CN111685861A - Degradable shape memory femoral internal fixation body - Google Patents
Degradable shape memory femoral internal fixation body Download PDFInfo
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- CN111685861A CN111685861A CN201910190887.8A CN201910190887A CN111685861A CN 111685861 A CN111685861 A CN 111685861A CN 201910190887 A CN201910190887 A CN 201910190887A CN 111685861 A CN111685861 A CN 111685861A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/74—Devices for the head or neck or trochanter of the femur
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
- C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/02—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group
- C08L2205/025—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group containing two or more polymers of the same hierarchy C08L, and differing only in parameters such as density, comonomer content, molecular weight, structure
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
- C08L2205/035—Polymer mixtures characterised by other features containing three or more polymers in a blend containing four or more polymers in a blend
Abstract
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.
Description
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.
Example 1:
the fracture addressed by example 1 was a fracture occurring at the neck of the femur.
A degradable shape memory femur internal fixation body, a fixation body, wherein the fixation body is made of biodegradable shape memory material, and the phase transition temperature of the fixation body is higher than the refrigeration temperature of a medical refrigerator and lower than the normal human body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape. The fixing body comprises a main body part and a fixing part, wherein the main body part is positioned at the middle part 1, and the fixing part is arranged at the upper end and the lower end of the main body part. The fixed part of the fixed body comprises a plurality of conical thorn structures 2.
When the fixture is placed in the medullary cavity of femur, the temperature of the fixture is raised to be higher than the phase transition temperature, and the fixture is stimulated by the temperature to automatically return to the original shape of 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 the 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.
The femoral neck is itself narrow and is prone to other post-operative problems such as secondary infection and femoral head necrosis. The femoral neck fracture is slightly dislocated, the femoral head necrosis rate is 15.7 percent, the femoral head necrosis rate is 35.7 percent for moderate dislocation, the femoral head necrosis rate is 51 percent for severe dislocation, the better the reduction quality is, and the lower the femoral head necrosis occurrence rate is.
The fixing body of the invention is specially processed aiming at the particularity of the femoral neck, and the size and the length of the fixing body are determined according to specific conditions.
Example 2:
example 2 is directed to intertrochanteric femoral fractures.
A degradable shape memory femur internal fixation body, a fixation body, wherein the fixation body is made of biodegradable shape memory material, and the phase transition temperature of the fixation body is higher than the refrigeration temperature of a medical refrigerator and lower than the normal human body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape. The fixing body comprises a main body part and a fixing part, wherein the main body part is positioned in the middle, and the fixing part is arranged at the upper end and the lower end of the main body part. The fixing part of the fixing body comprises a plurality of conical thorn structures.
When the fixing body is placed in the medullary cavity of femur, the temperature of the fixing body is raised to be higher than the phase transition temperature, and the fixing body is stimulated by the temperature to automatically recover from the temporary shape to the original shape of the shape memory;
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 the 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.
The fracture of trochanter department is compared to the fracture of femoral neck problem and is changed the appearance, and fracture between the femoral trochanter is the common damage of old person, and the patient's average age is higher than femoral neck fracture patient 5 ~ 6 years old. Because of the abundant blood circulation of the tuberosity part, the fracture rarely does not heal, but the hip varus is easy to occur.
The fixing body of the invention is specially processed aiming at the particularity among the femurs and the size and the length of the fixing body are different from those of the fracture fixing body of the femoral neck.
Example 3:
example 3 is directed to femoral diaphyseal fractures.
A degradable shape memory femur internal fixation body, a fixation body, wherein the fixation body is made of biodegradable shape memory material, and the phase transition temperature of the fixation body is higher than the refrigeration temperature of a medical refrigerator and lower than the normal human body temperature; when the temperature of the anchor is below the phase transition temperature, the anchor remains in the shape-memorized temporary shape. The fixing body comprises a main body part and a fixing part, wherein the main body part is positioned in the middle, and the fixing part is arranged at the upper end and the lower end of the main body part. The fixing part of the fixing body comprises a plurality of conical thorn structures.
When the fixing body is placed in the medullary cavity of femur, the temperature of the fixing body is raised to be higher than the phase transition temperature, and the fixing body is stimulated by the temperature to automatically recover from the temporary shape to the original shape of the shape memory;
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 the 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.
The femoral shaft fracture is relatively simple and convenient to process relative to the problem of femoral neck fracture.
The biodegradable shape memory material of examples 1-3 was composed of the following raw materials:
50% of polylactic acid, 20% of poly-caprolactone, 0-17% of lactide-caprolactone copolymer, 0-10% of inorganic filler, 1% of silane coupling agent and 1% of colorant; the white oil content is 1%. The inorganic filler is calcium carbonate, and the silane coupling agent is gamma-aminopropyl triethoxysilane. The L-content of polylactic acid is 60%, and the number average molecular weight of the polylactic acid is 100,000.
Example 4:
under the premise of keeping other conditions unchanged, the biodegradable shape memory material in the embodiment 1 is replaced, and the biodegradable shape memory material comprises the following raw materials:
60% of polylactic acid, 10% of poly-caprolactone, 18% of lactide-caprolactone copolymer, 10% of inorganic filler, 1% of silane coupling agent and 0.5% of colorant; the white oil content was 0.5%. The inorganic filler is calcium carbonate and titanium dioxide. The silane coupling agent is gamma-glycidyl ether oxypropyltrimethylsilane. The L-content of polylactic acid is 70%, and the number average molecular weight of the polylactic acid is 120,000.
Example 5
Under the premise of keeping other conditions unchanged, the biodegradable shape memory material in the embodiment 2 is replaced, and the biodegradable shape memory material comprises the following raw materials:
60% of polylactic acid, 10% of poly-caprolactone, 18% of lactide-caprolactone copolymer, 10% of inorganic filler, 1% of silane coupling agent and 0.5% of colorant; the white oil content was 0.5%. The inorganic filler is calcium carbonate and titanium dioxide. The silane coupling agent is gamma-glycidyl ether oxypropyltrimethylsilane. The L-content of polylactic acid is 70%, and the number average molecular weight of the polylactic acid is 120,000.
Example 6:
under the premise of keeping other conditions unchanged, the biodegradable shape memory material in the embodiment 1 is replaced, and 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%. The inorganic filler is calcium carbonate, and the silane coupling agent is gamma-aminopropyl triethoxysilane. The L-content of polylactic acid is 60%, and the number average molecular weight of the polylactic acid is 15,000.
Example 7:
under the premise of keeping other conditions unchanged, the biodegradable shape memory material in the embodiment 2 is replaced, and 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%. The inorganic filler is calcium carbonate, and the silane coupling agent is gamma-aminopropyl triethoxysilane. The L-content of polylactic acid is 60%, and the number average molecular weight of the polylactic acid is 15,000.
The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other. The device disclosed by the embodiment corresponds to the method disclosed by the embodiment, so that the description is simple, and the relevant points can be referred to the method part for description.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (9)
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.
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| CN112831032A (en) * | 2021-01-07 | 2021-05-25 | 江南大学 | Polylactic acid composite material with high melt fluidity and preparation method thereof |
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Application publication date: 20200922 |