Fusion cage and spinal implant
By designing a porous structure with gradient changes in the spinal implant, the elastic modulus is reduced and the elastic modulus is close to the elastic modulus of the bone, the problem of stress masking between the spinal implant and the bone is solved, and the bone growth performance of the bone and the structural strength of the implant are improved.
Patent Information
- Application Number
- CN202510103745.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-22
- Publication Date
- 2025-05-02
- Estimated Expiration
- 2045-01-22
AI Technical Summary
The elastic modulus of spinal implants differs greatly from that of bones, resulting in stress masking and weakening the bone growth performance of bones.
A spinal implant is designed, and the first porous part of its porous structure is arranged in the cavity of the frame, distributed along the first end to the second end of the frame, and the porosity changes in gradient to reduce the elastic modulus and make it close to the elastic modulus of the bone.
By reducing the elastic modulus of spinal implants, reducing stress masking, improving bone growth and integration of the spine and implants. At the same time, the structural strength in the middle of the implant is improved and the risk of breakage in the middle is reduced.
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Figure CN119908880A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical devices, and in particular to a fusion device and a spinal implant. Background Art
[0002] Spinal implants such as fusion devices and artificial vertebrae are commonly used medical devices in spinal surgery. They are mainly used to be implanted in the human spine to allow the spine and the spinal implant to grow and fuse to achieve restorative treatment of the spine.
[0003] In order to promote the growth and fusion of the spine and the spinal implant, the spinal implant needs to meet a better mechanical environment. However, in the related art, there is a large difference between the elastic modulus of the spinal implant and the elastic modulus of the bone. When the spinal implant is implanted in the spine, stress shielding is easily generated, which weakens the bone ingrowth performance of the bone. Summary of the invention
[0004] The embodiment of the present application provides a spinal implant, which aims to solve the problem in the related art that the elastic modulus of the spinal implant is significantly different from the elastic modulus of the bone, thus affecting the bone ingrowth performance of the bone.
[0005] The present application provides a fusion device, including:
[0006] A frame body, comprising a first end and a second end opposite to each other, wherein a cavity is disposed in the frame body, and the cavity penetrates the frame body in a direction from the first end to the second end; the frame body is provided with at least one opening communicating with the cavity, and the frame body comprises an outer peripheral surface, and the opening extends from the cavity to the outer peripheral surface;
[0007] A porous structure, comprising a first porous portion and a second porous portion connected to each other, wherein the first porous portion is accommodated in the cavity and connected to the frame, and the second porous portion is accommodated in the opening and connected to the inner circumference of the opening;
[0008] Among them, in the direction from the first end to the second end, the pores of the first porous part first decrease and then increase, and the pores of the second porous part first decrease and then increase; the first porous part includes a bone grafting window extending along the direction from the first end to the second end, and the porosity of the first porous part gradually decreases in the direction from the bone grafting window to the frame body.
[0009] The present application also provides a spinal implant, comprising:
[0010] A frame body, comprising a first end and a second end opposite to each other, wherein a cavity is disposed in the frame body, and the cavity penetrates the frame body in a direction from the first end to the second end;
[0011] The porous structure includes a first porous portion, which is accommodated in the cavity and connected to the frame. The first porous portion includes a first part, a second part and a third part distributed in sequence from the first end to the second end. The porosity of the first part and the third part is greater than the porosity of the second part.
[0012] In some embodiments, the porosity of the first portion gradually decreases from the first end to the second end; the minimum porosity of the first portion is greater than or equal to the maximum porosity of the second portion; and / or,
[0013] The porosity of the second portion gradually increases from the first end to the second end, and the minimum porosity of the second portion is greater than or equal to the maximum porosity of the third portion.
[0014] In some embodiments, the porosity of the first portion is substantially constant in a direction from the first end to the second end; and / or,
[0015] The porosity of the second portion is substantially constant in a direction from the first end to the second end; and / or,
[0016] The porosity of the third portion is substantially constant in a direction from the first end to the second end.
[0017] In some embodiments, the first portion extends from the first end to the second portion; and / or the third portion extends from the second end to the second portion.
[0018] In some embodiments, the porosity of the second portion first decreases and then increases along a direction from the first end to the second end.
[0019] In some embodiments, the second portion has a minimum porosity located in a middle portion of the spinal implant in a direction from the first end to the second end.
[0020] In some embodiments, in a direction from the first end to the second end, a difference between a maximum porosity and a minimum porosity of the first porous portion is greater than or equal to 60%.
[0021] In some embodiments, in the direction from the first end to the second end, the maximum porosity of the first porous portion is greater than or equal to 60% and less than or equal to 90%; and / or,
[0022] In a direction from the first end to the second end, a minimum porosity of the first porous portion is greater than or equal to 30% and less than or equal to 60%.
[0023] In some embodiments, in a direction from the first end to the second end, the porosity of the first porous portion increases or decreases by greater than or equal to 10% and less than or equal to 25% per 1 mm.
[0024] In some embodiments, the first porous portion includes a bone grafting window extending from the first end to the second end, the first porous portion includes a first end surface and a second end surface, the first end surface and the second end surface are sequentially distributed from the first end to the second end, and the first end surface and / or the second end surface are formed with a bone grafting port communicating with the bone grafting window;
[0025] The first porous portion includes a first sub-porous portion and a second sub-porous portion sequentially distributed along a direction from the bone graft window to the frame body, and the porosity of the first sub-porous portion is greater than the porosity of the second sub-porous portion.
[0026] In some embodiments, in the direction from the bone graft window to the frame, the porosity of the first sub-porous portion gradually decreases; and / or,
[0027] In a direction from the bone graft window to the frame, the porosity of the second sub-porous portion gradually decreases.
[0028] In some embodiments, in the direction from the bone graft window to the frame, the porosity of the first sub-porous portion is substantially constant; and / or,
[0029] In a direction from the bone graft window to the frame body, the porosity of the second sub-porous portion is substantially constant.
[0030] In some embodiments, in a direction from the bone graft window to the frame body, a difference between a maximum porosity and a minimum porosity of the first porous portion is greater than or equal to 60%.
[0031] In some embodiments, in the direction from the bone graft window to the frame, the maximum porosity of the first porous portion is greater than or equal to 60% and less than or equal to 90%; and / or,
[0032] In a direction from the bone graft window to the frame body, a minimum porosity of the first porous portion is greater than or equal to 30% and less than or equal to 60%.
[0033] In some embodiments, in the direction from the bone graft window to the frame body, the porosity of the first porous portion increases or decreases by more than or equal to 6% and less than or equal to 12% per 1 mm.
[0034] In some embodiments, the first porous portion includes a first end face and a second end face, and the first end face and the second end face are distributed sequentially along the direction from the first end to the second end; the first end face and / or the second end face are convexly provided with an anti-slip protrusion, and the anti-slip protrusion includes a contact surface for contacting the spine, and the contact surface is a convex curved surface.
[0035] In some embodiments, the first porous portion includes a bone grafting window extending in a direction from the first end to the second end, the first porous portion includes a first end face and a second end face, the first end face and the second end face are distributed in sequence along the direction from the first end to the second end, and the first end face and / or the second end face are formed with a bone grafting opening connected to the bone grafting window; the spinal implant also includes at least one first reinforcement portion, the first reinforcement portion extends along the circumference of the bone grafting window and is spaced apart from the frame.
[0036] In some embodiments, the first reinforcement portion is provided at at least one of the bone graft openings.
[0037] In some embodiments, at least one opening communicating with the cavity is formed on the periphery of the frame, the frame includes an outer peripheral surface, and the opening extends from the cavity to the outer peripheral surface;
[0038] The porous structure also includes a second porous portion connected to the first porous portion, the second porous portion is accommodated in at least one of the openings and connected to the inner circumference of the opening, and in the direction from the first end to the second end, the pores of the second porous portion first decrease and then increase.
[0039] In some embodiments, the spinal implant also includes a second reinforcement portion, a portion of which is located in the opening and spaced apart from the inner circumferential surface, the second reinforcement portion is provided with a through hole for instruments to pass through, and the second porous portion in the opening is connected between the second reinforcement portion and the inner circumferential surface.
[0040] In some embodiments, the spinal implant further comprises a third reinforcing portion disposed in at least one of the openings, the third reinforcing portion being connected to the inner circumferential surfaces on at least two sides of the opening, and the second porous portion in the opening being connected between the third reinforcing portion and the inner circumferential surface.
[0041] In some embodiments, the third reinforcing portion and the second reinforcing portion are distributed on both sides of the cavity.
[0042] In some embodiments, there are multiple openings, and the multiple openings are arranged at intervals along the circumference of the frame; and the second porous portion is disposed in each of the openings.
[0043] In some embodiments, the wire diameter width of the first porous portion is greater than or equal to 200 μm and less than or equal to 600 μm; and / or,
[0044] The inscribed circle diameter of the pores in the first porous portion is greater than or equal to 300 μm and less than or equal to 1200 μm.
[0045] In some embodiments, the spinal implant comprises an intervertebral fusion cage or an artificial vertebral body.
[0046] The spinal implant provided in the embodiment of the present application accommodates the first porous portion of the porous structure in the cavity of the frame, so that when the spinal implant is implanted in the spine, the portion of the first porous portion of the porous structure close to the first end and / or the second end of the frame can contact the bone tissue of the spine, allowing the bone tissue of the spine to grow and fuse together with the portion of the first porous portion close to the first end and / or the second end.
[0047] Moreover, in the direction from the first end to the second end of the frame, the first part, the second part and the third part of the first porous part are distributed in sequence, and the porosity of the first part and the third part are both greater than the porosity of the second part. In this way, the porosity of the first porous part can be set in a gradient in the direction from the first end to the second end, which is conducive to reducing the elastic modulus of the first porous part near the first end and the second end of the frame, so that the elastic modules of the two ends of the spinal implant along the first direction are close to the elastic modulus of the bone, so as to reduce stress shielding and improve the bone ingrowth performance of the bone. At the same time, it can also improve the structural strength of the spinal implant near the middle area of the first direction, and reduce the risk of the middle part of the spinal implant breaking after the two ends of the spinal implant in the direction from the first end to the second end are compressed. BRIEF DESCRIPTION OF THE DRAWINGS
[0048] The technical solution and other beneficial effects of the present application will be made apparent by describing in detail the specific implementation methods of the present application in conjunction with the accompanying drawings.
[0049] Figure 1 A schematic structural diagram of a first embodiment of a spinal implant provided in an embodiment of the present application;
[0050] Figure 2 A schematic structural diagram of a second embodiment of a spinal implant provided in an embodiment of the present application;
[0051] Figure 3 A schematic diagram of a structure of an embodiment of a Thiessen polygon structure provided in an embodiment of the present application;
[0052] Figure 4 A schematic structural diagram of a third embodiment of a spinal implant provided in an embodiment of the present application;
[0053] Figure 5A schematic structural diagram of a first embodiment of an anti-slip protrusion provided in an embodiment of the present application;
[0054] Figure 6 A schematic structural diagram of a second embodiment of the anti-slip protrusion provided in an embodiment of the present application;
[0055] Figure 7 A schematic structural diagram of a third embodiment of the anti-slip protrusion provided in the embodiments of the present application;
[0056] Figure 8 A schematic structural diagram of a fourth embodiment of the anti-slip protrusion provided in the embodiments of the present application;
[0057] Fig. 9 A schematic structural diagram of an embodiment of a frame and a first reinforcement portion provided in an embodiment of the present application;
[0058] Fig.10 A schematic structural diagram of an embodiment of a frame and a second reinforcement portion provided in an embodiment of the present application;
[0059] Fig.11 A schematic structural diagram of an embodiment of a frame and a third reinforcement part provided in an embodiment of the present application;
[0060] Fig.12 A schematic structural diagram of a fourth embodiment of a spinal implant provided in an embodiment of the present application;
[0061] Fig.13 A schematic structural diagram of a fifth embodiment of a spinal implant provided in an embodiment of the present application;
[0062] Fig.14 A schematic structural diagram of a sixth embodiment of a spinal implant provided in an embodiment of the present application;
[0063] Fig.15 This is a schematic structural diagram of a seventh embodiment of a spinal implant provided in an embodiment of the present application.
[0064] Spinal implant 10; frame 11; cavity 110; first end 111; second end 112; outer peripheral surface 113; opening 114; inner peripheral surface 115; first reinforcement part 116; second reinforcement part 117; through hole 1171; third reinforcement part 118; porous structure 12; wire diameter 120; first porous part 121; first part 1211; second part 1212; third part 1213; bone graft window 1214; bone graft opening 1215; first sub-porous part 1216; second sub-porous part 1217; first end surface 1218; second end surface 1219; anti-slip protrusion 122; contact surface 1221; protrusion 1222; second porous part 123; direction X from first end to second end; direction Y from bone graft window to frame. DETAILED DESCRIPTION
[0065] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.
[0066] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined.
[0067] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.
[0068] In the present application, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.
[0069] The disclosure below provides many different embodiments or examples to realize the different structures of the present application. In order to simplify the disclosure of the present application, the parts and settings of specific examples are described below. Of course, they are only examples, and the purpose is not to limit the present application. In addition, the present application can repeat reference numbers and / or reference letters in different examples, and this repetition is for the purpose of simplification and clarity, which itself does not indicate the relationship between the various embodiments and / or settings discussed. In addition, the present application provides various specific processes and examples of materials, but those of ordinary skill in the art can appreciate the application of other processes and / or the use of other materials.
[0070] Spinal implants such as fusion devices and artificial vertebrae are commonly used medical devices in spinal surgery. They are mainly used to be implanted in the human spine so that the spine and the spinal implant grow and fuse together to achieve spinal recovery treatment. In order to promote the growth and fusion of the spine and the spinal implant, the spinal implant needs to meet a better mechanical environment and reduce the stress shielding (also known as stress shielding, Stress Shielding Effect) of the spinal implant as much as possible, so that the bone tissue of the spine can receive sufficient mechanical stimulation, thereby promoting the bone ingrowth performance of the spine and enabling the spine to grow and fuse with the spinal implant faster.
[0071] However, the elastic modulus of spinal implants in related technologies is significantly different from that of bones. Spinal implants are harder than the spine. When implanted into the spine, stress shielding is likely to occur, which causes the bone tissue of the spine to be at a low stress level for a long time, weakening the bone ingrowth performance of the bones. In the later stages of recovery from orthopedic surgery, the bone tissue of the spine will develop symptoms such as osteoporosis due to insufficient mechanical stimulation.
[0072] In order to avoid the above problems, the present application provides a fusion cage and a spinal implant, which are described in detail below.
[0073] First, an embodiment of the present application provides a spinal implant.
[0074] Figure 1 The structural diagram of an embodiment of the spinal implant provided in the present application is shown in FIG. Figure 1As shown, the spinal implant 10 includes a frame 11 and a porous structure 12. The frame 11 includes a first end 111 and a second end 112 opposite to each other. A cavity 110 is provided in the frame 11. The cavity 110 penetrates the frame 11 along a direction X from the first end 111 to the second end 112. The porous structure 12 is a structure having a plurality of holes. At least a portion of the porous structure 12 is accommodated in the cavity 110 of the frame 11 and connected to the frame 11. When the spinal implant 10 is implanted in the spine, one side of the porous structure 12 along the direction from the first end 111 to the second end 112 and / or one side of the porous structure 12 along the direction from the second end 112 to the first end 111 can contact the spine. The plurality of holes of the porous structure 12 can promote the growth of bone tissue of the spine, so that the bone tissue of the spine grows faster into the plurality of holes of the porous structure 12, thereby allowing the bone tissue of the spine to grow and fuse with the porous structure 12 of the spinal implant 10 quickly.
[0075] It should be noted that the spinal implant 10 may be an intervertebral fusion device. Specifically, the spinal implant 10 may be a lumbar intervertebral fusion device (such as Fig.12 As shown), oblique lateral lumbar interbody fusion cage (as shown Fig.13 As shown), self-stabilizing fusion device (such as Fig.14 The lumbar interbody fusion device is mainly used for posterior lumbar interbody fusion (PLIF). The oblique lateral lumbar interbody fusion device is mainly used for oblique lateral lumbar interbody fusion (OLIF). The spinal implant 10 can be formed by 3D printing or by other processing methods. Of course, when the spinal implant 10 is formed by 3D printing, the processing of the spinal implant 10 is more convenient and the mechanical effect is better.
[0076] Or, if Fig.15 As shown, the spinal implant 10 may also be an artificial vertebral body for replacing vertebrae of the spinal column.
[0077] In addition, the spinal implant 10 can be implanted in the vertebrae of the spine, and at this time, the vertebrae grow and fuse with the porous structure 12 of the spinal implant 10 during the implantation period. Alternatively, the spinal implant 10 can be an implant implanted between two vertebrae of the spine, or implanted on one side of a vertebra of the spine, and at this time, the vertebrae grow and fuse with the porous structure 12 of the adjacent spinal implant 10.
[0078] It is understandable that if the spinal implant 10 is implanted in a vertebra, or between two adjacent vertebrae, the side of the spinal column along the direction from the first end 111 to the second end 112, and the side along the direction from the second end 112 to the first end 111 can contact the spinal column and grow and fuse together. If the spinal implant 10 is implanted only on one side of a vertebra of the spinal column, the vertebra grows and fuses together with the porous structure 12 of the pole implant.
[0079] In some embodiments, Figure 1 As shown, the porous structure 12 may include a first porous portion 121, which is accommodated in the cavity 110 and connected to the frame 11. After the spinal implant 10 is implanted in the spine, one side of the first porous portion 121 along the direction from the first end 111 to the second end 112, and / or one side of the porous structure 12 along the direction from the second end 112 to the first end 111 can contact the spine, and the bone tissue of the spine can grow faster into the multiple holes of the first porous portion 121 close to the first end 111 and / or the second end 112, so that the bone tissue of the spine and the first porous portion 121 of the spinal implant 10 grow and fuse together quickly.
[0080] The first porous portion 121 may include a first portion 1211 , a second portion 1212 and a third portion 1213 sequentially distributed from the first end 111 to the second end 112 , and the porosity of the first portion 1211 and the third portion 1213 are both greater than the porosity of the second portion 1212 .
[0081] The spinal implant 10 provided in the embodiment of the present application allows the first porous portion 121 of the porous structure 12 to be accommodated in the cavity 110 of the frame 11, so that when the spinal implant 10 is implanted in the spine, the first porous portion 121 of the porous structure 12 close to the first end 111 and / or the second end 112 of the frame 11 can contact the bone tissue of the spine, so that the bone tissue of the spine and the portion of the first porous portion 121 close to the first end 111 and / or the second end 112 can grow and fuse together.
[0082] Moreover, in the direction X from the first end 111 to the second end 112 of the frame 11, the first part 1211, the second part 1212 and the third part 1213 of the first porous part 121 are distributed in sequence, and the porosity of the first part 1211 and the third part 1213 are both greater than the porosity of the second part 1212. In this way, the porosity of the first porous part 121 can be set in a gradient in the direction X from the first end 111 to the second end 112, which is conducive to reducing the elastic modulus of the first porous part 121 close to the first end 111 and the second end 112 of the frame 11, so that the elastic modules of the two ends of the spinal implant 10 along the first direction are close to the elastic modulus of the bone, so as to reduce stress shielding and improve the bone ingrowth performance of the bone. At the same time, it can also improve the structural strength of the spinal implant 10 near the middle area of the first direction, and reduce the risk of the middle part of the spinal implant 10 being broken after the two ends of the spinal implant 10 in the direction from the first end 111 to the second end 112 are compressed.
[0083] It should be noted that the average porosity of the first part 1211 and the third part 1213 can be greater than the average porosity of the second part 1212, and the minimum porosity of the first part 1211 and the third part 1213 can be greater than the maximum porosity of the second part 1212. It is only necessary to make the elastic modulus of the first part 1211 and the third part 1213 smaller than the elastic modulus of the second part 1212.
[0084] In addition, the first portion 1211, the second portion 1212 and the third portion 1213 may be continuous portions or discontinuous portions with other porous structures 12 disposed therein. In the direction X from the first end 111 to the second end 112, the sum of the lengths of the first portion 1211, the second portion 1212 and the third portion 1213 may be equal to the total length of the first porous portion 121 or may be less than the total length of the first porous portion 121.
[0085] In some embodiments, the porosity of the first portion 1211 can be gradually reduced along the direction X from the first end 111 to the second end 112. The minimum porosity of the first portion 1211 is greater than or equal to the maximum porosity of the second portion 1212, so that the porosity of the first portion 1211 is greater than the porosity of the second portion 1212. Moreover, the porosity of the first part 1211 can be set in a gradient in the direction X from the first end 111 to the second end 112, which is conducive to flexible adjustment of the elastic modulus of the first part 1211, so that the elastic modulus of the first porous part 121 closer to the first end 111 is smaller, thereby further improving the ability of the spinal implant 10 to better meet the mechanical environment at the first end 111, and reducing the stress shielding of the spinal implant 10 at the first end 111 as much as possible, so that the bone tissue of the spine in contact with the side of the first porous part 121 close to the first end 111 can obtain sufficient mechanical stimulation to promote the bone ingrowth performance of the bone tissue of the spine in contact with the side of the first porous part 121 close to the first end 111, so that the spine can grow and fuse with the side of the spinal implant 10 close to the first end 111 faster.
[0086] In other embodiments, the porosity of the first portion 1211 of the first porous portion 121 can be made substantially constant in the direction X from the first end 111 to the second end 112, and the elastic modulus of the portion of the first porous portion 121 close to the first end 111 can also be reduced to a certain extent, and the porosity of the first portion 1211 only needs to be greater than the porosity of the second portion 1212. Moreover, when the porosity of the first portion 1211 of the first porous portion 121 is substantially constant in the direction X from the first end 111 to the second end 112, the processing of the first porous portion 121 can be made more convenient, which is conducive to improving the production efficiency of the spinal implant 10.
[0087] Similarly, the porosity of the third portion 1213 can be gradually increased along the direction X from the first end 111 to the second end 112. The minimum porosity of the second portion 1212 is greater than or equal to the maximum porosity of the third portion 1213, so that the porosity of the third portion 1213 is greater than that of the second portion 1212. Moreover, the porosity of the third part 1213 can be set in a gradient, which is conducive to flexible adjustment of the elastic modulus of the third part 1213, so that the elastic modulus of the part of the first porous part 121 closer to the second end 112 is smaller, which is conducive to further improving the ability of the spinal implant 10 to better meet the mechanical environment at the second end 112, and reducing the stress shielding of the spinal implant 10 at the second end 112 as much as possible, so that the bone tissue of the spine in contact with the side of the first porous part 121 close to the second end 112 can obtain sufficient mechanical stimulation to promote the bone ingrowth performance of the bone tissue of the spine in contact with the side of the first porous part 121 close to the second end 112, so that the spine can grow and fuse with the side of the spinal implant 10 close to the second end 112 faster.
[0088] In other embodiments, the porosity of the third portion 1213 may be made substantially constant in the direction X from the first end 111 to the second end 112, and the elastic modulus of the portion of the first porous portion 121 close to the second end 112 may also be reduced to a certain extent, and the porosity of the third portion 1213 only needs to be greater than the porosity of the second portion 1212. Moreover, when the porosity of the third portion 1213 of the first porous portion 121 is substantially constant in the direction X from the first end 111 to the second end 112, the processing of the first porous portion 121 may be made more convenient, which is beneficial to improving the production efficiency of the spinal implant 10.
[0089] It should be noted that only the porosity of the first portion 1211 is gradually reduced or kept substantially constant along the direction X from the first end 111 to the second end 112, or only the porosity of the second portion 1212 is gradually increased or kept substantially constant along the direction X from the first end 111 to the second end 112. In addition, the porosity of the first portion 1211 is gradually reduced along the direction X from the first end 111 to the second end 112, while the porosity of the second portion 1212 is gradually increased or kept substantially constant along the direction X from the first end 111 to the second end 112. Alternatively, the porosity of the first portion 1211 is kept substantially constant along the direction X from the first end 111 to the second end 112, while the porosity of the second portion 1212 is gradually increased or kept substantially constant along the direction X from the first end 111 to the second end 112.
[0090] In some embodiments, the porosity of the second portion 1212 can be first reduced and then increased along the direction X from the first end 111 to the second end 112, so that the porosity of the second portion 1212 is set in a gradient, which is conducive to flexible adjustment of the elastic modulus of the second portion 1212, so that the porosity of the middle portion of the first porous portion 121 in the direction from the first end 111 to the second end 112 of the frame 11 is as small as possible, and the elastic modulus is as high as possible, which is conducive to improving the strength of the middle portion of the first porous portion 121 in the direction from the first end 111 to the second end 112 of the frame 11, and reducing the risk of fracture of the middle portion of the spinal implant 10 after the two ends of the spinal implant 10 in the direction from the first end 111 to the second end 112 are compressed.
[0091] In the direction X from the first end 111 to the second end 112, the minimum porosity of the second portion 1212 can be located in the middle of the spinal implant 10. Thus, the elastic modulus of the middle portion of the first porous portion 121 in the direction from the first end 111 to the second end 112 of the frame 11 can be made higher, which is beneficial to improving the strength of the middle portion of the spinal implant 10 in the direction from the first end 111 to the second end 112, thereby further reducing the risk of fracture in the middle portion of the spinal implant 10.
[0092] In other embodiments, the porosity of the second portion 1212 can be made substantially constant in the direction X from the first end 111 to the second end 112, and the elastic modulus of the middle portion of the first porous portion 121 in the direction from the first end 111 to the second end 112 of the frame 11 can also be made higher, so as to reduce the risk of fracture of the middle portion of the spinal implant 10. Moreover, when the porosity of the second portion 1212 of the first porous portion 121 is substantially constant in the direction X from the first end 111 to the second end 112, the processing of the first porous portion 121 can be made more convenient, which is conducive to improving the production efficiency of the spinal implant 10.
[0093] In some embodiments, the first portion 1211 of the first porous portion 121 can be extended from the first end 111 of the frame 11 to the second portion 1212. Thus, the first portion 1211 can be closer to the first end 111 of the frame 11, and the elastic modulus of the portion of the first porous portion 121 close to the first end 111 can be adjusted by adjusting the porosity of the first portion 1211. In particular, when the porosity of the first portion 1211 gradually decreases along the direction X from the first end 111 to the second end 112, the elastic modulus of the portion of the first porous portion 121 close to the first end 111 can be smaller.
[0094] Similarly, the third portion 1213 of the first porous portion 121 can be extended from the second end 112 to the second portion 1212. Thus, the third portion 1213 can be closer to the second end 112 of the frame 11, and the elastic modulus of the portion of the first porous portion 121 close to the second end 112 can be adjusted by adjusting the porosity of the third portion 1213. In particular, when the porosity of the second portion 1212 gradually increases along the direction X from the first end 111 to the second end 112, the elastic modulus of the portion of the first porous portion 121 close to the second end 112 can be smaller.
[0095] In some embodiments, the difference between the maximum porosity and the minimum porosity of the first porous portion 121 in the direction X from the first end 111 to the second end 112 can be greater than or equal to 60%. Thus, the porosity of the first porous portion 121 in the direction X from the first end 111 to the second end 112 can have a large adjustment range, so that the first porous portion 121 forms a porous structure 12 with a lower porosity at a portion of the spinal implant 10 with a higher strength requirement, and forms a porous structure 12 with a higher porosity at a portion of the spinal implant 10 with a lower strength requirement.
[0096] Among them, the difference between the maximum porosity and the minimum porosity of the first porous portion 121 in the direction X from the first end 111 to the second end 112 can be 65%, 70%, 75%, etc., which can be determined according to the structure of the first porous portion 121 and the strength requirements of various parts of the spinal implant 10.
[0097] In some embodiments, the maximum porosity of the first porous portion 121 can be greater than or equal to 60% and less than or equal to 90% in the direction X from the first end 111 to the second end 112. Thus, the first porous portion 121 can have a smaller elastic modulus and lower strength at the maximum porosity in the direction X from the first end 111 to the second end 112.
[0098] The maximum porosity of the first porous portion 121 in the direction X from the first end 111 to the second end 112 may be 65%, 70%, 75%, etc., depending on the structure of the first porous portion 121 and the strength requirements of various parts of the spinal implant 10.
[0099] Specifically, the maximum porosity of the first part 1211 and / or the third part 1213 of the first porous portion 121 in the direction X from the first end 111 to the second end 112 can be greater than or equal to 60% and less than or equal to 90%, so that the first part 1211 and / or the third part 1213 have a smaller elastic modulus, which is convenient for reducing the strength of the spinal implant 10 at the first part 1211 and the third part 1213, and is beneficial to reducing stress shielding of the spinal implant 10 at the first end 111 and / or the second end 112.
[0100] In addition, in the direction X from the first end 111 to the second end 112, the minimum porosity of the first porous portion 121 is greater than or equal to 30% and less than or equal to 60%. Thus, the first porous portion 121 can have a larger elastic modulus and higher strength at the minimum porosity in the direction X from the first end 111 to the second end 112, which is beneficial to reduce the risk of fracture of the middle part of the spinal implant 10 after the two ends of the spinal implant 10 in the direction from the first end 111 to the second end 112 are compressed.
[0101] Among them, the difference between the maximum porosity and the minimum porosity of the first porous part 121 in the direction from the first end 111 to the second end 112 can be 35%, 40%, 45%, etc., which can be determined according to the structure of the first porous part 121 and the strength requirements of various parts of the spinal implant 10.
[0102] Specifically, the maximum porosity of the second part 1212 of the first porous portion 121 can be greater than or equal to 30% and less than or equal to 60%, so that the second part 1212 has a larger elastic modulus, which is convenient for improving the strength of the spinal implant 10 at the second part 1212 and helps reduce the risk of fracture in the middle of the spinal implant 10.
[0103] In some embodiments, the porosity of the first porous portion 121 may be increased or decreased by greater than or equal to 10% and less than or equal to 25% per 1 mm in the direction X from the first end 111 to the second end 112. Thus, the spinal implant 10 can have a lower elastic modulus at the first end 111 and / or the second end 112 to reduce stress shielding of the spinal implant 10 at the first end 111 and / or the second end 112, and can also have a higher strength in the middle portion of the spinal implant 10 in the direction X from the first end 111 to the second end 112 to reduce the risk of fracture in the middle portion of the spinal implant 10.
[0104] Among them, in the direction X from the first end 111 to the second end 112, the porosity of the first porous part 121 can be increased or decreased by 12%, 15%, 18%, 23% etc. per 1 mm, which can be specifically determined according to factors such as the structure and material of the frame 11 and the first porous part 121.
[0105] It should be noted that, in the direction X from the first end 111 to the second end 112, the porosity of the first porous portion 121 may be increased or decreased, which may be determined specifically according to the position of the first porous portion 121. For example, when the porosity of the first portion 1211 gradually decreases along the direction X from the first end 111 to the second end 112, the porosity of the first portion 1211 may be gradually decreased in the direction X from the first end 111 to the second end 112 at a porosity change rate of 10% to 25% per 1 mm.
[0106] When the porosity of the second portion 1212 first decreases and then increases in the direction X from the first end 111 to the second end 112, the porosity of the first portion 1211 can be gradually decreased in the direction X from the first end 111 to the second end 112 at a rate of change of 10% to 25% per 1 mm, and then gradually increased at a rate of change of 10% to 25% per 1 mm.
[0107] When the porosity of the third portion 1213 gradually increases along the direction X from the first end 111 to the second end 112, the porosity of the third portion 1213 can be gradually increased at a rate of increase of 10% to 25% per 1 mm in the direction X from the first end 111 to the second end 112.
[0108] In addition, the porosity of the first porous portion 121 that increases or decreases by 1 mm in the direction X from the first end 111 to the second end 112 is greater than or equal to 10% and less than or equal to 25%, which means the porosity change rate of the first porous portion 121 in the direction X from the first end 111 to the second end 112, not that the length of the first porous portion 121 in the direction X from the first end 111 to the second end 112 is greater than 1 mm.
[0109] like Figure 2 As shown, the first porous portion 121 may include a bone grafting window 1214 extending along the direction X from the first end 111 to the second end 112, and the first porous portion 121 includes a first end surface 1218 and a second end surface 1219, which are sequentially distributed along the direction X from the first end 111 to the second end 112, and the first end surface 1218 and / or the second end surface 1219 are formed with a bone grafting opening 1215 connected to the bone grafting window 1214. Therefore, during the process of implanting the spinal implant 10 into the spine, the bone can be placed in the bone grafting window 1214 through the bone grafting opening 1215 to increase the growth and fusion speed of the spinal implant 10 and the spine.
[0110] In some embodiments, the first porous portion 121 may include a first sub-porous portion 1216 and a second sub-porous portion 1217 distributed in sequence along a direction Y from the bone graft window 1214 to the frame body 11 , and the porosity of the first sub-porous portion 1216 is greater than that of the second sub-porous portion 1217 .
[0111] The first sub-porous part 1216 and the second sub-porous part 1217 of the first porous part 121 are sequentially distributed along the direction Y from the bone grafting window 1214 to the frame 11, and the porosity of the first porous part 121 is greater than the porosity of the second sub-porous part 1217. In this way, the porosity of the first porous part 121 can be set in a gradient in the direction Y from the bone grafting window 1214 to the frame 11, and the part of the first porous part 121 close to the frame 11 has a higher strength to improve the support stability of the spinal implant 10 to the spinal column after being implanted in the spinal column, and the area of the first porous part 121 close to the bone grafting window 1214 has a larger gap, which is conducive to bone growth into the first porous part 121.
[0112] It should be noted that the average porosity of the first sub-porous portion 1216 can be greater than the average porosity of the second sub-porous portion 1217, and the minimum porosity of the first sub-porous portion 1216 can be greater than the maximum porosity of the second sub-porous portion 1217, as long as the elastic modulus of the first sub-porous portion 1216 is smaller than the elastic modulus of the second sub-porous portion 1217.
[0113] In addition, the first sub-porous portion 1216 and the second sub-porous portion 1217 may be continuous portions, or may be discontinuous portions with other porous structures 12 disposed in the middle. In the direction Y from the bone graft window 1214 to the frame 11, the sum of the widths of the first sub-porous portion 1216 and the second sub-porous portion 1217 may be equal to the total width of the first porous portion 121, or may be smaller than the total width of the first porous portion 121.
[0114] In some embodiments, the porosity of the first sub-porous portion 1216 can be gradually reduced in the direction Y from the bone grafting window 1214 to the frame 11. Thus, the first sub-porous portion 1216 can be arranged in a gradient in the direction Y from the bone grafting window 1214 to the frame 11, which is conducive to flexibly adjusting the elastic modulus of the first sub-porous portion 1216, so that the elastic modulus of the first sub-porous portion 1216 near the bone grafting window 1214 is smaller and the gap is larger, thereby further improving the spinal column at the bone grafting window 1214 to better meet the mechanical environment, and facilitating the growth of bone tissue in the bone grafting window 1214 into the gap of the first sub-porous portion 1216.
[0115] In other embodiments, the porosity of the first sub-porous portion 1216 can be made substantially constant in the direction Y from the bone graft window 1214 to the frame 11, and the elastic modulus of the first porous portion 121 near the bone graft window 1214 can also be reduced to a certain extent, and the porosity of the first sub-porous portion 1216 only needs to be greater than the porosity of the second sub-porous portion 1217. Moreover, when the porosity of the first sub-porous portion 1216 of the first porous portion 121 is substantially constant in the direction Y from the bone graft window 1214 to the frame 11, the processing of the first porous portion 121 can be made more convenient, which is conducive to improving the production efficiency of the spinal implant 10.
[0116] Similarly, the porosity of the second sub-porous portion 1217 can be gradually reduced in the direction Y from the bone graft window 1214 to the frame 11. Thus, the second sub-porous portion 1217 can be arranged in a gradient in the direction Y from the bone graft window 1214 to the frame 11, which is conducive to flexibly adjusting the elastic modulus of the second sub-porous portion 1217, so that the elastic modulus of the second sub-porous portion 1217 near the frame 11 is larger and the gap is smaller, thereby further improving the structural strength near the frame 11, so that the spinal implant 10 can support the spine more stably.
[0117] In other embodiments, the porosity of the second sub-porous portion 1217 can be made substantially constant in the direction Y from the bone graft window 1214 to the frame 11, and the elastic modulus of the first porous portion 121 close to the frame 11 can also be improved to a certain extent, and the porosity of the first sub-porous portion 1216 only needs to be greater than the porosity of the second sub-porous portion 1217. Moreover, when the porosity of the second sub-porous portion 1217 of the first porous portion 121 is substantially constant in the direction Y from the bone graft window 1214 to the frame 11, the processing of the second sub-porous portion 1217 can be made more convenient, which is conducive to improving the production efficiency of the spinal implant 10.
[0118] It should be noted that the porosity of only one of the first sub-porous portion 1216 and the second sub-porous portion 1217 may be gradually reduced or kept substantially constant along the direction Y from the bone grafting window 1214 to the frame body 11, or the porosity of both the first sub-porous portion 1216 and the second sub-porous portion 1217 may be gradually reduced or kept substantially constant along the direction Y from the bone grafting window 1214 to the frame body 11. In addition, the porosity of the first sub-porous portion 1216 may be gradually reduced along the direction Y from the bone grafting window 1214 to the frame body 11, while the porosity of the second sub-porous portion 1217 may be kept substantially constant along the direction Y from the bone grafting window 1214 to the frame body 11. Alternatively, the porosity of the first sub-porous portion 1216 may be kept substantially constant along the direction Y from the bone grafting window 1214 to the frame body 11, while the porosity of the second sub-porous portion 1217 may be gradually reduced along the direction Y from the bone grafting window 1214 to the frame body 11.
[0119] In some embodiments, the difference between the maximum porosity and the minimum porosity of the first porous portion 121 can be greater than or equal to 60% in the direction Y from the bone graft window 1214 to the frame 11. Thus, the porosity of the first porous portion 121 can have a large adjustment range in the direction Y from the bone graft window 1214 to the frame 11, so that the first porous portion 121 forms a porous structure 12 with a lower porosity at a portion of the spinal implant 10 with a higher strength requirement, and forms a porous structure 12 with a higher porosity at a portion of the spinal implant 10 with a lower strength requirement.
[0120] Among them, the difference between the maximum porosity and the minimum porosity of the first porous part 121 in the direction Y from the bone graft window 1214 to the frame body 11 can be 65%, 70%, 75%, etc., which can be determined according to the structure of the first porous part 121 and the strength requirements of various parts of the spinal implant 10.
[0121] In some embodiments, the maximum porosity of the first porous portion 121 is greater than or equal to 60% and less than or equal to 90% in the direction Y from the bone graft window 1214 to the frame 11. Thus, the first porous portion 121 can have a smaller elastic modulus at the maximum porosity in the direction Y from the bone graft window 1214 to the frame 11, so that the spinal implant 10 has a lower strength at the maximum porosity of the first porous portion 121, thereby enabling the spinal implant 10 to meet a better mechanical environment.
[0122] The maximum porosity of the first porous portion 121 in the direction Y from the bone graft window 1214 to the frame 11 can be 65%, 70%, 75%, etc., depending on the structure of the first porous portion 121 and the strength requirements of various parts of the spinal implant 10.
[0123] Specifically, the maximum porosity of the first sub-porous portion 1216 in the direction Y from the bone graft window 1214 to the frame 11 can be greater than or equal to 60% and less than or equal to 90%, so that the first sub-porous portion 1216 has a smaller elastic modulus, which is convenient for reducing the strength of the spinal implant 10 at the first sub-porous portion 1216, and is beneficial for reducing stress shielding of the spinal implant 10 at the bone graft window 1214.
[0124] In addition, the minimum porosity of the first porous portion 121 can be greater than or equal to 30% and less than or equal to 60% in the direction Y from the bone graft window 1214 to the frame 11. Thus, the first porous portion 121 can have a larger elastic modulus and higher strength at the minimum porosity in the direction Y from the bone graft window 1214 to the frame 11, which is beneficial to improving the support stability of the spinal implant 10 on the spine.
[0125] Among them, the difference between the maximum porosity and the minimum porosity of the first porous part 121 in the direction Y from the bone graft window 1214 to the frame body 11 can be 35%, 40%, 45%, etc., which can be determined according to the structure of the first porous part 121 and the strength requirements of various parts of the spinal implant 10.
[0126] Specifically, the maximum porosity of the second sub-porous portion 1217 in the direction Y from the bone graft window 1214 to the frame 11 can be greater than or equal to 30% and less than or equal to 60%, so that the second sub-porous portion 1217 has a larger elastic modulus and strength, which is beneficial to improving the supporting stability of the spinal implant 10 on the spine.
[0127] In some embodiments, the porosity of the first porous portion 121 can be reduced by 1 mm to be greater than or equal to 6% and less than or equal to 12% in the direction Y from the bone graft window 1214 to the frame 11. Thus, the spinal implant 10 can have a lower elastic modulus near the bone graft window 1214 to reduce stress shielding of the spinal implant 10 at the bone graft window 1214, and can also have a higher strength near the frame 11 to reduce the risk of fracture in the middle of the spinal implant 10.
[0128] In the direction Y from the bone graft window 1214 to the frame 11 , the porosity of the first porous portion 121 can be reduced by 7%, 9%, 10%, 11% etc. per 1 mm, which can be specifically determined according to the structure and material of the frame 11 and the first porous portion 121 .
[0129] It should be noted that the porosity of the first porous portion 121 that decreases by 1 mm in the direction Y from the bone graft window 1214 to the frame body 11 is greater than or equal to 10% and less than or equal to 25%, which refers to the porosity change rate of the first porous portion 121 in the direction Y from the bone graft window 1214 to the frame body 11, and does not mean that the width of the first porous portion 121 in the direction Y from the bone graft window 1214 to the frame body 11 is greater than 1 mm.
[0130] In some embodiments, Figure 3 As shown, the porous structure 12 includes a plurality of wire diameters 120, and the plurality of wire diameters 120 are connected to each other and enclosed to form a plurality of gaps. The porous structure 12 may be a Thiessen polygon structure or other structures, which are not limited here.
[0131] In some embodiments, the wire diameter 120 width of the first porous portion 121 can be greater than or equal to 200 μm and less than or equal to 600 μm. The inscribed circle diameter of the holes in the first porous portion 121 is greater than or equal to 300 microns and less than or equal to 1200 μm. Thus, the maximum porosity of the first porous portion 121 can be greater than or equal to 60% and less than or equal to 90%, and the minimum porosity of the first porous portion 121 can be greater than or equal to 30% and less than or equal to 60%.
[0132] like Figure 4 , Figure 5 As shown, the first porous portion 121 includes a first end surface 1218 and a second end surface 1219, and the first end surface 1218 and the second end surface 1219 are sequentially distributed along the direction X from the first end 111 to the second end 112 of the frame body 11. Wherein, an anti-slip protrusion 122 is convexly provided on the first end surface 1218 and / or the second end surface 1219, and the anti-slip protrusion 122 includes a contact surface 1221 for contacting the spine, and the contact surface 1221 is a convex curved surface.
[0133] Thus, after the spinal implant 10 is implanted in the spine, the anti-slip protrusion 122 of the first end surface 1218 and / or the second end surface 1219 of the first porous part 121 will contact the corresponding spine, thereby increasing the friction between the first end surface 1218 and / or the second end surface 1219 of the first porous part 121 and the corresponding spine, and reducing the risk of the spinal implant 10 slipping out of the spine. In addition, since the contact surface 1221 of the anti-slip protrusion 122 for contacting the spine is a convex surface, when the anti-slip protrusion 122 contacts the spine, the anti-slip protrusion 122 is not likely to cause damage to the spine.
[0134] It should be noted that the anti-slip protrusion 122 may be provided on both the first end surface 1218 and the second end surface 1219 of the first porous portion 121, or the anti-slip protrusion 122 may be provided only on the first end surface 1218 or the second end surface 1219 of the first porous portion 121. Of course, the former enables both the first end surface 1218 and the second end surface 1219 of the first porous portion 121 to contact the corresponding spine through the anti-slip protrusion 122, which can further reduce the risk of the spinal implant 10 slipping out of the spine.
[0135] In some embodiments, the height of the anti-dropout protrusion 122 in the direction from the first end 111 to the second end 112 can be greater than or equal to 0.3 mm and less than or equal to 1 mm. Thus, after the anti-dropout protrusion 122 contacts the spine, it can generate a large friction force between the spine to limit the spinal implant 10 from falling out, while preventing the anti-dropout protrusion 122 from being too high and causing damage to the spine.
[0136] Among them, the height of the anti-slip protrusion 122 in the direction from the first end 111 to the second end 112 can be 0.4 mm, 0.5 mm, 0.7 mm, etc., which can be specifically determined according to factors such as the structure, quantity, and setting position of the anti-slip protrusion 122.
[0137] In some embodiments, the first end surface 1218 and / or the second end surface 1219 may be provided with a plurality of anti-dropout protrusions 122 to further enhance the anti-dropout effect of the spinal implant 10 .
[0138] Specifically, the plurality of anti-slip protrusions 122 of the first end surface 1218 are spaced apart along the circumference of the frame body 11 to form a plurality of anti-slip protrusion 122 groups, and each anti-slip protrusion 122 group includes a plurality of anti-slip protrusions 122 spaced apart along the direction Y from the bone graft window 1214 to the frame body 11. Similarly, the plurality of anti-slip protrusions 122 of the second end surface 1219 are spaced apart along the circumference of the frame body 11 to form a plurality of anti-slip protrusions 122 groups, and each anti-slip protrusion 122 group includes a plurality of anti-slip protrusions 122 spaced apart along the direction Y from the bone graft window 1214 to the frame body 11. The number of the plurality of anti-slip protrusions 122 included in each anti-slip protrusion 122 group is greater than or equal to 5, and less than or equal to 15.
[0139] In some embodiments, the contact surface 1221 of the anti-slip protrusion 122 may be a portion of a spherical surface (eg, Figure 5 As shown), part of the ellipsoid (as shown Figure 6 as shown), or Figure 7 As shown, the anti-slip protrusion 122 is in the shape of a truncated cone, and the surface of the truncated cone is a convex curved surface.
[0140] In some embodiments, Figure 8As shown, a plurality of protrusions 1222 may be provided on the contact surface 1221 of the anti-slip protrusion 122, and the plurality of protrusions 1222 are arranged at intervals. Thus, the friction between the anti-slip protrusion 122 and the spine can be further improved. Moreover, the gaps between the plurality of protrusions 1222 are conducive to the growth of bone tissue of the spine, so that the spine and the anti-slip protrusion 122 can grow and fuse together quickly.
[0141] The plurality of protrusions 1222 may be evenly distributed on the contact surface 1221 of the anti-slip protrusion 122 , or may be unevenly distributed on the contact surface 1221 of the anti-slip protrusion 122 .
[0142] In some embodiments, the height of the plurality of protrusions 1222 protruding from the contact surface 1221 may be greater than or equal to 10 μm and less than or equal to 30 μm, thereby further improving the friction between the plurality of protrusions 1222 and the spine. The height of the protrusions 1222 protruding from the contact surface 1221 may be 15 μm, 20 μm, 25 μm, etc., which is not limited here.
[0143] In some embodiments, the diameter of the circumscribed circle of the radial cross section of the protrusion 1222 can be greater than or equal to 100 μm and less than or equal to 300 μm, thereby increasing the friction between the plurality of protrusions 1222 and the spine. At the same time, it can also induce the growth of spinal bone tissue and promote faster growth and fusion of the spinal bone tissue and the anti-slip protrusion 122.
[0144] The diameter of the circumscribed circle of the radial cross section of the protrusion 1222 may be 120 μm, 140 μm, 150 μm, 170 μm, etc., which is not limited here. The shape of the radial cross section of the protrusion 1222 may be hexagonal, semicircular, square, etc. The protrusion 1222 may be a columnar structure, a conical structure, a hemispherical structure, etc., which is not limited here.
[0145] In some embodiments, Fig. 9 As shown, the spinal implant 10 may further include at least one first reinforcing portion 116, which extends along the circumference of the bone grafting window 1214 and is spaced apart from the frame 11. Thus, the shape of the bone grafting window 1214 can be made more stable by the first reinforcing portion 116, so as to facilitate placing bones in the bone grafting window 1214.
[0146] A first reinforcing portion 116 may be provided at at least one bone grafting opening 1215 to keep the shape of at least one bone grafting opening 1215 stable, so as to facilitate placing the bone into the bone grafting window 1214 through the bone grafting opening 1215 .
[0147] Specifically, the first reinforcement portion 116 is arranged in an annular shape. The bone grafting window 1214 is formed with a bone grafting opening 1215 on the first end surface 1218 of the first porous portion 121, and the first reinforcement portion 116 is arranged at the bone grafting opening 1215 to keep the shape of the bone grafting opening 1215 stable. The bone grafting window 1214 penetrates the first porous portion 121 along the direction X from the first end 111 to the second end 112, and the bone grafting window 1214 is also formed with a bone grafting opening 1215 on the second end surface 1219 of the first porous portion 121, and the first reinforcement portion 116 is arranged at the bone grafting opening 1215 to keep the shape of the bone grafting opening 1215 stable.
[0148] In other embodiments, the first reinforcing portion 116 may maintain a certain distance from the bone grafting opening 1215 of the bone grafting window 1214, which can also keep the shapes of the bone grafting window 1214 and the bone grafting opening 1215 stable to a certain extent.
[0149] like Figure 1 As shown, at least one opening 114 communicating with the cavity 110 is provided on the periphery of the frame 11, the frame 11 includes an outer peripheral surface 113, and the opening 114 extends from the cavity 110 to the outer peripheral surface 113. In some embodiments, the porous structure 12 may further include a second porous portion 123 connected to the first porous portion 121, the second porous portion 123 is accommodated in the at least one opening 114 and connected to the inner peripheral surface 115 of the opening 114, and in the direction X from the first end 111 to the second end 112, the pores of the second porous portion 123 first decrease and then increase.
[0150] By providing an opening 114 connected to the cavity 110 on the periphery of the frame 11, and arranging a second porous portion 123 connected to the first porous portion 121 in the opening 114, the porosity of the second porous portion 123 is first reduced and then increased in the direction X from the first end 111 to the second end 112, so that the elastic modulus of the frame 11 can be adjusted, and the strength of the frame 11 in the middle part in the direction from the first end 111 to the second end 112 is relatively higher, so that the strength of the spinal implant 10 in the middle part in the direction from the first end 111 to the second end 112 is higher and not easy to break. The strength of the frame 11 near the first end 111 and the second end 112 is relatively lower, which is conducive to reducing the stress shielding of the spinal implant 10 at the first end 111 and the second end 112.
[0151] In some embodiments, Fig.10As shown, the spinal implant 10 may further include a second reinforcing portion 117, a portion of which is located in the opening 114 and spaced apart from the inner circumferential surface 115, the second reinforcing portion 117 is provided with a through hole 1171 for the instrument to pass through, and the second porous portion 123 in the opening 114 is connected between the second reinforcing portion 117 and the inner circumferential surface 115. By providing the second reinforcing portion 117 with the through hole 1171 in the opening 114, the shape of the through hole 1171 can be kept stable, and the instrument can be stably connected to the spinal implant 10 after passing through the through hole 1171 of the second reinforcing portion 117, so that the doctor can operate the spinal implant 10 through the instrument to implant it into the spine.
[0152] The second reinforcement portion 117 may be connected to the inner circumferential surface 115 of the opening 114 through the second porous portion 123 in the opening 114 , so that the position of the second reinforcement portion 117 relative to the frame body 11 remains stable.
[0153] In some embodiments, Fig.11 As shown, the spinal implant 10 may further include a third reinforcing portion 118 disposed in at least one opening 114, the third reinforcing portion 118 being connected to the inner circumferential surface 115 on at least two sides of the opening 114, and the second porous portion 123 in the opening 114 being connected between the third reinforcing portion 118 and the inner circumferential surface 115. Thus, the structural strength of the frame 11 near the opening 114 can be improved by the third reinforcing portion 118. Moreover, by adjusting the shape and size of the third reinforcing portion 118, the structural strength of the frame 11 near the opening 114 can be adjusted, which is conducive to making the adjustment of the elastic modulus of the frame 11 more convenient.
[0154] It should be noted that the opening 114 may be circular, rectangular, elliptical, etc. The third reinforcing portion 118 may be connected to the inner circumferential surfaces 115 on both sides of the opening 114 along the direction from the first end 111 to the second end 112, or may be connected to the inner circumferential surfaces 115 on both sides of the opening 114 perpendicular to the direction from the first end 111 to the second end 112.
[0155] In some embodiments, the third reinforcement portion 118 and the second reinforcement portion 117 can be distributed on both sides of the cavity 110 to improve the structural stability of the frame 11, so that the frame 11 is not easily deformed during the process of the doctor inserting the instrument into the through hole 1171 of the second reinforcement portion 117 to operate the spinal implant 10 to be implanted into the spine.
[0156] In some embodiments, the number of openings 114 can be multiple, and the multiple openings 114 are arranged at intervals along the circumference of the frame body 11. A second porous portion 123 is provided in each opening 114. Thus, the elastic modulus of the frame body 11 can be adjusted more flexibly and conveniently.
[0157] The embodiment of the present application also provides a fusion device. The fusion device includes a frame 11 and a porous structure 12. The frame 11 includes a first end 111 and a second end 112 opposite to each other. A cavity 110 is provided in the frame 11. The cavity 110 penetrates the frame 11 along a direction X from the first end 111 to the second end 112. The frame 11 is provided with at least one opening 114 connected to the cavity 110. The frame 11 includes an outer peripheral surface 113. The opening 114 extends from the cavity 110 to the outer peripheral surface 113. The porous structure 12 includes a first porous portion 121 and a second porous portion 123 connected to each other. The first porous portion 121 is accommodated in the cavity 110 and connected to the frame 11. The second porous portion 123 is accommodated in the opening 114 and connected to the inner peripheral surface 115 of the opening 114.
[0158] In the direction X from the first end 111 to the second end 112, the pores of the first porous portion 121 first decrease and then increase, and the pores of the second porous portion 123 first decrease and then increase; the first porous portion 121 includes a bone grafting window 1214 extending along the direction X from the first end 111 to the second end 112, and in the direction Y from the bone grafting window 1214 to the frame 11, the porosity of the first porous portion 121 gradually decreases.
[0159] The specific structures of the frame 11 and the porous structure 12 may refer to the above embodiments, which will not be described in detail here.
[0160] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.
[0161] The above is a detailed introduction to a fusion device and a spinal implant provided in the embodiments of the present application. Specific examples are used in this article to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the technical solutions and core ideas of the present application. Ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.
Claims
1. A fusion device, characterized in that: include: A frame body, comprising a first end and a second end opposite to each other, wherein a cavity is disposed in the frame body, and the cavity penetrates the frame body in a direction from the first end to the second end; the frame body is provided with at least one opening communicating with the cavity, and the frame body comprises an outer peripheral surface, and the opening extends from the cavity to the outer peripheral surface; A porous structure, comprising a first porous portion and a second porous portion connected to each other, wherein the first porous portion is accommodated in the cavity and connected to the frame, and the second porous portion is accommodated in the opening and connected to the inner circumference of the opening; Among them, in the direction from the first end to the second end, the pores of the first porous part first decrease and then increase, and the pores of the second porous part first decrease and then increase; the first porous part includes a bone grafting window extending along the direction from the first end to the second end, and the porosity of the first porous part gradually decreases in the direction from the bone grafting window to the frame body.
2. A spinal implant, characterized in that: include: A frame body, comprising a first end and a second end opposite to each other, wherein a cavity is disposed in the frame body, and the cavity penetrates the frame body in a direction from the first end to the second end; The porous structure includes a first porous portion, which is accommodated in the cavity and connected to the frame. The first porous portion includes a first part, a second part and a third part distributed in sequence from the first end to the second end. The porosity of the first part and the third part is greater than the porosity of the second part.
3. The spinal implant according to claim 2, characterized in that The porosity of the first portion gradually decreases from the first end to the second end; the minimum porosity of the first portion is greater than or equal to the maximum porosity of the second portion; and / or, The porosity of the second portion gradually increases from the first end to the second end, and the minimum porosity of the second portion is greater than or equal to the maximum porosity of the third portion.
4. The spinal implant according to claim 2, characterized in that The porosity of the first portion is substantially constant in a direction from the first end to the second end; and / or, The porosity of the second portion is substantially constant in a direction from the first end to the second end; and / or, The porosity of the third portion is substantially constant in a direction from the first end to the second end.
5. The spinal implant according to claim 2, characterized in that The first portion extends from the first end to the second portion; and / or the third portion extends from the second end to the second portion.
6. The spinal implant according to claim 2, characterized in that The porosity of the second portion first decreases and then increases along a direction from the first end to the second end.
7. The spinal implant according to claim 6, characterized in that In a direction from the first end to the second end, the second portion has a minimum porosity at a location in a middle portion of the spinal implant.
8. The spinal implant according to any one of claims 2 to 7, characterized in that In a direction from the first end to the second end, a difference between a maximum porosity and a minimum porosity of the first porous portion is greater than or equal to 60%.
9. The spinal implant according to any one of claims 2 to 7, characterized in that In the direction from the first end to the second end, the maximum porosity of the first porous portion is greater than or equal to 60% and less than or equal to 90%; and / or, In a direction from the first end to the second end, a minimum porosity of the first porous portion is greater than or equal to 30% and less than or equal to 60%.
10. The spinal implant according to any one of claims 2 to 7, characterized in that In a direction from the first end to the second end, the porosity of the first porous portion increases or decreases per 1 mm by greater than or equal to 10% and less than or equal to 25%.
11. The spinal implant according to any one of claims 2 to 7, characterized in that The first porous portion includes a bone grafting window extending from the first end to the second end, the first porous portion includes a first end surface and a second end surface, the first end surface and the second end surface are sequentially distributed from the first end to the second end, and the first end surface and / or the second end surface are formed with a bone grafting opening communicating with the bone grafting window; The first porous portion includes a first sub-porous portion and a second sub-porous portion sequentially distributed along a direction from the bone graft window to the frame body, and the porosity of the first sub-porous portion is greater than the porosity of the second sub-porous portion.
12. The spinal implant according to claim 11, characterized in that In the direction from the bone graft window to the frame, the porosity of the first sub-porous portion gradually decreases; and / or, In a direction from the bone graft window to the frame, the porosity of the second sub-porous portion gradually decreases.
13. The spinal implant according to claim 12, characterized in that In the direction from the bone graft window to the frame, the porosity of the first sub-porous portion is substantially constant; and / or, In a direction from the bone graft window to the frame body, the porosity of the second sub-porous portion is substantially constant.
14. The spinal implant according to claim 11, characterized in that In a direction from the bone graft window to the frame body, a difference between a maximum porosity and a minimum porosity of the first porous portion is greater than or equal to 60%.
15. The spinal implant according to claim 11, characterized in that In the direction from the bone graft window to the frame, the maximum porosity of the first porous portion is greater than or equal to 60% and less than or equal to 90%; and / or, In a direction from the bone graft window to the frame body, a minimum porosity of the first porous portion is greater than or equal to 30% and less than or equal to 60%.
16. The spinal implant according to claim 11, characterized in that In the direction from the bone graft window to the frame body, the porosity of the first porous portion decreases by 1 mm by greater than or equal to 6% and less than or equal to 12%.
17. The spinal implant according to any one of claims 2 to 7, characterized in that The first porous portion includes a first end face and a second end face, and the first end face and the second end face are distributed sequentially along the direction from the first end to the second end; the first end face and / or the second end face are convexly provided with an anti-slip protrusion, and the anti-slip protrusion includes a contact surface for contacting the spine, and the contact surface is a convex curved surface.
18. The spinal implant according to any one of claims 2 to 7, characterized in that The first porous portion includes a bone grafting window extending in the direction from the first end to the second end, the first porous portion includes a first end face and a second end face, the first end face and the second end face are distributed in sequence along the direction from the first end to the second end, and the first end face and / or the second end face are formed with a bone grafting opening connected to the bone grafting window; the spinal implant also includes at least one first reinforcement portion, the first reinforcement portion extends along the circumference of the bone grafting window and is spaced apart from the frame.
19. The spinal implant according to claim 18, characterized in that The first reinforcement portion is provided at at least one of the bone graft openings.
20. The spinal implant according to any one of claims 2 to 7, characterized in that The outer periphery of the frame is provided with at least one opening communicating with the cavity, the frame comprises an outer peripheral surface, and the opening extends from the cavity to the outer peripheral surface; The porous structure also includes a second porous portion connected to the first porous portion, the second porous portion is accommodated in at least one of the openings and connected to the inner circumference of the opening, and in the direction from the first end to the second end, the pores of the second porous portion first decrease and then increase.
21. The spinal implant of claim 20, wherein: The spinal implant also includes a second reinforcement part, a portion of which is located in the opening and spaced apart from the inner circumference. The second reinforcement part is provided with a through hole for instruments to pass through, and the second porous part in the opening is connected between the second reinforcement part and the inner circumference.
22. The spinal implant of claim 21, wherein: The spinal implant further includes a third reinforcement portion disposed in at least one of the openings, the third reinforcement portion being connected to the inner circumferences of at least two sides of the opening, and the second porous portion in the opening being connected between the third reinforcement portion and the inner circumference.
23. The spinal implant of claim 22, wherein: The third reinforcement portion and the second reinforcement portion are distributed on both sides of the cavity.
24. The spinal implant of claim 20, wherein: There are multiple openings, and the multiple openings are arranged at intervals along the circumference of the frame; and the second porous portion is arranged in each opening.
25. The spinal implant according to any one of claims 2 to 7, characterized in that The wire diameter width of the first porous portion is greater than or equal to 200 μm and less than or equal to 600 μm; and / or, The inscribed circle diameter of the pores in the first porous portion is greater than or equal to 300 μm and less than or equal to 1200 μm.
26. The spinal implant according to any one of claims 2 to 7, characterized in that The spinal implant includes an intervertebral fusion cage or an artificial vertebral body.
Citation Information
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