KR20000049267A - Syringe with a Polyethylene Stopper - Google Patents

Abstract

PURPOSE: A medical syringe with an inserted stopper is provided which is intended to accommodate medicaments and diagnostic agents. CONSTITUTION: A 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 the 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.

Description

Syringe with a Polyethylene Stopper

Teflon Stopper:

German Patent DE 3346 351, published April 9, 1992, discloses a stopper provided with a Teflon coating at least partially. This stopper contacts the inner wall of the cylinder through a bead that exerts a certain pressure on the inner wall of the cylinder to ensure a sealing effect. The bead is designed so that the normal of the bead surface facing away from the stopper faces the wall of the barrel. This patent uses Teflon to provide a protective face between the medium and the rubber portion of the stopper. Therefore, this is only an insulation function and this document no longer considers the excellent sliding properties of Teflon. In this document, the term siliconization is not mentioned. Therefore, even in this case, it is assumed that those skilled in the art will understand that this document refers to a syringe in which the inner surface of the cylinder is siliconized, in accordance with universal technical knowledge in other respects (DIN German Industrial Standard Specification 13 098, Part 1, subsection 4.4, etc.). .

Sealing lip:

DE-GM 19 73 042 of November 23, 1967 discloses a plastic syringe made of synthetic resin, consisting of a plastic cylinder, a stopper and a plunger with a needle side opening and a stopper opening. The syringe has a shell or bowl stopper made of a commercially available material as a basic feature. However, such a sealing lip is only possible with lubricants, especially silicone oils. Without silicone oil, the sealing lip will be twisted and pushed upside down due to the large frictional force. In this document, the term siliconization is not mentioned. Therefore, it is assumed that those skilled in the art will understand that this document refers to a syringe which, in other respects, coincides with universal technical knowledge (DIN German Industrial Standard 13 098, Part 1, subsection 4.4, etc.) and also siliconizes the inner surface of the cylinder. .

Siliconization:

Patent AT-E68 979 discloses a syringe that is filled and finally sterilized. The syringe is made of plastic. The syringe has a cylinder with a distal end with a syringe discharge piece. The syringe discharge piece is sealed with a closure. Prior to filling, the inner wall of the syringe is coated with silicone oil. After filling, the syringe is sealed with an elastic rubber stopper, which can slide into the cylinder due to the silicone oil.

The process for making a filled, finally sterilized syringe therefore begins with the removal of waste particles or other contaminants from the obstructions and plungers. Eliminates microbial contaminants on obstructions and plungers. The cylinders are washed with multiple water jets to remove pyrogen and waste particles. Silicone oil is then applied to the inner wall of the syringe. The obstruction then slides onto the syringe discharge piece. The contrast agent is filled into the syringe through the base end of the syringe. The syringe is then sealed with a stopper. This assembled and filled syringe is sterilized in a high pressure vessel. In this case, additional support pressures are created in the high pressure vessel in addition to the high pressure vessel pressures normally used.

Pre-filled, finally disinfected cartridge-needle units provided with a silicone oil layer on the inner wall are described in E. VENTEN & J. HOPPERT (1978) Pharm. Ind. Vol. 40, No. 6, pp 665-671 Known from This cartridge-needle unit, with a stopper at the base end, is filled at the distal end through the rounded edge. The flange cap then attaches the sealing disc to the rounded edge to seal the rounded edge with the sealing disc (M. JUNGA (1973) Pham. Ind. Vol. 35, No. 11a, pp 824-829). This prefilled cartridge-needle unit is then transferred to a high pressure vessel. This high pressure vessel can be adjusted for temperature and pressure.

European patent application EP 0 553 926 (filed date: 1993/1/26) discloses a final method of disinfection of prefilled plastic syringes or glass syringes containing contrast agents. The inner wall of the disposable syringe is coated with silicone oil. The syringe consists of a barrel having a syringe discharge piece at the distal end. Moreover, disposable cartridge-needle units exhibit the form already described in Venten & Hoppert, supra. The disposable syringe has an open base end that can be sealed with a stopper that can slide into the disposable syringe. The plug is connected to the plunger.

WO 95/12482 discloses a process for the preparation of prefilled plastic syringes filled with contrast agents. The inner wall of the syringe is coated with silicone oil. The syringe consists of a syringe release piece, which is provided for cannula attachment at the cylinder and base end. The syringe also includes a stopper that can slide into the cylinder. This seals the base end of the syringe. The syringe was prepared according to the method of obtaining a target free of exothermic material. In addition, no further particles are present. The syringe is filled through the base end, in which case the syringe discharge piece is sealed with a blockage. The filled syringe is sealed with a stopper.

After the syringe part comes out of the die, the gas is blown out to remove particles. The syringe is then washed and the lubricant is provided. The syringe is then sterilized so that the syringe can be further processed, stored or transported as desired.

fault

A disadvantage of known syringes is the use of silicone oil to reduce the friction between the plug and the syringe inner wall. Although the rubber stopper is reasonable in terms of elasticity, the behavior related to sliding friction becomes a problem. Cohesive friction is even more a problem. Adhesive friction plays a very important role, especially for long term storage of syringes with plugs inserted. Moreover, cold-flow behavior should always be considered in the case of rubber plugs. Since the latter factor is important, a rubber plug of considerable prestressing should be used. In this case, the friction in all cases is so great that handling of the syringe is impossible without the use of silicone oil.

Even if a sealing lip made of rubber is used, the sealing lip in the static state does not seal properly or suffer from low temperature flow behavior. Also in this case, working with significant raw stress, silicone oil is also indispensable in this case.

Solid stoppers made of Teflon have a big disadvantage in the case of syringes exposed to thermal stress. Here, even temperature variations from -10 ° C to + 40 ° C are sufficient to allow the plastic of the syringe wall to expand with respect to the solid Teflon material. This is a normal temperature fluctuation. Also in this case, the low temperature flow behavior becomes disadvantageously apparent. In order for the plug to seal well, a large circular stress, which means large friction, is required because of the slight elastic action of the solid Teflon plug. Such teflon plugs should not be used in plastic syringes because cold flow behavior of the plastic syringe walls increases the inner diameter of the syringe at the plug height. As a result, a gap is formed through which the liquid can pass freely from the syringe. As a result, air can be sucked freely. Glass syringes that do not exhibit this cryogenic behavior still have to coat the silicon on the inner wall to reduce the friction caused by very high raw stress.

purpose

It is an object of the present invention to eliminate the need for the addition of lubricants in the form of silicone oils, thereby ensuring that the plastic stopper does not impair the ability to slide into the syringe while at the same time ensuring proper sealing of the contents of the syringe by the stopper against the outside of the syringe. It is to provide a medical syringe.

Accomplishment of purpose

a) the syringe

(i) cylinder with inner wall,

(ii) the proximal end,

(iii) a distal end, and

(iv) outlet

Including,

b) a syringe is prepared to receive the medium,

c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted with fluorine atoms,

d) the inner wall material of the cylinder is directly adjacent the plug surface in contact with the inner wall of the barrel,

e) the closure has at least one sealing lip which seals against the inner wall of the barrel,

f) forming an angle smaller than orthogonal to the axis of the syringe made of at least the surface or mass-resultant facing the distal or base of the sealing lip,

f ') the elastic force for urging the sealing lip towards the inner wall of the cylinder is caused by the region of the sealing lip lying outside of a line perpendicular to the inner wall of the cylinder passing through the contact area between the sealing lip and the inner wall of the cylinder, or

f ") that the elastic force that urges the sealing lip towards the inner wall of the cylinder when the plug is in static state is caused by an elastic region having a traction zone in addition to the compression zone.

This object is achieved by a medical syringe comprising an inserted stopper having characteristics.

The terms f), f ') and f ") are the description to be taken and are the same technical principle. More preferably, it is the description of f'), and most preferably the description from the term f").

Special embodiment

a) the syringe

(i) cylinder with inner wall,

(ii) a base end that can be sealed with a stopper,

(iii) a distal end sealed with a cylinder shell, and

(iv) discharge openings through the cylinder shell or through the inner wall of the cylinder;

Including,

b) a syringe is prepared for receiving or using the medium,

c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially at least partially substituted,

d) in the region of the cylinder shell the inner wall material of the cylinder is directly adjacent to the plug surface in contact with the inner wall of the barrel,

e) with at least one annular sealing lip which seals against the inner wall of the barrel so that the medium does not exit past the sealing lip unless the inner wall protrudes outward when the stopper moves in the distal direction,

f) forming an angle smaller than orthogonal to the axis of the syringe made of at least the surface or mass-reactant facing at least the base or base of the sealing lip,

f ') the elastic force for urging the sealing lip towards the inner wall of the cylinder is caused by the region of the sealing lip lying outside of a line perpendicular to the inner wall of the cylinder passing through the contact area between the sealing lip and the inner wall of the cylinder, or

f ") that the elastic force that urges the sealing lip towards the inner wall of the cylinder when the plug is in static state is caused by an elastic region having a traction zone in addition to the compression zone.

More particular embodiments of glass and / or plastic medical syringes with embedded plugs having properties are preferred.

Minimization of lubricant

a) the syringe

(i) cylinder with inner wall,

(ii) the proximal end,

(iii) a distal end, and

(iv) outlet

Including,

b) a syringe is prepared to receive the medium,

c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted with fluorine atoms,

d) between the plug surface in contact with the inner wall of the barrel and the inner wall of the cylinder

No lubricant

When the plug moves in the syringe in the usual manner when in use, the lubricant is present in a thickness that does not exceed the thickness that no longer allows satisfactory sliding and adhesive friction when using the rubber stopper;

or

-If the stopper is made of rubber, there is a lubricant at a thickness that does not allow the stopper to move in the syringe under normal conditions of use,

e) the closure has one or more annular sealing lips that seal against the inner wall of the barrel,

f) forming an angle smaller than orthogonal to the axis of the syringe made of at least the surface or mass-reactant facing at least the base or base of the sealing lip,

f ') the elastic force for urging the sealing lip towards the inner wall of the cylinder is caused by the region of the sealing lip lying outside of a line perpendicular to the inner wall of the cylinder passing through the contact area between the sealing lip and the inner wall of the cylinder, or

f ") that the elastic force that urges the sealing lip towards the inner wall of the cylinder when the plug is in static state is caused by an elastic region having a traction zone in addition to the compression zone.

A medical syringe comprising an inserted stopper with the characteristics also achieves the object.

Advantages

Removal of Grease:

The fact that the plug is located directly on the inner wall of the syringe means that no lubricant is necessary. In this case, the lubricant may be fat, silicone oil, or fine granules. A disadvantage of all these lubricants is that they can interact with the medium in the syringe. This is particularly important if the medium is in direct contact with the lubricant over a long period of time. In this case, due to the prior art, it is common to apply a lubricant to the inner wall of the syringe, resulting in a large surface in contact with the medium.

Improvement of solid stopper without sealing lip:

The stopper of DE 33 46 351 should not be used if the syringe has been sterilized in a high-pressure container in a prefilled form or exposed to thermal stress. In this situation, the expansion of the material always occurs because the plastic of the barrel or stopper has flow characteristics at elevated temperatures. For this purpose, the plastic is permanent and deformed at least in the closure, sometimes even in the syringe.

Teflon, also in the form of a coating, is one of the materials that changes during disinfection in high pressure containers due to thermal action.

Because the plug must be made to large dimensions, expansion occurs during high pressure vessel cycles or thermal stresses, causing permanent damage to the plug due to the flow action of the plug. In many cases, leakage occurs because the medium exits the prefilled syringe or air from the outside passes into the syringe. In both cases, this is undesirable contamination. Especially in the latter case, air can penetrate. As a result, contamination of the syringe contents can occur, which is very dangerous for the patient. The tests we performed demonstrated that solid plugs made of Teflon or Teflon coatings could not be used for syringes that were autoclaved in a pre-filled state or exposed to thermal stress. A test was also conducted to reveal the problem in the case of syringes prefilled with disposable syringes.

Polytetrafluoroethylene and fluoro substituted polyethylene or polypropylene materials:

The choice of material for the stopper is limited. Polytetrafluoroethylene and its modifications are particularly suitable because of their high temperature stability. Pressure disinfection of the plug according to the invention is readily possible. Although the stopper exhibits cold flow behavior, considering the imposed conditions, the stopper is stable since this behavior is virtually negligible. Therefore, the stopper is stable even in storage in direct contact with the syringe body for a long time. The sealing function of the plug is not impaired. The stopper is suitable for humans. Polytetrafluoroethylene is approved by the US Sanitation Authority (FDA). The recoverability of polytetrafluoroethylene is excellent and as a result, its storage period is practically dependent. Polytetrafluoroethylene exhibits good sliding properties, which forces in the inner wall of the syringe can be relatively large in this case without too negatively affecting the plug movement in the distal or base direction. The low temperature behavior of the material is satisfactorily small, even this has a beneficial effect on the storage period.

The force exerted on the inner wall of the cylinder by the closure according to the invention is considerably less than the force occurring in the case of other conventional elastomers. This is possible due to the material used and the structure of the sealing lip.

However, the shape of the sealing lip according to the prior art is not sufficient by itself to achieve this effect. Only when a lubricant is applied to the inner wall of the syringe or to the outside of the stopper, a good balance develops between the force in the longitudinal direction of the cylinder and the force in the inner wall direction of the cylinder.

The syringe according to the invention is advantageous in that the sealing lip has a surface towards the distal end and towards the axis of the syringe and transmits the force (in use or autoclaving) due to the internal pressure of the syringe towards the inner wall.

Unsatisfactory sealing lips made of rubber:

Syringes according to German patent DE-GM 19 73 042 of 23 November 1967 cannot be autoclaved in a prefilled form. During heating and disinfection, the bowl stopper can move in the base direction under the action of internal pressure. In this case, the sealing function is assured at this time. During cooling, the liquid and especially the residual gas are also drawn together into the syringe, creating a partial vacuum to ambient air pressure. The effect of this is that suction is applied to the stopper. Also in the case of the siliconized inner wall, the result is that this syringe draws air along the face of the sealing lip. This effect is basically hard to avoid unless silicone oil is used.

If no lubricant is used, the protrusion between the bowl and the inner wall of the cylinder is so great that the protrusion slides by elasticity, so the protrusion of the bowl stopper is bent when the bowl stopper is moved to the distal end.

Small amounts of lubricant have the following effects according to the invention.

If the simple task of the present invention is limited to the omission of lubricant in the context of the claims, this consists in reducing the amount of lubricant to an extent that is no longer appropriate for the rubber stopper. Since no lubricant is required for a plug made from a Teflon stopper or a Teflon derivative, a small amount of lubricant will be a method of providing an inferior embodiment. Since the toxicity of all substances depends on the concentration, it is therefore not physiologically important and at the same time not appropriate for rubber stoppers, but of course the amount of lubricant that can be used with Teflon stoppers can easily be chosen.

Synergy of Teflon and Sealing Lips:

The combination of the material and the specifically modified sealing lip ensures that the syringe of the other problem, for example, being autoclaved in a pre-filled state, can be made and stored without error.

We have the interaction of three different parameters.

First, there is material. Here, teflon or derivatives thereof are particularly advantageous because of the inert action of teflon on drugs. Moreover, Teflon has a low coefficient of friction. However, according to the technical teachings of the prior art, stoppers are made from Teflon in the usual form and satisfactory results cannot be obtained. Leakage of liquids or air and undesirable uptake can be observed as drawbacks.

Therefore, the second variable is important. Because of the shape of the sealing lip and the elasticity resulting therefrom, the sealing lip must be properly pressed against the inner wall of the syringe. In this case, in particular in the case of prefilled, sterilized syringes, static robustness is of particular importance. Long term storage and heat treatment do not necessarily lead to leakage. Because of the particular embodiment of the sealing lip when the material is specially selected, the tightness of the plug is found to be appropriate. For example, it is rigid during aspiration rather than sealing in the direction that occurs when injecting the syringe contents. This is particularly important when the stopper moves during autoclaving or during the withdrawal of liquid. During autoclaving, the plug follows a parallel comb strain of force consisting of the internal pressure of the syringe and the external pressure of the autoclave. To maintain the excessive pressure occurring in the syringe, the plug moves outwards during heating and disinfection. However, the movement in the reverse direction can be observed during the cooling state. A similar kind of action is found when the liquid is aspirated.

The fact that it is not coated with silicone oil is the third important variable. The use of lubricants is common in the case of known syringes which generally contain plastic stoppers. This is evident from the DIN standard (eg DIN standard 13 098). Only old glass syringes containing metal stoppers are not siliconized.

Justice

Direction of sealing lip:

The sealing lip generally has a triangular cross section basically. The bottom face towards the center of the plug and the two sides meet at the apex of the sealing lip. The surface of the sealing lip may change in a straight or curved line. It is preferred that the sealing lip is much wider at its base than at its apex. This has the effect that sealing is particularly effective without incurring high material costs. This base is considered to be a seal lip attachment point.

Instead of tapering the sealing lip at its end, it is also possible to arrange a reinforcing piece having the effect of the tip of the sealing lip being pressed against the inner wall of the cylinder. Therefore, the reinforcing piece has a function of providing another elastic region. The reinforcement piece may be made from another elastic material, namely high elastic rubber, which can be supported at the center of the stopper and presses the sealing lip against the inner wall of the cylinder inside the sealing lip.

Sealing lips are preferred that are relatively long and have a relatively flat angle with respect to the axis of the closure. This ensures that both functions are met. One is, in dynamic behavior, the sealing lip is pressed against the inner wall of the cylinder because of the pressure of the syringe. In addition, in static systems, there is a reasonable compromise between elasticity and plasticity. This is particularly important if additional pressures such as autoclaving, thermal stress (temperature during normal storage), pressure and solar radiation stress the material against plasticity.

Other properties in the direction of the sealing lip are provided with the aid of mass-reactant. Considering the sealing lip as a cross section, a line in the center of both faces can be drawn from the bottom of the sealing lip inserted into the plug (sealing lip attachment point) and from the apex of the sealing lip. For the triangle, we can talk about the bisection of the angle in this case. Here, the angle at the apex of the sealing lip is bisected. If the line described above is acute with respect to the axis of the syringe, the function of the sealing lip can be ensured. It is also conceivable to have an integrated behavior of "half bisector" or "half bisector". The surface of the sealing lip can be arched or indented, can have protrusions or grooves, and can be thickened at the vertex like a hammer or an axe. It is essential to compare the synthetic forces that occur when applying pressure to the sealing lips in the circumferential direction. This synthetic force is easy to measure, and the shape of the sealing lip does not matter. Although the distal direction is the preferred direction of the sealing lip, the base orientation is also possible. The sealing lip oriented to this base surely fulfills the sealing function to some extent.

Elastic area:

It is important that the sealing lip is pressed against the inner wall of the cylinder with a force perpendicular to the inner wall. Unlike in the case of beads of the prior art, using a sealing lip this force does not lie on a perpendicular line to the inner wall of the cylinder, but from the elastic force resulting from the deformable area lying through the contact area between the sealing lip and the inner wall of the cylinder. Obtained.

Towing zone and compression zone

The sealing lip is pressed against the inner wall of the barrel under raw stress. For this purpose, a force caused by the elastic zone of the sealing lip is needed. In this case, this elastic zone is subjected to both tension and shear forces. For the length of the sealing lip, a force acting laterally against the inner wall of the cylinder is used. In this case, it is important that the stopper behaves in a static manner. In this case, only the beads or the compressed parts of the thickened portions that compress against the inner wall of the cylinder are known from the prior art. If the stopper of the prior art only moves, a shear force is also applied to the bead which can also provide a traction zone at this stopper. Therefore, it is important that the tension and shear force be approximately parallel to the axis of the syringe. When the stopper is moved, the shear force is again exerted by the tension and shear force which are approximately perpendicular to the axis of the syringe, regardless of whether the movement is first or not.

Material Of Plugs:

Polytetrafluoroethylene is a material known as Teflon. Teflon has prominent properties, ie small mass loss only gradually occurs above about 300 ° C., and only above 400 ° C. destroys teflon. The friction rate of Teflon is low at an average of 0.3, and the adhesion friction rate is high at 0.05 to 0.1. In this case, pressure and sliding speed do not play any role. Even after prolonged storage, there is no high "cutting and starting moment" compared to other elastomers. Parts produced from Teflon are physiologically harmless. In animal feeding trials, no detrimental results were observed for ingestion of Teflon. Teflon also meets FDA regulations for contact with food. The term syringe refers to the term cartridge (large volume syringe with volume greater than 100 ml), ampoule syringe, disposable syringe, disposable cartridge-needle unit, batch cartridge-needle unit, batch syringe, infusion ampoule, disposable cartridge-needle unit, ready to spray Ampoules, cylinder ampoules, dual chamber cartridge-needle units, two chamber syringes, two chamber cartridge-needle units, two chamber syringes, and emergency syringes.

slush:

The lubricant is intended for the stopper to move the cylinder inwards without consuming much force. Preferred is silicone oil, which has a viscosity of at least 1000 cSt for plastic syringes and 300-400 cSt for glass, the grade being medical grade.

In the patent and technical scientific literature, the step of siliconization is not mentioned in detail. However, it is wrong to conclude by omitting this step. Rather, siliconization is an essential step and there is no syringe use and syringe preparation without siliconization.

Therefore, all documents should be understood in terms of universal technical knowledge. In this case, the siliconization step is always included as an essential process. This is undoubtedly evident from DIN Standard 13 098, Part 1 Subsection 4.4. Reference is made here to the essential siliconization of disposable syringes. For prefilled disposable syringes, the standard is not mandatory, but it can be used because other standards do not oppose this DIN standard 13 098.

Plug and Syringe Material:

Plastics are described in detail in Roempps-Chemie-Lexikon, publisher Juergen FLALBE and Manfred REGITZ, 9th edition, Stuttgart, 1990 pp 2398. COC, PP, and polymethylpentene are preferred. [COC = cycloolefin copolymer of the registered trademark CZ (Nihon Zeon) and TOPAS (Mitsui Chemicals and Hoechst)]. These plastics are particularly suitable for use in syringes that are prefilled and finally sterilized because their high melting point (130 ° C.) allows for steam disinfection (standard method 121 ° C.). Moreover, the optical properties for 100% visual inspection according to the pharmacopeias are appropriate.

Mode of plug:

Advantageous is a syringe in which the closure is guided such that the axis of the closure essentially coincides with the axis of the syringe. It can be guided from the lead to the guide pin or guide sliding surface. These parts have the purpose of preventing the plug from tipping and orienting the plug so that the axis of the plug and the axis of the syringe deviate only slightly from each other. The stopper can be attached to the plunger having a tool from which the plunger is guided and the plunger can move. However, the deflection (plunger and barrel) of the axis of 10 degrees or less, preferably 5 degrees or less, more preferably 3 degrees or less, can be easily handled.

syringe:

Glass syringes and plastic syringes are described in detail in the literature by Junga (M. JUNGA (1973) Pharm. Ind. Vol. 35, No. 11a, pp 824-829). Mixtures of glass and plastics appear in WO 96/00098 (June 23, 1995: filing date). Extremely hydrophobicity almost completely fry water. For this purpose, it is ensured that the interaction between the medium and the stopper is impossible. Because of the thickness of the plug, the diffusion of gas from the inside to the outside from the inside to the outside is negligible.

In a variant, the polyethylene is at least partially substituted. In this case, the hydrogen atom is at least partially substituted with a fluorine atom. It may be polytetrafluoroethylene or its derivatives in which all hydrogen atoms are unsubstituted.

Form of syringe:

The syringe is generally rotationally symmetrical, and only the finger holder and the container holder and sometimes the syringe outlet piece deviate from symmetry. Therefore, the syringe discharge piece can be arranged eccentrically. Particularly preferred is the Luer family, since it is used exclusively in the administration of contrast agents, if mechanical pump action devices are used. In addition, in the case of manual administration, the Luer and related tubes prevent unintentional movements by the physician directly from the cannula. Moreover, simple Luer nozzles and record nozzles are known.

It is also possible to bond the syringe discharge piece and thus seal it. It is then advantageous for the syringe release piece to have a predetermined breaking point that facilitates opening the syringe release piece before use.

Syringe ejection:

The distal and base ends of the syringe should be sealable. The distal end is sealed with a blockage that can be attached to the syringe discharge piece. The syringe release piece includes the shell of the barrel in this patent. Moreover, the syringe discharge piece comes into contact with the needle or hose and the needle or hose and surrounds the cylinder with a screw blade therein (thus the cylinder surrounds the end piece, for example with a screw blade for the Luer family) It includes a pipe leading to the fragment. In this case, the syringe discharge piece may be one part or multipart. The sheath may be arched, flat or pyramidal. Mixed forms are also conceivable. The stopper seals the base end of the syringe. It must be able to slide into the cylinder and the medium must be reliably protected from the environment. As far as possible, they should be impermeable to gases and liquids.

Temperature fluctuations should slow down without compromising function. As a rule, when the syringe is mechanically empty, the plug is supplied with a separate plunger. Rather, the plunger, which is part of the pump action mechanism, engages in a blockage inside the stopper so that the stopper moves easily.

Donations and Donations:

The terms base and base are defined from the physician's point of view. The distal end is, for example, a cannula or syringe discharge piece connected to a hose leading to the cannula. The proximal end is a stopper that compresses the medium through the proximal end during administration. The plug can move manually or mechanically. The term stopper also includes a plunger. For manual ejection of the syringe, it is helpful to the operator if the syringe has a finger holder at the base end. In this case, the finger holder generally has at least one face as a support for the index finger and the middle finger, and the face of the horn finger holder is basically perpendicular to the axis of the barrel. In the case of mechanical pumping devices, various models are known. The syringe then preferably has one or more container holders, preferably at the base end. Such mechanical pumps are described particularly well in EP 0 584 531 (Reilly et al., Filed Jul. 21, 1993). Mixed forms of finger holders and container holders are also possible.

medium:

The medium of the filled syringe is a mixture of fluid medium and one or more gases. In this case, the gas volume should be as small as possible, and preferably, the gas volume is a value of zero. The medium may be a liquid, solution, suspension, or emulsion. This type of phenomenon is described in W. SCHROETER et al., (1987) Chemistry: Facts and Laws, 14th edition, Leipzig pp. 23.

Preferred are fluid media that are contrast agents. These are contrast agents with common names such as amidotrizoic acid, gadopentetic acid, gadobutrol, gadolinium EOB-DTPA, iopamidol, iopromide, iotrollan, and itroxane.

Dynamic pressure increase

Very preferred is a syringe according to the invention in which at least one surface or mass-reactant of the sealing lip is directed back. For this purpose, the corresponding pressure is enhanced because the application pressure increases by increasing the pressure in the lumen of the syringe due to the dynamic action of the sealing lip.

The sealing lip is preferably annular.

A medical syringe according to the invention is preferred in which the sealing lip is tightly sealed against the inner wall of the syringe when there is pressure in the distal direction.

The sealing lip seals the inner wall of the syringe while applying circumferential movement and pressure, and the pressure inside the syringe at a volume provided to receive the free flowing medium

α) the inner wall and plug wall of the cylinder, or

β) formed by the inner wall of the cylinder and the open base end

Larger medical syringes than in compartments are more preferred.

When there is pressure in the distal direction from the stopper, the pressure at which the sealing lip is pushed against the inner wall of the syringe increases. Preferably, the increase in this applied pressure is linear, optionally greater and later at lower pressures. In this case, the sealing lip works like a lip valve or a sliding valve.

Preference is given to syringes according to the invention with a sealing lip directed towards the distal end and towards the axis of the syringe and having a surface through the force created by the internal pressure (in use or autoclaving) of the syringe towards the inner wall.

Minimize Residual Volume

The medical syringe according to the invention, in which the plug is configured complementary to the shape of the distal end of the syringe, advantageously reduces the residual volume that cannot be removed from the syringe despite the complete compression of the plug.

The present invention has a pyramidal, conical, truncated pyramid, truncated cone, or hemispherical shape with a convex, convex, planar or concave design, or else with expansion orientation towards the base or base, depending on the design of the distal end of the syringe. Preferred medical syringes are preferred.

Disposable syringes are preferred.

Contact pressure increase

Preference is given to syringes according to the invention having a reinforcing piece or thickened portion in which the sealing lip moving at least partially parallel to the inner wall of the syringe is connected to the sealing lip attachment point at the stopper through a plastic region and / or an elastic region.

Desirable material

Polytetrafluoroethylene

Elongation at break above 500%,

Deformation under a load of less than 10%,

SVI values less than 250,

Sulfur dioxide less than 310 at a film thickness of 1 mm and chlorine permeability less than 300 at a film thickness of 1 mm

Preference is given to syringes according to the invention which are TFMs having the property of.

Valve

Elongation at break according to ISO 12086,

Deformation according to ASTM D 621,

SVI value according to ISO 12086,

Permeability according to DIN 53380 at 1 mm film thickness

Measure according to the standard.

More preferred is a syringe according to the invention in which the plug is made of one material.

Even more preferred is a syringe according to the invention wherein the stopper's elastic strain is 550 ± 100 N / mm ² at 25 ° C.

Most preferred is a syringe according to the invention with an adhesive friction value of the plug of μ _t = 0.35 ± 0.05 and a sliding friction value of μ = 0.3 ± 0.05.

Filled, Sterilized Syringes

Preference is given to syringes according to the invention which can be filled with medium and autoclaved. More preferred are syringes according to the invention which can be autoclaved in the presence of a supporting pressure.

It is useful for at least the syringe body to be cast or injection molded in a sterile chamber at 250 ° C. or higher.

Disinfection syringes according to the invention which are capable of being packaged in disinfection containers having at least one gas permeable but bacterial impermeable wall are advantageous.

Description of Disinfection

The syringe must be disinfected with impurities. All particles that are separate fragments of the syringe, not the material of the syringe and the medium, are impurities.

Pyrogens are fragments of bacteria that cause immune responses in humans. In particular, this is the cell wall component of lipopolysaccharide, ie, gram negative bacteria.

As a chemical disinfection method, treatment with hydrogen peroxide and an ozone / vapor mixture in addition to ethylene oxide, propane-3-oxide, and diethyl dicarbonate is known.

It is also possible to disinfect with high energy radiation. Here, gamma rays and x-rays are known.

Heat sterilize the syringe or cartridge in a autoclave or sterilizer with hot air or microwave.

In order to prevent the plug from moving inside the cylinder, it is advantageous for the plug to be attached during disinfection.

It is possible or not possible to increase the supporting pressure in the sterilization chamber or the sterilization chamber of the autoclave by the gas of the sterilization chamber, so that the pressure at the outer surface of the syringe is greater than, equal to or less than the pressure at the inner surface of the syringe. The support pressure may be defined as the pressure equal to the total of the partial pressure in the sterilization chamber minus the partial pressure of the steam.

Moreover, it is preferable that the filled and finally filled syringe is packaged in sterile plastic film and / or aluminum foil, optionally under sterile conditions. In this case, it is advantageous that the syringe can optionally be packaged in a sterile blister in which sterile conditions exist.

Prefilled Sterilized Syringe

The present invention

a) cleaning and disinfection of syringe components manufactured or manufactured;

b) (i) the syringe is filled through the proximal end so that the distal end is closed,

(ii) where the syringe is filled through the distal end and the base end is closed,

Assembly of parts

c) random disinfection of the assembled syringe

d) filling the base or disc according to the remaining opening,

e) base obstruction by a stopper or distal obstruction by splicing an outlet obstruction or outlet,

f) disinfection of filled and sealed syringes,

g) optional disinfection packaging of the syringe in a container having one or more surfaces that are gas permeable, bacterial impermeable;

Also included is a method of making a prefilled syringe comprising such features.

This method is described in detail in European patents EP 0 227 401, EP 0 553 926 and US Pat. No. 5,207,983. E. Venten and J. Hoppert, Pharm. Ind. Vol. 40, no. 6 (1978), bibliographical references. In this document, including the documents cited herein, the disinfection method is considered in detail. Venten and Hoppert's literature is a citation application. The combination of the syringe and the dosing device according to the invention is particularly advantageous if the injector is a pumping system and the connection is made with the injector connecting the outlet of the syringe and the patient. Such injection formats are disclosed in EP 0 192 786 and the like.

Combination of syringe and injector

The present invention also provides a combination of a prefilled and finally sterilized syringe according to the present invention, and an injector and a dosing device in which the injector is a pumping system and the connection connects the outlet of the syringe with the patient. Include. Such a pumping system is disclosed in document EP 0 584 531.

51464AWOM2XX00 + P Oct 15, 1997 Wide

Specific embodiment

Preferred embodiments of the syringe according to the invention are shown in the drawings. The present invention is not limited to this embodiment.

1 shows a cross section through a Teflon plug.

2 shows the force ratio in cross section in the sealing lip.

3 shows a cross section through a plug piece having two sealing lips.

4 shows a section through a sealing lip with both sides concave.

5 shows a cross section through a sealing lip facing in different directions.

6 shows a pressure / surface area schematic associated with a cross section through two seal thicknesses.

7 shows a cross section through the sealing lip, and the associated pressure / surface area schematic.

8 shows a cross section through a sealing lip including a reinforcing piece.

1, which is a preferred embodiment, shows a cross section of the stopper 101 aligned to the barrel 102. The stopper 101 consists of a core 103 with three grooves 105 which are partially circular on the stopper cylinder edge 104. The grooves 105 are not directly adjacent to each other, but are connected by a web 106 directly adjacent to the inner wall 107 of the cylinder. Subsequently there are two sealing lips 108 and 109 aligned behind each other, below, ie facing the medium and away from the plunger. The base sealing lip 108 is formed by a side wall 111 adjacent to an acute angle of the base by the cylinder wall 110 of the stopper 101, and is formed into a side from which the opposite side 112 extends radially, and the hypotenuse 113 ) Forms a right triangle formed on the plug axis 114 with diagonally-facing sides. The hypotenuse 113 adjoins the cylinder inner wall 107 only in a small area adjacent to the opposite side 112.

The distal seal lip 109 is a triangle in which the base 115 is arranged obliquely to the plug axis 114. Two nearly identical sides 116 and 117 emerge from the bottom side 115, with the sides facing away from the closure axis 114 contacting the cylinder inner wall 107. Because of the material, the two sealing lips 108 and 109 are elastic and they are slightly pressed onto the cylinder inner wall 107 in the rest position.

2 shows the principal force ratio in the plug 201 according to the invention. It is a cross section through the stopper 201 aligned with the barrel 202. The stopper 201 consists of a core 203 having two grooves 205 rectangular to the stopper cylinder edge 204. The grooves 205 are not directly adjacent to each other, but are connected by a web 206 directly adjacent to the inner wall 207 of the cylinder.

The sealing lip 209 is almost triangular with the base 215 obliquely aligned with the closure axis 214. Two nearly identical sides 216 and 217, from which the side facing away from the closure axis 214, contacts the cylinder inner wall 207, emerge from the base 215.

Because of the material, the sealing lips 209 are elastic and they are slightly pressed onto the cylinder inner wall 207 in the rest position.

The forces on the sealing lip 209 are designed differently in dynamic and static states. When pressure is exerted on the plunger, there is a dynamic state such that the stopper 201 is pressed in the distal direction. In this case, the pressure inside the syringe of the medium is increased. In the static state, the equilibrium medium or plunger does not exert pressure on the stopper. If the friction coefficient is very small, if no force acts on it, the plunger will be free at this position.

The sealing lip 209 has a weak circular stress, and thus is easily adjacent to the cylinder inner wall 207. Because the contact pressure surface is very small, the surface compaction force is relatively higher. In the static state, the stopper 201 thus properly seals the interior space of the barrel 202. In this case, a small force is used. However, small forces mean that the low temperature flow behavior of polytetrafluoroethylene is not emphasized. Such a syringe can be stored for a long time without the material of the plug 201 being significantly deformed by cold flow.

In the dynamic state, the stopper 201 is pressed in the distal direction, so that the pressure increases in the medium. The latter is pressed onto the inwardly facing side 216, pushing the main portion of the sealing lip 209 outward. On the one hand, the force is caused by the bottom side 215, and on the other hand, by the frontal part of the outer side 217. Particularly mentioned at the end is that the pressure of the lip 209 on the cylinder inner wall 207 has a very high effect per unit surface area. In this case, the surface area should be large enough to successfully prevent the medium from overflowing from the lumen of the syringe into the surrounding space. Since the web 206 is not basically sealed, an atmospheric pressure different from the internal pressure of the syringe is exerted on the outward facing side 217.

3 shows a section through the stopper 301 aligned to the barrel 302. The stopper 301 consists of a core 303 with three grooves 305 rectangular on the stopper cylinder edge 304. The grooves 305 are not directly adjacent to each other, but are connected by a web 106 directly adjacent to the inner wall 307 of the cylinder.

There are then two sealing lips 308 and 309 aligned below each other, ie facing the medium and away from the plunger. The two sealing lips 308 and 309 are formed by the cylinder wall 310 of the stopper 301 with the side 311 adjacent to the acute angle facing the base, with the opposite side 312 extending radially. And a hypotenuse 313 forms a right triangle formed on the stopper axis 314 in a diagonally facing side. The hypotenuse 313 adjoins the cylinder inner wall 307 only in a small area adjacent to the opposite side 312.

4 shows the sealing lip 409 in a convex form at the outer side 417 and the inner side 9416 in another manner.

FIG. 5 shows three sealing lips, one with two sides 516 and 517 facing the distal side and one with two sides 516 'and 517' facing the base side. When there is a dynamic movement of the stopper 501, the elastic base 515 "expands slightly with respect to the direction of the movement and is compressed by the contact area facing the direction of the movement with respect to the cylinder inner wall 507. There is a pigeon tail web in between.

6 shows a seal according to the prior art. In this regard, the spatial distribution of the web to the surface pressure at a certain point of the web in the cylinder inner wall is shown. Clearly, the surface pressure is distributed over a fairly large area, in this case having a relatively low point pressure.

7 shows a sealing lip 709 according to the present invention having only a small contact surface with the cylinder inner wall 707 because of its shape. Here, a relatively large pressure is exerted at a certain point, but in this case the entire surface adjacent to the cylinder inner wall 707 is small.

6 and 7 should be identical when integrated. The basic difference is that in FIG. 7 the surface application force is greater than in FIG. 6.

In the dynamic state in which the medium is compressed in the syringe, a fairly large value occurs in FIG. 7, with the values in FIG. 6 being quantitatively identical and at most moving from their position to the base.

8 shows a cross section through a stopper 801 including a sealing lip 809 adjacent to the cylinder inner wall 807. The sealing lip 809 does not end with a sharp tapering, but has a thick portion 820. In addition, the elastic zone and the plastic zone 821 between the contact surface 823 between the sealing lip 809 and the cylinder inner wall 807 and the sealing lip protrusion point 822 are clearly shown from FIG. 8. Moreover, the elastic zone and the plastic zone 821 are aligned between the sealing lip protrusion point 822 and the thick portion 820. In the elastic zone, there is a compression zone 824 and a traction zone 825 that move almost parallel to the closure axis 814. In addition, the elastic zone 821 is on the vertical line of the cylinder inner wall 807, which passes through the contact side 823 at the same time. The elastic zone 821 then serves, in particular, when a constant pressure or thermal stress acts on the sealing lip 809 as occurs in autoclaving. This region simultaneously exhibits the flow behavior without sacrificing the overall elasticity of the sealing lip. A balanced relationship between plasticity and elasticity in region 821 is essential for successful closure of the closure. Forces and changes in this case can be easily checked by testing by one skilled in the art.

The present invention relates to a medical syringe for receiving or using a medium and a method for the final disinfection of the filled syringe. Such syringes are preferably provided for administering injectable diagnostic agents, in particular contrast agents injected into or acting upon blood vessels, organs, organ parts, body cavity and other vasculature.

Claims (12)

a) the syringe (i) cylinder with inner wall, (ii) the proximal end, (iii) a distal end, and (iv) outlet Including, b) a syringe is prepared to receive the medium, c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted with fluorine atoms, d) the inner wall material of the cylinder is directly adjacent the plug surface in contact with the inner wall of the barrel, e) the closure has at least one sealing lip which seals against the inner wall of the barrel, f ") that the elastic force that urges the sealing lip towards the inner wall of the cylinder when the plug is in static state is caused by an elastic region having a traction zone in addition to the compression zone. A medical syringe comprising an inserted stopper having characteristics. a) the syringe (i) cylinder with inner wall, (ii) a base end that can be sealed with a stopper, (iii) a distal end sealed with a cylinder shell, and (iv) discharge openings through the cylinder shell or through the inner wall of the cylinder; Including, b) a syringe is prepared for receiving or using the medium, c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted with fluorine atoms, d) in the region of the cylinder shell the inner wall material of the cylinder is directly adjacent to the plug surface in contact with the inner wall of the barrel, e) with at least one annular sealing lip which seals against the inner wall of the barrel so that the medium does not exit past the sealing lip unless the inner wall protrudes outward when the stopper moves in the distal direction, f ") that the elastic force that presses the sealing lip towards the inner wall of the cylinder when the stopper is static is caused by an elastic region having a traction band in addition to the compression band. A medical syringe made of glass and / or plastic comprising an inserted stopper having characteristics. a) the syringe (i) cylinder with inner wall, (ii) the proximal end, (iii) a distal end, and (iv) outlet Including, b) a syringe is prepared to receive the medium, c) at least the surface of the plug in contact with the inner wall of the barrel is made of polytetrafluoroethylene or substituted polyethylene or polypropylene, wherein the hydrogen atoms of the polyethylene or polypropylene are at least partially substituted with fluorine atoms, d) between the plug surface in contact with the inner wall of the barrel and the inner wall of the cylinder There is no lubricant, When the plug moves in the syringe in the usual manner when in use, the lubricant is present in a thickness that does not exceed the thickness that no longer allows satisfactory sliding and adhesive friction when using the rubber stopper; or -If the stopper is made of rubber, there is a lubricant at a thickness that does not allow the stopper to move in the syringe under normal conditions of use, e) the closure has at least one sealing lip which seals against the inner wall of the barrel, f ") that the elastic force that urges the sealing lip towards the inner wall of the cylinder when the plug is in static state is caused by an elastic region having a traction zone in addition to the compression zone. A medical syringe comprising an inserted stopper having characteristics. The medical syringe according to any one of claims 1 to 3, wherein the sealing lip seals the inner wall of the syringe while applying a pressure in the distal direction. 5. The syringe according to any one of claims 1 to 4, wherein the sealing lip seals the inner wall of the syringe while applying circumferential movement and pressure, and the pressure inside the syringe at a volume provided to receive the free flowing medium is increased. α) the inner wall and plug wall of the cylinder, or β) formed by the inner wall of the cylinder and the open base end Medical syringe larger than in the compartment. 6. The thickened reinforcement piece according to claim 1, wherein the sealing lip moving at least partially parallel to the cylinder inner wall is connected to the sealing lip attachment point on the plug via the plastic zone and / or the elastic zone. 7. Medical syringe with part. The method according to any one of claims 1 to 6, wherein the polytetrafluoroethylene is Elongation at break above 500%, Deformation under a load of less than 10%, SVI values less than 250, Sulfur dioxide permeability of less than 310 at a film thickness of 1 mm, Hydrochloric acid permeability less than 600 at film thickness 1 mm and chlorine permeability less than 300 at film thickness 1 mm Syringe with the characteristic of. 8. A syringe according to any one of the preceding claims wherein the plug is made of one material. The syringe according to claim 1, wherein the elastic strain of the plug is 550 ± 100 N / mm ² at 25 ° C. 10. The method according to any one of claims 1-9, wherein the adhesive friction value of the stopper μ _t = 0.35 ± 0.05, the syringe is sliding friction value μ = 0.3 ± 0.05. a) sterilization of syringe components or cleaning and sterilization of syringes made; b) (i) the syringe is filled through the proximal end if the distal end is blocked, (ii) the syringe is filled through the distal end when the proximal end is blocked, Assembly of parts, c) random disinfection of the assembled syringe, d) filling the base or disc according to the remaining opening, e) base obstruction by a stopper or distal obstruction by splicing an outlet obstruction or outlet, f) disinfection of filled and sealed syringes, g) optional sterile packaging of the syringe in a container having at least one gas permeable, bacterial impermeable surface; Method for producing a prefilled sterile syringe according to any one of claims 1 to 10, characterized in that. 12. A combination of a prefilled and finally sterilized syringe according to any one of claims 1 to 11 and an injector and a dosing device in which the injector is a pumping system and the connection connects the outlet of the syringe with the patient.