Medication infusion set

• US 6,056,718 A
• Filed: 03/04/1998
• Issued: 05/02/2000
• Est. Priority Date: 03/04/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Minimed, Inc. (Medtronic Plc)
• Inventors: Bowman, Leif N., Funderburk, Jeffery V.
• Primary Examiner(s): Polutta, Mark O.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/034,626
• Time in Patent Office: 790 Days
• Field of Search: 604/164, 604/165, 604/167, 604/169, 604/174, 604/175, 604/244, 604/245, 604/256, 604/263, 604/264, 604/272, 604/161, 604/162, 604/93
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26

Abstract

An improved medication infusion set is provided of the type having a soft cannula for subcutaneous delivery of a selected medication to a patient. The infusion set comprises a cannula housing having a soft cannula protruding therefrom and a self-sealing septum mounted at an upstream end of the cannula. The cannula housing is initially assembled with an insertion hub having an elongated insertion needle extending through the septum and cannula for transcutaneously placing the cannula followed by separation of the insertion hub from the cannula housing. An infusion hub is then assembled with the cannula housing and includes a short infusion needle for coupling the cannula with the selected medication supplied from a source via a length of infusion tubing. The infusion hub includes a protective shroud plate protruding beyond a tip end of the infusion needle to minimize risk of patient contact therewith, and adapted for slide-fit reception into a matingly shaped slot formed in the cannula housing to insure a one-way and high strength interconnection between the cannula housing and infusion hub. Releasible latch members interlock the infusion hub with the cannula housing in a manner permitting periodic separation when desired.

Claims

1. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing having a soft cannula mounted thereon with a distal end of said cannula protruding from said cannula housing, a resilient self-sealing septum mounted on said cannula housing generally at a proximal end of said cannula for normally closing said cannula proximal end, and a retainer mounted within said cannula housing for retaining said septum within said cannula housing, wherein said retainer comprises a retainer clip for snap-fit mounting within said cannula housing, said retainer clip having a needle port formed therein; and

an infusion hub having an infusion needle mounted thereon with a distal end of said infusion needle protruding from said infusion hub and being adapted for connection to a source of the selected medication, said infusion needle being adapted for insertion through said septum for coupling with said cannula,

wherein said infusion hub further includes a protective shroud protruding therefrom in overlying relation with said infusion needle, said shroud being a guide slidably insertable into a generally matingly shaped slot formed in said cannula housing for one-way guided reception of said infusion needle through said septum and

wherein said cannula housing and said infusion hub further includes releasibly interengageable latch members for releasibly connecting said infusion hub to said cannula housing with said infusion needle inserted through said septum.

2. The medication infusion set of claim 1, further including a rigid tubular needle guide interposed between said septum and said cannula proximal end.

3. The medication infusion set of claim 2, wherein said needle guide has a downstream end press-fit into said cannula proximal end.

4. The medication infusion set of claim 3, wherein said needle guide and said cannula proximal end are press-fit mounted into an open-sided channel formed in said cannula housing.

5. The medication infusion set of claim 2, wherein said infusion needle has a length to extend through said septum and partially into said needle guide when said cannula housing and infusion hub are connected together.

6. The medication infusion set of claim 2, wherein said needle guide comprises a metal needle guide.

7. The medication infusion set of claim 1, further including an insertion hub having an insertion needle mounted thereon with a distal end protruding therefrom, said insertion needle being insertable through said septum to extend through said cannula and terminating with a sharp distal end tip disposed at least slightly beyond a distal end of said cannula, said insertion hub being adapted for transcutaneously placing said cannula on a patient and thereafter being withdrawable from said cannula and cannula housing.

8. The medication infusion set of claim 7, wherein said cannula housing has an underside surface with an adhesive layer thereon, and further including an adhesive patch for placement onto a patient, said insertion needle being adapted for transcutaneously placing said cannula by piercing said patch, said adhesive layer on said cannula housing securing said cannula housing to said patch.

9. The medication infusion set of claim 8, wherein said adhesive patch has an area of attachment to the patient'"'"'s skin substantially greater than the area of said underside surface on said cannula housing.

10. The medication infusion set of claim 7, wherein said latch members comprise at least one resilient latch arm protruding from said insertion hub and at least one latch port having a latch detent therein formed on said cannula housing for snap-fit and releasible engagement with said latch arm.

11. The medication infusion set of claim 7, wherein said latch members comprise a pair of resilient latch arms protruding from said insertion hub at opposite sides of said insertion needle, and a corresponding pair of latch ports each having a latch detent therein formed on said cannula housing for snap-fit and releasible engagement with said latch arms.

12. The medication infusion set of claim 7, further including a needle guard for removable mounting onto said insertion hub when said insertion hub is assembled with said cannula housing to encase said insertion needle and said cannula protruding from said cannula housing.

13. The medication infusion set of claim 1, wherein said cannula proximal end is press-fit mounted into an open-sided channel formed in said cannula housing.

14. The medication infusion set of claim 1, further including a rigid tubular needle guide interposed between said septum and said cannula proximal end, said needle guide having a downstream end press-fit connected to said cannula proximal end, and an upstream end flared outwardly to form a generally conical seat for receiving and supporting said septum, and further including a retainer mounted within said cannula housing for retaining said septum within said conical seat.

15. The medication infusion set of claim 1, further including infusion tubing coupled to said infusion hub for coupling said infusion needle to the medication source.

16. The medication infusion set of claim 1, wherein said latch members comprise at least one resilient latch arm protruding from said infusion hub and at least one latch port having a latch detent therein formed on said cannula housing for snap-fit and releasible engagement with said latch arm.

17. The medication infusion set of claim 1, wherein said latch members comprises a pair of resilient latch arms protruding from said infusion hub at opposite sides of said shroud, and a corresponding pair of latch ports each having a latch detent therein formed on said cannula housing for snap-fit and releasible engagement with said latch arms.

18. The medication infusion set of claim 1, further including an adhesive layer on an underside surface of said cannula housing.

19. The medication infusion set of claim 1, further including an adhesive patch for removable mounting onto the skin of a patient at a selected infusion site, said insertion needle being adapted to pierce said patch and the patient'"'"'s skin to transcutaneously place said cannula, said adhesive patch being adapted to attach said cannula housing to said patch on the patient'"'"'s skin.

20. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing having a soft cannula mounted thereon with a distal end of said cannula protruding from said cannula housing, and a resilient self-sealing septum mounted on said cannula housing generally at a proximal end of said cannula for normally closing said cannula proximal end; and

an infusion hub having an infusion needle mounted thereon with a distal end of said infusion needle protruding from said infusion hub and being adapted for connection to a source of the selected medication said infusion needle being adapted for insertion through said septum for coupling with said cannula,

wherein said infusion hub further includes a protective shroud plate protruding therefrom in overlying relation with said infusion needle said shroud plate being slidably insertable into a generally matingly shaped slot formed in said cannula housing for guided reception of said infusion needle through said septum,

wherein said cannula housing and said infusion hub further includes releasibly interengageable latch members for releasibly connecting said infusion hub to said cannula housing with said infusion needle inserted through said septum, and

wherein said shroud plate comprises a plurality of generally planar facets, said slot formed in said cannula housing being generally matingly shaped for one-way reception of said shroud plate.

21. The medication infusion set of claim 20, wherein said shroud plate extends over the top and at opposite sides of said infusion needle.

22. The medication infusion set of claim 20, wherein said shroud plate extends from said infusion hub at least slightly beyond a distal end of said infusion needle.

23. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing having a soft cannula mounted thereon with a distal end of said cannula protruding from said cannula housing, and a resilient self-sealing septum mounted on said cannula housing generally at a proximal end of said cannula for normally closing said cannula proximal end; and

an infusion hub having an infusion needle mounted thereon with a distal end of said infusion needle protruding from said infusion hub and being adapted for connection to a source of the selected medication, said infusion needle being adapted for insertion through said septum for coupling with said cannula,

wherein said infusion hub further including a protective shroud plate of multifaceted configuration protruding therefrom in overlying relation with said infusion needle and projecting from said infusion hub at least slightly beyond a distal tip end of said infusion needle, said shroud plate being slidably insertable into a generally matingly shaped slot formed in said cannula housing for one-way guided reception of said infusion needle through said septum, and

wherein said cannula housing and said infusion hub further including releasibly interengageable latch members for releasibly connecting said infusion hub to said cannula housing with said infusion needle inserted through said septum.

24. The medication infusion set of claim 23, wherein said latch members comprise a pair of resilient latch arms protruding from said infusion hub at opposite sides of said shroud plate, and a corresponding pair of latch ports each having a latch detent therein formed on said cannula housing for snap-fit and releasible engagement with said latch arms.

25. The medication infusion set of claim 23, further including an insertion hub having an insertion needle mounted thereon with a distal end protruding therefrom, said insertion needle being insertable through said septum to extend through said cannula and terminating with a sharp distal end tip disposed at least slightly beyond a distal end of said cannula, said insertion hub being adapted for transcutaneously placing said cannula on a patient and thereafter being withdrawable from said cannula and cannula housing.

26. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing;

a soft cannula;

a rigid tubular needle guide having a downstream end press-fit mounted with a proximal end of said soft cannula, said needle guide and said cannula proximal end being carried within a bore formed in said cannula housing with a distal end of said cannula protruding from said cannula housing, said needle guide having an upstream end flared outwardly in a generally conical configuration;

a resilient self-sealing septum; and

a retainer for retaining said septum seated within said flared upstream of said needle guide, wherein said retainer fits within the cannula housing.

27. The medication infusion set of claim 26, wherein said needle guide downstream end is press-fitted into said cannula proximal end.

28. The medication infusion set of claim 26, wherein said needle guide and said cannula proximal end are press-fit mounted within an open-sided channel formed in said cannula housing.

29. The medication infusion set of claim 26, wherein said needle guide comprises a metal needle guide.

30. The medication infusion set of claim 26, wherein said septum comprises a self-sealing ball.

31. The medication infusion set of claim 26, wherein said retainer comprises a retainer clip for snap-fit mounting onto said cannula, said retainer clip having a needle port formed therein.

32. The medication infusion set of claim 26, wherein said infusion needle has a length to extend through said septum and partially into said needle guide and defining a distal end tip terminating short of said cannula.

33. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing having a soft cannula mounted thereon with a distal end of said cannula protruding from said cannula housing, and a resilient self-sealing septum mounted on said cannula housing generally at a proximal end of said cannula for normally closing said cannula proximal end; and

an infusion hub having an infusion needle mounted thereon with a distal end of said infusion needle protruding from said infusion hub and being adapted for connection to a source of the selected medication, said infusion needle being adapted for insertion through said septum for coupling with said cannula,

wherein said infusion hub further includes a protective shroud protruding therefrom in overlying relation with said infusion needle, said shroud being a guide slidably insertable into a generally matingly shaped slot formed in said cannula housing for one-way guided reception of said infusion needle through said septum,

wherein said cannula housing and said infusion hub further includes releasibly interengageable latch members for releasibly connecting said infusion hub to said cannula housing with said infusion needle inserted through said septum, and

wherein said septum comprises a resilient self-sealing ball.

34. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing having a soft cannula mounted thereon with a distal end of said cannula protruding from said cannula housing, and a resilient self-sealing septum mounted on said cannula housing generally at a proximal end of said cannula for normally closing said cannula proximal end; and

an infusion hub having an infusion needle mounted thereon with a distal end of said infusion needle protruding from said infusion hub and being adapted for connection to a source of the selected medication, said infusion needle being adapted for insertion through said septum for coupling with said cannula,

wherein said infusion hub further including a protective shroud plate of multifaceted configuration protruding therefrom in overlying relation with said infusion needle and projecting from said infusion hub at least slightly beyond a distal tip end of said infusion needle, said shroud plate being slidably insertable into a generally matingly shaped slot formed in said cannula housing for one-way guided reception of said infusion needle through said septum,

wherein said cannula housing and said infusion hub further including releasibly interengageable latch members for releasibly connecting said infusion hub to said cannula housing with said infusion needle inserted through said septum, and

wherein said shroud plate has a three-sided construction.

35. A medication infusion set for transcutaneous delivery of a selected medication to a patient, said infusion set comprising:

a cannula housing;

a soft cannula;

a rigid tubular needle guide having a downstream end press-fit mounted with a proximal end of said soft cannula, said needle guide and said cannula proximal end being carried within a bore formed in said cannula housing with a distal end of said cannula protruding from said cannula housing, said needle guide having an upstream end flared outwardly in a generally conical configuration;

a resilient self-sealing septum; and

a retainer for retaining said septum seated within said flared upstream of said needle guide,

wherein said needle guide downstream end is press-fitted into said cannula proximal end, and

wherein a channel is formed in an underside surface of said cannula housing, and further including an adhesive layer covering said underside surface.