CN113892987A - Absorbable interface screw for repairing cruciate ligament and manufacturing process thereof - Google Patents
Absorbable interface screw for repairing cruciate ligament and manufacturing process thereof Download PDFInfo
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- CN113892987A CN113892987A CN202111159980.6A CN202111159980A CN113892987A CN 113892987 A CN113892987 A CN 113892987A CN 202111159980 A CN202111159980 A CN 202111159980A CN 113892987 A CN113892987 A CN 113892987A
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- 210000003041 ligament Anatomy 0.000 title claims abstract description 51
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 20
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract description 56
- 239000004626 polylactic acid Substances 0.000 claims abstract description 56
- 239000002994 raw material Substances 0.000 claims abstract description 33
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims abstract description 30
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims abstract description 30
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims abstract description 27
- 238000000034 method Methods 0.000 claims abstract description 19
- 230000008569 process Effects 0.000 claims abstract description 19
- 239000002245 particle Substances 0.000 claims description 33
- 239000011246 composite particle Substances 0.000 claims description 24
- 239000000843 powder Substances 0.000 claims description 24
- 238000001746 injection moulding Methods 0.000 claims description 20
- 238000007710 freezing Methods 0.000 claims description 18
- 230000008014 freezing Effects 0.000 claims description 18
- 238000003825 pressing Methods 0.000 claims description 15
- 230000008439 repair process Effects 0.000 claims description 15
- 238000001035 drying Methods 0.000 claims description 14
- 238000002156 mixing Methods 0.000 claims description 14
- 238000010438 heat treatment Methods 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 13
- 238000000227 grinding Methods 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 12
- 238000011049 filling Methods 0.000 claims description 8
- 230000007704 transition Effects 0.000 claims description 8
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 6
- 238000001816 cooling Methods 0.000 claims description 6
- 230000002968 anti-fracture Effects 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 3
- 229910052757 nitrogen Inorganic materials 0.000 claims description 3
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 238000001291 vacuum drying Methods 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 2
- 210000002435 tendon Anatomy 0.000 abstract description 17
- 230000006378 damage Effects 0.000 abstract description 12
- 239000004696 Poly ether ether ketone Substances 0.000 abstract description 7
- 229910001069 Ti alloy Inorganic materials 0.000 abstract description 7
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 abstract description 7
- 229920002530 polyetherether ketone Polymers 0.000 abstract description 7
- 230000000694 effects Effects 0.000 abstract description 4
- 238000002513 implantation Methods 0.000 abstract description 4
- 210000000988 bone and bone Anatomy 0.000 description 14
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 10
- 239000000463 material Substances 0.000 description 9
- 239000000047 product Substances 0.000 description 6
- 238000005485 electric heating Methods 0.000 description 5
- 239000004310 lactic acid Substances 0.000 description 5
- 235000014655 lactic acid Nutrition 0.000 description 5
- 238000000926 separation method Methods 0.000 description 5
- 238000005520 cutting process Methods 0.000 description 4
- 239000002131 composite material Substances 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- OXIKLRTYAYRAOE-CMDGGOBGSA-N (e)-3-(1-benzyl-3-pyridin-3-ylpyrazol-4-yl)prop-2-enoic acid Chemical group N1=C(C=2C=NC=CC=2)C(/C=C/C(=O)O)=CN1CC1=CC=CC=C1 OXIKLRTYAYRAOE-CMDGGOBGSA-N 0.000 description 1
- 206010066054 Dysmorphism Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010061223 Ligament injury Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 210000001264 anterior cruciate ligament Anatomy 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 210000000629 knee joint Anatomy 0.000 description 1
- 238000001000 micrograph Methods 0.000 description 1
- 210000002967 posterior cruciate ligament Anatomy 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 210000002303 tibia Anatomy 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
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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
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L31/127—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix containing fillers of phosphorus-containing inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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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
- A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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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
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
- A61B2017/0648—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks threaded, e.g. tacks with a screw thread
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- Health & Medical Sciences (AREA)
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- Life Sciences & Earth Sciences (AREA)
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Abstract
The invention relates to an absorbable interface screw for repairing cruciate ligaments and a manufacturing process thereof. The manufacturing process of the absorbable interface screw for repairing the cruciate ligament comprises the following raw materials: polylactic acid, hydroxyapatite and beta-tricalcium phosphate. The invention also relates to a specific manufacturing method of the absorbable interface screw for repairing the cruciate ligament and a structure of the absorbable interface screw for repairing the cruciate ligament. The absorbable interface screw for repairing the cruciate ligament and the manufacturing process thereof solve the problem that the existing titanium alloy interface screw and PEEK interface screw need to be implanted into a human body for a long time or taken out for secondary operation to cause product residue or secondary damage to a patient, can be absorbed by the human body, eliminate the product residue damage, do not need to be taken out for the secondary operation, and avoid the secondary damage; in addition, through the structural design of the interface nail body, the interface nail body has the effects of preventing the screw from being broken and preventing the tendon from being cut in the implantation process.
Description
Technical Field
The invention relates to the field of medical consumables, in particular to an absorbable interface screw for repairing cruciate ligaments and a manufacturing process thereof.
Background
The interface screw is a medical consumable for treating anterior and posterior cruciate ligament injuries, and is used for performing cruciate ligament reconstruction by a doctor under an arthroscope. Specifically, a doctor weaves autologous tendons of a patient, drills bone channels for fixing ligaments at the tibia and the femur of the knee joint respectively, then squeezes the ligaments on the inner walls of the bone channels by using interface screws, and finally grows on the bone channels through human body self tissue repair, so that the cruciate ligaments of the patient recover functions.
The interface screw applied in China at present is mainly imported, the existing interface screw on the market in China is mainly made of titanium alloy materials, and a small amount of PEEK material interface screws begin to appear in China only in 2019. After the titanium alloy interface screw and the PEEK interface screw are implanted into a human body, the titanium alloy interface screw and the PEEK interface screw can stay in the human body for a long time or be taken out after a secondary operation, and both the titanium alloy interface screw and the PEEK interface screw can bring follow-up injuries to a patient after being kept in the human body and taken out after the operation for a long time. By 2 months of 2021, absorbable interface screws are still monopolized by foreign large medical equipment companies, and autonomously produced absorbable interface screws still do not appear in domestic markets.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the absorbable interface screw for repairing the cruciate ligament and the manufacturing process thereof can be absorbed by the human body, so that the harm of the product residue is eliminated, the secondary operation taking-out is not needed, and the secondary injury is also avoided; in addition, through the structural design of the interface nail body, the interface nail body has the effects of preventing the screw from being broken and preventing the tendon from being cut in the implantation process.
The manufacturing process of the absorbable interface screw for repairing the cruciate ligament comprises the following raw materials: polylactic acid, hydroxyapatite and beta-tricalcium phosphate. In the aspect of raw material selection, as the absorbable screw of the pure polylactic acid interface is degraded slowly, a large amount of lactic acid is generated in the middle and late stages, and the inflammatory reaction of a patient is initiated; due to the existence of the alkaline inorganic bone induction material, the polylactic acid/Hydroxyapatite (HA) composite interface screw can effectively solve the problems that the degradation is too fast and the lactic acid is neutralized, but the HA absorption speed is very slow and a pore channel cannot be formed; the polylactic acid/hydroxyapatite (TCP) composite interface screw has the problem that lactic acid cannot be neutralized in middle and late stages due to the excessively high absorption rate of TCP. By combining the reasons, the polylactic acid, the hydroxyapatite and the beta-tricalcium phosphate are mixed to modify the material, and the advantages of the materials are taken, so that the beta-tricalcium phosphate generates pore channels in the early and medium degradation process, the dissolution of lactic acid is facilitated, the accumulation of lactic acid is reduced, and the influence of the screw body on the pH value of the whole external environment is reduced.
Specifically, the raw materials are proportioned in the following weight ratio: 60-80 parts of polylactic acid, 5-30 parts of hydroxyapatite and 5-20 parts of beta-tricalcium phosphate.
Specifically, the polylactic acid is levorotatory polylactic acid according to the type of the main raw material.
Specifically, the number average molecular weight of the levorotatory polylactic acid is 40-100 ten thousand according to the physical indexes of raw materials, the particle size of the hydroxyapatite is 2-50 mu m, and the particle size of the beta-tricalcium phosphate is 60-1000 meshes.
Preferably, the raw materials are as follows in parts by weight: 60 parts of polylactic acid, 30 parts of hydroxyapatite and 10 parts of beta-tricalcium phosphate.
The manufacturing process of the absorbable interface screw for repairing the cruciate ligament specifically comprises the following steps,
s1-mixing: putting the millimeter-sized large-particle polylactic acid into a freezing and grinding machine, freezing and grinding the large-particle polylactic acid into micron-sized small-particle polylactic acid, and putting the micron-sized small-particle polylactic acid into a vacuum drier for high-temperature drying; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder; after the polylactic acid is ground, the particle sizes of the three raw materials tend to be consistent, so that the raw materials are mixed more uniformly, the dispersibility of the composite material is further improved, and the mechanical property of the cross-section screw of a final product is finally improved;
s2-pressing: putting the mixed raw material powder obtained by mixing in the step S1 into a tablet press, and pressing the mixed raw material powder into composite particles; the pressing process does not heat the raw materials, so the molecular weight of the raw materials cannot be reduced in the processing process;
s3-precision injection molding: and (4) putting the composite particles obtained by pressing in the step S2 into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament. Specifically, an electric heating system of the micro screw type precision injection molding machine is started, the temperature is set to be 180-260 ℃, and after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, the material is injected into a mold adopting a separation type heating mode through the pressure of 200-300 bar.
Specifically, the process conditions include that the freezing temperature of the freezing grinding in the step S1 is liquid nitrogen at-196 +/-10 ℃, the cooling time is 5-100 min, the grinding time is 10 min-120 min, the temperature of the vacuum drying is 40-80 ℃, and the drying time is 0.5-8 h. In the storage tank; and S3, setting the heating temperature of the precision injection molding machine to be 180-260 ℃ and the pressurizing pressure to be 200-300 bar.
The absorbable interface screw for repairing the cruciate ligament is characterized in that an anti-fracture structure is arranged inside the screw body, and an anti-cutting ligament structure is arranged outside the screw body, wherein the anti-fracture structure is a core rod filling type driving structure arranged at the central axis part of the screw body; the cut-proof ligament structure is a thread structure formed outside the screw body.
Specifically, the core bar filling type driving structure comprises a polygonal through groove formed in the center of the screw body and a polygonal screwdriver penetrating into the polygonal through groove, and the polygonal screwdriver and the polygonal through groove are tightly assembled. In the core rod filling type driving structure, the high-strength core rod which penetrates through the whole interface screw longitudinally and is completely matched is matched, so that the rotating force is uniformly dispersed to the whole screw, and the screw is protected from being twisted and broken.
Specifically, the thread structure is integrally formed on the outer wall of the screw body, and a smooth transition part is formed at the top of the thread structure. A hole is drilled on the bone of a patient in the operation process of a doctor, then an autologous tendon of the patient is taken to penetrate into a bone duct, and a part is reserved at the tail part to combine the tendon with the bone duct; the tendon reserved at the tail part is separated at the position of the bone channel opening, and the interface screw is screwed into the hole, so that the tendon is attached to the bone channel. The edge of the front end of the screw body is provided with an arc smooth transition part. In the process of implanting the interface screw, the thread of the thread structure can rotate in by friction with the tendon, and the tip of the outer side of the thread is subjected to smooth treatment, so that the cutting of the tendon is effectively avoided.
The absorbable interface screw for repairing the cruciate ligament and the manufacturing process thereof solve the problem that the existing titanium alloy interface screw and PEEK interface screw need to be implanted into a human body for a long time or taken out in a secondary operation to cause product residue or secondary damage to a patient, can be absorbed by the human body, eliminate the product residue damage, do not need to be taken out in the secondary operation, and avoid the secondary damage; in addition, through the structural design of the interface nail body, the interface nail body has the effects of preventing the screw from being broken and preventing the tendon from being cut in the implantation process.
Drawings
The absorbable interface screw for repairing cruciate ligament of the invention is further described with reference to the accompanying drawings:
FIG. 1 is a perspective view of the present resorbable interface screw for cruciate ligament repair;
FIG. 2 is a top plan view of the present absorbable interface screw for cruciate ligament repair;
FIG. 3 is a schematic view of a cross-sectional half-section of the present resorbable interface screw for cruciate ligament repair;
FIG. 4 is a scanning electron microscope image of the present absorbable interface screw for cruciate ligament repair;
FIG. 5 is a graph of the in vitro degradation pH of the absorbable interface screw for cruciate ligament repair;
fig. 6 is a torque graph illustrating an absorbable interface screw for cruciate ligament repair.
In the figure:
1-a screw body; 11-arc smooth transition;
2-an anti-fracture structure; 21-polygonal through groove and 22-polygonal screwdriver;
3-preventing cutting ligament structure; 31-smooth transition.
Detailed Description
In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the description of the present invention, it is to be understood that the terms "left", "right", "front", "back", "top", "bottom", "inner", "outer", etc., indicate orientations and positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be considered as limiting the present invention.
The technical solution of the present invention is further described with the following specific examples, but the scope of the present invention is not limited to the following examples and embodiments. As shown in the figures 1 to 6 of the drawings,
example 1: taking 60 parts of levorotatory polylactic acid, 30 parts of hydroxyapatite and 10 parts of beta-tricalcium phosphate, putting millimeter-sized large-particle polylactic acid into a freezing grinder, freezing and grinding the millimeter-sized large-particle polylactic acid into micron-sized small-particle polylactic acid, cooling the micron-sized small-particle polylactic acid at the freezing temperature of-196 +/-10 ℃ for 5-100 min and 10-120 min, putting the micron-sized small-particle polylactic acid into a vacuum drier, and drying the micron-sized small-particle polylactic acid at the high temperature of 40-80 ℃ for 0.5-8 h; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; and putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder. And (3) putting mixed raw material powder obtained by mixing into a tablet machine, and pressing the mixed raw material powder into composite particles. And putting the composite particles obtained by pressing into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament. Specifically, an electric heating system of the micro screw type precision injection molding machine is started, the temperature is set to be 180-260 ℃, and after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, the material is injected into a mold adopting a separation type heating mode through the pressure of 200-300 bar.
Example 2: taking 65 parts of levorotatory polylactic acid, 30 parts of hydroxyapatite and 5 parts of beta-tricalcium phosphate, putting millimeter-sized large-particle polylactic acid into a freezing grinder, freezing and grinding the millimeter-sized large-particle polylactic acid into micron-sized small-particle polylactic acid, cooling the micron-sized small-particle polylactic acid at the freezing temperature of-196 +/-10 ℃ for 5-100 min and 10-120 min, putting the micron-sized small-particle polylactic acid into a vacuum drier, and drying the micron-sized small-particle polylactic acid at the high temperature of 40-80 ℃ for 0.5-8 h; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; and putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder. And (3) putting mixed raw material powder obtained by mixing into a tablet machine, and pressing the mixed raw material powder into composite particles. And putting the composite particles obtained by pressing into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament. Specifically, an electric heating system of the micro screw type precision injection molding machine is started, the temperature is set to be 180-260 ℃, and after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, the material is injected into a mold adopting a separation type heating mode through the pressure of 200-300 bar.
Example 3: 70 parts of levorotatory polylactic acid, 25 parts of hydroxyapatite and 5 parts of beta-tricalcium phosphate are taken, millimeter-sized large-particle polylactic acid is put into a freezing grinder to be frozen and ground into micron-sized small-particle polylactic acid, the freezing temperature is-196 +/-10 ℃ liquid nitrogen, the cooling time is 5-100 min, the grinding time is 10-120 min, then the mixture is put into a vacuum drier to be dried at high temperature, the vacuum drying temperature is 40-80 ℃, and the drying time is 0.5-8 h; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; and putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder. And (3) putting mixed raw material powder obtained by mixing into a tablet machine, and pressing the mixed raw material powder into composite particles. And putting the composite particles obtained by pressing into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament. Specifically, an electric heating system of the micro screw type precision injection molding machine is started, the temperature is set to be 180-260 ℃, and after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, the material is injected into a mold adopting a separation type heating mode through the pressure of 200-300 bar.
Example 4: taking 80 parts of levorotatory polylactic acid, 15 parts of hydroxyapatite and 5 parts of beta-tricalcium phosphate, putting millimeter-sized large-particle polylactic acid into a freezing grinder, freezing and grinding the millimeter-sized large-particle polylactic acid into micron-sized small-particle polylactic acid, cooling the micron-sized small-particle polylactic acid at the freezing temperature of-196 +/-10 ℃ for 5-100 min and 10-120 min, putting the micron-sized small-particle polylactic acid into a vacuum drier, and drying the micron-sized small-particle polylactic acid at the high temperature of 40-80 ℃ for 0.5-8 h; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; and putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder. And (3) putting mixed raw material powder obtained by mixing into a tablet machine, and pressing the mixed raw material powder into composite particles. And putting the composite particles obtained by pressing into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament. Specifically, an electric heating system of the micro screw type precision injection molding machine is started, the temperature is set to be 180-260 ℃, and after the actual temperature of the micro screw type precision injection molding machine is consistent with the set temperature, the material is injected into a mold adopting a separation type heating mode through the pressure of 200-300 bar.
Embodiment 1: the absorbable interface screw for repairing the cruciate ligament comprises a screw body 1, wherein a fracture prevention structure 2 is arranged inside the screw body 1, and a cutting-proof ligament structure 3 is arranged outside the screw body 1, wherein the fracture prevention structure 2 is a core rod filling type driving structure arranged at the central axis part of the screw body 1; the cut-proof ligament structure 3 is a thread structure formed outside the screw body 1. The core bar filling type driving structure comprises a polygonal through groove 21 formed in the center of the screw body 1 and a polygonal screwdriver 22 penetrating into the polygonal through groove 21, wherein the polygonal screwdriver 22 is tightly assembled with the polygonal through groove 21. In the core rod filling type driving structure, the high-strength core rod which penetrates through the whole interface screw longitudinally and is completely matched is matched, so that the rotating force is uniformly dispersed to the whole screw, and the screw is protected from being twisted and broken. The periphery of the polygonal screwdriver 22 is provided with a plurality of driving angles extending outwards, and the groove shape of the polygonal through groove 21 is matched with that of the polygonal screwdriver 22. The cooperation runs through whole interface screw and complete complex dysmorphism screwdriver, makes revolving force homodisperse to whole screw, and the protection screw can not be by torsional fracture. The thread structure is integrally formed on the outer wall of the screw body 1, and a smooth transition part 31 is formed at the top of the thread structure. A hole is drilled on the bone of a patient in the operation process of a doctor, then an autologous tendon of the patient is taken to penetrate into a bone duct, and a part is reserved at the tail part to combine the tendon with the bone duct; the tendon reserved at the tail part is separated at the position of the bone channel opening, and the interface screw is screwed into the hole, so that the tendon is attached to the bone channel. The front end edge of the screw body 1 is provided with an arc smooth transition part 11. In the process of implanting the interface screw, the thread of the thread structure can rotate in by friction with the tendon, and the tip of the outer side of the thread is subjected to smooth treatment, so that the cutting of the tendon is effectively avoided. The remaining raw materials and the manufacturing method are as described in any of embodiments 1 to 6, and will not be described repeatedly.
And (3) performance testing:
the interface screws obtained in examples 1 to 4, equipped with a screwdriver, were subjected to the tests of resistance to extraction, torque, molecular weight, with the results shown in the following table,
| examples | Phi 6.0mm screw pull-out resistance (N) | Molecular weight | Screw torque (N/m) of phi 6.0mm |
| Example 1 | 770±30 | 22000±5000 | 1.4±0.1 |
| Example 2 | 730±30 | 22000±5000 | 1.4±0.1 |
| Example 3 | 710±30 | 22000±5000 | 1.4±0.1 |
| Example 4 | 680±30 | 22000±5000 | 1.4±0.1 |
In the above table, the N-screw resistance to pull-out forces; n/m torque.
And (4) conclusion: according to the test results, the mechanical property and the molecular weight of the interface screw obtained by the process are greatly increased compared with those of the conventional medical screw product.
The absorbable interface screw for repairing the cruciate ligament and the manufacturing process thereof solve the problem that the existing titanium alloy interface screw and PEEK interface screw need to be implanted into a human body for a long time or taken out for secondary operation to cause product residue or secondary damage to a patient, can be absorbed by the human body, eliminate the product residue damage, do not need to be taken out for the secondary operation, and avoid the secondary damage; in addition, through the structural design of the interface nail body, the interface nail body has the effects of preventing the screw from being broken and preventing the tendon from being cut in the implantation process.
The foregoing description illustrates the principal features, rationale, and advantages of the invention. It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments or examples, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The foregoing embodiments or examples are therefore to be considered in all respects illustrative and not restrictive. The scope of the invention is indicated by the appended claims rather than by the foregoing description, and all changes that come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (10)
1. A manufacturing process of an absorbable interface screw for repairing cruciate ligaments is characterized in that: the interface screw is manufactured by processing the following raw materials: polylactic acid, hydroxyapatite and beta-tricalcium phosphate.
2. The process of manufacturing an absorbable interface screw for cruciate ligament repair as claimed in claim 1, wherein: the weight ratio of the raw materials is as follows: 60-80 parts of polylactic acid, 5-30 parts of hydroxyapatite and 5-20 parts of beta-tricalcium phosphate.
3. The process of manufacturing an absorbable interface screw for cruciate ligament repair as claimed in claim 2, wherein: the polylactic acid is levorotatory polylactic acid.
4. The process of manufacturing an absorbable interface screw for cruciate ligament repair as claimed in claim 3, wherein: the number average molecular weight of the levorotatory polylactic acid is 40-100 ten thousand, the particle size of the hydroxyapatite is 2-50 mu m, and the particle size of the beta-tricalcium phosphate is 60-1000 meshes.
5. The process of manufacturing an absorbable interface screw for cruciate ligament repair as claimed in claim 4, wherein: the weight parts of the raw materials are as follows: 60 parts of polylactic acid, 30 parts of hydroxyapatite and 10 parts of beta-tricalcium phosphate.
6. The process for manufacturing an absorbable interface screw for cruciate ligament repair according to any one of claims 2 to 4, wherein: the process specifically comprises the following steps of,
s1-mixing: putting the millimeter-sized large-particle polylactic acid into a freezing and grinding machine, freezing and grinding the large-particle polylactic acid into micron-sized small-particle polylactic acid, and putting the micron-sized small-particle polylactic acid into a vacuum drier for high-temperature drying; respectively drying the hydroxyapatite and the beta-tricalcium phosphate, and then putting the hydroxyapatite and the beta-tricalcium phosphate into a mechanical stirrer according to the weight part ratio, and stirring the mixture until the mixture is uniformly mixed; putting the dried polylactic acid powder into a mechanical stirrer according to the weight part ratio, and stirring again until uniformly mixing to obtain mixed raw material powder;
s2-pressing: putting the mixed raw material powder obtained by mixing in the step S1 into a tablet press, and pressing the mixed raw material powder into composite particles;
s3-injection molding: and (4) putting the composite particles obtained by pressing in the step S2 into a micro screw rod type precision injection molding machine, heating the composite particles, pressurizing and injecting the heated composite particles into a mold, and maintaining the pressure and demolding to obtain the absorbable interface screw for repairing the cruciate ligament.
7. The process of manufacturing an absorbable interface screw for cruciate ligament repair as claimed in claim 6, wherein: in the step S1, the freezing temperature of the freeze grinding is-196 +/-10 ℃ liquid nitrogen, the cooling time is 5-100 min, the grinding time is 10-120 min, the temperature of the vacuum drying is 40-80 ℃, and the drying time is 0.5-8 h. In the storage tank; and S3, setting the heating temperature of the precision injection molding machine to be 180-260 ℃ and the pressurizing pressure to be 200-300 bar.
8. An absorbable interface screw for cruciate ligament repair, which is characterized in that: the absorbable interface screw for repairing the cruciate ligament is the absorbable interface screw for repairing the cruciate ligament of claims 1 to 7, and comprises a screw body (1), wherein a fracture-preventing structure (2) is arranged inside the screw body (1), a cut-preventing ligament structure (3) is arranged outside the screw body (1),
the anti-fracture structure (2) is a core rod filling type driving structure arranged at the central axis part of the screw body (1); the cut-preventing ligament structure (3) is a thread structure formed outside the screw body (1).
9. The absorbable interface screw for cruciate ligament repair of claim 8, wherein: the core bar filling type driving structure comprises a polygonal through groove (21) formed in the center of the screw body (1) and a polygonal screwdriver (22) penetrating into the polygonal through groove (21), wherein the polygonal screwdriver (22) is tightly assembled with the polygonal through groove (21).
10. The absorbable interface screw for cruciate ligament repair of claim 8, wherein: the thread structure is integrally formed on the outer wall of the screw body (1), and a smooth transition part (31) is formed at the top of a thread of the thread structure; the front end edge of the screw body (1) is provided with an arc smooth transition part (11).
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| CN104434289A (en) * | 2014-11-28 | 2015-03-25 | 贝尔泰克医疗器械江苏有限公司 | High-strength hollow bone screw |
| CN106151198A (en) * | 2015-04-13 | 2016-11-23 | 鸿富锦精密工业（深圳）有限公司 | Threaded fastener assembly and screw piece thereof |
| CN111494724A (en) * | 2020-05-28 | 2020-08-07 | 花沐医疗科技(上海)有限公司 | Composite absorbable interface screw and preparation method thereof |
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