Lactide/epsilon-caprolactone copolymer for medical implant, method for producing lactide/epsilon-caprolactone copolymer for medical implant, medical implant and artificial dura mater

A lactide and caprolactone technology, applied in the field of medical implants and artificial dura mater, can solve the problems of loss of flexibility and hesitation in use, and achieve high flexibility, high mechanical strength, high safety and high suture strength. Effect

Inactive Publication Date: 2010-11-03
GUNZE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the copolymer of lactide and ε-caprolactone has the following problem: although it has high flexibility immediately after polymerization, it gradually loses flexibility in the process of standing thereafter (hereinafter, this is also referred to as "self-curing". ")
[0007] However, in Patent Document 3, experiments were conducted on the premise that a higher alcohol was used as a polymerization initiator during the polymerization of a copolymer of lactide and ε-caprolactone. Residues, therefore, there is a problem of having to hesitate its use in medical implants

Method used

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  • Lactide/epsilon-caprolactone copolymer for medical implant, method for producing lactide/epsilon-caprolactone copolymer for medical implant, medical implant and artificial dura mater
  • Lactide/epsilon-caprolactone copolymer for medical implant, method for producing lactide/epsilon-caprolactone copolymer for medical implant, medical implant and artificial dura mater

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] 1440 g of L-lactide, 1140 g of ε-caprolactone, and 300 ppm of tin octoate (78 ppm in terms of tin) were placed in a detachable flask, and polymerized at 135° C. for 7 days under a nitrogen atmosphere after decompression.

[0062] The obtained copolymer was treated with a catalyst remover (acetic acid / isopropanol=30 / 70 v / v), and vacuum-dried at 40°C to obtain a lactide / ε-caprolactone copolymer.

[0063] The obtained lactide / ε-caprolactone copolymer was melt-molded with an extruder into a sheet with a thickness of 100 μm, and then heat-treated at 70° C. for 12 hours in a vacuum to obtain a sheet.

Embodiment 2

[0065] Put 1,440 g of L-lactide, 1,140 g of ε-caprolactone, and 300 ppm of tin 2-ethylhexanoate (78 ppm in terms of tin) into a detachable flask, and polymerize at 140°C under a nitrogen atmosphere after decompression for 7 sky.

[0066] The obtained copolymer was treated with an acetic acid-isopropanol solution (acetic acid / isopropanol=20 / 80 v / v), and vacuum-dried at 40°C to obtain a lactide / ε-caprolactone copolymer.

[0067] A sheet was obtained in the same manner as in Example 1 except that the obtained lactide / ε-caprolactone copolymer was used.

Embodiment 3

[0085] (1) Synthesis of lactide / ε-caprolactone copolymer

[0086] 1440 g of L-lactide, 1140 g of ε-caprolactone, and 300 ppm of tin 2-ethylhexanoate were placed in a detachable flask, and polymerized at 135° C. for 7 days under a nitrogen atmosphere after decompression.

[0087] The obtained lactide / ε-caprolactone copolymer was treated with an acetic acid-isopropanol solution (acetic acid / isopropanol=30 / 70 v / v), and vacuum-dried at 40°C.

[0088] The weight average molecular weight of the obtained copolymer was 320,000 (measured by GPC), and the metal content was less than 0.5 ppm (quantified by ICP emission spectroscopic analysis).

[0089] (2) Preparation of the outermost sheet

[0090] The obtained copolymer was melt-molded with an extruder to obtain a sheet having a thickness of 100 μm.

[0091] An 8 mg sample was cut out from the obtained sheet, and subjected to DSC measurement (DSC temperature increase rate: 10° C. / min), and the fusion enthalpy derived from the crystal...

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Abstract

It is intended to provide a lactide/epsilon-caprolactone copolymer for a flexible medical implant which has extremely high safety without containing a higher alcohol and is useful for producing a medical implant required to have flexibility such as artificial dura mater or artificial blood vessel. Further, it is intended to provide a method for producing the copolymer, a medical implant and artificial dura mater comprising the copolymer. The invention is directed to a lactide/e-caprolactone copolymer to be used for medical implant application, wherein a molar ratio of lactide to e-caprolactone (lactide/e-caprolactone) is from 40/60 to 60/40, a weight average molecular weight is 100,000 to 500,000 or less, a higher alcohol component is not contained, and a melting enthalpy of crystal obtained by heat-melting the copolymer to form a molded article is 10 J/g or less.

Description

technical field [0001] The present invention relates to a flexible lactide / ε-caprolactone copolymer for medical implants that does not contain higher alcohols, is extremely safe, and is useful for making medical implants that require flexibility, such as artificial dura mater and artificial blood vessels. things. In addition, it also relates to a method for producing the lactide / ε-caprolactone copolymer for medical implants, a medical implant using the lactide / ε-caprolactone copolymer for medical implants, artificial dura mater. Background technique [0002] In recent years, biodegradable absorbable polymers such as polylactide have been frequently used as medical implants made of polymer materials. Biodegradable absorbent polymers slowly lose their shape through hydrolysis, so there is no need for reoperation to remove them like conventional non-degradable medical implants, which can greatly reduce the burden on patients. [0003] For example, the dura mater interposed b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/00A61F2/02
CPCA61L27/18A61L27/26
Inventor 有村英俊平嗣良高桥佳丈
Owner GUNZE LTD
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