An artificial lamina for posterior spinal reconstruction and a method of making the same

Abstract

This invention relates to an artificial vertebral lamina for posterior spinal reconstruction and its preparation method. The artificial vertebral lamina comprises: an integrally formed rectangular plate and a biomimetic spinous process; the biomimetic spinous process is disposed on one side of the rectangular plate, and a through groove is provided on the side of the rectangular plate away from the biomimetic spinous process, wherein the axis of the biomimetic spinous process, the axis of the through groove, and the center line of the rectangular plate overlap; the roughness of the side of the rectangular plate with the through groove is less than the roughness of the side with the biomimetic spinous process; a plurality of first through holes are symmetrically arranged on the rectangular plate on both sides of the biomimetic spinous process, and a plurality of second through holes are uniformly distributed on the biomimetic spinous process; the diameter of the plurality of first through holes is smaller than the diameter of the plurality of second through holes. This device has the advantages of simple structure, no need for assembly, and high stability of spinal reconstruction.

Description

Technical Field

[0001] This invention belongs to the field of medical assistive device technology, specifically relating to an artificial vertebral lamina for posterior spinal structure reconstruction and its preparation method. Background Technology

[0002] An artificial lamina (AL) is a medical implant used in spinal surgery, primarily to repair vertebral laminae defects caused by laminectomy or other reasons. It aims to restore spinal stability and prevent postoperative complications such as epidural fibrosis, scar tissue formation, and spinal instability. The design of an artificial lamina must conform to the physiological morphology and functional anatomy of the human vertebral lamina, while also possessing biocompatibility, inducing new bone formation over time without causing adverse reactions to achieve bony fusion. Currently, there are no commercially available artificial lamina products; reconstruction mainly relies on replantation of autologous bone plates or allogeneic bone plates. This method suffers from complex structures and numerous fixation components, leading to unstable spinal reconstruction results and increasing the risk of postoperative secondary injury. Therefore, there is an urgent need to provide a new artificial lamina to overcome these problems. Summary of the Invention

[0003] To address the aforementioned problems in the prior art, this invention provides an artificial vertebral laminar plate for posterior spinal structure reconstruction and its preparation method. The technical problem to be solved by this invention is achieved through the following technical solution: In a first aspect, the present invention provides an artificial vertebral lamina for posterior spinal structure reconstruction, comprising: an integrally formed rectangular plate and a biomimetic spinous process; the biomimetic spinous process is disposed on one side of the rectangular plate, and a through groove is provided on the side of the rectangular plate away from the biomimetic spinous process, wherein the axis of the biomimetic spinous process, the axis of the through groove, and the center line of the rectangular plate overlap; the roughness of the side of the rectangular plate with the through groove is less than the roughness of the side with the biomimetic spinous process; a plurality of first through holes are symmetrically disposed on the rectangular plate on both sides of the biomimetic spinous process, and a plurality of second through holes are uniformly distributed on the biomimetic spinous process; the aperture of the plurality of first through holes is smaller than the aperture of the plurality of second through holes.

[0004] In some embodiments, the biomimetic spinous process is composed of a first surface, a second surface, a third surface, a fourth surface, a fifth surface, and a sixth surface; wherein the sixth surface is attached to the upper surface of the rectangular plate; the first surface and the second surface have the same structure and are mirror images of each other along the two sides of the rectangular plate; the fourth surface and the fifth surface have the same structure and are mirror images of each other between the first surface and the second surface; the third surface is located on the side of the first surface away from the rectangular plate to connect the first surface and the second surface; wherein the third surface and the sixth surface are both rectangular, and the area occupied by the third surface is smaller than the area occupied by the sixth surface; the fourth surface is composed of a straight surface and a curved transition surface, and the curved transition surface is in contact with the upper surface of the rectangular plate; the junction of the third surface with the first surface and the second surface is a circular arc transition.

[0005] In some embodiments, the height of the biomimetic spinous process ranges from 2.5cm to 3.5cm, the width of the third surface ranges from 2mm to 5mm, and the radius of the rounded corner at the junction of the curved transition surface of the fourth surface and the upper surface of the rectangular plate is greater than 3mm.

[0006] In some embodiments, the plurality of second through holes are arranged in a rectangular uniform hole array of M*N on the fourth and fifth surfaces of the biomimetic spinous process, wherein M and N are both positive integers.

[0007] In some embodiments, the diameter of each second through hole ranges from 1.5mm to 2.5mm, and the interval between two adjacent second through holes is greater than or equal to 5mm, and the distance between the second through hole closest to the edge of the bionic spinous process and the edge of the bionic spinous process is greater than or equal to 5mm.

[0008] In some embodiments, a plurality of the first through holes are arranged in a rectangular non-uniform hole array on one side of the biomimetic spinous process.

[0009] In some embodiments, the distance between any two first through holes is greater than 0.5 mm, and the diameter of each first through hole ranges from 0.3 mm to 1.2 mm.

[0010] In some embodiments, the width of the through groove ranges from 12mm to 17mm, and the roughness ranges from 0.5μm to 2μm.

[0011] In some embodiments, the rectangular plate and the biomimetic spinous process are both made of metallic materials or polymeric materials, wherein the metallic material is one of titanium alloy and tantalum alloy, and the polymeric material is one of PEEK and PEKK.

[0012] In a second aspect, the present invention provides a method for preparing an artificial vertebral lamina for posterior spinal structure reconstruction, the method being used to prepare the artificial vertebral lamina described in the first aspect above; the method comprising: Using 3D printing, a one-piece rectangular plate and a biomimetic spinous process are fabricated. Both the rectangular plate and the biomimetic spinous process are made of either a metal or a polymer. The metal is either a titanium alloy or a tantalum alloy, and the polymer is either PEEK or PEKK. A through groove is provided on the side of the rectangular plate away from the biomimetic spinous process. The axis of the biomimetic spinous process, the axis of the through groove, and the centerline of the rectangular plate overlap. The roughness of the side with the through groove is less than the roughness of the side with the biomimetic spinous process. Several first through holes are symmetrically arranged on both sides of the biomimetic spinous process, and several second through holes are provided on the biomimetic spinous process. The through groove is then sequentially ground and polished to obtain the artificial vertebral lamina.

[0013] Compared with the prior art, the beneficial effects of the present invention are as follows: To address the problems of existing artificial vertebral laminae, such as complex structures and numerous fixation devices leading to unstable spinal reconstruction results and increased risk of postoperative secondary injury, this invention provides an artificial vertebral laminae for posterior spinal structure reconstruction and its preparation method. This artificial vertebral laminae consists of an integrally molded rectangular plate and a biomimetic spinous process. Both the rectangular plate and the biomimetic spinous process are made of metallic or polymer materials, which solves the problem of insufficient material sources for artificial vertebral laminae and avoids rejection reactions in the human body, ensuring high reliability. Furthermore, the side of the rectangular plate away from the biomimetic spinous process is designed with... The presence of through-grooves improves the smoothness of the side with the grooves, preventing cell adhesion, reducing the complexity of secondary surgeries, and decreasing the likelihood of postoperative secondary damage. Furthermore, the presence of several first through-holes on the rectangular plate facilitates effective ingrowth of new bone and muscle tissue, achieving bony fusion, reducing the formation of early dead space, and improving the stability of the vertebral lamina. Additionally, the presence of several second through-holes on the bionic spinous process reduces edge stress concentration at the top of the bionic spinous process and facilitates surgical suturing. The design boasts advantages such as simple structure, no need for assembly, and high stability in spinal reconstruction. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of the structure of an artificial lamina for posterior spinal reconstruction provided in an embodiment of the present invention; Figure 2 This is a front view of an artificial vertebral lamina for posterior spinal structure reconstruction provided in an embodiment of the present invention; Figure 3 This is a schematic flowchart of the method for preparing an artificial lamina for posterior spinal structure reconstruction provided in an embodiment of the present invention.

[0015] Figure label: 1: Rectangular plate; 2: Bionic spike; 11: First through hole; 12: Through groove; 21: Second through hole. Detailed Implementation

[0016] The present invention will be further described in detail below with reference to specific embodiments, but the implementation of the present invention is not limited thereto.

[0017] In the description of this invention, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0018] The artificial vertebral lamina for posterior spinal structure reconstruction and its preparation method provided by the present invention will now be described in detail with reference to the accompanying drawings.

[0019] Figure 1 This is a schematic diagram of the artificial lamina for posterior spinal structure reconstruction provided in an embodiment of the present invention. Figure 1 As shown, it includes: an integrally formed rectangular plate 1 and a biomimetic spike 2; both the rectangular plate 1 and the biomimetic spike 2 are made of metal or polymer materials, the metal being either titanium alloy or tantalum alloy, and the polymer being either PEEK or PEKK; the biomimetic spike 2 is disposed on one side of the rectangular plate 1, and a through groove 12 is provided on the side of the rectangular plate 1 away from the biomimetic spike 2, wherein the axis of the biomimetic spike 2, the axis of the through groove 12, and the center line of the rectangular plate 1 overlap, and the roughness of the side of the rectangular plate 1 with the through groove 12 is less than the roughness of the side with the biomimetic spike 2; several first through holes 11 are symmetrically disposed on both sides of the rectangular plate 1 on both sides of the biomimetic spike 2, and several second through holes 21 are uniformly distributed on the biomimetic spike 2; the diameter of the several first through holes 11 is smaller than the diameter of the several second through holes 21.

[0020] Here, the thickness of the rectangular plate 1 is between 2mm and 3mm, preferably 2mm. Theoretically, the human spine appears as a straight line when viewed from the front and back, and should exhibit an S-shaped curve when viewed from the side. In actual operation, the length and width of the rectangular plate 1 need to be set according to the specific placement position of the artificial vertebral plate on the human spine. Furthermore, the width of the through groove 12 provided in the rectangular plate 1 ranges from 12mm to 17mm, the groove depth is 1mm to 1.5mm, preferably 1mm, and the roughness ranges from 0.5μm to 1μm. Here, the roughness range of the side of the rectangular plate 1 where the through groove 12 is provided is 0.5μm to 1μm, while the roughness range of the side of the rectangular plate 1 where the bionic spinous process 2 is provided is 2μm to 20μm.

[0021] Here, both the rectangular plate 1 and the biomimetic spinous process 2 are made of metallic materials or polymeric materials. The metallic materials are either titanium alloys or tantalum alloys, and the polymeric materials are either PEEK or PEKK. Alternatively, they can be other polyaryl ether ketone (PAEK) materials such as polyether ether ketone ketone (PEK) or polyether ether ketone ketone (PEEKK), or composite materials formed by polyaryl ether ketone (PAEK) with hydroxyapatite (HA), carbon fiber (CF), bioglass, bioceramics, etc. Using these materials to prepare the artificial vertebral lamina solves the problem of insufficient material sources for artificial vertebral lamina manufacturing, and avoids rejection reactions in the human body, ensuring high reliability.

[0022] During actual installation, the through groove 12 needs to be placed on the spine. By setting the roughness of the side with the through groove 12 to 0.5μm~1μm, it can be ensured that the side with the through groove 12 has a certain smoothness, which can reduce the growth of scar tissue into the spinal canal, prevent secondary spinal stenosis, and avoid adhesion between the artificial lamina and the dura mater, thus reducing the chance of secondary injury after surgery.

[0023] By integrating the rectangular plate 1 and the biomimetic spindle 2, there is no need to consider the assembly error between the two, which has the advantages of simple structure and high stability.

[0024] Figure 2 This is a front view of an artificial vertebral lamina for posterior spinal structure reconstruction provided in an embodiment of the present invention. Figure 1 and Figure 2As shown, the biomimetic spinous process 2 is composed of a first surface, a second surface, a third surface, a fourth surface, a fifth surface, and a sixth surface. The sixth surface is attached to the upper surface of the rectangular plate 1. The first and second surfaces have the same structure and are mirror images of each other on the two sides of the rectangular plate 1. The fourth and fifth surfaces have the same structure and are mirror images of each other between the first and second surfaces. The third surface is located on the side of the first surface away from the rectangular plate 1 to connect the first and second surfaces. Both the third and sixth surfaces are rectangular, and the area occupied by the third surface is smaller than that occupied by the sixth surface. The fourth surface consists of a straight surface and a curved transition surface, and the curved transition surface is connected to the upper surface of the rectangular plate 1. The connection between the third surface and the first and second surfaces is a circular arc transition.

[0025] In other words, the biomimetic spike 2 is narrower at the top and wider at the bottom, and the junction of the biomimetic spike 2 and the rectangular plate 1 is rounded. Specifically, the height of the biomimetic spike 2 ranges from 2.5cm to 3.5cm, the width of the third surface ranges from 2mm to 5mm, and the radius of the rounded corner at the junction of the curved transition surface of the fourth surface and the upper surface of the rectangular plate 1 is (…). Figure 2 The radius (R) is greater than 3mm. Here, the top of the bionic spinous process 2 is set to 2mm~5mm, which can better fit with the adjacent vertebrae and obtain better spinal reconstruction stability.

[0026] Please continue to refer to Figure 1 A plurality of the first through holes 11 are arranged in a rectangular non-uniform hole array on one side of the bionic spinous process 2. For example, three rows of first through holes 11 are provided on one side of the bionic spinous process 2, wherein the first row is closest to the bionic spinous process 2, and the number of first through holes 11 in the first row is 5. The positions of the plurality of first through holes 11 in the third row are aligned with the plurality of first through holes 11 in the first row, and the number is also 5. The plurality of first through holes 11 in the second row are equidistantly interspersed between the first row and the third row.

[0027] Here, the distance between any two first through holes 11 is greater than 0.5 mm, and the diameter of each first through hole 11 ranges from 0.3 mm to 1.2 mm. Taking the first two first through holes 11 in the first row and the first first through hole 11 in the second row as examples, the distance from the first first through hole 11 in the second row to the first first through hole 11 in the first row, or the distance to the second first through hole 11 in the first row, is greater than 0.5 mm.

[0028] Here, several first through holes 11 are provided on the rectangular plate 1, which can realize the effective ingrowth of new bone and the ingrowth and effective attachment of muscle tissue, achieve the effect of bone fusion, reduce the formation of early dead space, and improve the stability of the vertebral lamina.

[0029] Here, a plurality of second through holes 21 are arranged in a rectangular uniform hole array of M*N on the fourth and fifth surfaces of the biomimetic spinous process 2, where M and N are both positive integers. It should be understood that the embodiments of the present invention do not limit the values ​​of M and N, and their specific values ​​can be set according to actual needs. For example, the values ​​of M and N are the same, both being 3.

[0030] Here, the diameter of each second through hole 21 ranges from 1.5mm to 2.5mm, and the distance between two adjacent second through holes 21 is greater than or equal to 5mm. The distance between the second through hole 21 closest to the edge of the bionic spinous process 2 and the edge of the bionic spinous process 2 is greater than or equal to 5mm. In actual use, the operator sutures the artificial vertebral lamina to the desired position by manipulating the suture thread back and forth within several second through holes 21. Furthermore, by setting multiple second through holes 21 on the bionic spinous process 2 and limiting the spacing between the multiple second through holes 21 and the distance from the multiple second through holes 21 to the edge, stress concentration at the edge of the bionic spinous process 2 can be prevented.

[0031] Corresponding to the artificial lamina for posterior spinal structure reconstruction described above, the present invention also provides a method for preparing an artificial lamina for posterior spinal structure reconstruction. Figure 3 This is a schematic flowchart illustrating the preparation method of an artificial lamina for posterior spinal structure reconstruction provided in an embodiment of the present invention. Figure 3 As shown, the preparation method includes: Step 110: Using 3D printing, prepare an integrally formed rectangular plate 1 and biomimetic thorn 2. A through groove 12 is provided on the side of the rectangular plate 1 away from the biomimetic thorn 2. The axis of the biomimetic thorn 2, the axis of the through groove 12 and the center line of the rectangular plate 1 overlap. The roughness of the side with the through groove 12 is less than the roughness of the side with the biomimetic thorn 2. Several first through holes 11 are symmetrically provided on both sides of the biomimetic thorn 2, and several second through holes 21 are provided on the biomimetic thorn 2.

[0032] Here, the roughness range of the side of the rectangular plate 1 with the through groove 12 is 0.5μm~1μm, while the roughness range of the side of the rectangular plate 1 with the biomimetic spike 2 is 2μm~20μm.

[0033] Step 120: Grind and polish the through groove 12 in sequence to obtain the artificial lamina.

[0034] To address the problems of existing artificial vertebral laminae, such as complex structures and numerous fixation devices leading to unstable spinal reconstruction results and increased risk of postoperative secondary injury, this invention provides an artificial vertebral laminae for posterior spinal structure reconstruction and its preparation method. This artificial vertebral laminae consists of an integrally molded rectangular plate and a biomimetic spinous process. Both the rectangular plate and the biomimetic spinous process are made of metallic or polymer materials, which solves the problem of insufficient material sources for artificial vertebral laminae and avoids rejection reactions in the human body, ensuring high reliability. Furthermore, the side of the rectangular plate away from the biomimetic spinous process is designed with... The presence of through-grooves improves the smoothness of the side with the grooves, preventing cell adhesion, reducing the complexity of secondary surgeries, and decreasing the likelihood of postoperative secondary damage. Furthermore, the presence of several first through-holes on the rectangular plate facilitates effective ingrowth of new bone and muscle tissue, achieving bony fusion, reducing the formation of early dead space, and improving the stability of the vertebral lamina. Additionally, the presence of several second through-holes on the bionic spinous process reduces edge stress concentration at the top of the bionic spinous process and facilitates surgical suturing. The design boasts advantages such as simple structure, no need for assembly, and high stability in spinal reconstruction.

[0035] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. An artificial vertebral lamina for posterior spinal structure reconstruction, characterized in that, include: A one-piece molded rectangular plate (1) and a biomimetic spinous process (2); The bionic spike (2) is disposed on one side of the rectangular plate (1), and a through groove (12) is disposed on the side of the rectangular plate (1) away from the bionic spike (2), wherein the axis of the bionic spike (2), the axis of the through groove (12) and the center line of the rectangular plate (1) overlap, and the roughness of the side of the rectangular plate (1) with the through groove (12) is less than the roughness of the side with the bionic spike (2); A plurality of first through holes (11) are symmetrically arranged on the rectangular plate (1) on both sides of the bionic spinous process (2), and a plurality of second through holes (21) are evenly distributed on the bionic spinous process (2); the diameter of the plurality of first through holes (11) is smaller than the diameter of the plurality of second through holes (21).

2. The artificial vertebral laminar plate for posterior spinal structure reconstruction according to claim 1, characterized in that, The biomimetic spinous process (2) is composed of a first surface, a second surface, a third surface, a fourth surface, a fifth surface, and a sixth surface; wherein the sixth surface is attached to the upper surface of the rectangular plate (1), the first surface and the second surface have the same structure and are mirror images of each other on the two sides of the rectangular plate (1), the fourth surface and the fifth surface have the same structure and are mirror images of each other between the first surface and the second surface, and the third surface is located on the side of the first surface away from the rectangular plate (1) to connect the first surface and the second surface; The third and sixth surfaces are both rectangular, and the area occupied by the third surface is smaller than that occupied by the sixth surface; the fourth surface is composed of a straight surface and a curved transition surface, and the curved transition surface is connected to the upper surface of the rectangular plate (1); the third surface is connected to the first and second surfaces by a circular arc.

3. The artificial vertebral laminar plate for posterior spinal structure reconstruction according to claim 2, characterized in that, The height of the biomimetic spinous process (2) ranges from 2.5cm to 3.5cm, the width of the third surface ranges from 2mm to 5mm, and the radius of the rounded corner at the junction of the curved transition surface of the fourth surface and the upper surface of the rectangular plate (1) is greater than 3mm.

4. The artificial vertebral laminae for posterior spinal structure reconstruction according to claim 1, characterized in that, The plurality of second through holes (21) are arranged in a rectangular uniform hole array of M*N on the fourth and fifth surfaces of the biomimetic spinous process (2), wherein M and N are both positive integers.

5. The artificial vertebral laminae for posterior spinal structure reconstruction according to claim 4, characterized in that, The diameter of each second through hole (21) is in the range of 1.5mm to 2.5mm, and the interval between two adjacent second through holes (21) is greater than or equal to 5mm. The distance between the second through hole (21) closest to the edge of the bionic spinous process (2) and the edge of the bionic spinous process (2) is greater than or equal to 5mm.

6. The artificial vertebral laminae for posterior spinal structure reconstruction according to claim 1, characterized in that, The plurality of first through holes (11) are arranged in a rectangular non-uniform hole array on one side of the biomimetic spinous process (2).

7. The artificial vertebral laminae for posterior spinal structure reconstruction according to claim 6, characterized in that, The distance between any two first through holes (11) is greater than 0.5 mm, and the diameter of each first through hole (11) ranges from 0.3 mm to 1.2 mm.

8. The artificial vertebral laminae for posterior spinal structure reconstruction according to claim 1, characterized in that, The width of the through groove (12) ranges from 12mm to 17mm, and the roughness ranges from 0.5μm to 1μm.

9. The artificial lamina for posterior spinal structure reconstruction according to claim 1, characterized in that, The rectangular plate (1) and the biomimetic spinous process (2) are both made of metal or polymer materials. The metal material is either titanium alloy or tantalum alloy, and the polymer material is either PEEK or PEKK.

10. A method for preparing an artificial lamina for posterior spinal structure reconstruction, characterized in that, The preparation method is used to prepare the artificial vertebral lamina according to any one of claims 1 to 9; the preparation method includes: Using 3D printing, an integrally formed rectangular plate (1) and biomimetic thorn (2) are prepared. A through groove (12) is provided on the side of the rectangular plate (1) away from the biomimetic thorn (2). The axis of the biomimetic thorn (2), the axis of the through groove (12) and the center line of the rectangular plate (1) overlap. The roughness of the side with the through groove (12) is less than the roughness of the side with the biomimetic thorn (2). A plurality of first through holes (11) are symmetrically arranged on both sides of the biomimetic thorn (2), and a plurality of second through holes (21) are provided on the biomimetic thorn (2). The through groove (12) is ground and polished in sequence to obtain the artificial vertebral plate.

Images