Patent Publication Number: US-11046474-B2

Title: Container having a head piece, which container can be or is filled with a medium

Description:
FIELD OF THE INVENTION 
     The invention relates to a container having a head piece. The container can be or is filled with a medium and is produced from plastic materials using a blow molding, filling, and sealing method. A transition region between the container and at least one first type of a head surface, arranged on the head piece at a front end, can be penetrated by a piercing or cutting part and extends with a specifiable curvature. 
     BACKGROUND OF THE INVENTION 
     Plastic containers, which are produced with a blow molding, filling, and sealing method (BFS method), such as that described in EP 2 269 558 A1 (for example, also referred to as the Bottelpack® system in technical parlance) are used for staple and luxury foods and also used very effectively in the medicinal sector for packaging of pharmaceuticals, diagnostic products, enteral nutrition and medicinal products, e.g. rinsing solutions and dialysis solutions. A significant advantage of such containers intended for these kinds of applications is that the contents only come into contact with a polymer forming the container material, typically a plastic such as LDPE, HDPE or PP. With one-piece containers produced and filled using this BFS method, the low germ levels/sterility of the contents can be guaranteed over longer periods of time. Containers intended for injections or infusions have a special formation of the head region (hereinafter referred to simply as “head piece”) for obtaining access to the container contents. The integral formation of container and head piece allows ensuring the sterility of the filling material, while permitting particularly efficient realization of the production process. Caps with elastomer sealing elements (DIN ISO 15759) are mounted on the head piece by welding or injection molding. Such head pieces, as are known from DIN ISO 15759, for example, have a head surface in the form of a head membrane having a convex curvature, which head membrane can be penetrated by a spike or a cannula when the container is used. Containers with such head pieces have several disadvantages. The use of less sharp spikes is preferred because of the reduced risk of injury to the users. This use creates the risk that the head membrane pushes inwards during the piercing operation resulting in a leakage. Leakages can also occur when the head piece is punctured multiple times, e.g. with a spike for a removal operation or with a cannula for the transfer of a separate drug component into the corresponding container, before the actual administration of the container contents. 
     SUMMARY OF THE INVENTION 
     Based on this prior art, the problem addressed by the invention is to provide an improved container intended in particular for a medicinal use, which is characterized by improved functional characteristics and which ensures a particularly safe handling, for example, in the case of parenteral or enteral administration. 
     According to the invention, this problem is solved by a container having, as a significant special characteristic of the invention, at least one second type of a head surface, which likewise has a specifiable curvature, which matches the curvature of the head surface of the first type, but preferably is different therefrom, on the head piece forming an integral component of the container. The head surfaces transition into each other in such a way that an overall surface is formed, which overall surface spans the free end of the transition region directed away from the container. Because the invention, instead of having one uniform head membrane that spans the end of the head piece with a standard curvature, provides for the formation of different head surfaces, which preferably form different curves at the head piece end, the overall surface can have greater resistance to bending and puncturing, cutting or penetration that can be more easily achieved. The deformation of the head membrane during the opening operation and the risk of leaks is then minimal. This structure permits safe handling even when less sharp spikes, cutters or thick cannulas are used. The design of the different head surfaces and the provision of a penetration surface additionally provides a simple, economical solution for optimally adapting caps to the head surfaces, and has significantly smaller elastomer sealing elements compared with DIN ISO 15759. The sealing elements, according to the invention, essentially abut only the penetration surfaces or parts thereof. 
     Different types of the head surfaces provided on the head piece can transition into each other directly or via a connection region. The arrangement can advantageously be such that, in the case of two types of head surfaces, both have a convex curvature or the one head surface is convex and the other head surface is, relative thereto, concave. In particularly advantageous exemplary embodiments, another, third type of a head surface is provided, which in turn has a different curvature than the other two head surfaces. 
     The arrangement can also advantageously be such that head surfaces are formed rotationally symmetrical and extend concentric to a longitudinal axis of the container and/or of the transition region and have surface pieces arranged extending transverse to this longitudinal axis. 
     A particularly effective increase in resistance to bending of the head membrane can be achieved with exemplary embodiments in which the head surface of the first type forms a connecting bridge that spans the free end of the transition region. The other head surface of a different type connects to the connecting bridge at the edge thereof. 
     Furthermore, the arrangement can advantageously be such that at least one annularly closed head surface of the second type or of another type is arranged on the head surface of the first type. The region of the head surface of the first type surrounded by the annular surface can be provided as a piercing region/cutting region, which is reinforced by the surrounding annularly closed head surface. 
     The arrangement can particularly advantageously also be such that at least one of the head surfaces forms a bar-shaped stiffening rib, which is mounted on one adjacent head surface or which connects surface parts arranged next to one another of at least one other head surface to one another. 
     In particularly advantageous exemplary embodiments, at least one head surface of the first type is formed projecting in the manner of a knuckle relative to an adjacent head surface of another type. 
     Such exemplary embodiments can be particularly advantageously designed such that the projecting head surface and the corresponding cap form at least one connecting part with distinctive connection characteristics. A corresponding connecting part in the form of an adapter can be removably attached to the connecting part with distinctive connection characteristics for a media removal and/or media feed from or into the container. These adapter systems are state of the art. Such adapters can also, as is disclosed in WO 2012/143921 A1 or EP 0 565 103 B1, for example, be used for a measured addition of a separate fluid, semi-solid or solid drug component to the container. For the direct transfer of the additional component from a receptacle containing this additional component, such adapters have a spike that is sharp on both sides for establishing a direct connection, by which even solid substances, for instance in powder form, can be introduced into the container. The design of the head piece and of the puncturing surfaces envisaged according to the invention permits application-appropriate spacing of puncture points, e.g. in order to simultaneously apply spikes with wide drip chambers (DIN EN ISO 8536-4) and an infusion device with a dosing container (DIN EN ISO 8536-5). 
     The container according to the invention, for example, in the form of an infusion bottle, can also have at least two opposite or adjacent filling and/or removal openings. On at least one opening, a head piece with head surfaces of a first type and head surfaces of a second type is provided as an integral component of the container. 
     The subject matter of the invention also comprises multiple-chamber containers (e.g. WO 0076745 A1), which have more than one adjacent and/or opposite filling or removal openings. On at least one opening, a head piece with head surfaces of a first type and of a second type is provided as an integral component of the container. 
     The subject matter of the invention also comprises caps with elastomer sealing elements, which essentially abut only on the penetration surfaces of the respective head piece. 
     Other objects, advantages and salient features of the present invention will become apparent from the following detailed description, which, taken in conjunction with the drawings, discloses preferred embodiments of the present invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Referring to the drawings that form a part of this disclosure: 
       The invention is explained in detail below with reference to exemplary embodiments depicted in the drawings, in which: 
         FIG. 1  is a front view, slightly enlarged compared with a practical embodiment, of a container in the form of an infusion bottle with two removal openings, the upper one of which in the figure is provided with a head piece according to the prior art of DIN ISO 15759; 
         FIG. 2  is, on a smaller scale, a perspective view of the bottle of  FIG. 1 ; 
         FIG. 3 a    is, at approximately twice the size compared with a practical embodiment, a perspective view of a head piece of a container according to a first exemplary embodiment of the invention; 
         FIG. 3 b    is a partial side view in section showing a modified cross-sectional shape for the bar-shaped rib of the head piece of the exemplary embodiment of  FIG. 3   a;    
         FIG. 4 a    is a front view of a container according to a second exemplary embodiment of the invention; 
         FIGS. 4 b  and 4 c    are a front view and a top view, respectively, of the head piece of a container according to a third exemplary embodiment of the invention; 
         FIGS. 5 a  to 5 c    are a front view and perspective views, respectively, of head pieces according to fourth and fifth exemplary embodiments of the invention; 
         FIGS. 6 a  and 6 b    are a front view and a perspective view of a container and head piece, respectively, according to a sixth exemplary embodiment of the invention; 
         FIG. 7 a    is a front view of a container according to a seventh exemplary embodiment of the invention; 
         FIGS. 7 b , 7 c , 7 d    are perspective views ( 7   b ,  7   d ) and a side view ( 7   c ), respectively, of modified embodiments of the head piece of the exemplary embodiment of  FIG. 7   a;    
         FIGS. 8 a  and 8 b    are a front view and a perspective view of a container and head piece, respectively, according to an eighth exemplary embodiment of the invention; 
         FIGS. 9 a  and 9 b    are a front view and a perspective view of a container and head piece, respectively, according to a ninth exemplary embodiment of the invention; 
         FIGS. 10 a  and 10 b    are a front view and a perspective view of a container and head piece, respectively, according a tenth exemplary embodiment of the invention; 
         FIG. 11  is a perspective oblique view of a head piece according to an eleventh exemplary embodiment of the invention; 
         FIG. 11 a    is a perspective view of the head piece of  FIG. 11 , with an additional reinforcing rib; 
         FIGS. 12 and 13  are perspective views of head pieces according to twelfth and thirteenth exemplary embodiments of the invention; 
         FIG. 13 a    is a perspective view of the head piece of  FIG. 13 , with an additional reinforcing rib; 
         FIG. 14  is a perspective view of a modified embodiment of the head piece of  FIGS. 10 a    and  10   b;    
         FIG. 15 a    is a front view of a container according to a fourteenth exemplary embodiment of the invention, with a cross-sectional depiction of a cover cap of the head piece in the state prior to a welding operation; 
         FIG. 15 b    is a perspective view of a cover cap for the head piece of the exemplary embodiment of  FIG. 5   a;    
         FIG. 15 c    is a front view section of a head piece with a welded on cap according to  FIG. 15 b   , after the welding operation; 
         FIG. 16 a    is a perspective view of a modified embodiment of a cover cap for a container according to the invention, according to the exemplary embodiment of  FIG. 11 ; 
         FIG. 16 b    is a front view in section of the cap according to  FIG. 16 a    on a head piece according to the exemplary embodiment of  FIG. 11 ; 
         FIG. 17  is a front view of a container according to a fifteenth exemplary embodiment of the invention in the form of an infusion bottle with two removal openings, one of which is provided with a screw connection; 
         FIG. 18  is a front view of a container according to an exemplary embodiment of the invention, with a head piece according to  FIG. 5 a    provided on a removal opening; and 
         FIG. 19  is a front view, partially in section, of the infusion bottle of  FIG. 18 , wherein the head piece lying at the bottom is provided with an end cap according to  FIG. 15 b   , prior to the welding operation. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIGS. 1 and 2  show a container or container body produced using the mentioned blow-fill-seal (BFS) method in the form of an infusion bottle  1  with a top removal position  3  and a bottom removal position  5 . The bottle  1  is produced from a plastic material such as LDPE, HDPE, PP or PET. In the case of a multiple layer embodiment, polyolefins in combination with EVOH, PET, COC, COP, PA or the like, can be provided, for example. In  FIGS. 1 and 2 , the bottle  1  lying at the top in the drawings has a head piece  7 , which corresponds to the prior art according to DIN ISO 15759. In the case of containers with head pieces of this type, caps with an elastomer sealant (DIN ISO 15759) can be connected, e.g. by welding, injection molding or sealing, to the head piece of the filled and sealed bottle  1 . On the front end of the head piece  7 , a head surface  11  is provided for removal and/or feeding operations, which, in the form of a head membrane penetrable by a cannula or a spike, spans a transition region  13  at which the head piece  7  transitions into the neck part  9  of the bottle  1 . The head surface  11  formed by this head membrane spans the transition region  13  with a uniformly convex curvature in the prior art. 
       FIGS. 3 to 15   a  and  17  to  19  show, to some extent in separate depictions, i.e. without depicted bottle bodies  1 , different exemplary embodiments of containers according to the invention with head pieces  7 , which have different types of head surfaces.  FIG. 3 a    shows an example in which, in addition to a head surface  11  of the first type, which spans the transition region  13  with a convex curvature like the head surface  11  of the prior art, a head surface of the second type in the form of a reinforcing rib  15  is provided. Rib  15  forms a bar projecting significantly from the head surface  11  of the first type, spans the head surface  11  and lies diametrically therein. This bar-shaped rib  15  increases the resistance to the bending of the curvature of the head surface  11  into the inside of the container and permits the secure abutment of the elastomer component of a cover cap (not depicted), and thus, the secure sealing of the pierced spike.  FIG. 3 b    shows a modified cross-sectional shape for the reinforcing rib  15  of  FIG. 3 a   , wherein the top side of the rib  15  is not flat, but convex. 
       FIGS. 4 a  to 4 c    provide a bridge body  17  as a reinforcing or stiffening element, which, in the form of a projecting head with an oval contour, spans the free end of the transition region  13  and which, at its front top end, forms a head surface  19  of the first type with only a slightly convex curvature. Another head surface  21  connects to the foot of the bridge body  17 , which other head surface is once again convex, but with greater curvature than the head surface  19 . As  FIG. 4 c    shows, the largest width of the bridge body  17  is somewhat more than half of the diameter of the transition region  13 . Also, the height of the bridge body  17 , measured relative to the surrounding head surface  21 , is somewhat less than half of the largest width of the bridge body  17  as the comparison of  FIGS. 4 b  and 4 c    shows. From the front head surface  19 , the side wall  23  extends out from a rounding  25  surrounding the head surface  19 , to the surrounding head surface  21 . 
       FIGS. 5 a  and 5 b    show an exemplary embodiment, in which two nipple-shaped knuckles  29  project from a head surface  27  that spans the transition region  13 . The knuckles  29  lie at a distance from one another on a line extending diametrically on the head surface  27  and form, on their respective front end, a round, easily penetrable head surface  31 . These head surfaces have only an extremely slight curvature, i.e. they extend almost parallel to the main plane of the head surface  27 . A side wall  33  with concave curvature connects the front face surface  31  with the surrounding head surface  27 . In another embodiment (not depicted), a bar-shaped rib, as in  FIGS. 3 a  and 3 b   , can extend between the knuckles  29 .  FIG. 5 c    shows a modification compared with  FIGS. 5 a  and 5 b   , wherein the head surface  31  is not provided at the top end of the knuckles  29 , but is rather set back towards the inside. 
       FIGS. 6 a  to 9 b    show other exemplary embodiments, in which all of the head surfaces are formed rotationally symmetrical and extend concentric to a longitudinal axis  35  of the transition region  13 . In the example of  FIGS. 6 a  and 6 b   , a convex head surface  37  is formed torus-shaped on the front edge of the circular cylindrical transition region  13 . This head surface  37  surrounds concentrically a circular head surface  39  in the form of a concave depression, from which in turn another head surface  41  rises in the form of a convex dome, concentric to the axis  35 . The radial width of the edge-side, outer head surface  37  is approximately ⅙ of the diameter of the transition region  13 . The diameter of the dome forming the head surface  41  is approximately ⅓ of the diameter of the transition region  13 . The depth of the depression forming the head surface  39  is in turn approximately 1/16 of the diameter of the transition region  13 . 
     The head piece  7  of the exemplary embodiment of  FIGS. 7 a  to 7 d    has a convex head surface  43  connecting to the front edge of the circular cylindrical transition region  13 , which head surface, as part of a torus, encircles the transition region  13 . This head surface  43  surrounds a knuckle  45 , concentric to the axis  35 , which forms a convex head surface  47  at its top side. The radial width of the outer edge-side head surface  43  corresponds to the width of the edge-side head surface  37  of the example of  FIGS. 6 a  and 6 b   . The height of the knuckle  45  projecting above the edge-side head surface  43  is approximately ⅛ of the diameter of the transition region  13 . In the example shown in  FIGS. 7 c  and 7 d   , an additional reinforcing rib  48  is provided, which spans the head surface  47  diametrically. 
     The exemplary embodiment of  FIGS. 8 a  and 8 b    has a head surface  51  in the form of a convex annular surface connecting to the circumferential edge  52 . A knuckle  53  rises from the central region of this annular surface concentric to the axis  35 , which knuckle forms a head surface  55 , which is also convex, but with greater curvature than the head surface  51 . The diameter of the cylindrical transition region  13  is approximately two and a half times the diameter of the knuckle  53 . The height of the knuckle  53  relative to the surrounding head surface  51  is approximately ⅙ of the diameter of the knuckle  53 . 
     The exemplary embodiment of  FIGS. 9 a  and 9 b    has, like the exemplary embodiment of  FIGS. 6 a  and 6 b   , a head surface  59  with convex curvature surrounding the circumferential edge  57  of the cylindrical transition region  13 . A depression-shaped recess is connected to head surface  59 . The base of the recess forms a concave head surface  61 . The difference compared with the example of  FIGS. 6 a  and 6 b    is only that no knuckle is located in the center of the head surface  61 . The width of the convex head surface  39  at the edge  57  is, in the example of  FIGS. 9 a  and 9 b   , a little greater than the width of the edge-side head surface  37  in the example of  FIGS. 6 a  and 6 b   . The width of the head surface  61  formed by the central depression, or pocket, is a little more than half of the diameter of the transition region  13 . The axial depth of the depression forming the head surface  61  is approximately 1/10 of the diameter of the transition region  13 . 
     The exemplary embodiment of  FIGS. 10 a  and 10 b    resembles the exemplary embodiment of  FIGS. 4 a  to 4 c    to the extent that a bridge region  63  is provided. Bridge region  63  projects from a convex head surface  65 , which connects to the edge  66  of the connecting region  13 . By contrast with the oval bridge body  17  of  FIGS. 4 a  to 4 c   , the bridge region  63  of the present example has a contour in the shape of a horizontal figure eight, with side walls  67 , which descend from a front head surface  69 , relatively steeply relative to the surrounding head surface  65 . As  FIG. 10 a    more clearly shows, the head surface  69  has a convex curvature. The height of the bridge body  63  relative to the surrounding head surface  65  is approximately ¼ of the diameter of the circular cylindrical transition region  13 . The largest width of the bridge region  63  at the arms of the figure eight forming the contour is somewhat less than half of the diameter of the transition region  13 . 
       FIG. 11  shows an exemplary embodiment which, similarly to the head surface  11  in the exemplary embodiment of  FIG. 3 , has a convex head surface  74 , which connects to the edge  70  of the transition region  13  over the entire circumference thereof. Arranged on this head surface  74  are two annular bodies  71  in the form of flat circular rings, which are arranged at a spacing from one another along a line extending diametrically over the head surface  74 . The external diameter of these flat rings is approximately ⅙ of the diameter of the transition region  13 . The annular bodies  71  are arranged such that the spacing between them is greater than the spacing of each annular body  71  from the circumferential edge  70  of the transition region  13 . At their top side, the annular bodies  71  each form a head surface  73  in the form of a slightly convex circular surface. 
     In addition, as is also the case in the exemplary embodiments of  FIGS. 3 a  and 3 b   , a bar-type reinforcing rib  15  can be provided, extending diametrically over the head surface  74 , as depicted in  FIG. 11   a.    
     The exemplary embodiment of  FIG. 12  resembles the exemplary embodiment of  FIGS. 9 a  and 9 b   . In other words, it has a depression  77  delimited by the edge-side, convex head surface  75 , which depression  77  forms a concave head surface  79 . Mounted on the base of the depression  77 , a diametrically extending stiffening rib  81  extends in the form of a straight bar with axially parallel side walls and a slightly convex top side, which abuts the edge-side head surface  75  as another head surface  83 . 
       FIG. 13  shows an exemplary embodiment, in which a convex head surface  85  continuously spans the transition region  13  between its circumferential edge  86 . In a symmetrical arrangement, chamfers  89  lying diametrically opposite one another connect at arc-shaped connecting lines, which chamfers each form another, slightly convex head surface  91 . As  FIG. 13 a    shows, in a modification of the example of  FIG. 13  too, an additional bar-type reinforcing rib  15  can be provided, which rib spans the head surface  85 . 
     The exemplary embodiment of  FIG. 14  resembles the exemplary embodiment of  FIGS. 10 a  and 10 b   , wherein side penetration surfaces  101 , defined by the contour shape of the bridge body  63 , are formed. In this configuration, the penetration surfaces  101  have a maximum spacing from one another. This is advantageous when both locations are used for piercing and the corresponding spike or the drip chamber remains therein. A reinforcing rib  15  is additionally provided in the example of  FIG. 14  to ensure a high level of bending resistance. This reinforcing rib can also have a rounded shape, as depicted in  FIG. 3   b.    
       FIGS. 15 a  to 16 b    also show by way of an example cover caps  93 , with the design shown in  FIGS. 15 a  and 15 b    being provided for head pieces according to the examples of  FIGS. 5 a  to 5 c    and the design of  FIGS. 16 a  to 16 c    being provided for a head piece  7  according to the exemplary embodiment of  FIG. 11 , for example. The cover cap  93  of  FIGS. 15 a  to 15 c    is a hollow body made of a plastic, for example, the same material from which the bottle is made. The cover cap  93  has a hollow cylindrical main part  92 , which spans the transition region  13  of the head piece  7  and has, at the open end, an edge  95  forming a radial extension, in which a circumferential annular groove  96  is located. In the case of a cover cap  93  fixed onto the head piece  7  by welding, injection molding, adhesion or sealing, the edge  95  can form a connecting part for an adapter.  FIG. 15 a    shows a state prior to welding. As can be seen, a lug  106  is formed on the end edge of the main part  92 , which lug forms an energy guide for welding processes, such as ultrasonic welding. This lug  106  is welded so that, once a welding operation has been carried out, the state depicted in  FIG. 15 c    is obtained. Sleeve bodies  97  are molded onto the top side  94 , which sleeve bodies are aligned in such a way that they are flush with the knuckles  29  on the head piece  7 . In the initial state, which is depicted in the figures, the sleeve bodies  97  are closed by a disk  98  that can be torn off at predetermined breaking points. A tab  99  is installed that permits easy tearing off of the disks  98  so as to clear the way for access to the elastomer  103  bearing against the penetrable head surface  31  of the head piece  7 . 
     The example of  FIGS. 16 a  and 16 b    differs from the  FIG. 15 a - c    embodiment in that, instead of the projecting sleeve bodies  97  on the top side  94 , a dome-shaped hollow box construction  100  is provided. In box construction  100 , two openings  102  are arranged in such a way that they are aligned with the region of the annular bodies  71  of  FIG. 11 , which are located on the head surface  74  of the head piece  7 . For use operations, the part of the head surface  74  surrounded by the annular body  71  can therefore be penetrated via the openings  102 . As depicted, an elastomer  103  is provided above the penetration surface delimited by the annular bodies  71 , for the formation of a seal on the penetration surfaces. 
       FIG. 17  shows, in a depiction corresponding to  FIG. 1 , an embodiment of the bottle  1  which has two removal positions  3  and  5  lying opposite one another. The access lying at the bottom in the figure is provided with an external thread  105 . A head piece  7  according to the exemplary embodiment of  FIG. 1  is located at the top removal position. 
       FIG. 18  shows a bottle  1  corresponding to  FIG. 17  with a head piece  7  according to the example of  FIG. 5 b    located at the bottom removal position  5 . 
       FIG. 19  shows the bottle  1  of  FIG. 18 , wherein the head piece  7  at the bottom removal position  5  is provided with a cap  93  according to the example of  FIG. 15   b.    
     All solutions according to the invention described above have in common that the container  1  is produced using the blow molding, filling, and sealing method and is formed in one piece with its special head piece  7  according to the invention. Amongst other things, the container wall transitions continuously into the wall of the head piece  7 . 
     While various embodiments have been chosen to illustrate the invention, it will be understood by those skilled in the art that various changes and modifications can be made therein without departing from the scope of the invention as defined in the claims.