阅读说明：本技术 一种用于垂直骨增量的中空桥墩式支架 (Hollow pier type support for increasing vertical bones ) 是由 张文杰 蒋欣泉 孙宁佳 于 2020-08-31 设计创作，主要内容包括：本发明公开了一种用于垂直骨增量的中空桥墩式支架,其包含：若干个支架单元；支架单元包含：多孔支架和中空支柱；其中,多孔支架包含：多孔的主体、以及作为顶部并且孔径小于主体的多孔顶层；多孔顶层的孔径为20～50μm；中空支柱的上部穿入主体内,并且中空支柱的上部的管壁设有用于与多孔支架连通的连通孔；中空支柱的下部用于固定于颌骨内；使用状态下,成骨相关细胞能够通过中空支柱由颌骨骨髓区迁移至多孔支架。多孔顶层可以限制体积相对较大的成纤维细胞、上皮细胞向缺损区域长入。中空支柱有利于将颌骨中的骨髓、血液迅速引流向上；桥墩式支架配合“骨粉+骨修复膜”的使用方式,可将骨粉局限于术区,避免传统骨粉植入的位移塌陷。(The invention discloses a hollow pier type bracket for increasing vertical bones, which comprises: a plurality of rack units; the rack unit includes: a porous scaffold and a hollow strut; wherein the porous scaffold comprises: a porous body, and a porous top layer as a top and having a pore size smaller than the body; the aperture of the porous top layer is 20-50 mu m; the upper part of the hollow strut penetrates into the main body, and the pipe wall of the upper part of the hollow strut is provided with a communicating hole used for communicating with the porous bracket; the lower part of the hollow strut is used for being fixed in a jaw bone; in use, the bone formation-related cells can migrate from the bone marrow region of the jaw bone through the hollow struts to the porous scaffold. The porous top layer can limit the growth of fibroblasts and epithelial cells with relatively large volume to the defect area. The hollow support is beneficial to quickly draining bone marrow and blood in the jaw bone upwards; the pier-type bracket is matched with the use mode of the bone meal and the bone repair film, so that the bone meal can be limited in an operative area, and the displacement collapse of the traditional bone meal implantation is avoided.)

1. A hollow pier-type scaffold for vertical bone augmentation, comprising: a plurality of rack units; the support unit comprises: a porous scaffold and a hollow strut; wherein the content of the first and second substances,

the porous scaffold comprises: a porous body and a porous top layer as a top and having a pore size smaller than said body; the pore diameter of the porous top layer is 20-50 mu m;

the upper part of the hollow pillar penetrates into the main body, and the pipe wall of the upper part of the hollow pillar is provided with a communicating hole which is used for communicating with the porous bracket; the lower part of the hollow strut is used for being fixed in a jaw bone;

in use, the bone formation-related cells can migrate to the porous scaffold through the hollow struts.

2. The hollow pier scaffold for vertical bone augmentation of claim 1, wherein the porous top layer has a layer thickness of 0.2-0.5 mm.

3. The hollow pier scaffold for vertical bone augmentation according to claim 1, wherein the pore size of the main body of the porous scaffold is 200-500 μm.

4. The hollow pier scaffold for vertical bone augmentation according to claim 1, wherein the length of the porous scaffold in the buccolingual direction of the alveolar bone is 5mm to 10mm and the height thereof is 3mm to 10 mm.

5. The hollow pier scaffold for vertical bone augmentation of claim 1, wherein the scaffold unit comprises: 2 hollow pillars in a cylindrical shape.

6. The hollow pier scaffold for vertical bone augmentation of claim 1, wherein the upper portion of the hollow struts extends to the porous top layer.

7. The hollow pier scaffold for vertical bone augmentation of claim 1, wherein the hollow struts have a lower length of 3-8mm, a thickness of 0.3-0.5mm, and an inner diameter of 0.4-0.8 mm.

8. The hollow pier-type scaffold for increasing vertical bone volume according to claim 1, wherein in use, bone powder is provided around the scaffold units or between the scaffold units, and the surfaces of the scaffold units and the bone powder are covered with bone repair films.

9. The hollow pier scaffold for vertical bone augmentation of claim 1, wherein the scaffold units are of a degradable material.

10. The hollow abutment stent for vertical bone augmentation of claim 1, wherein the hollow abutment stent is adaptable to different bone defect cases by using stent units of different sizes and adjusting the number and spacing of the stent units.

Technical Field

The invention relates to the technical field of oral medical instruments, in particular to a hollow pier type bracket for increasing vertical bones.

Background

In recent years, oral implantation is widely used clinically for treating dentition defects and dentition defects. Ensuring good initial stability is the key to successful planting, therefore, insufficient bone mass and bone mass often result in failure of oral planting. In response to this problem, bone augmentation techniques have been developed to expand the indications for oral implantation, including Guided Bone Regeneration (GBR), distraction osteogenesis, maxillary sinus lift, and the like. The guided bone regeneration technology covers a biological barrier membrane on the surface of a bone graft implanted into a bone defect area, and blocks epithelial cells and fibroblasts from growing into the defect area, so that a good regeneration space is provided for the growth of the bone tissue below.

However, guided bone regeneration still faces problems that are not effectively solved. For example, the bone powder covered under the membrane cannot achieve better retention, and the bone powder is easy to displace and collapse under the action of chewing force or external force, so that the bone height is not recovered sufficiently; the blocky bracket material with a specific size is difficult to meet individual requirements, and is not beneficial to batch production and productization. Therefore, the bone powder is fixed by adopting titanium mesh or tent nails and the like clinically to achieve a stable bone augmentation effect, but the corresponding supporting materials cannot be degraded and have stress accumulation, so complications such as soft tissue wound cracking, titanium mesh exposure, secondary bone absorption and the like are caused frequently, the metal supporting materials have a stress shielding phenomenon and are not beneficial to new bone growth, and after the bone regeneration is realized, a secondary operation is required to take out the titanium mesh or tent nails, so that the surgical wound is increased.

In addition, the osteogenesis inducing properties of bone powder implant materials still need to be improved to increase the bone regeneration efficiency. It is well known that sufficient blood perfusion, induction of stimulators, mesenchymal stem cells, etc. are required for the induction of osteogenesis. Clinically, holes are usually drilled in cortical bones to form a structure similar to a trophoblast, so that new blood vessels can grow into bone implantation areas quickly to establish blood circulation, and drugs such as antibiotics can enter defect areas along with blood circulation to prevent infection and inflammation.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a hollow pier type bracket for vertical bone augmentation, which can guide bone marrow to be perfused to the bracket and a bone augmentation lifting area, establish an osteogenesis related cell migration channel and improve the bone regeneration effect.

In order to achieve the above objects, the present invention provides a hollow pier-type scaffold for vertical bone augmentation, comprising: a plurality of rack units; the support unit comprises: a porous scaffold and a hollow strut; wherein the porous scaffold comprises: a porous body and a porous top layer as a top and having a pore size smaller than said body; the pore diameter of the porous top layer is 20-50 mu m; the upper part of the hollow pillar penetrates into the main body, and the pipe wall of the upper part of the hollow pillar is provided with a communicating hole which is used for communicating with the porous bracket; the lower part of the hollow strut is used for being fixed in a jaw bone; in use, the bone formation-related cells can migrate to the porous scaffold through the hollow struts.

Preferably, the layer thickness of the porous top layer is 0.2-0.5 mm.

Preferably, the pore diameter of the main body of the porous scaffold is 200-500 μm.

Preferably, the length of the porous bracket in the buccal and lingual direction of the alveolar bone is 5mm-10mm, and the height of the porous bracket is 3mm-10 mm.

Preferably, the rack unit includes: 2 hollow pillars in a cylindrical shape.

Preferably, the upper portion of said hollow strut extends to said porous top layer.

Preferably, the length of the lower part of the hollow strut is 3-8mm, the thickness is 0.3-0.5mm, and the inner diameter is 0.4-0.8 mm.

Preferably, in a use state, bone powder is arranged around the bracket units or between the bracket units, and bone repair films are covered on the surfaces of the bracket units and the bone powder.

Preferably, the bracket unit is made of degradable materials.

Preferably, the hollow pier-type stent can be adapted to different bone defect cases by adopting stent units with different sizes and adjusting the number and the spacing of the stent units.

Compared with the prior art, the invention has the following beneficial effects:

1. the hollow strut of the pier-type scaffold is beneficial to rapidly draining bone marrow and blood in a jaw bone upwards, providing a migration channel for osteoblast-related cells, and accelerating the growth of cells in the scaffold so as to accelerate the bone regeneration process; the porous design of the matched bracket can accelerate the vascularization in the bracket and nourish the bone-related cells in the bracket.

2. The pore diameter of the porous top layer on the top of the porous support is 20-50 microns, the pore diameter is small, and fibroblast and epithelial cells with relatively large volumes can be limited from growing into a defect area, but can be used as a channel for blood to pass through and bone cells to grow into the support, so that a good bone regeneration environment is provided.

3. The hollow pier type bracket designed by the invention can load one or more induction factors such as BMP-2, PDGF-BB, VEGF, SDF-1 and the like to recruit cells to migrate to a defect area along the hollow strut and induce the cells to differentiate, thereby improving the bone regeneration effect.

4. The use mode of cavity pier formula support cooperation "bone meal + bone repair membrane" can confine the bone meal to the art district, effectively avoids the displacement that traditional bone meal implanted to collapse to have better bone regeneration effect.

5. The pier-type support stent of the present invention reduces the "stress shielding" phenomenon compared to retaining implanted bone meal by covering with titanium mesh or tent pegs.

6. Different sizes of stent units can be used in combination, and in addition, the number and the spacing of the stent units used can be further adjusted to adapt to different length ranges of bone defect cases.

Drawings

Fig. 1 is a perspective view of a stand unit.

Fig. 2 is a sectional view of the holder unit.

Fig. 3 is a schematic view of a state of use of the holder unit.

Fig. 4 is a schematic diagram of the steps of using the hollow pier-type stent of the present invention.

Fig. 5 is a diagram of animal experiment mode in animal experiment verification.

Fig. 6 is a flow chart of animal experiment operation in animal experiment verification.

FIG. 7 is a graph showing the results of X-ray examination of a control group in animal experimental verification.

FIG. 8 is a graph showing the X-ray results of experimental groups in animal experimental verification.

Detailed Description

The technical solution of the present invention is further described below with reference to the accompanying drawings and examples.

The terms "top", "upper", and the like, as used herein to describe orientation, refer to the end away from the autogenous bone.

The hollow pier-type bracket for increasing the vertical bone provided by the invention comprises a plurality of bracket units, and is used for being implanted into a bone defect area and supporting a bone regeneration space. Fig. 1 is a perspective view of the holder unit, and fig. 2 is a sectional view of the holder unit. As shown in fig. 1 and 2, the holder unit 1 includes: a porous scaffold and hollow struts 12. The porous scaffold comprises: a porous body 11, and a porous top layer 15 as a top and having a pore size smaller than that of the body 11; the pore diameter of the porous top layer 15 is 20-50 μm. The upper part of the hollow strut 12 penetrates into the main body 11, and the pipe wall of the upper part of the hollow strut 12 is provided with a communication hole 14 for communicating with the porous scaffold, and the communication hole 14 can be passed by the cells. Referring to fig. 3, the lower portion of the hollow post 12 is used to be fixed in the jawbone 2; in use, the osteogenic-related cells are able to migrate through the hollow struts 12 into the porous scaffold. The periphery of the jaw is soft tissue 4.

In the embodiment shown in fig. 1, the holder unit 1 is provided with 2 symmetrically arranged hollow legs 12. The hollow struts 12, like piers, can serve as a support, and since the hollow struts 12 are inserted into the jaw bone, a channel for guiding the bone marrow perfusion upward and cell migration can be established, thereby accelerating the migration and ingrowth of cells associated with osteogenesis.

Guided bone regeneration requires the use of bone meal to increase bone mass. The bone powder can be arranged around the bracket units 1 or between the bracket units 1, and the bone repair film is covered on the bracket units 1 and the surfaces of the bone powder. The use mode of the hollow pier-type bracket matched with the bone powder and the bone repair film can effectively avoid displacement collapse of traditional bone powder implantation and has better bone regeneration effect. The support units 1 are set to be large, medium and small, the support units 1 with different sizes can be combined for use, the number and the distance of the used support units 1 can be further adjusted to adapt to bone defect cases with different length ranges, and only supports with different sizes and different models need to be equipped to adapt to alveolar bones with different widths and different lifting heights, so that the defects of complex preparation process, high cost, long period and the like of personalized supports are avoided.

In the embodiment shown in FIG. 1, the square porous scaffold is in a grid shape with interconnected pores. The pore diameter of the porous top layer 15 on the top of the porous support is 20-50 microns, the pore diameter is small, blood can flow, osteoblasts with small volume can pass through easily, fibroblasts and epithelial cells with large volume can be limited to pass through, and the fibroblast and epithelial cells are further prevented from growing into a defect area together with a bone repair membrane, so that a good bone regeneration environment is provided.

The hollow strut 12 drains the upward bone marrow and blood, and the porous design of the porous support is matched, so that the whole bone defect area can be infiltrated, the osteogenesis related cells can migrate and grow into the bone defect area, the vascularization in the support is accelerated, and the osteogenesis related cells in the support are nourished.

In some embodiments, the layer thickness of the porous top layer 15 is 0.2-0.5 mm. The pore size of the porous scaffold was 200-500 μm. The length of the porous bracket on the buccal and lingual direction of the alveolar bone is 5mm-10mm, and the height is 3mm-10 mm. The length of the lower part of the hollow strut 12 is 3-8mm, the thickness is 0.3-0.5mm, and the inner diameter 13 is 0.4-0.8mm (see fig. 2 or fig. 5). The upper portion of the hollow strut 12 extends to a porous top layer 15.

In the embodiment shown in fig. 1, the hollow strut 12 is cylindrical.

The hollow pier type bracket is preferably made of degradable materials, such as calcium/phosphorus inorganic materials, organic polymer materials, natural biological materials, magnesium alloy and other degradable metal materials. The stent has the degradable characteristic, does not need to be taken out in a secondary operation, and avoids the wound of the secondary operation.

Animal experiment verification:

as shown in FIG. 4, the steps of using the hollow pier type scaffold designed by the invention are roughly divided into five steps.

S1: an implantation nest matched with the hollow pillar 12 of the hollow pier type bracket is prepared on the jaw bone, the diameter of the nest cavity is 1.2-1.5mm, and the length of the nest cavity is 3-8 mm.

S2: the hollow strut 12 of the hollow pier-type stent is inserted into the implant nest and fixed in the jaw.

S3: bone meal is implanted in or around the area between the plurality of scaffold units.

S4: covering the bone repairing film on the surface of the bracket and the implanted bone powder.

S5: the mucous membrane tissue is separated and loosened to achieve the effect of full tension reduction, and then the gingiva is closed up and sutured.

The hollow pier-type bracket designed by the invention is implanted into a bone defect area in a dog body, the materials are taken 6 weeks after the operation, and the bone increment effect is detected by X-ray photographing. The experiments were divided into 2 groups, i.e. a control group (using only bone meal + periosteum) and a hollow pier scaffold group (using hollow pier scaffold + bone meal + periosteum), depending on whether a hollow pier scaffold was used. The manner in which the scaffold and bone meal are used can also be seen in fig. 5. As shown in fig. 6, the animal experiment process is as follows: (1) establishing a dog mandible defect model; (2) the hollow pillar of the hollow pier type bracket designed by the invention is implanted into the jaw bone; (3) implanting bone meal around the scaffold; (4) covering the bone repairing film on the bracket and the bone powder. The results of the in vivo experimental X-ray treatment in dogs are shown in the control group of fig. 7 and the hollow pier stent group of fig. 8, where the bone height recovery of the control group of fig. 7 was poor, while the hollow pier stent group of fig. 8 achieved better bone increment height.

The scaffold of the invention is matched with growth factors with the functions of recruiting cell migration and inducing cell differentiation, and can obtain better bone regeneration effect.

In conclusion, the pier-type degradable porous scaffold designed by the invention has a special pipeline composite porous structure, and can obtain a good in-vivo quick vertical bone increment effect by matching with the use of bone powder and a bone repair membrane. The scaffold can support bone regeneration space, stably place bone powder between or around the scaffold, and avoid bone powder displacement and collapse, thereby better maintaining bone height.

While the present invention has been described in detail with reference to the preferred embodiments, it should be understood that the above description should not be taken as limiting the invention. Various modifications and alterations to this invention will become apparent to those skilled in the art upon reading the foregoing description. Accordingly, the scope of the invention should be determined from the following claims.