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Absorbable plugging device

An occluder, polymer technology, applied in medical science, prosthesis, surgery, etc., can solve problems such as inflammatory response, achieve long degradation period and reduce the effect of release concentration

Active Publication Date: 2017-03-15
LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, the absorbable polymer occluder is usually made of only one kind of polymer. During the degradation process of the absorbable polymer occluder, it usually degrades intensively within a certain period of time, and its degradation products will be released at this time. Intensive release in the segment exceeds the amount that can be absorbed by the tissue, resulting in a severe inflammatory response

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] In the occluder provided in this embodiment, the overall mass of the braided mesh of the occluder is 0.726g. The braided net includes 96 poly-L-lactic acid (PLLA) filaments with a weight-average molecular weight of 100,000 Da and a polydispersity coefficient of 6.02, a filament diameter of 0.15 mm, and a crystallinity of 50%. The in vitro degradation experiment was carried out on PLLA silk. After 6 months of degradation, the elastic modulus measured was 2.66GPa, and the elongation at break was 70%. It has a stable frame structure within one month, so as to achieve complete endothelial coverage; the change trend of PLLA silk mass retention rate with time is as follows: image 3 As shown in curve 1, the degradation cycle is about 4 to 5 years, and the polymer mass retention rate drops less than 5% every 2 months in the 6th to 56th month, indicating that the degradation products are in the 6th to 56th month. After 2 years of implanting the occluder into the pig's heart, t...

Embodiment 2

[0039] In the occluder provided in this embodiment, the overall mass of the braided mesh of the occluder is 0.726g. The braided net includes 96 PLLA filaments with a weight average molecular weight of 100,000 Da, a polydispersity coefficient of 5.12, a crystallinity of 50%, and a filament diameter of 0.15 mm. In vitro degradation experiments were carried out on PLLA silk. After 6 months of degradation, the elastic modulus measured was 2.86GPa, and the elongation at break was 66%. This shows that the occluder made of PLLA silk in this embodiment can guarantee It has a stable frame structure within 6 months, so as to achieve complete endothelial coverage; the change trend of the quality retention rate of PLLA silk over time is as follows: image 3 As shown in the curve 2, the degradation period is 4 to 5 years, and the decrease of the polymer mass retention rate every 2 months in the 6th to 52nd month is less than 5%, indicating that the degradation product is in the 6th to 52nd...

Embodiment 3

[0041] In the occluder provided in this example, the braided mesh includes 200 polylactic-co-glycolic acid (PLGA) wires with a weight-average molecular weight of 50,000 Da and a polydispersity coefficient of 10, with a wire diameter of 0.50 mm and a crystallinity of 80. %. The in vitro degradation experiment was carried out on PLGA silk, and the elastic modulus measured after 6 months of degradation was 3.01GPa, and the elongation at break was 75%. It has a stable frame structure within one month, so as to achieve complete endothelial coverage; the decline of PLGA silk every two months from the 6th to 54th month is less than 5%, and the change trend of the quality retention rate of PLGA silk with time is as follows: image 3 As shown in the curve 3, the degradation products are released slowly in the 6th to 54th months; two years after the occluder implanted in the heart of pigs, the occluder and surrounding myocardial tissue were analyzed by pathological slices, and the patho...

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Abstract

The invention discloses an absorbable plugging device which comprises a mesh grid. The mesh grid includes a degradable macromolecule silk. The polydispersity index of the degradable macromolecule silk material is 3 to 10. A range of weight-average molecular weight is 20,000 D a to 800,000 D a. The absorbable plugging device is capable of avoiding a serious organization inflammatory reaction caused by the centralized release within a certain period of time of the degradation product of the degradable macromolecule silk, forming the mesh grid.

Description

technical field [0001] The invention relates to a cardiovascular medical device, in particular to an absorbable occluder that can be used to occlude defects in the heart or blood vessels. Background technique [0002] Atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA) are several common congenital heart defects. The interventional therapy method of occluding cardiac defects with an occluder is the preferred treatment option for patients with indications for cardiac defects due to its mild trauma, safe operation, and definite short- and medium-term curative effect. [0003] At present, most occluders are made of metal alloy materials with shape memory function. After the occluder is implanted in the body, the tissue around the defect grows inward and completes endothelialization, and the occluder will exist at the defect site for life. Occluders made of metal alloy materials have the risk of long-term complications including atri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F2/02
CPCA61F2/02A61L31/06
Inventor 向冬颜莉陈贤淼张智伟
Owner LIFETECH SCIENTIFIC (SHENZHEN) CO LTD
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