Abstract:
The invention relates to a closure cap ( 1 ) for receptacles for receiving medical liquids, in particular receptacles filled with infusion solutions, transfusion solutions or liquids for enteral nutrition. The invention further relates to a receptacle ( 40 ) for receiving medical liquids, in particular a bottle, comprising such a closure cap. The closure cap ( 1 ) according to the invention is characterized by two injection parts ( 6  and  7 ) arranged separately from one another, each for injecting an additive. One injection part ( 6 ) serves to inject an additive with an injection syringe that has a needle (cannula), while the other injection part ( 7 ) serves to inject an additive with a needle-less injection syringe.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. application Ser. No. 13/133,674, filed Jun. 9, 2011, which is a National Stage of International Application No. PCT/EP2009/008622, filed on Dec. 3, 2009, which claims the priority of German Patent Application No. 10 2008 060 864.5, filed on Dec. 9, 2008. The contents of both applications are hereby incorporated by reference in their entirety. 
    
    
     FIELD OF DISCLOSURE 
     The invention relates to a closure cap for receptacles for receiving medical liquids, in particular for receptacles filled with infusion or transfusion solutions or liquids for enteral nutrition. The invention further relates to a receptacle for receiving medical liquids, in particular a bottle, with a closure cap of this kind. 
     BACKGROUND 
     A method known as a blow-fill-seal method (BFS method) is known in which receptacles, for example bottles made of extruded PE or PP, are blown in a sterile and pyrogen-free state into a desired shape in one operation and, directly after cooling, are filled aseptically with a sterile filler and hermetically sealed. The receptacles, in particular bottles, produced by the blow-fill-seal method are also referred to as BFS receptacles. 
     If the known BFS receptacles are used to receive sterile medical liquids, for example infusion solutions, the receptacles require a closure cap that allows the infusion solution to be transferred to the patient by means of an infusion appliance. The addition of medicaments to the infusion solution should likewise be possible. 
     WO 2008/095665 A1 discloses a closure cap for a receptacle for receiving medical liquids, in particular a BFS bottle. The known closure cap has a lid part and an edge part, with an injection part arranged in the lid part. The injection part has an outwardly directed connector part, with a conical recess that sealingly receives the conical stem of a needleless injection syringe, and an inwardly directed closure part, in which a self-sealing membrane is fitted. In addition to the injection part, the closure cap also has a withdrawal part for withdrawing a medical liquid using a spike. 
     A closure cap, which has a withdrawal part for withdrawing liquid and also an injection part for injecting an additive, is known from WO 2006/042579 A1. 
     The closure caps known from WO 2008/095665 A1 and from WO 2006/042579 A1 are characterized in that both closure caps have only one withdrawal part and one injection part. Both closure caps have proven effective in practice. The injection part permits subsequent injection of an additive or the injection of several additives in succession into the medical liquid. The injection part is closed in a sterile manner by a break-off part. A disadvantage is that, although the receptacle is still tightly sealed by the self-sealing membrane after the break-off part of the injection part has been broken off, the connector part of the injection part is exposed to a non-sterile environment. Therefore, there is in principle a danger of contamination of the injection part unprotected on the outside, and this proves disadvantageous if a further additive is to be injected at the injection part. 
     Closure caps for receptacles containing solutions for enteral nutrition are also known from U.S. Pat. No. 5,125,522 and U.S. Pat. No. 4,951,845. These closure caps only have one withdrawal site. In addition to the withdrawal site, the known closure caps have a vent opening, which is closed with a sterile filter. 
     WO 2006/115969 A3 describes a closure cap designed for a receptacle and having a large number of openings of different designs, for example round or star-shaped openings. All of the openings are distributed peripherally about the center of the closure cap. 
     Conical connectors with a conical stem and a conical sleeve whose conical surfaces are standardized are known in medical technology for connecting medical appliances. The unlockable cone connections with standardized cone surfaces are known as Luer connectors, and the lockable cone connections are known as Luer lock connectors. Luer syringes without screw connections and Luer lock syringes with screw connections are thus also known. 
     It is an object of the invention to make available a closure cap for receptacles for receiving medical liquids, in particular for receptacles filled with infusion or transfusion solutions or liquids for enteral nutrition, which closure cap is particularly easy to handle and can be used universally. It is also an object of the invention to make available a receptacle for receiving medical liquids, in particular a bottle, which is easy to handle and can be used universally. 
     According to the invention, these objects are achieved by the features specified in claims  1  and  17 . Preferred embodiments of the invention are set forth in the dependent claims. 
     The closure cap according to the invention is characterized by two injection parts arranged separately from each other and each designed for injection of an additive. One injection part is used for injection of an additive using a needleless syringe, while the other injection part is used for injection of an additive using an injection syringe that has a needle. It is therefore possible to inject different additives into the medical liquid contained in the receptacle using a needleless injection syringe and also using an injection syringe with needle. The closure cap according to the invention can thus be used universally. 
     If, for example, a first additive has been injected via the first injection part, a second additive can be injected via the second injection part. Both injection parts are preferably closed tightly with a break-off part. If the break-off part of one injection part is broken off, the other injection part remains protected by the break-off part that has not been broken off. This has the advantage that the as yet unused injection part cannot be contaminated. 
     In a preferred embodiment, the closure cap has a lid part and an edge part, wherein the lid part has an inner portion and an outer portion which protrudes outward from the inner portion. The first and second injection parts and the withdrawal part are preferably arranged on the outer outwardly protruding portion of the lid part. Thus, the injection site and the withdrawal site extend forward such that the injection sites and the withdrawal site on the closure cap are easily accessible. 
     In a preferred embodiment, the first and second injection parts and the withdrawal part are arranged preferably lying next to one another in a row on the outer portion of the lid part. The outer portion of the lid part should extend as far as possible across the entire width of the lid part. In this way, sufficient space is made available for the arrangement of the injection parts and of the withdrawal part. 
     In an alternative embodiment, the injection parts and the withdrawal part are arranged offset in relation to one another on the outer portion of the lid part. In this alternative embodiment, the outwardly protruding portion of the lid part preferably has a substantially rectangular shape, such that sufficient space is made available for the injection parts and the withdrawal part. 
     The break-off parts for closing the injection parts and the withdrawal part preferably have lateral grip tabs, which preferably extend across the outer portion of the lid part. In this way, the grip tabs can be easily gripped from the side. 
     The injection part for the needleless injection syringe has an outwardly directed connector part, with a recess for receiving the conical stem of the syringe, and an inwardly directed closure part, in which a self-sealing membrane is arranged. The outwardly directed connector part of the first injection part preferably has an outer thread, such that a known Luer lock syringe can be attached to the connector part. However, it is also possible that the connector part of the injection part has no outer thread, such that only the attachment of a known Luer syringe is possible. 
     In one embodiment a hollow body with a point is arranged in the recess of the connector part of the injection part which is designed for injecting an additive into the medical liquid using a needleless injection syringe, wherein the membrane and the hollow body are arranged in the recess of the connecting part in such a manner that the membrane is pierced when the syringe is connected to the connecting part, wherein the membrane is arranged above the hollow body in the recess of the connecting part and therefore, when the syringe is connected to the connecting part, the membrane is pressed by the syringe onto the point of the hollow body. In one embodiment the hollow body is designed as a cannula with a ground section. In a further embodiment the hollow body in the recess of the connecting part is fastened to a disk-shaped body which preferably has openings, preferably for ventilation purposes. These openings in the disk-shaped body are for instance bores which can be distributed circumferentially around the hollow body. 
     The receptacle according to the invention, in particular an infusion or transfusion receptacle or a receptacle for receiving a solution for enteral nutrition, is preferably designed as a bottle, in particular an SBM (stretch-blow-molding) bottle that is closed with the closure cap according to the invention. 
     According to one embodiment the closure cap comprises or consists of polypropylene and/or polyethylene. In one further embodiment the membrane comprises or consists of polyisoprene and/or brominebutyl and/or chlorinebutyl. 
     According to one embodiment the withdrawal part for withdrawing the medical liquid using a spike is adapted to receive a spike having a diameter in the range of approximately at least 5 mm to approximately 6.5 mm. In another embodiment the injection part for injecting an additive into the medical liquid using a needleless injection syringe is adapted to receive a Luer-Lock syringe having a cone diameter of about 4 mm. In one further embodiment the second injection part designed for injecting an additive into the medical liquid using an injection syringe that has a needle is adapted to receive a needle having a diameter up to about 5 mm. For instance the outer diameter of the closure cap is in the range of 30 mm to 40 mm. For instance the maximum height the closure cap (including the break-off parts) is in the range of 25 mm to 35 mm. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Two illustrative embodiments of the invention are explained in more detail below with reference to the drawings, in which: 
         FIG. 1  shows an illustrative embodiment of the closure cap according to the invention in a plan view in which the injection parts and the withdrawal part are arranged in a row, 
         FIG. 2  shows the closure cap from  FIG. 1  in a view from underneath, 
         FIG. 3  shows the closure cap from  FIG. 1  in a sectional view, wherein the break-off part is broken off from an injection part in order to inject an additive using a syringe that has a needle, 
         FIG. 4  shows the closure cap from  FIG. 1  in a sectional view, wherein the break-off part is broken off from the other injection part in order to inject an additive using a needleless syringe, 
         FIG. 5  shows the closure cap from  FIG. 1  in a sectional view, wherein the break-off part is broken off from the withdrawal part in order to withdraw liquid using a spike, 
         FIG. 6  shows a second illustrative embodiment of the closure cap according to the invention in a view from above, in which the injection parts and the withdrawal part are arranged offset in relation to one another, 
         FIG. 7  shows the closure cap from  FIG. 6  in a view from underneath, and 
         FIG. 8  shows an illustrative embodiment of receptacle according to the invention with a closure cap according to the invention. 
         FIG. 9  shows a zoom of an illustrative embodiment of the injection part with a hollow body for piercing the membrane. 
     
    
    
     DETAILED DESCRIPTION 
       FIGS. 1 and 2  show a first illustrative embodiment of the closure cap according to the invention in a plan view and a bottom view, while  FIGS. 3 to 5  show the closure cap in sectional views, wherein an additive is injected using an injection syringe or a liquid is withdrawn using a spike. Apart from the pierceable membranes, the closure cap is a one-piece plastic component that can be produced inexpensively in large numbers. 
     The closure cap  1  has a lid part  2  and an edge part  3 . The lid part  2  has a flat inner portion  4 , from which an outer portion  5  protrudes outward. The outer portion  5  of the lid part  2  has an elongate shape with two substantially rectilinear portions  5 A, which are adjoined at both sides by substantially semicircular portions  5 B. The outer portion  4  extends across the whole width of the inner portion  4  of the lid part  2 . A first injection part  6 , a second injection part  7  and a withdrawal part  8  are located on the top of the outer portion  5  of the lid part  2  in a manner easily accessible to the user. The first injection part  6  is used for injection of an additive using an injection syringe that has a needle ( FIG. 3 ), while the second injection part  7  is used for injection of an additive using a needleless injection syringe ( FIG. 4 ). The withdrawal part  8  is used for withdrawal of liquid using a spike ( FIG. 5 ). 
     The two injection parts  6  and  7  and the withdrawal part  8  are arranged lying close to one another in a row on the outer portion  5  of the lid part  2 . They lie on an axis  9  that corresponds to the longitudinal axis of the outer portion  5  of the lid part  2 . The two injection parts  6  and  7 , which have a smaller diameter than the withdrawal part  8 , are arranged lying closely next to each other, while the withdrawal part  8  lies close to the two injection parts  6 ,  7 . 
     The two injection parts  6 ,  7  and the withdrawal part  8  are described below in more detail with reference to  FIGS. 3 to 5 . 
     The first injection part  6 , arranged on the outer edge of the lid part  2  and designed for injection of an additive using an injection syringe ( FIG. 3 ) that has a needle, comprises an outwardly directed annular shoulder  10 , which encloses the injection site. The annular shoulder  10  is closed with a break-off part  11 , which adjoins the upper end of the annular portion  10  via an annular break-off zone  12  ( FIGS. 4 and 5 ). The break-off part  11  has a round cap  13 , to which a grip tab  15  is adjoined via a narrow web  14 , which grip tab  15  extends across the outer portion  5  of the lid part  2  and downward as far as the edge part  3  of the closure cap  1 . 
     From the annular portion  10  of the first injection part  6 , a closure part  16  is directed inward and has a recess  17 . A pierceable, self-sealing membrane  18  is fitted in the recess  17  of the closure part  16 . The membrane  18  is secured with a snap-fit in the recess  16 . The recess  16  has an upper cylindrical portion  16 A, which adjoins the annular portion  10  of the first injection part  6 . The upper cylindrical portion  16 A is adjoined by a lower cylindrical portion  16 B, which has a greater internal diameter than the upper cylindrical portion  16 A. The self-sealing membrane  18  accordingly has a lower cylindrical portion  18 A with a greater external diameter, which sits in the lower cylindrical portion  16 B of the recess  16 . The lower cylindrical portion  18 A of the membrane  18  is adjoined by an upper cylindrical portion  18 B with a smaller external diameter, which sits snugly in the upper cylindrical portion  16 A of the recess  16 . 
     To fix the membrane  18  with a clamping action in the recess  17 , the closure part  16  has an inwardly projecting edge  19  at the lower end of the closure part  16  that engages under the membrane  18 . The membrane  18  has a flat top and bottom and is not slotted. This means that, when the needle of an injection syringe has been pulled out, the membrane reliably seals again and no liquid escapes. 
     The second injection part  7 , arranged centrally, has an outwardly directed connector part  20  for the connection of a needleless Luer lock syringe ( FIG. 4 ). Otherwise, the second injection part  7  does not differ from the first injection part  6 . The connector part  20  of the second injection part has a conical recess  20 A, for sealingly receiving the conical stem of the syringe, and an outer thread  20 B. The conical recess  20 A and the outer thread  20 B are designed in such a way that a commercially standard Luer lock syringe can be attached to the connector part. 
     The connector part  20  is closed with a break-off part  21 , which is attached to the upper end of the connector part via an annular break-off zone  22 . The break-off part  22  has a round cap  23  which is adjoined, via a narrow web  24 , to a lateral grip tab  25 , which extends outward across the outer portion  5  of the lid part  2  and as far as the inner portion  4  of the lid part  2 . 
     The second injection part  7  also has a closure part  26 , which corresponds to the closure part  16  of the first injection site  6 . The closure part  26  of the second injection site again has a recess  27 , in which a membrane  28  is fixed with a clamping action. The closure part  26  of the second injection part  7  differs from the closure part of the first injection part  6  in terms of the membrane  28 , which has a lower annular portion  28 A adjoined, via a central web  28 B, to an upper plate-shaped portion  28 C, which has a cup-shaped depression  28 D. The plate-shaped portion  28 C of the membrane  28  is provided with one or more slits, for example being slotted crosswise. 
     The withdrawal part  8  of the closure cap  1  has an outwardly directed connector part  29  for the attachment of the spike of an infusion appliance ( FIG. 5 ). The connector part  29  has a recess  30  into which the spike of the infusion appliance is inserted. The recess  30  has an upper conical portion  30 A and a lower cylindrical portion  30 B, wherein the upper conical portion serves to center the spike, and the lower cylindrical portion serves to receive the spike sealingly. The recess  30  of the connector part  29  is closed with a break-off part  31 , which is attached to the upper end of the connector part via an annular break-off zone  32 . The break-off part  31  again has a lateral grip tab  33  which, like the grip tab of the break-off part of the first injection part, protrudes outward across the outer portion  5  of the lid part  2  and extends as far as the edge part  3  of the closure cap  1 . 
     The withdrawal part  8  has an inwardly protruding closure part  34  with a recess  35 , in which once again a pierceable, self-sealing membrane  36  is fixed with a clamping action. The self-sealing membrane  36  of the withdrawal part  8  has an outer annular upper portion  36 A, to which a plate-shaped lower portion  36 C is adjoined via a central web  36 B. The central web  36 B of the membrane  36  is held and clamped by an inwardly protruding edge  37  at the lower end of the closure part  34 . 
     At the lower edge of the edge part  3 , the closure cap  1  has a bead-shaped edge  38 , which has a circumferential groove  39  on the underside. The closure cap can be fitted onto a bottle, wherein the upper edge of the bottle neck engages in the groove  29  of the bead-shaped edge  38  of the closure cap  1 . 
       FIG. 8  shows a bottle  40 , in particular an SMB bottle, which is closed with the closure cap  1  according to the invention. The closure cap  1  sits securely on the bottle neck  41  of the bottle  40 , which is filled with an infusion solution for example. Since the bottle neck is not closed in the head area and is instead open, the liquid is in direct contact with the cap. It is therefore possible to inject a medicament using a needleless injection syringe or using an injection syringe with needle. The closure cap can be designed as a screw cap, which is screwed onto the bottle neck of the bottle. However, it is also possible to weld the closure cap to the bottle neck. 
     The handling of the closure cap  1  is described below. 
     To withdraw a liquid, for example an infusion solution, the break-off part  31  is broken off from the closure cap  1 , such that the membrane  36  of the withdrawal part  8  is exposed. The spike of the infusion appliance is then attached to the connector part  29  of the withdrawal part  8  ( FIG. 5 ). If a medicament is to be injected using an injection syringe with needle, the break-off part  11  of the first injection part  6  is broken off, such that the membrane  18  of the first injection part can be pierced by the needle of the syringe. In doing this, however, the second injection site remains protected by the associated break-off part ( FIG. 3 ). If a medicament is to be injected using a needleless injection syringe (Luer lock syringe), the break-off part  21  of the second injection part  7  is broken off, whereupon the Luer lock syringe can be screwed onto the connector part  20  of the second injection part  7  ( FIG. 4 ). 
       FIGS. 6 and 7  show an alternative embodiment of the closure cap  1 ′ according to the invention, which differs from the closure cap described with reference to  FIGS. 1 to 5  only in terms of the arrangement of the two injection parts and of the withdrawal part on the outer portion of the lid part. Therefore, the same reference signs are also used for the parts that correspond to each other. In the embodiment in  FIGS. 6 and 7 , the outer portion  5  of the lid part  2  of the closure cap  1 ′ has a substantially rectangular shape with rounded corners. The two injections parts  6 ,  7  and the withdrawal part  8  are arranged offset in relation to one another on the top of the upper portion  4  of the lid part  2 . The first injection part  6  and the withdrawal part  8  lie on one half, and the second injection part  7  on the other half, on the top of the outer portion  5  of the lid part  2 . The grip tabs  15 ,  25 ,  33  of the injection parts  6 ,  7  and of the withdrawal part  8  are directed radially outward. They extend outward across the outer portion  5  of the lid part  2  and reach downward as far as the edge part  3  of the closure cap  1 . The individual accesses are identified as injection parts or withdrawal part by the upwardly or downwardly directed arrows  42  on the grip tabs  15 ,  25 ,  33  of the break-off parts  11 ,  21 ,  31 . 
     Finally  FIG. 9  shows a zoom of an illustrative embodiment of the injection part  7  with a hollow body  100  for piercing the membrane  28 . In this embodiment upon connection of a syringe to the closure cap, the membrane  28  is pressed onto the point  102  or tip  102  of the hollow body  100  which is arranged below the membrane  28 . In this embodiment, the point  102  of the hollow body  100  is not at a distance from the membrane  28  but rather is directly therebelow, preferably in contact with the membrane  28 . In a non-shown embodiment the hollow body  100  is at a distance from the membrane  28 , i.e. not in contact. Due to the hollow body  100  the reliability of the membrane opening and/or membrane closing is enhanced. 
     Preferably the hollow body  100  for piercing the membrane  28  upon connection of the syringe is integrally formed on a disk-shaped body  101  which sits together with the membrane  28  in the recess  27  of the lid part  2  of the closure cap. The membrane  28  and the hollow body  100  together with the disk-shaped body  101  are held clamped in the recess  27  by a projecting, encircling extension  105  which engages under the disk-shaped body  101 . In this case, the lower portion  28 A of the membrane  28  is supported in the recess  27  of the lid part  2  of the closure cap by means of an upper, projecting extension  106  and the disk-shaped body  101  is supported therein by means of a lower, projecting extension  106 . However, it is also possible to adhesively bond or to weld the disk-shaped body to the lid part  2  of the closure cap. In one embodiment the projecting, encircling extension  105  is provided as a beading flange.