Connection arrangement and method for connecting a medical device to the improved connection arrangement

• US 8,790,330 B2
• Filed: 12/15/2008
• Issued: 07/29/2014
• Est. Priority Date: 12/15/2008
• Status: Active Grant

• Current Assignee: Carmel Pharma AB (Becton Dickinson & Co)
• Original Assignee: Carmel Pharma AB (Becton Dickinson & Co)
• Inventors: Rosenquist, Tobias
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US12/335,207
• Publication Number:
  US 20100152669A1
• Time in Patent Office: 2,052 Days
• Field of Search: 604/533, 604/535, 604/192, 604/241, 604/257, 604/403, 604/411, 604/414
• US Class Current: 604/533
• CPC Class Codes: A61M 2039/1038 Union screw connectors, e.g. hollow screw or sleeve having external threads
• CPC Class Codes: A61M 2039/1061 Break-apart tubing connectors or couplings
• CPC Class Codes: A61M 2039/1077 Adapters, e.g. couplings adapting a connector to one or several other connectors
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence

Abstract

The present invention relates to a connection arrangement and a method of assembly, for providing a substantially tamper resistant connection with at least a first medical device. The connection arrangement having a center axis, the connection arrangement comprises; a first connection member for connection to the first medical device by means of a rotational motion in a first direction, and a body. Additionally the first connection member and the body are connected directly or indirectly together via at least one designated ruptureable retaining member, the designated ruptureable retaining member is arranged to rupture at a predetermined breaking force, wherein the first connection member, and thereby the first medical device after assembly, can be displaced with respect to the body after rupture. The present invention provides for a substantially tamper safe connection arrangement which disables accidents such as wrongly disengage a connected medical device. A safer handling is provided for the involved user(s).

Claims

1. A connection arrangement for providing at least a first medical device with a substantially tamper resistant connection, said connection arrangement comprising;

a first connection member for connection to said at least one first medical device;

a second connection member having a membrane coupling having at least one guiding groove;

a body having a lock flange extending around the periphery of the body;

a supportive housing having a wedge protrusion;

wherein said first connection member and said body are connected via at least one designated ruptureable retaining member that is integrally formed with the body and a cylinder of the first connection member and is arranged to rupture when subjected to a predetermined breaking force, and

wherein said first connection member, and thereby said first medical device after assembly, can be displaced with respect to said body after rupture.

2. The connection arrangement according to claim 1, wherein said first connection member is arranged to connect to said first medical device by means of a threaded coupling in a first direction.

3. The connection arrangement according to claim 1, wherein said at least one designated ruptureable retaining member is arranged to rupture by means of a relative rotational motion imparted to said body with respect to said first connection member.

4. The connection arrangement according to claim 3, wherein said first direction is the same direction as said relative rotational motion.

5. The connection arrangement according to claim 4, wherein said first connection member and at least a part of said body together form a connection site to which said first medical device can be connected.

6. The connection arrangement according to claim 4, wherein said body comprises means for substantially preventing said first connection member from motion along a centre axis (A).

7. The connection arrangement according to claim 4, wherein said first connection member has a substantially cylindrical form.

8. The connection arrangement according to claim 7, wherein said first connection member comprises threads for a threaded coupling with said first medical device.

9. The connection arrangement according to claim 1, wherein said predetermined breaking force is between 10-40 Ncm.

10. The connection arrangement according to claim 9, wherein said predetermined breaking force is between 15-30 Ncm.

11. The connection arrangement according to claim 1, wherein at least one designated ruptureable retaining member is 1-10 designated ruptureable retaining members.

12. The connection arrangement according to claim 1, wherein at least one designated ruptureable retaining member is arranged to provide for a substantially planar fracture surface, to minimize the available friction forces between said body and said first connection member.

13. The connection arrangement according to claim 1, wherein at least one designated ruptureable retaining member comprises at least one notch to steer the position of a fracture surface.

14. The connection arrangement according to claim 1, wherein said first connection member comprises a connection site to which said first medical device can be connected.

15. The connection arrangement according to claim 1, wherein said body comprises a second connection site for connecting to a second medical device.

16. The connection arrangement according to claim 1, wherein said connection arrangement forms part of a medical adaptor device.

17. The connection arrangement according to claim 1, wherein said connection arrangement forms part of a piercing member protection device.

18. The connection arrangement according to claim 1, wherein said connection arrangement forms part of a syringe.

19. The connection arrangement according to claim 1, wherein said connection arrangement forms part of an infusion bag connection system.

20. A method for attaching a first medical device to a connection arrangement to form a substantially tamper resistant connection there between, said method comprising the steps of;

attaching said first medical device to a first connection member of said connection arrangement by moving in a first direction;

rupturing at least one designated ruptureable retaining member which is integrally formed with the first connection member and a body of said connection arrangement in a fixed position, by subjecting said designated ruptureable retaining member to a predetermined breaking force, so that a supportive housing permits said first connection member and said body to be displaced around a centre axis with respect to each other.

21. The method according to claim 20, wherein said at least one designated ruptureable retaining member is ruptured by means of a rotational motion in a first direction.

22. A female or a male coupling device having a centre axis A for connection with at least a first medical device, said coupling device comprising a connection site comprising;

a cylinder member having threads for providing a threaded coupling with a first medical device by means of a rotational motion in a first direction, said cylinder member comprising an inner and an outer surface,

a fluid transfer channel for enabling a fluid connection, wherein said cylinder member is arranged to at least partly encompass said fluid transfer channel, and

a body having a lock flange extending around the periphery of the body, and

a supportive housing having a wedge protrusion,

said fluid transfer channel extending inside of said body, wherein said cylinder member is connected to said body via at least one designated ruptureable retaining member integrally formed with the body and the cylinder, wherein said at least one designated ruptureable retaining member is arranged to rupture at a predetermined breaking force whereafter said supportive housing permits said cylinder member to freely rotate around said centre axis (A) and with respect to said body.

23. The female or male coupling device according to claim 22, wherein said first connection site comprises means for substantially preventing said cylinder member from motion in a direction along said centre axis A.

24. The female or male coupling device according to claim 22, wherein said coupling device is a female coupling device and in that said threads of said cylinder member is arranged on said outer surface of said cylinder member.

25. The female or male coupling device according to claim 22, wherein said coupling device is a male coupling device and in that said threads of said cylinder member is arranged on said inner surface of said cylinder member.

26. The female or male coupling device according to claim 22, wherein said at least one designated ruptureable retaining member is arranged to rupture by a subjected rotational motion to said cylinder member and in that said subjected rotational motion is in the same direction as said first direction.

27. The female or male coupling device according to claim 22, wherein said cylinder member comprises a first and a second end and in that said at least one designated ruptureable retaining member is arranged to said first end of said cylinder member.

28. The female or male coupling device according to claim 22, wherein said coupling device is of a luer-lock connection type.