A kind of enhanced absorbable ligation clip and its preparation method

An enhanced ligation clip technology, which is applied in medical formula, medical science, surgery, etc., can solve the problems of artifacts and deflection in MRI and CT, weak closure force of ligation clips, and risk of tissue damage, etc., and achieve good biodegradability Sexuality, strong closing force, and good biocompatibility

Active Publication Date: 2018-08-24
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Metal clips are easy to operate, have excellent mechanical properties, and are widely used in clinical practice. However, due to their metal properties, they have the following disadvantages: Interfering with imaging examinations, MRI and CT have artifacts and deflection; when using a coagulator during surgery, there is a risk of conductive damage to tissue ; Rigid structure, narrow ligation range
Polydioxanone (PPDO) has excellent flexibility and processability, and has become the preferred raw material for absorbable ligation clips, such as Johnson & Johnson Anshu Suppository TM, etc., but due to the influence of its mechanical strength and modulus, The closure force of the ligation clip is weak, and the FDA adverse event report shows that different types of Johnson & Johnson absorbable ligation clip products have over-closure failures
In addition, the healing time of the luminal tissue is only 2 weeks, while all marketed absorbable ligation clips, such as Johnson & Johnson Anshu SuppositoryTM, Tyco Lapro-ClipTM and Hangzhou Shengshi Sufeng, need more than 180 days to completely degrade. There is a long postoperative risk period, such as inflammation, adhesion, etc., which brings hidden dangers to the recovery of patients

Method used

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  • A kind of enhanced absorbable ligation clip and its preparation method
  • A kind of enhanced absorbable ligation clip and its preparation method
  • A kind of enhanced absorbable ligation clip and its preparation method

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preparation example Construction

[0034] The invention also discloses a method for preparing an enhanced absorbable ligature clip, comprising the following steps:

[0035] ① Vacuum-dry the polyester material at 100°C for 24 hours. Under the protection of nitrogen, put it in the screw of the spinning device to melt it. Under the voltage of 8~30KV, extrude and spin the filament at a constant speed. After receiving it in the vortex cooling liquid tank, the diameter 1-10 μm polyester fiber bundle; the polyester material is polyglycolide or polylactide;

[0036] ②Under the protection of nitrogen, heat-stretch the polyester fiber bundle obtained in step ① twice, each stretching ratio is 5-8 times, to obtain nanofibers with a diameter of 300-500nm;

[0037] When the material of the polyester fiber bundle obtained in step 1 is polyglycolide, the temperatures of the two thermal stretches are respectively 180°C and 160°C; The stretching temperatures are 150°C and 130°C respectively;

[0038] ③ The nanofibers obtained ...

Embodiment 1

[0053] A reinforced absorbable ligature clip, the material used in the ligature clip is composed of base material and nano-short fibers, the nano-short fibers maintain a crystalline form and are uniformly dispersed in the base material, and the mass percentage of nano-short fibers in the composite material is 5% ; The base material is polydioxanone; the nano-short fiber is a polyester material, and the polyester material is polyglycolide; the diameter of the nano-short fiber is 300nm, and the length is 20 μm.

Embodiment 2

[0055] A reinforced absorbable ligature clip, the material used in the ligature clip is composed of base material and nano-short fibers, the nano-short fibers maintain a crystalline form and are uniformly dispersed in the base material, and the mass percentage of nano-short fibers in the composite material is 50% ; The basic material is polytrimethylene carbonate; the nano-short fiber is a polyester material, and the polyester material is polylactide; the diameter of the nano-short fiber is 500nm, and the length is 50 μm.

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Abstract

The invention discloses a reinforced absorbable ligature clip and a preparation method thereof. The material used in the ligature clip is composed of basic materials and short nanofibers. The short nanofibers maintain a crystalline form and are uniformly dispersed in the basic material. The short nanofibers are compounded The mass percentage in the material is 5% to 50%; the enhanced absorbable ligation clip of the present invention has good biocompatibility and biodegradability, and will not cause tissue adhesion, infarction, sepsis and other phenomena after use. Among them, due to the rapid hydrolysis of short-fiber polyester materials such as polyglycolide or polylactide, generally after 30 days, a regional acidic environment will be formed inside the ligation clip, which will accelerate the degradation of the base material and reduce the absorption of the base material. The time is greatly shortened from the original 180 days to 90 days, and there is no foreign body adverse reaction, which can meet the clinical requirements of medical materials.

Description

technical field [0001] The invention relates to the technical field, in particular to an enhanced absorbable ligation clip and a preparation method thereof. Background technique [0002] Compared with the traditional silk ligation, the disposable ligation clip suitable for laparoscopic surgery is more convenient, accurate and efficient in operation, and its clinical effectiveness has been recognized. Because of its wide application range, large dosage and high added value, it has been favored by domestic and foreign enterprises and research institutes. People are widely concerned. At present, ligation clips are mainly divided into metal clips, non-absorbable plastic clips and absorbable ligation clips according to their materials. [0003] Metal clips are easy to operate, have excellent mechanical properties, and are widely used in clinical practice. However, due to their metal properties, they have the following disadvantages: Interfering with imaging examinations, MRI and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L17/12
CPCA61L17/12A61L2400/04
Inventor 刘阳朱爱臣马丽霞王宪朋董浩吴倩倩李俊起王传栋王勤
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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