阅读说明：本技术 一种胫骨高位截骨后用楔形人造骨及其制备方法 (Wedge-shaped artificial bone used after high tibial osteotomy and preparation method thereof ) 是由 陈梓煜 邓世捷 冯振锋 申超 陈良鹏 于 2019-10-12 设计创作，主要内容包括：本发明提供了一种胫骨高位截骨后用楔形人造骨,包括：短碳纤维增强聚醚醚酮楔形骨主体；开设于所述楔形骨主体的骨生长孔；填充于所述骨生长孔的可促进骨生长的填充物。本发明提供的胫骨高位截骨后用楔形人造骨既能维持机械力学的支持,防止塌陷,又能具备良好的生物学性能,促进骨愈合。(The invention provides a wedge-shaped artificial bone for high tibial osteotomy, which comprises: the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body; a bone growth hole opened in the wedge-shaped bone main body; and the filler is filled in the bone growth hole and can promote the bone growth. The wedge-shaped artificial bone for the high tibial osteotomy provided by the invention can maintain the support of mechanical mechanics, prevent collapse, has good biological performance and promotes bone healing.)

1. A wedge-shaped artificial bone for use after a high tibial osteotomy, comprising:

The short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body;

A bone growth hole opened in the wedge-shaped bone main body;

And the filler is filled in the bone growth hole and can promote the bone growth.

2. The wedge shaped artificial bone of claim 1, wherein the bone growth aperture extends through the wedge shaped bone body, or opens onto a surface of the wedge shaped bone body, or a combination thereof.

3. The wedge-shaped artificial bone according to claim 1, wherein the porosity of the short carbon fiber reinforced polyetheretherketone wedge-shaped bone body is 5 to 40%, and the diameter of the bone growth hole is 0.5 to 10 mm.

4. The wedge-shaped artificial bone according to claim 1, wherein the included angle of the inclined plane of the wedge-shaped artificial bone is 3-30 degrees.

5. The wedge-shaped artificial bone according to claim 1, wherein the filler is prepared from the following raw materials in parts by mass:

50-90 parts by mass of a bone regeneration material;

10-50 parts by mass of alpha-calcium sulfate hemihydrate;

1-5 parts by mass of stearic acid;

50-100 parts by mass of an osteocyte active factor;

50-100 parts by mass of physiological saline.

6. The wedge-shaped artificial bone according to claim 5, wherein the bone regeneration material is hydroxyapatite or tricalcium phosphate;

The bone cell active factor is selected from one or more of human broken bones, bone powder and bone growth factors.

7. The wedge-shaped artificial bone according to claim 5, wherein the aspect ratio of the short carbon fiber in the short carbon fiber reinforced polyetheretherketone is (50-300): 1, the fiber length of the short carbon fiber is 0.5-3 mm; the content of short carbon fibers was 30 wt%.

8. A method for preparing a wedge-shaped artificial bone for high tibial osteotomy according to any one of claims 1 to 7, comprising the steps of:

A) Preparing a short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body with bone growth holes according to the shape of the damaged bone;

B) Mixing a bone regeneration material, alpha-calcium sulfate hemihydrate, stearic acid, bone cell active factors and normal saline, pouring the mixture into bone growth holes of the wedge-shaped bone main body, and curing to obtain a wedge-shaped artificial bone precursor;

C) and carrying out heat treatment and disinfection on the wedge-shaped artificial bone precursor to obtain the wedge-shaped artificial bone.

9. The preparation method according to claim 8, wherein the method for preparing the short carbon fiber reinforced polyetheretherketone wedge-shaped bone body is mechanical manufacturing or 3D printing.

10. The preparation method according to claim 8, wherein the temperature of the heat treatment is 200-250 ℃ for 1-4 h.

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a wedge-shaped artificial bone used after high tibial osteotomy and a preparation method thereof.

background

The osteoarthritis patients in China exceed 10% of the total population, the treatment cost caused by the orthopaedic chronic diseases in China is increased to 850 billion by calculation in 2020, the incidence rate of the gonarthritis in 20 years in 1990-2010 is increased to 45%, and the disability rate is the second place in the world. For the early and middle stage arthritis disease cases with serious symptom signs, particularly the knee protection surgery mainly involving the medial compartment of the joint, which is the osteotomy orthopedic, is the mainstream means at present. High Tibial Osteotomy (HTO) is the most important and promising surgical procedure in knee protection surgery, and has the effects of avoiding or promoting TKA (total knee replacement artificial joint) surgery. However, due to individual differences of varus angles, whether to combine front and back inclination, the height and depth of the implanted prosthesis and the like of different patients, and lack of proper bone cutting, fixing, repairing and reconstructing materials, the problems of inaccurate bone cutting tools, unstable fixation, implant collapse, non-union of fracture and the like easily occur in clinic, so that the immediate stability and the long-term curative effect after bone cutting cannot be ensured. The selection of the orthopedic implant material and the structure can not only maintain the support of mechanical mechanics and prevent collapse, but also have good biological performance and promote bone healing, and is a difficult problem after HTO osteotomy.

After traditional HTO osteotomy, three materials are usually adopted as implant materials, including firstly, autogenous bone, but the problems of increased operative wound, susceptibility to infection and pain of the bone-taking part and the like exist; allogenic bone, which is easy to cause allograft rejection, and the controllability of absorption and regeneration of the implant is poor; ③ artificial bone materials, including hydroxyapatite, calcium phosphate, tricalcium phosphate (beta-TCP), etc., but insufficient mechanical structure, delayed healing associated with bone grafting, soft tissue infection and allergy, etc. And the three parts are fixed by adopting the steel plate due to insufficient strength of the implant, so that the problem that the steel plate needs to be taken out in a secondary operation is caused, and if the steel plate is not taken out in the secondary operation, great inconvenience is possibly caused for the TKA operation in the future.

Disclosure of Invention

In view of the above, the technical problem to be solved by the present invention is to provide a wedge-shaped artificial bone for high tibial osteotomy and a preparation method thereof, wherein the wedge-shaped artificial bone for high tibial osteotomy provided by the present invention can maintain mechanical support, prevent collapse, have good biological properties, and promote bone healing.

The invention provides a wedge-shaped artificial bone for high tibial osteotomy, which comprises:

the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body;

a bone growth hole opened in the wedge-shaped bone main body;

and the filler is filled in the bone growth hole and can promote the bone growth.

Preferably, the bone growth hole penetrates through the wedge-shaped bone body, or is arranged on the surface of the wedge-shaped bone body, or penetrates through the wedge-shaped bone body and is arranged on the surface of the wedge-shaped bone body in a combined manner.

Preferably, the porosity of the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body is 5% -40%, and the diameter of the bone growth hole is 0.5-10 mm.

Preferably, the included angle of the wedge-shaped artificial bone inclined plane is 3-30 degrees.

Preferably, the filler is prepared from the following raw materials in parts by mass:

50-90 parts by mass of a bone regeneration material;

10-50 parts by mass of alpha-calcium sulfate hemihydrate;

1-5 parts by mass of stearic acid;

50-100 parts by mass of an osteocyte active factor;

50-100 parts by mass of physiological saline.

preferably, the bone regeneration material is hydroxyapatite or tricalcium phosphate;

The bone cell active factor is selected from one or more of human broken bones, bone powder and bone growth factors.

Preferably, the length-diameter ratio of the short carbon fibers in the short carbon fiber reinforced polyether ether ketone is (50-300): 1, the fiber length of the short carbon fiber is 0.5-3 mm; the content of short carbon fibers was 30 wt%.

The invention also provides a preparation method of the wedge-shaped artificial bone for high tibial osteotomy, which comprises the following steps:

A) Preparing a short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body with bone growth holes according to the shape of the damaged bone;

B) mixing a bone regeneration material, alpha-calcium sulfate hemihydrate, stearic acid, bone cell active factors and normal saline, pouring the mixture into bone growth holes of the wedge-shaped bone main body, and curing to obtain a wedge-shaped artificial bone precursor;

C) And carrying out heat treatment and disinfection on the wedge-shaped artificial bone precursor to obtain the wedge-shaped artificial bone.

Preferably, the method for preparing the short carbon fiber reinforced polyetheretherketone wedge-shaped bone body is mechanical manufacturing or 3D printing.

Preferably, the temperature of the heat treatment is 200-250 ℃ and the time is 1-4 h.

Compared with the prior art, the invention provides a wedge-shaped artificial bone for high tibial osteotomy, which comprises: the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body; a bone growth hole opened in the wedge-shaped bone main body; and the filler is filled in the bone growth hole and can promote the bone growth. The wedge-shaped bone is provided with the bone growth holes, so that the wedge-shaped bone main body is matched with the strength of the bone tissue in the human body in strength, and the growth holes are filled with fillers capable of promoting bone growth. The new bone that osteoacusis produced can grow into the inside bone growth hole that the artificial bone main part was seted up, forms three-dimensional interpenetrating structure with original bone and new bone, is favorable to the combination of artificial bone and patient self bone, has solved artificial bone implantation patient internal unable technical defect with patient self bone fusion, can avoid artificial bone not hard up simultaneously, and patient's activity is more free, can not arouse painful uncomfortable sense because of friction between artificial bone and self skeleton.

Drawings

FIG. 1 is a schematic view of the included angle of the wedge-shaped bone bevel provided by the present invention;

FIG. 2 is a schematic structural view of a wedge-shaped artificial bone for high tibial osteotomy according to the present invention;

FIG. 3 is a schematic view of an HTO surgical osteotomy site;

FIG. 4 is an external view of a wedge-shaped artificial bone body;

FIG. 5 is a perspective view of a wedge-shaped artificial bone body;

Figure 6 is a cross-sectional view of a wedge-shaped artificial bone body.

Detailed Description

The invention provides a wedge-shaped artificial bone for high tibial osteotomy, which comprises:

The short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body;

A bone growth hole opened in the wedge-shaped bone main body;

and the filler is filled in the bone growth hole and can promote the bone growth.

the wedge-shaped artificial bone for the high tibial osteotomy is a polyether-ether-ketone wedge-shaped bone body reinforced by short carbon fibers.

the short carbon fiber reinforced polyether-ether-ketone material has a modulus more similar to that of human cortical bone; higher strength, and lower amount of deformation under force.

The length-diameter ratio of short carbon fibers in the short carbon fiber reinforced polyether ether ketone is (50-300): 1, the fiber length of the short carbon fiber is 0.5-3 mm; the content of short carbon fibers was 30 wt%.

The mechanical properties of the short carbon fiber reinforced polyetheretherketone used in the present invention are shown in Table 1

TABLE 1 mechanical Properties of short carbon fiber reinforced polyetheretherketone

The wedge-shaped artificial bone body according to the present invention is not particularly limited in its structure, and any material structure known to those skilled in the art for preparing artificial bone from short carbon fiber-reinforced polyetheretherketone material may be used in the present invention. In the invention, the wedge-shaped artificial bone main body is preferably prepared from the following raw materials in parts by mass:

69 parts of medical grade polyether-ether-ketone powder, 30 parts of short carbon fiber and 1 part of methyl cellulose.

The compact area of the wedge-shaped bone body has 100 percent strength and modulus, and is close to the modulus of human cortical bone. The framework pore area reduces the strength and modulus, and can be adjusted to be similar to the cancellous bone of a human body. Therefore, when the artificial bone scaffold with high porosity is manufactured, the short carbon fiber reinforced polyether-ether-ketone material can better meet the requirement on strength.

the wedge-shaped artificial bone main body is prepared by taking short carbon fiber reinforced polyether-ether-ketone as a material, has high mechanical strength, can prevent the artificial bone main body from collapsing due to stress after being moved into a human body, but generates a stress shielding effect due to the fact that the strength of bone tissues in the human body is too high. Therefore, the invention adjusts the porosity of the wedge-shaped bone main body by arranging the bone growth holes on the wedge-shaped bone main body, adjusts the elastic modulus and the strength of the artificial bone to be close to those of the human bone and avoids the stress shielding phenomenon. And the porosity of the wedge-shaped bone main body provided by the invention is greatly improved compared with the artificial bone manufactured by the traditional method, thereby being more beneficial to the growth of the bone and better combining with the artificial bone.

in the invention, the bone growth hole penetrates through the wedge-shaped bone body, or is arranged on the surface of the wedge-shaped bone body, or penetrates through the wedge-shaped bone body and is combined with the wedge-shaped bone body.

According to the characteristics of the implanted artificial bone, the hole-shaped structure can be selected to penetrate through the artificial bone body or only perforate the surface, or the combination of the penetration and the surface perforation; wherein, if the surface of the artificial bone body is perforated, the adjacent hole-shaped structures can also be designed to be communicated with each other at the bottom. The bone growth holes penetrating through the artificial bone body may be crossed and penetrated inside the artificial bone body. The design of the porous structure needs to be individually designed according to the characteristics of the implantation position.

The bone growth pores need to ensure sufficient strength and rigidity of the artificial bone, and if the pore structure proportion is too large or a single pore structure is too large, the strength and rigidity of the artificial bone may be insufficient or the local strength is insufficient; meanwhile, it is also necessary to ensure that the implanted artificial bone can be fused well with the original bone in the body of the patient, and if the ratio of the porous structure is too small or the local pore diameter is too small, the artificial bone may not be fused well or locally with the original bone in the body of the patient. Therefore, in the invention, the porosity of the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body is 5-40%, and the diameter of the bone growth hole is 0.5-10 mm. The porosity and the diameter of the bone growth pores are adjusted according to the elastic modulus and strength of the human bone.

Referring to fig. 1, fig. 1 is a schematic view of the included angle of the wedge-shaped bone bevel provided by the present invention. In fig. 1, a represents the inclination angle of the wedge-shaped artificial bone, i.e. the included angle of the inclined plane of the wedge-shaped artificial bone. The inclination angle of the wedge-shaped artificial bone is the most critical parameter of the wedge-shaped artificial bone, and the correction angle of the artificial bone to a patient is concerned. Referring to the figure, the inclined angle of the wedge-shaped artificial bone, namely the included angle of the inclined plane of the wedge-shaped artificial bone, is 3-30 degrees.

Furthermore, the upper and lower surfaces of the wedge-shaped artificial bone can be in a plane shape, a sawtooth shape, an irregular shape and the like, and are determined according to the specific conditions of patients.

Furthermore, the cross section of the hole-shaped structure in the wedge-shaped artificial bone can be in the shape of a regular cross section such as a cylinder, a square, a triangle and the like, or in the shape of an irregular cross section, a cross structure, a space grid and the like, and the design of the hole-shaped structure can be changed according to the specific shape of the artificial bone

The wedge-shaped artificial bone provided by the invention also comprises a filler which is filled in the bone growth hole and can promote bone growth, wherein the filler is prepared from the following raw materials in parts by mass:

50-90 parts by mass of a bone regeneration material;

10-50 parts by mass of alpha-calcium sulfate hemihydrate;

1-5 parts by mass of stearic acid;

50-100 parts by mass of an osteocyte active factor;

50-100 parts by mass of physiological saline.

The raw materials for preparing the filler provided by the invention comprise 50-90 parts by mass of the bone regeneration material, preferably 60-80 parts by mass, and more preferably 65-75 parts by mass. The bone regeneration material is hydroxyapatite or tricalcium phosphate;

among them, hydroxyapatite is the main inorganic component of human and animal bones. It can be chemically bonded with organism tissue on interface, has certain solubility in vivo, can release harmless ions to organism, participate in vivo metabolism, stimulate or induce hyperostosis, promote repair of defective tissue, and exhibit bioactivity.

Tricalcium phosphate is ubiquitous in human bones, is a good bone repair material, has good biocompatibility, bioactivity and biodegradability, and is an ideal human hard tissue repair and replacement material.

the raw materials for preparing the filler also comprise 10-50 parts by mass of alpha-calcium sulfate hemihydrate, preferably 20-40 parts by mass, and more preferably 25-35 parts by mass. The alpha-calcium sulfate hemihydrate has good biocompatibility and degradability, can promote osteoblasts to attach and form bones, enables osteoclasts to absorb calcium sulfate to form biodegradation, is used as a filler of a gap in a bone defect area, forms a micro-acid environment, is favorable for the growth of blood vessels and osteoblasts, and provides a matrix required by bone formation.

For the invention, the alpha-calcium sulfate hemihydrate has an important characteristic that crystal water is generated after the alpha-calcium sulfate hemihydrate meets water, and the crystal water is solidified and hardened into calcium sulfate dihydrate, so that the raw material is powdery or fluid filler slurry which can be solidified into solid in the bone growth hole of the wedge-shaped bone main body, thereby facilitating subsequent processing on one hand and further improving the strength of the artificial bone on the other hand.

the raw materials for preparing the filler provided by the invention also comprise 1-5 parts by mass of stearic acid, preferably 2-4 parts by mass. Wherein, the stearic acid is used as a lubricant, an anti-adhesion agent and a glidant, so that the filler slurry has better fluidity and is easier to inject into the bone growth hole.

The raw materials for preparing the filler provided by the invention also comprise 50-100 parts by mass of bone cell active factors, preferably 60-90 parts by mass, and more preferably 70-80 parts by mass. The bone cell active factor is selected from one or more of human broken bones, bone powder and bone growth factors. Wherein, the bone cell active factor can promote the growth of tissues, provide matrix required by bone formation for the tissues and reduce the rejection.

The wedge-shaped artificial bone for the high tibial osteotomy further comprises a fixing hole arranged in the wedge-shaped bone main body, and the fixing hole is used for connecting the wedge-shaped artificial bone with a defect part after HTO osteotomy. The present invention is not limited to the above-mentioned connection method, and the connection method known to those skilled in the art may be used.

Referring to fig. 2, fig. 2 is a schematic structural view of a wedge-shaped artificial bone for high tibial osteotomy provided by the present invention. In fig. 2, 1 is a wedge-shaped bone main body of short carbon fiber reinforced polyetheretherketone, 2 is a bone growth hole opened in the wedge-shaped bone main body, and 3 is a fixing hole. Wherein a filler capable of promoting bone growth is filled in the bone growth hole (not shown).

The invention also provides a preparation method of the wedge-shaped artificial bone for high tibial osteotomy, which comprises the following steps:

A) preparing a short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body with bone growth holes according to the shape of the damaged bone;

B) Mixing a bone regeneration material, alpha-calcium sulfate hemihydrate, stearic acid, bone cell active factors and normal saline, pouring the mixture into bone growth holes of the wedge-shaped bone main body, and curing to obtain a wedge-shaped artificial bone precursor;

C) And carrying out heat treatment and disinfection on the wedge-shaped artificial bone precursor to obtain the wedge-shaped artificial bone.

According to the invention, firstly, a short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body is prepared according to the shape of a damaged bone. Referring to fig. 3, fig. 3 is a schematic view of an HTO surgical osteotomy site. In the invention, the method for preparing the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone body is mechanical manufacturing or 3D printing, preferably two processes of 3D printing or CNC machining, and further preferably 3D printing.

in the invention, the specific method for preparing the short carbon fiber reinforced polyether-ether-ketone wedge-shaped bone main body by 3D printing comprises the following steps:

Step one, data acquisition and modeling are carried out: the method comprises the steps of collecting damaged bone data, preparing a 3D bone model according to the data, and arranging a plurality of hole-shaped structures on the surface and/or inside the 3D bone model.

firstly, observing the force line of the lower limb at the affected side according to the lower limb full-length orthostatic X-ray film of a patient, accurately measuring the angle of the femur and tibia, and calculating the degree to be corrected, wherein the angle is the angle of the wedge-shaped artificial bone.

And then according to CT scanning data of a bone part to be implanted, introducing MIMICS software for processing, outputting an STL format file, introducing the file into 3-MATIC software for 3D modeling, establishing a 3D model of the wedge-shaped artificial bone, and outputting the STL format file (for 3D printing) or an IGES format file (for machining).

because of individual differences of the varus angle, whether to combine front and back inclination, the height and depth of the implanted prosthesis and the like of different patients, the specific shape and size of the wedge-shaped artificial bone need to be determined according to actual conditions.

Step two, preparing the artificial bone main body: the artificial bone body is prepared by 3D printing or machining.

The artificial bone has a high complexity of structure because it needs to be matched with surrounding bones, and at the same time, a porous structure is needed to be arranged on the surface and inside of the artificial bone, so that the complexity of the structure of the artificial bone is further improved. In order to ensure that the complex and fine artificial bone can be prepared and reduce the waste of raw materials in the preparation process of the artificial bone main body, the preparation of the artificial bone main body can be carried out by adopting a 3D printing mode in the technical scheme provided by the invention.

The wedge-shaped artificial bone can also be prepared by machining when the structure is less complicated. The non-porous wedge-shaped short carbon fiber reinforced polyether-ether-ketone substrate can be prepared firstly, and then the substrate is perforated.

The preparation method of the non-porous wedge-shaped short carbon fiber reinforced polyetheretherketone substrate is not particularly limited, and the method known by the person skilled in the art can be used.

Step three, filling material injection: and D, injecting the filling layer slurry into the porous structure of the artificial bone main body prepared in the step two, and curing to obtain the wedge-shaped artificial bone precursor.

In the present invention, the slurry is prepared as follows:

Uniformly mixing the bone regeneration material, alpha-calcium sulfate hemihydrate, stearic acid, bone cell active factors and normal saline to obtain slurry.

the mixing method is not particularly limited, and any mixing method capable of uniformly mixing the raw materials can be applied to the present invention.

And pouring the slurry into the bone growth holes of the wedge-shaped bone main body, and curing. Wherein, the perfusion method is syringe perfusion.

The curing temperature is room temperature, and the curing time is 2-5 minutes. In the present invention, the room temperature is defined as 25. + -. 5 ℃.

and step four, sequentially carrying out heat treatment and disinfection on the precursor to obtain the wedge-shaped artificial bone product.

through the heat treatment step, the internal stress of the artificial bone product can be eliminated or reduced, and the mechanical property and the biological property of the artificial bone product can be improved. Specifically, the heat treatment process can be carried out at the temperature of 200-250 ℃ for 1-4 h; can be finely adjusted according to the actual characteristics of the artificial bone structure.

the method of sterilization is not particularly limited in the present invention, and a method of sterilization known to those skilled in the art may be used.

The wedge-shaped bone is provided with the bone growth holes, so that the wedge-shaped bone main body is matched with the strength of the bone tissue in the human body in strength, and the growth holes are filled with fillers capable of promoting bone growth. The new bone that osteoacusis produced can grow into the inside bone growth hole that the artificial bone main part was seted up, forms three-dimensional interpenetrating structure with original bone and new bone, is favorable to the combination of artificial bone and patient self bone, has solved artificial bone implantation patient internal unable technical defect with patient self bone fusion, can avoid artificial bone not hard up simultaneously, and patient's activity is more free, can not arouse painful uncomfortable sense because of friction between artificial bone and self skeleton.

for further understanding of the present invention, the wedge-shaped artificial bone for high tibial osteotomy and the method for preparing the same according to the present invention will be described below with reference to the following examples, but the scope of the present invention is not limited by the following examples.