Abstract:
Device for connecting a tubular part having a first end provided with a tip, and a second end provided with a connecting device. The connecting device connects an inside of the tubular part with a syringe and with the inside of a bottle, which bottle includes a neck having a stopper penetrable by the tip of the tubular part. Device includes a supporting device for sealing and fitting the device into place on the neck of the bottle in a tight and substantially centered manner. A holding device holds the tubular part in a displaceable manner relative to the supporting device in a penetration direction of the tip of the tubular part. Holding device includes a tight, deformable membrane with two edges, one edge of which is connected tightly to the tubular part and another edge of which is connected tightly to the supporting device.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of application Ser. No. 11/715,934, filed Mar. 9, 2007, which application Ser. No. 11/715,934 is a continuation of application no. PCT/EP2005/009536, filed Sep. 6, 2005, which claims the priority of German application no. 10 2004 044 288.6, filed Sep. 10, 2004, and each of which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates to a device for connecting a tubular part to the inside of a bottle, and which bottle includes a neck provided with a stopper which can be penetrated by the tip of the tubular part. 
       BACKGROUND OF THE INVENTION 
       [0003]    To remove a medical fluid from a bottle sealed with a stopper that can be penetrated, it is generally known to use a hollow needle connected to a syringe to penetrate the stopper, insert the needle into the fluid, and draw the fluid into the syringe. In doing so, there exists the danger of puncture wounds, this danger being particularly great when lay medical workers in the private sector are handling the syringe. To avoid this danger, devices generally known as transfer and removal systems are known that permit needleless operation and thus protect the user from puncture wounds. 
         [0004]    A device is known from U.S. Pat. No. 6,706,031 B2 in which a disk, which surrounds the tubular part and can be displaced within a cylindrical space, forms a guide device to laterally guide the tubular part. This does not result in parallel guiding in the penetration direction, which occurs only when a syringe has been put into position on the connecting device on the second, rear end of the tubular part. After the cylindrical body of the syringe has been put into position on the connecting device, it enters a cylindrical housing part of the device, and thereby forms a second lateral guide with the result that the tubular part as a unit is guided in the penetration direction. The design is expensive and cannot be used with all types of syringes. 
         [0005]    Similar complicated devices are known from the European patent specifications EP 1 150 639 B1 and EP 1 006 981 B1. They all have the disadvantage that they include a plurality of parts, so that their manufacture and assembly is lavish and expensive. 
         [0006]    A device of the type which includes a device for connecting a tubular part, a first end of which is provided with a tip, and a second end of which is provided with connecting device for connecting the inside of the tubular part to a syringe, and wherein the holding device is formed by elastic tongues, which are deformable in a direction parallel to the penetration direction in order to escort the motion of the piston in the penetration direction, is known from DE 600 04 082 T2. A piston, which can slide within the internal bore of a sleeve disposed on the supporting device, which is adjacent to the neck of the bottle, is provided to guide the tubular part. This known device is complicated and lavish and therefore also expensive. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0007]    The object addressed by the invention is to create a device of the type in question which does not possess the disadvantages of the known devices, is especially simple and inexpensive to manufacture, and is easy to handle and safe to use. 
         [0008]    The object according to the invention is solved by the teachings set forth herein. 
         [0009]    The basic idea of the invention includes configuring the inventive guide device in such a manner that the guide device, together with the tubular part which serves for penetrating the stopper of a bottle, the guide device, and the supporting device, can be manufactured as one integral part. Fundamentally, for this purpose, the configuration of the holding device is as a membrane, which extends between the supporting device and the tubular part. This means that a deformation of the membrane guides the tubular part during the penetration process. Given that the membrane is tight and its edges are tightly connected to the adjacent parts, it seals the tip of the tubular part and parts adjacent to the tubular part against the environment. In addition, there are no dead spaces which could become filled with the medicine and retain a portion of the medicine. In addition, there is no danger of sucking in air and consequent foaming. 
         [0010]    An advantageous embodiment of the device according to the invention is specified herein. In this embodiment, the membrane is formed by an expandable hose part, one edge of which is directly connected tightly to the tubular part and the other edge of which is connected tightly to the supporting device. A membrane configured in this manner is simple to manufacture, especially, for example, when it is injection-molded out of a piece of appropriately flexible plastic together with the parts adjacent to it. 
         [0011]    The diameter of the hose part is advantageously larger than the diameter of the tubular part, wherein the edge of the hose part connected to the tubular part extends toward the tubular part in a disk-shaped manner. During the penetration process, radial stresses expand or deform the disk-shaped part into the shape of a frustum in the penetration direction, wherein the hose-shaped part is deformed in the direction of the disk-shaped part and thereby becomes shorter. 
         [0012]    According to a further embodiment, the disk-shaped part can also be configured frustum-shaped from the outset, wherein the edge of the frustum having the larger diameter is connected to the supporting device and the edge having the smaller diameter is connected to the tubular part. In this embodiment, the forces that act radially inwardly on the cylindrical part during the penetration process are reduced. This causes or supports the deformation process of the hose-shaped part. 
         [0013]    In all cases, the tip of the tubular part is of course dimensioned in such a manner relative to the supporting device that the tip actually penetrates the stopper when it is in its forward state, thereby producing the connection to the inside of a bottle adjacent to the supporting device. Given that only the membrane and the hose-shaped part experience deformation during the penetration process, it is possible to manufacture them, together with the tubular part and the supporting part, as one piece, for example, by injection-molding a plastic that makes possible the deformation of the membrane. 
         [0014]    An advantageous embodiment of the invention includes that the tip of the tubular part projects over a supporting surface of the supporting device in the penetration direction in such a manner that, when the device is placed on the neck of a bottle, the tip presses into the surface of the stopper without penetrating the stopper. The tubular part is therefore laterally guided not only by the membrane, but also by the tip of the tubular part, which is partially pressed into the stopper, so that the tubular part is in a parallel position, which then transitions into a parallel guide during the penetration process. 
         [0015]    The membrane is tight around its entire perimeter. If the connecting device for connecting the inside of the tubular part to a syringe or the like is sealed with a peelable film, such as an aluminum foil, then the assembled device is sterilizable and the sterility will be maintained. 
         [0016]    The supporting part advantageously includes a cylindrical housing part, one end of which forms a supporting surface or supporting edge for fitting into place on the mouth of a bottleneck, while the other end is fastened to the external edge of the membrane. By dimensioning the extent of the cylindrical housing part in the axial direction, a space is created into which the membrane extends in the forward position, and assumes the shape of a cone, which tapers in the penetration direction. 
         [0017]    The membrane can also be configured stepped or undulated. To this end, the flexibility is effected by accordion-like deformation. 
         [0018]    In an advantageous embodiment, the perimeter of the supporting device includes an edge that projects in the penetration direction for engaging the neck of a bottle and for centering. According to another embodiment of the invention, the supporting part includes snap hooks in the inside of this edge, these snap hooks allowing the part to be delivered either fully assembled on and inseparably connected to the glass bottle or to be snapped onto this bottle later. 
         [0019]    The supporting device advantageously includes a continuous sealing lip projecting in the penetration direction for tight support on the surface of a stopper. 
         [0020]    The connecting device for connecting the inside of the tubular part is preferably configured a conical recess or conical journal to which it is possible to connect a complementary connecting piece. The conical recess can advantageously be sealed by a peelable cover, in the form of a peelable seal for example. But it is also possible to seal the conical recess or conical journal with a sealing cap. 
         [0021]    The tubular part can include two channels separated from one another, of which one serves as an extraction channel and one as a ventilation channel, which is connected to the environment via a lateral passageway. A filter can be advantageously arranged in the passageway. It is also advantageous for the hole or holes in the tip of the tubular part to be sealed by a cap, which is likewise penetrated when the stopper is displaced. This fitting arrangement makes it possible to pre-assemble the system with pre-filled syringes. 
         [0022]    The invention will be explained in more detail based on the drawing. 
     
    
     
       BRIEF DESCRIPTION OF THE INVENTION 
         [0023]      FIG. 1  depicts a first embodiment of the invention with the hose-shaped membrane; 
           [0024]      FIG. 2  depicts the embodiment of  FIG. 1  with a partially penetrating tip; 
           [0025]      FIG. 3  depicts the embodiment of  FIG. 1  with a completely penetrated tip; 
           [0026]      FIG. 4  depicts a modification of the embodiment of  FIG. 1 ; 
           [0027]      FIG. 5  depicts the embodiment of  FIG. 4  with a partially penetrated tip; 
           [0028]      FIG. 6  depicts the embodiment of  FIG. 4  with a completely penetrated tip; 
           [0029]      FIG. 7  depicts an embodiment with a frustum-shaped membrane on a bottle; 
           [0030]      FIG. 8  depicts a modification of the embodiment of  FIG. 7 ; 
           [0031]      FIG. 9  depicts a modification of the embodiment of  FIG. 7  on a bottle; 
           [0032]      FIG. 10  depicts a modification of the embodiment of  FIG. 9 ; 
           [0033]      FIG. 11  depicts a further modification of the embodiment of  FIG. 9  on a bottle; 
           [0034]      FIG. 12  depicts a modification of the embodiment of  FIG. 11 ; 
           [0035]      FIGS. 13 ,  14  and  15  explain the use of the embodiment of  FIG. 9 ; 
           [0036]      FIG. 16  corresponds to the illustration in  FIGS. 13 and 14  and depicts a stepped membrane; 
           [0037]      FIG. 17  depicts an embodiment with a zigzag-shaped membrane in a half-penetrated position; and 
           [0038]      FIGS. 18 and 19  illustrate the function of a cap for sealing the tip of the tubular part. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0039]      FIG. 1  depicts a first embodiment of a device according to the invention. It includes a tubular part  2 , one end of which includes a tip  4  for penetrating a stopper  6 , which seals a bottle  8 . An internal channel  10  of the tubular part  2  flows into a conical recess  12  for inserting a complementary conical journal  17  of a syringe  18 . The conical recess  12  is disposed in a connecting part  14 , on the outer surface of which an external thread  16  is disposed to tighten the syringe  18  in a known manner. 
         [0040]    A hose part  20  extends from the connecting part  14  and a flange  22 , which serves to fit and seal the stopper  6  and is held on the stopper by an aluminum crimp cap  24 , is formed on the end of the hose part  20  opposite the connecting part  14 . It must be noted that the tip  4  of the tubular part  2  projects over the flange  22  in the axial direction. As a result, the tip  4  presses into the stopper  6  to some extent without penetrating it when the device is put into position on the stopper  6 . This causes the tubular part  2  to be twice guided laterally prior to the penetration of the stopper  6 , once by the tip  4 , which is partially pressed into the stopper  6  and once by the connection of the hose part  20  with the connecting part  14 . 
         [0041]      FIGS. 2 and 3  explain the use of the device of  FIG. 1 . After the tip  18  has been connected, it is pressed in the direction of the bottle  8 , thereby pushing the tubular part  2  forward in the direction of its tip  4  through the stopper  6 , which seals the bottle  8 . The hose part  20  is expanded by this process, as depicted in  FIG. 2 . Finally, the syringe is pressed further forward so that the tip  4  of the tubular part  2  projects completely into the inside of the stopper  6  and thereby into the bottle  8  when the tubular part reaches its end position. In this position, the hose part  20  is half deformed in the sense that the half adjacent to the tubular part  2  is disposed within the half connected to the flange  22 . 
         [0042]      FIGS. 4 to 6  depict modifications of the embodiment of  FIGS. 1 to 3 . Identical or corresponding parts are referenced by the same reference numerals. The difference is that the diameter of a hose part  26  is substantially larger than the diameter of the tubular part  2 , wherein the edge  28  connected to the tubular part  2  extends disk-shaped toward the tubular part  2 . As evident from  FIGS. 5 and 6 , the hose part  26  and its disk-shaped edge  28  expand frustum-shaped in the penetration direction. To this end, the cylindrical part of the hose part  26  shortens itself and, in the end position of the penetration process of  FIG. 6 , by approximately half of its original length. 
         [0043]      FIG. 7  depicts a second embodiment of the invention. Identical or corresponding parts are referenced by the same reference numerals. The essential difference to the embodiment of  FIG. 1  is that the cylindrically configured hose part in the embodiment of  FIG. 1  is replaced by a frustum-shaped hose part  30 , the edge  32  of which is connected to the connection part  14  in the vicinity of its transition into the tubular part  2 , whereas the other edge  34  transitions into a cylindrical part  36 , from which a flange  38  extends for fitting into place on a stopper (not illustrated) corresponding to the stopper  6  in  FIG. 1 . A sealing bead  40  for a secure seal against a stopper is disposed on the flange  38 . 
         [0044]      FIG. 8  depicts a modification of the embodiment of  FIG. 7 . Identical or corresponding parts are referenced by the same reference numerals. The difference is that a ventilation channel  44 , which is connected to the environment via a lateral hole  46 , is provided in the tubular part  2  next to a channel  42 , which corresponds to the channel  10  in  FIG. 1  and serves to conduct fluid, so that air can penetrate into the inside of the bottle. A filter  48 , which is supposed to prevent the penetration of impurities from the ambient air, is arranged in the hole  46 . 
         [0045]      FIG. 9  depicts an embodiment similar to the embodiment of  FIG. 7  together with the top part of a bottle  50 , which is sealed by a penetrable stopper  52 , the flange-like projection  54  of which rests on an edge  56  of the mouth of a bottleneck  58  of the bottle  50 . An inner flange  60  of a cylindrical sheet metal part  62  made of aluminum, which is permanently dovetailed to the bottleneck  58 , holds the projection  54  in this position. In this embodiment, the bottle  50  and its content, together with the device according to the invention for removing the fluid, thus form a ready-to-use object, which maintains the sterility of the spike and the inside surface of the hose part  30 . A peelable seal  64  seals the inside of the connecting part  14  and the tubular part  2  to maintain the sterility. 
         [0046]      FIG. 10  depicts a modification to the embodiment of  FIG. 9 . The difference is that a removable cap  66 , which also ensures the sterility of the exterior of the device according to the invention if it is tightly connected to the device, is put on instead of the peelable seal  64 . To this end, the inner wall of the cap, which is not illustrated, can be configured conical, so that it is tightly adjacent to the cylindrical part  36  when put on. 
         [0047]      FIG. 11  depicts a modification to the embodiment of the device according to the invention in the illustration of  FIG. 9 . Identical or corresponding parts are referenced by the same reference numerals. The difference is that a collar  68 , which on its interior side includes hooks  70 , which engage a continuous projection  72  of the bottleneck  58  when the device according to the invention is placed on the neck of the bottle  50  thereby tightly connecting the device according to the invention to the bottleneck  58  prior to and during use, extends from the flange  60  of the device in the axial direction. To this end, even the sheet metal part  62  for dovetailing and for secure fastening of the stopper  52  can be dispensed with. The stopper  52  for sealing the bottle  50  and the device for removing its content can therefore already be connected in a simple manner by the manufacturer. 
         [0048]      FIG. 12  depicts a modification of  FIG. 11 . Identical or corresponding parts are referenced by the same reference numerals. The difference is that the manufacturer has already connected the stopper  52  with its flange-like projection  54  around the bottleneck by means of a dovetailed, cylindrical sheet metal part  74 . 
         [0049]      FIGS. 13 ,  14  and  15  explain the use of the device according to the invention in connection with the illustration of  FIG. 9 . Identical or corresponding reference numerals are used in all illustrations. In  FIG. 13 , a syringe  76  having a conical journal  78  is inserted into the corresponding complementary conical recess  12  of the connecting part  14  and tightly connected by a screw connection of an inside thread  79  to the external thread  16 . The tubular part  2  is connected to the conically tapered side of the hose part  30  and is thus laterally guided. The tip  4  of the other end of the tubular part  2  projects into the stopper  52 . 
         [0050]      FIG. 14  depicts an intermediate position of the penetration process in which the tip  4  has penetrated the stopper  52  halfway. In this position, the hose part  30  assumes a partially distorted position, partly adjoining the inside wall of the cylindrical part  36  and partly extending radially. If the tubular part is now moved further in the penetration direction, the hose-shaped part  30  will assume the shape of a frustum illustrated in  FIG. 15 , wherein the tapered part extends in the penetration direction. In this position, the hose part  30  is again able to apply forces in the penetration direction, holding the lower part of the connecting part  14  in a tight and standardized support on the surface of the stopper  52 . 
         [0051]      FIG. 16  depicts an embodiment similar to that of  FIG. 3 . Identical or corresponding parts are referenced by the same reference numerals. The difference is that the membrane is configured as a stepped annular disk  80 . To this end, the steps extend ring-shaped to the tubular part  2  and are partially cylindrically parallel and centric thereto. 
         [0052]      FIG. 17  depicts an embodiment in which the membrane is configured as an annular disk  82 , which extends radially to the tubular part  2  and zigzag-shaped when the tubular part  2  has penetrated halfway as illustrated. 
         [0053]      FIGS. 18 and 19  basically depict the top portion of the illustration of  FIG. 9 . Identical or corresponding parts are referenced by the same reference numerals.  FIG. 18  shows that a cap  86  made of thin film seals the front outlet of channel  10 . This film is penetrated when the tubular part  2  penetrates the stopper  52  and is held back by a surface  88  of the stopper  52  and pushes itself rearwards on the external surface of the tubular part  2  so that the mouth of the inner channel  10  is exposed. 
         [0054]    While this invention has been described as having a preferred design, it is understood that it is capable of further modifications, and uses and/or adaptations of the invention and following in general the principle of the invention and including such departures from the present disclosure as come within the known or customary practice in the art to which the invention pertains, and as may be applied to the central features hereinbefore set forth, and fall within the scope of the invention or limits of the claims appended hereto.