Needleless IV medical delivery system

• US 6,146,362 A
• Filed: 08/19/1998
• Issued: 11/14/2000
• Est. Priority Date: 08/27/1993
• Status: Expired due to Term

• Current Assignee: Medpro Safety Products, Inc.
• Original Assignee: Baton Development, Inc.
• Inventors: Turnbull, Christopher J., Globensky, Richard L.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/136,478
• Time in Patent Office: 818 Days
• Field of Search: 604/256, 604/415, 604/244, 604/246, 604/905, 604/167, 604/533, 604/537, 604/411, 604/414, 604/403, 604/167.01-167.04, 251/149
• US Class Current: 604/256
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

An injection site and unsharpened drug transfer spike for facilitating coupling a syringe to a fluid line. The injection site has a uniquely designed housing and septum comprised of only two parts. The drug transfer spike has a positive locking member for restricting retraction from the injection site once it is inserted for injecting a medicant. The positive locking member preferably comprises a annular ridge defined about the shaft of the drug transfer spike. The septum includes a pair of axially aligned, oppositely oriented conical recesses with adjacent apices either separated by a thin membrane or intersecting at the time of manufacture. The housing has an inlet for receiving the septum and comprises a plurality of fingers with inwardly extending tabs for constraining the septum therewithin. The septum is ideally adapted to be applied to injection sites, Y-connectors, vial adaptors, single or multi-dose vials and blood collection tubes. When the drug transfer spike is made to penetrate the septum, the walls of the septum or the inwardly extending tabs tightly engage the shaft of the spike to preclude inadvertent withdrawal.

Claims

1. An injection site comprising a housing with an inlet socket defined by a plurality of resilient fingers separated from one another by narrow slots, each finger including an inwardly extending tab at a proximal end thereof, and a septum received in said housing inlet socket and retained by said tabs, said septum comprising a cylindrical resilient elastomeric member having an axially aligned upper and lower conically-shaped recesses initially separated from one another prior to use by a imperforate membrane.

2. The injection site as specified in claim 1 wherein said upper conically-shaped recess has a volume less than a volume of said lower conically-shaped recess.

3. The injection site as specified in claim 1 wherein said housing is comprised of an elongated tubular member having a pair of opposed ends, with said inlet socket located at one of said ends, and having a Luer lock disposed at the other of said ends, said Luer lock being in fluid communication with said inlet socket.

4. The injection site as specified in claim 1 wherein said housing comprises a vial adaptor having said inlet socket defined at one end and having a cylindrical wall defining a cylindrical recess at the other end, said housing having a tubular drug transfer spike axially disposed in said cylindrical recess and in fluid communication with said inlet socket.

5. The injection site as specified in claim 4 wherein said tubular drug transfer spike extends only partially into said cylindrical recess from said housing.

6. The injection site as specified in claim 4 wherein said housing cylindrical wall has a notch adapted to receive a branch of a standard Y-connector therein.

7. The injection site as specified in claim 1 wherein said housing comprises a Y-connector having a main tubular branch, a first tubular branch aligned with said main branch and a second tubular branch intersecting said main tubular branch at an angle each said first and second branches being in fluid communication with said main branch, said housing inlet socket disposed at a proximal end of said first tubular branch.

8. The injection site as specified in claim 1 wherein said septum occupies less than the entire housing inlet socket when inserted therein.

9. The injection site as specified in claim 1 wherein said septum has a diameter greater than the diameter of said housing inlet socket before insertion therein.

10. The injection site as specified in claim 1 wherein said resilient elastomeric member is a thermoplastic rubber exhibiting a durometer in the range of from 10 to 70 shore A.

11. A medical drug administering apparatus comprising, in combination, a medicament vial having a neck defining an open top adapted to be covered by an elastomeric member having first and second major surfaces with generally conically shaped upper and lower recesses formed, respectively, in said first and second major surfaces, the upper and lower conical recesses each having an apex, the apices of said upper and lower conically shaped recesses being adjacent but separated from one another to define a readily pierceable membrane therebetween;

and means for securing said elastomeric member to said neck without covering said upper recess, said membrane being readily pierceable by a blunt drug transfer spike.

12. An injection site for a blood collection tube having one closed end and one open end comprising:

a septum adapted to be received in said open end, said septum comprising a cylindrical, resilient, elastomeric member having axially aligned upper and lower conically-shaped recesses with the upper and lower conical recesses each having an apex, the apices of each separated from one another by a readily pierceable membrane.