Closure device for flexible pouches
View Patent ↗The present invention relates to a sterile closure device that is particularly suited for flexible containers, or pouches, that contain medical fluids. The sterile closure device provides a port for a conventional spike set to puncture in order to attach a patient feeding line. The sterile closure device features at least two protection mechanisms that enhance sterility. Between the two protection mechanisms is a sterile chamber that minimizes leakage of medical fluid from the flexible container when the protection mechanisms are breached by a the spike set. The sterile closure device also features finger support to facilitate the user in grasping and puncturing the sterile closure device.
1. A closure device for a flexible container containing a medical fluid comprising:
a boat-shaped base section having a top wall, a bottom wall, said base section adapted to fit said flexible container;
a mid-section connected to said top wall,
a support connected to said mid-section and adapted for a user to grip said closure device wherein said mid-section includes at least one spacer disposed between said top wall of said base section and said support;
a cylindrical member extending through said base section, said mid-section and said support, said cylindrical member having a first opening in said base section and a second opening in said support, said cylindrical member adapted to allow said medical fluid to flow therethough and exit said flexible container;
a first seal blocking said cylindrical member and capable of being breached; and
a second seal covering said second opening and capable of being defeated;
wherein a portion of said cylindrical member between said first seal and said second seal defines a chamber.
2. The closure device of claim 1 , wherein said first seal covers said first opening.
3. The closure device of claim 2 , wherein said first seal comprises a weakened section.
4. The closure device of claim 1 , wherein said second seal is a peelable foil.
5. The closure device of claim 1 , wherein said cylindrical member has a diameter from about 0.5 mm to about 12 mm.
6. The closure device of claim 5 , wherein said cylindrical member is adapted to receive a spike set.
7. The closure device of claim 1 , wherein said support has at least one wing.
8. The closure device of claim 1 , wherein said chamber is sterile after said closure device has experienced a sterilization process.
9. The closure device of claim 1 , wherein said at least one spacer comprises first and second wall members orthogonally disposed between said top wall of said base section and said support.
10. A container for a medical fluid comprising:
a pouch having a port and at least a single edge such that said edge defines a reservoir within said pouch that is adapted to contain a medical fluid; and a closure device adapted to fit said port and comprises
a base section having a top wall and a bottom wall, said base section sealingly attached to said edge of said pouch at said port;
a mid-section connected to said top wall;
a support connected to said mid-section and adapted for a user to grip said closure device, wherein said support further comprises a raised surface;
a cylindrical member extending through said base section, said mid-section and said support, said cylindrical member having a first opening in said base section and a second opening in said support, said cylindrical member adapted to allow said medical fluid to flow therethough and exit said port;
a first seal blocking said cylindrical member and capable of being breached; and
a second seal covering said second opening and capable of being defeated, wherein said second seal is a peelable foil;
wherein a portion of said cylindrical member between said first seal and said second seal defines a chamber.
11. The container of claim 10 , wherein said first seal covers said first opening of said cylindrical member.
12. The container of claim 11 , wherein said first seal is a weakened area.
13. The container of claim 10 , wherein said closure device is made of a polymer material.
14. The container of claim 10 , wherein said chamber is sterile after said closure device is sterilized.
15. The container of claim 10 , wherein said cylindrical member has a diameter from about 0.5 mm to about 12 mm.
16. The container of claim 10 , wherein said support has at least one wing.
17. A closure device for a flexible container containing a medical fluid comprising:
a boat-shaped base section having a top wall and a bottom wall, said base section adapted to fit said flexible container and having a first width;
a mid-section connected to said top wall, said mid-section having a second width that is smaller than said first width,
a support connected to said mid-section, said support comprising at least one wing angulated with respect to said top wall and adapted for a user to grip said closure device wherein said mid-section includes at least one spacer disposed between said top wall of said base sectyion and said support;
a cylindrical member extending through said base section, said mid-section and said support, said cylindrical member having a first opening in said base section and a second opening in said support, said cylindrical member adapted to allow said medical fluid to flow therethough and exit said flexible container;
a first seal blocking said cylindrical member and capable of being breached; and
a second seal covering said second opening and capable of being defeated;
wherein a portion of said cylindrical member between said first seal and said second seal defines a chamber.