Plastic closure for vials and other medical containers

• US 6,382,442 B1
• Filed: 10/08/1998
• Issued: 05/07/2002
• Est. Priority Date: 04/20/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Niermann, Volker, Thibault, Jean-Claude, Jansen, Hubert
• Primary Examiner(s): Garbe, Stephen P.
• Assistant Examiner(s): Eloshway, Niki M.
• Application Number:
  US09/168,502
• Time in Patent Office: 1,307 Days
• Field of Search: 215/247, 215/249, 215/251, 215/274, 215/317, 215/321, 215/320, 215/324, 215/325, 215/327, 215/DIG.3, 215/248, 215/253, 215/297, 215/250, 215/252, 215/295, 215/296, 222/81, 222/83, 222/83.5, 141/2, 141/25, 141/26, 141/27, 141/28, 141/329, 141/330, 141/18, 141/21, 604/403, 604/406, 604/411-416, 220/265-268, 220/278
• US Class Current: 215/249
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: Y10S 215/03 Medical

Abstract

The plastic closure of this invention is particularly, but not exclusively adapted for sealing medicament vials and other medical containers or as a collar for retaining a fluid transferset on a medical container. The plastic closure of this invention includes a generally tubular portion which surrounds the rim of the container and a free end portion which is permanently radially deformed or crimped into the neck of the container. The plastic closure of this invention is formed of a polymer, preferably a polymeric alloy or melt blend, which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain the seal between the plastic closure and the container following deformation. A preferred polymer for the plastic closure of this invention is an alloy or melt blend comprising a relatively rigid polymer such as polycarbonate and a soft malleable co-polymer such as a polyester. Where the plastic closure of this invention is used to seal a vial, for example, the closure includes a radial portion overlying the rim portion of the stopper having a central opening and a cup-shaped cap is received over the collar having retainer portions received within the central opening of the cap which may be removed by finger pressure. When the collar of this invention is used to secure a fluid transferset on a vial, the collar includes a proximate tubular portion integral with the radial portion which surrounds at least a portion of the transferset. In one embodiment, the second tubular portion surrounds the entire transferset and the open end is sealed with a peel-off seal and in another embodiment a separate cap surrounds the distal end of the transferset.

Claims

1. A sealed medical container and transferset assembly, said medical container having an open end, a rim portion surrounding said open end, a neck portion adjacent said rim portion having a diameter smaller than said rim portion, and a pierceable closure located in said open end of said medical container;

said transferset comprising;

an integral generally tubular polymeric collar member having a first tubular portion surrounding said rim portion of said medical container including a free end permanently deformed radially inwardly into said neck portion and permanently securing said collar member to said medical container, a radial portion overlying said rim portion of said medical container and supported by said medical container rim portion and a second tubular portion generally coaxially aligned with said first tubular portion extending from said rim portion of said medical container and coaxially aligned with said open end of said medical container having an open end, said integral tubular polymeric collar member formed of a polymer which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain a seal between said collar and said medical container;

a closure overlying said open end of said second tubular portion of said collar member and secured thereto in sealed relation; and

a piercing member telescopically supported within said second tubular portion and moveable relative to said second tubular portion to pierce said pierceable closure in said open end of said medical container to provide fluid communication between said medical container and said transferset.

2. The sealed medical container and transferset assembly defined in claim 1, wherein said transferset further includes a tubular transfer member located within said second tubular portion of said collar member coaxially aligned with said open end of said sealable closure of said medical container sealingly engaging said sealable closure and telescopically receiving said piercing member.

3. The sealed medical container and transferset defined in claim 2, wherein said tubular transfer member is integral with said second tubular portion of said collar member.

4. The sealed medical container and transferset assembly defined in claim 2, wherein said tubular transfer member includes a free distal open end having a Luer Lock connector for receipt of a Luer Lock connector of a second container.

5. The sealed medical container and transferset assembly defined in claim 1, wherein said polymeric collar member is formed of a polyamid polymer or a composite polymer including a relatively soft malleable co-polymer and a relatively rigid polymer.

6. The sealed medical container and transferset assembly defined in claim 1, wherein said free end of said first tubular portion includes an annular resilient ring retained on an internal surface of said collar member adjacent said free end biased against said medical container rim portion and preventing rotation of said collar member on said medical container.

7. A sealed vial and transferset assembly comprising a vial having an open end, a radial rich portion surrounding said open end and a reduced diameter neck portion adjacent said rim portion and a pierce closure located with said vial open end sealing said vial, and a transferset mounted on said vial open end of said vial for transferring fluid between said vial and a container, said transferset including a tubular transfer member having a first open end engaging said pierceable closure in sealed relation and a second open end, a piercing member reciprocally supported within said tubular transfer member and moveable relative to said tubular transfer member to pierce said pierceable closure and establish fluid communication between said vial and said tubular transfer member, and a plastic collar having first a tubular portion surrounding said rim portion of said vial having a free end permanently deformed radially inwardly into said vial neck portion permanently retaining said collar on said vial aid a second integral tubular portion surrounding said tubular transfer member having an open end and a closure closing said open end of said second tubular portion of said collar, said plastic collar formed of a polymer which is sufficiently malleable to permit radial deformation, yet sufficiently rigid to retain its shape following deformation and sufficiently resistant to creep to maintain the seal between said collar and said vial following deformation.

8. The sealed vial and transferset assembly defined in claim 7, wherein said plastic collar is formed of a polyamid polymer or a composite polymer including a relatively soft malleable co-polymer and a relatively rigid polymer.

9. The sealed vial and transferset assembly defined in claim 8, wherein said plastic collar is formed of a polymer alloy comprising a relatively soft malleable co-polymer and polycarbonate as said relatively rigid polymer.

10. The sealed vial and transferset assembly defined in claim 7, wherein said tubular portion of said plastic collar includes an annular resilient ring retained on an internal surface of said collar adjacent said free end biased against said vial radial rim portion and preventing rotation of said collar on said vial.

11. The sealed vial and transferset assembly defined in claim 10, wherein said internal surface of said tubular portion includes an annular groove adjacent said free end and said resilient ring is received and retained in said annular groove.

12. The sealed vial and transferset assembly defined in claim 7, wherein said tubular portion of said plastic collar includes an elastomeric coating on an internal surface thereof integrally bonded to said internal surface.

13. The sealed vial and transferset assembly as defined in claim 7, wherein said tubular transfer member is integral with said plastic collar.

14. The sealed vial and transferset assembly as defined in claim 13, wherein said tubular transfer member is integrally joined to said second tubular portion of said collar in coaxial spaced relation by an integral radial web portion.

15. The sealed vial and transferset assembly as defined in claim 13, wherein said plastic collar includes an integral radial portion between said first and second integral tubular portions overlying said pierceable closure of said vial and engaging said pierceable closure in sealed relation.

16. The sealed vial and transferset assembly as defined in claim 7, wherein said plastic collar includes an integral radial portion between said first and second integral tubular portions and said tubular transfer member includes an integral radially outwardly extending portion adjacent said first open end extending between said plastic collar radial portion and said vial open end sealingly engaging said pierceable closure.

17. A sealed medical container and transferset assembly, said medical container having an open end, a rim portion surrounding said open end, a neck portion adjacent said rim portion having a diameter smaller than said rim portion, and a pierceable closure received in said open end of said medical container sealing said container, said transferset comprising:

an integral generally tubular polymeric collar member having a first tubular portion surrounding said rim portion of said medical container including a free end portion permanently deformed radially into said neck portion permanently securing said collar member to said medical container and a second tubular portion generally coaxially aligned with said first tubular portion extending from said rim portion of said medical container having an open end coaxially aligned with said open end of said medical container;

a tubular transfer member located within said second tubular portion of said collar member coaxially aligned with said open end of said container having a first open end sealing engaging said pierceable closure and a second open end having a connector portion for attachment to a second medical container; and

a piercing member telescopically supported within said tubular transfer member and moveable relative to said tubular transfer member pierce said pierceable closure and providing fluid communication between said medical container through said tubular transfer member to said second medical container.

18. The sealed medical container and transferset defined in claim 17, wherein said fluid transfer member is integral with said second tubular portion of said collar member.

19. The sealed medical container and transferset assembly as defined in claim 17, wherein said second tubular portion of said tubular polymeric collar surrounds said tubular transfer member in generally coaxial spaced alignment and said collar member includes an integral radial portion between said first and second tubular portions supported by said rim portion of said medical container.

20. The sealed medical container and transferset assembly as defined in claim 19, wherein said tubular transfer member is integral with said plastic collar second tubular portion and said radial portion sealingly engages said pierceable closure.

21. The sealed medical container and transferset assembly as defined in claim 19, wherein said tubular transfer member includes an integral radially outwardly extending portion adjacent said first open end extending between said plastic collar radial portion and said vial open end sealingly engaging said pierceable closure.