Bone fixation system and bone fixation instrument

Abstract

The present disclosure relates to a bone fixation system and a bone fixation instrument for forming the bone fixation system, the bone fixation system comprising a first fixation member configured to be implanted into a host bone tissue and at least one second fixation member configured to be implanted into the host bone tissue and to form a fixation configuration with the first fixation member to fix the host bone tissue, wherein in the fixation configuration, the second fixation member is arranged offset to the first fixation member and forms a limiting cooperation with the first fixation member to limit at least a part of a movement of the first fixation member relative to the host bone tissue. According to the present disclosure, a bone fixation system and a bone fixation instrument can be provided which can reduce the difficulty of implantation and improve the flexibility of implantation path selection.

Description

Technical Field

[0001] This disclosure generally relates to the field of biomedical engineering technology, and specifically to a bone fixation system and a bone fixation device. Background Technology

[0002] Fractures are one of the most common types of injuries in orthopedic clinics. For fractures with significant displacement, instability, or high degree of comminutedness, internal fixation implants are usually required to reduce and fix the fracture ends to maintain the stability of the fracture site and provide a good biomechanical environment for bone healing. The calcaneus, as the largest tarsal bone in the human body, is an important weight-bearing bone in the foot and is prone to fracture under external forces such as jumping and falling, including complex calcaneal fractures such as Sanders type II, Sanders type III, and Sanders type IV.

[0003] Currently, for internal fixation of fractures such as calcaneal fractures, the clinical approach typically employs a single main nail combined with multiple shielding nails. Specifically, the main nail is usually inserted along the long axis of the host bone tissue and has multiple circumferential through-holes. Multiple shielding nails pass through these through-holes in different directions, forming a fixation configuration. The main nail secures the major bone fragments, while the shielding nails secure other fragments. This fixation configuration restricts rotation, axial movement, or other loosening of the main nail, thereby improving the stability of the entire bone fixation system.

[0004] However, it is difficult to accurately pass the shielding pin through the corresponding through hole on the main nail. In addition, the position of the through hole on the main nail is usually preset, but the fracture line and the position of bone fragments vary from patient to patient. In order to make the shielding pin pass through the through hole and fix the target bone fragment, it is often difficult to meet both requirements of the shielding pin passing through the through hole and fixing the target fracture fragment. This restricts the implantation path of the shielding pin and reduces the adaptability of the bone fixation system to different fracture types. Summary of the Invention

[0005] This disclosure is made in view of the above-mentioned state of the prior art, and its purpose is to provide a bone fixation system and bone fixation device that can reduce the difficulty of implantation and increase the flexibility of implantation path selection.

[0006] To this end, the first aspect of this disclosure provides a bone fixation system, comprising: a first fixation member configured to be implanted into host bone tissue; at least one second fixation member configured to be implanted into the host bone tissue and to form a fixation configuration with the first fixation member to fix the host bone tissue; wherein, in the fixation configuration, the at least one second fixation member is offset from the first fixation member and forms a limiting cooperation with the first fixation member to restrict at least a portion of the movement of the first fixation member relative to the host bone tissue.

[0007] In the bone fixation system disclosed herein, the first fixator and the second fixator are staggered. The second fixator does not need to pass through the first fixator but is staggered from it. This avoids the structural requirement of traditional shielding screws having to pass through the main screw hole, thereby reducing the precision requirements for the implantation angle and position of the second fixator and reducing the implantation difficulty of the bone fixation system. In addition, since the second fixator can form a limiting fit with the first fixator, it can restrict at least part of the movement of the first fixator relative to the bone tissue (e.g., rotation, swinging, radial displacement, or axial movement), improving the fixation stability of the entire bone fixation system for the host bone tissue. Furthermore, the second fixator can more flexibly select the implantation path, and while forming a limiting fit with the first fixator, it also facilitates the connection and fixation of some fracture fragments, thus further improving the overall stability of the fracture ends and providing a more stable mechanical environment for bone tissue healing.

[0008] Furthermore, in the bone fixation system disclosed herein, optionally, in the fixation configuration, the outer surface of at least one second fixator is in contact with or less than or equal to the outer surface of the first fixator. In this case, since the second fixator maintains a small distance or even direct contact with the first fixator, the second fixator can more effectively restrict the first fixator. In addition, for fixators made of absorbable materials, the material may absorb liquid and expand to a certain extent after implantation, causing the originally close-set first and second fixators to come into further contact, thereby forming a more stable limiting fit and improving the stability of the bone fixation system.

[0009] Furthermore, in the bone fixation system disclosed herein, optionally, the first fixator and the second fixator are formed of absorbable material; and / or, the first fixator has a first channel extending along its axial direction, and the second fixator has a second channel extending along its axial direction. In this case, the absorbable material can be gradually degraded and absorbed as the bone tissue heals, eliminating the need for secondary surgery for removal, while also reducing long-term stress shielding. Moreover, if the first and second fixators are made of absorbable material, and if the implantation path of the second fixator intersects with the first fixator during implantation, the second fixator may come into contact with the first fixator during implantation, potentially causing either the first or second fixator to fracture under stress. Therefore, by staggering the first and second fixators, the risk of fracture can be reduced. Additionally, by forming a through channel within the fixator, not only can a guide needle with radiopaque function pass through for guided implantation (absorbable materials typically do not have radiopaque function, thus requiring a guide needle for guidance), but a fluid circulation channel can also be formed after implantation, which is beneficial for bone tissue metabolism and bone healing.

[0010] Additionally, in the bone fixation system disclosed herein, optionally, at least one of the first fixator and the second fixator has a surface limiting structure on its surface, forming the limiting fit through the surface limiting structure. In this case, by providing a surface limiting structure on the surface of the fixator, the contact stability between the first fixator and the second fixator can be further increased, and the anti-slip capability between them can be improved, thereby further improving the stability of the bone fixation system.

[0011] A second aspect of this disclosure provides an instrument for bone fixation, used to form the aforementioned bone fixation system, comprising: a first positioning component configured to be connected to a first fixation member; a second positioning component adjustable relative to the first positioning component to form a plurality of positioning positions for guiding the second fixation member into the host bone tissue; at any of the positioning positions, the second positioning component causes the second fixation member to be implanted into the host bone tissue in a manner offset from the first fixation member, so as to form a fixation configuration in the host bone tissue.

[0012] In the bone fixation device disclosed herein, the first fixation member can be positioned by the first positioning component; the second positioning component can guide the implantation of the second fixation member at multiple different positioning positions, and each implantation path can stagger the second fixation member from the first fixation member to form a fixation configuration. Therefore, the bone fixation device can be used to form a fixation configuration that reduces implantation difficulty and increases implantation flexibility.

[0013] Additionally, in the bone fixation device disclosed herein, optionally, the second positioning component is provided with at least one positioning hole, the at least one positioning hole corresponding to at least one implantation path, and the second fixation members implanted along the implantation path are all offset from the first fixation members. In this case, by pre-designing the implantation path corresponding to the positioning hole, the implantation direction of the second fixation member can be guided through the positioning hole, thereby improving implantation efficiency.

[0014] In addition, in the bone fixation device disclosed herein, optionally, the first fixator has a first channel extending along its axial direction, and the second fixator has a second channel extending along its axial direction; the bone fixation device further includes a guide pin for guiding the implantation direction of the first fixator and / or the second fixator, the outer diameter of the guide pin being smaller than the inner diameter of the first channel and the inner diameter of the second channel; the positioning hole is configured to allow the guide pin to pass through and its diameter is smaller than the diameter of the second fixator. In this case, the guide pin can first establish an implantation path, and then implant the corresponding fixator along the guide pin, thereby improving the implantation accuracy of the fixator; moreover, by first positioning with the guide pin (which is thinner) and determining the position before implanting the second fixator, damage to bone tissue can be reduced compared to directly implanting the second fixator; if the guide pin has a radiopaque function, it is also convenient to confirm whether the implantation path can fix other bone fragments; in addition, since the positioning hole only allows the guide pin to pass through, it can ensure that the second fixator enters the host bone tissue along the predetermined implantation path, improving the accuracy of the implantation position.

[0015] Additionally, in the bone fixation device disclosed herein, optionally, the first positioning component has a hollow channel; when the first fixation member is connected to the first positioning component, the hollow channel communicates with the first channel and forms a communicating channel through which the guide pin can pass. In this case, the bone tissue can be initially fixed by the guide pin, and then the first fixation member can be implanted along the guide pin (for example, a guide pin with imaging function can be used under X-ray equipment to connect the main bone fragments, and then the first fixation member can be implanted at the position of the guide pin to fix the main bone fragments using the first fixation member). The hollow channel can reduce the influence of the guide pin on the first positioning component connected to the first fixation member.

[0016] Additionally, in the bone fixation devices disclosed herein, optionally, the implantation path is always located in the peripheral region of the first fixation member, so that the implanted second fixation member and the first fixation member form the fixation configuration. In this case, the implantation path being located in the peripheral region of the first fixation member helps to ensure that the second fixation member does not interfere with the first fixation member.

[0017] Additionally, in the bone fixation device disclosed herein, optionally, the second positioning component includes a positioning part and a clearance part, the positioning hole being disposed in the positioning part, and the clearance part covering the orthographic projection area of ​​the first fixation member on the second positioning component. In this case, the clearance part corresponds to the area where the first fixation member is located, thus helping to ensure that the positioning holes all correspondingly avoid the implantation path of the first fixation member, improving the rationality of the positioning structure design.

[0018] According to this disclosure, a bone fixation system and bone fixation device can be provided that can reduce the difficulty of implantation and increase the flexibility of implantation path selection. Attached Figure Description

[0019] This disclosure will now be explained in further detail by way of example only with reference to the accompanying drawings, in which: Figure 1 This is a schematic diagram illustrating the structure of a bone fixation system in the prior art.

[0020] Figure 2 This is a schematic diagram illustrating the structure of the bone fixation system involved in the example of this disclosure.

[0021] Figure 3 This is a schematic diagram illustrating the structure of the first or second fastener involved in the example of this disclosure.

[0022] Figure 4 This is a schematic diagram illustrating the structure of the first fastener of another example involved in this disclosure.

[0023] Figure 5 This is a schematic diagram illustrating the structure of a bone fixation device according to an example of this disclosure.

[0024] Figure 6A This is a schematic diagram illustrating the first step of forming a fixation configuration using the bone fixation device involved in the example of this disclosure.

[0025] Figure 6B This is a schematic diagram illustrating the second step of forming a fixation configuration using the bone fixation device involved in the example of this disclosure.

[0026] Figure 6C This is a schematic diagram illustrating the third step of forming a fixation configuration using the bone fixation device involved in the example of this disclosure.

[0027] Figure 6D This is a schematic diagram illustrating the fourth step of forming a fixation configuration using the bone fixation device involved in the example of this disclosure.

[0028] Figure 6E This is a schematic diagram illustrating the fifth step of forming a fixation configuration using the bone fixation device involved in the example of this disclosure.

[0029] Explanation of reference numerals in the attached figures: 1000… Bone fixation system, 100… Fixation configuration, 110… First fixation element, 111… First channel, 112… Lateral channel; 120… Second fixation element, 121… Second channel, 130… Surface limiting structure, 800… Bone fixation instrument, 810… First positioning component, 811… Hollow channel, 820… Second positioning component, 821… Positioning part, 822… Avoidance part, 8211… Positioning hole, 830… Connecting component, 840… Guide pin, 841… First guide pin, 842… Second guide pin, A… Host bone tissue. Detailed Implementation

[0030] Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In the following description, the same reference numerals are used for the same components, and repeated descriptions are omitted. Furthermore, the drawings are merely schematic diagrams, and the proportions of the components or the shapes of the components may differ from actual figures.

[0031] It should be noted that the terms "comprising" and "having" and any variations thereof in this disclosure, such as a process, method, system, product, or device that includes or has a series of steps or units, are not necessarily limited to those steps or units that are explicitly listed, but may include or have other steps or units that are not explicitly listed or that are inherent to such processes, methods, products, or devices.

[0032] Furthermore, the subheadings and similar terms used in the following description of this disclosure are not intended to limit the content or scope of this disclosure; they are merely intended to serve as reading prompts. Such subheadings should not be construed as dividing the content of the article, nor should the content under a subheading be limited to the scope of that subheading.

[0033] It should be noted that the terms "first," "second," and "third" in this disclosure are used only to distinguish different components and do not indicate their importance, installation order, or spatial relationship.

[0034] In addition, the terms “comprising,” “having,” “equipped with,” and “formed with” in this disclosure should be understood as having an open meaning, that is, in addition to being explicitly defined, they may include other components or steps that are not explicitly listed.

[0035] Furthermore, in this disclosure, "axial," "radial," and "circumferential" all refer to the axis of the corresponding fastener itself as the reference direction. Specifically, the axial direction can be the direction extending along the length of the fastener; the radial direction can be the direction perpendicular to the axial direction; and the circumferential direction can be the direction formed by rotation about the axial direction.

[0036] Furthermore, the term "contact" in this disclosure includes not only direct contact, but also situations where contact is eventually formed due to material absorption and expansion, tissue growth, or post-implantation stress. The term "offset arrangement" in this disclosure not only means that the two fasteners do not pass through each other, but also includes various situations where they spatially avoid each other, forming a limiting relationship.

[0037] Figure 1 This is a schematic diagram showing the structure of a prior art bone fixation system 1000 (with a shielding screw passing through the interior of the main screw). Figure 2 This is a schematic diagram illustrating the structure of the bone fixation system 1000 involved in the example of this disclosure.

[0038] See Figure 2 This disclosure relates to a bone fixation system 1000. The bone fixation system 1000 can be used for fractures, cracks, defects, or other conditions requiring fixation of host bone tissue. In some examples, the host bone tissue can be the calcaneus. However, this disclosure is not limited to this. The host bone tissue can also be the talus, scaphoid, cuboid, cuneiform, metatarsal, tibia, fibula, femur, humerus, ulna, radius, clavicle, scapula, patella, pelvis, or other bone tissue of the human body suitable for fixation with bone fixation devices. In some examples, the bone fixation system 1000 can be used to fix bone tissue on both sides of a crack in the host bone tissue.

[0039] In some examples, the bone fixation system 1000 may include a first fixation member 110. The first fixation member 110 may be configured to be implanted into the host bone tissue. In some examples, the first fixation member 110 may be implanted into the host bone tissue as a master nail. In some examples, the first fixation member 110 may be used to achieve primary fixation of the bone tissue across a large fracture fracture area.

[0040] In some examples, the bone fixation system 1000 may include a second fixation member 120. The second fixation member 120 may be configured to be implanted into host bone tissue. In some examples, the second fixation member 120 may be implanted into the host bone tissue as a shielding screw. In some examples, the second fixation member 120 may be used to further restrict at least partial movement (e.g., rotation, oscillation, radial displacement, or axial movement) of the first fixation member 110 relative to the host bone tissue. In some examples, the second fixation member 120 may be used for auxiliary fixation of localized fracture fragments.

[0041] In some examples, the bone fixation system 1000 may include at least one second fixation member 120. For example, in some examples, the bone fixation system 1000 may include one, two, three, or four second fixation members 120.

[0042] In some examples, the second fixation member 120 may be configured to form a fixation configuration 100 with the first fixation member 110 to fix host bone tissue. In other words, in some examples, the bone fixation system 1000 may include a fixation configuration 100 that can be used to fix host bone tissue. For example, the fixation configuration 100 may be used to fix a fracture site in the host bone tissue.

[0043] In some examples, the fixed configuration 100 may be formed by a first fastener 110 and at least one second fastener 120. For example, see Figure 2 The fixed configuration 100 can be formed by a first fixing member 110 and two second fixing members 120. In some examples, the fixed configuration 100 can be understood as a spatial fixing relationship formed by the first fixing member 110 and at least one second fixing member 120.

[0044] In some examples, the second fixation member 120 can be configured to be implanted into the host bone tissue and form a fixation configuration 100 with the first fixation member 110 to fix the host bone tissue. Thus, compared to using only a single bone screw for fixation, this disclosure can improve the overall stability of the fracture ends and reduce the local load on each fixation member by forming a spatial support structure through multiple fixation members. In other examples, the fixation configuration 100 can also connect multiple fracture fragments simultaneously, thereby improving the overall stability among multiple fracture ends.

[0045] In some examples, in the fixation configuration 100, the second fixator 120 may be offset from the first fixator 110. In some examples, in the fixation configuration 100, at least one second fixator 120 may be offset from the first fixator 110. It should be noted that "offset" here can be understood as the second fixator 120 being located in the peripheral region of the first fixator 110, and the two spatially avoid each other, without any intersecting relationship. In other words, the second fixator 120 will not pass through the first fixator 110. For example, they may maintain a certain distance from each other. For example, their outer surfaces may be in direct contact. For example, they may be tangent. For example, they may gradually come into contact due to swelling from fluid absorption after implantation. For example, they may also indirectly form support through bone tissue.

[0046] In some examples, in the fixation configuration 100, multiple second fixators 120 can be located at different circumferential positions of the first fixator 110. Furthermore, the multiple second fixators 120 can intersect each other. Additionally, the multiple second fixators 120 can form a spatial grid structure. This further improves the overall fixation stability of the fixation configuration 100 for the fracture area.

[0047] In some examples, in the fixation configuration 100, at least one second fixation member 120 forms a limiting engagement with the first fixation member 110 to restrict at least partial movement of the first fixation member 110 relative to the host bone tissue. It should be noted that the movement of the first fixation member 110 relative to the host bone tissue can include rotation, axial movement, lateral movement, and oscillation. For example, when the host bone tissue is subjected to loads generated by walking or standing, the first fixation member 110 may tend to rotate about its own axis. Since the second fixation member 120 is located on the outer periphery of the first fixation member 110, the second fixation member 120 can form a mechanical barrier, restricting the first fixation member 110 from continuing to rotate. Additionally, when the first fixation member 110 experiences radial displacement, the second fixation member 120 can also restrict the first fixation member 110 from continuing to move.

[0048] See Figure 1 In the existing bone fixation system 1000 or fixation configuration 100, the second fixator 120 passes through the first fixator 110. The first fixator 110 has at least one transverse through hole in its circumferential direction for the second fixator 120 to pass through. It should be noted that the transverse through hole here refers to a radial through hole penetrating the first fixator 110; the longitudinal direction corresponding to the transverse direction refers to the length direction (i.e., axial direction) of the first fixator 110.

[0049] In the existing fixation configuration 100, the second fixator 120 passes through the first fixator 110 to form a mechanical lock. This scheme requires the second fixator 120 to accurately enter the transverse through-hole of the first fixator 110, thus requiring high implantation precision. In addition, since the first fixator 110 needs to form one or more transverse through-holes, it is easy to reduce the local strength of the first fixator 110.

[0050] In the fixation configuration 100 of this disclosure, the second fixator 120 does not need to pass through the first fixator 110. Instead, the second fixator 120 is located in the outer peripheral region of the first fixator 110. This forms a new fixation configuration 100. Since the second fixator 120 does not need to pass through the first fixator 110, the doctor can effectively avoid having to search for the internal through-hole of the first fixator 110. In addition, since the second fixator 120 does not need to pass through the first fixator 110, the doctor only needs to position the second fixator 120 in the outer peripheral region of the first fixator 110. Therefore, the second fixator 120 is not restricted by the position of the transverse through-hole of the first fixator 110 during implantation, and thus there is no need to repeatedly adjust the angle of the second fixator 120, thereby significantly reducing the difficulty of implantation. Furthermore, compared to this, this disclosure does not require a transverse through-hole for the second fixator 120 to pass through on the first fixator 110. Therefore, the first fixator 110 can maintain a more complete main structure, thereby improving the structural strength of the first fixator 110 itself.

[0051] It should be noted that in the fixation configuration 100 of this disclosure, the second fixator 120 can still restrict at least part of the movement of the first fixator 110, thus ensuring fixation effectiveness while reducing implantation difficulty. Furthermore, when the host bone tissue is subjected to load, the first fixator 110 may tend to rotate around its own axis. Since the second fixator 120 is located on the outer periphery of the first fixator 110 and forms a limiting fit with the first fixator 110, the second fixator 120 can prevent the first fixator 110 from continuing to rotate. Additionally, when the first fixator 110 undergoes radial movement, the second fixator 120 can also provide mechanical resistance.

[0052] In some examples, the second fixation member 120 can form a limiting engagement with the first fixation member 110. It should be noted that the limiting engagement may include, but is not limited to, mechanical locking. For example, it may include contact limiting, tangential limiting, or friction limiting, or it may be a limiting engagement formed jointly by the fixation member and the bone tissue.

[0053] In some examples, in the fixed configuration 100, the outer peripheral surface of the second fastener 120 can be in direct contact with the outer peripheral surface of the first fastener 110. In this case, the two can directly transfer forces.

[0054] In some examples, in the fixation configuration 100, the distance between the outer peripheral surface of the second fixator 120 and the outer peripheral surface of the first fixator 110 may not exceed 5 mm. In some examples, the distance between the outer peripheral surface of the second fixator 120 and the outer peripheral surface of the first fixator 110 may not exceed 3 mm. For example, in the fixation configuration 100, the distance between the outer peripheral surface of the second fixator 120 and the outer peripheral surface of the first fixator 110 may be 5 mm, 4 mm, 3 mm, 2 mm, 1.5 mm, 1 mm, 0.5 mm, 0.3 mm, or 0.1 mm. This reduces interference during implantation and ensures a stable limiting relationship after implantation.

[0055] Figure 3 This is a schematic diagram showing the structure of the first fastener 110 or the second fastener 120 involved in the examples of this disclosure. Figure 4 This is a structural schematic diagram illustrating the first fastener 110 of another example involving the present disclosure. Figure 3 In the image, the left side is a left view of the first fastener 110 (or the second fastener 120), the right side is a front view of the first fastener 110 (or the second fastener 120), and the bottom side is a sectional view of the first fastener 110 (or the second fastener 120). It should be noted that both the first fastener 110 and the second fastener 120 can be... Figure 3 The structure shown. Both the first fastener 110 and the second fastener 120 can be adopted. Figure 4The structure shown.

[0056] See Figure 3 In some examples, the first fixation member 110 (or the second fixation member 120) may include a body. This body may be integrally elongated. For example, the body may be cylindrical. Of course, other structures suitable for implantation into bone tissue may also be used.

[0057] In some examples, at least one of the first fastener 110 and the second fastener 120 has a surface limiting structure 130 on its surface. In other words, the surface of the first fastener 110 and / or the second fastener 120 may have a surface limiting structure 130 formed thereon. For example, the surfaces of the first fastener 110 and the second fastener 120 may both have a surface limiting structure 130.

[0058] In some examples, a limiting fit can be formed by the surface limiting structure 130. In other words, a limiting fit can be formed between the first fixation member 110 and the second fixation member 120 by the surface limiting structure 130. In this case, by providing the surface limiting structure 130 on the surface of the fixation member, the contact stability between the first fixation member 110 and the second fixation member 120 can be further increased, and the anti-slip ability between them can be improved, thereby further improving the stability of the bone fixation system 1000.

[0059] In some examples, the surface limiting structure 130 can be a threaded structure. This allows for a limiting fit between the first fixation member 110 and the second fixation member 120 via the threaded structure. Furthermore, the thread facilitates smooth implantation of the fixation members. Thus, when the first fixation member 110 and the second fixation member 120 are close to or in contact with each other, the surface limiting structure 130 can further increase the anti-slip capability between them. In some examples, the threaded structure can be a single-start thread, a double-start thread, or a multi-start thread; it can also employ equal-pitch threads, variable-pitch threads, self-tapping threads, self-drilling threads, sawtooth threads, trapezoidal threads, or other threaded structures suitable for bone tissue fixation. This disclosure is not limited in this respect.

[0060] In some examples, the surface limiting structure 130 may also be at least one of the following: a spiral ridge structure, an annular boss structure, a serrated structure, a knurled structure, a granular protrusion structure, a roughened surface structure, a longitudinal ridge structure, a transverse ridge structure, a cross-grooved structure, and other structures that can increase friction or form a mechanical interlocking effect.

[0061] In some examples, the surface limiting structure 130 may form the entire outer peripheral region of the first fixing member 110 or the second fixing member 120. In some examples, the surface limiting structure 130 may form a partial region of the first fixing member 110 or the second fixing member 120. For example, it may be formed only in the middle or at the end. Of course, this disclosure is not limited in this respect, and the surface limiting structure 130 may be disposed in different positions according to different stress conditions.

[0062] In addition, the surface limiting structure 130 can also increase the bonding force between the fixation member (first fixation member 110 or second fixation member 120) and the bone tissue, thereby further improving the overall fixation stability of the bone fixation system 1000.

[0063] In addition, the surface limiting structure 130 can increase the contact area between the fixation member (first fixation member 110 or second fixation member 120) and the bone tissue, thereby improving the resistance to withdrawal of the first fixation member 110.

[0064] In some examples, the first fixation member 110 can be a headless structure. In some examples, the second fixation member 120 can be a headless structure. It should be noted that a headless structure means that the first fixation member 110 or the second fixation member 120 does not have a head that is significantly larger than the diameter of the rod, or the difference between the two is small. Therefore, after the first fixation member 110 or the second fixation member 120 is implanted into the host bone tissue, the foreign body sensation after implantation can be reduced. Figure 1 The first fixing member 110 and the second fixing member 120 shown in the prior art are headed structures.

[0065] In some examples, the first fastener 110 or the second fastener 120 may have a drive structure for connection to a drive tool. For example, a hexagonal head, a triangular head, a star-shaped head, or the like can be formed for connection to a drive tool.

[0066] In some examples, the second fastener 120 may have the same or similar shape and structure as the first fastener 110. In other examples, the second fastener 120 may have a different shape or structure than the first fastener 110.

[0067] In some examples, the first fixation member 110 and the second fixation member 120 may have the same dimensions. In other examples, the second fixation member 120 may have different dimensions. For example, the length of the second fixation member 120 may be less than that of the first fixation member 110. For example, the diameter of the second fixation member 120 may be less than that of the first fixation member 110. Thus, it is possible to select fixation members of different specifications according to different fracture sites.

[0068] See Figure 3In some examples, the first fixation member 110 may have a first channel 111. The first channel 111 may extend through the entire fixation member axially. In this case, the first channel 111 can improve the flow of body fluids within the bone tissue, promote nutrient exchange, and also promote blood vessel ingrowth, thereby promoting bone healing. In some examples, the first channel 111 may allow a guide pin 840 (described in detail later) to pass through. Thus, during implantation, the guide pin 840 can be implanted first, and then the first fixation member 110 can be implanted along the guide pin 840, thereby improving the accuracy of the implantation position.

[0069] In some examples, the second fixation member 120 may have a second channel 121. The second channel 121 may extend through the entire fixation member axially. In this case, the second channel 121 can improve the flow of body fluids within the bone tissue, promote nutrient exchange, and also promote blood vessel ingrowth, thereby promoting bone healing. In some examples, the second channel 121 may allow a guide pin 840 (described in detail later) to pass through. Thus, during implantation, the guide pin 840 can be implanted first, and then the second fixation member 120 can be implanted along the guide pin 840, thereby improving the accuracy of the implantation position.

[0070] See in some examples Figure 4 The first fixation member 110 may also have one or more lateral channels 112. The lateral channels 112 may communicate with the first channel 111. This can further improve the flow of body fluids within the bone tissue.

[0071] In some examples, the multiple lateral channels 112 can be uniformly arranged along the length of the first fastener 110. Of course, they can also be non-uniformly arranged, for example, spirally or staggered.

[0072] In some examples, the second fastener 120 can also form the aforementioned lateral channel 112.

[0073] In some examples, the first fixation member 110 may be formed of an absorbable material. In some examples, the second fixation member 120 may be formed of an absorbable material. Absorbable materials are those that can be gradually and completely broken down and absorbed by the human body. In this case, by using a biodegradable material, the porous structure formed after degradation can provide a scaffold for osteoblasts to adhere, proliferate, and differentiate, thereby guiding new bone growth. Furthermore, it eliminates the need for a second surgical removal after degradation, reducing patient suffering.

[0074] In some examples, the absorbable material may include at least one of the following: calcium-phosphorus compounds, calcium-silica-based bioactive ceramics, polymers, or composites thereof. In some examples, the calcium-phosphorus compound may include at least one of hydroxyapatite and β-tricalcium phosphate. In some examples, the calcium-silica-based bioactive ceramic may include at least one of calcium silicate and a calcium oxide-silica composite. In some examples, the polymer may include at least one of polylactic acid (PLA), polyglycolic acid (PGA), polylactic-co-glycolic acid copolymer (PLGA), polycaprolactone (PCL), polydioxanone (PDO), and polyglycolic acid (PGA). It should be noted that the above materials have good biocompatibility and are all biodegradable. The calcium and phosphorus in the materials can effectively participate in the mineralization process of new bone, promoting new bone formation.

[0075] Furthermore, when absorbable materials are used to form the first fixation member 110 and the second fixation member 120, the material may swell to a certain extent after absorbing bodily fluids, thus allowing for a closer contact between the first fixation member 110 and the second fixation member 120. This further improves the positioning effect. In some examples, after the first fixation member 110 and the second fixation member 120 are implanted into the human body, they can make contact through their own swelling caused by absorbing bodily fluids.

[0076] It should be noted that absorbable materials are generally not radiopaque. In other words, the first fixation element 110 or the second fixation element 120 is not well radiopaque under X-ray. Therefore, a guide needle 840 with radiopaque function (described in detail later) can be used for assisted implantation.

[0077] In some examples, the degradation time of the absorbable material can be matched with the healing cycle of the host bone space. In some examples, the degradation time of the first fixation member 110 or the second fixation member 120 can be from 6 months to 48 months. Thus, it can be matched with the bone healing time.

[0078] Of course, this disclosure is not limited thereto. In other examples, the first fastener 110 or the second fastener 120 may also be made of a metallic material. For example, titanium alloy, medical-grade stainless steel, cobalt-chromium alloy, etc., may be used.

[0079] This disclosure also provides a bone fixation device 800. The bone fixation device 800 can be used to form the aforementioned bone fixation system 1000 or fixation configuration 100. Specifically, the bone fixation device 800 can be used to assist in the implantation of the first fixation member 110 and / or the second fixation member 120 into the host bone tissue and to form the fixation configuration 100. Compared to the traditional method that relies on the surgeon's experience to find the position of the transverse through-hole of the main screw, this disclosure pre-defines the implantation path of the first fixation member 110 and / or the second fixation member 120 through the bone fixation device 800, thus reducing the difficulty for the surgeon to adjust the implantation angle and improving implantation convenience.

[0080] Figure 5 This is a schematic diagram showing the structure of the bone fixation device 800 according to the example of this disclosure. Figure 6A This is a schematic diagram illustrating the first step of forming a fixation configuration 100 using the bone fixation device 800 according to the example of this disclosure. Figure 6B This is a schematic diagram illustrating the second step of forming a fixation configuration 100 using the bone fixation device 800 according to the example of this disclosure. Figure 6C This is a schematic diagram illustrating the third step of forming the fixation configuration 100 using the bone fixation device 800 according to the example of this disclosure. Figure 6D This is a schematic diagram illustrating the fourth step of forming the fixation configuration 100 using the bone fixation device 800 according to the example of this disclosure. Figure 6E This is a schematic diagram illustrating the fifth step of forming a fixation configuration 100 using the bone fixation device 800 according to the example of this disclosure.

[0081] In some examples, the bone fixation device 800 may include a first positioning component 810.

[0082] In some examples, the first positioning component 810 can be configured to connect to the first fixing member 110. Thus, the first positioning component 810 can position the first fixing member 110. It should be noted that this connection can be a fixed connection or a detachable connection. The connection method can be at least one of the following: clamping, snap-fit, plug-in, and magnetic connection.

[0083] In some examples, the connection between the first positioning component 810 and the first fixator 110 is a torque-transmitting connection. In some examples, the first positioning component 810 can drive the first fixator 110 to rotate about its own axis. In some examples, the first positioning component 810 can drive the first fixator 110 to implant into the host bone tissue A. The driving method can be manual or electric. In some examples, in addition to driving the first fixator 110 to rotate, the first positioning component 810 may also have a depth-limiting function. For example, a limiting shoulder can be provided. When the first positioning component 810 is implanted to a predetermined depth, its further implantation is limited. In addition, the first positioning component 810 may also be provided with a torque-limiting mechanism. When the implantation torque exceeds a predetermined value, further rotation is automatically stopped. This prevents the first fixator 110 from breaking.

[0084] In some examples, the main structure of the first positioning component 810 can be a cylindrical handle, a T-handle, or a gun handle-like structure that is easy to grip.

[0085] In some examples, the first positioning component 810 can also be used to drive the second fixation member 120 into the host bone tissue A. That is, the same first positioning component 810 can be used to implant both the first fixation member 110 and the second fixation member 120, thereby reducing the number of surgical instruments. Of course, in some examples, other first positioning components 810 or other driving mechanisms can also be used to drive the second fixation member 120 into the host bone tissue A.

[0086] See Figure 5 In some examples, the first positioning component 810 may have a hollow channel 811. The hollow channel 811 may extend through the first positioning component 810 along its length.

[0087] In some examples, when the first fastener 110 is connected to the first positioning assembly 810, the hollow channel 811 communicates with the first aperture 111. In some examples, when the first fastener 110 is connected to the first positioning assembly 810, the hollow channel 811 communicates coaxially with the first aperture 111.

[0088] In some examples, the hollow channel 811 can form a connecting channel for the guide needle 840 to pass through after it is connected to the first channel 111.

[0089] In some examples, the guide needle 840 can be implanted into the host bone tissue A first to provide initial fixation of the bone tissue. Figure 6AThe first fixation member 110 is then implanted into the host bone tissue A with the guide pin 840 positioned within the first channel 111, and then the first positioning component 810 is connected to the first fixation member 110. In some examples, the guide pin 840 can be implanted into the host bone tissue A first to perform preliminary fixation of the bone tissue, and then the first positioning component 810 is connected to the first fixation member 110, with the guide pin 840 positioned within the first channel 111, causing the first positioning component 810 to drive the first fixation member 110 to be implanted into the host bone tissue A. In some examples, the guide pin 840 can pass sequentially through the first channel 111 and the hollow channel 811. It should be noted that in this case, the bone tissue can be initially fixed by the guide pin 840, and then the first fixation member 110 can be implanted along the guide pin 840 (for example, the main bone fragments can be connected using a guide pin 840 with imaging function under X-ray equipment, and then the first fixation member 110 can be implanted at the position of the guide pin 840 to fix the main bone fragments using the first fixation member 110). The hollow channel 811 reduces the impact of the guide pin 840 on the first positioning component 810 connected to the first fixing member 110. In other words, by providing the hollow channel 811, the guide pin 840 can pass through the first positioning component 810 connected to the first fixing member 110 without obstructing the guide pin 840.

[0090] Therefore, the first fixation member 110 can always be implanted along the path established by the first guide pin 841. This reduces the possibility of the first fixation member 110 deviating and improves implantation accuracy. Furthermore, the first guide pin 841 can be removed after the first fixation member 110 is implanted. In this case, the first channel 111 can still be preserved and further form a fluid circulation channel, promoting bone healing.

[0091] In some examples, the bone fixation device 800 may include a guide pin 840. The guide pin 840 may be used to guide the implantation direction of the first fixation member 110 and / or the second fixation member 120.

[0092] In some examples, the guide needle 840 may have imaging capabilities under X-ray. In some examples, the guide needle 840 may be made of at least one of the following materials: stainless steel, nickel-titanium alloy, or titanium alloy.

[0093] In some examples, the guide needle 840 can be a Kirschner wire.

[0094] In some examples, the outer diameter of the guide pin 840 may be smaller than the inner diameter of the first channel 111 and the second channel 121. This facilitates the passage of the guide pin 840 through the first channel 111. In some examples, the outer diameter of the guide pin 840 may be smaller than the inner diameter of the second channel 121. This facilitates the passage of the guide pin 840 through the second channel 121.

[0095] In some examples, guide pin 840 may include a first guide pin 841. In some examples, guide pin 840 may include a second guide pin 842. The first guide pin 841 may be used to guide the implantation direction of the first fixation member 110. The second guide pin 842 may be used to guide the implantation direction of the second fixation member 120. Of course, both may be reused as the same guide pin 840.

[0096] In some examples, the length of the guide pin 840 can be designed to accommodate the length of the host bone tissue A to be fixed as needed.

[0097] See Figure 5 In some examples, the bone fixation device 800 may include a second positioning component 820. The second positioning component 820 may be used to guide the second fixation member 120 into the host bone tissue A.

[0098] In some examples, the second positioning component 820 can be positioned relative to the first positioning component 810. In some examples, the second positioning component 820 can be angularly adjusted relative to the first positioning component 810. In some examples, the second positioning component 820 can rotate around the first positioning component 810.

[0099] In some examples, the second positioning component 820 may be located on the outer periphery of the first positioning component 810. In some examples, the second positioning component 820 may be rotatably connected to the outer periphery of the first positioning component 810. In some examples, the second positioning component 820 may be detachably connected to the first positioning component 810.

[0100] In some examples, the second positioning component 820 can form multiple positioning positions. In some examples, the second positioning component 820 can be adjusted relative to the first positioning component 810 to form multiple positioning positions. In some examples, the second positioning component 820 can be adjusted relative to the first positioning component 810 to form multiple positioning positions for guiding the second fixation member 120 into the host bone tissue A. In other words, the second positioning component 820 can form multiple positioning positions through positional changes, and these positioning positions can be used to guide the implantation direction of the second fixation member 120. It should be noted that the multiple positioning positions disclosed herein can be understood as multiple different implantation directions.

[0101] In some examples, at any positioning location, the second positioning component 820 can implant the second fixation member 120 into the host bone tissue A in a manner that is offset from the first fixation member 110, so as to form a fixed configuration 100 in the host bone tissue A.

[0102] In some examples, the second positioning component 820 can guide the guide needle 840 to be implanted into the host bone tissue A. In some examples, the guide needle 840, which is implanted by the second positioning component 820, is used to further guide the second fixation member 120 to be implanted into the host bone tissue A, and the second fixation member 120 and the first fixation member 110 form a fixation configuration 100.

[0103] In some examples, the guide needle 840 can be implanted into the host bone tissue A at a specific location using the second positioning component 820. Subsequently, the physician can examine the implanted guide needle 840 under X-ray (to see if it has passed through other bone fragments). If no adjustment is needed, the guide needle 840 can be directly used to guide the implantation direction of the second fixator 120. If adjustment is required, the guide needle 840 is removed, and then it is implanted into the host bone tissue A again at another specific location using the second positioning component 820. This allows the second fixator 120 to connect with other bone fragments, further improving the fixation effect.

[0104] In some examples, the second positioning component 820 can be plate-shaped as a whole. For example, a rectangular plate, an arc-shaped plate, a fan-shaped plate, an arc panel, etc.

[0105] See Figure 5 In some examples, the second positioning component 820 may include at least one positioning hole 8211. For example, in some examples, the second positioning component 820 may include one, three, five, ten, fifteen, or twenty positioning holes 8211. In some examples, the second positioning component 820 may extend through it.

[0106] In some examples, at least one positioning hole 8211 corresponds to the implantation path of at least one second fixation member 120, and the second fixation members 120 implanted along this implantation path are all offset from the first fixation member 110. In other words, See Figure 5 In some examples, the second positioning component 820 may include a positioning portion 821. In some examples, the positioning portion 821 may have a plurality of positioning holes 8211. The positioning portion 821 can be understood as the main body forming the positioning holes 8211. In other words, in some examples, the positioning holes 8211 may be provided on the positioning portion 821.

[0107] In some examples, the positioning hole 8211 can be used for the guide needle 840 to pass through. In some examples, the outer diameter of the positioning hole 8211 can be approximately equal to the outer diameter of the guide needle 840. The outer diameter of the positioning hole 8211 can be 1 to 1.5 times the outer diameter of the guide needle 840. This can improve the implantation stability of the guide needle 840. In some examples, the cross-section of the positioning hole 8211 can be circular, elliptical, or square. In some examples, the cross-section of the positioning hole 8211 can be adapted to the guide needle 840.

[0108] In some examples, multiple positioning holes 8211 can be distributed in an array in the positioning section 821. For example, they can be distributed in a rectangular array.

[0109] In some examples, multiple positioning holes 8211 can provide multiple implantation paths, i.e., different alternatives can be provided. For example, if a fragmented bone is found along one of the implantation paths, the corresponding positioning hole 8211 can be selected so that the guide needle 840 passes through the corresponding positioning hole 8211. This further improves clinical adaptability.

[0110] In some examples, the positions of each positioning hole 8211 can be designed based on the outer diameter of the first fixing member 110 and the outer diameter of the second fixing member 120. Preferably, each positioning hole 8211 can both allow the second fixing member 120 to avoid the first fixing member 110 and allow the second fixing member 120 to form a contact or close-proximity limiting relationship with the first fixing member 110 after implantation, thereby forming the desired fixation configuration 100. Thus, the positioning holes 8211 not only serve a guiding function but also, by pre-defining the implantation path of the second fixing member 120, enable the formed fixation configuration 100 to have the desired limiting effect.

[0111] See Figure 5 In some examples, the second positioning component 820 may include a clearance portion 822. The clearance portion 822 may be used to limit the implantation path so that the second fixation member 120 implanted along the implantation path does not pass through the first fixation member 110. In some examples, no positioning hole 8211 is provided at the clearance portion 822.

[0112] In some examples, the clearance portion 822 can take the form of at least one of the following: a boss structure, a slot, and a cutout.

[0113] In some examples, the clearance portion 822 may be located in the center of the positioning portion 821. It may correspond to the area where the first fixing member 110 is located.

[0114] In some examples, the avoidance portion 822 can cover the orthographic projection area of ​​the first fixation member 110. In this case, the implantation path corresponding to the positioning hole 8211 can avoid the first fixation member 110, and the doctor does not need to make an additional judgment on whether the blocking screw (second fixation member 120) will collide with the main screw (first fixation member 110).

[0115] In some examples, the first fixing member 110 can be orthographically projected onto the surface of the second positioning assembly 820 facing the first fixing member 110 to form an orthographic projection area. Here, orthographic projection refers to projecting the first fixing member 110 onto the surface of the second positioning assembly 820 in a direction perpendicular to the surface facing the first fixing member 110, forming the area. Specifically, the first fixing member 110 can be connected to the first positioning assembly 810, and the second positioning assembly 820 can be rotatably connected to the outer periphery of the first positioning assembly 810, with the orthographic projection of the first fixing member 110 onto the surface of the second positioning assembly 820 forming the orthographic projection area. In some examples, the axial direction of the first fixing member 110 can be parallel to the surface of the second positioning assembly 820.

[0116] In some examples, the positioning hole 8211 may be located outside the orthographic projection area. In other words, the orthographic projection area may not have any positioning hole 8211.

[0117] In some examples, the second positioning component 820 can rotate about the first positioning component 810. When the first positioning component 810 is connected to the first fixing member 110, the second positioning component 820 can rotate about the axial direction of the first fixing member 110. In some examples, the rotation of the second positioning component 820 can be continuous, intermittent, or progressive, thus having multiple positioning positions.

[0118] In some examples, the second positioning component 820 can rotate to any position around the axis of the first fixing member 110 without changing the position of the orthographic projection area. It should be noted that since the clearance part 822 rotates synchronously with the positioning part 821, the clearance part 822 always corresponds to the orthographic projection area of ​​the first fixing member 110, and the positioning hole 8211 is always located outside the orthographic projection area.

[0119] refer to Figure 5 In some examples, the bone fixation device 800 may include a connection component 830.

[0120] In some examples, the second positioning component 820 is connected to the first positioning component 810 via a connecting component 830. The connecting component 830 can be understood as a bridge connecting the two positioning components. For example, the connecting component 830 can form an arc-shaped connecting arm.

[0121] In some examples, one end of the connecting component 830 can be rotatably connected to the first positioning component 810, and the other end can be connected to the second positioning component 820. In this case, the second positioning component 820 can rotate relative to the first positioning component 810 and remain on one side of the first fixing member 110 via the connecting component 830.

[0122] In some examples, the connecting component 830 may allow the second positioning component 820 to rotate about the first positioning component 810. In some examples, the connecting component 830 may form a pivot or universal joint to allow the second positioning component 820 to rotate circumferentially about the first positioning component 810.

[0123] In some examples, the second positioning component 820 can rotate around the first positioning component 810 by angles of 10°, 20°, 30°, 45°, 60°, 90°, or even 360° continuously. This allows the second positioning component 820 to cover more implantation directions.

[0124] In some examples, the connecting component 830 may also be equipped with a locking mechanism that can be locked after the doctor selects the position to prevent further rotation.

[0125] In some examples, the first positioning component 810 may be detachably connected to the second positioning component 820. This detachable connection may be achieved by a detachable connection between the first positioning component 810 and the connecting component 830, or by a detachable connection between the connecting component 830 and the second positioning component 820, or by other means that allow the second positioning component 820 to exit the operating space.

[0126] The following is combined Figures 6A to 6E This describes the formation process of the bone fixation system 1000 disclosed herein.

[0127] First step ( Figure 6A ): Under the guidance of X-ray fluoroscopy, the physician can insert the first guide pin 841 into the host bone tissue A. Preferably, the first guide pin 841 can pass through most of the fracture line. This allows for initial fracture reduction. Furthermore, the first guide pin 841 can establish a path for the subsequent implantation of the first fixator 110. Therefore, there is no need to search for the correct direction again, further improving implantation efficiency.

[0128] Second step ( Figure 6B ): The first fixation member 110 is installed on the first positioning component 810. The first positioning component 810 is rotated and the first fixation member 110 is driven to gradually screw into the first guide pin 841, and finally enter the host bone tissue A, thus completing the implantation of the first fixation member 110.

[0129] Third step ( Figure 6C ): The second positioning component 820 is rotatably mounted to the first positioning component 810 via the connecting component 830. The second positioning component 820 is rotated to a suitable position, and the physician selects a suitable positioning hole 8211 based on X-ray observation results, inserting the second guide needle 842 through the positioning hole 8211 into the host bone tissue A. At this time, the second guide needle 842 can be operated once or multiple times (e.g., switching positioning positions or switching positioning holes 8211 to implant the second guide needle 842). It is worth noting that regardless of which positioning hole 8211 is selected, the second guide needle 842 will not pass through the first fixation member 110.

[0130] Fourth step ( Figure 6D ): Once the second guide pin 842 has established the implantation path, the second positioning component 820 can be removed from the first positioning component 810, while the second guide pin 842 remains in the host bone tissue A. Subsequently, the second fixation member 120 can be implanted into the host bone tissue A along the second guide pin 842.

[0131] After the second fixation member 120 is implanted, it can be offset from the first fixation member 110 and used to form a fixation configuration 100.

[0132] In other examples, the second fastener 120 can ultimately maintain a small distance from the first fastener 110. For example, the distance between them may not exceed 3 mm.

[0133] In some examples, the second fastener 120 is eventually able to contact the outer surface of the first fastener 110.

[0134] Fifth step ( Figure 6E ): Once the second fixation member 120 is fully implanted into the host bone tissue A, the first guide pin 841 (or the first guide pin 841 can be removed immediately after the first fixation member 110 is implanted into the host bone tissue A) and the second guide pin 842 can be removed. At this time, the first fixation member 110 and the second fixation member 120 remain together within the host bone tissue A. The first fixation member 110 and the second fixation member 120 together form the fixation configuration 100.

[0135] In some examples, Figure 6C , Figure 6D and Figure 6EThe steps can be repeated multiple times so that the multiple second fasteners 120 can be located at different circumferential positions of the first fastener 110 to form the final fastening configuration 100. In some examples, the multiple second fasteners 120 are located on both sides of the first fastener 110. For example, they can be located above and below the first fastener 110, respectively. For example, they can be located in different tilt directions. For example, they can also be arranged intersecting each other. Thus, the multiple second fasteners 120 can respectively restrict the movement of the first fastener 110 in different directions.

[0136] In some examples, after a fixation configuration 100 is formed in the host bone tissue A by the bone fixation device 800, the fracture site of the host bone tissue A can be fixed. As the bone tissue heals, the fixation configuration 100 is also degraded and absorbed.

[0137] In summary, in the bone fixation system 1000 disclosed herein, the first fixator 110 and the second fixator 120 are staggered. The second fixator 120 does not need to pass through the first fixator 110, but is staggered from the first fixator 110. This avoids the structural requirement of traditional shielding screws having to pass through the main screw through-hole, thereby reducing the precision requirements for the implantation angle and position of the second fixator 120 and reducing the implantation difficulty of the bone fixation system 1000. In addition, since the second fixator 120 can form a limiting fit with the first fixator 110, it can restrict at least part of the first fixator 110 from moving relative to the bone tissue (e.g., rotation, swinging, radial displacement, or axial movement), improving the fixation stability of the entire bone fixation system 1000 for the host bone tissue A. Furthermore, the second fixator 120 can more flexibly choose the implantation path, and while forming a limiting fit with the first fixator 110, it is also convenient to connect and fix some fracture fragments, thus further improving the overall stability of the fracture ends and providing a more stable mechanical environment for bone tissue healing.

[0138] While the present disclosure has been specifically described above in conjunction with the accompanying drawings and examples, it is to be understood that the foregoing description does not limit the present disclosure in any way. Those skilled in the art can make modifications and variations to the present disclosure as needed without departing from its essential spirit and scope, and all such modifications and variations shall fall within the scope of the present disclosure.

Claims

1. A bone fixation system, characterized in that, include: The first fixation element is configured to be implanted into the host bone tissue; At least one second fixation member is configured to be implanted into the host bone tissue and form a fixation configuration with the first fixation member to fix the host bone tissue; In the aforementioned fixation configuration, the at least one second fixation member is offset from the first fixation member and forms a limiting engagement with the first fixation member to restrict at least a portion of the movement of the first fixation member relative to the host bone tissue.

2. The bone fixation system according to claim 1, characterized in that, In the fixed configuration, the outer surface of the at least one second fixing member is in contact with or at a distance of less than or equal to 3 mm from the outer surface of the first fixing member.

3. The bone fixation system according to claim 1, characterized in that, The first and second fasteners are formed of absorbable material; and / or, The first fastener has a first channel extending along its axial direction, and the second fastener has a second channel extending along its axial direction.

4. The bone fixation system according to claim 1, characterized in that, At least one of the first and second fasteners has a surface limiting structure on its surface, and the limiting fit is formed by the surface limiting structure.

5. A bone fixation device for forming a bone fixation system as described in any one of claims 1 to 4, characterized in that, include: A first positioning component is configured to be connected to a first fixing member; The second positioning component is adjustable relative to the first positioning component to form multiple positioning positions for guiding the second fixation member to be implanted into the host bone tissue; at any of the positioning positions, the second positioning component causes the second fixation member to be implanted into the host bone tissue in a manner offset from the first fixation member, so as to form a fixed configuration in the host bone tissue.

6. The bone fixation device according to claim 5, characterized in that, The second positioning component is provided with at least one positioning hole, the at least one positioning hole corresponds to at least one implantation path, and the second fixation members implanted along the implantation path are all staggered from the first fixation members.

7. The bone fixation device according to claim 6, characterized in that, The first fastener has a first channel extending along its axial direction, and the second fastener has a second channel extending along its axial direction. The bone fixation device further includes a guide pin for guiding the implantation direction of the first fixation member and / or the second fixation member, wherein the outer diameter of the guide pin is smaller than the inner diameter of the first channel and the inner diameter of the second channel; the positioning hole is configured to allow the guide pin to pass through and has a diameter smaller than the diameter of the second fixation member.

8. The bone fixation device according to claim 7, characterized in that, The first positioning component has a hollow channel; when the first fixing member is connected to the first positioning component, the hollow channel communicates with the first channel and forms a communicating channel through which the guide needle can pass.

9. The bone fixation device according to claim 6, characterized in that, The implantation path is always located in the outer peripheral region of the first fixation member, so that the implanted second fixation member and the first fixation member form the fixation configuration.

10. The bone fixation device according to claim 6, characterized in that, The second positioning component includes a positioning part and a clearance part. The positioning hole is disposed in the positioning part, and the clearance part covers the orthographic projection area of ​​the first fixing member on the second positioning component.

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