CN217853979U - Cleft lip and palate repair material - Google Patents

Cleft lip and palate repair material Download PDF

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CN217853979U
CN217853979U CN202221714302.1U CN202221714302U CN217853979U CN 217853979 U CN217853979 U CN 217853979U CN 202221714302 U CN202221714302 U CN 202221714302U CN 217853979 U CN217853979 U CN 217853979U
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bionic
palate
repair material
cleft lip
bone
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崔云
朱金亮
宋天喜
何志敏
胡艳丽
仇志烨
吴晶晶
胡刚
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Aojing Medical Technology Co ltd
Weifang Aojing Health Technology Co ltd
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Beijing Aojing Health Technology Co ltd
Aojing Medical Technology Co ltd
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Abstract

The utility model relates to a cleft lip and palate repair material technical field, in particular to a cleft lip and palate repair material. A cleft lip and palate repair material comprises a bionic cortical bone layer and a bionic cancellous bone which are made of biological ceramics; the bionic cortical bone layer is of a sheet and compact structure; the bionic cancellous bone is in an irregular block shape with a porous structure, and the shape of the irregular block is the same as that of a damaged part of cleft lip and palate; the surface of the bionic cancellous bone comprises a first surface and a second surface, the first surface is the surface of the bionic cancellous bone which is adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate, the second surface is the surface of the bionic cancellous bone which is not adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate, and the bionic cortical bone layer is adhered to the second surface and used for protecting the bionic cancellous bone. The embodiment of the utility model provides a cleft lip and palate repair material, which can provide an artificial material for repairing cleft lip and palate.

Description

Cleft lip and palate repair material
Technical Field
The utility model relates to a cleft lip and palate repair material technical field, in particular to cleft lip and palate repair material.
Background
Alveolar ridge cleft is a common and concurrent maxillary alveolar bone defect in patients with cleft lip and palate.
The existing treatment is mainly autologous bone grafting repair, but autologous bone grafting can cause postoperative pain at a bone taking position, skin scar, postoperative activity limitation, accidental injury of a bone supply area or postoperative infection and other complications, so that a patient bears a large additional risk, more importantly, autologous bone taking can increase huge mental burden to the patient, and the patient is not easily accepted by the patient.
Therefore, in order to overcome the above disadvantages, a cleft lip and palate repair material is urgently needed.
SUMMERY OF THE UTILITY MODEL
The embodiment of the utility model provides a cleft lip and palate repair material, which can provide an artificial material for repairing cleft lip and palate.
The embodiment of the utility model provides a cleft lip and palate repair material, which comprises a bionic cortical bone layer and a bionic cancellous bone which are made of biological ceramics;
the bionic cortical bone layer is in a sheet shape and has a compact structure;
the bionic cancellous bone is in an irregular block shape with a porous structure, and the shape of the irregular block shape is the same as that of a damaged part of cleft lip and palate;
the surface of the bionic cancellous bone comprises a first surface and a second surface, the first surface is the surface of the bionic cancellous bone which is adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate, and the second surface is the surface of the bionic cancellous bone which is not adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate; the bionic cortical bone layer is attached to the second surface and used for protecting the bionic cancellous bone.
Preferably, the porous structure comprises a first porous structure and a second porous structure, the pore diameter of the first porous structure is 150-500 μm, and the pore diameter of the second porous structure is 20-100 μm.
More preferably, the first porous structure has a pore size of 200 to 400 μm, and the second porous structure has a pore size of 40 to 80 μm.
Preferably, the porosity of the porous structure is 50 to 70%.
More preferably, the porosity of the porous structure is 60 to 70%.
Preferably, the bioceramic is hydroxyapatite or β -tricalcium phosphate.
Preferably, the connection mode between the bionic cortical bone layer and the bionic cancellous bone is bonding by a bonding agent.
Preferably, the binder is a bioglass.
Preferably, the thickness of the bionic cortical bone layer is 0.1-0.5 μm.
Compared with the prior art, the utility model following beneficial effect has at least:
in the utility model, the biological ceramics has good biocompatibility and bioactivity, is nontoxic and non-carcinogenic to human body, and can be firmly combined with natural bone through biochemical reaction in vivo. The bionic cortical bone layer with a compact structure can have excellent supporting performance, can bear pressure and protect bionic cancellous bone attached to the bionic cortical bone layer. The first surface of the bionic cancellous bone is attached to the bone tissue of a human body, so that the new bone cells can enter the porous bionic cancellous bone through the first surface, the bionic cancellous bone prepared from the bioceramic can be degraded, the new bone cells enter the bionic cancellous bone in the degradation process, and the new bone gradually replaces the bioceramic until finally the new bone completely replaces the degraded bioceramic.
Drawings
In order to clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the description below are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is an electron microscope image of a bionic cortical bone layer of a cleft lip and palate repair material provided by an embodiment of the present invention;
fig. 2 is an electron microscope image of a bionic cancellous bone of another material for repairing cleft lip and palate provided by an embodiment of the present invention;
fig. 3 is a schematic diagram of the position of a bionic cortical bone layer of a cleft lip and palate repair material provided by an embodiment of the present invention;
fig. 4 is a schematic view of a bionic cancellous bone of a cleft lip and palate repair material provided by an embodiment of the present invention;
fig. 5 is a schematic view illustrating a repairing effect of a cleft lip and palate repairing material provided by an embodiment of the present invention.
Detailed Description
In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the following will combine the drawings in the embodiments of the present invention to clearly and completely describe the technical solution in the embodiments of the present invention, and obviously, the described embodiments are some embodiments of the present invention, rather than all embodiments, based on the embodiments in the present invention, all other embodiments obtained by a person of ordinary skill in the art without creative work belong to the scope of the present invention.
In the description of the embodiments of the present invention, unless explicitly specified or limited otherwise, the terms "first", "second", and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance; the term "plurality" means two or more unless specified or indicated otherwise; the terms "connected," "fixed," and the like are to be construed broadly and may, for example, be fixedly connected, detachably connected, integrally connected, or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.
In the description of the present invention, it should be understood that the terms "upper" and "lower" used in the embodiments of the present invention are used in the angle shown in the drawings, and should not be construed as limiting the embodiments of the present invention. In addition, in this context, it will also be understood that when an element is referred to as being "on" or "under" another element, it can be directly on "or" under "the other element or be indirectly on" or "under" the other element via an intermediate element.
As shown in fig. 1 and fig. 2, an embodiment of the present invention provides a cleft lip and palate repair material, including a bionic cortical bone layer and a bionic cancellous bone made of bioceramic;
the bionic cortical bone layer is in a sheet shape and has a compact structure;
the bionic cancellous bone is in an irregular block shape with a porous structure, and the shape of the irregular block shape is the same as that of a damaged part of cleft lip and palate;
the surface of the bionic cancellous bone comprises a first surface and a second surface, the first surface is the surface of the bionic cancellous bone which is attached to the human bone tissue after the lip and palate repair material repairs the lip and palate cleft, the second surface is the surface of the bionic cancellous bone which is not attached to the human bone tissue after the lip and palate repair material repairs the lip and palate cleft, and the bionic cortical bone layer is attached to the second surface and used for protecting the bionic cancellous bone.
In this embodiment, the bioceramic has good biocompatibility and bioactivity, is non-toxic and non-carcinogenic to human body, and can be firmly combined with natural bone through biochemical reaction in vivo. As shown in fig. 3 to 5, the bionic cortical bone layer with a compact structure can have excellent supporting performance, can bear pressure, and protects the bionic cancellous bone attached thereto (the white-bottom black-dot part in fig. 3 is the bionic cortical bone layer). The first surface of the bionic cancellous bone is attached to the bone tissue of a human body (fig. 4 and 5), so that the new bone cells can enter the interior of the porous bionic cancellous bone through the first surface, the bionic cancellous bone prepared by the bioceramic can be degraded, the new bone cells enter the interior of the bionic cancellous bone in the degradation process, and the new bone gradually replaces the bioceramic material until finally the new bone completely replaces the degraded bioceramic.
In this embodiment, the first surface is a surface of the bionic cancellous bone attached to the cleft lip and palate defect, and the area of the first surface is equal to the surface area of the cleft lip and palate defect.
The biological ceramic can obtain a compact bionic cortical bone layer by utilizing hot-pressing sintering treatment, and the high pressure applied by the hot-pressing sintering treatment increases the density of the prepared bionic cortical bone layer, thereby increasing the compressive strength of the bionic cortical bone layer.
In this embodiment, specifically, the bioceramic, the water, the dispersant, the binder and the polymethyl methacrylate particles are uniformly mixed to obtain a solid-liquid mixture; the dispersing agent can uniformly distribute each substance in the solid-liquid mixture, prevent the mutual aggregation and precipitation among solid particles and obtain stable dispersion. The binder can improve the suspension stability of the solid-liquid mixture. Polymethyl methacrylate particles are used as pore-forming agent.
And pouring the solid-liquid mixture into a mold containing the bionic cortical bone layer, and performing freeze-drying treatment to solidify and shape the solid-liquid mixture so as to form the solid-liquid mixture and the bionic cortical bone layer in the mold to obtain the repair material matched with the lip crack repair part, wherein the solid-liquid mixture is not subjected to volume shrinkage after freeze-drying treatment, and the obtained solid is loose. Through sintering treatment, the pore-forming agent polymethyl methacrylate particles are melted and decomposed to obtain porous bionic cancellous bone, the pore-forming agent can obtain a stable and controllable porous structure, holes in the porous structure can facilitate crawling and growth of osteocytes, and bone repair efficiency is improved.
It is noted that the polymethylmethacrylate particles are available from alfacarb, CAS:9011-14-7 with molecular weight of 12 ten thousand.
In some embodiments of the present invention, the cleft lip and palate repair material is prepared by a customized graphite crucible mold, and the preparation method of the graphite crucible mold is:
acquiring CT (computed tomography) imaging data at cleft lip and palate;
preparing a model by utilizing a 3D printing technology according to CT (computed tomography) imaging data, wherein the model has the same shape as the cleft lip and palate defect;
and (5) utilizing the model to prepare the mould through mould turnover.
In this example, a mold for preparing a cleft lip and palate repair material was prepared according to the shape of a cleft lip and palate defect, so that the cleft lip and palate repair material prepared by customizing the mold could be matched with the defect.
In some embodiments of the present invention, the porous structure comprises a first porous structure and a second porous structure, the first porous structure has a pore size of 150 to 500 μm, and the second porous structure has a pore size of 20 to 100 μm.
In this embodiment, porous structure includes the first porous structure of large aperture and the second porous structure of aperture, and wherein, the aperture of first porous structure does benefit to the growth and the crawling of new bone cell, and the second porous structure can form the capillary water absorption effect, and the body fluid of being convenient for carries beneficial substance entering bionical cancellous bone.
In some embodiments of the present invention, the first porous structure has a pore size of 200 to 400 μm and the second porous structure has a pore size of 40 to 80 μm.
In the embodiment, the aperture of the first porous structure is 200-400 μm, which is more beneficial to the growth and crawling of new bone cells; the aperture of the second porous structure is 40-80 μm, and the capillary water absorption effect is more obvious.
In some embodiments of the present invention, the porosity of the porous structure is between 50 and 70%.
In this embodiment, the higher the porosity, the more favorable the new bone growth, the faster the degradation rate, and the better the repair effect.
In some embodiments of the present invention, the porosity of the porous structure is 60 to 70%.
In this embodiment, the higher the porosity, the more favorable the new bone growth, the faster the degradation rate, and the better the repair effect.
In some embodiments of the invention, the bioceramic is hydroxyapatite or β -tricalcium phosphate.
In the embodiment, the hydroxyapatite and the beta-tricalcium phosphate have excellent biocompatibility and bioactivity, are non-toxic to human bodies and have no carcinogenic risk. Hydroxyapatite has osteoconductivity, can guide the growth of new bone formed by host bone to the interior of an implant along the interface of the implant (namely, a repair material), and can form a apatite layer on the bone surface contacted with hydroxyapatite, thereby forming good osseous bond with the surrounding bone tissue. The beta-tricalcium phosphate has high degradation speed, and the degradation product Ca thereof 2+ 、PO 4 3+ The plasma can enter into the body fluid of the living body to provide raw materials for the formation of new bones and promote the growth of the new bones. Therefore, the repair material prepared by hydroxyapatite and beta-tricalcium phosphate can replace the autologous bone to repair cleft lip and palate.
In some embodiments of the present invention, the connection between the bionic cortical bone layer and the bionic cancellous bone is adhesive bonding.
In this embodiment, the bionic cortical bone layer and the bionic cancellous bone may be bonded by an adhesive, or may be connected by other means, such as a bolt and nut/thread connection made of bioceramic.
In some embodiments of the present invention, the binder is bioglass.
In this embodiment, the bioglass may be Na 2 O-CaO-SiO 2 -P2O 5 Or CaO-MgO-NaO 2 -P 2 O 5 Or may also be Na 2 O-K 2 O-MgO-CaO-P 2 O 5 -SiO 2 Or SiO 2 -Al 2 O 5 -B 2 O 3 -MgO-CaO-Na 2 And O-F. The bioglass has ideal bioactivity, bone reconstruction function and high mechanical strength, and the degradation product can promote the cell proliferation and the growth of bone tissue.
The bioglass is used as a binder, and is required to be melted by applying high temperature to be bonded, and the bioglass and the bioceramic for preparing the bionic cancellous bone can be crushed and blended, and then the blended substances are applied with high temperature to form the bionic cortical bone layer of the bionic ceramic and bond the bionic cortical bone layer with the bionic cancellous bone.
In some embodiments of the present invention, the thickness of the bionic cortical bone layer is 0.1-0.5 μm.
In this embodiment, the thickness of the bionic cortical bone layer is consistent with the thickness of the human cortical bone layer.
The cleft lip and palate repair material provided by the embodiment has excellent strength, and the compressive strength test and the flexural strength test are respectively carried out on the bionic cortical bone layer and the bionic cancellous bone of 5 samples of the cleft lip and palate repair material obtained by the utility model, and the obtained test results are shown in table 1;
TABLE 1
Figure DEST_PATH_GDA0003863772740000061
According to table 1, the utility model provides a cleft lip and palate repair material's bionical cortical bone layer is similar with the mechanical strength of human cortical bone (compressive strength 141.84MPa, rupture strength 70.92 MPa), the utility model provides a cleft lip and palate repair material's bionical cancellous bone is similar with the cancellous bone mechanical strength of human (compressive strength 50MPa, rupture strength 3.5 MPa).
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; such modifications or substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims (9)

1. A cleft lip and palate repair material is characterized by comprising a bionic cortical bone layer and a bionic cancellous bone which are made of biological ceramics;
the bionic cortical bone layer is in a sheet shape and has a compact structure;
the bionic cancellous bone is in an irregular block shape with a porous structure, and the shape of the irregular block shape is the same as that of a damaged part of cleft lip and palate;
the surface of the bionic cancellous bone comprises a first surface and a second surface, the first surface is the surface of the bionic cancellous bone which is adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate, and the second surface is the surface of the bionic cancellous bone which is not adhered to the human bone tissue after the lip and palate repair material repairs the cleft lip and palate; the bionic cortical bone layer is attached to the second surface and used for protecting the bionic cancellous bone.
2. The cleft lip and palate repair material according to claim 1, wherein the porous structure comprises a first porous structure and a second porous structure, the pore size of the first porous structure is 150 to 500 μm, and the pore size of the second porous structure is 20 to 100 μm.
3. The cleft lip and palate repair material according to claim 2, wherein the pore size of said first porous structure is 200 to 400 μm and the pore size of said second porous structure is 40 to 80 μm.
4. The cleft lip and palate repair material according to claim 1, wherein the porosity of said porous structure is between 50 and 70%.
5. The cleft lip and palate repair material according to claim 4, wherein said porous structure has a porosity of 60 to 70%.
6. The cleft lip and palate repair material of claim 1, wherein said bioceramic is hydroxyapatite or β -tricalcium phosphate.
7. The cleft lip and palate repair material according to claim 1, wherein said connection means between said biomimetic cortical bone layer and said biomimetic cancellous bone is adhesive bonding.
8. The cleft lip and palate repair material of claim 7, wherein said adhesive is bioglass.
9. The cleft lip and palate repair material according to claim 1, wherein the thickness of said biomimetic cortical bone layer is 0.1 to 0.5 μm.
CN202221714302.1U 2022-06-28 2022-06-28 Cleft lip and palate repair material Active CN217853979U (en)

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