Needle cap device for a pre-fillable one-time injection apparatus

• US 5,980,495 A
• Filed: 04/22/1998
• Issued: 11/09/1999
• Est. Priority Date: 04/23/1997
• Status: Expired due to Term

• Current Assignee: Schott AG (Carl-Zeiss-Stiftung)
• Original Assignee: CLAAS KGaA mbH
• Inventors: Spallek, Michael, Heinz, Jochen
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Hayes, Michael J.
• Application Number:
  US09/064,496
• Time in Patent Office: 566 Days
• Field of Search: 604/192, 604/198, 604/199, 604/263, 128/917, 128/919
• US Class Current: 604/263
• CPC Class Codes: A61M 2005/3109 Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: Y10S 128/919 Syringe, means to protect user

Abstract

The pre-filled single-use hypodermic devices must be provided with a needle cap device (1) during storage for protection of the injector needle (4) and the contents of the hypodermic device which is removed prior to use. The two-part needle cap device (1) includes a plastic outer casing (5) of hard elastic transparent material which is provided inside with a lining member (6) sealing the tip of the injector needle and made from a soft elastic material. The injector head (2) and the plastic outer casing (5) have a coupling device for making a mechanical stable form-fitting connection and/or a positive-locking connection with a reliable microbiological seal when the injector head (2) is inserted in the outer casing (5). This coupling device is formed by elements on or features of the injector head (2) and outer casing (5). The needle cap according to the invention permits a drop-free removal since the injector head and the form of the needle cap cooperate with and conform to each other so that the tip of the needle injector is released from the lining member (6) only when a pressure inside the outer casing corresponds to the external air pressure.

Claims

1. A needle cap device for a pre-fillable single-use hypodermic syringe device, said single-use hypodermic syringe device comprising an injector head (2) and an injector needle (4) extending from the injector head and having a tip, wherein said needle cap device includes

a stiff plastic outer casing (5) made of a hard elastic material that is sufficiently transparent so that the injector needle is visible when the outer casing (5) is connected to the injector head (2);

a sealing lining member (6) made of a soft material and arranged inside the stiff plastic outer casing (5), said sealing lining member having a predetermined shape to fit in the stiff plastic outer casing so that the tip of the injector needle (4) is inserted in the sealing lining member (6) when the outer casing (5) is connected to the injector head (2); and

means (7,8;

11,12;

13,14) for connecting the stiff plastic outer casing (5) with the injector head (2) so that said outer casing (5) directly contacts said injector head (2) to provide a microbiological seal of an interior of the outer casing from an exterior thereto and to provide a stable mechanical connection of the injector head to the outer casing that limits displacement of the outer casing on the injector head when the injector head is inserted in the outer casing;

wherein the means for connecting, the lining member, the outer casing and the injector head are positioned and dimensioned so that an opening in the tip of the injector needle is not released from the sealing lining member (6) of the outer casing (5) until a pressure in the interior of the outer casing corresponds to an external air pressure during removal of the outer casing from the injector head (2), whereby a drop-free removal of the sealing lining member from the injector needle occurs.

2. The needle cap device as defined in claim 1, wherein said means for connecting is a snap coupling.

3. The needle cap device as defined in claim 2, wherein the means for connecting includes a groove-like circumferential depression (11) provided around said injector head (2) and a complementary bulged portion (12) provided on an interior wall of the outer casing (5).

4. The needle cap device as defined in claim 2, wherein the means for connecting comprises a circular bulged portion or a circular thickened portion (7,13) on the injector head (2) and a complementary recess (8,14) fitting said bulged or thickened portion.

5. The needle cap device as defined in claim 1, wherein the injector head (2) tapers conically to a tip of the injector head to facilitate aeration of the interior of the outer casing (5).

6. The needle cap device as defined in claim 1, wherein the injector head (2) has a longitudinal groove (15) for aeration of the interior of said outer casing (5).

7. The needle cap device as defined in claim 6, wherein the longitudinal groove (15) is V-shaped and widens in the direction of a tip of the injector head (2).

8. The needle cap device as defined in claim 1, wherein the means for connection has an axial position and the lining member (6) has an axial extent adjusted to each other such that, before the tip of the injector needle is released from the lining member (6) during removal of the needle cap, the interior of the outer casing (5) is aerated.

9. The needle cap device as defined in claim 1, wherein the stiff plastic outer casing (5) is closed on all sides.

10. The needle cap device as defined in claim 1, wherein the stiff plastic outer casing (5) has a casing tip and is provided with an opening at the casing tip and the comparatively soft lining member (6) is inserted in the opening in the casing tip to provide a microbiological seal of the opening in the casing tip.

11. The needle cap device as defined in claim 1, wherein the stiff plastic outer casing (5) has a constraining guide (10) for the injector needle (4) in the interior thereof.

12. A pre-fillable single-use hypodermic syringe device comprising

a hollow injector body (3) provided with an injector head (2);

an injector needle (4) connected to the injector head (2) and having an opening in the vicinity of a tip of the injector needle; and

a needle cap device (1) comprising a stiff plastic outer casing (5) made of a hard elastic material and a sealing lining member (6) made from a soft material and fitting inside the stiff plastic outer casing (5) so that, when the outer casing (5) is mounted on the injector head (2), the injector needle (4) is closed by the sealing lining member (6); and

means for connecting the injector head with the stiff plastic outer casing (5) of the needle cap device so that said outer casing (5) directly contacts said injector head (2) to provide a mechanically stable connection of the injector head with the outer casing limiting displacement of the outer casing (5) on the injector head (2) and to provide a microbiological seal of an interior of the outer casing (5) from an exterior thereto, said means for connecting including elements (7,8;

11,12;

13,14) provided on the injector head (2) and the stiff plastic outer casing (5);

wherein the stiff plastic outer casing (5) of the needle cap device is made of a transparent or semitransparent translucent plastic material so that the injector needle is visible even when the outer casing (5) is connected to the injector head (2), said means for connecting has only one stop position and the means for connecting, the injector head (2), the lining member (6) and the outer casing (5) are dimensioned and positioned so that the opening of the tip of the injector needle is not released from the lining member of the outer casing on removal of the outer casing (5) until a pressure in an interior of the outer casing corresponds to an external air pressure, whereby a drop-free removal of the sealing lining member from the injector needle occurs.