Orthopedic implant

Abstract

The utility model provides an orthopedic implant which comprises a main body, a groove is formed in the side face, facing a bone, of the main body, magnesium alloy or magnesium is embedded in the groove, the groove extends in the length direction of the main body, an opening of the groove is gradually narrowed, a groove opening is formed in the groove, and the magnesium alloy or magnesium is arranged to be a magnesium wire. And the part of the magnesium wire embedded in the groove is exposed outside through the groove opening. The orthopedic implant is simple in structure, low in cost, convenient to install and use, high in fixing strength, stable in supporting and long in supporting time, magnesium alloy or magnesium is long in acting time, safe, reliable and high in practicability, the technical problems that an existing orthopedic implant harms human body safety and is unstable in supporting are solved, and the orthopedic implant belongs to the technical field of medical instruments.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to orthopedic implants. Background Art

[0002] At present, for fracture symptoms of tibia, femur, etc., medical treatment usually adopts the form of pre-fixing with bone plates or intramedullary nails to keep the bones stable and promote bone healing. In order to ensure the relative position stability of the fractured bones and avoid movement, bone plates and intramedullary nails generally adopt materials with higher hardness and strength to ensure the fixation effect.

[0003] Magnesium alloy material is a new type of biodegradable medical material. After being implanted into the human body, it will react with body fluids and gradually degrade. Its degradation products can not only promote the healing and repair of bones, but also be gradually absorbed by surrounding tissues. Based on the advantages of magnesium alloy, magnesium alloy is widely used in bone plates. However, when magnesium alloy material is used alone as an internal fixation system for long bone fractures, there is a problem of low strength. As the magnesium alloy material degrades, its mechanical properties decay rapidly, and there is a risk of fixation failure. Therefore, due to the too fast degradation rate of magnesium alloy material and poor corrosion resistance, there is an easy problem of insufficient strength during service, resulting in the loss of its therapeutic and repair functions in the human body.

[0004] The Chinese invention patent with the publication number of CN103908328A discloses a bone implant, which includes a body and a magnesium or magnesium alloy component. The body has one or more recesses, and the magnesium or magnesium alloy component is filled in at least one recess; or the body has a cavity and at least one window communicating with the cavity is provided on the body, and the magnesium or magnesium alloy component is placed in the cavity and exposed to the window. However, since the magnesium or magnesium alloy component is in a block shape and the recess or window is square, the contact area between the magnesium or magnesium alloy and body fluids is large, resulting in rapid degradation of the magnesium or magnesium alloy in a short time, that is, the action time of the magnesium or magnesium alloy is short; and a large amount of magnesium is degraded and absorbed by the human body in a short time, which may cause toxic side effects to the human body and endanger human safety; moreover, the block-shaped magnesium or magnesium alloy component has a large volume, and a large recess or window needs to be opened on the body, which will reduce the strength of the body and lead to unstable support. In addition, this patent does not provide a fixing device for the magnesium or magnesium alloy component. During use, the magnesium or magnesium alloy component may fall off from the body due to degradation, affecting the healing and repair of the magnesium or magnesium alloy component on the bones; and if the scheme of an internal magnesium or magnesium alloy component is adopted, the internal manufacturing process of the magnesium or magnesium alloy component is complex and difficult to achieve. Based on the above problems, it is urgent to develop a new orthopedic implant. Content of the Utility Model

[0005] The purpose of this application is to provide an orthopedic implant, aiming to solve the technical problems of endangering human safety and unstable support existing in the existing orthopedic implants.

[0006] Embodiments of the present application provide an orthopedic implant, including a main body. A groove is provided on a side of the main body facing the bone. A magnesium alloy or magnesium is inlaid in the groove. The groove extends along the length direction of the main body. An opening of the groove gradually narrows. A groove opening is provided on the groove. The magnesium alloy or magnesium is configured as magnesium wire, and a part of the magnesium wire inlaid in the groove is exposed outside through the groove opening.

[0007] In one embodiment, the main body is a bone plate or an intramedullary nail.

[0008] In one embodiment, when the main body is a bone plate, one side surface of the main body is an arc surface, and the number of the grooves is an even number. The even number of grooves are distributed on the left and right sides of the arc surface of the main body.

[0009] In one embodiment, when the main body is an intramedullary nail, the number of the grooves is greater than 2, and a plurality of the grooves are circumferentially distributed on an outer side surface of the main body.

[0010] In one embodiment, both a depth and a transverse dimension of the groove are less than 1.5 mm.

[0011] In one embodiment, a maximum transverse dimension of the groove is 1.07 - 1.20 times a transverse dimension of the groove opening.

[0012] In one embodiment, a cross-section of the groove includes a jaw type, a large cut circle type, a triangle with a missing top angle part, or a square.

[0013] In one embodiment, an inner surface of the groove or outer surfaces of two ends of the magnesium wire are coated with a degradable material layer.

[0014] In one embodiment, a material of the main body is a titanium alloy.

[0015] In one embodiment, two ends of the groove are closed.

[0016] The present utility model provides an orthopedic implant. Compared with the prior art, its beneficial effects are as follows:

[0017] (1) By arranging the groove to extend along the length direction of the main body and configuring the magnesium alloy or magnesium as magnesium wire, the volume of the filamentous magnesium alloy or magnesium is small, and only a groove with a small size needs to be opened on the main body to accommodate it, ensuring the strength of the main body and making the support more stable; moreover, the magnesium wire is convenient to process and has a low cost, and it can be inlaid in the groove through an external force, and the installation is simple and convenient; furthermore, the groove can be opened on the existing main body structure substrate, reducing the cost of re-designing the main body structure.

[0018] (2) By setting the groove into a shape with a gradually narrowing opening, the magnesium wire can be fixed, avoiding the phenomenon that magnesium alloy or magnesium falls off from the main body during use due to degradation, and improving the effect of the magnesium wire on bone healing and repair.

[0019] (3) By setting both ends of the groove to be closed, the contact area between the magnesium alloy or magnesium and body fluid is reduced, the degradation time of the magnesium alloy or magnesium is prolonged, that is, the action time of the magnesium alloy or magnesium is prolonged. The magnesium alloy or magnesium can generate magnesium ions for a longer time, and at the same time, it avoids absorbing a large amount of magnesium decomposition products in a short time, improving the safety of the orthopedic implant.

[0020] The utility model has a simple structure, low cost, convenient installation and use, high fixing strength, stable support, long support time of the orthopedic implant, long action time of the magnesium alloy or magnesium, safety and reliability, and high practicability. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figure 1 It is a front view structural schematic diagram of the bone plate provided in Embodiment 1 of the present application;

[0023] Figure 2 For Figure 1 It is a right view structural schematic diagram of the bone plate shown;

[0024] Figure 3 For Figure 1 It is a sectional structural schematic diagram of the A position of the bone plate shown;

[0025] Figure 4 For Figure 1 It is a sectional structural schematic diagram of another angle of the A position of the bone plate shown;

[0026] Figure 5 For Figure 1 It is a rear view structural schematic diagram of the bone plate shown;

[0027] Figure 6 For Figure 5 It is a sectional structural schematic diagram of the B position of the bone plate shown;

[0028] Figure 7 For Figure 5 It is a sectional structural schematic diagram of the C position of the bone plate shown;

[0029] Figure 8 ForFigure 1 Axonometric view of the bone plate shown;

[0030] Figure 9 Structural schematic diagram of the bone plate provided in Embodiment 2 of the present application;

[0031] Figure 10 is Figure 9 Structural schematic diagram of the cross-section at D of the bone plate shown;

[0032] Figure 11 Main view structural schematic diagram of the intramedullary nail provided in Embodiment 3 of the present application;

[0033] Figure 12 is Figure 11 Structural schematic diagram of the cross-section at E of the intramedullary nail shown;

[0034] Figure 13 is Figure 11 Structural schematic diagram of the cross-section at F of the intramedullary nail shown;

[0035] Figure 14 is Figure 11 Axonometric view of the intramedullary nail shown;

[0036] Figure 15 Structural schematic diagram of the intramedullary nail provided in Embodiment 4 of the present application;

[0037] Figure 16 is Figure 15 Structural schematic diagram of the cross-section at G of the intramedullary nail shown.

[0038] Symbol description in the figure:

[0039] 1. Main body; 101. Arc surface; 2. Groove; 201. Groove opening; 3. Magnesium wire; 4. Mounting hole. Specific embodiments

[0040] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present application clearer, the following further details the present application in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0041] It should be noted that when an element is referred to as being "fixed" or "set" to another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or indirectly connected to the other element.

[0042] It should be understood that the orientation or positional relationship indicated by terms such as "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description, and should not be construed as indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present application. In addition, terms such as "first", "second", "third", etc. are only used for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0043] Embodiment 1

[0044] Please refer to Figure 1 , which is the front view structural schematic diagram of the bone plate provided by Embodiment 1 of the present application. For the convenience of description, only the parts related to this embodiment are shown and are described in detail as follows:

[0045] Please combine with Figures 3 - 7 , in this embodiment, the orthopedic implant is a bone plate, including a main body 1. The main body 1 is in a plate shape as a whole. A groove 2 is provided on the side of the main body 1 facing the bone. A magnesium alloy or magnesium is inlaid in the groove 2. The groove 2 extends along the length direction of the main body 1. The cross-section of the groove 2 is set in a shape with a gradually narrowing opening. A groove opening 201 is provided on the groove 2. The magnesium alloy or magnesium is set as magnesium wire 3, and a part of the magnesium wire 3 inlaid in the groove 2 is exposed outside through the groove opening 201.

[0046] By setting the groove 2 to extend along the length direction of the main body 1 and setting the magnesium alloy or magnesium as the magnesium wire 3, the volume of the filamentous magnesium alloy or magnesium is small, and only a groove 2 with a small size needs to be opened on the main body 1 to accommodate it, ensuring the strength of the main body 1 and making the support more stable; moreover, the manufacturing process of the magnesium wire 3 is simple, the processing is convenient, and the cost is low. It can be inlaid in the groove 2 through external force, and the installation is simple and convenient; furthermore, the groove 2 can be opened on the existing main body 1 structure substrate, reducing the cost of re-designing the main body 1 structure.

[0047] By setting the groove 2 in a shape with a gradually narrowing opening, the magnesium wire 3 is fixed, avoiding the phenomenon that the magnesium alloy or magnesium falls off from the main body 1 due to degradation during use, and improving the effect of the magnesium wire 3 on bone healing and repair.

[0048] Specifically, please refer to Figure 2 , one side of the main body 1 is an arc surface 101. During use, the arc surface 101 is the side close to the bone, and the arc surface 101 is set according to the shape of the bone surface; setting one side of the main body 1 as the arc surface 101 can make it have a larger contact area with the bone surface and be able to support the bone more stably.

[0049] Please refer toFigures 3 - 4 The number of the grooves 2 is even, and the even number of grooves 2 are symmetrically distributed on the left and right sides of the arc surface 101 of the main body 1. In this embodiment, the number of the grooves 2 is two. When the number of the grooves 2 is excessive, the strength of the main body 1 will be reduced, and it can be adjusted according to the actual situation during actual processing. The grooves 2 are arranged on the left and right sides of the arc surface 101, that is, on the side facing the bone, and the direction of the groove opening 201 faces the bone fracture site. The magnesium wires 3 arranged in the grooves 2 are closer to the bone, so that the degraded magnesium is more likely to concentrate at the fracture site, which is beneficial for the bone to absorb the decomposition products of the magnesium wires 3 and better promotes the healing and repair of the fracture site.

[0050] Please refer to Figures 5 - 6 The depth and the transverse dimension of the groove 2 are both less than 1.5 mm. The size of the groove 2 is small. During actual processing, the groove 2 can be opened on the existing structural substrate of the main body 1, which can reduce the cost of re-designing the structure of the main body 1. At the same time, the small-sized groove 2 has little influence on the structural mechanical properties of the main body 1, ensuring the strength of the main body 1 and making the support more stable.

[0051] Please refer to Figure 7 The maximum transverse dimension L2 of the groove 2 is 1.07 - 1.20 times the transverse dimension L1 of the groove opening 201. Such a setting can ensure that the magnesium wires 3 can be easily embedded into the groove 2, and can ensure that the groove 2 firmly fixes the magnesium wires 3. At the same time, it can avoid excessive contact between the magnesium wires 3 embedded in the groove 2 and the tissue fluid and being degraded too quickly.

[0052] Please refer to Figure 7 The cross-section of the groove 2 includes a jaw type, a large-segment circular shape, a triangle with a missing top angle part, or a square shape. Preferably, it is a large-segment circular shape, preferably 2 / 3 - 8 / 9 of a circle. The cross-section of the groove 2 can also be other shapes, depending on the actual situation. As long as the cross-section of the groove 2 is a shape with a gradually narrowing opening, the magnesium wires 3 can be fixed, avoiding the phenomenon that the magnesium alloy or magnesium falls off from the main body 1 during use due to degradation, and improving the healing and repair effect of the magnesium wires 3 on the bone.

[0053] Please refer to Figures 3 - 6 The magnesium wires 3 are arranged flush with the side wall of the main body 1. If the magnesium wires 3 are higher than the height of the side wall of the main body 1, when fixing the bone plate, the magnesium wires 3 directly contact the bone. As the magnesium wires 3 degrade, a gap will be generated between the bone plate and the bone, reducing the supporting force of the bone plate on the bone.

[0054] During the manufacturing process, the diameter or length of the magnesium wires 3 can be adjusted according to the needs of the patient's recovery time. The magnesium wires 3 can be arranged in segments. First, the magnesium wires 3 are inserted into both ends of the groove 2, and then the magnesium wires 3 are inserted at the middle groove opening 201, which can reduce the embedding difficulty of the magnesium wires 3.

[0055] Please refer to Figure 1 , a degradable material layer is coated on the inner surface of the groove 2 or the outer surfaces of both ends of the magnesium wire 3. The degradable material layer can be any one or a combination of at least two of poly-4-hydroxybutyric acid, polylactic acid, polyglycolic acid, polytrimethylene carbonate, glycolide / lactide / polytrimethylene carbonate, or silk fibroin. The degradable material layer can increase the smoothness of the embedding of the magnesium wire 3 and at the same time prevent the magnesium wire 3 from degrading too fast in the body.

[0056] Please refer to Figure 8 , the material of the main body 1 is titanium alloy, which can not only improve the fixing strength of the bone plate but also provide a supporting effect for a longer time, making the support more stable. Mounting holes 4 are provided on the main body 1 for passing screws to fixedly connect the bone plate to the bone.

[0057] Embodiment 2

[0058] Please refer to Figure 9 , which is a front view structural schematic diagram of the bone plate provided by Embodiment 2 of the present application. For the convenience of description, only the parts related to this embodiment are shown and are described in detail as follows:

[0059] Please combine Figure 10 , compared with Embodiment 1, the difference in this embodiment is that: in this embodiment, both ends of the groove 2 are closed, and the total length of the closed area is 0.5-2.0 times the length of the groove opening 201. The middle part of the magnesium wire 3 is exposed outside through the groove opening 201. In this way, the magnesium wire 3 at both ends of the groove 2 will not contact the tissue fluid, and the degradation time of the magnesium wire 3 is longer, having a more lasting effect on promoting fracture healing.

[0060] In this embodiment, the magnesium wire 3 can be set into two sections and inserted into the closed grooves at both ends of the groove 2 through the groove opening 201 respectively.

[0061] In this embodiment, the magnesium wire 3 can be set into one section. Both ends of the groove 2 can be open first. After inserting the magnesium wire 3, both ends of the groove 2 are blocked with a biocompatible material. The degradation rate of the biocompatible material is slower than that of magnesium alloy or magnesium, so that the magnesium wire 3 at both ends of the groove 2 will not contact the tissue fluid, making the degradation time of the magnesium wire 3 longer.

[0062] By setting both ends of the groove 2 to be closed, the contact area between the magnesium alloy or magnesium and the body fluid is reduced, and the degradation time of the magnesium alloy or magnesium is prolonged, that is, the acting time of the magnesium alloy or magnesium is prolonged. The magnesium alloy or magnesium can generate magnesium ions for a longer time, and at the same time avoid absorbing a large amount of magnesium decomposition products in a short time, improving the safety of orthopedic implants.

[0063] The structures, shapes, sizes, and materials of the groove 2, the groove opening 201, the magnesium wire 3, and the mounting hole 4 are the same as those in Embodiment 1 and will not be described herein again.

[0064] Example 3

[0065] Please refer to Figure 11 , which is the front view structural schematic diagram of the intramedullary nail provided by Embodiment 3 of the present application. For the convenience of description, only the parts related to this embodiment are shown and are described in detail as follows:

[0066] Please combine with Figures 12 - 14 . Compared with Embodiment 1, the difference in this embodiment is that: in this embodiment, the orthopedic implant is an intramedullary nail, including a main body 1. The main body 1 is in a nail shape as a whole. There is a groove 2 on the side of the main body 1 facing the bone. A magnesium alloy or magnesium is inlaid in the groove 2. The groove 2 extends along the length direction of the main body 1. The opening of the groove 2 gradually narrows. There is a groove opening 201 on the groove 2. The magnesium alloy or magnesium is set as magnesium wire 3, and a part of the magnesium wire 3 inlaid in the groove 2 is exposed outside through the groove opening 201.

[0067] Specifically, please refer to Figure 12 . The number of the grooves 2 is greater than 2, and multiple grooves 2 are circumferentially distributed on the outer side of the main body 1. In this embodiment, the number of the grooves 2 is 4, and 4 grooves 2 are circumferentially distributed on the outer side of the main body 1. The structures, shapes, sizes and materials of the groove 2, the groove opening 201 and the magnesium wire 3 are the same as those in Embodiment 1, and will not be described in detail here.

[0068] Both ends of the main body 1 are provided with mounting holes 4 for passing screws to fix the intramedullary nail in the bone.

[0069] Example 4

[0070] Please refer to Figure 15 , which is the front view structural schematic diagram of the intramedullary nail provided by Embodiment 4 of the present application. For the convenience of description, only the parts related to this embodiment are shown and are described in detail as follows:

[0071] Please combine with Figure 16 . Compared with Embodiment 3, the difference in this embodiment is that: in this embodiment, both ends of the groove 2 are closed, and the total length of the closed area is 0.5 - 2.0 times the length of the groove opening 201. The middle part of the magnesium wire 3 is exposed outside through the groove opening 201. In this way, the magnesium wire 3 at both ends of the groove 2 will not contact the tissue fluid, and the degradation time of the magnesium wire 3 is longer, having a more lasting effect on promoting fracture healing.

[0072] In this embodiment, the magnesium wire 3 can be set into two sections and respectively inserted into the closed grooves at both ends of the groove 2 through the groove opening 201.

[0073] In this embodiment, the magnesium wire 3 can be provided as a single segment. The two ends of the groove 2 can be open initially. After inserting the magnesium wire 3, the two ends of the groove 2 are then sealed with a biocompatible material. The degradation rate of the biocompatible material is slower than that of the magnesium alloy or magnesium, so that the magnesium wire 3 at the two ends of the groove 2 will not come into contact with the tissue fluid, and the degradation time of the magnesium wire 3 can be prolonged.

[0074] The structures, shapes, sizes, and materials of the groove 2, the groove opening 201, the magnesium wire 3, and the mounting hole 4 are the same as those in Embodiment 3 and will not be elaborated here.

[0075] The present utility model provides an orthopedic implant. By arranging the groove to extend along the length direction of the main body and setting the magnesium alloy or magnesium as a magnesium wire, the volume of the filamentous magnesium alloy or magnesium is small, and only a groove with a relatively small size needs to be opened on the main body to accommodate it, ensuring the strength of the main body and making the support more stable. Moreover, the magnesium wire is convenient to process and has a low cost, and it can be embedded in the groove by external force, and the installation is simple and convenient. Furthermore, a groove can be opened on the existing main body structure substrate, reducing the cost of re-designing the main body structure. By arranging the groove to have a shape with a gradually narrowing opening, the magnesium wire can be fixed, avoiding the phenomenon that the magnesium alloy or magnesium falls off from the main body during use due to degradation, and improving the healing and repair effect of the magnesium wire on the bone. By arranging the two ends of the groove to be closed, the contact area between the magnesium alloy or magnesium and the body fluid is reduced, the degradation time of the magnesium alloy or magnesium is prolonged, that is, the acting time of the magnesium alloy or magnesium is prolonged, the magnesium alloy or magnesium can generate magnesium ions for a longer time, and at the same time, the absorption of a large amount of magnesium decomposition products in a short time is avoided, improving the safety of the orthopedic implant. The structure of the present utility model is simple, with low cost, convenient installation and use, high fixing strength, stable support, long support time, long acting time of the magnesium alloy or magnesium, safe and reliable, and high practicality, and can be widely applied to the technical field of medical devices.

[0076] The above-described embodiments are only used to illustrate the technical solutions of the present application and are not intended to limit them. Although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments or perform equivalent replacements for some of the technical features. However, such modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present application and should all be included within the protection scope of the present application.

Claims

1. An orthopedic implant, comprising a main body (1), wherein a groove (2) is provided on the side of the main body (1) facing the bone, wherein magnesium alloy or magnesium is embedded in the groove (2), characterized in that: The groove (2) extends along the length direction of the main body (1), the opening of the groove (2) gradually narrows, a groove opening (201) is provided on the groove (2), the magnesium alloy or magnesium is configured as a magnesium wire (3), and a portion of the magnesium wire (3) embedded in the groove (2) is exposed to the outside through the groove opening (201).

2. The orthopedic implant according to claim 1, characterized in that The main body (1) is a bone plate or an intramedullary nail.

3. The orthopedic implant according to claim 2, characterized in that: When the main body (1) is a bone plate, one side surface of the main body (1) is a curved surface (101), the number of the grooves (2) is an even number, and the even number of the grooves (2) are distributed on the left and right sides of the curved surface (101) of the main body (1).

4. The orthopedic implant according to claim 2, characterized in that: When the main body (1) is an intramedullary nail, the number of the grooves (2) is greater than 2, and the plurality of grooves (2) are circumferentially distributed on the outer side surface of the main body (1).

5. The orthopedic implant according to claim 1, characterized in that: The depth and transverse dimension of the groove (2) are both less than 1.5 mm.

6. The orthopedic implant according to claim 1, characterized in that The maximum transverse dimension of the groove (2) is 1.07-1.20 times the transverse dimension of the groove opening (201).

7. The orthopedic implant according to claim 6, characterized in that The cross section of the groove (2) includes a jaw shape, a large cut circle, a triangle with a partially missing top corner, or a square.

8. The orthopedic implant according to claim 1, characterized in that: The inner surface of the groove (2) or the outer surfaces of both ends of the magnesium wire (3) are coated with a degradable material layer.

9. The orthopedic implant according to claim 1, characterized in that: The main body (1) is made of titanium alloy.

10. The orthopedic implant according to any one of claims 1 to 9, characterized in that: Both ends of the groove (2) are closed.

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