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Use of collagen implants in the preparation of surgical-assisted restorations for glaucoma

A collagen and implant technology is applied in the field of cowhide purified collagen implants to assist in the field of glaucoma trabeculectomy wound recovery, which can solve the problems of drainage tube displacement, high surgical failure rate, and eye movement disorders.

Active Publication Date: 2019-01-25
VIA TECH BIOMEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the implant, which cannot be decomposed, is a foreign body, and the failure rate of the operation is high, often accompanied by side effects such as blocked passage, eye infection, drainage tube displacement, and eye movement disturbance.

Method used

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  • Use of collagen implants in the preparation of surgical-assisted restorations for glaucoma
  • Use of collagen implants in the preparation of surgical-assisted restorations for glaucoma
  • Use of collagen implants in the preparation of surgical-assisted restorations for glaucoma

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1. Operation Example of Collagen Implant Assisted Trabeculectomy

[0032] The collagen implant used as an example in the present invention is completely composed of 100% pure Type I atelocollagen (100% pure Type I Atelocollagen) purified from dried and dehydrated cowhide, with a diameter of 20 to 200 microns three-dimensional holes. Scanning electron microscope observation results enlarged by the appearance of the test piece ( figure 1 ) It can be found that in the dry collagen layered structure, each layer has many micron-scale pores (about 20-200 microns in diameter), and the layers are randomly arranged at intervals of 10-20 microns, And there are many irregular brackets bridging to form holes. Therefore, the three-dimensional structure of the collagen implant of the present invention can be beneficial to the growth of fibroblasts, so that the fibroblasts can grow in the pores of the collagen implant at the initial stage of wound formation, so that A tissu...

Embodiment 2

[0034] Example 2. Endotoxin Content Test of Absorbable Collagen Implants

[0035] Endotoxins are substances produced by Gram-negative bacteria, which can easily trigger allergic and inflammatory reactions in the human body. In order to avoid the impact of endotoxins that may be produced during the manufacturing process of medical devices on the human body, it is necessary to carefully test and evaluate their safety in use. The test system is Limulus amebocyte lysate (LAL). In this example, the endotoxin content of the collagen implant of the present invention was tested by the kinetic coloring method. Endotoxin determination is processed and tested according to the methods and conditions described in ISO10993-12, USP and USP specifications.

[0036] Take 3 test substances (collagen implants), and extract each piece with 5.00mL pyrogen-free water at 37±1°C for 1 hour according to the ratio of 0.2g±10% / mL, and the mixed extract is the test solution. Test substances The test s...

Embodiment 3

[0043] Example 3. Biosafety Testing of Absorbable Collagen Implants

[0044] The composition of medical equipment should consider whether it will cause adverse reactions to the human body. When a medical device is expected to come into contact with human tissue, relevant biocompatibility tests should be carefully performed according to the contact method and time, so as to avoid possible physiological damage caused by the production or contamination of toxic substances during the manufacturing process of the medical device. This example evaluates the possible response of the absorbable collagen implant of the present invention to the muscle of SD rats implanted into the test object 28 days after the muscle implantation stimulation test.

[0045] USP high density polyethylene reference standard (USP high density polyethylene reference standard) (Lot. No. IOK217) was used as a control group. Both the test object (collagen implant of the present invention) and the control object...

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Abstract

The invention discloses the use of a collagen implant in the preparation of glaucoma surgery auxiliary restoration, wherein the collagen implant is composed of dried and dehydrated bovine hide purified collagen, and has 20- 200 microns of three-dimensional voids.

Description

【Technical field】 [0001] The invention relates to the use of a collagen implant as an auxiliary restoration device in glaucoma surgery. More particularly, the present invention relates to the use of a bovine hide purified collagen implant for assisting wound recovery in glaucoma trabeculectomy surgery (Trabeculectomy). 【Background technique】 [0002] Glaucoma is one of the leading causes of blindness. There are more than 66 million glaucoma patients in the world, accounting for about 1.0-1.2% of the population. About one tenth of the glaucoma patients in the world need microsurgery every year, so it is estimated that there will be 6.6 million patients each year. people, more than 10 million glaucoma surgery needs. According to studies, it is estimated that there will be 76 million and 110 million glaucoma patients by 2020 and 2040, respectively (Y.C. Tham et al., Ophthalmology 121:2081-2090, 2014). According to statistics in 2013, the prevalence rate in Asia is about 3.54...

Claims

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Application Information

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IPC IPC(8): A61K38/39A61P27/06
CPCA61K38/39A61K9/0051
Inventor 洪铭山
Owner VIA TECH BIOMEDICAL
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