Abstract:
A closure piece for closing a distal opening of a syringe cone of a syringe body includes a fastening element which is or can be arranged on the syringe body about the distal opening, and a closure cap which closes the distal opening in a sealed manner and which is connected releasably to the fastening element. The closure cap, in the area of the fastening element, is connected by material bonding to the fastening element by at least one connection point or one connection surface, and the closure cap includes a hard area and an elastomer part. The elastomer part securely closes the distal opening by being placed on or enclosing a short portion in an area of a tip of the distal opening.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This is a continuation of PCT application No. PCT/EP2013/001688, entitled “CLOSURE PIECE, IN PARTICULAR A SYRINGE CLOSURE PIECE FOR CLOSING A DISTAL OPENING OF A SYRINGE BODY IN A SEALED MANNER”, filed Jun. 10, 2013, which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to a closure element, in particular a syringe closure element for closing in a sealing manner a distal opening such as a syringe cone on a syringe body. 
         [0004]    2. Description of the Related Art 
         [0005]    Syringe closure elements of different types are known from a multitude of patent specifications. U.S. Pat. No. 6,190,364, for example, describes a syringe closure element for a syringe body. The syringe body itself comprises a distal syringe and a distal opening extending through same, in particular in the embodiment of a syringe cone so that a liquid which is located inside the syringe body can leave the syringe body through the distal opening or, respectively, the syringe cone. The syringe body moreover comprises a fastening element which is arranged or can be arranged on the syringe body. This fastening element can be part of a single component syringe or may be placed on the distal tip of the syringe body and be firmly connected with same. The fastening element moreover has threads or bayonet structures which interact with the threads of a two-component closure cap in order to hold the closure cap on the fastening element. The closure cap surrounds the region of the distal syringe or, respectively, the syringe cone and closes and seals the distal opening of the syringe cone. To be able to inject the syringe liquid, the closure cap in U.S. Pat. No. 6,190,364 is unscrewed from the fastening element and an injection cannula is secured on the syringe body in such a manner that a needle opening extending through the injection cannula forms a flow connection with the distal opening of the injection body. 
         [0006]    One problem with syringe closure elements of this type is that it must be ensured that they cannot be reused in certain fields of applications, for example, with another medication or for another application. Such second use would present a high risk of infection of the patient due to contamination, for example though foreign particles and germs. An additional risk exists in that when reusing the syringe closure element on a syringe body other than the original one, a contamination of the second medication occurs since traces of the original medication may be present in the closure cap which could be transferred into the second medication and could lead to incorrect treatment of the patient. 
         [0007]    To eliminate possible manipulations and a second use of the syringe closure element according to U.S. Pat. No. 6,190,364, the syringe closure element is provided with a sealing strip which is detachably connected with the fastening element as well as with the closure cap so that the sealing strip tears when the closure cap is released from the fastening element. With a closure element according to U.S. Pat. No. 6,190,364 it is disadvantageous that several separate parts must be manufactured which are subsequently connected with each other, incurring additional costs. 
         [0008]    A syringe closure element for sealing and closing has therefore become known from EP 1600190 A1 which on the one hand recognizes manipulations at the syringe opening, and whereby on the other hand manufacture has been significantly simplified compared to U.S. Pat. No. 6,190,364. For this purpose, the fastening device in EP 1 600 190 A1 was provided with a locking device which locks with a locking device of the closure cap. Moreover the locking devices of the fastening element as well as that of the closure cap are designed such that they cannot be unlocked without damaging them. This means that after unlocking, a damage free relocking is not possible. Even though damage-free relocking is ruled out in EP 1 600 190 A1 it is possible to again lock the closure cap with the fastening element by accepting damage. Protection from multi-use—in order to ensure single use for a syringe—is also not provided by EP 1 600 190 A1. 
         [0009]    A closure element for a pre-fillable single use plastic syringe having a syringe body and a syringe needle which is firmly connected with said syringe body&#39;s delivery end, consisting of a rigid outer plastic protective cap for the needle, consisting of a hard elastic material which can be placed directly onto the syringe body, surrounding the syringe needle and which, on the inside at least in the region of the needle tip is provided with a sealing lining consisting of a soft elastic material has become known from EP 1101505, wherein the plastic protective cap for the needle is welded or glued directly circumferentially with the syringe body whereby an intended separation point is provided in the welded or glued seam. 
         [0010]    A closure cap that is connected with a fastening element for closing a distal opening of a syringe body is known from US 2001/003150 A. With this arrangement, it was disadvantageous that multiple use of the closure cap could not be ruled out with certainty. 
         [0011]    EP 1 034 810 A1 shows a syringe for medical purposes with a needle connecting piece that is attached on the syringe cylinder and closed by a closure cap, for example a tip-cap, until the syringe is used, wherein said connecting piece is arranged in the form of a Luer-cone for attachment of a cannula, wherein the closure cap together with the end of the needle connecting piece is enclosed by a safety cap and the closure cap is held in the safety cap by interlocking or frictional connection, also with a retaining ring which is lockable on the needle connecting piece in its position on the needle connecting piece. 
         [0012]    When using the syringe the connection between the safety cap and a retaining ring can be severed. 
         [0013]    With the system according to EP 1 034 810 A1 multiple use can also not be ruled out with certainty. 
         [0014]    The elastomer closure elements (tip caps) described in the aforementioned applications for plastic or glass syringes can all be returned to their original conditions after intentional or unintentional opening. Since these closure elements have no tamper-evident seals or indicators, visual recognition of first use is not available. Therefore there is the danger that these elastomer closure elements and thereby the syringe or, respectively, the medication can possibly be used multiple times over, or be mixed up without being noticed. 
         [0015]    Intentional or unintentional opening of the tip caps also damages the sterility barrier of the syringe, since the non-sterile environment at the time of opening is in direct contact with the content of the syringe (for example medication). This could allow foreign matter (for example bacteria, germs, viruses, particles, fungi, etc.) to enter the sterile region and to thereby contaminate the content of the syringe. If the contaminated content of the syringe is administered to a patient this could lead to infections, thus endangering the health of the patient. 
         [0016]    The original content of a syringe can moreover be altered after opening of the tip cap, and the syringe reclosed without being noticed. Patients could thereby be administered an incorrect dose of a medication, or the content of a syringe could be administered to several patients. This could cause serious health problems. 
         [0017]    As described previously, tip caps can—after having been opened—be attached to another syringe with another medication. Traces of one medication could thereby be transferred through the tip cap to another syringe and could thereby contaminate the medication. Because of such contamination the effect of the medication can be altered or destroyed. This may have serious health consequences for patients. 
         [0018]    A syringe can be charged after opening of the tip cap with other medications and reclosed without being noticed. The effect of the medication is thus altered. If the altered medication is administered to a patient, this could result in serious health consequences. 
         [0019]    With the closure elements according to the current state of the art willful manipulations can occur without being noticed. This represents a great hazard potential for the patient, the user and the pharmacist. In the event of improper use, this detection is not possible due to absent tamper-evidence. 
         [0020]    What is needed in the art is a syringe that can avoid some of the disadvantages of the prior art and a closure element to seal a syringe opening that simply and reliably provides single use of the closure cap. Moreover, these functions should be provided with the fewer possible components and associated low manufacturing costs. 
       SUMMARY OF THE INVENTION 
       [0021]    The objective is met in that a closure element for sealing a distal opening of a syringe cone of a syringe body is provided that overcomes some of the previously described disadvantages. 
         [0022]    The syringe closure element includes a fastening element that is arranged or can be arranged on the syringe body around the distal opening, such as around the syringe cone; and a closure cap that closes the distal opening, such as the syringe cone, in a sealing manner and that is connected detachably with the fastening element. The closure cap is connected by material bonding, such as exclusively by material bonding, with the fastening element, which can be a Luer-Lock or Luer-Lock adapter. The material bonded connection can occur through at least one connecting point or at least one connecting surface. The closure cap includes at least one hard region and one elastomer part, the elastomer part tightly sealing the distal opening by simply being placed in a region of a tip of the distal opening. For tight closure, only axially acting forces or an axially acting pressure are essentially or, in other words, predominantly necessary. Forces acting radially upon the tip of the syringe or the distal opening are substantially or completely avoided, so that over the life of the closure element no, or only a minimal increase of the, turning torques occurs. 
         [0023]    Due to the fact that the closure cap is connected positively or by material bonding with a Luer-Lock or Luer-Collar or Luer-Lock-adapter by connection points or connection surfaces or, respectively, by weld- and/or adhesion points, a tamper evident closure element is provided in a simple and in a material saving manner that provides visual indication in regard to first use. Multiple uses or improper use can reliably be avoided after breaking open a tamper evident closure element in that the distal opening or, respectively, the syringe cone is not completely surrounded by the elastomer part, but only partially, or is even only placed on the distal opening and the opening closes in an unexpected manner, air tight simply through the placement. A further indication of a multiple use or improper use with an embodiment according to the invention is also ensured by the non-existing thread. After opening or, respectively, after use of the closure element, a positive connection between the closure element and a Luer-Lock or a Luer-Lock-adapter is thereby prevented. 
         [0024]    Pressure-tight in this application is understood to be, for example, a tight seal of the distal opening with a pressure of at least 1 bar or more for at least 30 sec. 
         [0025]    Due to the fact that the elastomer part only rests on the opening, there is no possibility after breaking open the tamper evident closure element of holding the closure cap, for example, on a thread because of having broken the positive material connection. Also, holding, for example, by gripping the distal opening with the elastomer part, as is the case in the prior art, is not possible. A second use of the closure cap is thus reliably prevented. 
         [0026]    In one embodiment, the closure cap is connected with the fastening element on the connection point(s) or connection surface(s) through a joining process. The joining process can be gluing and/or welding, such as laser-welding and/or ultrasonic welding. 
         [0027]    The hard region of the closure cap is thus material bonded with the fastening element or, respectively, the Luer-Lock or the Luer-Lock-adapter. 
         [0028]    During welding, there are at least one or more contact surfaces on the hard region, for example in the form of welding columns. Local welding points or welding surfaces can thus be produced. During welding, the contact surfaces or connecting points or, respectively, connecting surfaces can be melted through ultrasonic or lateral impingement of the laser beam, thereby producing a materially bonded connection between the hard region of the closure cap and the fastening element. This connection represents the only support on the syringe which is irreparably damaged by opening of the closure element. 
         [0029]    Basically, the connecting point(s) or connecting surface(s) can be arranged at different locations of the hard region of the closure cap. The closure cap can include a head part and a foot part, whereby the foot part engages into the fastening element and the head part represents the closure end. 
         [0030]    In one embodiment, the connecting point(s) or connecting surface(s) is/are arranged on a side of the head part facing the fastening element. Alternatively, the connecting point(s) or connecting surface(s) can be arranged on a side of the foot part facing the fastening element. 
         [0031]    In the case of plastic syringes, the fastening element, the fastening ring, the Luer-Collar, or the Luer-Lock is sprayed onto the injection body, resulting in a single-piece component. In the case of glass syringes, the fastening element, fastening ring, or the Luer-Lock-adapter is a separate component that engages, for example, on a bead of the glass syringe at a predetermined, in other words, predefined height. The tightness of the connection between closure cap and distal opening or, respectively, the cone of the glass syringe is ensured through the predetermined distance and the engagement of the fastening element, fastening ring, or Luer-Lock-adapter. 
         [0032]    The syringe closure element according to the current invention can be used for a syringe body consisting of a glass material, as well as one consisting of thermoplastics. 
         [0033]    As previously described, the fastening element on a glass syringe body can be a separate component, such as a fastening ring which engages into a bead of the glass syringe at a predetermined height, whereas in contrast on a plastic syringe body—such as one consisting of thermoplastics—the fastening element is part of the syringe body. 
         [0034]    In another embodiment, the closure cap includes an elastomer part with which the distal opening, for example the syringe cone, is closed as well as a region that consists of a hard component—a so-called hard region. 
         [0035]    The hard component or, respectively, the hard region of the closure cap can be positively interlocked with the elastomer part, such as in a region surrounding the distal opening, for example the syringe cone. The positive interlocking connection of the threaded component or the hard component with the elastomer component offers the advantage that over-tightening of the base component is prevented. In order to design the closure cap to be capable of being sterilized in all conventional sterilization methods, such as gamma radiation, ethylene oxide (ETO), and steam at temperatures of 121° C. and higher, as well as electron radiation, the elastomers of the base material can be selected accordingly. This allows broad use, in addition to glass syringes, with thermoplastic syringes. 
         [0036]    The handling region of the closure cap can be integrated into the base material or the base component of the closure cap. 
         [0037]    To guarantee protection from multiple uses, another embodiment provides that the base component only surrounds a small part of the syringe cone with the distal opening or even only covers the distal opening. This ensures that the elastomer part cannot hold itself alone on the syringe cone without the positive interlocking connection between hard region and closure cap and the fastening element or, respectively, Luer-Lock or Luer-adapter. 
         [0038]    In such a case, the elastomer part has only an axial extension that, at a maximum, is consistent with the axial length of the head part of the closure cap, but it can be even shorter than the axial extension of the head part of the closure cap. 
         [0039]    All materials used for the closure cap, in other words the elastomer as well as also the hard components or respectively the hard component, are selected so that they can be used for pharmaceutical applications. The materials can have a USP-class-VI-classification. Moreover, they can also be colored. 
         [0040]    Elastomers which are permissible for pharmaceutical applications and butyl rubber can be used. 
         [0041]    As hard materials, in particular for the hard component, all permissible thermoplastics can be utilized. Thermoplastics which can survive as many types of sterilization as possible without undergoing significant geometric or material changes can be used. Exemplary thermoplastics are polycarbonate, polyetheretherketone, polyetherimid, polyether block amide, copolyester. 
         [0042]    In a method for the production of the syringe closure element, a conventional injection molding process can be used for the hard component, such as the compression or vulcanization method. The elastomer component can moreover also be produced in a transfer-injection or injection molding process. The two components are combined and connected with each other in an additional process step by an assembly system. 
         [0043]    The sealing cap for sealing of the distal opening, in particular the syringe closure element, consists of a hard region and an elastomer component. The connection between the elastomer component and the hard component can be positive and can be achieved in various ways. 
         [0044]    The various possibilities of a positive connection are discussed in detail below. 
         [0045]    In one arrangement of the closure cap, the hard component, which can be a bushing such as an outer cap, includes a through-opening in an axial direction. The opening can be oval, circular or polygonal. 
         [0046]    In one arrangement the hard region or, respectively, the hard component, such as a bushing or outer cap, includes at least one axial section which has at least one recess, such as one opening and/or grooves distributed over a circumference of the section. 
         [0047]    The distal region of the outside geometry of the elastomer component can be arranged such that it is congruent with the continuous opening of the hard component. In contrast to the hard component or, respectively, the hard region, the distal section of the elastomer component can include one or several radially projecting protrusions or longitudinally shaped ribs which, in design number, correspond to the longitudinally shaped recesses, such as openings inside the hard component or the hard region. In an assembled or fitted condition, the protrusion or ribs of the elastomer component are then accommodated by the openings and/or grooves of the hard component or, respectively, the hard region. 
         [0048]    The outside diameter of the ribs or protrusions can be dimensioned so that it is at least as large as the outside diameter of the hard component, such as a little larger. Due to the projection of the ribs or protrusions over the hard component or, respectively, the hard region, an anti-slip surface is created which considerably improves gripping and turning of the closure cap. Additional design elements for this purpose may furthermore be omitted. 
         [0049]    Due to the engagement of the ribs or protrusions into the windows, both components are interlocked axially and radially with each other. 
         [0050]    By unscrewing the closure cap from the fastening element, the elastomer component is forcibly moved together with the hard component or, respectively, the hard region, in axial and radial direction and is therefore separated from the syringe cone. 
         [0051]    In another arrangement of a closure cap, the hard component or, respectively, the hard region includes an opening, such as a continuous stepped opening, in axial direction. The opening of the hard component can be smaller on the distal side than the opening of the hard component on the proximal side. The opening on the proximal side can be ring-shaped and the opening in at least one axial section not circular in its cross section, such as oval or polygonal. In another arrangement with two axial sections of the opening, the opening in the distal region with the non-circular cross section or, respectively, a cross sectional area with non-circular inside contour includes ribs or protrusions which are directed inwards, in other words extending radially from the inside contour into the axial opening of the hard component. The number of ribs or protrusions can correspond with the polygonal arrangement of the opening. In such an arrangement, the distal region of the outside geometry of the elastomer component or the base component is arranged such that it is congruent with the continuous stepped opening of the hard component, meaning that one section of the elastomer component is not circular, in its cross section, and can be polygonal. In one embodiment, the section with the non-circular outside contour include grooves into which the ribs or protrusions of the hard region engage in an assembled state. Due to the engagement of the ribs into the grooves, both components are axially and radially interlocked with each other. 
         [0052]    By unscrewing the closure cap from the fastening element, the elastomer component is forcibly moved together with the hard component in axial and radial direction and is therefore separated from the syringe cone. 
         [0053]    In yet another arrangement of a connection of hard component or, respectively, hard region and elastomer component, the hard component includes an opening, such as a continuous stepped opening in axial direction. The openings at the ends of the hard component in axial direction are larger than that of an opening located between them. In other words, the cross section of the intermediate opening in axial direction has a first cross section (Q 1 ) which is always smaller than the second cross section (Q 2 ) and the third cross section (Q 3 ) of the end regions of the opening in axial direction. The inside contour of the opening at the ends can be circular, oval or polygonal. The inside contour of the opening in the first axial region is not circular or round, such as polygonal, multi-edged, or oval. The elastomer component or, respectively, the elastomer part is designed so that it is congruent with the continuous stepped opening of the hard component or, respectively, hard region, at least in the distal region. This type of arrangement provides an axial interlocking of hard and elastomer component or, respectively, base component. 
         [0054]    By unscrewing the closure cap from the fastening element, the elastomer component or, respectively, elastomer part is forcibly moved together with the hard component or, respectively, the hard region in axial direction and is therefore separated from the syringe cone. Due to the non-circular, which can be polygonal, arrangement of the two components, rotational security is achieved. This means, if the hard component or, respectively, the hard region is turned to be released, the elastomer component or, respectively, the elastomer part turns with it. Moreover, due to the polygonal design, the torque when unscrewing the closure cap is reduced since the elastomer part turns along with it. The expenditure of force can thus be greatly reduced. 
         [0055]    The technical advantages of the previously described arrangements of the closure cap are found in an efficient and robust design. The axial and radial connection of both components can be realized in a simple manner. This in turn results in that both components can be produced cost effectively and in that the expenditure for the production can be kept low. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0056]    The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein: 
           [0057]      FIGS. 1A-1C ,  4 A- 4 C, and  7 A- 7 C illustrate a first embodiment of a syringe closure element with connecting points on the head part of the hard region of the closure cap, whereby the syringe is a glass syringe and the fastening element is a separate component with which the closure cap is positively connected; 
           [0058]      FIGS. 2A-2C ,  FIGS. 5A-5C , and  FIGS. 8A-8C  illustrate another embodiment of a syringe closure element with connecting points on the head part of the hard region of the closure cap, whereby the syringe is a plastic syringe and the fastening element with which the closure cap is positively connected is part of the plastic syringe; 
           [0059]      FIG. 2D  illustrates a pressure-tight seal of the distal opening with an embodiment of an elastomer part according to the present invention; 
           [0060]      FIG. 2E  illustrates a pressure-tight seal of the distal opening with the elastomer part according to the prior art; 
           [0061]    FIGS.  3 A 1 - 3 A 3 , FIGS.  6 A 1 - 6 A 3 , and FIGS.  9 A 1 - 9 A 3  illustrate a hard region of a closure cap for a closure element according to  FIGS. 1A-2C ,  FIGS. 4A-5C , and  FIGS. 7A-8C ; 
           [0062]    FIGS.  3 B 1 - 3 C 3 , FIGS.  6 B 1 - 6 C 3 , and FIGS.  9 B 1 - 9 C 3  illustrate an elastomer part of a closure cap for a closure element according to  FIGS. 1A-2C , FIGS.  6 B 1 - 6 C 3 ,  FIGS. 4A-5C , and  FIGS. 7A-8C ; 
           [0063]    FIGS.  3 D 1 - 3 F,  FIGS. 6A-6F , and FIGS.  9 D 1 - 9 F illustrate a closure cap consisting of an elastomer part and hard region for a closure element according to  FIGS. 1A-2C ,  FIGS. 4A-5C , and  FIGS. 7A-8C ; 
           [0064]      FIGS. 10A-10C ,  FIGS. 13A-13C , and  FIGS. 16A-16C  illustrate another embodiment of a syringe closure element with connecting points on the foot part of the hard region of the closure cap, whereby the syringe is a glass syringe and the fastening element is a separate component with which the closure cap is positively connected; 
           [0065]      FIG. 10D  is a top view of an embodiment of a fastening element according to the present invention; 
           [0066]      FIG. 10E  is a cross-section through the fastening element shown in  FIG. 10D  along line A-A, with connecting points or connecting surfaces; 
           [0067]      FIGS. 11A-11C ,  FIGS. 14A-14C , and  FIGS. 17A-17C  illustrate another embodiment of a syringe closure element with connecting points on the foot part of the hard region of the closure cap, whereby the syringe is a plastic syringe and the fastening element with which the closure cap is positively connected is part of the plastic syringe; 
           [0068]    FIGS.  12 A 1 - 12 A 3 , FIGS.  15 A 1 - 15 A 3 , and  18 A 1 - 18 A 3  illustrate a hard region of a closure cap for a closure element according to  FIGS. 10A-11C ,  FIGS. 13A-14C , and  FIGS. 16A-17C ; 
           [0069]      FIGS. 13A-14C ,  FIGS. 16A-17C , FIGS.  12 B 1 - 12 C 3 , FIGS.  15 B 1 - 15 C 3 , and FIGS.  18 B 1 - 18 C 3  illustrate an elastomer part of a closure cap for a closure element according to  FIGS. 10A to 11C ,  FIGS. 13A-14C , and  FIGS. 16A to 17C ; and 
           [0070]    FIGS.  12 D 1 - 12 F, FIGS.  15 D 1 - 15 F, and FIGS.  18 D 1 - 18 F illustrate a closure cap, consisting of an elastomer part and hard region according to  FIGS. 10A-11C ,  FIGS. 13A-14C , and  FIGS. 16A-17C . 
       
    
    
       [0071]    Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0072]    An embodiment of a complete syringe closure element  1  according to the invention is illustrated in  FIG. 1A-2C ,  4 A- 5 C,  7 A- 8 C.  FIGS. 1A-1C ,  FIGS. 4A-4C ,  FIGS. 7A-7C  illustrate hereby one embodiment of the present invention, wherein syringe body  2  is a glass syringe and fastening element  3  is a separate component, a so-called Luer-Lock-adapter  3 . 1 .  FIGS. 2A-2C ,  FIGS. 5A-5C , and  FIGS. 8A-8C  illustrate one embodiment of the invention, wherein syringe body  2  is a plastic syringe and fastening element  3 , the so-called Luer-Lock  3 . 2  or, respectively, Luer-Lock collar is part of syringe body  2 . Complete syringe closure element  1  comprises a syringe body  2  with a distal opening  4 . On distal opening  4 , elastomer part  10  of closure cap  20  is placed, which can comprise an elastomer that is approved for pharmaceutical use. Distal opening  4  of syringe body  2  is hereby closed and sealed. In contrast to the prior art, elastomer part  10  encloses the distal opening  4  or, respectively, the syringe cone only partially or not at all when resting on it, so that the closure element  1  after first use can no longer be fastened on the syringe  2 , since there is no longer a positive connection possible on the closure element  1 . The support surface for the elastomer part can then as shown in FIG.  2 B—be only edge  9  of distal opening  4  of the syringe cone. “Pressure-tight” in this application is understood to be, for example, a tight seal or closure of the distal opening at a pressure of at least 1 bar or more for at least 30 seconds. Thermoplastic elastomers and butyl rubbers are acceptable elastomers. 
         [0073]    The elastomers are selected such that the entire closure cap  20 , comprising a hard region  30  into which elastomer part  10  is introduced, is capable of being sterilized in all conventional sterilization methods, for example gamma radiation, at for example 20 KGy or ETO or steam at temperatures for example of 121° C. and higher for at least 20 min., as well as electron radiation. This allows broad use of closure caps  20  in glass syringes as well as thermoplastic syringes. In the case of plastic syringes, the fastening element or, respectively, fastening ring  3  and syringe body  2  of the plastic syringe can be a single component, as shown. 
         [0074]    In addition to elastomer part  10 , closure cap  20  includes at least one hard part or component  30  as a second component. 
         [0075]    The hard component or, respectively, hard region  30  is material-bonded with fastening element  3 , in other words with Luer-Lock  3 . 1  and in the case of a plastic syringe with Luer-Lock-adapter  3 . 2 —such as by shaping technology 
         [0076]    In one embodiment, illustrated in FIGS.  1 A to  9 C 3 , contact points or contact surfaces  40 . 1  can be provided on underside  42  of hard region  30  of the closure cap  20  which is located opposite top side  44  of fastening element  3  or, respectively,  3 . 1  or  3 . 2 . The attachment points or, respectively, contact surfaces can be, for example, welding columns which are melted, for example, through ultrasonic or lateral coupling of laser radiation onto the welding surfaces, thereby providing a materially bonded connection between underside  42  of hard region  30  and top side  44  of the fastening element  3  and, consequently, a material-bonded connection between closure cap  20  and fastening element  3 . This connection represents the only holding device on the syringe and is irreparably damaged by removal of the closure cap  20  or, respectively, tip caps. The connecting surface or, respectively, the welding columns  40 . 1  is illustrated especially detailed in  FIGS. 1C ,  2 C,  4 C,  5 C,  7 C and  8 C. In one embodiment of the invention, each of these FIGS. illustrates that front surface  42  of the hard region is connected by material bonding through the connecting points, or, respectively, connecting surfaces  40 . 2  with top side  44  of the fastening element, or respectively, through Luer-Lock or Luer-Lock-adapter, in the case of glass syringes, materially bonded through a joining process such as, for example, adhesive bonding, ultrasonic welding or laser welding. 
         [0077]    Alternatively to the illustrated connection between the end face of hard region  30  and top side  44  of fastening element  3 , as shown in FIGS.  1 A to  9 C 3 , it is possible according to another embodiment—as illustrated in FIGS.  10 A to  18 C 3 —to not connect the hard region  30  of closure cap  20  which consists of a head part  32  and a foot part  34  in the region of head part  32  as is the case in the arrangement shown in FIGS.  1 A to  9 C 3 , but instead to connect foot part  34  of hard region  30  of the closure cap with base  46  of fastening element  3  in the embodiment of Luer-Lock  3 . 1  or respectively Luer-Lock-adapter  3 . 2 . This other embodiment, wherein the connecting points or, respectively, connecting surfaces of hard region  30  are provided with fastening element  3  in the region of foot part  34  of hard region  30  of the closure cap, is illustrated in FIGS.  10 A to  18 C 3 . This connection can be seen in particular in  FIGS. 10C ,  11 C,  13 C,  14 C,  16 C and  17 C. Same components as in FIGS.  1 A to  9 C 3  are illustrated for the other embodiment in FIGS.  10 A- 18 C 3 . 
         [0078]    In  FIG. 10D , the fastening element  3 , representative of that shown in  FIGS. 11A-11C ,  14 A- 14 C and  17 A- 17 C is shown in a top view in further detail. Fastening element  3 . 2  illustrated in  FIG. 10D  is a Luer-Lock-adapter as is generally used with glass syringes. In the illustrated arrangement, the Luer-Lock-adapter surrounding distal opening  4  comprises an annular tube  3000 , wherein grippers  3002 . 1 ,  3002 . 2 ,  3002 . 3 ,  3002 . 4 ,  3002 . 5 ,  3002 . 6 ,  3002 . 7 ,  3002 . 8  extend from annular tube  3000  radially toward the inside to the distal opening  4 . Grippers  3002 . 1 ,  3002 . 2 ,  3002 . 3 ,  3002 . 4 ,  3002 . 5 ,  3002 . 6 ,  3002 . 7 ,  3002 . 8 , which are under tension, engage into an indentation around the distal opening and thus, through clamping, secure the position of the Luer-Lock-adapter on distal opening  4  of the glass syringe. Annular tube  3000  is largely tension free while the grippers are under tension.  FIG. 10E  illustrates a cross-section along line A-A in  FIG. 10D . Grippers  3002 . 4 ,  3002 . 8  that under tension fit against the glass syringe in the region of indentation  3004  are clearly recognizable. Also clearly recognizable is tube  3000  which comprises a thread  3010  for screwing on a needle after breaking open the closure element, sealing the distal opening, as well as a support surface  3012  or, respectively, base  46  which accommodate connecting points  40 . 1 ,  40 . 2  of the non-illustrated hard region of the closure cap and provide for material-bonded connection of the closure cap with the fastening element. The material bonded connection of closure cap and fastening element is arranged in the region of the fastening element that is not under pressure, so that an unintended break of the material-bonded connection of the regions that are under pressure, for example during and after the assembly of the fastening element onto distal opening  4  of the glass syringe, is reliably prevented. 
         [0079]    As shown in  FIG. 10E , connecting points  40 . 1 ,  40 . 2  are arranged in regions where there is little to no mechanical tension—such as during or after the assembly of the Luer-Lock-adapter or, respectively, the fastening element on a glass syringe. These regions are located in the region of tube  3000  or, respectively, the support surface  3012 , for example between two grippers  3002 . 4 ,  3002 . 5  or  2002 . 1 ,  2002 . 8  that secure the Luer-Lock-adapter positively with the glass syringe. 
         [0080]    Various arrangements of closure cap  20  are illustrated in FIGS.  3 A 1  to  3 F, FIGS.  6 A 1  to  6 F, as well as FIGS.  9 A 1  to  9 F. Here, FIGS.  3 A 1  to  3 A 3 , FIGS.  6 A 1  to  6 A 3  and FIGS.  9 A 1  to  9 A 3  show different versions of hard region  30  of closure cap  20 . Clearly recognizable in the arrangement according to FIG.  3 A 1  to  3 A 3  is the opening in axial direction  100  that is introduced into hard region  30  into which the elastomer part illustrated in FIGS.  3 B 1  to  3 C 3  can be inserted. Clearly visible in FIGS.  3 A 1  to  3 A 3  are connecting points  40 . 1 ,  40 . 2 ,  40 . 3  that are arranged on underside  42  of the head part and that can be connected by means of a joining process through material bonding with fastening element  3 . Clearly recognizable is also the foot part hard region  30 . In the arrangement shown in FIG.  3 A 1  to  3 A 3 , the hard region includes grip recesses  102  for gripping the closure cap. The elastomer part illustrated in FIGS.  3 A 1  to  3 A 3  that is inserted as illustrated in FIGS.  3 D 1  to  3 D 2  into the hard region according to FIGS.  3 A 1  to  3 A 3  includes two variations. The elastomer part can be designed symmetrically, allowing for very easy manufacture. The elastomer part can include a center part  200  and a head part  202 . 1 ,  202 . 2 . Head part  202 . 1 ,  202 . 2  can include an indentation  204  into which the syringe cone can engage in a closed state of the closure cap. The indentation can be such that only a small part of the syringe cone is surrounded. In the arrangement shown in FIG.  3 C 1 , end part  202 . 3 ,  202 . 4  is designed without indentation so that—as shown in FIG.  2 B—the elastomer part with sealed syringe body only rests on the syringe cone. 
         [0081]    An embodiment of the closure element according to the present invention is illustrated in  FIG. 2D .  FIG. 2D  shows symmetrical elastomer part  10  resting on edge  9  or, respectively, the tip of distal opening  4 .  FIG. 2E , in contrast, shows a prior art arrangement wherein elastomer part  1000  completely surrounds distal opening  4 . In the embodiment according to the present invention shown in  FIG. 2D , elastomer part  10  rests on distal opening  4  after assembly of the closure cap with hard region (not illustrated). An axial pressure  1100 , only sufficient for tightness, is exerted upon the distal opening  4 . The extension of elastomer part  10  with D 1  compared to elastomer part  1000  according to the prior art with D 0  is substantially shorter, so that in contrast to the prior art a radial pressure  1200  in addition to the axial pressure  1100  is not exerted upon distal opening  4 . In contrast to the prior art, the additional radial pressure is not necessary for the tightness of the distal opening  4 . A radial pressure that is too great, such as occurs in the prior art with nearly complete surround of the distal opening, is disadvantageous in regard to the mechanical characteristics, since with increasing dwell time of elastomer part  10  on distal opening  4  of the syringe the value of the turning torque increases in the prior art. In the prior art, this is attributed to the fact that the elastomer sets with increasing time on the tip, so that toward the end of the serviceable life of the product, turning or removal of the elastomer part is considerably more difficult. According to the present invention, only the tip or, respectively, edge  9  of distal opening  4  of syringe body  2  is sealed. Because of the mostly or, respectively, completely absent radial forces  1200  an increase in the turning torques can be avoided; in other words, an additional radial pressure, as is common in the prior art, is absent. 
         [0082]    As is clearly recognizable, in an assembled state the elastomer part is substantially shorter in its axial extension D 1  than the entire hard component  30  with extension D 2  or, respectively, than head part  32  of the hard component with extension D 3 . 
         [0083]    The arrangement according to FIGS.  6 A 1  to  6 F shows essentially a difference in the design in the shape of the elastomer, as illustrated in FIGS.  6 B 1 - 6 C 3 . Here too, the elastomer part  6   b . 1  - 6   c . 3  is designed substantially symmetrical and is considerably shorter in its length than entire hard region  30  with length D 2 . Elastomer part  10  is carried along in the rotational movement by hard component  30  in that protrusions  300  in the hard component  30 , as shown in  FIGS. 6   a . 1  to  6   a . 3 , engage into indentation  302  of the elastomer part, as illustrated in FIGS.  6 D 1  to  6 C 3 . Same components as in previous Figs. are identified with the same reference numbers. Protrusions  302  are again located in center part  200  of the elastomer component. End surfaces  202 . 1   202 . 2  of the elastomer part are equipped with indentations  204 , as is the case in the embodiment shown in FIGS.  3 B 2  and  3 B 2 , whereas in contrast the end surfaces according to FIGS.  6 C 1  and  6 C 2  are flat. 
         [0084]    The embodiments shown in FIGS.  9 A 1  to  9 F essentially differ from the preceding arrangements of a closure cap in that hard region  30  has openings  400 . The corresponding elastomer part is illustrated in FIGS.  9 B 1  to  9 C 3  and also has a symmetrical shape as well as protrusions  402  that engage into the windows of hard region  400  and protrude beyond same, so that the closure cap can be gripped positively in the head region. The elastomer part is carried along during turning due to protrusions  402  of the elastomer part that engage into windows  400  or respectively into the longitudinal cut-outs in the hard region. 
         [0085]    Same components as in previous Figs. are again identified with the same reference numbers. 
         [0086]    The Figs. of another embodiment of the invention differs basically in that the connecting points are not arranged on head part  32  of hard region  30 , but instead on foot part  34  of the hard region. Other than that, the embodiments according to FIGS.  12 A 1  to  12 B 2  correspond with those according to FIGS.  3 A 1  to  3 F. Accordingly, same components as shown in FIGS.  3 A 1  to  3 F are identified with the same reference numbers in FIGS.  12 A 1  to  12 F. 
         [0087]    Reference should again be made to connecting points  40 . 4 ,  40 . 5 ,  40 . 6  that are arranged on foot part  45  of hard region  30 . 
         [0088]    With the exception of the configuration of connecting points  40 . 4 ,  40 . 5 ,  40 . 6  in foot region  34 , the embodiment according to FIGS.  15 A 1  to  15 F corresponds with that according to FIGS.  6 A 1  to  6 F. In this respect, reference is made to that description and those reference numbers. 
         [0089]    FIGS.  18 A 1  to  18 F correspond essentially to the embodiment of the closure cap according to FIGS.  9 A 1  to  9 F. In this respect, reference is made to that and same reference numbers are used. The only difference in the embodiment according to FIGS.  18 A 1  to  18 F compared with the embodiment in FIGS.  9 A 1  to  9 F is the configuration of connecting points  4 . 4 ,  4 . 5 ,  4 . 6  in foot region  34  of hard region  30 . 
         [0090]    With the closure element according to the invention, a closure element for a syringe cone is specified in that it can reliably be used only once and in that any possibility of a second use is prevented in a simple manner. This is ensured in that a material-bonded connection is provided between the closure cap and the fastening element on the syringe cone which must be broken during use. Due to the design of the elastomer part that, surprisingly, also provides a tight closure of the syringe body when only resting on the syringe cone and not, or only partially, surrounding same, ensures that the closure element after having broken the material-bonded connection after a first use can no longer be secured on the syringe cone. The hard region has no thread. A positive locking connection is therefore impossible. 
         [0091]    Moreover, simple manufacturability is ensured since the elastomer part is substantially symmetrical. An additional advantage of the symmetrical design is that the elastomer parts do not need to be aligned in a certain direction. For the elastomer parts, expensive sorting devices have been necessary to date in the prior art in order to align the elastomer parts in a certain assembly direction. This alignment is expensive and can be avoided with the current invention. 
         [0092]    While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.