Liquid container with predetermined breaking point

Information

  • Patent Grant
  • 9642774
  • Patent Number
    9,642,774
  • Date Filed
    Friday, September 7, 2012
    12 years ago
  • Date Issued
    Tuesday, May 9, 2017
    7 years ago
Abstract
Liquid container with a predetermined break point (4), which is covered by an elastomer septum (3). The container forms a hollow body (10) made of a single material that is compatible with critical liquids such as medicines. The elastomer septum (3) and the predetermined break point (4) can be pierced by a hollow needle (51) in order to withdraw liquid from the container.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a national phase entry under 35 U.S.C. ยง371 of International Application No. PCT/EP2012/003762 filed Sep. 7, 2012, which claims priority from German Patent Application No. 10 2011 112 516.0 filed Sep. 7, 2011, the disclosures of which are hereby incorporated herein by reference.


The invention relates to a container for containing a liquid, a container filled with liquid, as well as a package comprising a container filled with liquid and a liquid withdrawal device.


For appropriately conserving liquid medicines, glass ampoules are used, wherein for withdrawing liquid, the ampoule head has to be broken off whereupon the content can be withdrawn by means of an injection syringe. Opening the glass ampoules is not without problems, which is the reason why containers have already been used, the cover of which consists of an elastomeric material, for example silicone or isobutyl rubber, and which is secured by means of a metallic crimp cap. Withdrawing the liquid is carried out via a hollow needle by means of which the cover wall can be pierced.


In the case of such containers with covers, there is the danger that volatile constituents can escape along the sealing surfaces or through the material itself, or that the useful liquid dissolves material constituents out of the elastomeric materials, which material constituents are undesirable in the useful liquid. Specifically in the case of medicines, all constituents of the container, even during prolonged storage, have to prove to be compatible with the liquid medicine. If substances are dissolved out of the container, they have to be toxicologically examined. The examination efforts required for this are significant.


EP 0694498 A1 and EP 0919215 A1 describe the withdrawal of a liquid from a closed glass ampoule by means of a blunt hard object, for example a thick-walled cannula. The bottom of the glass ampoule the shaft region connected thereto can be enclosed by an elastomeric part so as to retain glass splinters occurring in the ampoule region. While in the case of EP 0694498 A1, no predetermined breaking point is provided in the bottom of the glass ampoule, the bottom in the case of EP 0919215 A1, due to its shape and/or a coating, has a defined predetermined breaking point region which can be destroyed with little expenditure of force. In detail, the bottom of the ampoule has a recessed region with a point-like ceramic coating that serves as point of engagement for the opening tool of the ampoule.


It is an object of the invention to provide a liquid container that securely seals the contained liquid and avoids the danger of separating constituents from the sealing material. In comparison with glass ampoules, safe and injury-free withdrawal of liquid shall be enabled.


In order to achieve the given object, the container comprises a hollow body and an elastomer septum. Said hollow body comprises an inner wall from a single material that is compatible with the liquid. A predetermined breaking point that can be pierced with a hollow needle is provided on the hollow body. The predetermined breaking point is covered by an elastomer septum that is fixedly connected to the hollow body. In this configuration of the container, the point of the hollow needle is guided through the elastomer septum and is stabilized when piercing the predetermined breaking point. When piercing the elastomer septum, the material thereof is laterally displaced resulting in good sealing at the circumference of the hollow needle. The liquid can then be suctioned out of the container interior or can be withdrawn by generating overpressure.


The preferred material for the septum comprises silicone, isobutyl rubber and neoprene. Provided that the liquid is not in direct contact with the septum during storage, particularly inexpensive, commercially available materials can be used for the septum.


The thickness of the septum is selected in dependence on the desired degree of sealing to the hollow needle. If a very good sealing effect between the septum and the hollow needle is required, a septum thickness in the range of 3 mm is advantageous. However, if the demands on the sealing effect are lower, a thickness in the range of 1 mm can already be reasonable.


As a material for the inner wall of the hollow body, plastics or also glass can be considered.


For example, plastics from the class of polyamides, in particular PA 6.6 or PA 12, or from the class of cyclic olefin copolymers (COC), have proved to be particularly suitable for use as material for the inner wall.


Furthermore, preferably used plastics comprise the group polypropylene or polyethylene. The plastics polypropylene and polyethylene can advantageously be used for an aqueous, unproblematic liquid. Here, polypropylene is characterized, for example, by its low production costs as well as its low density and its good general material resistance with respect to various liquids.


As a glass, preferably such glass materials are used which are produced as hollow glass bodies and are suitable for pharmaceutics. Such glasses can be categorized according to their hydrolytic resistance according to ISO 719. According to this classification, glasses of the hydrolytic class 1 such as, for example, borosilicate glasses are particularly preferably used for the inner wall.


The predetermined breaking point is formed from a thickness-reduced spot of the wall of the hollow body. This thickness-reduced wall spot can be formed as a wall indentation.


The hollow body can be produced based on a jar and a cover which, after filling the container, are welded or fused together so that a gapless inner wall from a single material is formed. The use of additional filler materials and sealants can be completely dispensed with.


For withdrawing liquid, a standard needle can be used which, at its end opposite the needle point, has a customary connector to which an injection syringe for extracting the liquid can be attached. It is also possible to use a hollow needle that is supplied together with the liquid-filled container and together with the same represents a package. It is also conceivable to press the liquid out of the container by means of gas pressure.





Exemplary embodiments of the invention are described with reference to the drawings.


In the figures:



FIG. 1 shows a container filled with liquid and with a covered predetermined breaking point on the container cover,



FIG. 2 shows individual parts of another container and a withdrawal device in an exploded view,



FIG. 3 shows another configuration of a container with an attached liquid withdrawal device,



FIG. 4 shows the container during withdrawal of liquid,



FIG. 5 shows a container with another liquid withdrawal device, and



FIG. 6 shows a container with yet another liquid withdrawal device.






FIG. 1 shows a container that is filled with liquid and comprises a hollow body 10 and a septum 3 from an elastomeric plastic. The hollow body 10 is constructed from a jar 1 and a cover 2, wherein the inner wall consists of a single material. In the cover 2, a predetermined breaking point 4 is provided. In the case of FIG. 1, the jar 1 is bottle-shaped and is formed with a neck 11 and a bottle rim 12 so as to be able to easily carry out the welding with the cover 2. This is advantageous for the glass design since the welded joint is located remote from the hollow body 10. However, it is also possible to produce it from plastic. The predetermined breaking point 4 is incorporated in the form of a funnel-shaped dent or groove in the center of the cover 2, resulting in a thickness reduction in the wall. The predetermined breaking point 4 is covered by the septum 3 that may have a mark 30 as a piercing point for the withdrawal needle. As a method for attaching the septum, adhesive bonding or injection molding on the whole can be taken into account.



FIG. 2 illustrates another possible shape of the container. The jar 1 is cylindrical and has a bottom 13 in which there is the predetermined breaking point 4. The elastomer septum 3 is secured above the predetermined breaking point on the bottom 13. After filling the interior 10 of the container, the cover 2 is inserted with its insert 21 into the jar opening 14, and the bottle rim 22 is welded together with the jar rim 14a. The shape of the container is suitable for production from plastic, but also from glass.



FIG. 2 also schematically illustrates a liquid withdrawal device 4 which is composed of a hollow needle 51 and a tubular body 52 that has a transverse opening 53. The hollow needle 51 and the tubular body 52 enclose a withdrawal channel 50. In the transverse opening 53, a filter can be arranged that is permeable with respect to air or other gases, but is impermeable with respect to liquids. Depending on the hardness of the container material, the hollow needle 51 consists of hard plastics or metal.



FIG. 3 shows another possible shape of the container. The jar 1 has a flanged rim 12 onto which the cover 2 is attached and secured by welding. The predetermined breaking point 4 is formed as a semi-circular dent in the bottom 13 of the jar 1. FIG. 3 further shows another embodiment of the liquid withdrawal device 5. The latter has a guide cage 54 with a plurality of guide grooves 55 which interact with guide ribs 15 on the circumference of the jar 1. The guide grooves 55 and the guide ribs 15 extend in the axial direction of the cylindrical jar 1 and thus guide the hollow needle 51 when breaking through the predetermined breaking point 4 (FIG. 4).


Apart from that, FIG. 4 shows another shape of the container having a flat cover 2 that is welded to the cylindrical rim 14a of the jar 1.



FIG. 5 shows another embodiment of the container and the liquid withdrawal device 5. The jar 1 is ampoule-shaped and has a relatively narrow filler opening 16 which is closed by means of a cover 2 that has an insert 21 and a bottle rim 22. The predetermined breaking point 4 is incorporated in the bottom 13 and can be formed as a cylindrical recess, as illustrated. The liquid withdrawal device 5 has a screw-cap-shaped cage 54 that is provided on the inner side with an internal thread 57 that interacts with the screw thread 17 on the circumference of the jar 1. By turning the cage 54 with respect to the jar 1, the predetermined breaking point 4 can be pierced and the container can be opened and thus the liquid can be withdrawn.


Another embodiment is shown in FIG. 6. Here, the predetermined breaking point 4 lies in the region of the portion 61 to be welded.


Handling during withdrawal of the liquid takes place as follows:


If it is intended to withdraw the liquid with a set of injection instruments, the hollow needle is placed onto the marked point 30 of the septum 3, pierces therethrough and breaks through the predetermined breaking point 4 so as to reach the interior 10 of the container. Subsequently, as much liquid as needed is suctioned from the content of the container. Further liquid can be suctioned via the usual connector for standard needles.


It is also possible to work with special liquid withdrawal devices 5 as they have been described above.


The liquid withdrawal device 5 according to FIG. 2 is positioned at the marked point 30 so as to pierce the septum 3 and the predetermined breaking point 4. Thereby, a discharge channel 50 from the interior 10 of the container is opened, as a result of which liquid can flow into a jar that is not illustrated here. The filter in the transverse opening 53 allows air or gas bubbles to rise through the channel 50 into the interior 10 of the container.


It is also possible to feed gas pressure through the transverse opening 53 in order to push liquid out of the interior of the container. Gas supply can take place through a cannula into the interior 50 of the hollow needle 51 so as to provide for a clear separation of the flows within the hollow needle (not illustrated).


In the embodiments according to the FIGS. 3 to 5, the hollow needle 51 is pressed through the septum 3 by means of the guide device 54, and the predetermined breaking point 4 is broken open so as to get access into the interior of the container. Thereafter, the liquid is withdrawn via the channel 50 as described above.


In the case of hollow bodies 10 made from glass or other brittle materials, splinters can form when the point of the hollow needle breaks through the predetermined breaking point 4, which splinters can be caught by filter material. A filter fleece can be used in the channel 50, or the channel 50 is connected to a filter unit via which the liquid is delivered to the intended location.


In the above description, diverse measures and features of different embodiments of the container have been described. It is understood that these measures and features can also be used in combinations other than those described here so as to obtain further embodiments of the invention.

Claims
  • 1. A container for containing a liquid, comprising: a hollow body having a wall with a bottom along a portion of the wall; andan elastomer septum,wherein a thickness-reduced section of the bottom of the wall of the hollow body has a reduced thickness relative to the rest of the bottom that provides a predetermined breaking point in which the thickness-reduced section is pierceable by the point of a hollow needle, andwherein the elastomer septum lies directly above the predetermined breaking point and is fixedly connected to the hollow body at the wall thereof.
  • 2. The container for containing a liquid according to claim 1, wherein the thickness of the septum is in the range of 0.3 to 15 mm.
  • 3. The container for containing a liquid according to claim 1, wherein the hollow body consists of plastic.
  • 4. The container for containing a liquid according to claim 3, wherein said plastic comprises any of the materials from the group polyamide, in particular PA 6.6 or PA 12, cyclic olefin copolymers (COC), polypropylene and polyethylene.
  • 5. The container for containing a liquid according to claim 1, wherein the hollow body consists of glass.
  • 6. The container for containing a liquid according to claim 5, wherein the glass is selected from the glasses of the hydrolytic class 1 according to ISO 719 (DIN 12111) or from a class corresponding to this class with comparable properties.
  • 7. The container for containing a liquid according to claim 1, wherein the thickness-reduced section is formed as a funnel-shaped dent or groove.
  • 8. The container for containing a liquid according to claim 1, wherein the thickness-reduced section is formed as a thickness-reduced wall.
  • 9. A container according to claim 1, the container being filled with liquid, wherein said hollow body comprises a jar and a cover which are welded or fused together so as to form an inner wall from a single material.
  • 10. A package, comprising: a container filled with liquid according to claim 9; anda liquid withdrawal device having a hollow needle for piercing the thickness-reduced section.
  • 11. The package according to claim 10, further comprising a tube having a transverse opening therethrough, the hollow needle being inserted into the tube and having an interior, wherein the transverse opening communicates with the interior via a filter membrane in the transverse opening that is permeable to gases including air and impermeable to liquids.
  • 12. The container according to claim 1, wherein the hollow body further includes a jar having an opening, and wherein the wall is a cover covering the opening of the jar.
  • 13. A container for containing a liquid, comprising: a hollow body having a wall; andan elastomer septum,wherein the wall of the hollow body includes a wall indentation that provides a predetermined breaking point in which the wall indentation is pierceable by the point of a hollow needle,wherein the elastomer septum lies directly above the predetermined breaking point and is fixedly connected to the hollow body at the wall thereof, andwherein the elastomer septum comprises any of the materials from the group of silicone, isobutyl rubber and neoprene.
  • 14. The container for containing a liquid according to claim 13, wherein the thickness of the septum is in the range of 0.3 to 15 mm.
  • 15. The container for containing a liquid according to claim 13, wherein the hollow body consists of plastic.
  • 16. The container for containing a liquid according to claim 13, wherein the hollow body consists of glass.
  • 17. The container for containing a liquid according to claim 13, wherein the wall indentation is formed as a funnel-shaped dent or groove.
  • 18. A container according to claim 13, the container being filled with liquid, wherein said hollow body comprises a jar and a cover which are welded or fused together so as to form an inner wall from a single material.
  • 19. The container according to claim 13, wherein the hollow body further includes a jar having an opening, and wherein the wall is a cover covering the opening of the jar.
  • 20. A container for containing a liquid, comprising: a hollow body having a wall; andan elastomer septum,wherein the wall of the hollow body includes a wall indentation that provides a predetermined breaking point in which the wall indentation is pierceable by the point of a hollow needle, andwherein the elastomer septum lies directly above the predetermined breaking point and is fixedly connected to the hollow body at the wall thereof.
  • 21. The container for containing a liquid according to claim 20, wherein the thickness of the septum is in the range of 0.3 to 15 mm and the wall indentation is formed as a funnel-shaped dent or groove.
Priority Claims (1)
Number Date Country Kind
10 2011 112 516 Sep 2011 DE national
PCT Information
Filing Document Filing Date Country Kind 371c Date
PCT/EP2012/003762 9/7/2012 WO 00 3/7/2014
Publishing Document Publishing Date Country Kind
WO2013/034302 3/14/2013 WO A
US Referenced Citations (153)
Number Name Date Kind
1680616 Horst Aug 1928 A
1744893 Hein Jan 1930 A
2425093 Fosler Aug 1947 A
2638022 Reyes May 1953 A
3036819 Edwin May 1962 A
3228565 Stanzel Jan 1966 A
3506006 Lange, Jr. Apr 1970 A
3654926 Rietman Apr 1972 A
3739947 Baumann et al. Jun 1973 A
3742988 Kush Jul 1973 A
3869315 Dolgner Mar 1975 A
3872867 Killinger Mar 1975 A
3892237 Steiner Jul 1975 A
3945382 Ogle Mar 1976 A
3983994 Wyslotsky Oct 1976 A
3986838 Reichert Oct 1976 A
3995630 van de Veerdonk et al. Dec 1976 A
4043335 Ishikawa Aug 1977 A
4178928 Tischlinger Dec 1979 A
4180070 Genese Dec 1979 A
4185582 Bryant Jan 1980 A
4218525 Selgin Aug 1980 A
4227528 Wardlaw Oct 1980 A
4241850 Speer et al. Dec 1980 A
4246229 McBride et al. Jan 1981 A
4272479 Huneke et al. Jun 1981 A
4298777 Bryant Nov 1981 A
4306554 Schwartz et al. Dec 1981 A
4312344 Nilson Jan 1982 A
4328754 Goodman May 1982 A
4340007 Hogan Jul 1982 A
4375504 Jensen et al. Mar 1983 A
4423724 Young Jan 1984 A
4453934 Gahwiler et al. Jun 1984 A
4463875 Tepic Aug 1984 A
4465183 Saito et al. Aug 1984 A
4467588 Carveth Aug 1984 A
4483049 Gustavsson et al. Nov 1984 A
4505433 Selenke Mar 1985 A
4515586 Mendenhall et al. May 1985 A
4526758 Alengoz et al. Jul 1985 A
4528268 Andersen et al. Jul 1985 A
4533641 Holt Aug 1985 A
4676406 Frischmann et al. Jun 1987 A
4676655 Handler Jun 1987 A
4693706 Ennis, III Sep 1987 A
4743229 Chu May 1988 A
4757916 Goncalves Jul 1988 A
4799801 Bruning Jan 1989 A
4801009 Amos Jan 1989 A
4808184 Tepic Feb 1989 A
4865189 Guerra et al. Sep 1989 A
4936446 Lataix Jun 1990 A
4968302 Schluter et al. Nov 1990 A
4973168 Chan Nov 1990 A
5051482 Tepic Sep 1991 A
5058770 Herold et al. Oct 1991 A
5100241 Chan Mar 1992 A
5145250 Planck et al. Sep 1992 A
5181909 McFarlane Jan 1993 A
5193907 Faccioli et al. Mar 1993 A
5252301 Nilson et al. Oct 1993 A
5306277 Bryant et al. Apr 1994 A
5328262 Lidgren et al. Jul 1994 A
5330426 Kriesel et al. Jul 1994 A
5350372 Ikeda et al. Sep 1994 A
5393497 Haber et al. Feb 1995 A
5435645 Faccioli et al. Jul 1995 A
5443182 Tanaka et al. Aug 1995 A
5501520 Lidgren et al. Mar 1996 A
5531683 Kriesel et al. Jul 1996 A
5545460 Tanaka et al. Aug 1996 A
5549380 Lidgren et al. Aug 1996 A
5564600 Renault Oct 1996 A
5588745 Tanaka et al. Dec 1996 A
5624184 Chan Apr 1997 A
5628353 Ruther May 1997 A
5634714 Guild Jun 1997 A
5639029 Sundholm Jun 1997 A
5709668 Wacks Jan 1998 A
5779356 Chan Jul 1998 A
5797678 Murray Aug 1998 A
5826713 Sunago et al. Oct 1998 A
5827262 Neftel et al. Oct 1998 A
5876116 Barker et al. Mar 1999 A
5879081 Chordia Mar 1999 A
5934803 Hutter Aug 1999 A
5948366 Ruther Sep 1999 A
5975751 Earle Nov 1999 A
6024480 Seaton et al. Feb 2000 A
6027472 Kriesel et al. Feb 2000 A
6033105 Barker et al. Mar 2000 A
6042262 Hajianpour Mar 2000 A
6099532 Florea Aug 2000 A
6116773 Murray Sep 2000 A
6120174 Hoag et al. Sep 2000 A
6120490 Neftel Sep 2000 A
6145703 Opperman Nov 2000 A
6174304 Weston Jan 2001 B1
6176607 Hajianpour Jan 2001 B1
6210031 Murray Apr 2001 B1
6286670 Smith Sep 2001 B1
6312149 Sjovall et al. Nov 2001 B1
6379033 Murray Apr 2002 B1
6387074 Horppu et al. May 2002 B1
6406175 Marino Jun 2002 B1
6425897 Overes et al. Jul 2002 B2
6572256 Seaton et al. Jun 2003 B2
6598815 Hsieh Jul 2003 B2
6626328 Ritsche et al. Sep 2003 B2
6645171 Robinson et al. Nov 2003 B1
6648499 Jonsson Nov 2003 B2
6655828 Vendrely et al. Dec 2003 B2
6682518 Rothstein Jan 2004 B1
6706031 Manera Mar 2004 B2
6709149 Tepic Mar 2004 B1
6736537 Coffeen et al. May 2004 B2
6743203 Pickhard Jun 2004 B1
6755563 Wahlig et al. Jun 2004 B2
6796701 Wahlig et al. Sep 2004 B2
6832703 Scott et al. Dec 2004 B1
6871996 Jonsson Mar 2005 B2
6902543 Cherif-Cheikh et al. Jun 2005 B1
6940782 Matsui Sep 2005 B2
6948522 Newbrough Sep 2005 B2
6984063 Barker et al. Jan 2006 B2
7018089 Wenz et al. Mar 2006 B2
7029163 Barker et al. Apr 2006 B2
7073936 Jonsson Jul 2006 B1
7171964 Moore et al. Feb 2007 B2
7311436 Barker et al. Dec 2007 B2
7462164 Moir Dec 2008 B2
7563018 Wilander Jul 2009 B2
7563245 Mu Jul 2009 B2
7621887 Griffiths et al. Nov 2009 B2
7661561 Ophardt et al. Feb 2010 B2
7793655 Hochrainer Sep 2010 B2
7823751 Ophardt et al. Nov 2010 B2
7938572 Lidgren et al. May 2011 B2
7959349 Sattig et al. Jun 2011 B2
7980754 Wilander et al. Jul 2011 B2
8128275 Axelsson et al. Mar 2012 B2
8128276 Axelsson et al. Mar 2012 B2
8132959 Smit Mar 2012 B2
8256949 Melsheimer et al. Sep 2012 B2
20020123739 Haacke Sep 2002 A1
20030155381 Chan Aug 2003 A1
20050113762 Kay et al. May 2005 A1
20050228396 Jonsson Oct 2005 A1
20060101925 Peng et al. May 2006 A1
20090180349 Barker et al. Jul 2009 A1
20090264891 Bogert et al. Oct 2009 A1
20100046315 Merkhan et al. Feb 2010 A1
Foreign Referenced Citations (32)
Number Date Country
60012383 Sep 2005 DE
69634704 Mar 2006 DE
60126156 Oct 2007 DE
102007041666 Apr 2009 DE
0380867 Aug 1990 EP
0493363 Jul 1992 EP
0674888 Oct 1995 EP
0694498 Jan 1996 EP
0725674 Aug 1996 EP
0919215 Jun 1999 EP
1005900 Jun 2000 EP
1020167 Jul 2000 EP
1031333 Aug 2000 EP
1395208 Jan 2007 EP
1741413 Jan 2007 EP
1886648 Feb 2008 EP
1920738 May 2008 EP
1413976 Oct 1965 FR
9013264 Nov 1990 WO
9300366 Jan 1993 WO
9302322 Feb 1993 WO
9322041 Nov 1993 WO
9400415 Jan 1994 WO
9426403 Nov 1994 WO
9509641 Apr 1995 WO
9607472 Mar 1996 WO
9718031 May 1997 WO
9967015 Dec 1999 WO
0035506 Jun 2000 WO
0043116 Jul 2000 WO
03031042 Apr 2003 WO
2010105807 Sep 2010 WO
Non-Patent Literature Citations (3)
Entry
International Search Report dated Apr. 8, 2012 in PCT/EP2012/003762.
International Search Report issued in PCT/EP2010/001665 and dated Jul. 20, 2010.
Written Opinion dated Apr. 8, 2012 in PCT/EP2012/003762.
Related Publications (1)
Number Date Country
20140202980 A1 Jul 2014 US