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Flexible absorbable composite interface screw sheath and preparation method thereof

An interface screw and flexible technology, applied in medical science, surgery, etc., can solve the problems of lack of ductility and impact toughness, easy cracking of the interface screw sheath, decrease in strength, etc., and achieve the effect of excellent ductility, enhanced strength, and improved strength.

Inactive Publication Date: 2019-07-26
HANGZHOU REJOIN MASTIN MEDICAL INSTR CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, at present, medical absorbable materials are mainly lactide polymers, glycolide polymers or their copolymers. These materials have the disadvantage of being hard and brittle, such as lactide polymer PLA, whose elongation at break is less than 10%. Notched impact strength below 5kJ / m 2 , lack of ductility and impact toughness, and poor flexibility. The interface screw sheath prepared by it is easy to crack during use, which will cause huge problems for both the doctor's operation and the patient's repair. Therefore, it needs to be modified. After improving the flexibility for the preparation of screw sheaths
For example, some scholars use PEG400 to carry out ring-opening polymerization with maleic anhydride and lactide to obtain PESL copolymers. Using 30wt% PESL for blending modified PLA, the elongation at break can be achieved in the presence of epoxy chain extender ADR. increased to 300%, but the strength of the modified material dropped from about 60MPa of PLA raw material to 24MPa

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A method for preparing a flexible absorbable composite interface screw sheath, the steps are as follows:

[0033] (1) Adding caprolactone monomer, molecular weight is polyethylene glycol and stannous octoate of 1000g / mol in reaction flask, wherein, the mass ratio of caprolactone monomer and polyethylene glycol is 7:3, and octoate The molar ratio of tin to caprolactone monomer is 1:25000. Before starting the reaction, the reactant was dried under reduced pressure at 50° C. for 0.5 h, and then the gas atmosphere in the reaction bottle was purified with dry nitrogen several times. After that, the oil bath was heated up, and the ring-opening polymerization was carried out at 180°C. After about 5 hours, the viscosity of the product no longer increased significantly. The contents of alcohol segment and polycaprolactone segment are 30wt% and 70wt% respectively.

[0034] (2) Pre-blending L-polylactic acid with a weight average molecular weight of 600,000g / mol and polyethylene...

Embodiment 2

[0042] A method for preparing a flexible absorbable composite interface screw sheath, comprising poly(ethylene glycol)-polycaprolactone copolymer synthesized in the step (1) of Example 1 and L-polylactic acid with a weight average molecular weight of 600,000 g / mol and β-TCP with an average particle size of 500nm was pre-blended, and then melt-blended by a twin-screw extruder and extruded to granulate, and the particles were injection-molded to obtain a flexible absorbable composite interface screw sheath, in which L-polylactic acid and The mass ratio of polyethylene glycol-polycaprolactone copolymer is 8:2, and the mass content of β-TCP is 3% of the sum of the mass content of polylactic acid and polyethylene glycol-polycaprolactone copolymer. During extrusion granulation, the temperature range of each barrel and die in the twin-screw extruder is 190°C to 220°C, the screw speed is 200rpm, the injection temperature during injection molding is 200°C, and the mold temperature is 50...

Embodiment 3

[0046] A method for preparing a flexible absorbable composite interface screw sheath, the steps are as follows:

[0047] (1) Adding caprolactone monomer, molecular weight is polyethylene glycol and stannous octoate of 1000g / mol in reaction flask, wherein, the mass ratio of caprolactone monomer and polyethylene glycol is 9:1, and octoate The molar ratio of tin to caprolactone monomer is 1:25000. Before starting the reaction, the reactant was dried under reduced pressure at 50° C. for 0.5 h, and then the gas atmosphere in the reaction bottle was purified with dry nitrogen several times. After that, the oil bath was heated up, and the ring-opening polymerization was carried out at 180°C. After about 5 hours, the viscosity of the product no longer increased significantly. The contents of alcohol segment and polycaprolactone segment are respectively 10wt% and 90wt%.

[0048] (2) Pre-blending racemic polylactic acid with a weight-average molecular weight of 600,000g / mol, polyethyl...

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Abstract

The invention relates to a flexible absorbable composite interface screw sheath and a preparation method thereof. The flexible absorbable composite interface screw sheath is prepared by melt blendingand extrusion granulation of the mixture and injection molding, wherein the mixture mainly comprises a base material and polyethylene glycol, or mainly consists of a matrix material, a polyethylene glycol-flexible polylactone copolymer and beta-TCP, wherein the matrix material is polylactic acid and / or a copolymer thereof, and the flexible polylactone is a polymer of caprolactone and / or valerolactone; the flexible absorbable composite interface screw sheath has elongation at break of not less than 103%, the impact strength of not less than 10 kJ / m<2> and the breaking strength of not less than25 MPa. By adopting the method, the ductility, strength and impact toughness of the absorbable composite interface screw sheath are improved, and the prepared absorbable composite interface screw sheath has high elongation at break, high impact strength and high enough breaking strength, and has good application prospect.

Description

technical field [0001] The invention belongs to the technical field of biomedical materials, and relates to a flexible absorbable composite interface screw sheath and a preparation method thereof. Background technique [0002] Cruciate ligament injury is a common injury of the knee joint. At present, the common treatment method for ligament injury is to use interface screws as fixators to fix the tendons and ligaments on the tunnel holes made in the bone in advance. However, the interface screw is very easy to cut the ligament during the implantation process, causing damage to the ligament. In order to reduce the ligament damage caused during the implantation process of the interface screw, the existing method is to use a sheathed interface screw. The sheath can form a protection between the interface screw and the ligament, so that the screw mainly cuts the sheath during extrusion, thereby reducing the damage to the ligament. [0003] Absorbable interfacial screw with good...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/06A61L31/02A61L31/14C08G63/664C08G63/85
CPCA61L31/028A61L31/06A61L31/14A61L31/148C08G63/664C08G63/823
Inventor 李若云蒋冠森李凌晨胡程程王建铨
Owner HANGZHOU REJOIN MASTIN MEDICAL INSTR CO LTD
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