Device of OLIF (Optical Lumbar Interbody Fusion) approach lumbar fusion cage and fixing piece and manufacturing method

Abstract

The invention provides an OLIF approach lumbar vertebra fusion cage and fixing piece device and a manufacturing method of the OLIF approach lumbar vertebra fusion cage and fixing piece device. According to the device, reinforcing ribs and grids are arranged on a fusion cage, a right upper through hole and a left lower through hole which are vertically and obliquely crossed are formed in the right rear end of the fusion cage, the front end of the exterior of a fixing part body is conical and provided with self-tapping threads, the rear end of the exterior of the fixing part body is provided with external threads, and a stretching mechanism is arranged in the fixing part body. The anti-retreating mechanisms are arranged on the two sides of the front outer portion of the fixing piece body and connected with the stretching mechanism through the medical steel wires. The method comprises the following steps: 1, constructing a model; 2, 3D printing manufacturing; 3, assembling the fixing piece main body; 4, preparing a bone induction factor solution; 5, soaking the fusion cage; 6, disinfection treatment; and 7, storing at low temperature. According to the device, the fusion cage is in threaded connection with the fixing part main body, so that the stability of the fusion cage in the gap between the upper vertebral body and the lower vertebral body is improved, and the postoperative displacement and retreating of the fusion cage are effectively prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of medical device research and development, and in particular to a device and a manufacturing method of an OLIF approach lumbar fusion device and a fixing piece. Background Art

[0002] At present, lumbar fusion has been widely used in the treatment of lumbar degenerative diseases and has achieved satisfactory results. In the past, posterior lumbar fusion surgery was often used in clinical practice, but this surgical method has a high risk of complications. With the advancement of medical technology, minimally invasive technology has begun to be widely used in the field of spinal neurosurgery, and oblique lateral interbody fusion (OLIF) is a new minimally invasive interbody fusion surgery that has received much attention in clinical practice in recent years. Oblique lateral interbody fusion (OLIF) is a popular lumbar minimally invasive technology in the world. It was first introduced by Mayer in 1997. It was not until 2012 that Silvestre first reported and officially named this minimally invasive technology. OLIF surgery uses the anatomical gap between the aorta / inferior vena cava (IVC) and the psoas major muscle to enter the intervertebral disc space, without opening the spinal canal and without damaging the posterior muscles, ligaments and bony structures; at the same time, because it can remove enough intervertebral disc tissue, the contact area between the cage and the end plate is large, which can greatly increase the support strength of the cage. Therefore, the technology and concept of OLIF have been rapidly promoted and applied internationally. The cages currently used in China include the OLIF fusion cage made in the United States by Medtronic, which provides initial stability with lateral inserts; the fusion cage is made of polyaryletherketone (Peek) material with metal inserts, which is very expensive, and the cage also has the phenomenon of slippage. At present, due to the regulation of medical insurance policies in China, such products are generally not used in clinical practice. Domestic products are often split structures, that is, the fusion device and the fixed parts are two separate parts, and the fixing screws used are double-threaded screws, and they also need to be used with an arc frame. However, domestic fusion devices (Cage) have obvious advantages in price, which is only 1 / 3 of the price of imported products. However, due to technical limitations, domestic fusion devices (Cage) still have some defects and installation difficulties.

[0003] At present, the development of fusion devices in OLIF surgery is constantly innovating, but the following problems and difficulties are common: 1. OLIF surgical approach The patient lies on the right side, and a left oblique incision is made through the intermuscular spaces of the external oblique muscle, internal oblique muscle, and transverse abdominal muscle to enter the retroperitoneal space. A working channel is placed between the abdominal aorta and the psoas major muscle, and lumbar discectomy and intervertebral fusion are performed in the channel.

[0004] 2. OLIF treatment of degenerative lumbar spondylolisthesis: Domestic fusion cages may slip, move, and collapse repeatedly in the lumbar vertebrae after installation. In the medical field, "CAGE slippage" refers to the displacement of the intervertebral fusion cage (Cage). Intervertebral fusion cages are mainly used in spinal fusion surgery, such as lumbar or cervical fusion. When the cage slips, it is a relatively serious surgical complication. It may cause nerve compression, causing symptoms such as pain, limb numbness, and weakness, affecting the stability of the spine. In severe cases, reoperation may be required to correct it. The cause of its occurrence may be related to surgical operation, premature excessive activity of patients after surgery, inappropriate fusion selection, and other factors. Once CAGE slippage occurs, the probability of requiring reoperation is high, about 30%-50%. The recovery of patients after reoperation varies depending on individual differences, the interval between the first operation and the reoperation, the degree of slippage, and whether there are complications such as infection. Some patients can relieve symptoms and recover certain spinal functions after reoperation, but some patients may still have residual pain, neurological dysfunction and other problems, and the poor prognosis rate is about 20%-30%.

[0005] 3. Lateral displacement of the fusion device: The oblique lateral spinal fusion fixation system PIVOXTM is based on the classic OLIF fusion device (Cage) with the addition of lateral small screw fixation, but its mechanical strength is far less than that of posterior pedicle screws. The biomechanical stability of posterior screw fixation is stronger than that of lateral plate fixation. Therefore, when rigid fixation and elimination of abnormal movement are required, posterior pedicle screw fixation is generally preferred. The significance of PIVOXTM is more to reduce the lateral displacement of the fusion device, and its stability is not enough to replace posterior pedicle screw fixation.

[0006] The patent application number is 202210236294.2, and the patent name is an invention patent for an OLIF approach lumbar fusion device. The disclosed technical features are that the fusion device body includes: an upper surface, the upper surface extends to both sides thereof; and a lower surface, the lower surface extends to both sides thereof, and the extension direction of the lower surface is the same as the extension direction of the upper surface; and a front side surface, the front side surface extends to both sides thereof, and the extension direction of the front side surface is the same as the extension direction of the upper surface, and the front side surface is a curved surface recessed into the fusion device body; and a rear side surface, the rear side surface extends to both sides thereof, and the extension direction of the rear side surface is the same as the extension direction of the upper surface, and the rear side surface is a curved surface protruding from the fusion device body; the width of the front side surface is greater than the width of the rear side surface. The patent application number is 202310308818.9, and the patent name is OLIF new lateral angle nail plate fixation system. Its technical features include a lateral angle locking steel plate, a locking fusion device is provided on one side of the lateral angle locking steel plate, a sleeve hole is opened on one side of the lateral angle locking steel plate, a fusion device locking screw is movably sleeved on the inner circular wall surface of the sleeve hole, a thread groove is opened on one side of the locking fusion device, and the inner circular wall surface of the thread groove is threadedly connected with the outer circular wall surface of the fusion device locking screw; a fixing component, the fixing component is arranged on one side of the lateral angle locking steel plate, and is used to increase the fixing effect of the lateral angle locking steel plate on the spine, the lower vertebral double-threaded locking screw can maintain a certain inclination angle like the upper vertebral double-threaded locking screw, and then a sleeve is added to the thread groove on the surface during tapping to ensure that the lower vertebral double-threaded locking screw maintains a ten-degree inclination angle and is screwed into the interior of the spine.

[0007] However, many spinal surgeons still have concerns about the safety of OLIF. Studies have shown that the complication rate of OLIF is lower than that of PLIF, but similar to that of mi-TLIF. Some scholars have systematically reviewed the studies on OLIF for the treatment of degenerative lumbar spondylolisthesis and found that the average incidence of OLIF complications was 19%. The most common complications were pain and numbness in the lower limbs on the surgical side and hip flexion weakness, which may be related to the traction and injury of structures such as the iliohypogastric nerve, ilioinguinal nerve, lumbar plexus, and genitofemoral nerve. Other studies have shown that the incidence of hip flexion weakness caused by OLIF is 1.2%-3.0%, and most patients gradually recovered 2 weeks after surgery, and all recovered completely at the last follow-up. The sympathetic chain located in the anterior 1 / 3 of the psoas major muscle at the L1-L4 level is also a structure that is easily damaged by OLIF. Its injury is manifested by a decrease in skin temperature in the lower limbs on the surgical side after surgery, which can generally be cured within a few weeks after surgery. For sympathetic chains that are damaged during OLIF of 3 or more segments, a longer recovery time is required.

[0008] Therefore, the technical personnel of the present application provide a device and a manufacturing method of an OLIF approach lumbar fusion device and a fixing device. Summary of the invention

[0009] The purpose of the present invention is to provide a device and manufacturing method for an OLIF approach lumbar fusion device and a fixing device. The technical problems to be solved by the present invention are: through reasonable design, the fusion device and the fixing device are connected by threads, which solves the problem of multiple approach components and cumbersome process during OLIF approach lumbar surgery; through computer software, a three-dimensional model is constructed and materials are selected according to the design, and a 3D printing device is used to make the model, which solves the technical problem of precision machining; through the stretching mechanism set on the fixing device, the anti-retraction mechanism set on both sides of the fixing device is unfolded, effectively solving the problems of postoperative displacement and withdrawal of the fusion device.

[0010] The design concept of the present invention is: through the redesign of the OLIF approach lumbar fusion device, the energy analysis is performed using computer modeling software, and the external structure of the fusion device, the internal hollow grid support structure, and the two upper and lower staggered oblique through holes with internal threads for rear mounting of the fixing device, as well as the structural design of the fixing device are designed. The model is made using 3D printing equipment, and the material is selected from TC4 titanium alloy (Ti-6Al-4V alloy). The saturated solution of osteoinductive factor (BMP) is prepared by the immersion adsorption method in the prior art, and the fusion device is immersed in the saturated solution of osteoinductive factor (BMP), so that the osteoinductive factor (BMP) covers the inner and outer surfaces of the fusion device. The fixing device is threadedly connected to the two upper and lower staggered oblique holes at the rear end of the fusion device. The interior of the fixing device is hollow, and a stretching mechanism is arranged inside. An anti-retraction mechanism is arranged on the front and outside of the fixing device. The anti-retraction mechanism is connected to the stretching mechanism through medical steel wire. The anti-retraction mechanism arranged on both sides of the fixing device is unfolded to form an angle of 20-30° with the fixing device body. The front end of the fixture is conical and has a self-tapping thread, and the rear end of the fixture is provided with an external thread for connection with the fusion device. The fusion device and the fixture are sterilized by gamma ray radiation (cobalt 60) and then packaged for use.

[0011] To achieve the above object, the technical solution of the present invention is: A device for lumbar fusion device and a fixing device through OLIF approach comprises: a fusion device, a reinforcing rib, a fixing device body, a grid, an upper right through hole, a lower left through hole, a medical steel wire, a self-tapping thread, an internal thread, an external thread, a stretching mechanism, and an anti-retraction mechanism, wherein the stretching mechanism comprises: a pull rod, a rotating block, a connecting block, a fixed shaft, a bearing group, and a rotating nut; the anti-retraction mechanism comprises: an anti-retraction thorn piece, a rotating shaft, a steel wire perforation, and a rotating shaft seat; the fusion device of the device has a trapezoidal shape in appearance, reinforcing ribs are arranged on both sides of the fusion device, a grid is arranged in the hollow part of the fusion device, an upper right through hole and a lower left through hole are arranged at the right rear end of the fusion device, and internal threads are arranged in the upper right through hole and the lower left through hole; the front end of the outer part of the fixing device body is conical and is provided with a self-tapping thread, the rear end of the outer part of the fixing device body is provided with an external thread, and a screwdriver slot is arranged at the tail end; the stretching mechanism is arranged inside the fixing device body, and the anti-retraction mechanism is arranged on both sides of the front outer part of the fixing device body, and the anti-retraction mechanism is connected to the stretching mechanism through the medical steel wire.

[0012] The stretching mechanism in the device is provided with an internal thread at the front section of the fixing body, the bearing group is fixedly installed in the rotating block, a pull rod is fixedly installed on the rotating block, a rotating nut is fixedly installed at the end of the pull rod, a screwdriver slot is provided on the rotating nut, a fixed shaft is fixedly installed on the connecting block, the end of the fixed shaft is fixedly installed in the bearing group, an external thread is provided on the outer surface of the rotating block, the rotating block is threadedly connected to the fixing body, medical steel wires are respectively fixedly installed on the top of the connecting block, and the two medical steel wires pass through the holes provided in the fixing body and are respectively connected to the anti-retraction mechanisms on both sides of the fixing body.

[0013] The anti-retraction mechanism in the device is respectively provided with a rotating shaft seat in the grooves on both sides of the fixing body, the anti-retraction thorn piece is fixed on the rotating shaft, and the two ends of the rotating shaft are respectively installed on the rotating shaft seat, and the anti-retraction thorn piece is provided with a steel wire through-hole, and the medical steel wire passes through the steel wire through-hole and the hole provided in the fixing body to be connected with the connecting block.

[0014] The fusion device, the fixing body, the pull rod, the anti-retraction thorn piece, the rotating block, the connecting block, the fixed shaft, the bearing group, the rotating shaft, the rotating nut and the rotating shaft seat in the device are made of TC4 titanium alloy material by 3D printing equipment.

[0015] A method for manufacturing an OLIF approach lumbar fusion device and a fixing device, the method comprising the following steps: 1. Model building: Use computer software to build a three-dimensional model and select materials based on the structure of the designed fusion device, the main body of the fixing part, the stretching mechanism, and the anti-retraction mechanism. After the three-dimensional model building and material selection are completed, the three-dimensional model and the selected materials are input into the 3D printing equipment; 2. 3D printing: Use the 3DLMP-250 laser metal 3D printing system to print and manufacture the fusion device, the fixing body, the anti-backstab sheet, the bearing group, and the rotating shaft in batches or by custom. At the same time, the pull rod, the rotating block, and the rotating nut are printed and manufactured as a whole. The fixing body and the rotating shaft seat are printed and manufactured as a whole. The connecting block and the fixed shaft are printed and manufactured as a whole. 3. Assembly of the fixing body: embed the printed bearing group into the rotating block, install the fixed shaft on the bearing group, fix the medical wire on the connecting block, install the anti-backward thorn piece on the rotating shaft seat through the rotating shaft, thread the assembled stretching mechanism into the cavity of the fixing body, and connect the medical wire to the anti-backward mechanism through the hole set in the fixing body; 4. Prepare osteoinductive factor solution: add osteoinductive factor to phosphate buffer solution, and prepare osteoinductive factor solution at a temperature of 10-20°C and a pH value of 7.3-7.4 for use; 5. Soaking the fusion device: inject the osteoinductive factor solution prepared in step 4 into the soaking pool, and soak the fusion device in the saturated solution of osteoinductive factor by the soaking adsorption method in the prior art. During the soaking, the temperature is controlled at 10-20°C, and the soaking time is 8-12 hours, so that the osteoinductive factor covers the inner and outer surfaces of the fusion device, so that the fusion device is coated with biological osteoinductive components. After the soaking is completed, take out the fusion device and dry it, and store it at 10-20°C for standby use; 6. Disinfection: Encapsulate the fusion device and the fixing body, and sterilize them by gamma ray radiation (cobalt 60); 7. Low temperature storage: The sterilized fusion device and the fixing body should be stored at 10-20℃ for future use.

[0016] The 3D printing equipment involved in the device is the 3DLMP-250 laser metal 3D printing system produced by Shanghai Shuzao 3D Technology Co., Ltd. It is sterilized using the gamma ray radiation (cobalt 60) sterilization method in the existing technology. The TC4 titanium alloy (Ti-6Al-4V alloy) material, phosphate buffer, and bone induction factor are all mature products in the existing technology.

[0017] Compared with the prior art, the present invention has the following beneficial effects: 1. The fusion device and the fixing part of the device are connected by threads, so that the fusion device and the fixing part of the lumbar spine through OLIF approach become an integrated intervertebral fusion device, which improves the stability of the fusion device body in the gap between the upper and lower vertebrae and prevents the fusion device from shifting and retreating; 2. The device uses computer software to construct a three-dimensional model and select materials according to the design, and uses 3D printing equipment to make the model, solving the technical problems of precision machining; 3. The fusion device, the main body of the fixing part and each assembly part of the device are made of TC4 titanium alloy (Ti-6Al-4V alloy) material and 3D printing, so that the fusion device, the main body of the fixing part and each assembly part have high strength, low density, good corrosion resistance, good weldability and good biocompatibility; 4. The device uses the soaking and adsorption method to soak the fusion device in a saturated solution of osteoinductive factors, so that the osteoinductive factors cover the inner and outer surfaces of the fusion device, so that the fusion device is coated with biological osteoinductive components to promote bone tissue growth; 5. The fusion device and fixing parts of the device are sterilized by gamma ray radiation (cobalt 60). Since the gamma ray radiation (cobalt 60) sterilization method is a cold sterilization method with small temperature changes, the sterilization process does not damage the structure of the bone induction factor, so the biological bone induction component of the fusion device dressing is intact; 6. The fixing part of the device is provided with a stretching mechanism and an anti-retraction mechanism. The stretching mechanism drives the anti-retraction mechanism to expand, which greatly improves the stability of the fusion device body in the gap between the upper and lower vertebrae and effectively prevents the displacement and withdrawal of the fusion device. 7. The device ensures the safety of OLIF approach lumbar spine surgery, improves the efficiency of OLIF approach lumbar spine surgery, reduces the difficulty of surgery, saves surgery time, and avoids the damage caused by secondary surgery; 8. The device has a reasonable structural design, is simple, convenient and practical to operate, reduces economic costs, greatly reduces the cost of surgery and materials, and is suitable for most medical research institutions and hospitals. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technology of the present invention, the drawings required for use in the implementation are briefly introduced. The drawings described below are only exemplary, and for ordinary technicians in this field, other implementation drawings can be derived from the provided drawings without creative work.

[0019] The structures, proportions, sizes, etc. of the drawings shown in this specification are only used to match the contents disclosed in the specification so as to facilitate the understanding and reading of those skilled in the art, and are not used to limit the conditions under which the present invention can be implemented. Any structural modification, change in proportion or adjustment in size should still fall within the scope of the technical contents disclosed in the present invention without affecting the effects and purposes that can be achieved by the technology of the present invention.

[0020] Figure 1 , a schematic diagram of the main structure of the fusion device and the fixing device; Figure 2 , schematic diagram of the top view of the fusion device; Figure 3, a schematic diagram of the right view of the fusion device; Figure 4 , a schematic diagram of the main cross-sectional structure of the fixing part; Figure 5 , a left-side structural diagram of the fixing member; Figure 6 , schematic diagram of the local structure of the stretching mechanism; Figure 7 , a schematic diagram of the structure of the anti-retreat mechanism; Figure 8 ,for Figure 7 A schematic diagram of the local enlarged structure at point A in the middle; Fig. 9 , a flowchart of the manufacturing process of the fusion device and the fixing device.

[0021] In the figure: 1. fusion device, 2. reinforcing ribs, 3. fixing body, 4. grid, 5. upper right through hole, 6. lower left through hole, 7. pull rod, 8. anti-retraction thorn piece, 9. medical steel wire, 10. rotating block, 11. connecting block, 12. self-tapping thread, 13. fixed shaft, 14. bearing group, 15. rotating shaft, 16. rotating nut, 17. internal thread, 18. external thread, 19. steel wire perforation, 20. rotating shaft seat. DETAILED DESCRIPTION

[0022] The technical solution of the present invention is further clearly and completely described below through examples and in combination with the accompanying drawings. The following specific implementation methods are only used to further illustrate the present application and cannot be understood as limiting the scope of protection of the present application. Technical personnel in this field can make some non-essential improvements and adjustments to the present application based on the above application content. Example

[0023] See attached Figure 1-8 , the connection and installation of the fixing body 3, using the 3DLMP-250 laser metal 3D printing system to print the pull rod 7, the rotating block 10, and the rotating nut 16 as a whole, the fixing body 3 and the rotating shaft seat 20 are printed as a whole, and the connecting block 11 and the fixed shaft 13 are printed as a whole. The printed bearing group 14 is embedded in the rotating block 10, and the fixed shaft 13 is fastened to the bearing group 14, while ensuring that the bearing group 14 can rotate freely. The medical steel wire 9 is fixed on the connecting block 11, and the anti-retraction thorn sheet 8 is installed on the rotating shaft seat 20 through the rotating shaft 15. The assembled stretching mechanism is threadedly connected to the cavity of the fixing body 3, and the medical steel wire 9 passes through the holes set in the fixing body 3 and the steel wire perforation 19 and is fixedly connected to the anti-retraction thorn sheet 8 in the anti-retraction mechanism on both sides of the fixing body 3. The assembled fixing body 3 is ready for use.

[0024] The fusion device 1 is printed and manufactured using the 3DLMP-250 laser metal 3D printing system. The manufactured fusion device 1 is divided into large, medium and small sizes to meet the needs of different parts of the lumbar spine surgery via the OLIF approach. The osteoinductive factor is added to the phosphate buffer solution, and the osteoinductive factor solution is prepared at a temperature of 10-20°C and a pH value of 7.3-7.4. The prepared osteoinductive factor solution is injected into the soaking pool, and the fusion device 1 is soaked in the saturated solution of the osteoinductive factor using the soaking adsorption method in the prior art. During the soaking, the temperature is controlled at 10-20°C, and the soaking time is 8-12 hours. The osteoinductive factor is covered on the inner and outer surfaces of the fusion device 1, so that the fusion device 1 is coated with biological osteoinductive components. After the soaking is completed, the fusion device 1 is taken out and dried, and stored at a temperature of 10-20°C.

[0025] The fusion device 1 and the fixing body 3 are packaged and sterilized by gamma ray radiation (cobalt 60). The sterilized fusion device 1 and the fixing body 3 are stored at 10-20°C for future use.

[0026] When in use, the fusion device 1 is placed into the lumbar intervertebral space through the OLIF approach lumbar spine surgery. When the position of the fusion device 1 is confirmed to be correct, the fixing body 3 is respectively drilled into the lumbar vertebrae through the upper right through hole 5 and the lower left through hole 6 through the self-tapping thread 12 on the outer front end cone of the fixing body 3 by surgical tools. When the position of the fixing body 3 is confirmed to be correct, the rotating nut 16 at the end of the pull rod 7 is rotated by surgical tools to make the rotating block 10 threadedly connected in the cavity of the fixing body 3 move toward the end of the fixing body 3. When the rotating block 10 moves, it drives the connecting block 11 to move together. The connecting block 11 pulls the medical wire 9, and the medical wire 9 pulls the anti-retraction thorn sheet 8 to rotate along the rotating shaft 15, so that the anti-retraction thorn sheets 8 on both sides of the front outer side of the fixing body 3 are unfolded and inserted into the lumbar vertebrae at the same time. After confirming that there is no retreat, the subsequent surgical process is completed.

[0027] Example detection results 200 patients were randomly selected as surgical comparison subjects, including 100 subjects for OLIF surgery with new fusion devices and fixation devices, and 100 subjects for OLIF surgery with traditional fusion devices and fixation devices. Among them, 37 subjects for OLIF surgery with new fusion devices and fixation devices were male, 63 were female, and the average age was 68.25±4.58 years. The subjects for OLIF surgery with traditional fusion devices and fixation devices were male, 32 were female, and the average age was 67.35±6.25 years. For specific comparison data, please refer to Tables 1 and 2.

[0028] Table 1: Data of two groups of patients undergoing OLIF surgery with different fusion cages and fixation devices

[0029] Note: ａ Data are expressed as cases (%); ｂ Data It stands for body mass index (BMI).

[0030] Table 2: Comparison of surgical conditions between the two groups of patients ( ,%)surface

[0031] P value < 0.01, statistically significant.

[0032] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the technical essence of the present invention should be included in the protection scope of the present invention.

Claims

1. An OLIF approach lumbar fusion device and a fixation device, comprising: A fusion device (1), a reinforcing rib (2), a fixing body (3), a grid (4), an upper right through hole (5), a lower left through hole (6), a medical steel wire (9), a self-tapping thread (12), an internal thread (17), an external thread (18), a stretching mechanism, and an anti-retraction mechanism, wherein the stretching mechanism comprises: a pull rod (7), a rotating block (10), a connecting block (11), a fixed shaft (13), a bearing group (14), and a rotating nut (16); the anti-retraction mechanism comprises: an anti-retraction thorn sheet (8), a rotating shaft (15), a steel wire perforation (19), and a rotating shaft seat (20), characterized in that: the fusion device (1) of the device has a trapezoidal shape, and the fusion device (1) is Reinforcing ribs (2) are arranged on both sides of the fixing device (1), a grid (4) is arranged in the hollow part of the fusion device (1), an upper right through hole (5) and a lower left through hole (6) are arranged at the right rear end of the fusion device (1) and are obliquely crossed from top to bottom, and internal threads (17) are arranged in the upper right through hole (5) and the lower left through hole (6), the front end of the external part of the fixing device body (3) is conical and is provided with a self-tapping thread (12), the rear end of the external part of the fixing device body (3) is provided with an external thread (18), and a screwdriver slot is arranged at the tail end, a stretching mechanism is arranged inside the fixing device body (3), and anti-retraction mechanisms are arranged on both sides of the front external part of the fixing device body (3), and the anti-retraction mechanism is connected to the stretching mechanism through a medical steel wire (9).

2. The device of lumbar fusion cage and fixing member for OLIF approach according to claim 1, characterized in that: The stretching mechanism in the device is provided with an internal thread (17) at the front section of the fixing body (3), the bearing group (14) is fixedly mounted in the rotating block (10), a pull rod (7) is fixedly mounted on the rotating block (10), a rotating nut (16) is fixedly mounted at the end of the pull rod (7), a screwdriver slot is provided on the rotating nut (16), a fixed shaft (13) is fixedly mounted on the connecting block (11), the end of the fixed shaft (13) is fixedly mounted in the bearing group (14), an external thread (18) is provided on the outer surface of the rotating block (10), the rotating block (10) is threadedly connected to the fixing body (3), and medical steel wires (9) are respectively fixedly mounted on the top of the connecting block (11), and the two medical steel wires (9) pass through holes provided in the fixing body (3) and are respectively connected to the anti-retraction mechanisms on both sides of the fixing body (3).

3. The device of lumbar fusion cage and fixing member through OLIF approach according to claim 1, characterized in that: The anti-retraction mechanism in the device is provided with rotating shaft seats (20) in grooves on both sides of the fixing body (3), the anti-retraction thorn sheet (8) is fixed on the rotating shaft (15), and the two ends of the rotating shaft (15) are respectively mounted on the rotating shaft seats (20), the anti-retraction thorn sheet (8) is provided with a steel wire through hole (19), and the medical steel wire (9) passes through the steel wire through hole (19) and the hole provided in the fixing body (3) to be connected with the connecting block (11).

4. The OLIF approach lumbar fusion device and fixation device according to claim 1, characterized in that: The fusion device (1), the fixing body (3), the pull rod (7), the anti-retraction thorn sheet (8), the rotating block (10), the connecting block (11), the fixed shaft (13), the bearing group (14), the rotating shaft (15), the rotating nut (16), and the rotating shaft seat (20) in the device are made of TC4 titanium alloy material and are manufactured by 3D printing equipment.

5. The method for manufacturing the OLIF approach lumbar fusion cage and fixing member according to claim 1, characterized in that: The method comprises the following steps: (1) Model construction: A three-dimensional model is constructed and materials are selected based on the structure of the designed fusion device (1), the fixing body (3), the stretching mechanism, and the anti-retraction mechanism through computer software. After the three-dimensional model construction and material selection are completed, the three-dimensional model and the selected materials are input into a 3D printing device; (2) 3D printing: using a 3DLMP-250 laser metal 3D printing system to print and manufacture the fusion device (1), the fixing body (3), the anti-spine sheet (8), the bearing group (14), and the rotating shaft (15) in batches or on a custom basis, and at the same time, printing and manufacturing the pull rod (7), the rotating block (10), and the rotating nut (16) as a whole, the fixing body (3) and the rotating shaft seat (20) as a whole, and the connecting block (11) and the fixing shaft (13) as a whole; (3) Assembling the fixing body: the printed bearing group (14) is embedded in the rotating block (10), the fixed shaft (13) is installed on the bearing group (14), the medical wire (9) is fixed on the connecting block (11), the anti-retraction thorn sheet (8) is installed on the rotating shaft seat (20) through the rotating shaft (15), the assembled stretching mechanism is threadedly connected in the cavity of the fixing body (3), and the medical wire (9) passes through the hole set in the fixing body (3) and is connected to the anti-retraction mechanism; (4) Preparation of osteoinductive factor solution: adding osteoinductive factor to phosphate buffer, at a temperature of 10-20° C. and a pH value of 7.3-7.4, to prepare osteoinductive factor solution for use; (5) Soaking the fusion device: injecting the osteoinductive factor solution prepared in step (4) into the soaking pool, and using the soaking adsorption method in the prior art, soaking the fusion device (1) in the saturated solution of the osteoinductive factor. During the soaking, the temperature is controlled at 10-20° C., and the soaking time is 8-12 hours. The osteoinductive factor is covered on the inner and outer surfaces of the fusion device (1), so that the fusion device (1) is coated with biological osteoinductive components. After the soaking is completed, the fusion device (1) is taken out and dried, and stored at a temperature of 10-20° C. for future use; (6) Sterilization: Encapsulating the fusion device (1) and the fixing body (3), and sterilizing them by gamma ray radiation (cobalt 60); (7) Low temperature storage: The sterilized fusion device (1) and the fixing body (3) are stored at a temperature of 10-20°C for future use.

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