CN110464515A - A kind of Invasive lumbar fusion device - Google Patents

Abstract

The present disclosure provides an intervertebral fusion device, the intervertebral fusion device has a hexahedral structure; the top surface and the bottom surface of the intervertebral fusion device are formed with protrusions, and the protrusions are connected with the upper surface and the lower surface of the vertebral joint The shape fits. By providing protrusions on the top and bottom surfaces, the intervertebral fusion device can be better fixed between the vertebrae, preventing horizontal slippage between the intervertebral fusion device and the vertebrae, and helping to improve the stability of the intervertebral fusion device. .

Description

an intervertebral fusion

technical field

The present disclosure relates to the technical field of biomedical materials, in particular to an intervertebral fusion device.

Background technique

The intervertebral fusion cage has functions such as support and load sharing, and can better restore the height of the intervertebral space and the physiological curvature of the spine.

At present, polyether ether ketone (PEEK) material is mostly used in intervertebral fusion cages. However, PEEK, as a material for intervertebral fusion cages, has no biological activity and cannot achieve real fusion with the upper and lower bony endplate tissues. Most of the surfaces are covered with fibers. Tissue coverage is prone to fretting, which in turn affects the biomechanical stability between the vertebral bodies, that is, the stability of the overall structure cannot be guaranteed.

Most of the existing intervertebral fusion devices are composed of a solid frame structure and a through-hole structure. The solid support mostly adopts solid lateral support surfaces or lateral support columns, which will greatly occupy the volume of the fusion cage, resulting in too small porosity of the fusion cage and affecting the effect of bone fusion. The through-hole structure of the existing cage mostly adopts the main through-hole or pore structure on the upper and lower surfaces. If the size of the main through-hole is too large, it will affect the elastic modulus of the cage; The porosity of the upper and lower surfaces or the left and right sides of the fusion device cannot be customized. In the prior art, the fusion cage is not provided with an anti-slip structure, which easily causes problems of loosening and displacement in the later stage of implantation.

public content

(1) Technical problems to be solved

In order to solve the above technical problems, the present disclosure proposes an intervertebral fusion device.

(2) Technical solutions

The present disclosure provides an intervertebral fusion device, the intervertebral fusion device has a hexahedral structure; the top surface and the bottom surface of the intervertebral fusion device are formed with protrusions, and the protrusions are connected with the upper surface and the lower surface of the vertebral joint The shape fits.

(3) Beneficial effects

(1) By setting the protrusions on the top and bottom surfaces, the intervertebral fusion device can be better fixed between the vertebrae, and horizontal slip occurs between the intervertebral fusion device and the vertebrae, which is beneficial to improve the fixation of the intervertebral fusion device stability.

(2) During the surgical operation, the surgical instrument utilizes the instrument hole to operate the intervertebral fusion device, which improves the operation convenience of the operation and the installation accuracy of the intervertebral fusion device.

(3) By setting the pore structure, the pore structure includes multiple through holes, the elastic modulus of the intervertebral cage is close to the elastic modulus of human bone, which can avoid stress shielding, and the porosity reaches 5% to 90%, which is conducive to bone ingrowth The intervertebral fusion device and the fusion of the bone and the intervertebral fusion device are beneficial to improve the operation effect.

(4) The intervertebral fusion cage is made of titanium alloy, which has good biocompatibility and supporting strength.

(5) The pore structure of the intervertebral fusion cage bears the supporting role to maximize the porosity of the intervertebral fusion cage, taking into account the two functions of reducing the elastic modulus and increasing the porosity.

Description of drawings

Fig. 1 is a structural diagram of an intervertebral fusion device according to an embodiment of the present disclosure.

Fig. 2 is a bottom view of an intervertebral fusion device according to an embodiment of the present disclosure.

Fig. 3 is a side view of an intervertebral fusion cage according to an embodiment of the present disclosure.

Fig. 4 is a front view of an intervertebral fusion device according to an embodiment of the present disclosure.

5 is a rear view of an intervertebral fusion cage according to an embodiment of the present disclosure.

【Symbol Description】

1-central hole; 2-protrusion; 3-through hole; 4-instrument hole; 5-top; 6-bottom; 7-front; 8-back; 9-side; 10-plane groove.

Detailed ways

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below in conjunction with the embodiments and the drawings in the embodiments. Apparently, the described embodiments are only some of the embodiments of the present disclosure, not all of them. Based on the embodiments in the present disclosure, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present disclosure.

An embodiment of the present disclosure provides an intervertebral fusion device, as shown in FIG. 1 , the intervertebral fusion device is a hexahedral structure similar to an intervertebral disc.

As shown in FIG. 1 , a central hole 1 is opened in the middle of the intervertebral cage, including: a top surface 5 , a bottom surface 6 , a front surface 7 , a back surface 8 , and two side surfaces 9 . Wherein, the top surface 5, the bottom surface 6, the front surface 7, the back surface 8, and the two side surfaces 9 of the intervertebral fusion device are only for convenience of description, showing that the intervertebral fusion device has six surfaces, which do not constitute any direction to the intervertebral fusion device. limit.

Referring to Fig. 1 and Fig. 2, both the top surface 5 and the bottom surface 6 of the intervertebral cage are provided with protrusions. The protrusion includes a plurality of protrusions 2, and these protrusions 2 are arranged on the top surface 5 and the bottom surface 6 according to certain rules, and conform to the shape of the upper surface and the lower surface of the vertebral joint. The intervertebral fusion device of this embodiment can be applied to various vertebrae including cervical vertebrae, thoracic vertebrae, and lumbar vertebrae.

In this embodiment, the shape of the protrusion 2 is not limited. The plurality of protrusions 2 may be distributed in an orderly manner or in a disordered manner. When the distribution of the protrusions 2 is ordered, the distribution of the protrusions 2 may be uniform or non-uniform. The so-called uniformity refers to whether the distribution density of the protrusions 2 is consistent. The protrusions 2 can be arranged in a two-dimensional array, that is, form a matrix distribution of multiple rows and multiple columns. The shape of the protrusion 2 can be hilly, wavy, pyramidal, boss, circular truncated, cone, pyramid and other structures, and the cross section of the protrusion 2 parallel to the top surface 5 and the bottom surface 6 can be circular, oval, square, strip shapes, triangles, polygons, etc.

The intervertebral fusion device of this embodiment can better fix the intervertebral fusion device between the vertebrae by providing protrusions on the top surface 5 and the bottom surface 6, and place the intervertebral fusion device to slide horizontally between the vertebrae. It is beneficial to improve the stability of intervertebral fusion device fixation.

The intervertebral fusion device of this embodiment, as shown in Fig. 2, Fig. 3 and Fig. 5, the back side 8 of the intervertebral fusion device is an arc surface, and has a plane groove 10, and an instrument hole 4 is opened in the plane groove 10 . The instrument holes 4 are used for inserting surgical instruments. During the operation, the surgical instrument utilizes the instrument hole 4 to operate the intervertebral fusion device, which improves the operation convenience of the operation and the installation accuracy of the intervertebral fusion device.

The intervertebral cage of this embodiment is shown in Fig. 1, Fig. 3 and Fig. 4. The two side faces 9 of the intervertebral cage are also curved surfaces, and the front face 7 is a plane. A front wall is formed between the front face 7 and the central hole 1, and two side walls 9 and the central hole 1 form two side walls respectively. The front wall and the two side walls form a porous structure. The pore structure includes a plurality of through holes 3, which communicate with the central hole 1 of the intervertebral cage.

The plurality of through holes 3 in the pore structure may be distributed in an orderly manner or in a disordered manner. When the through holes 3 are distributed in an orderly manner, the through holes 3 may be distributed uniformly or unevenly. The so-called uniformity refers to whether the distribution density of the through holes 3 is consistent. The through holes 3 may be arranged in a two-dimensional array, that is, form a matrix distribution of multiple rows and multiple columns. The porosity of the front and side walls is 5% to 90%.

In this embodiment, the shape of the through hole is not limited, and the through hole may be a regular shaped hole such as a round hole, a square hole, a rectangular hole, a triangular hole, a polygonal hole, an elliptical hole, or an irregular shaped hole.

In the intervertebral fusion device of this embodiment, by setting a pore structure on the front wall and two side walls, the pore structure includes a plurality of through holes 3, and the elastic modulus of the intervertebral fusion device is close to the elastic modulus of human bone, which can avoid stress shielding , the porosity reaches 5% to 90%, which is beneficial for the bone to grow into the intervertebral fusion device and the fusion between the bone and the intervertebral fusion device, and is beneficial to improve the operation effect.

The structural parameters of the intervertebral fusion device of this embodiment are shown in Table 1.

Table 1

parameter L θ W W_t h H_t D&D_t Value range 11-16mm 0-7° 11-16mm 3-6mm 4-12mm 0.6mm 300-800um

L is the length of the intervertebral cage, that is, the distance from the front 7 to the back 8, which is 11-16mm. The top surface 5 and the bottom surface 6 of the intervertebral cage are not parallel to each other, and the height of the back 8 of the intervertebral cage is greater than the height of the front 7, so that an included angle θ is formed between the top surface 5 and the bottom surface 6, and the range of the included angle θ is 0-7°. The width W of the intervertebral cage is 11-16 mm, and the width refers to the width of the back side 8 . The wall thickness Wt of the intervertebral cage is 3-6mm, and the wall thickness refers to the thickness of the side wall. The height H of the intervertebral cage is 4-12mm, and said height refers to the height of the back side 8 . The height Ht of the protrusions 2 on the top surface 5 and the bottom surface 6 of the intervertebral cage is 0.6 mm. The diameter D of the through holes 3 on the front wall and the side wall is 100-800 μm, and the distance Dt between the through holes 3 is 100 um-1500 um.

In the intervertebral fusion device of this embodiment, each part is integrally formed and prepared by 3D printing. The components of the intervertebral cage are shown in Table 2.

Table 2 (% mass fraction)

As shown in Table 2, the main components of the intervertebral cage are Ti, Al and V. The matrix is Ti, the content of Al is 5.5-6.75%, and the content of V is 3.5-4.5%. Impurities include: Fe, C, N, H, and O, etc. Among them, Fe content≤0.3%, C≤0.08%, N≤0.05%, H≤0.015%, O≤0.2%.

The intervertebral fusion device of this embodiment has a compression stiffness close to the stiffness of human bones, which can reduce the stress shielding effect, and the compression stiffness is 10000-100000 N/mm.

In the intervertebral cage of this embodiment, the pore structures of the front wall and the side wall can also be filled with crystal lattices. The lattice can be integrally formed with the intervertebral fusion cage through 3D printing. In this embodiment, the type of lattice is not limited, and lattices with any structure can be selected from the lattice library. Wherein, the rod diameter of the unit cell is 100-800 μm, and the pore diameter of the unit cell is 100 um-1500 um.

The cost of filling the lattice is low, and the intervertebral fusion device of this embodiment does not need to be re-implanted with human bone by filling the lattice, which can reduce surgical trauma.

The intervertebral fusion device of this embodiment is made of titanium alloy material, which has better biocompatibility and supporting strength. The pore structure of the intervertebral cage bears the supporting role to maximize the porosity of the intervertebral cage, taking into account the two functions of reducing the elastic modulus and increasing the porosity.

It should be noted that, in the accompanying drawings or in the text of the specification, implementations that are not shown or described are forms known to those of ordinary skill in the art, and are not described in detail. In addition, the above definition of each element is not limited to the various specific structures, shapes or methods mentioned in the embodiments, and those skilled in the art can easily modify or replace them, for example:

(1) The directional terms mentioned in the embodiments, such as "up", "down", "front", "back", "left", "right", etc., are only referring to the directions of the drawings, and are not used to limit the protection scope of this disclosure;

(2) The above embodiments can be mixed and matched with each other or with other embodiments based on design and reliability considerations, that is, technical features in different embodiments can be freely combined to form more embodiments.

The specific embodiments described above further describe the purpose, technical solutions and beneficial effects of the present disclosure in detail. It should be understood that the above descriptions are only specific embodiments of the present disclosure, and are not intended to limit the present disclosure. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present disclosure shall be included within the protection scope of the present disclosure.

Claims (8)

1. a kind of Invasive lumbar fusion device, which is characterized in that the Invasive lumbar fusion device is hexahedron structure；The top of the Invasive lumbar fusion device Face and bottom surface are formed with protruding portion, and the upper and lower surfaces shape of the protruding portion and vertebral joint is coincide.

2. Invasive lumbar fusion device as described in claim 1, which is characterized in that the back side of the Invasive lumbar fusion device is provided with instrument hole.

3. Invasive lumbar fusion device as described in claim 1, which is characterized in that the Invasive lumbar fusion device is provided with centre bore, the vertebra Between the positive of fusion device form antetheca between the centre bore, two sides form two side walls with the centre bore respectively； The antetheca and two side walls form pore structure, and the pore structure includes multiple through-holes.

4. Invasive lumbar fusion device as claimed in claim 3, which is characterized in that the porosity of the pore structure is 5% to 90%.

5. Invasive lumbar fusion device as described in claim 1, which is characterized in that the Invasive lumbar fusion device by 3D printing one at Type.

6. Invasive lumbar fusion device as described in claim 1, which is characterized in that the compression stiffness of the Invasive lumbar fusion device is 10000- 100000N/mm。

7. Invasive lumbar fusion device as claimed in claim 3, which is characterized in that the pore structure fills lattice, adjacent cell it Between gap form the through-hole.

8. Invasive lumbar fusion device as claimed in claim 7, which is characterized in that the structure cell bar diameter of lattice is 100~800 μm, structure cell Aperture is 100um-1500um.