Titanium mesh fusion device for spinal intervertebral fusion and preparation method thereof

Abstract

The present invention discloses a titanium mesh fusion device for spinal intervertebral fusion, comprising a first half cylinder and a second half cylinder, wherein the first half cylinder and the second half cylinder are configured to be connected by a buckle. The first half cylinder has a first buckle end, wherein the first buckle end is provided with a convex portion, and the second half cylinder has a second buckle end, wherein the second buckle end is provided with a concave portion, and the first half cylinder and the second half cylinder are configured to be buckled by the cooperation of the convex portion and the concave portion. The present invention adopts a titanium mesh fusion device with a split design, which can reduce the difficulty of implanting the intervertebral space through a smaller surgical field and operating space during spinal tumor surgery, and provides the possibility for minimally invasive surgical operations. The design of the convex portion and the concave portion can ensure that the assembled titanium mesh fusion device has good axial compressive resistance, thereby providing good axial support. At the same time, the design also enables the assembled titanium mesh fusion device to have anti-rotation and anti-shear stress performance.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a titanium mesh fusion device for spinal intervertebral fusion and a preparation method thereof. Background Art

[0002] The treatment of spinal vertebral tumors requires vertebral resection, which often leaves a large defect. A larger titanium mesh fusion device or autologous iliac bone needs to be implanted to maintain the stability of the spine. The implant height is generally around 40-50mm. Although autologous bone is an ideal bone graft material with good bone growth activity and a high fusion rate, it will increase the operation time and intraoperative bleeding, and may cause complications such as infection, pain, and fractures in the bone donor area. The in situ bone grafting method using a titanium mesh fusion device is widely used by spinal surgeons because it is easy to operate, can avoid complications in the bone donor area, and has a high bone graft fusion rate. During the operation, the bone fragments from the subtotal vertebral resection are filled into the titanium mesh fusion device and implanted into the decompression groove, which can effectively reconstruct the physiological curvature of the spine and the intervertebral height, maintain the stability of the lumbar spine, and make full use of the bone fragments after local decompression to achieve the purpose of autologous bone graft fusion.

[0003] However, the existing titanium mesh fusion device is often designed as an integrated device. During surgery, it is necessary to increase the exposure of the surgical site, and it is often necessary to cut off one or two nerve roots before the integrated titanium mesh fusion device can be implanted into the vertebral body. This operation can be achieved in the thoracic spine because the intercostal and subcostal nerves of the thoracic spine are not very important. However, in the lumbar spine, since the nerve roots have the function of controlling the movement and inductive sensation of the lower limbs, if the lumbar nerve roots are cut during surgery, it will cause motor and sensory dysfunction of the lower limbs. If the integrated titanium mesh fusion device is designed as a split type, the split titanium mesh fusion device can be implanted between adjacent nerve roots respectively, which undoubtedly reduces the difficulty of implanting it into the vertebral body, and there is no need to cut off the nerve roots during surgery, thereby avoiding the motor and sensory dysfunction of the lower limbs caused by nerve damage. Summary of the invention

[0004] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is how to reduce the difficulty of implanting a titanium mesh fusion device into the intervertebral space.

[0005] To achieve the above object, the present invention first provides a titanium mesh fusion device for spinal intervertebral bone grafting, comprising a first half cylinder and a second half cylinder, wherein the first half cylinder and the second half cylinder are configured to be connected by a buckle.

[0006] Furthermore, the first half cylinder has a first snap-on end with a convex portion, the second half cylinder has a second snap-on end with a concave portion, and the first half cylinder and the second half cylinder are configured to achieve snap-on connection through cooperation between the convex portion and the concave portion.

[0007] Furthermore, the first half cylinder has a first joint end, which is configured to correspond to the end plate morphology of the upper vertebra; the second half cylinder has a second joint end, which is configured to correspond to the end plate morphology of the lower vertebra; the first joint end and the second joint end are configured to be formed by 3D printing.

[0008] Furthermore, end surfaces of the first joint end and the second joint end have porous structures.

[0009] Further, the first semi-cylinder includes a first fixed body and a first ring body, the first fixed body is located on the first inner surface of the first semi-cylinder, the first ring body is located in the center of the first semi-cylinder, and the first ring body and the first fixed body are connected via a first connecting portion; the second semi-cylinder includes a second fixed body and a second ring body, the second fixed body is located on the second inner surface of the second semi-cylinder, the second ring body is located in the center of the second semi-cylinder, and the second ring body and the second fixed body are connected via a second connecting portion.

[0010] The present invention also provides a method for manufacturing a titanium mesh fusion cage for spinal intervertebral bone grafting and fusion, comprising the following steps:

[0011] (1) A titanium mesh fusion device for spinal intervertebral bone grafting and fusion is provided, comprising a first half cylinder and a second half cylinder, wherein the first half cylinder and the second half cylinder are configured to be connected by a buckle;

[0012] (2) designing the first joint end of the first half cylinder according to the endplate morphology of the upper vertebral body, so that the first joint end corresponds to the endplate morphology of the upper vertebral body; designing the second joint end of the second half cylinder according to the endplate morphology of the lower vertebral body, so that the second joint end corresponds to the endplate morphology of the lower vertebral body;

[0013] (3) The first joint end and the second joint end are printed by 3D printing.

[0014] Furthermore, the first half cylinder has a first snap-on end with a convex portion, the second half cylinder has a second snap-on end with a concave portion, and the first half cylinder and the second half cylinder are configured to achieve snap-on connection through cooperation between the convex portion and the concave portion.

[0015] Furthermore, end surfaces of the first joint end and the second joint end have porous structures.

[0016] Further, the first semi-cylinder includes a first fixed body and a first ring body, the first fixed body is located on the first inner surface of the first semi-cylinder, the first ring body is located in the center of the first semi-cylinder, and the first ring body and the first fixed body are connected via a first connecting portion; the second semi-cylinder includes a second fixed body and a second ring body, the second fixed body is located on the second inner surface of the second semi-cylinder, the second ring body is located in the center of the second semi-cylinder, and the second ring body and the second fixed body are connected via a second connecting portion.

[0017] The present invention also provides a method for assembling a titanium mesh fusion cage for spinal intervertebral fusion, comprising the following steps:

[0018] (1) A titanium mesh fusion device for spinal intervertebral bone grafting and fusion is provided, comprising a first half cylinder and a second half cylinder, wherein the first half cylinder and the second half cylinder are configured to be connected by a buckle;

[0019] (2) filling the first half cylinder and the second half cylinder with bone particles or bone mud in vitro;

[0020] (3) delivering the first half cylinder and the second half cylinder to the site requiring reconstruction through the minimally invasive hole;

[0021] (4) The first half cylinder and the second half cylinder are connected by snap fasteners at the site that needs reconstruction to form a complete titanium mesh fusion device.

[0022] Compared with the prior art, the present invention has the following specific beneficial effects:

[0023] 1. Compared with the integrated titanium mesh fusion device, the present invention adopts a split-type titanium mesh fusion device, which can reduce the difficulty of implanting the device between vertebrae through a smaller surgical field and operating space during spinal tumor surgery, thus providing the possibility for minimally invasive surgical operations.

[0024] 2. The first half cylinder and the second half cylinder are connected by convex and concave parts. The design of the convex and concave parts can ensure that the assembled titanium mesh fusion device has good axial compression resistance, thereby providing good axial support. At the same time, this design also makes the assembled titanium mesh fusion device have the performance of anti-rotation and anti-shear stress.

[0025] 3. After the titanium mesh fusion device is filled with autologous granular bone in vitro, it is implanted into the part that needs reconstruction and assembled at the part. The first half cylinder and the second half cylinder are fitted together, which is conducive to the complete fusion of the bone grafting area. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a schematic diagram of a titanium mesh fusion cage for spinal intervertebral bone graft fusion before assembly according to a specific embodiment of the present invention;

[0027] Figure 2 This is a schematic diagram of an assembly of a titanium mesh fusion cage for spinal intervertebral bone grafting and fusion according to a specific embodiment of the present invention;

[0028] Figure 3 A schematic diagram of a first half cylinder according to a specific embodiment of the present invention;

[0029] Figure 4 It is a schematic diagram of the second half cylinder of a specific embodiment of the present invention. DETAILED DESCRIPTION

[0030] The following describes several preferred embodiments of the present invention with reference to the drawings in the specification, so that the technical content is clearer and easier to understand. The present invention can be embodied in many different forms of embodiments, and the protection scope of the present invention is not limited to the embodiments mentioned in the text.

[0031] In the drawings, components with the same structure are indicated by the same numerical reference numerals, and components with similar structures or functions are indicated by similar numerical reference numerals. The size and thickness of each component shown in the drawings are arbitrarily shown, and the present invention does not limit the size and thickness of each component. In order to make the illustration clearer, the thickness of the components is appropriately exaggerated in some places in the drawings.

[0032] According to a specific embodiment of the present invention, Figure 1 and 2 As shown, the titanium mesh fusion device 1 for spinal intervertebral bone grafting and fusion includes a first half cylinder 11 and a second half cylinder 12. The first snap-fit ​​end of the first half cylinder 11 is provided with a convex portion 111, and the second snap-fit ​​end of the second half cylinder 12 is provided with a concave portion 121. The first half cylinder 11 and the second half cylinder 12 can be snap-connected by cooperating with the convex portion 111 and the concave portion 121 to form a closed titanium mesh fusion device 1.

[0033] Taking lumbar vertebral body tumor resection as an example, the current traditional lumbar tumor resection and reconstruction surgical methods are combined anterior and posterior approaches or simple anterior approaches. In combined anterior and posterior approaches, first the posterior approach is used for pedicle screw internal fixation, and then the anterior approach is used to remove the vertebral body through the pararectus abdominis approach or the retroperitoneal approach, and an integrated titanium mesh fusion device or a large piece of iliac bone is implanted to achieve structural support to maintain the stability of the spine. However, in combined anterior and posterior approaches, it is necessary to turn over and change the position, which not only prolongs the operation time, but also increases the possibility of intraoperative bleeding. In simple anterior approaches, the tumor is exposed and removed in the anterior approach, and an integrated titanium mesh fusion device or a large piece of iliac bone is implanted to complete the structural support. It is also necessary to assist the anterior approach with the fixation of the implanted integrated titanium mesh fusion device or large piece of iliac bone by the anterior approach screw plate system. However, simple anterior approaches increase the risk of intraoperative damage to the ureter, lumbar sympathetic ganglion, and iliac blood vessels, and the commonly used lumbar anterior fixation screw plate system on the market is expensive, about twice the price of the posterior approach pedicle system.

[0034] The implementation of simple posterior approach surgery can overcome the problems existing in traditional lumbar tumor resection and reconstruction surgical methods, but the implementation of simple posterior approach surgery requires the removal of lumbar nerve roots, which have important functions and are involved in controlling the sensation and movement of the lower limbs, so the lumbar nerve roots must be retained during the operation. Therefore, there is a contradiction between the implementation of simple posterior approach surgery and the retention of lumbar nerve roots. In order to resolve this contradiction, the titanium mesh fusion device 1 used in the present invention can be implanted into the intervertebral space through a smaller surgical field and operating space respectively without removing the lumbar nerve roots during the implementation of simple posterior approach surgery. After implantation into the intervertebral space, the first half cylinder 11 and the second half cylinder 12 can be combined together through the convex portion 111 and the concave portion 121 to form a stable structure supported between the vertebrae.

[0035] In another specific embodiment of the present invention, the first end face 112 of the first joint end of the first semi-cylinder 11 is designed and formed by data obtained by three-dimensional scanning of the upper vertebral body, and the upper layer is a porous structure suitable for bone growth. The second end face 122 of the second joint end of the second semi-cylinder 12 is designed and formed by data obtained by three-dimensional scanning of the upper vertebral body, and the upper layer is a porous structure suitable for bone growth. The titanium mesh fusion device 1 completely matches the morphology of the lumbar vertebrae at the implantation site, and can perfectly match the end plates of the upper and lower vertebrae after implantation, which can avoid cutting damage to the end plates caused by traditional titanium mesh fusion devices, protect the end plate structure, and thus avoid sedimentation of the titanium mesh fusion device. The first end face 112 and the second end face 122 are provided with a porous structure, which is conducive to the growth of the host bone at the end plate into the porous structure, so that the titanium mesh fusion device has a good bone integration effect and increases the long-term stability of the titanium mesh fusion device.

[0036] like Figure 3 and 4 As shown, the first semi-cylinder 11 includes a first fixed body 116, a first ring body 115 and a first connecting portion 114. The first fixed body 116 is arranged on the first inner surface 117 of the first semi-cylinder 11. The first ring body 115 is connected to the first fixed body 116 through the first connecting portion 114, which plays a role in fixing the first semi-cylinder. The second semi-cylinder 12 includes a second fixed body 123, a second ring body 125 and a second connecting portion 124. The second fixed body 123 is arranged on the second inner surface 126 of the second semi-cylinder 12. The second ring body 125 is connected to the second fixed column 123 through the second connecting portion 124, which plays a role in fixing the second semi-cylinder.

[0037] During manufacturing, the end plates of the upper and lower vertebrae to be adapted are first subjected to a three-dimensional scan such as CT to obtain the shape data of the end plates of the upper and lower vertebrae, and then the first end face 112 of the first joint end of the first semi-cylinder 11 and the second end face 122 of the second joint end of the second semi-cylinder 12 are manufactured by 3D printing according to the shape data of the end plates of the upper and lower vertebrae. Subsequently, a convex portion 111 is provided at the first buckle portion of the first semi-cylinder 11, and a concave portion 121 is provided at the second buckle portion of the second semi-cylinder 12. The convex portion 111 and the concave portion 121 are matched by buckle connection to form a complete titanium mesh fusion device 1.

[0038] In vitro, bone particles or bone mud are filled into the first half cylinder 11 and the second half cylinder 12, and then the first half cylinder 11 and the second half cylinder 12 are respectively implanted into the part to be reconstructed through the minimally invasive surgical channel, and assembled in vivo through the convex part 111 and the concave part 121 to form a complete titanium mesh fusion device 1. After the first ring body 115 and the second ring body 125 are attached together, the bone grafting area is connected as a whole, and good intervertebral fusion can be achieved.

[0039] The preferred specific embodiments of the present invention are described in detail above. It should be understood that a person skilled in the art can make many modifications and changes based on the concept of the present invention without creative work. Therefore, any technical solution that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the concept of the present invention on the basis of the prior art should be within the scope of protection determined by the claims.

Claims

1. A titanium mesh fusion cage for spinal intervertebral fusion, characterized in that: It includes a first half cylinder and a second half cylinder, the first half cylinder and the second half cylinder are configured to be connected by a snap-fit, the first half cylinder has a first snap-fit ​​end, the first snap-fit ​​end is provided with a convex portion, the second half cylinder has a second snap-fit ​​end, the second snap-fit ​​end is provided with a concave portion, the first half cylinder and the second half cylinder are configured to achieve the snap-fit ​​connection through the cooperation of the convex portion and the concave portion, the first half cylinder has a first joint end, the first joint end is configured to correspond to the end plate morphology of the upper vertebral body; the second half cylinder has a second joint end, the second joint end is configured to correspond to the end plate morphology of the lower vertebral body; the first joint end and the second joint end are configured to be formed by 3D printing.

2. The titanium mesh fusion cage for spinal intervertebral fusion according to claim 1, wherein: End surfaces of the first joint end and the second joint end have porous structures.

3. The titanium mesh fusion cage for spinal intervertebral fusion according to claim 2, wherein: The first semi-cylinder includes a first fixed body and a first ring body, the first fixed body is located on the first inner surface of the first semi-cylinder, the first ring body is located in the center of the first semi-cylinder, and the first ring body is connected to the first fixed body via a first connecting portion; the second semi-cylinder includes a second fixed body and a second ring body, the second fixed body is located on the second inner surface of the second semi-cylinder, the second ring body is located in the center of the second semi-cylinder, and the second ring body is connected to the second fixed body via a second connecting portion.

4. A method for manufacturing a titanium mesh fusion cage for spinal intervertebral fusion, characterized in that: The following steps are involved: (1) A titanium mesh fusion device for spinal intervertebral fusion is provided, comprising a first half cylinder and a second half cylinder, wherein the first half cylinder and the second half cylinder are configured to be connected by a snap-fit ​​connection; (2) designing the first joint end of the first half cylinder according to the end plate morphology of the upper vertebral body, so that the first joint end corresponds to the end plate morphology of the upper vertebral body; designing the second joint end of the second half cylinder according to the end plate morphology of the lower vertebral body. A coupling end, wherein the second coupling end corresponds to the shape of the end plate of the lower vertebral body; (3) printing the first joint end and the second joint end by 3D printing; (4) The first half cylinder has a first snap-on end, the first snap-on end is provided with a convex portion, the second half cylinder has a second snap-on end, the second snap-on end is provided with a concave portion, and the first half cylinder and the second half cylinder are configured to achieve the snap-on connection through the cooperation between the convex portion and the concave portion.

5. The method for manufacturing a titanium mesh fusion cage for spinal intervertebral fusion according to claim 4, wherein: End surfaces of the first joint end and the second joint end have porous structures.

6. The method for manufacturing a titanium mesh fusion cage for spinal intervertebral fusion according to claim 5, wherein: The first semi-cylinder includes a first fixed body and a first ring body, the first fixed body is located on the first inner surface of the first semi-cylinder, the first ring body is located in the center of the first semi-cylinder, and the first ring body is connected to the first fixed body via a first connecting portion; the second semi-cylinder includes a second fixed body and a second ring body, the second fixed body is located on the second inner surface of the second semi-cylinder, the second ring body is located in the center of the second semi-cylinder, and the second ring body is connected to the second fixed body via a second connecting portion.

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