CN103550831A - Artificial heart-lung machine extracorporeal circulation pipeline - Google Patents

Artificial heart-lung machine extracorporeal circulation pipeline Download PDF

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Publication number
CN103550831A
CN103550831A CN201310569852.8A CN201310569852A CN103550831A CN 103550831 A CN103550831 A CN 103550831A CN 201310569852 A CN201310569852 A CN 201310569852A CN 103550831 A CN103550831 A CN 103550831A
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CN
China
Prior art keywords
parts
extracorporeal circulation
circulation pipeline
lung machine
artificial heart
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201310569852.8A
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Chinese (zh)
Inventor
刘承武
吕汝举
林庆
李志敏
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Shandong Weigao Newlife Medical Device Co Ltd
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Shandong Weigao Newlife Medical Device Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shandong Weigao Newlife Medical Device Co Ltd filed Critical Shandong Weigao Newlife Medical Device Co Ltd
Priority to CN201310569852.8A priority Critical patent/CN103550831A/en
Publication of CN103550831A publication Critical patent/CN103550831A/en
Pending legal-status Critical Current

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Abstract

The invention relates to an artificial heart-lung machine extracorporeal circulation pipeline. The artificial heart-lung machine extracorporeal circulation pipeline is prepared from the following raw materials in parts by mass: 100 parts of poly vinyl chloride resin, 30-60 parts of 1,2-cyclohexanedimethanoicacid and diisononyl ester plasticizer, 0.5-5 parts of organic tin or calcium zinc stabilizer, 5-10 parts of epoxidized soybean oil stabilizer and 0.2-5 parts of lubricating agent. A preparation method of the artificial heart-lung machine extracorporeal circulation pipeline comprises the following steps: uniformly mixing the raw materials, then pelletizing the mixture in a double screw extrusion pelletizing machine to obtain a polyvinyl chloride composite material, and then directly moulding the polyvinyl chloride composite material on an injection moulding machine and an extruding machine in a 100000-degree purification workshop, thereby obtaining the artificial heart-lung machine extracorporeal circulation pipeline product. The obtained artificial heart-lung machine extracorporeal circulation pipeline product is uniform in colour and lustre, good in appearance and qualified; requirements of artificial heart-lung machine extracorporeal circulation pipeline series products are met.

Description

A kind of heart-lung machine's extracorporeal circulation pipeline
Technical field
The present invention relates to medical material, specifically a kind of heart-lung machine's extracorporeal circulation pipeline.It is by polrvinyl chloride (PVC) the material processing and fabricating that does not contain DEHP (adjacent benzene class plasticizer).
Background technology
The extracorporeal circulation of cardiopulmonary bypass system refers to that using artificial pipeline is connected human body trunk with heart-lung machine, from Venous system, draw venous blood, and oxygenate in vitro, then through blood pump by the overall process of defeated time Arterial system of oxygenated blood, be mainly used in human heart, Great Vessel Operations.Extracorporeal circulation pipeline raw material mostly is polrvinyl chloride (PVC), soft, flexible for guaranteeing product, has added the plasticiser of 40%-50% in PVC material, and the plasticiser of extracorporeal circulation pipeline application is at present that phthalate (is called for short: DEHP).In clinical use procedure, plasticiser can be separated out, and along with blood enters human body, foreign literature report is accepted DEHP intake in the infant blood of CPB operation and be can reach 5.1 μ g/ mL; In the From Neonates of use ECMO, DEHP concentration is 18-98 μ g/ mL.Increasing research shows that DEHP can affect human reproductive system, has teratogenecity, carcinogenecity simultaneously, larger to neonate, prepuberal male's hazardness.The mechanisms such as U.S. FDA, the EDQM of European Union have issued the application risk of DEHP in medical product.Due to the toxicity problem of DEHP in PVC granular material in medical use, the impact on health and environment, some developed countries start to abandon the product by this raw material production gradually, and wherein European Union, the U.S., Japan are for very.
Summary of the invention
Technical problem to be solved by this invention is in order to overcome the harm of plasticizer DEHP to human body in existing PVC pellet, provide a kind of formula reasonable, stable performance, good biocompatibility, non-toxic and safe, the cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline that can produce in enormous quantities in cleaning shop.
The technical scheme that the present invention addresses the above problem employing is as follows: a kind of heart-lung machine's extracorporeal circulation pipeline, it is characterized in that: it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, in raw material, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,30~60 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 0.5~5 part of calcium zinc stabilizer, 5~10 parts of epoxy soybean oil stabilizers, 0.2~5 part of lubricant.
The raw materials used middle employing plasticizer cyclohexane alkane 1 of the artificial heart-lung machine extracorporeal circulation of the present invention pipeline, 2-dioctyl phthalate diisononyl esters (CAS registration number: 166412-78-8), avoided plasticizer DEHP to separate out the adverse effect to human body.Against existing technologies, the present invention forms, formula is reasonable, stable performance, and technique is simple, and cost is low, good biocompatibility, non-toxic and safe.Can produce in enormous quantities in cleaning shop.Product meets YY 1048-2007 < < heart-lung machine extracorporeal circulation pipeline > > technical standard, meet the requirement of cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline series of products, can injection moulding, extrude processing.Nontoxic containing DEHP, avoided extracorporeal circulation pipeline in use DEHP separate out the harm to human body.
The specific embodiment
Below in conjunction with embodiment, the invention will be further described.
A kind of heart-lung machine's extracorporeal circulation of the present invention pipeline, it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, in raw material, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,30~60 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 0.5~5 part of calcium zinc stabilizer, 5~10 parts of epoxy soybean oil stabilizers, 0.2~5 part of lubricant.
Preferred embodiments of the present invention are: raw materials usedly Corvic, plasticizer, stabilizing agent, lubricant, consist of, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,45 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 3 parts of calcium zinc stabilizers, 5 parts of epoxy soybean oil stabilizers, 2 parts of lubricants.
During the present invention is raw materials used, using Corvic as main body plastics.Plasticizer is cyclohexane extraction 1,2-dioctyl phthalate diisononyl esters (CAS registration number: 166412-78-8).Its effect is the softening range that reduces plastics, improves its processability, pliability or ductility.In formula, if plasticizer cyclohexane alkane 1,2-dioctyl phthalate diisononyl ester content is less than 20%, and the softening point of PVC pellet can raise, and the fragility of material, hardness etc. also can raise, unfavorable to its processing characteristics.If its content is greater than 40%, due to the too high levels of plasticizer, can cause separating out of plasticizer, affect properties of product.Stabilizing agent is organotin or calcium zinc stabilizer and epoxy soybean oil.Its effect is to contribute to material property keep original value or approach original value.In formula, if heat stabilizer content is too small, the heat producing in the course of processing can make the oxidative degradation of PVC own, and causes the flavescence of PVC raw material.If heat stabilizer too high levels, stabilizing agent can not be dissolved in PVC completely, can promote on the contrary the degraded of PVC, also affects the transparency of material simultaneously.Lubricant is to improve the mobile performance of plastic melt, reduces or avoids the friction of equipment and adhesion and the surface brightness etc. that improves goods.
The raw materials used middle employing plasticizer cyclohexane alkane 1 of the present invention, 2-dioctyl phthalate diisononyl esters (CAS registration number: 166412-78-8), avoided plasticizer DEHP to separate out the adverse effect to human body.The present invention forms, formula is reasonable, stable performance, and technique is simple, and cost is low, can produce in enormous quantities in cleaning shop.Product meets YY 1048-2007 < < heart-lung machine extracorporeal circulation pipeline > > technical standard, meet the requirement of cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline series of products, can injection moulding, extrude processing.Nontoxic containing DEHP, avoided extracorporeal circulation pipeline in use DEHP separate out the harm to human body.
Embodiment 1: a kind of heart-lung machine's extracorporeal circulation pipeline, it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,30 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 5 parts of calcium zinc stabilizers, 10 parts of epoxy soybean oil stabilizers, 3 parts of lubricants.By above-mentioned various raw material mix homogeneously, then pelletize in double-screw extruding pelletizing machine, the polyvinyl chloride composite material obtaining, then directly carries out molding on the injection machine in 100,000 grades of cleaning shops, extruder, obtains goods.Resulting product color and luster is even, and outward appearance is good, is up to the standards.Meet the requirement of cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline series of products.
Embodiment 2: a kind of heart-lung machine's extracorporeal circulation pipeline, it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,60 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 0.5 part of calcium zinc stabilizer, 8 parts of epoxy soybean oil stabilizers, 5 parts of lubricants.By above-mentioned various raw material mix homogeneously, then pelletize in double-screw extruding pelletizing machine, the polyvinyl chloride composite material obtaining, then directly carries out molding on the injection machine in 100,000 grades of cleaning shops, extruder, obtains goods.Resulting product color and luster is even, and outward appearance is good, is up to the standards.Meet the requirement of cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline series of products.
Embodiment 3: a kind of heart-lung machine's extracorporeal circulation pipeline, it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, concrete component content (quality) is: 100 parts of Corvics, cyclohexane extraction 1,45 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 3 parts of calcium zinc stabilizers, 5 parts of epoxy soybean oil stabilizers, 2 parts of lubricants.By above-mentioned various raw material mix homogeneously, then pelletize in double-screw extruding pelletizing machine, the polyvinyl chloride composite material obtaining, then directly carries out molding on the injection machine in 100,000 grades of cleaning shops, extruder, obtains goods.Resulting product color and luster is even, and outward appearance is good, is up to the standards.Meet the requirement of cardiopulmonary bypass system heart-lung machine extracorporeal circulation pipeline series of products.

Claims (2)

1. heart-lung machine's extracorporeal circulation pipeline, it is characterized in that: it is raw materials used is comprised of Corvic, plasticizer, stabilizing agent, lubricant, in raw material, concrete component mass content is: 100 parts of Corvics, cyclohexane extraction 1,30~60 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 0.5~5 part of calcium zinc stabilizer, 5~10 parts of epoxy soybean oil stabilizers, 0.2~5 part of lubricant.
2. heart-lung machine's extracorporeal circulation pipeline according to claim 1, it is characterized in that: its raw materials used concrete component mass content is: 100 parts of Corvics, cyclohexane extraction 1,45 parts of 2-dioctyl phthalate diisononyl ester plasticisers, organotin or 3 parts of calcium zinc stabilizers, 5 parts of epoxy soybean oil stabilizers, 2 parts of lubricants.
CN201310569852.8A 2013-11-13 2013-11-13 Artificial heart-lung machine extracorporeal circulation pipeline Pending CN103550831A (en)

Priority Applications (1)

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Application Number Priority Date Filing Date Title
CN201310569852.8A CN103550831A (en) 2013-11-13 2013-11-13 Artificial heart-lung machine extracorporeal circulation pipeline

Publications (1)

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CN103550831A true CN103550831A (en) 2014-02-05

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080194736A1 (en) * 2007-02-13 2008-08-14 Minqiu Lu PVC nanocomposite manufacturing technology and applications
CN101696308A (en) * 2009-10-27 2010-04-21 广东联塑科技实业有限公司 Polyvinyl chloride composition and transparent pipe thereof
CN101798428A (en) * 2010-03-12 2010-08-11 扬州凯尔化工有限公司 Special N-phthalate reinforced soft polyethylene plastics for circulation loop and preparation method thereof
CN103172953A (en) * 2013-04-15 2013-06-26 江西3L医用制品集团股份有限公司 Method for preparing detaining needle long catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080194736A1 (en) * 2007-02-13 2008-08-14 Minqiu Lu PVC nanocomposite manufacturing technology and applications
CN101696308A (en) * 2009-10-27 2010-04-21 广东联塑科技实业有限公司 Polyvinyl chloride composition and transparent pipe thereof
CN101798428A (en) * 2010-03-12 2010-08-11 扬州凯尔化工有限公司 Special N-phthalate reinforced soft polyethylene plastics for circulation loop and preparation method thereof
CN103172953A (en) * 2013-04-15 2013-06-26 江西3L医用制品集团股份有限公司 Method for preparing detaining needle long catheter

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Application publication date: 20140205