Extratracheal stent suitable for children and preparation method thereof

A technology of external stent and trachea, which is applied in the field of medical devices, can solve the problems of poor biodegradability, and achieve the effects of improving safety, simple preparation process, and avoiding human adverse reactions

Inactive Publication Date: 2021-10-26
广州博汇医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the stent is bent or squeezed, it can return to its original shape, but it has poor biodegradability

Method used

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  • Extratracheal stent suitable for children and preparation method thereof
  • Extratracheal stent suitable for children and preparation method thereof
  • Extratracheal stent suitable for children and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1. A kind of extratracheal stent suitable for children and its preparation method

[0026] Composition: L-polylactic acid 85.0%, racemic polylactic acid 11.3%, trimethallyl isocyanate 2.0% and polyglutamic acid 1.7%.

[0027] Preparation method: S1. Weigh L-polylactic acid, racemic polylactic acid, polyglutamic acid and trimethallyl isocyanate in formula amounts and carry out melt blending to obtain a blend;

[0028] S2, carrying out multi-stage stretching extrusion of the blend obtained in step S1, and granulating to obtain plastic pellets;

[0029] S3, performing fused deposition 3D printing on the plastic pellets prepared in step S2 to obtain a formed initial product;

[0030] S4, using a cobalt source irradiation device to irradiate, crosslink and sterilize the primary product prepared in step S3, and control the irradiation dose to be 15 kGy, to obtain an extratracheal stent.

Embodiment 2

[0031] Embodiment 2. A kind of extratracheal stent suitable for children and its preparation method

[0032] Composition: L-polylactic acid 70.0%, racemic polylactic acid 23.2%, triallyl isocyanurate 4.0% and polyglutamic acid 2.8%.

[0033] Preparation method: S1. Weigh L-polylactic acid, racemic polylactic acid, polyglutamic acid and trimethallyl isocyanate in formula amounts and carry out melt blending to obtain a blend;

[0034] S2, carrying out multi-stage stretching extrusion of the blend obtained in step S1, and granulating to obtain plastic pellets;

[0035] S3, performing fused deposition 3D printing on the plastic pellets prepared in step S2 to obtain a formed initial product;

[0036] S4, using a cobalt source irradiation device to irradiate, crosslink and sterilize the initial product prepared in step S3, and control the irradiation dose to be 25 kGy, to obtain an extratracheal stent.

Embodiment 3

[0037] Embodiment 3. A kind of extratracheal stent suitable for children and its preparation method

[0038] Composition: L-polylactic acid 65.0%, racemic polylactic acid 25.1%, trimethylolpropane triacrylate 6.0% and polyglutamic acid 3.9%.

[0039] Preparation method: S1. Weigh L-polylactic acid, racemic polylactic acid, polyglutamic acid and trimethallyl isocyanate in formula amounts and carry out melt blending to obtain a blend;

[0040]S2, carrying out multi-stage stretching extrusion of the blend obtained in step S1, and granulating to obtain plastic pellets;

[0041] S3, performing fused deposition 3D printing on the plastic pellets prepared in step S2 to obtain a formed initial product;

[0042] S4, using a cobalt source irradiation device to irradiate, cross-link and sterilize the primary product prepared in step S3, and control the irradiation dose to be 40 kGy to obtain an extratracheal stent.

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Abstract

The invention belongs to the field of medical apparatus and instruments, and particularly relates to an extratracheal stent suitable for children and a preparation method thereof. L-polylactic acid, racemic polylactic acid, a cross-linking agent and an auxiliary agent are blended, a 3D printer is adopted for printing, and then the mixture is placed in a cobalt source irradiation device or an electron accelerator for irradiation cross-linking and sterilization to obtain the extratracheal stent. The L-polylactic acid, the racemic polylactic acid, the cross-linking agent and the auxiliary agent are mixed according to a specific proportion, radiation cross-linking is carried out in the preparation process, the mechanical performance of the prepared extratracheal stent is remarkably enhanced, and the L-polylactic acid and the racemic polylactic acid are compounded, so that the controllable degradation performance of the extratracheal stent can be effectively enhanced; the mechanical strength and biocompatibility of the extratracheal stent are further enhanced by adding the auxiliary agent, the defects of poor mechanical property, poor biocompatibility and uncontrollable biodegradation of the existing stent are effectively overcome, and the clinical requirements of children and other patients at different age stages are better met.

Description

technical field [0001] The invention belongs to the field of medical devices, in particular to an extratracheal stent suitable for children and a preparation method thereof. Background technique [0002] Tracheomalacia or tracheobronchiomalacia (TBM) is a congenital or acquired defect of the trachea and / or bronchial cartilage. These conditions can be characterized by relaxation of the bronchi or bronchial cartilage, leading to airway obstruction, difficulty breathing, and even death in severe cases. Affecting an estimated 1 in 2,100 children, TBM presents with dyspnea, chronic cough, wheezing, recurrent infections and, in severe cases, life-threatening conditions. Surgical intervention may be required for adults and infants with severe forms of TBM that do not respond to medical therapy or have life-threatening symptoms. Severe cases can result in death or require a tracheostomy and ventilation for 2-3 years, placing a burden on the child and family. Current treatment tec...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61L31/04A61L31/14A61M16/04B33Y10/00B33Y30/00B33Y80/00B33Y70/00
CPCA61L31/041B33Y80/00B33Y10/00B33Y30/00A61L31/148A61L31/14A61M16/04B33Y70/00C08L67/04
Inventor李乐雷勇陈卫平辜英杰王璐
Owner广州博汇医疗科技有限公司