A skeletal fixing system that can be gradually changed from rigid fixing to axial non-rigid fixing.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- 董谢平
- Filing Date
- 2020-07-02
- Publication Date
- 2026-07-31
- Estimated Expiration
- Not applicable · inactive patent
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention belongs to the field of medical devices, and particularly relates to a skeletal fixation system that can be gradually changed from rigid fixation to axially non-rigid fixation.
Background Art
[0002] After more than 50 years of evolution, the international mainstream fracture fixation method has changed from the AO theory and device of rigid fixation to the BO theory and device of elastic fixation. However, from the perspective of the fracture healing process, early rigid fixation can prevent displacement of the fracture ends and fixation failure, and provide conditions for early functional movement. In the middle and late stages of fracture healing, changing to elastic fixation with relatively weak fixation strength helps to reduce stress shielding of the fracture ends. As a result, the bone fracture ends can obtain axial physiological stress stimulation that promotes bone healing, thereby improving the quality of bone healing and reducing disuse osteoporosis under the protection of the fixation device. That is, rigid fixation is superior to elastic fixation in the early stage of fracture healing, and elastic fixation is superior to rigid fixation in the middle and late stages of fracture healing. However, implants that can provide sufficient fixation strength to weight-bearing bones in the initial stage of fixation cannot be converted into elastic fixation by themselves in the middle and late stages, and surgery is required to reduce the fixation strength. After using an intramedullary nail to fix a fracture, minor surgery may be required to remove the locking nail at one end of the intramedullary nail 3 months after surgery so that the initial static fixation can be converted into dynamic fixation, but this method is often unacceptable to patients. Patients with plate fixation have no options for reoperation unless there is fracture nonunion or delayed union. Therefore, it is still difficult to reduce the incidence of fracture delayed union, nonunion, and refracture at present.
Prior Art Documents
Patent Documents
[0003]
Patent Document 1
Summary of the Invention
[0004] The present invention aims to provide a skeletal fixation system that overcomes the shortcomings of the prior art, adapts to the needs of patients, does not require surgery, can gradually change from strong fixation to elastic fixation in the body over time, can gradually change from rigid to axially non-rigid fixation, and achieves self-conversion from AO strong fixation to BO elastic fixation. [Means for solving the problem]
[0005] The present invention includes a bone-fixing bridge to which connecting members are attached and which is fixed by bone-fixing nails, the bone-fixing bridge spans the fracture ends and is positioned on the surfaces of the skeleton on both sides of the fracture ends, the bone-fixing nail at one of the bone fracture ends fixes the skeleton to the bone-fixing bridge directly or via the connecting members, and the bone-fixing nail at the other fracture end fixes the skeleton to the bone-fixing bridge via the connecting members using the bone-fixing nail.
[0006] A biodegradable gasket made of a rigid, biodegradable biomaterial is added and installed between the joint between the connecting member fixed to the fractured end of the bone on the other side and the bone fixation bridge. The bone fixation nail, connecting member, biodegradable gasket, bone fixation bridge, and both ends of the fractured skeleton fixed to the bone fixation bridge form a stable fracture / fixation complex in the initial stages of fixation, thereby forming stable static fixation.
[0007] As the biodegradable gasket gradually decomposes and is absorbed into the body, the connection between the connecting member on which the biodegradable gasket is located and the bone fixation bridge also gradually loosens. However, the positional relationship between the bone fixation nail, bone fixation bridge, and the skeleton on both sides of the fractured end remains a stable, rigid structure. The connection between the connecting member on which the gasket is located and the bone fixation bridge becomes merely a clearance fit. The bone fixation bridge, connecting member, and fractured end constrained by the bone fixation nail can only slide axially along the bone fixation bridge under the action of external force. In other words, the fracture / fixation complex becomes an axially non-rigid connection, and the fixation of the entire fixation system gradually changes to an axially non-rigid dynamic fixation.
[0008] The bone-fixing bridge is a plate-shaped bone-fixing plate, and the bone-fixing plate includes bone-fixing nail through holes and sliding grooves.
[0009] The connecting member is a slide block embedded in the slide groove of the bone joint plate, and at least one bone joint nail through hole is provided in the slide block.
[0010] The side walls of the slide block are smooth planes, the side walls of the slide block and the inner walls of the slide groove engage using a radially contacting surface contact method, the slide block and the slide groove have a sliding gap in the axial direction of the bone fixation plate, the disassemblable gasket is positioned within this sliding gap, and the bone fixation nails are connected to the bone fixation plate with smooth ordinary nail heads or screw-type locking nail heads via bone fixation nail through holes in the bone fixation plate and bone fixation nail through holes in the slide block attached to the bone fixation plate, thereby completing the assembly and fixation of the fracture / fixation system.
[0011] The slide groove is a through groove that penetrates the surface of the bone joint plate, a keyway is made in one or both side walls of the slide block, a key pin hole is made in the side wall of the slide groove corresponding to the keyway, the axial length of the keyway along the slide block is greater than the diameter of the key pin, allowing both the key pin and the keyway to move relative to each other, the key pin is fixedly connected to the key pin hole and extends into the keyway to restrict the slide block so that it can only perform axial translational motion within the through groove.
[0012] The slide groove is a through groove that penetrates the surface of the bone joint plate, and swallowtail-shaped or rectangular projections are provided on the left and right inner walls of the slide block, respectively, and groove areas corresponding to the projections are provided on the inner wall of the through groove, forming a mortise and tenon joint structure of swallowtail or rectangular grooves that are joined together, and the projections are embedded in the groove areas and can slide within the groove areas, restricting the slide block to perform only axial translational motion within the through groove.
[0013] The slide groove is a through groove that penetrates the surface of the bone fixation plate, and both side walls of the slide block and both inner walls of the through groove are arc-shaped and symmetrically concentric circles, and the slide block is rotated and embedded in the through groove via a common axis between the two, and the direction of insertion of the bone fixation nail can be changed by deflecting the slide block via the common axis during the fracture fixation surgery, and after the fixation surgery is completed, the two arc-shaped inner walls of the through groove surround the two side walls of the slide block, restricting the slide block to perform only axial translation within the through groove.
[0014] The slide block is provided with a deformation joint positioned along the axial direction of the slide block, which converts the closed bone-fixing nail through-holes of the slide block into fully open or partially open bone-fixing nail through-holes, causing the slide block to have lateral elastic deformation conditions, and after the bone-fixing nails are screwed into the bone-fixing nail through-holes, a pressing force can be applied to the side walls of the bone-fixing nail through-holes on both sides of the deformation joint, prompting the two side walls of the slide block to press the inner walls of the through-grooves.
[0015] All fully open deformed joints penetrate the side wall of the slide block through the nail holes for bone fixation, while the partially open deformed joints, which extend from shallow to deep or from the inner edge to the outer edge, do not penetrate the side wall of the slide block.
[0016] The aforementioned slide groove is a groove that does not penetrate the surface of the bone joint plate, and the slide block is embedded in the groove.
[0017] A through hole is provided at the bottom of the groove, and the through hole is larger than the diameter of the bone nail. As the disassemblable gasket gradually disassembles, the integrated slide block and the skeletal fracture end can move axially along the through hole together with the bone fixation nail.
[0018] A removable, lay-type disassemblable gasket, which has the same shape as the bottom surface of the slide block, is further installed between the bottom of the slide block and the groove. After the bone-fixing nails are fastened into the frame by passing through the bone-fixing nail through-holes on the slide block and the lay-type disassemblable gasket, the connection between the slide block and the bone-fixing plate becomes a rigid connection.
[0019] The bone-fixing bridge is a rod-shaped connecting rod, the connecting member is a connecting block, the connecting block has a through hole for the implantation portion of the bone-fixing nail to pass through and a rod clamp arm for fixing the connecting rod, the rod clamp arm of the connecting block restrains the connecting rod and then fixes it to the outer surface of the skeleton by the bone-fixing nail implanted in the bone through the through hole of the connecting block, the disassemblable gasket is backed between the rod clamp arm and the connecting rod to prevent the rod clamp arm from directly pressing the connecting rod, the bone-fixing nail, the connecting block and the connecting rod, or the disassemblable gasket and the two skeletal fracture ends of the skeleton they fix together constitute a stable, rigid fracture / fixation complex.
[0020] The through hole in the connecting block is either a hole without threads or a screw hole, and the rod clamp arm of the connecting block is adjacent to the through hole. The bone fixation nail consists of a front implantation portion and a rear locking portion. The implantation portion of the bone fixation nail is implanted into the bone, and the locking portion of the bone fixation nail is connected to a through-hole in the connecting block.
[0021] The disassemblable gasket is tile-shaped and backs the rod clamp arm and the connecting rod, and its cross-section is a shallow arc less than a semicircle.
[0022] The through hole in the connecting block is a hole without threads, the bone-fixing nail locking portion has a normal nail head with a screwdriver joint at the rear end, and its diameter is larger than the smallest part of the hole without threads in the connecting block, and the normal nail head may be an integrated normal nail head manufactured together with the bone-fixing nail, or it may be an assembled normal nail head in which a crimping nut and the nail body are screwed together.
[0023] The threadless hole is divided into an upper part and a lower part. The upper part is a spherical surface with a larger upper part and a smaller lower part, and the lower part is a conical surface with a smaller upper part and a larger lower part. The lower end surface of the normal nail head of the bone-joint nail locking part is a spherical surface that coincides with the upper spherical surface of the threadless hole. The diameter of the implant part of the bone-joint nail is smaller than the minimum diameter of the threadless hole. The bone-joint nail can swing in a conical shape within the range constrained by the conical surface at the lower part of the threadless hole.
[0024] The through-hole of the connection block is a threaded hole, the locking part of the bone-joint nail is a thread matching it, and the thread lead of the implant part of the bone-joint nail is the same as that of the locking part.
[0025] The rod clamping arm is one or two located on both sides of the through-hole respectively. The rod clamping arm restrains the connecting rod by semi-enclosure restraint where the end face of the rod clamping arm is free, or restrains the connecting rod by full-enclosure restraint where the rod clamping arm clamps the connecting rod.
[0026] The block body of the connection block is an integral type or a combination of a hook sheet and a nail sheet stacked together. When the connection block is a combination of a hook sheet and a nail sheet, the hook sheet constitutes the lower half of the connection block, has the rod clamping arm and the through-hole, and the through-hole is circular or elliptical through which the main body of the bone-joint nail can pass. The nail sheet constitutes the upper half of the connection block, has a through-hole and a mating surface matching the locking part of the bone-joint nail. The nail sheet can further include the rod clamping arm, and the rod clamping arms of the nail sheet and the hook sheet are respectively arranged on both sides of the through-hole.
[0027] The joint surface of the hook sheet and the nail sheet coincides, and their contact surface has a rough structure that helps to increase friction.
[0028] The connecting rod is also provided with a stopper that can restrict the sliding distance of the connecting rod, which can slide axially due to the action of an external force after the disassemblable gasket has disassembled and absorbed. The stopper is a U-shaped hoop that can be inserted into the connecting rod, and one end of the stopper has a set screw and a corresponding set screw hole to point at the connecting rod to prevent it from falling out or being displaced.
[0029] The axial sliding gap between the slide block and the bone joint plate of the slide groove is 0.2 to 1 mm, the thickness of the embedded disassembly gasket is 0.2 to 1 mm, the thickness of the laid disassembly gasket is 0.1 to 0.5 mm, and the thickness of the tile-type disassembly gasket is 0.2 to 1 mm.
[0030] The biodegradable gasket is manufactured from a biodegradable metallic magnesium or zinc, or a composite of magnesium and zinc, or from a composite of magnesium and polylactic acid coated on its exterior, or from a composite of zinc and polylactic acid coated on its exterior, or from a composite of magnesium and zinc and polylactic acid coated on its exterior. The aforementioned decomposable gasket is either a complete gasket or a gasket made of several layers of the same composite material or several layers of different composite materials, stacked together to control the rate of decomposition. [Effects of the Invention]
[0031] The beneficial effects of the present invention are as follows: Fracture internal fixation performed by the present invention can achieve rigid fixation early, and as the fracture heals, the biomaterial gradually decomposes, the axial fixation strength gradually weakens, the contact between the fracture ends gradually tightens, and the mutual axial compressive stress between the two fracture ends gradually increases. Once the biomaterial has completely decomposed, the two fracture ends acquire physiological axial compressive stress unaffected by fixation while maintaining lateral and rotational stability. Therefore, not only is it unnecessary to convert static fixation to dynamic fixation in a second surgery before the fracture heals, but because stress shielding is gone, there is also no need for another surgery to remove the internal fixator after fracture healing. This not only improves the quality of fracture fixation and reduces the risks of delayed fracture healing, pseudoarthrosis, and fracture and loosening of the internal fixator, but it can also accelerate healing, shorten the course of treatment, reduce physical disability, reduce costs, and generate enormous social and economic benefits.
[0032] The present invention, like the bridging assembly type fracture internal fixation device described in Patent Document 1: Publication No. CN200510010654.3, allows surgery to be performed in a manner equivalent to first determining the direction of the bridge surface (connecting rod), suspending the bridge surface at the desired fixation position, and then constructing bridge piers by driving in piles (implanting nails). Furthermore, it offers a fixation method different from existing limb internal fixation devices, in which, first, bone fixation screws without nail heads are screwed in according to the need for fracture fixation, and then the connecting rods are attached to the bone fixation screws. The bone fixation screws and the connection blocks can be positioned on the side, secured with crimp nuts after the connection blocks are fitted, and the bone fixation screws and connection blocks can be positioned non-vertically. In other words, the surgery can be performed in a manner equivalent to first selecting the location for the piles and constructing the bridge piers (planting the nails), and then erecting the bridge deck (connecting rods). The former offers greater flexibility and freedom, allowing for proper adjustment of the nail insertion direction even when the axis of the through-hole of the connection block is at the edge of the skeleton. Screwing the bone fixation screws into the hardest bone possible better accommodates the fixation needs of complex comminuted fractures and further reduces the bending and shaping operations of the connecting rods. [Brief explanation of the drawing]
[0033] [Figure 1] Figure 1 is a structural effect diagram of the keyway insertion embedded type bone fixation plate in Example 1. [Figure 2] Figure 2 is a structural effect diagram of the mortise and tenon joint insertion embedded type bone joint plate in Example 2. [Figure 3] Figure 3 is a two-dimensional diagram of the structures of two types of insertable and embedded slide blocks / through grooves, Example 1 and Example 2. [Figure 4] Figure 4 is a structural effect diagram of the rotational implantable bone fixation plate in Example 3. [Figure 5] Figure 5 is a two-dimensional schematic diagram of the assembly process of the rotary embedded slide block / through groove of Example 3. [Figure 6] Figure 6 is a two-dimensional schematic diagram of the rotary embedded slide block / through groove locking fit type of Example 3. [Figure 7] Figure 7 shows multiple types of rotary-embedded slide blocks from Example 3 and their structural effects when fixing two fractures. [Figure 8] Figure 8 shows the effect of the fixation structure for epiphyseal fractures in Example 3. [Figure 9] Figure 9 shows the assembly effect of the tile groove type bone joint plate in Example 4. [Figure 10] Figure 10 is an exploded view of the structure of Example 5, showing an integrated conventional nail head and a single rod clamp arm pressing against a rod. [Figure 11] Figure 11 is a two-dimensional structural diagram of Example 5, showing an integrated conventional nail head and a single rod clamp arm pressing against a rod. [Figure 12] Figure 12 is a schematic exploded view of the structure of Example 5, in which a rod is clamped with an integrated conventional nail head and a single rod clamp arm. [Figure 13] Figure 13 is a two-dimensional structural diagram of Example 5, showing an integrated conventional nail head and a single rod clamp arm clamping a rod. [Figure 14]Figure 14 is a structural effect diagram of Example 5, showing how a standard assembled nail head and a single-rod clamp arm press against a rod. [Figure 15] Figure 15 is a two-dimensional structural diagram of Example 5, showing an assembled type of conventional nail head and a single-rod clamp arm pressing against a rod. [Figure 16] Figure 16 is an exploded view of the structure of Example 5, in which a conventional nail head assembly and a single rod clamp arm press against a rod. [Figure 17] Figure 17 is a schematic diagram of the disassembled structure and operating principle of Example 5, in which an assembled conventional nail head and a single rod clamp arm press against a rod. [Figure 18] Figure 18 is an exploded view of the structure in Example 5, showing the locking nail head and the single rod clamp arm pressing against the rod. [Figure 19] Figure 19 is a two-dimensional structural diagram of the locking nail head and the single rod clamp arm pressing the rod in Example 5. [Figure 20] Figure 20 is a two-dimensional schematic diagram of the structure in Example 5 in which an integrated conventional nail head and a double-bar clamp arm clamp and press the rod. [Figure 21] Figure 21 is a schematic diagram of the structure of some different nail head and rod clamp arm connection blocks in Example 5. [Figure 22] Figure 22 is a schematic diagram of the structure of bone-fixing nails with different nail head structures in Example 5. [Figure 23] Figure 23 is a two-dimensional schematic diagram of the integrated conventional nail head of Example 5 and the structure in which the rod is pressed by a single rod clamp arm of the assembled connection block. [Figure 24] Figure 24 is an exploded view of the structure of Example 5, showing an integrated conventional nail head and a single rod clamp arm of an assembled connecting block pressing against a rod. [Figure 25] Figure 25 is a two-dimensional schematic diagram of the integrated conventional nail head of Example 5 and the structure in which the rod is pressed by the double rod clamp arm of the assembled connecting block. [Figure 26] Figure 26 is an exploded view of the structure of Example 5, showing the integrated conventional nail head and the double-rod clamp arm of the assembled connecting block pressing the rod. [Figure 27]Figure 27 is an exploded view of the structure in Example 5, showing how a conventional assembled nail head and a double-bar clamp arm of an assembled connecting block press and clamp the rod. [Figure 28] Figure 28 is a schematic diagram illustrating the effect of variable center distance and swing angle in a conventional nail-head assembly-type connecting block of Example 5. [Figure 29] Figure 29 is a schematic diagram illustrating the effects of the fixing method and axial sliding mechanism of Example 5. [Figure 30] Figure 30 is a two-dimensional and schematic diagram of the stopper in Example 5. [Modes for carrying out the invention]
[0034] To further clarify the technical problems, technical solutions, and beneficial effects addressed by this application, the present invention will be described in more detail below, along with examples. In this description, orientations or positional relationships indicated by terms such as "left and right" and "up and down" should be understood to be based on the orientations or positional relationships shown in the drawings. "End" refers to the axial edge, "side" refers to the radial edge, "top" refers to the side of the bone fixation plate facing the practitioner, and "bottom" refers to the opposite side of the "top." "Proximal fracture end" and "distal fracture end" refer to the fracture line, with the former being a relatively fixed end closer to the shoulder or hip joint and the latter being a relatively free end further from the aforementioned joint. These terms are for convenience in describing the application of this invention and do not require that the application of this invention be constructed and operated in a particular direction, and therefore should not be understood as limitations of the invention.
[0035] The present invention can be realized in many embodiments and, in summary, can be divided into plate-type and rod-type fixing systems depending on the shape and structure of the bone-fixing bridge. The plate-type fixing system can be divided into two main types, through-grooves and grooves, depending on whether the slide groove penetrates the entire layer of the bone-fixing plate. Correspondingly, the shape and combination method of the slide block and slide groove of the through-groove can be divided into two main types, embedded and tiled. That is, through-grooves correspond to embedded types, and grooves correspond to tiled types. Furthermore, if the shape and combination method of the slide block and slide groove of the through-groove is embedded, the embedding method of the slide block and slide groove can also be of two types: insert-embedded and rotary-embedded. Moreover, the combination method of the insert-embedded can be further divided into two types: mortise and tenon and keyway.
[0036] Specific examples will be further described below with reference to the drawings, of which Examples 1, 2, 3, and 4 are plate-shaped fixing systems, and Example 5 is a rod-shaped fixing system.
[0037] Example 1: Figure 1 is a structural effect diagram showing the use of a through-groove type bone fixation plate using the keyway insertion and embedding structure of the present invention for fixing a single fracture of the diaphysis. In the figure, the right side of fracture line A3 is the distal fracture end A1, and the left side of fracture line A3 is the proximal fracture end A2. The bone fixation plate 3 has bone fixation nail through holes 12 that fix the distal fracture end A1 side, and these are lock screw holes without slide blocks. The number of these holes is not limited to the two shown in Figure 1. The bone fixation plate 3 that fixes the proximal fracture end A2 side has a through groove 31, and all bone fixation nail through holes 12 are located in slide blocks 1 within the through groove 31. The slide block 1 shown in Figure 1 is simplified to a porous slide block 1(a) structure with only two bone fixation nail through holes 12. The bone fixation nail through holes 12 are also lock screw holes. The shape of the slide block 1 is basically the same as the shape of the through groove 31 of the bone fixation plate 3, but its length is slightly shorter than the through groove 31, and its width is the same, but it is a clearance fit. Preferably, the slide block 1 is 0.2 to 1 mm shorter than the through groove 31. That is, the axial gap between the slide block 1 and the through groove 31 is 0.2 to 1 mm and is used to embed an embedded disassemblable gasket 21 having the same shape and size as the gap. The porous slide block 1(a) has one key groove 11 axially positioned on at least one side, and key pin holes 32 are provided in the side wall of the bone joint plate 3 corresponding to the center of the key groove 11. Preferably, two pairs, i.e., four key groove / key pin hole pairs, are provided on both sides of the bone joint plate 3. The slide block 1 is embedded in the through groove 31, inserted into the key groove 11 via the key pin holes 32 with key pins 34, and after fixing the key pins 34, the slide block 1 and the bone joint plate 3 are integrally connected, and the slide block 1 can only move axially in parallel within the through groove 31. To meet the different fracture fixation needs, preferably the length of the keyway 11 allows the slide block 1 to be moved parallel to each end by at least 1 mm, and the connection method between the key pin 34 and the key pin hole 32 may be of multiple types, such as screw connection, riveting, or welding.
[0038] The number of nail penetration holes 12 for bone fixation in the bone fixation plate 3, and the number of fixed bone fixation nail penetration holes 12 and sliding bone fixation nail penetration holes 12 distributed at both ends of the fracture line can be selected according to the preoperative plan and the actual situation during surgery.
[0039] It must be emphasized that during surgery, the gap between the slide block 1 and the through groove 31 must be left close to the fracture line A3. In this way, the gap, restored after the embedded disintegrable gasket 21 has been absorbed, provides space for axial stress generated by muscle tension and limb activity to move parallel to the proximal fracture end A2, driving the osteosynthesis nail 4 and osteosynthesis plate 3 to which the distal fracture end A1 is fixed, thereby making the contact between the distal fracture end A1 and the proximal fracture end A2 tighter and providing an axial compressive stress stimulus between the fracture ends that promotes fracture union.
[0040] Example 2: Figure 2 is a structural effect diagram of a through-groove type bone fixation plate using the mortise and tenon insertion embedded structure of the present invention, used for fixing a single fracture of the diaphysis. In the figure, everything is the same as in Embodiment 1, except that the embedding method of the slide block 1 and the through-groove 31 has been changed to a rectangular insertion mortise and tenon structure. That is, rectangular projections 14 are provided on the left and right inner walls of the slide block 1, and groove areas 35 corresponding to the projections 14 are provided on the inner walls on both sides of the through-groove 31, and are connected to each other by forming a rectangular groove-shaped mortise and tenon structure. The projections 14 are embedded in the groove areas 35 and can slide within the groove areas 35, restricting the slide block 1 and allowing it to perform only axial translational motion within the through-groove 31.
[0041] The aforementioned mortise and tenon joint structure can also be of other forms, such as dovetail joints. The left side of the center line in Figure 3 shows the mortise and tenon joint structure, while the right side shows a two-dimensional schematic diagram of the assembled keyway / key pin hole structure.
[0042] Example 3: Figure 4 is a structural effect diagram of a through-groove type bone fixation plate using the rotational embedded structure of the present invention, used for fixing a single fracture of the diaphysis. In the figure, all structures except for the embedded structure of the slide block 1 and the through-groove 31 are the same as in Example 1.
[0043] In Embodiment 3, the two side walls of the slide block 1 and the two inner walls of the through groove 31 are arranged as symmetrical concentric circles. The slide block 1 is embedded in the through groove 31 by rotating, and as shown in Figures 5 and 6, the edges on both sides of the through groove 31 of the bone joint plate 3 can be chamfered to form an arc shape in order to facilitate screwing the slide block 1 into the through groove 31. In this way, the first slide block 1 can be easily screwed into the through groove 31. Secondly, the slide block 1 can be rotated laterally during the fixing process, using the vertical axis of the bone-fixing plate 3 as the axis of rotation. This allows for stepless adjustment of the angle between the axis of the bone-fixing nail through-hole 12 on the slide block 1 and the vertical axis of the bone-fixing plate surface. This facilitates finding a thicker and stronger skeleton for the bone-fixing nails 4 to penetrate the bone-fixing plate 3 at an inclined angle and be screwed into the bone. This increases the fixing strength and allows for the formation of a cross-arrangement structure of nails that is more resistant to external forces that loosen and pull the nails. Thirdly, this does not destroy the storability of the slide groove 31 within the slide block 1. Except for the rotation mechanism that was used when the slide block 1 was embedded in the through groove 31, it was prevented from being dislodged from the through groove 31 by any external force. After the bone-fixing nails 4, which were fixed into the skeleton by passing through the bone-fixing nail through holes 12 on the slide block 1, were tightened, the slide block 1, which had been pushed out by the bone-fixing nails 4, could still push out the through groove 31. As a result, the slide block 1 and the through groove 31 were integrally connected to form a complete bone-fixing plate 3.
[0044] To facilitate screwing the slide block 1 into the through groove 31, a deformation joint 15 can be made in one end side wall of the single-hole slide block 1(b), which runs longitudinally through the entire layer of the slide block along the axial direction of the bone joint plate 3. This changes the closed bone joint nail through hole 12 of the slide block 1 into an open bone joint nail through hole 12, and the other end side wall of the slide block 1, which is symmetrical to the side wall of the slide block 1 where the deformation joint 15 is made, is either a complete side wall structure or a crack that does not penetrate the side wall, opening from shallow to deep or from the inner edge to the outer edge. The slide block 1 has an incomplete side wall structure, which provides the slide block 1 with lateral elastic deformation conditions, and the porous slide block 1(a) has the same or similar structure at both ends as the single-hole slide block 1(b), but deformation joints 15 are made along the axial direction in all the side walls between all the bone joint nail through holes 12 on the entire porous slide block 1(a), and both sides of the entire slide block 1 maintain their continuity by relying only on the complete side wall at one end or the side wall of the remaining portion, and Figure 7 shows the structures of multiple types of slide block 1 of Embodiment 3.
[0045] Figure 7 also shows important points regarding the placement of the embedded gaskets 21 when two fractures of the diaphysis are fixed. First, all bone fixation nail through-holes 12 at the proximal fracture end A2 and distal fracture end A1 must be placed on the slide block 1, and all embedded disassemblable gaskets 21 must be placed at one end of the through-groove 31 closest to the fracture line A3. Second, all bone fixation nail through-holes 12 on the free bone portion in the center of the fracture must not slip. If the bone fixation nail through-holes 12 on the bone fixation plate corresponding to the free bone portion are placed on the slide block rather than directly on the bone fixation plate, it is necessary to embed non-disassemblable gaskets 20 of the same shape and size into the gap to eliminate the gap and increase the rigidity between the slide block 1 and the bone fixation plate 3.
[0046] Figure 8 is a structural effect diagram for fixing an epiphysical fracture according to Embodiment 3 of the present invention. In the figure, A2 represents the diaphysis of a tubular bone and is located near the fracture line, while A1 represents the metaphysis of a tubular bone near the joint, such as the distal end of the radius, and is located at the distal end of the fracture line. The bone fixation nail through-hole 12 that fixes the A1 side is also a lock screw hole without a slide block, but the bone fixation nail through-hole 12 can only be positioned horizontally, and accordingly the bone fixation plate 3 at the fracture end can only be expanded in the lateral direction, so the entire bone fixation plate 3 takes on a "T" shape or an "L" shape.
[0047] Example 4: Figure 9 is a structural effect diagram for fixing diaphysis fractures using a tile groove type bone fixation plate according to the present invention. In the figure, all structures except for the slide block 1 and the slide groove are the same as in Example 1.
[0048] In Figure 9, the slide groove on the left side of the bone joint plate 3 is installed as a smooth groove 36 located on the upper surface of the bone joint plate 3, which does not penetrate the entire layer of the bone joint plate 3. The width of the groove 36 is greater than the diameter of the bone joint nail 4, and a through hole 38 is made in the center of the bottom surface of the groove 37 through which the bone joint nail 4 can pass. The size and shape of the through hole 38 allow the bone joint nail 4 passing through the slide block 1 to move along the axial direction of the bone joint plate 3. The shape of the slide block 1 is basically the same as the shape of the groove 36, except that its length is slightly shorter than the groove 36 and its width is the same as the groove 36, but it is a gap fit. The size and position of the bone joint nail through hole 12 of the slide block 1 also correspond to the through hole 38 of the groove 36, and it can be laid within the groove 36. Preferably, the slide block 1 is 0.2 to 1 mm shorter than the groove 36, that is, the axial gap between the slide block 1 and the groove 36 is 0.2 to 1 mm, and one removable gasket 21 of the same shape and size as the gap can be embedded in one end of the slide block 1 closest to the fracture line A3.
[0049] In Example 4, a lay-type disassemblable gasket 22, whose shape and size correspond to the shape of the groove bottom surface 37 and whose thickness is less than 1 mm, can be laid between the slide block 1 and the groove 36. This eliminates micro-movement between the slide block 1 and the groove 36 during the initial fixing phase, and after the lay-type disassemblable gasket 22 is disassembled and absorbed, a gap is formed between the slide block 1 and the groove 36 that does not hinder the sliding of both and does not cause lateral rotation or micro-movement of the slide block 1.
[0050] As shown in Figure 9, the bone joint plate 3 employing tile-type slide blocks can use both an embedded disassembly gasket 21 and a lay-out disassembly gasket 22 simultaneously.
[0051] Example 5: Example 5 shows a rod-shaped fixing system consisting of a connecting rod 6, a connecting block 5, a bone fixing nail 4, and an additional disassemblable gasket 2.
[0052] As shown in Figures 10-19, the connecting rod 6 is in the shape of a round bar, preferably with a diameter equal along its entire length and a smooth outer surface or a jagged surface such as straight grain or net grain.
[0053] The connecting block 5 consists of a block body 51 and a rod clamp arm 52 that are integrally connected. The block body 51 is flat and has a through hole 511 in its central portion through which the implant portion 41 of the bone fixation nail passes. The through hole 511 of the connecting block 5 is either a hole without threads or a screw hole, and the shape of the hole without threads can be a cylindrical surface, a circular table surface, or a spherical surface, etc.
[0054] Preferably, as shown in any of Figures 10 to 17, if the through hole 511 is a non-threaded hole, the channel is divided into an upper and a lower part. The upper part is a spherical surface that is larger at the top and smaller at the bottom, matching the lower end surface of the spherical nail head of the bone fixation nail locking portion 43 or the lower end surface of the spherical crimping nut 44 that is screw-engaged with the bone fixation nail locking portion 43. The lower part is a conical surface that is smaller at the top and larger at the bottom, and the diameter of the implant portion 41 of the bone fixation nail is smaller than the minimum diameter of the through hole 511 and can swing conically within the range constrained by the conical surface of the through hole.
[0055] As shown in Figures 18 and 19, the through hole 511 of the connecting block 5 can be a screw hole, and the screw hole can be straight or conical, and can be single or double threaded, in which case the locking portion 43 of the bone fixation nail is a thread pair that matches the screw hole, and the thread leads of the implant portion 41 and the locking portion 43 of the bone fixation nail are the same.
[0056] As shown in Figures 20 and 21, a bar clamp arm 52 is further connected to one side or symmetrically to both sides of the block body 51. The method of fixing the bar clamp arm 52 to the connecting rod 6 is divided into two types: rigid pressing and elastic clamping. The end face of the rigid pressing bar clamp arm 52 is free, and one side approaching the bone is concave, forming a bar pressing frame 521. The inner surface of the bar pressing frame 521 is a small arcuate surface, a semi-arcate surface, or a U-shaped surface, and the radius of the arcuate surface is the same as the radius of the connecting rod 6. The bar pressing frame 521 forms a half-enclosed state with respect to the connecting rod 6 and must be clamped together with the bone surface to fix the connecting rod 6. The elastic clamping bar clamp arm 52 is a bar clamp frame 522. In other words, the end face of the rigid pressing arm extends around the surface of the connecting rod 6 and the lower surface of the block body 51, forming a complete enclosure similar to a jointed tubular shape with respect to the connecting rod 6, and a smooth through hole 511 is made in the projection portion of the through hole in the block body 51, fixing the connecting rod 6 in the manner of an elastic clamp similar to a hold hoop. This structure allows for strong fixing of the connecting rod 6, which is not in close contact with the bone surface. The widths of the two upper and lower concave arc surfaces of the rod clamp frame 522 need to be set so that, after the tile-type disassemblable gasket 23 embedded between the rod clamp frame 522 and the connecting rod 6 is disassembled and absorbed, it can form only a gap in the compression direction, i.e., a gap coaxial or nearly coaxial with the bone joint nail 4.
[0057] Furthermore, the rod clamp arm 52 of the connecting block 5 is adjacent to the through hole 511, and the axes of the two are perpendicular or nearly perpendicular but do not intersect. The rod clamp arm 52 may be one or two, each positioned on either side of the through hole 511, and a connecting block 5 with two rod clamp arms 52 can clamp two parallel connecting rods 6, thereby strengthening the fixation of the fracture.
[0058] Furthermore, the connecting block 5 can employ five structural modes: single-rod pressing type, single-rod clamp type, double-rod pressing type, double-rod clamp type, and a combination of rod pressing and clamping. The through-holes 511 of each structural mode can be further divided into two types: a hole without threads and a screw hole type, and each was used in combination with the following three types of bone-fixing nails 4.
[0059] As shown in Figure 22, the bone fixation nail 4 consists of a front graft portion 41 and a rear lock portion 43. The graft portion 41 preferably has the shape of a bone fixation screw thread and can be embedded in the bone, and the lock portion 43 is connected to the connection block 5.
[0060] The locking portion 43 has three structural configurations.
[0061] As shown in Figures 10 to 13, the first type of structure of the locking portion 43 is an integrated conventional nail head 491 having a diameter larger than the diameter at the smallest part of the smooth through hole 511 of the connecting block 5 and having a screwdriver joint 1 45 at its rear end, the integrated conventional nail head 491 having a lower spherical surface that matches the upper spherical surface of the through hole 511.
[0062] As shown in Figures 14 to 17, the second type of structure of the locking part 43 is an assembled conventional nail head 492, which consists of a threaded rod with a screwdriver joint 2 46 on its rear end face and a crimping nut 44 that matches the threaded rod in a shape similar to an integrated conventional nail head 491, wherein the crimping nut 44 has a lower spherical surface that matches the upper spherical surface of the smooth through hole 511 of the connecting block 5 and has a screwdriver joint 3 47, and the bone fixation nail 4 having this structure also has a bare rod-shaped limiting part 42 that is approximately equal to the graft part 41 between the locking part 43 and the graft part 41, thereby limiting the depth of the bone fixation nail 4 embedded in the bone, and the assembled conventional nail head 492 has the same shape and function as the integrated conventional nail head 491, but the bone fixation nail 4 is first embedded, and then the positions of the connecting rod 6 and connecting block 5 can be determined according to the position and axial direction of the bone fixation nail 4. The operation is more flexible and free.
[0063] As shown in Figures 18 and 19, the third type of structure of the locking portion 43 is a locking nail head 493 that coincides with the screw hole 13 of the connecting block 5 and has a screwdriver joint 4 48 on its rear end face.
[0064] Therefore, the present invention allows for the flexible application of 15 different combination methods, formed from different types of connecting blocks 5 and bone fixation nails 4, to fracture fixation according to the needs during surgery, forming multiple different embodiments, and Figures 20 and 21 show some examples of combination forms.
[0065] Furthermore, as shown in Figures 23 to 28, the connecting block 5 can also be formed by overlapping a hook sheet 53 and a nail sheet 54. The hook sheet 53 constitutes the lower half of the connecting block 5, and the nail sheet 54 constitutes the upper half of the connecting block 5. The joining surfaces of the hook sheet 53 and the nail sheet 54 are fitted together, and the contact surfaces between them have a rough structure that helps to increase friction. The hook sheet 53 has the rod clamp arm 52 and the lower half of the through hole 511. The through hole 511 of the hook sheet 53 is circular or elliptical in shape for the nail body of the bone-jointing nail 4 to pass through. The nail sheet 54 has the upper half of the through hole 511. The through hole 511 of the nail sheet 54 is a mating surface that fits with the nail head or locking portion of the bone-jointing nail 4, such as a cylindrical surface or a circular table surface, and is preferably spherical or threaded. The nail sheet 54 may further have the rod clamp arm 52, and the rod clamp arm 52 of the nail sheet 54 and the rod clamp arm 52 of the hook sheet 53 are each positioned on either side of the through hole 511, preferably the rod clamp arm 52 connected to the hook sheet 53 is of the rod pressing type and the rod clamp arm 52 connected to the nail sheet 54 is of the rod clamp type. This spliced connection block 5 is more convenient for adjusting the fixing position and direction of the bone fixation nail 4, is better adapted to complex and changing clinical situations, and enriches the combination method of the present invention.
[0066] The operating mechanism of this embodiment will be explained below by referring to Figure 29 as an example.
[0067] When the connecting rod 6 is fixed to the fractured bone with multiple bone fixation nails 4 through the through holes 511 on the connecting block 5, the bone fixation nails 4, the connecting block 5, the connecting rod 6, and the two fractured ends A1 and A2 on both sides of the fracture line A3 can be connected to form a single rigid fracture / fixation complex.
[0068] By inserting the same number of bone fixation nails 4 one by one through the through holes 511 in the connecting block 5 and screwing them into the skeleton, and tightening the bone fixation nails 4, the connecting rod 6 and the fractured bones A1 and A2 can be connected via the connecting block 5 and bone fixation nails 4 to form a single rigid fracture / fixation complex. To achieve the self-conversion of fracture fixation from initial rigid fixation to axial non-rigid fixation, the present invention employs a method of embedding a biodegradable gasket 2 made of a rigid biodegradable biomaterial between the connecting block 5 and the connecting rod. As shown in Figures 10, 12, 14, 16, 18 and 24, the biodegradable gasket 2 is a tile-like biodegradable gasket 23 that is backed between the rod clamp arm 52 and the connecting rod 6, and its cross-section is a shallow arc less than a semicircle. Furthermore, the tile-type biodegradable gasket 23 can be installed in a shape that folds upward, with one or both ends slightly longer than the connecting block 5, to facilitate installation, and the amount of biodegradable metal used can be increased to form a more concentrated metal ion microenvironment at the bone fracture site, which is beneficial for antibacterial, anti-inflammatory, and bone healing at the bone fracture site.
[0069] After embedding the tile-type disassemblable gasket 23 between all the connecting blocks 5 and connecting rods 6 positioned at the proximal fracture end A2, the connecting blocks 5, connecting rods 6, bone fixation nails 4 and the fractured bone form a rigidly connected fracture / fixation complex in the initial stages of fixation, the entire nail-rod system still forms a stable static fixation in the initial stages of fixation, and the fracture / fixation complex remains a stable rigid structure. After the tile-type biodegradable gasket 23 is gradually decomposed and absorbed in the body, gaps gradually form between all the connecting blocks 5 and connecting rods 6 on the proximal fracture end A2 side, and the connections between them gradually loosen accordingly. However, the positional relationship between the bone fixation nail 4 and the proximal fracture end A2 remains rigid, and only the connection between the connecting block 5 and the connecting rod 6 becomes a gap fit. The connecting block 5, whose position is restricted by the bone fixation nail 4, can also slide only axially along the connecting rod 6. In other words, the connection between the connecting block 5 and the connecting rod 6 becomes an axially non-rigid connection, and the fixation of the entire nail-rod system gradually changes to an axially non-rigid dynamic fixation.
[0070] During surgery, the connecting rod 6 is positioned across the fracture line A3 on the surfaces of the distal fracture end A1 and the proximal fracture end A2, and at least two connecting blocks 5 are placed on each fracture end as needed. The connecting block 5 fixed to the distal fracture end A1 is directly connected and fixed to the connecting rod 6, and a tile-type disassemblable gasket 23 is backed between the connecting block 5 fixed to the proximal fracture end A2 and the connecting rod 6. The proximal fracture end, to which the tile-type disassemblable gasket 23 has been added, needs to penetrate the bone fixation nail 4 of the connecting block 5 and be distributed as far as possible to both sides of the connecting rod 6. In this way, after the tile-type disassemblable gasket 23 has disassembled and been absorbed, the pressure contact between the linearly contacting circular connecting rod 6 and the arcuate bone surface becomes a loose contact. The connecting rod 6 can slide axially towards the proximal fracture end A2 side together with the distal fracture end A1 that is closer to the proximal fracture end A2 under the action of external force. However, the gaps formed between the two or more connecting blocks 5 and connecting rod 6 fixed to the proximal fracture end A2 are in different directions in the cross-section of the connecting rod 6. At this time, the connecting rod 6 loses the radial compression applied by the connecting blocks 5, but can obtain radial micro-movement in the same direction as the pressure. However, the two or more connecting blocks 5 positioned at the same proximal fracture end A2 allow the connecting rod 6 to micro-move in different radial directions, so they restrict each other, and therefore there is no radial micro-movement that does not promote fracture union between the proximal fracture end A2 and the distal fracture end A1.
[0071] Furthermore, as shown in Figure 30, in order to prevent axial slippage from occurring beyond a 1 mm range that does not promote bone healing in unstable fractures such as oblique fractures and comminuted fractures, the present invention also designs a stopper 7 that limits the range of movement of the connecting rod 6. Preferably, the stopper 7 is a U-shaped hoop that can be inserted into the connecting rod 6, the width of which is greater than or equal to the diameter of the connecting rod 6, and one free end side wall of the stopper 7 has a set screw 72 directed toward the connecting rod 6 and a corresponding set screw hole 71 to prevent the connecting rod 6 from falling out or being displaced. The stopper 7 can be fixed to the connecting rod 6 by clamping it to the connecting rod 6 and by the set screw 72 passing through the set screw hole 71 and contacting the connecting rod 6. When the stopper 7 moves axially with the connecting rod 6 and hits the connecting block 5, it can prevent the connecting rod 6 from continuing to move in that direction. By attaching one of the stoppers 7 to one side of any one of the connecting blocks 5 to which the tile-type disassemblable gasket 23 has been added, the unidirectional axial movement of the entire fracture / fixation complex toward the opposite side can be restricted, and the range of that axial movement can be predetermined. If the stoppers 7 are attached to both sides of the connecting block 5, the axial movement of the entire fracture / fixation complex toward both sides can be restricted, and the range of that axial movement can be predetermined.
[0072] The biodegradable gasket 2 in the above-mentioned Examples 1 to 5 of the present invention is manufactured from a biodegradable metallic magnesium or zinc, or a composite composed of magnesium and zinc, or a composite composed of magnesium and polylactic acid coated on its exterior, or a composite composed of zinc and polylactic acid coated on its exterior, or a composite composed of a magnesium and zinc and polylactic acid coated on its exterior. The biodegradable gasket may be a complete gasket, or gaskets made of several layers of the same composite material or several layers of different composite materials may be stacked and used to control the rate of decomposition.
[0073] The above embodiments are preferred embodiments of this application and do not exhaustively cover other embodiments. Accordingly, modifications, equivalent substitutions, and improvements made by using the contents of the specification and drawings disclosed herein are within the scope of protection of this application.
[0074] The embodiments of the present invention present preferred embodiments, but are not limited thereto. Those skilled in the art will find it very easy to understand the spirit of the invention through the above embodiments and to make different extensions and modifications, which will remain within the scope of the invention as long as they do not deviate from the spirit of the invention. [Explanation of Symbols]
[0075] 1-Slide block, 1(a)-Multi-hole slide block, 1(b)-Single-hole slide block, 11-Keyway, 12-Nail through hole for bone joint, 13-Side wall, 14-Projection, 15-Deformed joint, 2- Degradable gaskets, 21- Embedded degradable gaskets, 22- Lay-on degradable gaskets, 23- Tile-type degradable gaskets, 20- Non-degradable gaskets, 3-Osteointegration plate, 31-Through groove, 32-Key pin hole, 33-Key pin, 34-Inner wall, 35-Groove area, 36-Groove, 37-Groove bottom, 38-Through hole, 4-Bone joint nail, 41-Transplant section, 42-Restriction section, 43-Locking section, 44-Crimping nut, 45-Driver joint 1, 46-Driver joint 2, 47-Driver joint 3, 48-Driver joint 4, 49-Nail head, 491-Integrated standard nail head, 492-Assembly type standard nail head, 493-Locking nail head, 5-Connecting block, 51-Block body, 511-Through hole, 52-Rod clamp arm, 521-Rod pressing frame, 522-Rod clamp frame, 53-Hook sheet, 54-Nail sheet, 6 - Connecting rods, 7-Stopper, 71-Set screw hole, 72-Set screw, a- Center of oscillation of the bone fixation nail, b- Angle of oscillation of the bone fixation nail, c- Horizontal adjustment distance of the bone fixation nail, A1-Distal fracture end, A2-Proximal fracture end, A3-Fracture line
Claims
1. A skeletal fixation system comprising a bone fixation bridge that fixes bones with bone fixation nails via connecting members, wherein the bone fixation bridge spans both sides of a fracture line and is positioned on the surface of the skeleton on both sides of the fracture line, and the bone fixation nails at one bone fracture end, which is one of the skeletons on both sides of the fracture line, fix the skeleton to the bone fixation bridge directly or via the connecting members, and the bone fracture end on the other side, which is the other skeleton on both sides of the fracture line, fixes the skeleton to the bone fixation bridge via the connecting members using the bone fixation nails, The bone-fixing bridge is a plate-shaped bone-fixing plate, and the bone-fixing plate includes bone-fixing nail through holes and sliding grooves. The connecting member is a slide block embedded in the slide groove of the bone fixation plate, and the slide block is provided with at least one bone fixation nail through hole. The side walls of the slide block are smooth planes, the side walls of the slide block and the inner walls of the slide groove engage using a contact surface method, the slide block fixed to the other bone fracture end and the slide groove have a sliding gap in the longitudinal direction of the bone fixation plate, a biodegradable gasket made of a rigid biodegradable biomaterial fills the sliding gap, the biodegradable gasket is an embedded biodegradable gasket, the bone fixation nails are connected to the bone fixation plate via bone fixation nail through holes in the bone fixation plate and bone fixation nail through holes in the slide block connected to the bone fixation plate with smooth ordinary nail heads or screw-type locking nail heads, The bone fixation nails, connecting members, disassemblable gaskets, bone fixation plates, and the one bone fracture end and the other bone fracture end fixedly connected to the bone fixation plate constitute a stable fracture / fixation complex in the initial stages of fixation, forming stable static fixation. Even if the biodegradable gasket is gradually broken down and absorbed into the body, the positional relationship between the bone fixation nail and bone fixation plate and the bone on one side of the bones on either side of the fracture line fixed thereto remains a fixed structure. When the biodegradable gasket is gradually decomposed and absorbed into the body, a gap is created between the connecting member and the bone fixation plate where the biodegradable gasket was located, allowing the skeleton on both sides of the fracture line, which is restrained by the bone fixation plate, the connecting member, and the bone fixation nails, to slide along the bone fixation plate in the longitudinal direction of the bone fixation plate under the action of an external force. A skeletal fixation system characterized by the following:
2. The slide groove is a through groove that penetrates the surface of the bone joint plate, a keyway is made in one or both side walls of the slide block, a key pin hole is made in the side wall of the slide groove corresponding to the keyway, the length of the keyway, which is installed along the longitudinal direction of the slide block, is greater than the diameter of the key pin, allowing both the key pin and the keyway to move relative to each other, the key pin is fixedly connected to the key pin hole, extends into the keyway to restrict the movement of the slide block, and allows it to perform only longitudinal translational motion within the through groove. The skeletal fixation system according to claim 1.
3. The aforementioned slide groove is a groove that does not penetrate the surface of the bone joint plate, and the slide block is embedded in the groove. A through hole is provided at the bottom of the groove, and the through hole is larger than the diameter of the bone fixation nail, so that as the embedded disassemblable gasket gradually disassembles, the slide block and the skeletal fracture end can move longitudinally along the through hole together with the bone fixation nail. A removable, lay-down type disassembly gasket, which has the same shape as the bottom surface of the slide block, is further installed between the bottom of the slide block and the groove. After the bone-fixing nails are fastened into the frame by passing through the bone-fixing nail through-holes on the slide block and the lay-down type disassembly gasket, the connection between the slide block and the bone-fixing plate becomes a fixed connection. The skeletal fixation system according to claim 1.
4. A skeletal fixation system comprising a bone fixation bridge that fixes bones with bone fixation nails via connecting members, wherein the bone fixation bridge spans both sides of a fracture line and is positioned on the surface of the skeleton on both sides of the fracture line, and the bone fixation nails at one bone fracture end, which is one of the skeletons on both sides of the fracture line, fix the skeleton to the bone fixation bridge via the connecting members, and the bone fracture end on the other side, which is the other of the skeletons on both sides of the fracture line, fixes the skeleton to the bone fixation bridge via the connecting members using the bone fixation nails, The bone-fixing bridge is a rod-shaped connecting rod, the connecting member includes a connecting block, the connecting block has a through hole for the implantation portion of a bone-fixing nail to pass through and a rod clamp arm for fixing the connecting rod, the connecting rod is fixed to the outer surface of the skeleton by the bone-fixing nail implanted in the bone through the through hole of the connecting block after the rod clamp arm of the connecting block has restrained the connecting rod, a biodegradable gasket made of a rigid biodegradable biomaterial is backed between the rod clamp arm and the connecting rod to prevent the rod clamp arm from directly pressing the connecting rod, the bone-fixing nail, the connecting block and the connecting rod, or the biodegradable gasket and the two skeletal fracture ends of the skeleton they fix together constitute a fracture / fixation complex. The bone fixing nail, connecting member, disassemblable gasket, connecting rod, and the one-sided and the other-sided bone fracture ends fixedly connected to the connecting rod constitute a stable fracture / fixation complex in the initial stages of fixation, forming stable static fixation. When the biodegradable gasket is gradually decomposed and absorbed into the body, a gap is created between the connecting member and the connecting rod where the biodegradable gasket was located, allowing the skeleton on both sides of the fracture line, which is restrained by the connecting rod, the connecting member, and the bone-fixing nail, to slide along the connecting rod in the longitudinal direction of the connecting rod under the action of an external force. A skeletal fixation system characterized by the following:
5. The block body of the connecting block is either a single unit or a combination of a hook sheet and a nail sheet. When the connecting block is a combination of a hook sheet and a nail sheet, the hook sheet constitutes the lower half of the connecting block and includes the rod clamp arm and the through hole, the through hole being circular or oval in shape through which the bone-fixing nail can pass. The nail sheet constitutes the upper half of the connecting block and includes a through hole and mating surface that aligns with the locking portion of the bone-fixing nail. The nail sheet further includes the rod clamp arm, and the rod clamp arm of the nail sheet and the rod clamp arm of the hook sheet are each positioned on either side of the through hole. The skeletal fixation system according to claim 4.
6. The longitudinal sliding distance of the bone-fixing bridge of the slide block is limited to 0.2 to 1 mm, the thickness of the embedded disassemblable gasket is 0.2 to 1 mm, and the thickness of the laid disassemblable gasket is 0.1 to 0.5 mm. The aforementioned decomposable gasket is either a gasket made of one type of material, or a composite gasket made of multiple types of materials laminated in multiple layers to control the decomposition rate, or a composite gasket made of multiple types of materials is used, and gaskets of different types of composite materials are laminated in multiple layers. The biodegradable gasket consists of a biodegradable metallic magnesium or zinc, or a composite made of biodegradable magnesium and zinc, or a composite made of biodegradable magnesium and a biodegradable polylactic acid coating on its exterior, or a composite made of biodegradable zinc and a biodegradable polylactic acid coating on its exterior, or a composite made of biodegradable magnesium and zinc and a biodegradable polylactic acid coating on its exterior. The skeletal fixation system according to claim 1.