Biodegradable lacrimal duct embolus and preparation method thereof

A biodegradable, lacrimal duct technology, applied in the field of medical devices, can solve the problems of patient pain, complicated implantation process, and complicated drug loading process, and achieve the goal of simplifying the implantation process, good biocompatibility, and relieving dry eye symptoms Effect

Active Publication Date: 2011-04-20
HE EYE HOSPITAL SHENYANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The degradable lacrimal embolus is mainly made of collagen, which can be loaded with drugs. It can be automatically degraded in a short period of time (about one week) after being implanted in the lacrimal duct, and does not need to be taken out again. It is mainly used to treat seasonal dry eye and experimental Treatment; non-degradable lacrimal plugs are usually made of silica gel or polyacrylate materials. Since the material itself is not degradable, it needs to be taken out again after treatment, and the drug loading process is relatively complicated
For the above two types of lacrimal emboli, whether they are degradable or non-degradable, the implantation process is more complicated. Generally, the diameter of the lacrimal duct should be measured before implantation, and then the tear duct that meets the requirements should be selected according to the individual conditions. If there is an embolus, the operation will be performed, so the operation will bring additional pain to the patient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The lactide-caprolactone copolymer (lactide accounts for 83% by mole percent and the weight average molecular weight is 200,000) is melt-extruded by a melt extruder, the extrusion temperature is 140 ℃, and the diameter of the extrudate is about 0.5 mm. The extrudate was stretched at 45 °C, and the diameter after hot stretching was about 0.3 mm. After stretching, it was quickly placed in a 0 °C environment, cut into cylinders with a length of about 3.5 mm, and frozen for later use.

[0018] Through experiments, the prepared lacrimal embolus was implanted into the lacrimal duct 2 mm, and the remaining part was completely retracted into the lacrimal duct within 10 s under the influence of the temperature of the lacrimal duct lumen.

Embodiment 2

[0020] Copolymer of lactide-caprolactone (90% by mole of lactide, weight average molecular weight of 250,000) and copolymer of glycolide-caprolactone (mole of glycolide The percentage is 75%, the weight average molecular weight is 300,000) of the mixture (the mass ratio of lactide-caprolactone copolymer and glycolide-caprolactone copolymer is 1 / 1) melt extrusion, the extrusion temperature is 150 °C, the diameter of the extrudate is about 0.8 mm. The extrudate was stretched at 45 °C, and the diameter after hot stretching was about 0.4 mm. After stretching, it was quickly placed in a 0 °C environment, cut into cylinders with a length of about 3.0 mm, and frozen for later use.

[0021] Through experiments, the prepared lacrimal embolus was implanted 2 mm into the lacrimal duct, and the remaining part was completely retracted into the lacrimal duct within 17 s under the influence of the temperature of the lacrimal duct lumen.

Embodiment 3

[0023] Lactide-caprolactone copolymer (the mole percentage of lactide is 70% and the weight average molecular weight is 500,000), glycolide-caprolactone copolymer (the mole percentage of glycolide The percentage is 95%, the weight average molecular weight is 400,000), the mixture of lactide-p-dioxanone copolymer (lactide accounts for 89% by mole percentage, the weight average molecular weight is 300,000) mixture (lactide-hexyl The mass ratio of lactone copolymer, glycolide-caprolactone copolymer and lactide-p-dioxanone copolymer is 1 / 1 / 1) melt extrusion, extrusion temperature is 130 ℃, extrusion The object diameter is about 0.8 mm. The extrudate was stretched at 45 °C, and the diameter after hot stretching was about 0.5 mm. After stretching, it was quickly placed in a 0 °C environment, cut into cylinders with a length of about 4.0 mm, and frozen for later use.

[0024] Through experiments, the prepared lacrimal embolus was implanted 2.5mm into the lacrimal duct, and the rema...

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Abstract

The invention discloses a biodegradable lacrimal duct embolus and a preparation method thereof. The lacrimal duct embolus is prepared by using one or more of a lactide/caprolactone copolymer, a glycolide/caprolactone copolymer, a lactide/dioxane ketone copolymer and a lactide/trimethylene carbonate copolymer as raw materials through the following steps of sequentially carrying out melt extrusion,hot stretching and cold cutting on the raw materials in an inert gas atmosphere. The biodegradable lacrimal duct embolus is used for treating dry eye syndromes; in the process of operation, a part ofthe lacrimal duct embolus is implanted into a lacrimal duct, and the rest of the lacrimal duct embolus can automatically be shrunk into the lacrimal duct, therefore, in the process of operation, a patient feels no pain, the diameter of the lacrimal duct of the patient is not required to be measured before operation, and the lacrimal duct embolus in one product specification can be suitable for the lacrimal ducts in different sizes; in the process of preparing the biodegradable lacrimal duct embolus, the embolus can load anti-inflammatory agents, antibiotics and antiproliferative drugs so as to avoid the generation of complications such as inflammations, wrapping and the like; and in addition, the lacrimal duct embolus is good in biocompatibility and can be completely biodegraded in the lacrimal duct, and the final products of the embolus are non-toxic water and carbon dioxide, thereby avoiding secondary surgery of the patient.

Description

technical field [0001] The invention belongs to the field of medical equipment. Specifically, the present invention relates to a lactide-caprolactone copolymer, glycolide-caprolactone copolymer, lactide-p-dioxanone copolymer, lactide-trimethylene One or more kinds of carbonate copolymers are used as raw materials, and the drug-loadable biodegradable lacrimal duct embolus prepared by the process of "melt extrusion-heat stretching-cold cutting" and its preparation method. Background technique [0002] The human tear film usually includes the following three layers: (1) monomolecular lipid layer; (2) aqueous liquid layer; (3) mucin layer. The tear film can ensure the smoothness of the cornea, effectively protect the cornea and conjunctiva, and provide nutrients for the cornea at the same time. Therefore, the existence of the tear film is crucial to maintaining the health of the ocular surface. It has been clinically shown that any layer of the tear film can lead to dry eye du...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/06A61L31/16
Inventor 王连嵩李文姬何伟
Owner HE EYE HOSPITAL SHENYANG
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