WO1998017339A1 - Syringe with a polyethylene stopper - Google Patents

Syringe with a polyethylene stopper

Info

Publication number
WO1998017339A1
WO1998017339A1 PCT/DE1997/002514 DE9702514W WO9817339A1 WO 1998017339 A1 WO1998017339 A1 WO 1998017339A1 DE 9702514 W DE9702514 W DE 9702514W WO 9817339 A1 WO9817339 A1 WO 9817339A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
syringe
plug
zyiinderinnenwandung
sealing lip
sealing
Prior art date
Application number
PCT/DE1997/002514
Other languages
German (de)
French (fr)
Inventor
Reiner Kolberg
Ralf-Siegbert Hauck
Original Assignee
Schering Aktiengesellschaft
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

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2/06Hot gas
    • A61L2/07Steam
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513Piston constructions to improve sealing or sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31521Pistons with a forward extending skirt at their front end

Abstract

The invention relates to a medical syringe with an inserted stopper (101). The syringe has the following features: a) the syringe comprises a cylinder with a proximal end and a distal end, and an outlet b) the syringe contains a medicament or a diagnostic agent c) the surfaces of the stopper (101) in contact with the inner wall (107) of the syringe cylinder are made of polytetrafluorethylene d) the surfaces of the stopper (101) in contact with the inner wall (107) of the syringe cylinder fit closely against the material of said wall e) the stopper has at least one sealing lip (108 and 109) and the resulting mass of the sealing lip forms a sharp angle with the syringe axis in distal direction. The syringe is intended to accommodate medicaments and diagnostic agents.

Description

Syringe with syringe stopper made of polyethylene

Introduction The invention relates to a medical syringe for containing a medium or for use and a method for terminal sterilization of these filled syringes. These syringes are preferably provided for the use of injectable diagnostic agents, in particular contrast agents to be injected, for example, in blood vessels, organs, parts of organs, cavities and other vessels or exert an imaging effect.

State of the art

Teflon plugs: In the German patent DE 3346 351 with publication date of 9 April 1992, a plug is described which is at least partially provided with a Teflon coating. Such a plug touches the

Inner cylinder having beads, which exert on the barrel inner wall, a specific pressure, whereby the sealing effect is to be ensured. The beads are formed so that the direction away from the plug perpendicular to the bead surface facing the back wall of the Spriztenzylinders. The patent uses Teflon to provide a protective surface between the medium and the rubber portion of the stopper. It is therefore in this case only an insulating function, the excellent sliding properties of Teflon are thereby further ignored. In this publication, the term siliconization was not mentioned. Thus, it can be assumed that this text also reads in this case, the person skilled in the effect that it is an otherwise common general knowledge (for example, DIN standard 13 098 part 1, Section 4.4) corresponding syringe, which is also on the inside of is siliconized cylinder.

Sealing lips:

In DE-GM 19 73 042, 23.11.1967, a plastic syringe of synthetic resin is disclosed which consists of a plastic cylinder having Nadelöffung and plug opening, a stopper and a plunger. The syringe as an essential feature has a bowl or bowl-shaped plug which is made of commercially available material. However, such sealing lip is only in combination with a lubricant, in particular silicone oil, executable. Not available silicone, the sealing lips would change due to the high friction and they would turning the power evasive. In this publication, the term siliconization was also not mentioned. Thus, there also is assumed that a skilled man reading this text to the effect that it is an otherwise common general knowledge (for example, DIN standard 13 098 part 1, Section 4.4) corresponding syringe, which also siliconized on the inner side of the cylinder is.

siliconise:

In the patent document AT-E 68 979 a filled terminally sterilized syringe is described. The syringe is made of plastic. The syringe has a barrel having a distal end with a syringe outlet. The syringe outlet is sealed by a closure. Prior to filling the inner wall of the syringe is coated with silicone oil. The syringe is sealed after filling with a flexible rubber stopper which is slidable in the cylinder also because of the silicone oil. The process for producing a filled, terminally sterilized syringe begins with debris or other contaminants from the closure and the piston are removed. Microbial contaminants on the closure and the piston are destroyed. The cylinder is washed with a multiplicity of jets of water to remove debris and pyrogens. Subsequently, the silicone oil is applied to the inner wall of the syringe. The closure is then attached to the syringe outlet. Through the proximal end of the syringe, the contrast medium is filled into the syringe. The syringe is then sealed with the stopper. This composite and filled syringe is sterilized in an autoclave. In addition to the usual autoclave pressure, an additional supporting pressure will be generated in the autoclave.

From the publication by Venten and Hoppert (E. VENTEN and J. HOPPERT (1978) Pharm. Ind. Vol. 40, No. 6, pp. 665-671) prefilled terminally sterilized prefilled syringes are known which on the inner wall with a silicone oil layer are provided. The spray ampoule having a plug at the proximal end are filled distally through the rolled edge. The rolled edge is then sealed by a sealing plate, wherein a flanged cap fixes the sealing disc on the roller edge. (M. JUNGA (1973) Pharm. Ind. Vol. 35, no. 11, pages 824-829) The pre-filled injection ampoules are then transferred to an autoclave. This autoclave with respect to the temperature and pressure regulated.

In the European patent application EP 0553926 (filing date 26.01.1993) discloses a method for terminal sterilization of a prefilled plastic syringe or glass syringe, said syringe containing a contrast agent. The inner wall of disposable syringes is coated with silicone oil. The syringe consists of a syringe barrel having a syringe outlet piece at the distal end. In addition, one-time injection ampoules are cited in the aforementioned even at Venten and Hoppert form. The syringes have an open proximal end which is closable by a slidable in the disposable syringe stopper. The plug is connected with a stamp.

WO 95/12482 describes a process for the preparation of pre-filled plastic syringes that are filled with a contrast medium. The inner wall of the syringe is coated with silicone oil. The syringes consist of a cylinder and a syringe at the distal end which is prepared for a needle hub. Further, the syringe comprises a plug, which can slide in the cylinder. It seals the proximal end of the syringe. The syringe has been prepared by a process that results in pyrogen-free objects. Likewise, no more particles are present. The syringe is filled through the proximal end, while, the syringe is sealed with a closure. The filled syringe is closed with the stopper.

After the syringe parts come from the mold, they are blown with gas to remove particles. The syringe is then washed and provided with a lubricant. The syringe is then sterilized so that the syringe optionally further processed, stored, or may be transported.

disadvantage

A disadvantage of the known syringes that silicone oil must be used to lower the friction between the stopper and the syringe occur. However worthy is rubber stopper with respect to the elastic forces so problematic is the behavior with respect to the sliding friction. A fortiori, the static friction is even more unfavorable. Especially in a long-term storage of the syringe with an inserted plug the static friction plays a very important role. Furthermore, with rubber stopper, the cold flow properties is always observed. Since this is a non-negligible size, rubber plugs must be used with a significant bias. The friction in all cases is so great that no silicone oil is not possible handling of the syringes.

Although sealing lips are used of rubber, they are not sufficiently sealed in a static state or suffer from the cold flow properties. Also in this case, is to work with a considerable prestress, so that silicone oil is indispensable in this case. A solid plug made of Teflon has a considerable disadvantage in syringes that are exposed to a thermal load. Here already in temperature range from -10 ° C to + 40 ° C in order to allow the plastics of the syringe to expand compared to the very solid Teflon material. This is customary in temperature. Also in this case, the cold flow behavior makes a negative impact. In order to make the stopper seal good, a high bias voltage is necessary because of the low elastic behavior of solid Teflon plug, which has thereby follow a large friction. For plastic syringes, such a Teflon stopper can not be used because the Kaltflieverhalten the syringe wall made of plastic increases the inner diameter of the syringe at the level of the plug. In this way, gaps can pass from the syringe in an uncontrolled manner through the liquid form. Characterized also can be sucked air in an uncontrolled manner. Glass syringes that do not show such a cold flow behavior, but must be coated with silicone oil on the inner wall in order to lower friction which is caused by the very high preload.

task

thus, it has as its object to provide a medical syringe, in which is without the addition of a lubricant in the form of, for example, silicone oil, without thereby is affected in the syringe, the lubricity of the plug which is made of plastic and at the same time an sufficient sealing of the contents of the syringe is ensured by the stopper relative to the syringe outer area. Solution of the problem

The object is achieved by a medical syringe with an inserted plug, said syringe comprises the following features: a) the syringe comprises

(I) a cylinder having a cylinder inner wall, (ii) a proximal end, (iii) a distal end, and (iv) preparing an outlet, b) the syringe for receiving a medium, c) at least the surfaces of the plug, contacting the inner cylinder of the syringe, are made of polytetrafluoroethylene or of substituted polyethylene or polypropylene, while the hydrogen atoms of polyethylene or

are polypropylene at least partially substituted by fluorine atoms, d) the surface of the plug, which contact the inner cylinder of the syringe, is the material of the Zyiinderinnenwandung directly, e) the plug has at least one sealing lips which sealingly abuts the Zyiinderinnenwandung the syringe f) at least the pointing distal or proximal surface or Massenresultierende the sealing lip forms with the axis of the syringe at an angle which is smaller than a right angle, or f) the elastic forces which press the sealing lip against the Zyiinderinnenwandung be through a region of the sealing lip caused, which is the area outside the normal to Zyiinderinnenwandung, wherein the perpendicular passing through the contact region between the sealing lip and Zyiinderinnenwandung, or f ') the elastic forces of which the sealing lip against

Zyiinderinnenwandung press, are caused in the static state of the plug by an elastic region having a tensile zone in addition to a compression zone.

The points> f); f); and f ") are alternative descriptions of the same technical solution principle. More preferably, the description of f), the description is most preferred by the point f").

More specific embodiment:

Preferably, a more specific embodiment of a medical syringe made of glass and / or plastic with an inserted plug, having the following features: a) the syringe comprises

(I) a cylinder having a Zylinderinnerwandung, (ii) a proximal end which is closed by the plug, (iii) a distal end which is closed by a cylinder cover, and (iv) an outlet of the cylinder ceiling or Zyiinderinnenwandung penetrates, b) the syringe is for receiving a medium or for use prepared, c) at least the surfaces of the plug which contact the Zyiinderinnenwandung the syringe are made of polytetrafluoroethylene or of substituted polyethylene or

Polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted by fluorine atoms, d) the surface of the plug, the Zyiinderinnenwandung which the

Contact syringe, is the material of the Zyiinderinnenwandung in the region of the cylinder jacket directly, e) the plug has at least one annular sealing lip that abuts the Zyiinderinnenwandung the syringe sealing, so that upon movement of the plug in the distal direction no

Medium may slide past the sealing lip, except that the inner wall has an outward bulge, f) at least the pointing distal or proximal surface or Massenresultierende the sealing lip forms with the axis of the syringe at an angle which is smaller than a right angle or f) the elastic forces which press the sealing lip against the Zyiinderinnenwandung be caused by a region of the sealing lip, which range is outside the normal to Zyiinderinnenwandung, wherein the perpendicular passing through the contact region between the sealing lip and Zyiinderinnenwandung, or f ') the elastic forces which the sealing lip against the

Zyiinderinnenwandung press, are caused in the static state of the plug by an elastic region having a tensile zone in addition to a compression zone. ,

Minimization of the lubricant

fgabe is also achieved by a medical syringe with an inserted plug, said syringe comprises the following features: a) the syringe comprises (i) a cylinder having a Zyiinderinnenwandung,

(Ii) a proximal end, (iii) a distal end, and (iv) preparing an outlet, b) the syringe for receiving a medium, c) at least the surfaces of the plug, the

Contact Zyiinderinnenwandung the syringe are made

Polytetrafluoroethylene or d) is selected from substituted polyethylene or polypropylene, while the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted by fluorine atoms between the surface of the plug, which contact the Zyiinderinnenwandung the syringe, and the Zyiinderinnenwandung no lubricants, or

- a lubricant in at most such a thickness that a satisfactory sliding friction and stiction which would occur in use of plugs made of rubber, then no longer allows in practice the usual movement of the stopper in the syringe, or

- a lubricant in such a thickness that does not allow a movement of the plug within the syringe using standard conditions, when the plug made of rubber would, e) the plug has at least one sealing lips which sealingly abuts the Zyiinderinnenwandung the syringe, f) at least the distally or proximally facing surface or Massenresultierende the sealing lip forms with the axis of the syringe at an angle which is smaller than a right angle, or f) the elastic forces which press the sealing lip against the Zyiinderinnenwandung be caused by a region of the sealing lip, which range is outside the normal to Zyiinderinnenwandung, wherein the perpendicular passing through the contact region between the sealing lip and Zyiinderinnenwandung, or f ') the elastic forces which press the sealing lip against the Zyiinderinnenwandung be caused in the static state of the plug by an elastic region of a having tensile zone in addition to a compression zone. , advantages

Waiver of lubricant:

The direct concern of the stopper on the inner wall of the syringe with the result that can be dispensed lubricant. Here, lubricant greases, silicone oil or fine granules can be. The disadvantage of all these lubricants that they can interact with the medium in the syringe. This is just of importance when the medium over a long period of time in direct contact with the lubricant is. due to the prior art, here is customary to apply the lubricant on the inner wall of the syringe, whereby a large surface results, which is in contact with the medium.

Improvement of the solid plug without sealing lip: The plugs in DE 33 46 351 are then not be used when the syringe is autoclaved in pre-filled form or is subjected to a thermic load. In such a situation, widening of the material always occurs because the plastics of the syringe barrel or the plug at elevated temperatures have flow properties. In this way, the plastic material is sometimes permanently deformed and staying well to the syringe at least on the plug. Also, the Teflon coating in the form of one of the substances which are changed as a result of thermal exposure during autoclaving. Because of the interference, which must have the stopper, arising during the Autoklavierenszykluses or the thermal load expansion, which leads to permanent damage of the plug because of the flow behavior of the plug. This leads in many cases to leaks, whether that material exiting the pre-filled syringe, or that any air entering from the exterior into the syringe. In both cases there is contamination, which are not desirable. Especially in the latter case, the occurrence of penetrating air is possible. In this way, there may be a contamination of the syringe content, which is highly dangerous for the patient. Because of attempts that have been made in our house, it has been found that solid plug, which are either made of Teflon or Teflon-coated, not for such syringes are used, the autoclaved or in pre-filled state are exposed to thermal stresses. Experiments have shown that also cause problems in syringes that are not pre-filled as disposable syringes.

Material polytetrafluoroethylene and fluorine-substituted polyethylene or polypropylene: The selection of the material of the plug is limited. Polytetrafluoroethylene and its modifications are particularly suitable since the temperature resistance is very high. Autoclaving the plug according to the invention is possible. The plugs are resistant, although they have a cold flow behavior, which is, however, negligible in practice with the set requirements. Thus, the plugs are long shelf-stable even in direct contact with the syringe body. The sealing function of the stopper is not compromised. The plugs are tolerated by humans, polytetrafluoroethylene has been approved by the US Food and Drug Administration (FDA). The Back resilience of the polytetrafluoroethylene is respectable, the storability is also positively influenced. Polytetrafluoroethylene exhibits good sliding properties, whereby the forces acting on the wall of the syringe can be relatively large without influencing the movement of the plug in the distal or proximal direction negative. The cold flow properties of the material is desirably small, so that this aspect acts conducive to the storage stability.

The forces exerted by the inventive stopper in the Zyiinderinnenwandung, are significantly less than the forces that occur in other conventional elastomers. This is possible because of the material used and the design of the sealing lips. However, shaping of the sealing lips in accordance with the prior art is not sufficient alone to achieve such an effect. Only when adding a lubricant to the inner wall of the syringe or on the outside of the stopper blank such good proportion between the forces towards the cylinder longitudinal direction and the forces arising in the direction of Zyiinderinnenwandung. a syringe according to the invention, in which the sealing lip points in direction toward the distal end and has a forwardly to the axis of the syringe surface, which forwards the force which is caused by the syringe pressure (when using or autoclaving) in the direction of the inner wall is advantageous.

Unsatisfactory sealing lips made of rubber:

A syringe according to DE-GM 19 73 042, 11.23.1967 is not autoclaved in prefilled form. Although it is possible during the heating and sterilization phase, that is shifted in the proximal direction due to the internal pressure of the cup-shaped stopper. In this case, at this moment, the sealing function is ensured. In the course of cooling, the liquid and, above all, the residual gas moves into the syringe back together, creating a negative pressure relative to the surrounding atmosphere. This results in that suction is applied to the stopper. Even with a siliconized inner wall, it causes such a syringe draws on the side of the sealing lips air. Such an effect is even more so then not be avoided, if they are not silicone oil. If no lubricants are used, the protuberances of the cup-shaped stopper flap on to distal movement, because the friction between the plug and Zyiinderinnenwandung is so large avoid the protuberances due to the elasticity.

Even small amounts of lubricant have the effect of the invention:

A simple bypass form of the invention, when in the wording of the claims only limited to the omission of a lubricant would be to reduce the amount of lubricant in such a way that it would no longer sufficient for a rubber stopper. Since no lubricant is required for the Teflon stopper or stoppers made of derivatives of Teflon, of lubricant would be a small amount of a possibility to offer a deteriorating embodiment. Since the harmfulness of all substances is concentration dependent, thus an amount of lubricant can be chosen easily, which is no longer physiologically noteworthy and thereby at the same time is not sufficient for a rubber stopper, however, would of course be used in conjunction with a Teflon stopper. Synergism of Teflon and sealing lips:

The combination of the material and the specific shaped sealing lips ensuring that otherwise problem exemplary syringes are autoclaved for example in pre-filled state can be made without failures and stored.

We have the interplay of three different parameters. First, there is the material. Here is Teflon or its derivatives particularly advantageous due to its inert behavior towards drugs. Furthermore, Teflon on a low coefficient of friction. However, following the teachings of the prior art and provides one plug with conventional form of Teflon ago, a satisfactory result can not be obtained. Leaks and unwanted feeding of liquid or air is seen as a disadvantage.

Therefore, the second aspect is also important. The shape of the sealing lip must be designed so that the sealing lips are sufficiently pressed against the inner wall of the syringe due to the cold flow behavior and the resulting elasticity. In this case, in particular in pre-filled, sterilized syringes, the static tightness of particular importance. Long storage and thermal treatment must not lead to leaks. Due to the special shaped portions of the sealing lips in the particular selection of the material is ensured that a leak of the plugs present in sufficient shape. This is not just about the seal in one direction, for example, is produced during the pressing of the syringe, but also the tightness while absorbing is guaranteed. This is also particularly important if in fact the plug during autoclaving or wicking of liquid moved. during autoclaving, the plug follows a parallelogram of forces, which is composed of pressure inside the syringe and external pressure in the autoclave. In order to give rise not too high pressures in the syringe, the stopper moves during the heating and sterilization phase to the outside. During the cooling phase, however, is to observe the opposite wall construction. A similar behavior occurs when aspirating liquids. As the third further essential aspect of the lack of coating can be seen with silicone oil. to use lubricant is previously known syringes with plastic plugs generally usual. This is apparent from the DIN standards (for example DIN Standard 13 098). Ledilgich the old glass syringes with a metal plugs were not siliconized. definitions

Direction of the sealing lips, the sealing lips typically have a substantially triangular cross-section. The base has the center of the stopper, the two legs meet at the tip of the sealing lip. The surfaces of the sealing lips can be straight or curved bent. Preferred is when the sealing lips are designed considerably wider at the base than at its tip. This results in that the seal has been particularly successful without making a great deal of effort. This base is called a sealing lip attachment point.

it is possible instead of the tapered sealing lip also to arrange a reinforcement at the end, which has the effect that even the tip of the sealing lip is pressed against the Zyiinderinnenwandung. This reinforcement thus has the function to create a more elastic range. Also, it is possible to produce the reinforcement from another resilient material such expresses a highly elastic rubber, which may be supported on the center of the plug and on the inside of the sealing lip the sealing lip against the Zyiinderinnenwandung.

What is desired is a sealing lip which is formed relatively long and having a relatively shallow angle to the axis of the plug. In this way, two functions are fulfilled. For one thing, in the dynamic behavior it so that the sealing lip is pressed against the Zyiinderinnenwandung because of the pressure in the syringe. Further, a useful compromise between elasticity and plasticity has been closed in the static system. This is particularly important when additional burdens such as autoclaving, thermal stress (Temeperatur during normal storage), pressure and solar radiation the Materieal claim plasticity respect.

Another characterization of the direction of the sealing lips can be specified using the Massenresultierenden. If the seal is viewed in cross-section, it can be from the base of the sealing lip, which is inserted in the plug (sealing lip attachment point) and the tip of the sealing lip draw a line which lies in the center of both sides. With respect to a triangle one would speak in such a case of the bisecting line. The angle is halved, which is located in the tip of the sealing lip. , The line described above forms an acute angle with the axis of the syringe, so the function of the sealing lip is ensured. Also an integral behavior of the "bisecting" or "Massenhalbierenden" is conceivable. Thus, the surfaces of the sealing lip can be curved or indented, they may have protrusions or indentations, it may be thickened or hammerfömig axtförmig at the top. Significantly, the resultant of the forces to be compared occurring when pressure is applied in the distal direction on the sealing lip. These resultant forces can easily be determined, no matter what shape has the sealing lip. The distal direction is the preferred direction of the sealing lips, however, the proximal alignment is possible. Such a proximally directed sealing lip will fulfill to a certain extent the sealing function well.

Elasticity range:

wesenlich is that the sealing lip with a force that is on the senkrekt Zyiinderinnenwandung expresses the same. This force is obtained at the sealing lips unlike the beads of the prior art made of elastic forces, which are caused by a deformable portion which is not on the perpendicular to the Zyiinderinnenwandung which lies through the contact region between the sealing lip and Zyiinderinnenwandung.

Tension zone and compression zone:

The sealing lips are pressed under a bias voltage to the Zyiinderinnenwandung the syringe. For this purpose, a force is necessary, which is caused by a zone of elasticity of the sealing lip. This elasticity zone does, on both tension and shear forces. Based on the length of the sealing lip has a laterally acting force is spent against the Zyiinderinnenwandung. It is essential that the

behaves stopper static. In such a case only a compression of beads or thickening known from the prior art, which press against the Zyiinderinnenwandung. Only when the stopper is moved in the art, a shear force is further applied to the beads, which can be a tensile zone are also formed in this stopper. It is important therefore that the tensile and shear forces parallel to the axis of the syringe in about. During the movement of the plug, whether new or old, tensile forces and shear forces are exerted by the shear force further extending approximately perpendicular to the axis of the syringe. Materials of the plug:

The substance polytetrafluoroethylene is the substance that is known as Teflon. Teflon has remarkable properties, so is above 300 ° C gradually a small weight loss a, only above 400 ° C decomposes Teflon. The Teflon has a low coefficient of friction of an average of 0.3, the coefficient of static friction is the value 0.05 to 0.1 higher. The pressure and the sliding speed does not matter. It is particularly advantageous that no high "breakaway and starting torques" occur even after prolonged storage life compared to other elastomers. Parts made of Teflon are physiologically acceptable. In feeding experiments with animals, no adverse effects have been observed in the absorption of Teflon. Teflon meets the FDA regulations on food contact. Teflon is, the term syringe comprises the terms cartridge (large-volume syringe with at least 100 ml volume), ampoule syringes, disposable syringes, disposable injection ampoules, disposable injection ampoules, disposable syringes, injection ampoules, disposable injection ampoules, RTS ampoule, cartridge, dual-chamber injection cartridge, two-chamber syringe, dual-chamber injection cartridge, two-chamber syringe and instant syringe.

Lubricant:

Lubricants intended that the plug without excessive force can be moved within the cylinder. Preference is given to silicone oil having which the following properties: viscosity at least 1000 cSt for plastic syringes and 300-400 cSt at glass (heat curing); Quality: medical grade.

In the property rights and technical, scientific publications, the step of siliconization is not mentioned explicitly. However, the conclusion is false, that has been dispensed with this step. Rather, the siliconizing is a mandatory step, without which the syringe application and hence the syringe production can not exist.

All publications to be read in terms of general knowledge. It should be noted that the Silikonisierungsschritt will always read along as a mandatory procedure. That it is, of course, is determined by the DIN standard 13 098 part 1 in section 4.4. clear. Here is drawn to the inevitable siliconization of disposable syringes. For prefilled syringes, the standard is not mandatory, but can also be used, as no other type standard, this DIN standard 13098 opposes.

Material of the stopper and the syringe: plastics are described in detail in Römpp - illustrated encyclopedia, publishers Jürgen FALBE and Manfred REGITZ, 9th Edition, Stuttgart, 1990, pages 2398 ff - chemistry. COC, PP and polymethylpentene are preferred. [COC cyclic olefin copolymer with the brand name CZ (manufactured by Nihon Zeon) and TOPAS (produced by Mitsui Chemicals, and Hoechst)]. These plastics are particularly suitable for use in prefilled terminally sterilized syringes, since their high melting point (at least 130 ° C) a steam sterilization (121 ° C standard method) allow. In addition, the optical properties according to pharmacopeia visual wholly owned inspection are sufficient.

Shape of the plug:

is advantageously a syringe, in which the plug is guided so that the axis of the plug is substantially coincident with the axis of the syringe. A guide can be achieved by guide ribs on the plug or Führungsgleitflächen. These parts have the task of hinderen the plug from tilting to grant the alignment of the plug so that the axis of the plug and the axis of the syringe may differ from each other only slightly. It is also possible that the plug is fixed with a punch, which is guided itself or which has a guide in which the plunger is movable. However, deviation are both axis (piston and

Syringe barrel) up to 10 °, preferably 5 ° to absorb more preferably 3 ° problems

syringes:

Glass syringes and plastic syringes are described in the publication by Junga (M. JUNGA (1973) Pharm. Ind. Vol. 35, no. 11, pp to 829, 824) described in detail. A mixture of glass and plastic is represented 96/00098 (filing date 23.06.1995) in WO. extremely hydrophobic and repels water from almost completely. This ensures that an interaction between the medium and the plug is excluded. Due to the thickness of the plug, the diffusion of gases from the outside inward and from the medium from the inside to the outside is negligible.

The polyethylene is substituted in a variant at least partially. The hydrogen atoms are at least partially replaced by fluorine atoms. It can involve them to polytetrafluoroethylene or a derivative in which not all hydrogen atoms are substituted.

Shape of the syringes:

The syringes are usually rotationally symmetrical; only the gen Fingerhalterun- and device holders and occasionally also the syringe deviate from the symmetry. Thus, the syringe may be disposed eccentrically. Particularly preferred is the luer - lock as it comes into play only in the application of contrast agents when mechanical pumping devices are used. Even with the manual appli- cation, the Luer - Lock and hose related that unintentional movement of the doctor are transferred directly to the cannula. Furthermore, the simple Luer and also record nozzle are known.

It is also possible to weld, the syringe and thereby seal. It is then advantageous that a syringe outlet has a predetermined breaking presented that allows easily opening the Sphtzenauslaßstückes before use.

Syringe outlet: The proximal and distal end of the syringe must be lockable. The distal end is sealed by a closure which is placed on the syringe. The syringe outlet includes in this property right the cover of the barrel. Further, the syringe comprises a tube that leads to the needle or the hose, an end piece, WEL ches communicates with the needle or the hose into contact and a cylinder with thread on the inner side, said cylinder surrounding the end piece and a thread for contributes Lock - one, for example Luer. In this case, the syringe may be integral or multi-piece. The cover can be arched, flat or pyramidal. Mixed forms are also conceivable. The plug closes the proximal end of the syringe. He has to be slidably received in the cylinder and the medium must surely hold back from the environment. He will be permeable as little as possible for gases and liquids. Temperature fluctuations must be collect without malfunction. Typically, the stopper at the mechanical emptying of the syringes is not provided with a dedicated stamp. Rather, a plunger which is part of the pumping device, in a closure in the inside the plug, such that movement of the plug is easily possible. (EP 0584531, see.)

Proximally and distally:

The terms proximal and distal are defined from the perspective of the attending

Physician. At the distal end is the syringe where, for example, the cannula or a tube leading to a cannula is connected. At the proximal end of the plug, presses the medium through the distal end during administration. The movement of the plug can be done manually or mechanically. The term also includes stopper flask. For manual operation of the syringe, it is helpful for the nal Bedienungsperso- when the syringe at the proximal end carries finger supports. The finger holders usually have at least one surface as an abutment for the index finger and middle finger, whereby the surface of the fingers gerhalterung substantially perpendicular to the axis of the syringe barrel. In mechanical pumping devices, various models are known. A syringe carries then preferably one or more device holders, preferably the proximal end. Especially good, such a mechanical pump in EP 0,584,531 (Reilly et al. Filing 21. 07. 1993). Mixed forms of finger holders and device holders are possible.

Medium:

The medium in the filled syringe is a mixture of a fluid medium and at least one gas. Thereby to precipitate as small as possible the volume of gas, desirable is a gas volume, which takes up the zero value. The medium may be a liquid, a solution, a suspension or an emulsion. These manifestations are in W. SCHRÖTER et al, (1987) Chemistry. Facts and Laws, 14th edition, Leipzig on pages 23 and following.

a fluid medium, which is a contrast medium is preferred. These are the following contrast media with the generic name: amino dotrizoesäure, gadopentetic, gadobutrol, gadolinium EOB-DTPA, lopami- dol, iopromide, iotrolan and lotroxinsäure. Dynamic pressure boost

Very preferably, the syringe of the invention, wherein at least one surface or the Massenresultierende the sealing lip has distally is. In this way, appropriate pressures can be built up, since the dynamic behavior of the sealing lips of the contact pressure by the pressure increase in the lumen of the syringe is increased.

The sealing lip is preferably annular.

a medical syringe according to the invention, in which the sealing lip is pressed with the pressure in the distal direction sealingly against the inner wall of the syringe is preferred.

More preferred is a medical syringe, in which the sealing lip is pressed during the movement and pressure in the distal direction sealingly against the inner wall of the syringe, wherein the pressure within the syringe in the prepared for receiving the flowable medium volume is greater than in the compartment, which α) is formed either by the Zyiinderinnenwandung and plug wall or ß) by the Zyiinderinnenwandung and the open proximal end.

The contact pressure of the sealing lips against the inner wall of the syringe increases to the plug in the distal direction with pressure. Preferably, this increase in the contact pressure is linear, optionally at low pressures large and smaller later abusive. The sealing lip unfolded while a function such as a lip valve or sailing valve.

a syringe according to the invention, in which the sealing lip points in direction toward the distal end and has a forwardly to the axis of the syringe surface, which forwards the force which is caused by the syringe pressure (when using or autoclaving) in the direction of the inner wall is preferred.

Minimizing the residual volume of medical syringes of the present invention, wherein the plug is configured complementary to the shape of the distal end of the syringe to minimize a residual volume which can not be removed from the syringe, despite full depression of the stopper, are advantageous.

Preferred is a medical syringe according to the invention, wherein the stopper convex, plane or having concave configuration, or pyramidal, conical, frusto-pyramidal, frusto-conical or hemispherical configurations, said points depending on the design of the end of the syringe, the protuberance to the distal or proximal.

Disposable syringes are preferred.

Andruckverstärkung

Preferably a syringe according to the invention, in which the sealing lip, which at least partially extends axially parallel to the Zyiinderinnenwandung, having a reinforcement or thickening of the material, which is connected to the sealing lip point of attachment to the plug via a plasticity range and / or elastic region.

preferred material

Syringes according to the invention, in which the polytetrafluoroethylene is a TFM, which has the following properties are preferred:

Elongation at break greater than 500%,

Deformation under load of less than 10%; SVI value is less than 250,

Permeability of sulfur dioxide is less than 310 at a film thickness of 1 mm,

Hydrochloric acid permeability of less than 600 at a film thickness of 1 mm, permeability of chlorine less than 300 at a film thickness of 1 mm. The values ​​are measured according to the following standards: elongation at break according to ISO 12086, bacg deformation ASTM D 621; SVI value ISO 12086, permeability according to DIN 53380 at a film thickness of 1 mm.

More preferred is a syringe of the invention, in which the plug is einstoffig.

Even more preferably, is a syringe according to the invention, wherein the plug has an elastic modulus of 550 ± 100 N / mm 2 at 25 ° C.

Most preferred is a syringe according to the invention, in which the plug having a coefficient of friction of μ τ = 0.35 ± 0.05 and a coefficient of sliding friction of μ 0.3 ± 0.05.

Filled, sterilized syringe

a syringe according to the invention, in which the syringe is filled with a medium and is autoclavable is preferred.

More preferred is a syringe of the invention in which the syringe can be autoclaved at a support pressure.

It is useful is that at least the syringe body, or poured in a sterile room at least 250 ° C is sprayed.

a syringe according to the invention, in which the sterile syringe can be packed in a sterile container, which has at least a gas-permeable, but not germ-permeable wall is advantageous.

Notes to Steriiisierung

A syringe must be cleaned of debris. Foreign bodies are all the particles which are not made of the material of the syringe and the medium and the detached fragments of the syringe. Pyrogens are substances that provoke as fragments of the bacterial an immune response in humans. In particular, it is lipopolysaccharide of saccharides, ie cell wall components of gram-negative bacteria.

As chemical sterilization methods are the treatment with ethylene oxide, propane-3-olide and diethyl dicarbonate, also known hydrogen peroxide, and an ozone / vapor mixture.

Sterilization with high-energy radiation is also possible. Here are known gamma-rays and X-rays.

The syringe or cartridge is thermally sterilized in an autoclave or steriliser with hot air or by microwave.

Thus, the stopper does not move within the cylinder, it is advantageous if the stopper is fixed during sterilization.

Optionally, it is possible to build a supporting pressure in the sterilization chamber of the autoclave or the sterilizing chamber by a gas in the sterilization chamber, the pressure on the outer surface of the syringe is greater than, equal to or less than the pressure on the inner surface of the syringe. The supporting pressure is to be defined as the pressure corresponding to the sum of the partial pressures in the sterilization chamber minus the partial pressure of the vapor.

A further advantage is that the filled and terminally filled syringe is packed in sterile conditions plastic and / or aluminum foil, optionally aseptic loading. It is advantageous here that the syringe is packaged in sterile blister may, optionally aseptic conditions prevail.

A process for producing a pre-filled sterile syringe The invention also comprises a process for the preparation of a pre-filled sterile syringe, which comprises the following features: a) sterile preparation of the syringe parts or cleaning and sterilization of the syringe parts produced, b) assembling the parts, (i) where the distal end is sealed at proximal filling or

(Ii) the proximal end closed by the plug at the distal filling, c) proximal optionally sterilizing the assembled syringe, d) or distal filling, depending on the still remaining opening, e) proximal sealing by the plug or distal sealing by an outlet closure or welding the

Outlet, f) sterilizing the filled and sealed syringe, g) optionally sterile packaging of the syringe into a container having at least one surface which is gas permeable but not keimpermeabel.

Such methods are described in detail in EP 0227401, EP 0553926 and the US Patent US 5,207,983. Similarly, reference is made to the document E. Venten and J. Hoppert, Pharm. Ind. Vol. 40, no. 6 (1978). In this publication, including the references cited therein, will be made in detail to sterilization methods. The publication of Venten and Hoppert is quote part of the application. It is particularly advantageous if a combination of the syringes of the invention and an application device of injectomat and from terminals, wherein the injectomat is a pump system and the connections connect the outlet of the syringe to the patient. Such injectomat z. Example, in EP 0192786 described.

Combination of syringe and injectomat The invention further comprises a combination of a prefilled terminally sterilized syringe according to the invention and an application device of automatic injector and from terminals, the injectomat is a pumping system, and the terminals connecting the outlet of the syringe to the patient. Such a pump system is described in the publication EP 0,584,531.

51464AWOM2XX00 + P 15.10.1997 far Specific embodiments

The preferred embodiments of a syringe according to the invention can be seen in the figures. The invention is not limited to these embodiments.

1 shows a cross section through a Teflon stopper. Figure 2 shows in cross section the relationship of forces on the sealing lip. Figure 3 shows a cross section through a plug portion with two sealing lips. Figure 4 shows a cross section through a biconcave sealing lip.

Figure 5 shows a cross section through two pointing in different directions sealing lips. Figure 6 shows a cross section through two sealing thickened portions and the associated pressure / area chart. Figure 7 shows a cross section through a sealing lip and the associated pressure / area chart. Figure 8 shows a cross-section through a sealing lip with reinforcement.

The Figure 1, which is the preferred embodiment, shows a cross section through a plug 101, which is positioned in a syringe barrel 102nd The plug 101 comprises a core 103, which has on the plug cylinder edge 104 has three notches 105, which are part-circular. The notches 105 do not abut each other directly, but are connected by webs 106 attached directly to the cylinder inside 107th

Then downwardly, that is, facing toward the medium and away from the plunger, there are two sealing lips 108 and 109, which are arranged one behind the other. The proximal sealing lip 108 forms a right triangle, wherein the adjacent side 111 is formed on the acute angle which is located proximally through the cylinder 110 of the plug 101, the opposite side 112 through a radially extending side and the hypotenuse 113 by an angle to the plug axis 114 facing side. The hypotenuse 113 is the cylinder inner wall 107 on only in a small area, which abuts the opposite side 112th

The distal sealing lip 109 has a triangular shape, the base 115 is disposed obliquely with respect to the plug axis 114th From the base 115 go from two approximately equal legs 116 and 117, with only the direction away from the plug axis 114 contacts the leg Zylinderinnwandung 107th Because of the material the two sealing lips 108 and 109 are elastic, they press also in the rest state of the light 107 to Zyiinderinnenwandung.

Figure 2 shows the basic relationship of forces in an inventive plug 201. It provides a cross section through the plug 201 which is disposed within a syringe barrel 202nd The plug 201 comprises a core 203, which has on the plug cylinder edge 204, two notches 205 which are rectangular. The notches 205 do not abut each other directly, but are connected by a web 206 which bears the cylinder inside wall 207 directly.

The sealing lip 209 has an almost triangular shape, the base 215 is disposed obliquely with respect to the plug axis 214th From the base 215 go from two approximately equal legs 216 and 217, with only the direction away from the plug axis 214 contacts the leg Zylinderinnwandung 207th Because of the material, the sealing lip 209 is elastic, it presses itself even at rest easily the Zyiinderinnenwandung 207 at.

The forces on the sealing lip 209 are designed differently in the dynamic and static state. The dynamic state is when a pressure is exerted on the plunger, so that the plug is pressed in the distal direction two hundred and first Here, the syringe internal pressure of the medium is increased. In the static condition neither the medium nor the plunger exerts a pressure on the plug of which is in equilibrium. If the friction coefficient infinitely small, the punch befände when no forces acting on it, volunteer in this position.

The sealing lip 209 has a slight bias, it is characterized of Zyiinderinnenwandung 207 slightly. Since the contact surface is very small, the Flächenpreßdruck is still relatively high. In the static state of the plug 201 thus seals the interior of the syringe barrel 202 from sufficient. Here, small forces are spent. but small forces also mean that the cold flow properties of the polytetrafluoroethylene is not overused. A long storage period of such a syringe is also possible, without changing the material of the plug 201 remarkable deformed by cold flow. In the dynamic state of the stopper 201 is pressed in the distal direction in the medium pressure is built up. This presses on the inwardly facing leg 216, whereby the mass of the seal lip 209 is urged outwardly. The force is collected on the one hand by the base 215 and on the other hand through the front part of the outer leg 217th Especially the latter part causes the pressure of the lip 209 on the Zyiinderinnenwandung 207 per unit area is very high. The area is sufficiently large to prevent passage of the medium from the lumen of the syringe into the surrounding space successful. The webs 206 are not substantially sealingly, is applied 217 to atmospheric pressure on the outwardly facing limb, which faces the syringe internal pressure.

3 shows a cross section through a plug 301 disposed in a syringe barrel 302nd The plug 301 comprises a core 303, which has on the plug cylinder edge 304 three notches 305, which are rectangular. The notches 305 do not abut each other directly, but are connected by webs 306 attached directly to the cylinder inside 307th

Then distally, that is facing toward the medium and away from the plunger, there are two sealing lips 308 and 309, which are arranged one behind the other. These two sealing lip 308 and 309 form a right-angled triangle, wherein the major catheti, are formed 311 to the acute angle which points in the proximal direction through the cylinder 310 of the plug 301, the Gegenkatheten 312 through a radially extending side and the hypotenuses 313 by an inclined to plug axis 314 facing side. The hypotenuses 313 are the cylinder inner wall 307 only in a small area, which abuts the opposite side 312th

4 shows deviating a sealing lip 409 which has a convex shape in both the outer legs 417 and in the inner leg 416th

5 shows three sealing lips, one that includes both legs 516 and 517 distally and a facing with the two legs 516 'and 517' proximally. Between the two there is a dovetail-shaped ridge, which is sealed during dynamic movement of the plug 501 also because it easily bends due to the resilient base 515 "against the direction of movement and is pushed by his pointing in the direction of movement contact area on the Zyiinderinnenwandung 507th

6 shows a seal according to the prior art. Here, the spatial allocation of the webs with respect to the selective area pressing the webs was prepared in the Zyiinderinnenwandung. It is obvious that the surface pressure is distributed over a larger area and thereby has a selective pressure which is relatively low.

7 shows a sealing lip according to the invention 709, which has only a small contact area with the Zyiinderinnenwandung 707 due to their shape. Here relatively high pressures are applied selectively, while maintaining the total area is smaller, which bears the Zyiinderinnenwandung 707th

The hatched areas in Figures 6 and 7 should be with respect to the integral of the same size. The essential difference that is larger than in the figure 6 in Figure 7 of the Fächenanpreßdruck. Furthermore, and this is the main point of this printing-surface diagram shows only the static state. In the dynamic state, wherein said medium is compressed in the syringe, contact with the Figure 7 to significantly higher values, while the values ​​remain in the Figure 6 quantitatively equal, the highest shifted in position in the proximal direction.

8 shows a cross section through a plug 801 having a sealing lip 809 that abuts the Zyiinderinnenwandung 807th The sealing lip 809 does not end pointed, but has a thickening 820. Further, the elasticity and plasticity zone zone 821 can be seen from the Figure 8 clearly that lies between the sealing lip attachment point 822 and the contact surface 823 between the sealing lip 809 and Zyiinderinnenwandung 807th Furthermore, the zone of elasticity and plasticity zone 821 between the sealing lip attachment point 822 and the thickened portion 820 are arranged. In the field of elasticity zone there is a compression zone 824, and a tension zone 825, both of which run approximately parallel to the plug axis 814th Furthermore, it is seen that the elastic zone 821 is not located on the line perpendicular to the Zyiinderinnenwandung 807 which go simultaneously through the vertical contact surface 823rd The Piastizitätszone 821 comes into play when a constant pressure or a thermal load on the sealing lip 809 acting, as this occurs particularly in autoclaving. This area has a flow behavior without at the same time the entire elasticity of the sealing lip is abandoned. The balance between plasticity and elasticity in this region 821 is essential for a successful sealing of the stopper. The forces and changes occurring can be easily checked by an expert experimentally.

Claims

claims
1. Medical syringe with an inserted plug, said syringe comprises the following features: a) the syringe comprises
(I) a cylinder having a Zyiinderinnenwandung, (ii) a proximal end, (iii) a distal end, and (iv) preparing an outlet, b) the syringe for receiving a medium, c) at least the surfaces of the plug, contacting the Zyiinderinnenwandung the syringe are made of polytetrafluoroethylene or of substituted polyethylene or polypropylene, while the hydrogen atoms of polyethylene or
Are polypropylene at least partially substituted by fluorine atoms, d) the surface of the plug, which contact the Zyiinderinnenwandung of the syringe, is the material of the Zyiinderinnenwandung directly, e) the plug has at least one sealing lip, which abuts the Zyiinderinnenwandung the syringe sealing, f " ) the elastic forces which press the sealing lip against the Zyiinderinnenwandung be caused in the static state of the plug by an elastic region comprising a
having tensile zone in addition to a compression zone.
2. Medical syringe made of glass and / or plastic with an inserted plug, having the following features: a) the syringe comprises
(I) a cylinder having a Zylinderinnerwandung,
(Ii) a proximal end which is closed by the plug, (iii) a distal end which is comparable concluded by a cylinder cover, and
(Iv) an outlet which passes through the cylinder cover or the Zyiinderinnenwandung, b) the syringe is for receiving a medium or for use prepared, c) at least the surfaces of the plug which contact the Zyiinderinnenwandung the syringe are made of polytetrafluoroethylene or of substituted polyethylene or
Polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted by fluorine atoms, d) the surface of the plug, the Zyiinderinnenwandung which the
Contact syringe, is the material of the Zyiinderinnenwandung in the region of the cylinder jacket directly, e) the plug has at least one annular sealing lip that abuts the Zyiinderinnenwandung the syringe sealing, so that upon movement of the plug in the distal direction no
Medium may slide past the sealing lip, except that the inner wall has an outward bulge, f ') the elastic forces which press the sealing lip against the Zyiinderinnenwandung be in the static state of the
Stopper caused by a range of elasticity, which is a
having tensile zone in addition to a compression zone.
3. Medical syringe with an inserted plug, said syringe comprises the following features: a) the syringe comprises
(I) a cylinder having a Zyiinderinnenwandung, (ii) a proximal end, (iii) a distal end, and (iv) preparing an outlet, b) the syringe for receiving a medium, c) at least the surfaces of the plug, contacting the Zyiinderinnenwandung of the syringe are, d) is made of polytetrafluoroethylene or of substituted polyethylene or polypropylene, while the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted by fluorine atoms between the surface of the plug, which contact the Zyiinderinnenwandung the syringe, and the Zyiinderinnenwandung there is no lubricants, or
- a lubricant in at most such a thickness that a satisfactory sliding friction and stiction which would occur in use of plugs made of rubber, then no longer allows in practice the usual movement of the stopper in the syringe, or
- a lubricant in such a thickness that does not allow a movement of the plug within the syringe using standard conditions, when the plug made of rubber would, e) the plug has at least one sealing lips which sealingly abuts the Zyiinderinnenwandung the syringe, f "), the elastic forces, which press the sealing lip against the Zyiinderinnenwandung be caused in the static state of the plug by an elastic region comprising a
having tensile zone in addition to a compression zone.
4. Medical syringe according to any one of the preceding claims, wherein the sealing lip is pressed with the pressure in the distal direction sealingly against the inner wall of the syringe.
5. Medical syringe according to any one of the preceding claims, wherein the sealing lip is pressed during the movement and pressure in the distal direction sealingly against the inner wall of the syringe, wherein the pressure within the syringe in the prepared for receiving the flowable medium volume is greater than in the which α) is formed either by the Zyiinderinnenwandung and plug wall or ß) by the Zyiinderinnenwandung and the open proximal end compartment.
6. Medical syringe according to any one of the preceding claims, wherein the sealing lip, which at least partially extends axially parallel to the Zyiinderinnenwandung, having a reinforcement or thickening of the material, which is connected to the sealing lip point of attachment to the plug via a plasticity range and / or elastic range.
7. A syringe according to one of the preceding claims, wherein the polytetrafluoroethylene has the following properties:
Elongation at break greater than 500%, deformation under load of less than 10%;
SVI value is less than 250,
Permeability of sulfur dioxide is less than 310 at a film thickness of 1 mm,
Hydrochloric acid permeability of less than 600 at a film thickness of 1 mm, permeability of chlorine less than 300 at a film thickness of
1 mm.
8. A syringe according to one of the preceding claims, wherein the plug is einstoffig.
9. A syringe according to one of the preceding claims, wherein the plug has an elastic modulus of 550 ± 100 N / mm 2 at 25 ° C.
10. A syringe according to one of the preceding claims, wherein the plug having a coefficient of friction of μ τ = 0.35 ± 0.05 and a coefficient of sliding friction of μ 0.3 ± 0.05.
11. A process for the preparation of a pre-filled sterile syringe according to any one of the preceding claims, comprising the following features: a) the preparation of the sterile syringe parts or cleaning and sterilization of the syringe parts produced, b) assembling the parts,
(I) while the distal end is sealed at proximal filling or (ii) the proximal end through the plug at the distal
Filling closed, c) optionally, sterilizing the assembled syringe, d) proximal or distal filling, depending on the still remaining opening, e) proximal sealing by the plug or distal sealing by an outlet closure or welding of the outlet, f) sterilizing the filled and closed syringe, g) optionally sterile packaging of the syringe into a container having at least one surface which is gas permeable but not keimpermeabel.
12. combination of a prefilled terminally sterilized syringe according to one of the preceding claims, and an application device of automatic injector and from terminals, the injectomat is a pumping system, and the terminals connecting the outlet of the syringe to the patient.
PCT/DE1997/002514 1996-10-18 1997-10-17 Syringe with a polyethylene stopper WO1998017339A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
DE1996144622 DE19644622C2 (en) 1996-10-18 1996-10-18 Medical, pre-filled, sterilized syringe
DE19644622.8 1996-10-18
DE19735566.8 1997-08-11
DE1997135566 DE19735566A1 (en) 1997-08-11 1997-08-11 Prefilled hypodermic syringe

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA 2268655 CA2268655A1 (en) 1996-10-18 1997-10-17 Syringe with a polyethylene stopper
EP19970948684 EP0935476A1 (en) 1996-10-18 1997-10-17 Syringe with a polyethylene stopper
JP51884698A JP2001502568A5 (en) 1997-10-17

Publications (1)

Publication Number Publication Date
WO1998017339A1 true true WO1998017339A1 (en) 1998-04-30

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ID=26030809

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PCT/DE1997/002514 WO1998017339A1 (en) 1996-10-18 1997-10-17 Syringe with a polyethylene stopper
PCT/DE1997/002513 WO1998017338A1 (en) 1996-10-18 1997-10-17 Prefilled sterile syringes with polyethylene stoppers

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/DE1997/002513 WO1998017338A1 (en) 1996-10-18 1997-10-17 Prefilled sterile syringes with polyethylene stoppers

Country Status (4)

Country Link
EP (1) EP0935476A1 (en)
KR (1) KR100484458B1 (en)
CA (1) CA2268655A1 (en)
WO (2) WO1998017339A1 (en)

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JP2001502568A (en) 2001-02-27 application
CA2268655A1 (en) 1998-04-30 application
KR100484458B1 (en) 2005-04-22 grant
WO1998017338A1 (en) 1998-04-30 application
EP0935476A1 (en) 1999-08-18 application
KR20000049267A (en) 2000-07-25 application

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