Disconnect for medical access devices

• US 5,820,614 A
• Filed: 05/01/1997
• Issued: 10/13/1998
• Est. Priority Date: 03/15/1996
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Erskine, Timothy J., Howell, Glade
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/848,944
• Time in Patent Office: 530 Days
• Field of Search: 604/283, 604/280, 604/905, 604/240-243, 604/247, 604/256
• US Class Current: 604/533
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321
• CPC Class Codes: F16L 37/30 with fluid cut-off means in each of two pipe-end fittings
• CPC Class Codes: F16L 37/38 with fluid cut-off means in only one of the two pipe-end fittings
• CPC Class Codes: F16L 55/1007 Couplings closed automatically when broken
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A disconnect device for placement in a medical tubing set of the present invention includes a first portion with a first passageway therethrough that has a first valve therein. While the first valve is biased in a normally closed position to close the first passageway, it is operative to an open position. The disconnect device of the invention has a second portion with a second passageway therethrough that has a second valve therein. The second valve is also biased in a normally closed position to close the second passageway and it also is operative to an open position. The second portion is releasably attached to the first portion, connecting the first and second passageways in fluid communication, to overcome the bias of the first valve and the second valve, to open the valves and to allow a fluid flow through the device. When a preselected force, that is, for example, less than a force necessary to physically disrupt a medical access device attached to the tubing set, is applied to the second portion, it is detached from the first portion. With this detachment, the first valve and the second valve are operative to their normally closed positions substantially to stop fluid flow from the fluid reservoir and the medical access device.

Claims

1. A disconnect device for placement in a medical tubing set comprising:

a first portion having a first passageway therethrough having a first valve therein biased in a normally closed position to close said first passageway, said first valve being operative to an open position;

a second portion having a second passageway therethrough having a second valve therein biased in a normally closed position to close said second passageway, said second valve being operative to an open position;

attachment means for releasable attachment of said second portion onto said first portion thereby to connect said first and second passageways in fluid communication, to overcome said bias of said first valve and said second valve, to open said valves and to allow a fluid flow through said device; and

said second portion being detachable from said first portion at said attachment means by a preselected force, said first valve and said second valve thereby operative to said normally closed position upon detachment.

2. The disconnect device of claim 1 wherein said attachment means is frangible so that said first portion and said second portion are not re-attachable once detached.

3. The disconnect device of claim 2 wherein each of said first valve and said second valve each comprise a resilient duckbill and said disconnect device further comprises a hollow tube positioned to hold each said duckbill in said open position and allow fluid flow, each said valve being operative to said normally closed position by detachment of said first portion from said second portion at said frangible attachment means and withdrawal of said hollow tube from said each duckbill.

4. The disconnect device of claim 3 wherein said hollow tube has an outside surface having a coil spring attached thereto and positioned to facilitate withdrawal of said tube from each duckbill when said first portion is detached from said second portion.

5. The disconnect device of claim 2 wherein said attachment means is formed as a unitary structure from polyethylene with said frangibility provided by at least one frangible member, said force for detachment and said frangibility being predetermined by the thickness of said member.

6. The disconnect device of claim 5 wherein said frangible member is formed in a plurality of thicknesses, said attachment means each further including a marking scheme to distinguish attachment means having one detachment force from attachment means having another detachment force.

7. The disconnect device of claim 6 wherein said marking scheme includes a color code.

8. The disconnect device of claim 6 wherein said marking scheme includes numbering.

9. The disconnect device of claim 1 wherein said first valve comprises a pierceable resilient septum;

said disconnect device further comprising an adapter having a passageway therethrough sized to fit over and expose said septum to receive releasably said second portion; and

said second valve including a piercing member having a bore therethrough and a resilient member normally positioned to occlude said bore, said second valve operative to said open position when said second portion is releasably positioned in said adapter so that said piercing member pierces said resilient septum and moves said resilient member to open said valve.

10. A medical tubing set having a disconnect device comprising:

a proximal adapter to attach a tubing set in fluid communication to a fluid reservoir;

a proximal tubing connected in fluid communication to said proximal adapter;

a disconnect device having a first portion attached to said proximal tubing having a first passageway therethrough connected in fluid communication to said tubing, said passageway having a first valve therein biased in a normally closed position to close said first passageway, said first valve being operative to an open position;

a second portion having a second passageway therethrough having a second valve therein biased in a normally closed position to close said second passageway, said second valve being operative to an open position;

attachment means for releasable attachment of said second portion onto said first portion to connect said first and said second passageways in fluid communication, to overcome said bias of said first valve and said second valve, to operate said valves to said open position and to allow a fluid flow through said disconnect device;

said second portion being detachable from said first portion at said attachment means by application of a preselected force, said first valve and said second valve thereby operative to said normally closed position upon said detachment;

a distal tubing portion connected to said second portion in fluid communication; and

a distal adapter connected to said distal tubing portion in fluid communication to attach said tubing set in fluid communication to a medical access device.

11. The tubing set of claim 10 wherein said proximal adapter further includes piercing means for piercing a pierceable member on the fluid reservoir.

12. The tubing set of claim 11 wherein said piercing means on said proximal adapter further includes a substantially blunt cannula for piercing a pre-slit pierceable member on the fluid reservoir.

13. The tubing set of claim 10 further including a flow rate regulator.

14. The tubing set of claim 10 wherein said distal adapter includes a male luer fitting.

15. The tubing set of claim 10 wherein said second portion is directly attached to said distal adapter.

16. The tubing set of claim 10 wherein said first portion is directly attached to said proximal adapter.

17. The tubing set of claim 10 wherein said attachment means is frangible so that said first portion cannot be reattached to said second portion once detached.