the prosthesis body 10 has a first porous structure, and the prosthesis end plate 20 is made of a degradable material. The two built-in supports 30 are movably arranged in the receiving cavity 11, and the two built-in supports 30 are connected to the two prosthesis end plates 20 in a one-to-one correspondence. The surface of the built-in support 30 has a second porous structure. The elastic intermediate body 40 is arranged in the receiving cavity 11 and located between the two built-in supports 30. The elastic intermediate body 40 is connected to the built-in support 30 to move the two built-in supports 30 away from each other.
[0039] Applying the intervertebral fusion prosthesis provided in this embodiment, by utilizing the characteristics of the degradable material and the dynamic adjustment ability of the elastic intermediate body 40, the dual purposes of adaptive height compensation after prosthesis implantation and bone tissue growth are achieved. When the prosthesis end plate 20 begins to degrade, the elastic intermediate body 40 gradually expands the two built-in supports 30 to make up for the height loss caused by the degradation of the prosthesis end plate, thereby maintaining the stability of the intervertebral space, reducing prosthesis subsidence, and improving the success rate of the operation.
[0040] Moreover, since the surface of the prosthesis end plate 20 away from the prosthesis body 10 has a first porous structure and the surface of the built-in support 30 has a second porous structure, the cooperation of the first porous structure and the second porous structure can improve the bone integration effect of the intervertebral fusion prosthesis. In addition, since the two built-in supports 30 are movably arranged in the receiving cavity, the cooperation of the elastic intermediate body 40 and the two built-in supports 30 can improve the elastic modulus matching effect. In summary, using this intervertebral fusion prosthesis can simultaneously solve the problems of poor elastic modulus matching and poor bone integration effect.
[0041] In this embodiment, both the first porous structure and the second porous structure are trabecular bone-like structures.
[0042] Specifically, the entire built-in support 30 has a trabecular bone-like structure. The manufacturing material of the built-in support 30 is orthopedic implant materials such as titanium and titanium alloys, tantalum metal, etc.
[0043] Among them, the manufacturing material of the prosthesis endplate is a biodegradable metal material, such as magnesium and magnesium alloys, etc.
[0044] In some embodiments, a coating is provided on the surface of the prosthesis endplate 20 to change the degradation rate of the prosthesis endplate 20 to match the speed of human intervertebral fusion. By providing the coating, the degradation rate of the prosthesis endplate 20 can be adapted to people in different physical states (such as different age groups).
[0045] Specifically, the coating includes but is not limited to polymer coatings, oxide coatings, calcium phosphate coatings, and drug-releasing coatings. 1) Polymer coatings include coatings formed by biodegradable polymers such as polylactic acid (PLA), polycaprolactone (PCL), polyhydroxybutyrate (PHB), etc. These materials can delay the direct contact between the metal surface and body fluids, thereby controlling the degradation rate. The polymer coating gradually exposes the metal matrix of the prosthesis endplate through its own slow degradation characteristics, and then controls the degradation rate of the metal to ensure that it matches the process of human intervertebral fusion. 2) Oxide coatings include magnesium oxide or magnesium hydroxide coatings formed by anodic oxidation treatment. This coating is formed on the surface of the magnesium alloy and can slow down the degradation rate of the magnesium alloy. The oxide coating acts as a barrier to reduce the direct reaction between the metal and body fluids, and at the same time, 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). The calcium phosphate coating not only has good biocompatibility and osteogenic properties but also degrades slowly, and its degradation rate can be adjusted according to the coating thickness and composition to synchronize the degradation of the prosthesis endplate with bone fusion. 4) The drug-releasing coating is a polymer coating containing growth factors such as bone morphogenetic proteins (BMPs), antibacterial drugs, or anti-inflammatory drugs. While controlling the degradation of the metal, this coating can also release drugs to promote bone tissue growth, prevent infection, or reduce postoperative inflammation, further optimizing the biomedical performance of the implant.
[0046] Generally speaking, by selecting appropriate coating materials and techniques, the degradation rate of the prosthesis endplate can be adjusted to enable it to meet the needs of patients of different age groups and different health conditions, as well as the dynamic process of intervertebral fusion.
[0047] In some embodiments, a control member, a driving member, and a detecting member capable of real-time monitoring the degradation degree of the prosthesis endplate are provided inside the intervertebral fusion prosthesis. The control member is respectively in signal connection with the driving member and the detecting member. The control member can control the driving member to work according to the parameters detected by the detecting member. The driving member can accurately control the compensation action of the elastic intermediate body to ensure that the fine adjustment of the intervertebral space height meets the actual needs of the patient and improves the personalization level of prosthesis implantation. For example, the driving member is an electric push rod. The two ends of the electric push rod are respectively connected to the two built-in supports 30, and the elongation or shortening of the electric push rod is used to accurately control the compensation action of the elastic intermediate body.
[0048] It should be noted that the elastic intermediate body 40 can have various structural forms in design, aiming to provide appropriate elastic support while allowing the ingrowth of biomaterials and the growth of bone tissue. Among them, the elastic intermediate body 40 can be entirely elastic in structure or partially elastic in structure. The following are some examples of specific structures:
[0049] (1) Helical spring structure: Similar to a common mechanical spring, the elastic intermediate body can be designed as a helical spring made of metal or polymer material and embedded in the holes inside the prosthesis. This structure can provide uniform elastic support while allowing the filling of biomaterials at the helical gaps.
[0050] (2) Mesh elastic structure: A mesh structure made of elastic metal or polymer material, such as a titanium alloy mesh or a PEEK mesh similar to spring steel. The mesh holes can serve as channels for implanting biomaterials, and at the same time, the mesh structure itself provides elastic restoring force to compensate for the height loss after the degradation of the prosthesis endplate.
[0051] (3) Bellows structure: The elastic intermediate body can be designed as a bellows shape made of elastic material, such as silica gel or a specific engineering plastic. The bellows has good deformation ability and can adapt to the degradation process of the prosthesis endplate, maintaining the prosthesis height through stretching and compression.
[0052] (4) Elastic foam structure: Using a foam material with a high elastic recovery rate (such as polyurethane foam), which can have open or closed pore structures inside. These pores not only allow the penetration of biomaterials but also expand after the degradation of the prosthesis endplate to maintain the stability and height of the prosthesis.
[0053] As Figure 2 shown, in this embodiment, there is a bone filling interval 50 between the surface of the elastic intermediate body 40 and the surfaces of the two built-in supports 30. The existence of the bone filling interval 50 is to provide additional space for facilitating the implantation of bone filling materials, thereby further improving the bone ingrowth and bone integration effects and enhancing the biocompatibility and long-term stability of the prosthesis.
[0054] As Figure 2 andFigure 9 As shown, in this embodiment, the elastic intermediate body 40 includes a base plate 41 and an elastic mechanism 42. There is a bone filling space 50 between the base plate 41 and the surface of the two built-in support bodies 30. The elastic mechanism 42 is located in the bone filling space 50. One end of the elastic mechanism 42 is connected to the base plate 41, and the other end of the elastic mechanism 42 is connected to the corresponding built-in support body 30. The cleverness of this structure is that the elastic mechanism 42 can automatically unfold during the degradation of the prosthetic end plate 20 to compensate for the height loss without interfering with the implantation of the bone filling material. The base plate 41 serves as a support platform to ensure the stability and positioning accuracy of the elastic mechanism 42, while the dynamic characteristics of the elastic mechanism 42 ensure the adaptability of the prosthesis at different stages. This design significantly improves the accuracy and success rate of intervertebral 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 in the design of intervertebral fusion prosthesis, the elastic mechanism 42 plays a key role, especially in compensating for the height change caused by degradation of the prosthesis endplate and maintaining the stability of the intervertebral space. The following are some examples of specific structures:
[0056] (1) Spring structure: A coil spring is provided between the built-in support body 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 materials (such as PEEK) into a bellows-shaped elastic support and placed around the connecting through hole.
[0058] (3) Elastic polymer skeleton: A three-dimensional skeleton composed of medical-grade elastic polymers (such as polyester or polyurethane) is constructed. The skeleton is covered with micropores and can be implanted between the prosthesis end plate and the base plate.
[0059] In this embodiment, the elastic mechanism 42 is a coil spring, which has the advantages of simple structure and low cost.
[0060] Specifically, the prosthetic endplate 20 is provided with a connecting post 21, the internal support body 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 is inserted into the first connecting through-hole 31 and the second connecting through-hole 411. With this structure, the connecting post 21 will also degrade after implantation, thereby promoting bone formation within the prosthesis.
[0061] Moreover, the provision of the connecting columns 21 also ensures the positioning accuracy and stability between the prosthetic endplate 20, the built-in support 30, and the base plate 41, maintaining the structural integrity even under the complex loads of the spine. The alignment and threading 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 the precise docking between components, enhancing the overall stability of the prosthesis.
[0062] In this embodiment, both the base plate 41 and the built-in support 30 are provided with elastic mechanism connection holes 34, and both ends of the elastic mechanism 42 are respectively inserted into the elastic mechanism connection holes of the base plate 41 and the built-in support 30.
[0063] As Figure 5 shown, in this embodiment, the connecting column 21 is provided with a bone grafting hole 211. The design of the bone grafting hole 211 aims to promote the growth of bone tissue. By implanting bone filling materials into the bone grafting hole 211, the bone integration process can be accelerated, enhancing the biological bonding between the prosthesis and the vertebral body.
[0064] As Figure 8 shown, in this embodiment, the end of the built-in support 30 close to the base plate 41 is provided with a first implantation hole 32 capable of implanting degradable materials, and the base plate 41 is provided with a second implantation hole 412 capable of implanting degradable materials. The provision of the first implantation hole 32 and the second implantation hole 412 provides a way to promote bone formation inside the prosthesis. By implanting degradable materials such as magnesium and magnesium alloys, the growth of bone tissue can be further promoted, improving the bone integration effect. The advantage of this design is that even after the degradation of the prosthetic endplate 20, the prosthesis can still promote bone formation through the degradable materials implanted in the implantation holes, thus maintaining the stability of the vertebral space and the biological activity of the prosthesis, and extending the effective service life of the prosthesis.
[0065] As Figure 9 shown, in this embodiment, the surface of the base plate 41 is provided with a plurality of strip-shaped channels 413. The plurality of strip-shaped channels 413 penetrate the side wall of the base plate 41 in the first direction, and the plurality of strip-shaped channels 413 are arranged at intervals in the second direction perpendicular to the first direction. The base plate 41 is provided with a plurality of hole-shaped channels 414 penetrating therethrough, and the plurality of hole-shaped channels 414 are arranged at intervals along the circumference of the base plate 41. The provision of the strip-shaped channels 413 and the hole-shaped channels 414 aims to increase the surface roughness of the base plate 41, improve the hydrophilicity, and thus promote the attachment and growth of bone tissue.
[0066] Specifically, both the strip-shaped channels 413 and the hole-shaped channels 414 are processed by laser etching technology. The application of laser etching technology ensures the fineness and uniformity of the channels, providing an ideal microenvironment for the growth of bone cells.
[0067] This design is particularly suitable for situations where the speed of bone integration needs to be accelerated, such as intervertebral fusion surgeries for elderly patients or patients with osteoporosis. During the recovery period after surgery, bone cells can quickly attach and grow along the guidance of the flow channels, shortening the fusion time between bone tissue and the prosthesis and improving the overall surgical effect.
[0068] In this embodiment, the material of the substrate 41 is PEEK.
[0069] As Figure 6 shown, in this embodiment, one end of the built-in support 30 facing the corresponding prosthesis end plate 20 is provided with a riveting protrusion 33, and the prosthesis end plate 20 is provided with a riveting hole 22. The riveting protrusion 33 is inserted into the riveting hole 22. The cooperation between the riveting protrusion 33 and the riveting hole 22 ensures the stable connection between the prosthesis end plate 20 and the built-in support 30, and can maintain the structural integrity even under the dynamic load of the spine.
[0070] Moreover, as the prosthesis end plate 20 degrades, the riveting protrusion 33 will directly contact the vertebral body, playing an anchoring role to prevent the prosthesis from shifting or falling off, and improving the long-term stability of the prosthesis.
[0071] As Figure 7 shown, in this embodiment, one end of the riveting protrusion 33 away from the built-in support 30 is provided with a bone ingrowth hole 331. The design of the bone ingrowth hole 331 provides a growth channel for bone tissue, enabling bone cells to grow from the vertebral body into the prosthesis, strengthening the combination of bone tissue and the prosthesis, and improving the fusion rate of the surgery.
[0072] In this embodiment, a plurality of riveting protrusions 33 are provided on the built-in support 30, and the plurality of riveting protrusions 33 are arranged at intervals along the circumferential direction of the built-in support 30. A plurality of riveting holes 22 are provided on the prosthesis end plate 20, and the plurality of riveting holes 22 are arranged in one-to-one correspondence with the plurality of riveting protrusions 33. The setting of the plurality of riveting protrusions 33 and the plurality of riveting holes 22 increases the number of connection points of the prosthesis, improves the reliability and stability of the connection, and can keep the position of the prosthesis unchanged even under extreme conditions. Moreover, after surgical implantation, bone tissue will gradually grow into the plurality of bone ingrowth holes 331 to form a stable biological connection, reducing the risk of prosthesis displacement, providing more durable vertebral support for the patient and a better postoperative experience.
[0073] As Figure 3 shown, in this embodiment, the prosthesis body 10 includes a frame 12 and a plurality of porous layers 13. The frame 12 has a plurality of installation openings arranged at intervals, and the plurality of porous layers 13 are respectively installed in the plurality of installation openings. The frame 12 and the plurality of porous layers 13 together enclose a receiving cavity 11. The combination of the frame 12 and the porous layers 13 not only ensures the structural strength of the prosthesis body 10, but also provides the porous structure required for bone tissue growth, achieving the balance between mechanical support and biological activity.
[0074] In this embodiment, both the prosthesis body 10 and the built-in support 30 are anodized parts. 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 cancellous bone-like structure. The manufacturing material of the prosthesis body 10 is an orthopedic implant material such as titanium and its alloys or tantalum metal. The solid structure plays a role in increasing the strength of the prosthesis, and the cancellous bone-like structure can enhance the bone ingrowth effect. At the same time, the prosthesis body is anodized to enhance the corrosion resistance.
[0076] It should be noted that since both the prosthesis body and the built-in support have a cancellous bone-like structure, the elastic modulus of the prosthesis can be significantly reduced. The prosthesis endplate is made of a degradable material such as magnesium and its alloys, and the matrix is made of PEEK material. These two materials have a lower elastic modulus. Thus, through the selection of the structural materials, the overall elastic modulus of the prosthesis is significantly reduced, making the elastic modulus of the prosthesis match that of the human vertebral bone tissue, reducing prosthesis subsidence, and improving the clinical application effect of the prosthesis.
[0077] As Figure 10 shown, in this embodiment, the intervertebral fusion prosthesis further includes a fixing member 60. The fixing member 60 includes a fixing plate 61 and fixing nails 62 provided on the fixing plate 61. The fixing nails 62 have third implantation holes 621 capable of implanting degradable materials. The provision of the fixing member 60, especially the third implantation holes 621 in the fixing nails 62, allows degradable materials to be implanted inside the fixing nails 62, thereby strengthening the connection between the fixing nails 62 and the vertebral body and improving the stability of the entire system.
[0078] Among them, the fixing member 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 the corrosion resistance.
[0080] In this embodiment, the manufacturing material of the fixing member 60 is titanium alloy.
[0081] The intervertebral fusion prosthesis provided by this embodiment has the following beneficial effects:
[0082] (1)Two-way osteogenesis promotion: The prosthesis design can promote bone tissue growth bidirectionally from the outside and inside. Externally, the prosthesis endplate 20 is made of a degradable metal material (such as magnesium and magnesium alloys), which promotes the integration of the surrounding bone tissue during the degradation process in the body; internally, degradable materials can be implanted into the implantation holes of the built-in support 30 and the elastic intermediate 40 to promote internal bone growth, thus 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 enables the riveting protrusion 33 to come into direct contact with the vertebral bone tissue, playing an anchoring role to prevent prosthesis displacement and shedding, ensuring long-term stability.
[0084] (3)Reduced elastic modulus and stress shielding: By using materials with a low elastic modulus (such as magnesium alloys and PEEK) and a structural design (such as a trabecular bone-like structure), the overall elastic modulus of the prosthesis is significantly reduced, making it closer to the elastic modulus of the human vertebral bone tissue, thereby reducing stress shielding and avoiding prosthesis subsidence, improving the clinical application effect.
[0085] (4)Adjustable intervertebral height: The structure of the built-in support 30 and the elastic intermediate 40 inside the prosthesis body 10 can automatically compensate for the prosthesis height after the degradation of the prosthesis endplate 20, maintaining the stability of the intervertebral space and reducing the risk of postoperative loss of intervertebral height.
[0086] (5)Improved biocompatibility and antibacterial properties: Anodic oxidation treatment not only enhances the corrosion resistance of the prosthesis but also can introduce ions such as Ca, Mn, Cu, Ag, Zn, and P on the surface. These ions contribute to bone growth promotion and antibacterial functions, further improving the biocompatibility and safety performance of the prosthesis.
[0087] In summary, the intervertebral fusion prosthesis provided in this embodiment significantly improves the bone integration effect, stability, and biocompatibility of the implant through a unique material combination, structural design, and layout of the implantation holes. At the same time, it reduces the risk of postoperative complications and improves the clinical application effect of medical implants.
[0088] It should be noted that the terms used here are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used here, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, 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 their combinations.
[0089] Unless otherwise specifically stated, the relative arrangements of components and steps, numerical expressions, and numerical values set forth in these embodiments do not limit the scope of the present invention. At the same time, it should be understood that, for the sake of convenience of description, the dimensions of the various parts shown in the drawings are not drawn in actual proportional relationships. Technologies, methods, and devices known to those of ordinary skill in the relevant art may not be discussed in detail, but where appropriate, the said technologies, methods, and devices should be regarded as part of the specification. In all the examples shown and discussed here, any specific values should be construed as merely exemplary and not as a limitation. Therefore, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following drawings, and thus, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.
[0090] In the description of the present invention, it should be understood that "a plurality of" means two or more in number. The orientation or positional relationships indicated by orientation terms such as "front, rear, upper, lower, left, right", "lateral, vertical, perpendicular, horizontal", and "top, bottom", etc. are usually based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description. Without contrary description, these orientation terms do not indicate and imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and thus should not be construed as limiting the protection scope of the present invention; the orientation terms "inside, outside" refer to the inside and outside relative to the contour of each component itself.
[0091] For the convenience of description, spatial relative terms such as "above...", "over...", "on the upper surface of...", "above-mentioned", etc. can be used here to describe the spatial positional relationship between a device or feature shown in the drawings and other devices or features. It should be understood that the spatial relative terms are intended to include different orientations in use or operation in addition to the orientation described in the drawings of the device. For example, if the device in the drawing is inverted, the device described as "above other devices or structures" or "over other devices or structures" will then be positioned as "below other devices or structures" or "under other devices or structures". Thus, the exemplary term "above..." can include both the orientation of "above..." and "below...". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and corresponding interpretations should be made for the spatial relative descriptions used here.
[0092] In addition, it should be noted that the use of words such as "first", "second", etc. to limit components is only for the convenience of distinguishing the corresponding components. Without additional statement, the above words have no special meanings, and thus should not be construed as limiting the protection scope of the present invention.
[0093] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, various modifications and variations can be made to the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.
Claims
1. An intervertebral fusion prosthesis, characterized in that, The intervertebral fusion prosthesis includes: A prosthesis body (10) having a receiving cavity (11); Two prosthesis end plates (20) respectively located at both ends of the prosthesis body (10). The surface of the prosthesis end plate (20) away from the prosthesis body (10) has a first porous structure, and the prosthesis end plate (20) is made of a degradable material; Two built-in supports (30) movably arranged in the receiving cavity (11). The two built-in supports (30) are respectively connected to the two prosthesis end plates (20) in a one-to-one correspondence. The surface of the built-in support (30) has a second porous structure; An elastic intermediate body (40) arranged in the receiving cavity (11) and located between the two built-in supports (30). The elastic intermediate body (40) is connected to the built-in support (30) to move the two built-in supports (30) away from each other.
2. The intervertebral fusion prosthesis according to claim 1, characterized in that, There is a bone filling space (50) between the elastic intermediate body (40) and the surfaces of the two built-in supports (30).
3. The intervertebral fusion prosthesis according to claim 2, characterized in that, The elastic intermediate body (40) includes a substrate (41) and an elastic mechanism (42). There is the bone filling space (50) between the substrate (41) and the surfaces of the two built-in supports (30). The elastic mechanism (42) is located in 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).
4. The intervertebral fusion prosthesis according to claim 3, characterized in that, The prosthesis end plate (20) is provided with a connecting column (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). The connecting column (21) passes through the first connecting through hole (31) and the second connecting through hole (411).
5. The intervertebral fusion prosthesis according to claim 4, wherein, The connecting column (21) is provided with a bone grafting hole (211).
6. The intervertebral fusion prosthesis according to claim 3, characterized in that A first implantation hole (32) capable of implanting a degradable material is provided at one end of the built-in support (30) facing the substrate (41); and / or, The substrate (41) is provided with a second implantation hole (412) capable of implanting a degradable material.
7. The intervertebral fusion prosthesis according to claim 3, characterized in that A plurality of strip-shaped flow channels (413) are provided on the surface of the substrate (41). The plurality of strip-shaped flow channels (413) penetrate the side wall of the substrate (41) in a first direction, and the plurality of strip-shaped flow channels (413) are arranged at intervals in a second direction perpendicular to the first direction; and / or, A plurality of hole-shaped flow channels (414) are provided through the substrate (41). The plurality of hole-shaped flow channels (414) are arranged at intervals along the circumferential direction of the substrate (41).
8. The intervertebral fusion prosthesis according to any one of claims 1 to 7, characterized in that, One end of the built-in support body (30) facing the corresponding prosthesis end plate (20) is provided with a riveting protrusion (33), the prosthesis end plate (20) is provided with a riveting hole (22), and the riveting protrusion (33) is inserted into the riveting hole (22).
9. The intervertebral fusion prosthesis according to claim 8, wherein One end of the riveting protrusion (33) away from the built-in support body (30) is provided with a bone ingrowth hole (331); and / or A plurality of the riveting protrusions (33) are arranged on the built-in support body (30), and the plurality of riveting protrusions (33) are arranged at intervals along the circumferential direction of the built-in support body (30). A plurality of the riveting holes (22) are arranged on the prosthesis end plate (20), and the plurality of riveting holes (22) are arranged in one-to-one correspondence with the plurality of riveting protrusions (33).
10. The intervertebral fusion prosthesis according to any one of claims 1 to 7, wherein The prosthesis body (10) includes a frame (12) and a plurality of porous layers (13). The frame (12) has a plurality of installation openings arranged at intervals, and the plurality of porous layers (13) are respectively installed in the plurality of installation openings. The frame (12) and the plurality of porous layers (13) together define the accommodation cavity (11); and / or Both the prosthesis body (10) and the built-in support body (30) are anodized parts; and / or The intervertebral fusion prosthesis further includes a fixing member (60). The fixing member (60) includes a fixing plate (61) and fixing nails (62) arranged on the fixing plate (61). The fixing nails (62) have third implantation holes (621) capable of implanting a degradable material, and the fixing member (60) is an anodized part.
Citation Information
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