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A developmental biological heart occluder with controllable degradation rate

A technology of degradation rate and occluder, which is applied in X-ray contrast agent preparation, medical science, surgery, etc. It can solve the problem that doctors cannot know the shape and exact position of the implanted device, the patient's tissue is vulnerable, and the electron density is low. problems, to achieve good compliance, avoid long-term complications and safety hazards, and achieve the effect of large deformation

Active Publication Date: 2016-03-09
MALLOW MEDICAL SHANGHAICO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most biodegradable polymer materials only contain elements with low electron density or low specific gravity such as C, H, and O, which cannot be detected by X-ray perspective. After being implanted into the human body, doctors cannot know the specific shape of the implanted device in the body and accurate position, it cannot be placed accurately in the heart defect site, and the patient's tissue is also vulnerable to damage during the operation, which brings difficulties to the operation

Method used

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  • A developmental biological heart occluder with controllable degradation rate
  • A developmental biological heart occluder with controllable degradation rate
  • A developmental biological heart occluder with controllable degradation rate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]The L-lactide / caprolactone copolymer (70 / 30) monofilament blended with iohexol was used to make the support structure of the occluder, and the L-lactide / caprolactone copolymer (70 / 30) was non-woven Cloth acts as the flow-blocking membrane of the occluder. Using iohexol with a particle size distribution of 0.1 to 1 micron as a developing material, L-lactide / caprolactone copolymer (70 / 30) and iohexol are blended at a mass ratio of 70:30, blending The temperature is 120-140°C, and the blending time is 10 minutes. A blend of L-lactide / caprolactone copolymer (70 / 30) and iohexol was then melt extruded to form monofilaments with a diameter of 0.3 mm, which were braided into Tubular structure, then tie one end of the network pipe into a bundle, then put the bundled end into a mold for processing screw parts to heat and melt, and after cooling and solidifying, it will be processed into a screw part of the conveying connection control part. Then put the mesh body with the thread...

Embodiment 2

[0033] L-lactide / caprolactone copolymer (85 / 15) monofilament blended with barium sulfate to make the support structure of the occluder, L-lactide / caprolactone (85 / 15) copolymer non-woven fabric As the blocking membrane of the occluder. Barium sulfate with a particle size of 1-10 μm is used as a developing material, L-lactide / caprolactone copolymer (85 / 15) and barium sulfate are blended at a mass ratio of 80:20, and the blending temperature is 155 to 175°C, the blending time is 8min. A blend of L-lactide / caprolactone copolymer (85 / 15) and barium sulfate was then melt extruded to form monofilaments with a diameter of 0.2 mm, and the monofilaments were braided into a tube Then tie one end of the network pipe into a bundle, then put the bundled end into the mold for processing the threaded part to heat and melt, and after cooling and solidifying, it will be processed into the screwed part of the conveying connection control part. Then put the mesh body with the threaded parts in...

Embodiment 3

[0038] Blend the L-lactide / glycolide copolymer (85 / 15) monofilament of bismuth subcarbonate to make the mesh support structure of the occluder, and the L-lactide / glycolide copolymer non-woven fabric ( 85 / 15) as the blocking membrane of the occluder. Using bismuth subcarbonate with a particle size distribution of 10-30 microns as the developing material, L-lactide / glycolide copolymer (85 / 15) and bismuth subcarbonate are blended at a mass ratio of 95:5. The blending temperature is 165-185° C., and the blending time is 12 minutes. A blend of L-lactide / glycolide copolymer (85 / 15) and bismuth subcarbonate was then melt extruded to form monofilaments with a diameter of 0.3 mm and the monofilaments were braided Form a tubular structure, then tie one end of the network pipe into a bundle, then put the bundled end into a mold for processing ring parts to heat and melt, and after cooling and solidifying, it will be processed into a ring part of the conveying connection control part. T...

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Abstract

The invention discloses a developing biological heart occluder with controllable degradation rate, which is composed of a monofilament woven support structure and at least two layers of flow-resistant films sewed in the support structure; monofilament is made of a biodegradable high polymer material added with a developing material; the proportion range of the biodegradable high polymer material to the developing material is 70-98 wt% to 30-2 wt%; the particle size range of the developing material is 10 nm to 30 microns; the flow-resistant films are made of non-woven fabrics prepared from the biodegradable high polymer material. According to the invention, long-term complications and potential safety hazards caused by metal preserved in bodies are avoided; because of being manufactured by adopting the monofilament woven structure and the thermal forming method, the developing biological heart occlude is better in compliance and recovery, also good in locating and occluding effect, simple in preparation method and environment-friendly; in addition, experiments prove that the developing biological heart occluder with controllable degradation rate is applied to industrial production and has clinical application prospect.

Description

technical field [0001] The invention belongs to the field of implantation devices for the treatment of congenital heart disease, in particular to a biodegradable heart occluder visible under X-ray perspective. Background technique [0002] The material used for the main support structure of the clinically used cardiac occluder is mainly nickel-titanium alloy material. This nickel-titanium alloy occluder can present a clear image under X-ray fluoroscopy, so that the exact position of the implanted product can be judged. and released state. However, since this kind of metal material cannot be degraded, long-term implantation will cause inflammation, blood coagulation and other reactions with human tissues, and even a certain degree of damage, so there are certain defects, and there may still be the following risks in use: (1) Nickel-titanium The alloy is a non-degradable metal alloy material. Although its biocompatibility has been demonstrated, the long-term risk of long-term...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K49/04A61L31/06A61L31/18A61L31/14
Inventor 张瑾张健张纯斌马彩霞黄晓敏马绍华
Owner MALLOW MEDICAL SHANGHAICO LTD
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