阅读说明：本技术 一种可降解形状记忆股骨内固定体 (Degradable shape memory femoral internal fixation body ) 是由 田大为 熊敏 何宏生 陈洁 刘娜 于 2019-03-13 设计创作，主要内容包括：本发明公开了一种可降解形状记忆股骨内固定体,包括固定体本体,固定体由可生物降解形状记忆材料制成,其相转变温度高于医用冷藏箱冷藏温度且低于正常人体体温；当固定体的温度低于相转变温度时,所述的固定体保持在形状记忆的暂时形状。可生物降解形状记忆材料的组成原料如下：聚乳酸50-80％,聚ε-己内酯0-40％,丙交酯-ε-己内酯共聚物0-18％,无机填料0-40％,硅烷偶联剂0-1％,着色剂0-1％；白油为0-1％。本发明中的可降解形状记忆材料透气耐水性好,具有记忆功能,即将已经塑型的固定材料升温的时候,它将自动恢复到原来的形状。(The invention discloses a degradable shape memory femoral internal fixation body, which comprises a fixation body, wherein the fixation body is made of biodegradable shape memory materials, and the phase transition temperature of the fixation body is higher than the refrigeration temperature of a medical refrigerator and lower than the normal body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape. The biodegradable shape memory material comprises the following raw materials: 50-80% of polylactic acid, 0-40% of poly-caprolactone, 0-18% of lactide-caprolactone copolymer, 0-40% of inorganic filler, 0-1% of silane coupling agent and 0-1% of colorant; white oil is 0-1%. The degradable shape memory material has good air permeability and water resistance and has a memory function, namely, when the temperature of the molded fixing material is raised, the degradable shape memory material can automatically recover to the original shape.)

1. A degradable shape memory femoral internal fixation body, comprising: the fixing body is made of biodegradable shape memory materials, and the phase transition temperature of the fixing body is higher than the refrigeration temperature of the medical refrigerator and lower than the normal body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape.

2. The degradable shape memory femoral internal fixation body according to claim 1, wherein the fixation body comprises a main body part and a fixation part, the main body part is located at the middle part, and the fixation part is arranged at the upper end and the lower end of the main body part.

3. The degradable shape memory femoral internal fixation body of claim 2, wherein the fixation portion of the fixation body comprises a plurality of tapered barb structures.

4. The degradable shape memory femoral internal fixation of claim 3 wherein the temperature of the fixation body increases above the phase transition temperature after the fixation body is placed in the intramedullary canal of the femur, and the fixation body is stimulated by the temperature to automatically return from the temporary shape to the shape memory of the original shape;

the fixing body in the temporary shape can be smoothly placed into the medullary cavity of the femur through the fractured end;

the main body part of the fixing body is stretched and lengthened, and the radial dimension of the main body part is contracted to be smaller than the inner diameter of a medullary cavity of a fracture part;

the fixing body barbs in the initial shape penetrate into the inner wall of the medullary cavity of the femoral bone, and the ribs on two sides of the fracture end are firmly fixed at two ends of the main body part; under the restoring force effect of the shape memory effect, the head parts at the two ends of the fixing part are divided into a plurality of barbs which are extended towards the outer periphery, the main body part of the fixing body is radially expanded and shortened in length, and the thighbones at the two sides of the broken end of the fracture are drawn to be close to each other and firmly folded.

5. The degradable shape memory femoral internal fixation body according to any one of claims 1 to 4, wherein the biodegradable shape memory material comprises the following raw materials:

50-80% of polylactic acid, 0-40% of poly-caprolactone, 0-18% of lactide-caprolactone copolymer, 0-40% of inorganic filler, 0-1% of silane coupling agent and 0-1% of colorant; white oil is 0-1%.

6. The degradable shape memory femoral internal fixation body according to claim 5, wherein the degradable shape memory femoral internal fixation body comprises 50% of polylactic acid, 20% of poly-caprolactone, 17% of lactide-caprolactone copolymer, 10% of inorganic filler, 1% of silane coupling agent and 1% of coloring agent; the white oil content is 1%.

7. The degradable shape memory femoral internal fixation body of claim 5, wherein the inorganic filler is one or more of calcium carbonate, titanium dioxide, barium sulfate or montmorillonite.

8. The degradable shape memory femoral internal fixation body of claim 5, wherein the silane coupling agent is gamma-aminopropyltriethoxysilane, gamma-glycidoxypropyltrimethylsilane or gamma-methacryloxypropyltrimethoxysilane.

9. The degradable shape memory femoral internal fixation body according to claim 5, wherein the L-content of the polylactic acid is 60-90%, and the number average molecular weight of the polylactic acid is 10,000-150,000.

Technical Field

The invention relates to orthopedic medical instruments or equipment, in particular to degradable fracture fixation equipment for realizing femoral fracture internal fixation by utilizing a shape memory material.

Background

Femur fracture is a common fracture in clinic, such as hip joint fracture (including femoral neck fracture and intertrochanteric fracture), and fracture of femoral shaft. The femoral fracture is caused by various factors such as direct violent striking, high falling, vehicle impact and the like; the femoral neck and the femoral tuberosity part are turning points of the trunk and the lower limbs, stress is concentrated, the part is also a fractured and well-developed part, and particularly hip joint fracture can occur to the old due to osteoporosis under a small external force. In femoral fracture, due to traction of limb muscle and ligament, shortening, angulation and lateral displacement deformity are often generated, and part of patients even injure vascular nerves, and need to be intervened by operation.

The treatment of femoral fractures usually takes three forms of external fixation, extramedullary fixation (steel plate) and intramedullary fixation (intramedullary needle), but the three treatments have respective advantages and disadvantages. The plaster and the small splint can be used for fixing bones when the fracture displacement is not obvious, the fracture can be slowly healed in a traction mode, the wound is small, but the possibility of joint stiffness, dropsy pneumonia and urinary infection is fixed for a long time. For the displacement of the obvious comminuted fracture, the operation treatment is the key. The incision reduction extramedullary fixation (such as steel plate) can obtain better fracture reduction, but the biggest disadvantage of the fixation is that periosteum needs to be stripped, and the operation wound is large. The intramedullary fixation is small in operation wound, firm in fixation and capable of moving in the early stage, but the operation learning curve is long, and the operation is difficult. And the internal fixation patient needs the secondary operation to take out the internal fixation, and the patient needs to experience the anesthesia operation risk again, has certain danger to old patient or weak and internal medicine disease patient. How to improve the cure rate of femoral fracture, the form and material of fixation are important influencing factors.

The Chinese invention patent 'bidirectional shape memory polymer composite material and a preparation method thereof' (invention patent No. ZL200610136572.8 grant No. CN101164770B) discloses a polymer composite material with bidirectional shape memory effect and a preparation method thereof, wherein the polymer composite material is formed by overlapping and bonding a polymer material with shape memory function and an elastic material capable of actively returning and has bidirectional shape memory effect. The polymer composite material has a wide shape memory recovery temperature range, can obtain the two-way shape memory function of different shape recovery temperatures by selecting different shape memory polymers, has a large deformation amount and a better two-way shape memory function, and the two-way shape memory performance can be obtained by adjusting the thickness of the shape memory polymers, the thickness of elastic materials and the like. However, the polymer composite is not a biodegradable material and cannot be used to manufacture a degradable and absorbable orthopedic fixation device because it has no tissue compatibility.

Therefore, how to provide a degradable shape memory femoral internal fixation body is a technical problem to be solved by those skilled in the art.

Disclosure of Invention

In view of the above, the present invention provides a degradable shape memory femoral internal fixation body.

In order to achieve the purpose, the invention adopts the following technical scheme:

a degradable shape memory femoral internal fixation body, comprising: the fixing body is made of biodegradable shape memory materials, and the phase transition temperature of the fixing body is higher than the refrigeration temperature of the medical refrigerator and lower than the normal body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape.

Further, the fixing body comprises a main body part and a fixing part, the main body part is located in the middle, and the fixing part is arranged at the upper end and the lower end of the main body part.

Further, the fixing part of the fixing body comprises a plurality of conical thorn structures.

Furthermore, when the temperature of the fixing body rises above the phase transition temperature after the fixing body is placed in the medullary cavity of the femur, the fixing body is stimulated by the temperature and automatically returns to the original shape with shape memory from the temporary shape;

the fixing body in the temporary shape can be smoothly placed into the medullary cavity of the femur through the fractured end;

the main body part of the fixing body is stretched and lengthened, and the radial dimension of the main body part is contracted to be smaller than the inner diameter of a medullary cavity of a fracture part;

the fixing body barbs in the initial shape penetrate into the inner wall of the medullary cavity of the femoral bone, and the ribs on two sides of the fracture end are firmly fixed at two ends of the main body part; under the restoring force effect of the shape memory effect, the head parts at the two ends of the fixing part are divided into a plurality of barbs which are extended towards the outer periphery, the main body part of the fixing body is radially expanded and shortened in length, and the thighbones at the two sides of the broken end of the fracture are drawn to be close to each other and firmly folded.

Further, the biodegradable shape memory material comprises the following raw materials:

50-80% of polylactic acid, 0-40% of poly-caprolactone, 0-18% of lactide-caprolactone copolymer, 0-40% of inorganic filler, 0-1% of silane coupling agent and 0-1% of colorant; white oil is 0-1%.

Further, the biodegradable shape memory material comprises the following raw materials:

50% of polylactic acid, 20% of poly-caprolactone, 17% of lactide-caprolactone copolymer, 10% of inorganic filler, 1% of silane coupling agent and 1% of colorant; the white oil content is 1%.

Further, the inorganic filler is one or more of calcium carbonate, titanium dioxide, barium sulfate or montmorillonite.

Further, the silane coupling agent is gamma-aminopropyltriethoxysilane, gamma-glycidoxypropyltrimethylsilane or gamma-methacryloxypropyltrimethoxysilane.

Further, the L-content of the polylactic acid is 60-90%, and the number average molecular weight of the polylactic acid is 100,000-150,000.

Compared with the prior art, the degradable shape memory femoral internal fixation body is provided.

The invention has the beneficial effects that:

the degradable shape memory femoral internal fixation body realizes internal fixation of the fracture broken end by utilizing the shape memory effect, has firm connection and difficult displacement, is simple and convenient to operate after being placed in an operation, does not need special surgical instruments, and can reduce the medical cost. The degradable shape memory femoral internal fixation body of the invention can firmly close the fracture broken end by the restoring force of the shape memory effect without suture reinforcement, thereby not only avoiding influencing the fracture healing due to the influence of the suture on the blood supply of periosteum, but also relieving the pain of patients. The degradable shape memory femoral internal fixation body is made of biodegradable materials, can be gradually degraded and absorbed, does not need to be taken out by a secondary operation, and does not influence the later-stage chest CT and MRI examination.

The degradable shape memory material has good air permeability and water resistance, good mechanical property, good toughness and no fracture, tensile fracture, damage and the like when in use; because the material of the invention has memory, the material can be restored to the original shape after being heated to the plastic temperature for the second time; and (3) biodegradation after waste: polylactic acid is a well-known completely biodegradable material, and wastes can be completely degraded without causing pollution to the environment.

In addition, the invention has low cost, has obvious market competitive advantage compared with other products, and the product of the invention is convenient to use: putting the fixing material in warm water to soften the fixing material; the fixing material is taken out and applied to the body part needing fixing, reshaping or positioning, the shaping operation is carried out, and the material is completely hardened along with the reduction of the temperature. The fixing material has a memory function, namely, when the temperature of the molded fixing material is raised, the fixing material automatically restores to the original shape.

Drawings

In order to more 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 described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

Fig. 1 is a schematic diagram provided in embodiment 1 of the present invention.

Fig. 2 is a schematic diagram provided in embodiment 2 of the present invention.

Fig. 3 is a schematic diagram provided in embodiment 3 of the present invention.

FIG. 4 is a schematic structural diagram of the fixing body of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The embodiment of the invention discloses a degradable shape memory femoral internal fixation body.