CN101664367A - Plug for sealing medical system - Google Patents

Plug for sealing medical system Download PDF

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Publication number
CN101664367A
CN101664367A CN200810214389A CN200810214389A CN101664367A CN 101664367 A CN101664367 A CN 101664367A CN 200810214389 A CN200810214389 A CN 200810214389A CN 200810214389 A CN200810214389 A CN 200810214389A CN 101664367 A CN101664367 A CN 101664367A
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China
Prior art keywords
stopper
necessity
medical
case
ethylene
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CN200810214389A
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Chinese (zh)
Inventor
托马斯·尼古拉
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POLYCINE GmbH
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POLYCINE GmbH
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Priority to CN200810214389A priority Critical patent/CN101664367A/en
Publication of CN101664367A publication Critical patent/CN101664367A/en
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Abstract

The invention relates to a cylindrical plug for sealing a medical system, and relates to a method for sealing the medical system and the medical system sealed by means of the plug of the invention. The plug has great significance for the medical system such as a medical bag, realizes the control of closing of the medical system by using the plug with a simple structure and a simple mode, and has firm and durable sealing effect. The plug can be pierced by a needle or a long thrust needle so as to ensure that liquid can be extracted from the medical system once or repeatedly. The plug comprisesa core and an outer layer consisting of a plurality of cores. A material for the outer layer and a material for the core when the outer layer does not exist can flow at the temperature of above 90 DEGC. The invention relates to production of the plug and the medical bag produced by using the method. Moreover, the invention also relates to a device for implementing the method, and the medical bagcontaining the plug.

Description

The stopper of sealing medical system
Technical field
The present invention relates to a kind of stopper of sealing medical system, and relate to a kind of method of sealing medical system and the medical system itself that seals by stopper of the present invention.
Background technology
Medical system such as medical bag are used for preserving blood or injecting fluid medically using very extensively.For this purpose, they must thorough disinfection, this normally by be heated at least 100 ℃, particularly 121 ℃ realize.In addition, this sack must be light and cheap, must be able to create in Manufacturing Automated process, because cost is lower, can abandon after use.
At US-A 4,516, a kind of typical medical bag is disclosed in 977, wherein, disclose a kind ofly by the sack that constitutes based on polyolefinic plastics, also having with the polyolefin in addition is that polyethylene, polypropylene and butyl are the polybutene on basis.Except this these homopolymers, also can be described as the plastics material, it is meant that alternate alkene has the substituent plastics of alkene in addition, has for example to have methyl, ethyl, vinyl or halogen element atom sub substituent group.Also in the document, also chemical copolymerization thing thing or the mixture that is made of corresponding associated materials used in suggestion at this, and the polyethylene that especially preferably has middle density or high density, high molecular and narrow molecular weight distribution is used for medical bag.Fill perfusion fluid in order to make the material discharge in the bag or to make to sack, for example used and can use insert, it can stretch into sack inside.
This insert is known different various structures, for example this has been carried out having description in DE 33 05 365 C2 and DE196 34 944 C1.When adopting insert,, use two kinds production methods of employing usually at this for the sack perfusion fluid being poured into to medical.One can pour into corresponding liquid in the dress earlier in medical bag, and then, promptly finish the back in perfusion insert is soldered on the sack, and it is whole that wherein it seals into a medical bag simultaneously.Its two another kind of known method be that insert pours into afterwards just being combined in before the filling process on the medical bag again.Usually use perfusing hole separately, it is made of the notch on the seam of bag film, and welds or seal after perfusion finishes for this reason.
Another kind of provide the interface and/or the aperture that can be connected to flexible pipe, use insertable plug closes on it the scheme of its inner material discharge medical packed full or be.This system mostly and bag material link together, manufacturing cost is very high usually.
Summary of the invention
Therefore, the objective of the invention is to, the stopper of for example medical bag of a kind of sealing medical system is provided, it is with simple structure and mode, be fit to use this medical system, that is to say the closure of openings that makes medical system firmly and enduringly, make liquid wherein keep sealing.In addition, this stopper should be with syringe needle or lunge needle pierces, thereby guarantees and can take out liquid in one or many ground from medical system.The present invention also aims in addition, a kind of method is provided, it can simply and economically seal medical system, particularly medical bag.
This purpose by preferably cylindrical, have stopper two opposed end faces, that medical system is sealed and be achieved, wherein stopper has core and one or more in case of necessity aspect that surrounds core.Stopper has:
A. plastics core, it is made than the polymer of high resilience by having in a kind of or many, be selected from: polyphenylene oxide, polyethylene and ethylene copolymers, acetate ethylene copolymer (EVA), styrene/ethylene/butyl-block copolymer (SEB), styrene/ethylene/propylene-copolymer (SEP), polypropylene (PP), medicinal white oils (liquid paraffin), styrene/butadiene/styrene-copolymer (SBS), polybutene (PB), ethylene-propylene-dicyclopentadiene rubber (EPDM), ethylene/propylene alkene plastics and styrene/butadiene/styrene-block copolymer (SBS)
B. one or more in case of necessity intermediate layers, it is made by the plastics that one or more are selected from following polymer: functionalized polypropylene (PP), polyethylene (PE), functional styrene/ethylene/butyl-block copolymer (SEB), polyethylene plastomers, polyethylene and ethylene copolymers, ethylene/vinyl acetate (EVA), styrene/ethylene/propylene-copolymer (SEP), oil, polypropylene (PP), polyethylene (PE), styrene/isoprene/styrene block copolymer (SIS), polybutene (PB); With
C. skin in case of necessity, it is made by the plastics that are selected from following polymer in a kind of or many: the mixture of polypropylene, polyester, polyethylene plastomers, Merlon, polyethylene and ethylene copolymers, ethylene/vinyl acetate (EVA), PCCE or SEB/SEP, PMP, PB, softening PVC (PVC-W) or these materials
Wherein, for the material of outer (C), perhaps at the material of outer (C) core (A) when not existing, during greater than 90 ℃, it is flowable in temperature.
In framework of the present invention, term " can flow " and be meant, corresponding material down to the small part deliquescing, combines it and on every side material in set point of temperature, when being cooled to than low low 20 ℃ the temperature at least of set point of temperature, forms lasting and stable combination.
Outer (C) has so style characteristic, and promptly it makes core (A) and intermediate layer (B) have processing stability, when machine-shaping, can adopt coextrusion, the materials processing of stopper become a root multi-layer rectangular, just stopper is rectangular.。
Term " high resilience " is interpreted as in the present invention, selects the material of stopper core (A) like this, even promptly it still can closely seal after repeatedly inserting and extract through injection needle.
The preferred material of core (A) is polyphenylene oxide, SEPS/SEP-copolymer, medicinal white oils and polybutene (PB).Press embodiments of the invention, core A is made by the SEB that accounts for weight 20% to 40%, the medicinal white oils that accounts for weight 20% to 40%, the polyphenylene oxide that accounts for weight 5% to 15%, the inserts that accounts for the polypropylene (PP) of weight 10% to 30% and be no more than weight 10%.
In addition, each monolayer of stopper or the core of stopper also can comprise the inserts that the professional knows, for example TiO2, SiO2, whiting, kieselguhr, zinc oxide, quartz, Pulvis Talci, and these mixtures of material.The content of inserts in core (A) and/or intermediate layer (B) and/or outer (C) is no more than 10% of weight.
In addition, stopper can also comprise the additive that the professional knows, and it normally accurately regulates properties of materials by the requirement of each self-application, is used for improving chemistry and mechanical performance.These additives comprise softening agent, antioxidant and lubricant, and this all is that professional in the plastics technology field is known.These additives account for 10% of weight at the most in core (A) or intermediate layer (B) or outer (C).
Is flowable skin (C) in temperature during greater than 90 ℃, its, the polymer that comprises the following stated, its content is basis with total component of outer C: polypropylene account for weight 70% to 100%, polyethylene and ethylene copolymers account at the most weight 70%, PCCE 100% or the SEB/SEP that account for weight account for weight 100%, PB accounts for 80% to 100% of weight, acetate ethylene copolymer (EVA) accounts for 70% of weight at the most.For outer (C), preferred copolymer composition is: polyacrylic poly combination; The combination of polypropylene and SEB/SEP; By polypropylene, SEB and polyethylene and ethylene copolymers mixture.
By another embodiment of the present invention, stopper is fit to be used for sealing sack, special sealing medical bag.Can use as previously described stopper at this, core material (A) when it lacks skin (C) or cladding material (C) have mobile when temperature surpasses 90 ℃.
By another embodiment of the present invention, outer (C) made by the polyester that accounts for weight 100%, the PMP that accounts for the Merlon of weight 100% or account for weight 100%.This stopper is fit to be used for sealing medical system, particularly medical bag, wherein the sack thin film is towards the surface of stopper or the opening of medical system, the material that thin film or port wrap is flowable in temperature during greater than 90 ℃, has therefore guaranteed realizing persistent connection between sack thin film and the stopper or between the flexible pipe port of sack and the stopper.
Can be cylindrical or conical by stopper of the present invention, be fit to be used for sealing medical system.In framework of the present invention, term " medical system " can be broadly interpreted as the coupling assembling of all containers that are applied in the Medical Technology aspect, vascular, flexible pipe, sack and subordinate most, they have specific purposes targetedly, can with health body fluid such as blood, or be used for required liquid of human rehabilitation treatment such as intravenous drip the transfusion contact.This optimum system choosing is a kind of sack, is meant the sack that is welded with on it as the flexible pipe of flexible pipe port especially.In framework of the present invention, term " system " be applied in the layout that this also comprises at least two parts or assembly, for using this system, they should be fixed and be connected with each other safely, therefore can not produce danger during in zero defect ground enforcement function when this system.The medical bag system that is used for liquid belongs to exemplary medical system, and they are equipped with interface, part or connection tube, and links to each other with flexible pipe, hose system or hose set, is used for guaranteeing the transmission of medication solution, carries out medical care.In addition, hose set self also belongs to medical system, and this flexible pipe will be connected with each other with a plurality of assemblies, and for example all assemblies familiar and that use in the professional of field of medical technology link to each other with the connector that meets this purpose or with other.
In framework of the present invention, between stopper and medical system, form the lasting connection of liquid seal, by having the surface that constitutes by plastics on the part of the present invention, to be connected for this reason.The lip-deep a certain at least section of each of this part is made of plastics, and is just enough, and wherein this section is used to constitute contacting with each other when connecting.For example on stopper and the sack, a contact area has been determined on the surface that part contacts with each other.Be that contact area need be limited on the surface section to be contacted that is made of plastics at least what this need adhere to.By the present invention,, and simultaneously under 90 ℃ of heat treatments and refrigerative effect thereafter more than the temperature, can make part realization liquid seal and persistent connection by the contact on surface.
Be understood that, part for example compresses the position by inserting or insert mutually one of generation, it compresses piece surface to be contacted mutually with dynamics, on the one hand, before constituting firmly and connecting lastingly, guarantee to reach certain shape stability by the structure that part to be connected constitutes, on the other hand, together fixed to one another when being formed in the facial section of parts list in the contact area and carrying out material contact closely on surface to be contacted.
By the present invention, by selecting and determine in contact area, to constitute the polymer of plastics suitably, can realize a kind of like this connection layout, it is in independent heat treatment process, particularly be lasting and firm in autoclave sterilization, do not need to use extra stickers, sealing member or latching member.Content of the present invention is focussed in particular on, and produces persistent connection between preferred medical bag system of medical system and stopper of the present invention, and they interconnect securely after Overheating Treatment, particularly high-temperature sterilization and cooling procedure subsequently.
By the present invention, " plastic material " can be regarded as such material, its key component is made up of macromolecular organic compound, plastics one or more polymer wherein, also can be called polymer simply, wherein particularly the homopolymer of various materials mentioned above and copolymer (block copolymer and/or graft copolymer) and their mixture (mixture or chemical compound) all belong to polymer.
For the present invention, be stopper skin (C) and medical system (or rather, in contact area) in plastics select and during the regulation polymer, its major criterion is the heat-resistant deforming characteristic (flowable) of polymer under conditions for sterilization, and this heat-resistant deforming characteristic is main relevant with the softening temperature and the material hardness of used material.
Press embodiments of the invention, stopper has lower polymer of softening temperature or polymeric blends, its content be no more than medical bag polymer weight 40%, and have than the lower hardness of medical bag polymer.If the viscosity of material is definite like this, promptly the part of the polymer of sack is positioned on the surface of stopper, or the polymer of outer (C) has low molecular composition, then can reach better adhesion.Therefore, the present invention can adapt to the different heat treatment under the different temperatures in principle.
Making the surface of parts to be connected carry out remollescent temperature is particular importance, and it also is very important also having heat treated temperature, and sterilization or steam disinfection all carry out under this temperature usually.In framework of the present invention, steam disinfection generally is meant, be used for killing and be encapsulated in all microorganisms (virus) in the high-intensity tangible package or make it lose mobility, material wherein of the present invention can stand to be at least steam disinfection in 116 ℃ the high-pressure bottle at steam especially, also be that so-called autoclave sterilization or autoclaving are handled, and can not produce damage.By general embodiment of the present invention, heat treatment is in 90 to 130 ℃ temperature range, preferably carry out in 116 to 121 ℃ scope.These temperature are enough guaranteed to realize liquid seal, stopper firmly and are enduringly cooperated.
By general embodiment of the present invention, stopper aspect big or small be installed in sack on conduit or the flexible pipe port that is arranged on the sack consistent.The diameter of stopper is in 3 to 15mm scope, preferably in the scope of 6mm to 9mm.The diameter of stopper can be selected like this, and promptly it is consistent with the interior diameter of conduit/flexible pipe.But size also can be definite like this, and promptly when stopper put in place, it can make conduit/flexible pipe expansion.The length of stopper of the present invention is transformable, in the scope of 3mm to 15mm, preferably change in the scope of 5mm to 8mm.
Press embodiments of the invention, have fossaperturate at least one end face of stopper, it is convenient to the insertion of syringe needle and extracts, and avoids deface.By this fossaperturate, even after repeatedly inserting and extract with syringe needle or lunge syringe needle, still can guarantee stopper safety, that is to say liquid be repeated the sealing.The degree of depth of fossaperturate is transformable, can change in 1 to 3mm scope usually, and be preferably 1mm.Press embodiments of the invention, this fossaperturate exists the shape of " X " or " Y ".Only on two end faces of end face that stopper and sack deviate from or stopper, exist fossaperturate.Press embodiments of the invention, exist the fossaperturate of Y shape on the end face of correspondence, they are arranged in 30 ° to 180 ° the angular range mutually, preferably are provided with mutually with 180 ° angle.These fossaperturates make that syringe needle is easier to be inserted in the stopper of the present invention, even and under situation about repeatedly inserting with syringe needle or lunge syringe needle, the sealing that core material still can almost seal after extracting.
By another embodiment of the present invention, at least one end face of stopper of the present invention is covered by thin film at least in part, and skin of preferred film and stopper (C) or core (A) are fixedly linked, and preferably link together.The material of this thin film should be fit to be used for making bag film, and it is preferably consistent with bag material, and guarantees that liquid and stopper seal isolator in the bag.Therefore can guarantee, in the stopper material movably composition for example plasticizer can not enter into the liquid of sack.By more preferred embodiments of the present invention, the internal layer of the material of thin film sack at this towards sack inside.
Another content of the present invention is to make the method for stopper of the present invention, comprises following steps:
(a) process by the plastics that are used for core (A), outer (C) and intermediate layer in case of necessity (B) are carried out coextrusion, make one multiwalled rectangular,
(b) cool off in step (a), produce rectangular in case of necessity, be rolled into a circle in case of necessity,
(c) scribe a fossaperturate in case of necessity,
(d) cover one deck overlay film in case of necessity rectangular end face,
(e) according to the stopper length of expection, be cut into pieces rectangular,
(f) scribe in case of necessity another fossaperturate and
(g) give the other end cover film of stopper in case of necessity, as primary closing membrane.
By other embodiments of the invention, stopper of the present invention is used for sealing medical system, particularly is used for sealing and/or make medical bag.The method of sealing and/or make medical bag comprises following steps:
(a *) prepare stopper of the present invention, its in case of necessity one or two end face be provided with fossaperturate, also be provided with in case of necessity and have one or two cover layer, prepares two medical bag of thin film,
(b *) stopper is positioned between two sack thin film,
(c *) by the sack thin film is linked together, make medical bag, and by connection and heat treatment stopper and medical bag are connected together,
(d *) in case of necessity with the outer face of thin film covering stopper, constitute primary closing membrane.
Like this, obtained medical bag, wherein, can between sack is inside and outside, carry out fluid exchange by in stopper, inserting and extracting syringe needle with simple mode and method.
But itself and stopper of the present invention are sealed in the blow molding of medical bag, heat-treat then.Blowing is normally carried out in greater than 90 ℃ high temperature, and after blowing finished, the firm and competent sealing of stopper and thin-film material made bag interior liquid sealed.
For making combination between stopper and the sack reach the purpose of persistent liquid seal, by another preferred implementation of the present invention be, stopper of the present invention with the contact point of bag material on have the lip of extruding from stopper.By another embodiment of the present invention, this lip also can be that hot pressing forms.Preferred stopper is ship shape.
Another aspect of the present invention is to the method that medical system, particularly medical bag seal, to comprise following steps by stopper of the present invention:
It is rectangular that (a ') prepares medical system and stopper or stopper,
(b ') stopper of the present invention is inserted in the opening of medical system,
(c ') in case of necessity, cover with thin film on the other end of stopper, as primary closing membrane,
(d ') heat-treat, the skin (C) of stopper and medical system are coupled together.
For the opening that covers medical system and guarantee that it on the opening is a thin film that can tear off that sterilization (this opening has been used plug closes of the present invention now) is contained in.The opening of medical system for example can be the opening on sack thin film or the flexible pipe port.
Stopper of the present invention can with the sealing that coincide of the surface of opening, by another embodiment of the present invention, the position of the sealing that coincide also can after move 1mm to 10mm scope, thereby can more easily be inserted in the stopper with for example injection needle or lunge syringe needle.
Heat treatment in step (d ') can be above-cited high-temperature sterilization process.
By the preferred embodiments of the present invention, bag film is used as medical system and is used.Stopper is strip at this, directly imports in the sack processing machine, in step (b ') before, and just before the actual flexible pipe port that is inserted into sack of stopper, the rectangular length that is cut into expectation.This mode has been simplified the sealing of medical system, particularly sack greatly.Saved stopper done and similarly cut, put in order in advance and step such as alignment, because the stopper of elongate in shape accurately imported in the opening of medical system with regard to target before cutting, stopper is rectangular also can be equally to be cut according to expection length afterwards in step (b ').
Step below available is made medical bag, thereby realizes sealing medical system of the present invention, the particularly method of medical bag:
(a 1) between two thin film, connect a flexible pipe, in the next production stage of medical bag, proceed processing then, make a medical bag.
For making between flexible pipe and the sack in conjunction with the effect that reaches persistent liquid seal, preferably, flexible pipe with the contact point of bag material on, have lip in the planar range between thin film upper surface and lower surface, it is extruded to add at flexible pipe and forms man-hour.By other embodiments of the invention, this lip also hot pressing forms.This lip flexible pipe is known for the professional.
In addition, the invention still further relates to a kind of device of implementing method noted earlier, also relate to a kind of medical system, it can be by making by method of the present invention.
The specific embodiment
Describe the present invention in detail by the following examples:
Embodiment 1
In the multilamellar extrusion device, extrude stopper
By the water cooling adjuster, as described below in the multilamellar extrusion device, the stopper of making diameter and be 8mm is rectangular:
A (core) :-No. 45 extruders of sheared/mixed screw rod, a rate of extrusion 15kg/h had
-material: the APP 304 of Polycine(DE) Co., Ltd. (Polycine),
-processing temperature: 200 ℃
B (intermediate layer) :-do not have
C (skin) :-have the sheared/mixed screw rod No. 30 extruders, rate of extrusion 1kg/h
-processing temperature is 200 ℃
-material: the APP 306 of the Bo Lixini company (Polycine) of Germany
The rectangular coiled length of the stopper of coextrusion is about the reel of 400m.
Embodiment 2
On stopper, add fossaperturate Y shape, that 1mm is dark
Process by rectangular in the FFS machine of producing the medical film bag, the continuation of stopper that embodiment 1 makes.The rectangular fossaperturate of scribing on end face of stopper, end face and a sack thin film of pointing to sack inside are welded together, and die-cut neat.And then, stopper is inserted into forward in the flexible pipe port of stopper with its end that is capped, and the thin film of aluminum/PP constitutes untouched closing membrane, is placed on from sack on the stopper end face outstanding, that be not capped and around the flexible pipe, to weld then.The stopper and the flexible pipe port that are made of the APP1 07-S of the Bo Lixini company (Polycine) of Germany intactly seal.Welding is by the traditional hot soldering method, and temperature is 120 ℃-150 ℃.Weld strength is regulated by welding temperature, pressure and time at this.Usually in 0.5 to 4 second scope, preferably in 1 to 3 second scope, be preferably 2 seconds especially weld interval.The heat treatment of the sack that has sealed is at 121 ℃, is in to carry out under the common conditions for sterilization.
Embodiment 3
Make the rectangular and sealing medical bag of another stopper
Similar to Example 1, diameter is rectangular following the making of the stopper of 6mm:
A (core) :-material: the APP 304 of Polycine(DE) Co., Ltd. (Polycine),
-rate of extrusion 12kg/h
-processing temperature is 220 ℃
B (intermediate coat) :-do not have
C (adventitia) :-material: the APP310 of the Bo Lixini company (Polycine) of Germany,
-processing temperature is 190 ℃
Stopper in the-use-case 3 seals sack
The rectangular end face of stopper is provided with fossaperturate X-shaped, that 0.5mm is dark, and the length of stopper cuts into 8mm.The end face of this stopper towards sack inside is provided with APP 114 thin film, and the internal layer of this thin film is towards sack inside.Stopper is inserted in the flexible pipe port of medical bag subsequently, and locatees like this, and promptly it is to the closed edge rollback 1mm of flexible pipe port.And then, the original closing membrane shape that is made of the PET/PP thin film flushes ground, particularly is placed on the flexible pipe port with pushing deeply.In 121 ℃ that carry out subsequently disinfecting process, stopper and flexible pipe port link together.
Embodiment 4
Copy the method among the embodiment 1, the manufacturing diameter is that another stopper of 7mm is rectangular
A (core) :-material is the APP 304 of the Bo Lixini company (Polycine) of Germany,
-rate of extrusion 14kg/h
-processing temperature is 220 ℃
B (intermediate layer) :-material is APP 310
-rate of extrusion 1kg/h
220 ℃ of-processing temperatures
C (skin) :-material is a polypropylene, the APP 305 of the Bo Lixini company (Polycine) of Germany,
-rate of extrusion 2kg/h
-processing temperature is 190 ℃.

Claims (19)

1. the stopper that has two opposing end surfaces is used for sealing medical system, and wherein stopper has core and one or more aspects that surround core in case of necessity, and this stopper is by forming with the lower part:
A. plastics core, it is made by one or more polymer with high rebound characteristics, and polymer is selected from: polyphenylene oxide, polyethylene and ethylene copolymers, ethylene-vinyl acetate copolymer (EVA), styrene/ethylene/butyl-block copolymer (SEB), styrene/ethylene/propylene-copolymer (SEP), polypropylene (PP), medicinal white oils, styrene/butadiene/styrene-copolymer (SBS), polybutene (PB), ethylene-propylene-dicyclopentadiene rubber (EPDM), ethylene/propene-plastics and styrene/butadiene/styrene-block copolymer (SBS);
B. one or more in case of necessity intermediate layers, it is made of the plastics that one or more are selected from following polymer: functional polypropylene (PP), polyethylene (PE), functional styrene/ethylene/butyl-block copolymer (SEB), polyethylene plastomers, polyethylene and ethylene copolymers, ethylene-vinyl acetate copolymer (EVA), styrene/ethylene/propylene--copolymer (SEP), oil, polybutene (PP), polyethylene (PE), styrene/isoprene/styrene-block copolymer (SIS), polybutene (PB); With
C. skin in case of necessity, it is made of the plastics that one or more are selected from following polymer: polypropylene, polyester, Merlon, polyethylene and ethylene copolymers, polyethylene plastomers, ethylene-vinyl acetate copolymer (EVA), PCCE or SEB/SEP, PMP, PB, softening PVC (PVC-W) or these mixtures of material
In stopper, the material of the core (A) during outer (C) disappearance, or the material of outer (C) when it surpasses 90 ℃ in temperature, have mobile.
2. stopper according to claim 1, its diameter range are 3mm to 15mm, and length range is 3mm to 15mm.
3. according to claim 1 or 2 each described stoppers, it is characterized in that stopper has one 1 to 3mm dark fossaperturate at least on an end face.
4. stopper according to claim 3 is characterized in that, fossaperturate is " Y " font.
5. stopper according to claim 4 is characterized in that, has " Y " shape fossaperturate on two end faces of stopper, and they are arranged in 30 ° to 180 ° the angular range mutually.
6. according to each described stopper in the claim 1 to 5, it is characterized in that at least one end face of stopper is hidden at least in part by thin film, described thin film is made by the material that is fit to the medical bag of manufacturing.
7. stopper according to claim 6 is characterized in that, the adventitia of thin film and stopper (C) is bonded at or is welded together.
8. make method, comprise following steps according to each described stopper in the claim 1 to 7:
(a) process by the plastics that are used for core (A), outer (C) and intermediate layer in case of necessity (B) are carried out coextrusion, make one multiwalled rectangular,
(b) cool off in step (a), produce rectangular in case of necessity, be rolled into a circle in case of necessity,
(c) scribe a fossaperturate in case of necessity,
(d) cover one deck overlay film in case of necessity rectangular end face,
(e) according to the stopper length of expection, be cut into pieces rectangular,
(f) scribe in case of necessity another fossaperturate and
(g) give the other end cover film of stopper in case of necessity, as primary closing membrane.
9. the method for making medical bag comprises following steps:
(a *) prepare stopper of the present invention, its in case of necessity one or two two end faces be provided with fossaperturate, also be provided with in case of necessity and have one or two cover layer, prepares two medical bag of thin film,
(b *) stopper is positioned between two sack thin film,
(c *) by the sack thin film is linked together, make medical bag, and by connection and heat treatment stopper and medical bag are connected together,
(d *) in case of necessity with the outer face of thin film covering stopper, constitute primary closing membrane.
10. according to claim 9 or 10 described methods, wherein used stopper, the material of its skin (C) is selected from polyester, Merlon and PMP, wherein the surface of sack thin film sensing stopper or the opening of medical system comprise such material, and this material has liquidity preference when temperature surpasses 90 ℃.
11., it is characterized in that heat treatment is meant the high-temperature sterilization process according to claim 9,10 or 11 each described methods.
12. method according to claim 9 is characterized in that, medical bag system is applied in the medical treatment as medical system.
13., it is characterized in that stopper is to be strip according to each described method in the claim 9 to 13, at step (b ') or (a *) directly cut into the length of expectation before.
14., it is characterized in that stopper had directly covered a thin film according to each described method in the claim 9 to 14 before being inserted into the opening of medical system at least one end face.
15., also comprise such step according to each described method in the claim 9 to 15:
(a 1) between two thin film, connect a flexible pipe, in the next production stage of medical bag, proceed processing then, make a medical bag.
16., it is characterized in that used flexible pipe and ship shape port, it has a lip or a ship shape edge in the contact site with bag material according to claim 14 or 15 described methods.
17. be used for implementing the device of the arbitrary method described in the claim 8 to 17.
18. have the medical system of each described stopper in the claim 1 to 7.
19. the medical system of making according to arbitrary method in the claim 9 to 17.
CN200810214389A 2008-09-05 2008-09-05 Plug for sealing medical system Pending CN101664367A (en)

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CN (1) CN101664367A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102883698A (en) * 2010-06-22 2013-01-16 三菱化学株式会社 Rubber stopper for medical use

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039432A1 (en) * 2001-11-09 2003-05-15 Taisei Plas Co., Ltd. Leak stop plug against needle piercing and method of manufacturing the leak stop plug
CN2716159Y (en) * 2004-07-06 2005-08-10 侯炯 Rubber plug with multiplayer membrane

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039432A1 (en) * 2001-11-09 2003-05-15 Taisei Plas Co., Ltd. Leak stop plug against needle piercing and method of manufacturing the leak stop plug
CN2716159Y (en) * 2004-07-06 2005-08-10 侯炯 Rubber plug with multiplayer membrane

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102883698A (en) * 2010-06-22 2013-01-16 三菱化学株式会社 Rubber stopper for medical use
CN102883698B (en) * 2010-06-22 2015-03-25 三菱化学株式会社 Rubber stopper for medical use
US9080044B2 (en) 2010-06-22 2015-07-14 Mitsubishi Chemical Corporation Rubber stopper for medical treatment

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Application publication date: 20100310