Fusion unit and fusion

Abstract

This invention discloses a fusion device unit and a fusion device, belonging to the field of orthopedic implant technology. The fusion device unit includes an upper support plate and a lower support plate arranged opposite each other. An adjustment structure is provided at the middle of the opposite end faces of the upper and lower support plates, which can adjust the distance between the upper and lower support plates. An elastic support structure is provided around the opposite end faces of the upper and lower support plates. The elastic support structure includes a vertical beam, with its two ends connected to the upper and lower support plates respectively. The fusion device unit and fusion device of this invention have certain torsional and elastic functions, and their height is adjustable.

Description

Technical Field

[0001] This invention relates to the field of orthopedic implant technology, and in particular to a fusion device unit and a fusion device. Background Technology

[0002] Clinically, conventional interbody fusion cages are mostly made of non-absorbable polyetheretherketone (PEEK) or titanium alloy. However, the former has disadvantages such as poor osteogenic capacity, bioinertness, and non-absorbability, resulting in poor fusion outcomes; the latter, due to the stress shielding effect caused by its high modulus, can lead to adverse reactions such as bone resorption and pseudoarthrosis. Absorbable composite materials, due to their excellent mechanical properties, osteogenic capacity, absorbability, and lack of radiographic interference, are more suitable for clinical needs.

[0003] Currently, there are no absorbable interbody fusion cage products available for clinical application, mainly because existing absorbable fusion cages largely follow the design structure of traditional fusion cages. The shortcomings are at least:

[0004] 1) The contact surface with the final plate is a solid, absorbable structure;

[0005] 2) The overall solid structure loses the ability to twist and maintain elastic physiological movement of the intervertebral discs;

[0006] 3) The height is fixed and cannot be adjusted;

[0007] 4) It cannot adjust its flexibility according to the patient's condition;

[0008] 5) The fixation strength cannot be adjusted according to the patient's condition;

[0009] 6) Cannot be used alone and cannot be consciously combined;

[0010] 7) It cannot simultaneously address both controllable degradation and development issues. Summary of the Invention

[0011] The technical problem to be solved by the present invention is to provide a fusion unit and fusion unit with certain torsional and elastic functions and adjustable height.

[0012] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0013] On the one hand, a fusion unit is provided, comprising an upper support plate and a lower support plate disposed opposite to each other, wherein:

[0014] An adjustment structure is provided at the middle of the opposite end faces of the upper support plate and the lower support plate, and the adjustment structure can adjust the distance between the upper support plate and the lower support plate;

[0015] An elastic support structure is provided around the opposite end faces of the upper support plate and the lower support plate. The elastic support structure includes a vertical beam, and the two ends of the vertical beam are respectively connected to the upper support plate and the lower support plate.

[0016] Furthermore, the elastic support structure includes a horizontal beam connecting the vertical beam, and both the vertical beam and the horizontal beam are S-shaped;

[0017] And / or, both the upper support plate and the lower support plate are designed using 3D printing;

[0018] And / or, both the upper support plate and the lower support plate are trabecular structures;

[0019] And / or, both the upper support plate and the lower support plate are made of absorbable material;

[0020] And / or, the elastic support structure is made of biodegradable magnesium alloy or biodegradable polyester material;

[0021] And / or, the elastic support structure adopts a single-cell structure.

[0022] Furthermore, the adjustment structure includes a plug-in post disposed on one of the upper support plate and the lower support plate and a plug-in hole disposed on the other. The plug-in post and the plug-in hole cooperate with each other, and a gear control component for adjusting the relative position of the two and locking the gear is provided between the plug-in post and the plug-in hole.

[0023] Furthermore, the gear adjustment component includes an annular toothed gear position disposed on the inner sidewall of the insertion hole, and a stop member disposed on the insertion post that cooperates with the annular toothed gear position.

[0024] Furthermore, the stop is an elastic fixing tooth fixed on the plug-in post and capable of moving the plug-in post in one direction inward. The elastic fixing tooth has a negative angle concave design.

[0025] Furthermore, the stop member is a pair of elastic insert arms hinged to the plug post and capable of moving the plug post inward in one direction.

[0026] Furthermore, the pair of elastic inserts are provided with limiting steps that cooperate with each other to allow the pair of elastic inserts to swing within a certain range.

[0027] Furthermore, the upper support plate has at least two upper insert holes on both sides, and the lower support plate has a lower insert hole at a position corresponding to the upper insert hole. Each upper insert hole has a first insert extending downward and used for insertion into the lower insert hole, and each lower insert hole has a second insert extending upward and used for insertion into the upper insert hole, and the first insert and the second insert are slidably engaged.

[0028] Furthermore, the first insert has a first connecting portion at its end, and the second insert has a second connecting portion at its end. The first connecting portion is provided with a first anti-retraction tooth, and the second connecting portion is provided with a second anti-retraction tooth.

[0029] And / or, both the first insert and the second insert are made of biodegradable magnesium or magnesium alloy material;

[0030] And / or, both the upper support plate and the lower support plate are made of absorbable polyester material;

[0031] And / or, the upper support plate is provided with an upper groove extending toward the lower support plate at the upper insert hole, and the lower support plate is provided with a lower groove extending toward the upper support plate at the lower insert hole.

[0032] On the other hand, a fusion device is provided, which is formed by connecting at least two of the above-mentioned fusion device units side by side, wherein the first insert of the upper support plate of the upper fusion device unit is inserted into the upper groove of the upper support plate of the lower fusion device unit, and the second insert of the lower support plate of the lower fusion device unit is inserted into the lower groove of the lower support plate of the upper fusion device unit, and the first anti-retraction tooth of the first insert of the upper support plate of the upper fusion device unit can cooperate with the second anti-retraction tooth of the second insert of the lower support plate of the lower fusion device unit.

[0033] The present invention has the following beneficial effects:

[0034] The fusion unit and fusion device of the present invention include an upper support plate and a lower support plate arranged opposite to each other. An adjustment structure is provided in the middle of the opposite end face of the upper support plate and the lower support plate. The adjustment structure can adjust the distance between the upper support plate and the lower support plate. An elastic support structure is provided around the opposite end face of the upper support plate and the lower support plate, so that the fusion unit has a certain torsional and elastic function, which can restore human physiological activity. Furthermore, the height of the fusion unit has a certain adjustment range. It can be actively pre-adjusted to the use height, or it can be adaptively adjusted to the corresponding elasticity and final height according to the human body's own weight, resulting in good performance. Attached Figure Description

[0035] Figure 1 This is a three-dimensional structural diagram of the fusion unit of the present invention;

[0036] Figure 2 for Figure 1 Structural diagram omitting the elastic support structure;

[0037] Figure 3This is a schematic diagram of the structure of embodiment 1 of the fusion device of the present invention, wherein (a) is a top view, (b) is a cross-sectional view of (a) along the AA direction and an enlarged view of the elastic fixing tooth is also shown, and (c) is a cross-sectional view of (a) along the BB direction.

[0038] Figure 4 This is an exploded structural diagram of the plug-in post and plug-in hole in embodiment 2 of the fusion device of the present invention;

[0039] Figure 5 for Figure 4 The diagram shows the usage status of the device, where (a) is the structural diagram before the pair of elastic inserts enter the ring tooth position, (b) is the structural diagram after the pair of elastic inserts enter the ring tooth position, and (c) is the structural diagram after the pair of elastic inserts are pulled back.

[0040] Figure 6 for Figure 4 Schematic diagram of the structure of the flexible insert arm;

[0041] Figure 7 for Figure 1 The diagram shows the structure of the fusion unit after assembly, where (a) is the assembly process diagram and (b) is a cross-sectional view of the insert in (a);

[0042] Figure 8 This is a schematic diagram of the trabecular structure of the upper and lower support plates of the fusion unit of the present invention, where (a)-(h) represent eight different structures. Detailed Implementation

[0043] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with the accompanying drawings and specific embodiments.

[0044] In the description of this invention, it should be understood that the terms "upper", "lower", "front", "rear", "left", "right", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0045] On the one hand, the present invention provides a fusion unit, such as Figure 1-6 As shown, it includes an upper support plate 1 and a lower support plate 2 arranged opposite to each other, wherein:

[0046] An adjustment structure is provided at the middle of the opposite end faces of the upper support plate 1 and the lower support plate 2, and the adjustment structure can adjust the distance between the upper support plate 1 and the lower support plate 2.

[0047] An elastic support structure 3 is provided around the opposite end faces of the upper support plate 1 and the lower support plate 2. The elastic support structure 3 includes a vertical beam 31, and the two ends of the vertical beam 31 are respectively connected to the upper support plate 1 and the lower support plate 2.

[0048] During the procedure, the fusion unit of the present invention is pre-adjusted to the usage height using the adjustment structure before being implanted into the patient's body. After the procedure, under the influence of the patient's own weight, the adjustment structure can adaptively adjust the height of the fusion unit until it is adjusted to the patient's corresponding elasticity and final height.

[0049] The fusion unit of the present invention includes an upper support plate and a lower support plate arranged opposite to each other. An adjustment structure is provided in the middle of the opposite end face of the upper support plate and the lower support plate. The adjustment structure can adjust the distance between the upper support plate and the lower support plate. An elastic support structure is provided around the opposite end face of the upper support plate and the lower support plate, so that the fusion unit has a certain torsional and elastic function, which can restore human physiological activity. Furthermore, the height of the fusion unit has a certain adjustment range. It can be actively pre-adjusted to the use height, or it can be adaptively adjusted to the corresponding elasticity and final height according to the human body's own weight, resulting in good performance.

[0050] like Figure 1 As shown, the elastic support structure 3 may include a horizontal beam 32 connecting the vertical beam 31. Both the vertical beam 31 and the horizontal beam 32 may be S-shaped. The setting of the horizontal beam 32 can improve the stability of the elastic support structure 3. The S-shaped design gives the elastic support structure 3 good elasticity, so that the fusion unit has good torsional and elastic functions and can better restore human physiological activities.

[0051] The adjustment structure can take various structural forms readily conceived by those skilled in the art, and the present invention preferably adopts the following structural forms:

[0052] The adjustment structure may include a plug-in post 21 disposed on one of the upper support plate 1 and the lower support plate 2 and a plug-in hole 11 disposed on the other. The plug-in post 21 and the plug-in hole 11 cooperate with each other. A gear control component is provided between the plug-in post 21 and the plug-in hole 11 for adjusting their relative position and locking the gear. In this way, the gear control component can be used to pre-adjust the fusion device unit of the present invention to the use height and lock the gear before implantation into the patient. After the operation, under the action of the patient's own gravity, the gear control component can adaptively adjust the height of the fusion device unit until it is adjusted to the patient's corresponding elasticity and final height.

[0053] At this time, the gear shift control component can adopt various structural forms that are easily conceived by those skilled in the art, and the present invention preferably adopts the following structural form:

[0054] like Figure 3As shown in (b), the gear control assembly may include an annular toothed gear 12 disposed on the inner sidewall of the insertion hole 11, and a gear member disposed on the insertion post 21 that cooperates with the annular toothed gear 12.

[0055] Depending on the structure of the component, the present invention can have the following embodiments:

[0056] Example 1

[0057] like Figure 3 As shown, the stop can be an elastic fixing tooth 22 fixed on the insertion post 21, allowing the insertion post 21 to move unidirectionally inward. This ensures that the insertion post 21 can only move unidirectionally inward relative to the insertion hole 11, and cannot move in the opposite direction. After the fusion unit is implanted into the patient, under the patient's own weight, the insertion post 21 moves unidirectionally inward, and the elastic fixing tooth 22 passes one annular tooth stop 12 and enters the next annular tooth stop 12, until it is adjusted to the patient's corresponding elasticity and final height. Furthermore, the elastic fixing tooth 22 can be designed with a negative angle concave inward to facilitate the insertion post 21 moving unidirectionally inward relative to the insertion hole 11, and cannot move in the opposite direction.

[0058] Example 2 (Plug-in Arm Pull-back Positioning Structure)

[0059] like Figure 4-6 As shown, the stop can be a pair of elastic arms 22' hinged to the insertion post 21 and capable of moving the insertion post 21 in one direction inward (the pair of elastic arms 22' can rotate around the hinge axis), so that the insertion post 21 can only move inward relative to the insertion hole 11 in one direction and cannot move in the opposite direction. At this time, after the fusion unit is implanted into the patient's body, under the action of the patient's own weight, the insertion post 21 moves inward in one direction, and the pair of elastic arms 22' retracts past one annular tooth stop 12 and enters the next annular tooth stop 12 until it is adjusted to the corresponding elasticity and final height of the patient. When pulled back, the pair of elastic arms 22' unfolds and is then restricted at the annular tooth stop 12.

[0060] Furthermore, a pair of elastic insert arms 22' may be provided with mutually cooperating limiting steps 221' for swinging the pair of elastic insert arms 22' within a certain range. Due to the limitation of the limiting steps 221', the initial swing angle of the pair of elastic insert arms 22' is as follows: Figure 5 As shown in (a). In specific implementation, the maximum distance between the two tips of a pair of elastic inserts 22' can be slightly greater than the bottom diameter of the annular toothed stop 12, and can be pressed into each stop according to the elasticity of the material; after pressing into a certain stop (see... Figure 5 In (b) of the middle section, due to the structure of the insert arm, it can be extended and thus restricted to that position during pullback (see [reference]). Figure 5 (c)), while also possessing a certain range of elasticity.

[0061] like Figure 3As shown in (c), the upper support plate 1 may have at least two upper insert holes 13 on both sides, and the lower support plate 2 has lower insert holes 23 at positions corresponding to the upper insert holes 13. Each upper insert hole 13 has a first insert 14 extending downward for insertion into the lower insert hole 23, and each lower insert hole 23 has a second insert 24 extending upward for insertion into the upper insert hole 13. The insert holes and inserts play a guiding role in the height adjustment of the fusion unit. At the same time, as the height of the fusion unit is adjusted, the length of the inserts extending out of the insert holes also increases, and they can be inserted into the vertebral bodies on both sides of the fusion unit, thereby improving the overall fixation stability.

[0062] Specifically, the end of the first insert 14 may be provided with a first connecting part 141, and the end of the second insert 24 may be provided with a second connecting part 241. The first connecting part 141 is provided with a first anti-retraction tooth 142, and the second connecting part 241 is provided with a second anti-retraction tooth 242. By providing anti-retraction teeth, when the insert is inserted into the corresponding vertebral body, the insert can be prevented from falling out, thereby improving the overall connection strength and facilitating its use during surgery.

[0063] In this embodiment, the anti-retraction tooth structure is the same as the elastic fixing tooth 22 structure, and the first anti-retraction tooth 142 and the second anti-retraction tooth 242 are oriented in directions that are far away from each other, thereby ensuring that the vertebral body can be easily inserted and that dislodgement can be avoided.

[0064] Specifically, the upper support plate 1 has an upper groove 15 extending toward the lower support plate 2 at the upper insert hole 13, which is the upper groove 15 for accommodating the first connecting part 141 of the first insert 14 of another fusion device unit with the same structure. The lower support plate 2 has a lower groove 25 extending toward the upper support plate 1 at the lower insert hole 23, which is the lower groove 25 for accommodating the second connecting part 241 of the second insert 24 of another fusion device unit with the same structure. In this way, the fusion device unit of the present invention can be connected side by side through the cooperation of the first connecting part 141, the second connecting part 241, the upper groove 15 and the lower groove 25, so that the fusion device units can be combined and arranged in multiple stages for use, forming a fusion device that better meets clinical needs, reducing costs and development difficulty. Furthermore, the combined fusion device can adjust the extension fixed length of the insert connecting part according to the patient's own weight, which is convenient for use during surgery.

[0065] like Figure 1As shown, both the upper support plate 1 and the lower support plate 2 can be designed using 3D printing to facilitate personalized customization based on the patient's individual intervertebral space conditions and needs. This allows for the design of support plates with corresponding heights and angles, perfectly fitting the patient's intervertebral space and enhancing the self-stabilizing performance of the fusion device. Both the upper support plate 1 and the lower support plate 2 feature trabecular bone structures 16 and 26 (specifically, these can be installed only on the upper surface of the upper support plate 1 and the lower surface of the lower support plate 2), resulting in better bone ingrowth. The specific structure of the trabecular bone can be found in [reference needed]. Figure 8 As shown ( Figure 8 (This is only a reference diagram of the trabecular structure.)

[0066] Both the upper support plate 1 and the lower support plate 2 can be made of absorbable (polyester) material to achieve controlled degradation. The first insert 14 and the second insert 24 can both be made of biodegradable magnesium or magnesium alloy material to ensure strong intraoperative imaging positioning and height maintenance. The elastic support structure 3 can be made of biodegradable magnesium alloy or biodegradable polyester material to achieve degradation. The elastic support structure 3 (i.e., the vertical beam 31 and the horizontal beam 32) can adopt a single-cell structure, the size of which meets the ingrowth requirements of osteoblasts, facilitating bone ingrowth and resulting in good postoperative stability. The fusion unit can be designed in various shapes, such as quadrilateral or waist-shaped.

[0067] On the other hand, the present invention provides a fusion device, such as Figure 7 As shown, the fusion unit is formed by connecting at least two of the above-mentioned fusion units side by side. The first insert 14 of the upper support plate 1 of the upper fusion unit is inserted into the upper groove 15 of the upper support plate 1 of the lower fusion unit. The second insert 24 of the lower support plate 2 of the lower fusion unit is inserted into the lower groove 25 of the lower support plate 2 of the upper fusion unit. The first anti-retraction tooth 142 of the first insert 14 of the upper fusion unit can cooperate with the second anti-retraction tooth 242 of the second insert 24 of the lower support plate 2 of the lower fusion unit. Understandably, the first anti-retraction tooth 142 of the first insert 14 of the upper support plate 1 of the upper fusion unit and the second anti-retraction tooth 242 of the second insert 24 of the lower support plate 2 of the lower fusion unit work together to ensure the reliability of the connection between the upper and lower fusion units. Simultaneously, both the second insert 24 of the upper fusion unit and the first insert 14 of the lower fusion unit can extend and insert into the vertebral bodies on both sides, further improving the fixation effect. Since the structure of the fusion unit is the same as above, it will not be described again here.

[0068] The fusion device of the present invention includes an upper support plate and a lower support plate arranged opposite to each other. An adjustment structure is provided in the middle of the opposite end face of the upper and lower support plates. The adjustment structure can adjust the distance between the upper and lower support plates. An elastic support structure is provided around the opposite end face of the upper and lower support plates, so that the fusion device has a certain torsional and elastic function, which can restore human physiological activity. Furthermore, the height of the fusion device has a certain adjustment range. It can be actively pre-adjusted to the use height, or it can be adaptively adjusted to the corresponding elasticity and final height according to the human body's own weight, resulting in good performance.

[0069] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A fusion unit, characterized in that, Includes an upper support plate and a lower support plate that are positioned opposite each other, wherein: An adjustment structure is provided at the middle of the opposite end faces of the upper support plate and the lower support plate, and the adjustment structure can adjust the distance between the upper support plate and the lower support plate; An elastic support structure is provided around the opposite end faces of the upper support plate and the lower support plate. The elastic support structure includes a vertical beam, and the two ends of the vertical beam are respectively connected to the upper support plate and the lower support plate. The upper support plate has at least two upper insert holes on both sides, and the lower support plate has a lower insert hole at a position corresponding to the upper insert hole. Each upper insert hole has a first insert extending downward and used for insertion into the lower insert hole, and each lower insert hole has a second insert extending upward and used for insertion into the upper insert hole. The first insert has a first connecting portion at its end, and the second insert has a second connecting portion at its end. The first connecting portion has a first anti-retraction tooth, and the second connecting portion has a second anti-retraction tooth. The upper support plate has an upper groove extending toward the lower support plate at the upper insert hole, and the lower support plate has a lower groove extending toward the upper support plate at the lower insert hole. When two fusion units are connected side by side, the first insert of the upper support plate of the upper fusion unit is inserted into the upper groove of the upper support plate of the lower fusion unit, and the second insert of the lower support plate of the lower fusion unit is inserted into the lower groove of the lower support plate of the upper fusion unit. The first anti-retraction tooth of the first insert of the upper support plate of the upper fusion unit can cooperate with the second anti-retraction tooth of the second insert of the lower support plate of the lower fusion unit.

2. The fusion unit according to claim 1, characterized in that, The elastic support structure includes a horizontal beam connecting the vertical beam, and both the vertical beam and the horizontal beam are S-shaped; And / or, both the upper support plate and the lower support plate are designed using 3D printing; And / or, both the upper support plate and the lower support plate are trabecular structures; And / or, both the upper support plate and the lower support plate are made of absorbable material; And / or, the elastic support structure is made of biodegradable magnesium alloy or biodegradable polyester material; And / or, the elastic support structure adopts a single-cell structure.

3. The fusion unit according to claim 1, characterized in that, The adjustment structure includes a plug-in post disposed on one of the upper support plate and the lower support plate and a plug-in hole disposed on the other. The plug-in post and the plug-in hole cooperate with each other, and a gear control component for adjusting the relative position of the two and locking the gear is provided between the plug-in post and the plug-in hole.

4. The fusion unit according to claim 3, characterized in that, The gear adjustment component includes an annular toothed gear position disposed on the inner side wall of the insertion hole, and a stop member disposed on the insertion post that cooperates with the annular toothed gear position.

5. The fusion unit according to claim 4, characterized in that, The stop is an elastic fixing tooth fixed on the plug post and capable of moving the plug post in one direction inward. The elastic fixing tooth has a negative angle concave design.

6. The fusion unit according to claim 4, characterized in that, The stop is a pair of elastic arms that are hinged to the plug post and can cause the plug post to move inward in one direction.

7. The fusion unit according to claim 6, characterized in that, The pair of elastic arms are provided with limiting steps that cooperate with each other to allow the pair of elastic arms to swing within a certain range.

8. The fusion unit according to claim 1, characterized in that, Both the first insert and the second insert are made of biodegradable magnesium or magnesium alloy material; And / or, both the upper support plate and the lower support plate are made of absorbable polyester material.

9. A fusion device, characterized in that, It is formed by connecting at least two fusion unit units as described in any one of claims 1-8 side by side.

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