Infusion set

• US 8,956,330 B2
• Filed: 02/22/2011
• Issued: 02/17/2015
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: TecPharma Licensing AG (Ypsomed Holding AG)
• Inventors: Fangrow, Thomas F. Jr.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US13/032,559
• Publication Number:
  US 20110295209A1
• Time in Patent Office: 1,456 Days
• Field of Search: 604174-180, 604/131, 60416401-17003, 60428801-28804
• US Class Current: 604/175
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2025/0246 fixed on the skin having a cover for covering the holding means
• CPC Class Codes: A61M 2025/0266 using pads, patches, tapes or the like
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• 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 25/0612 Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An infusion set comprises a base member (60), an introducer cap (64), and an infusion cap (54). The base member (60) preferably comprises a soft cannula (52) extending from a lower side (118) of the base member (60), and a port (62) on an upper side (92) thereof. The port (62) is configured to be in fluid communication with the cannula (52). The port (62) also comprises a septum (130) adapted to seal the port (62) against unwanted fluid flow. The introducer cap (64) is adapted to be mounted to the base member (60) and has a needle (66) adapted to extend through the septum (130) and said soft cannula (52) in an assembled position. The infusion cap (54) comprises a lumen (160) adapted to receive an elongate flexible tube (162). The infusion cap (54) also comprises a hard cannula (170) adapted to be inserted through the septum (130) and to place said soft cannula (52) in fluid communication with said lumen (160).

Claims

1. An infusion set, comprising:

a base having upper and lower sides, a base cannula extending downwardly from the lower side, and a port extending upwardly on the upper side and being in fluid communication with a first open end of the base cannula, and a septum configured to inhibit fluid communication through the port to the first open end of the base cannula, the septum providing the only path through which to access the first open end of the base cannula besides through the base cannula itself from a second open end;

an adhesive layer mounted to the lower side of the base;

a first cap comprising an upper side, a lower side, a tubing extending from the upper side and a cap cannula extending from the lower side, the cap cannula configured to extend into the septum of the base when the first cap is attached to the upper side of the base so as to place the tubing in fluid communication with the base cannula; and

a second cap comprising;

an upper side and a lower side opposite the upper side;

a guide wall inwardly spaced from a periphery of the second cap and extending downwardly on the lower side of the second cap and sized to closely surround the septum and port of the base when the second cap is attached to the base such that the guide wall facilitates location of the second cap on the base as the second cap is being attached to the base, and thereby preventing access to the septum apart from access from the second open end of the base cannula;

first and second engagement members configured to engage the base to retain the second cap on the base; and

grooves positioned inwardly of the engagement members to facilitate flexure of the engagement members for release of the engagement members from the base to permit removal of the second cap from the base, the second cap having no needle configured to pass through the septum of the base when the second cap is attached to the base;

wherein attachment of the first cap to the base prevents the second cap from attaching the base and attachment of the second cap to the base prevents the first cap from attaching to the base.

2. The infusion set of claim 1, wherein the base further comprises a rim that surrounds the base.

3. The infusion set of claim 1, wherein the base cannula is rigid.

4. The infusion set of claim 1, wherein the first cap further comprises a guide wall inwardly spaced from a periphery of the first cap and extending downwardly on the lower side of the first cap and sized to closely surround the port when the first cap is attached to the base such that the guide wall facilitates location of the first cap on the base as the first cap is being attached to the base, and first and second engagement members configured to engage the base to retain the first cap on the base.

5. The infusion set of claim 1, wherein the first and second engagement members of the second cap comprise feet.

6. The infusion set of claim 5, wherein the feet comprise inwardly extending barbs.

7. The infusion set of claim 1, wherein the second cap further comprises upwardly extending portions to facilitate release of the engagement members from the base.

8. The infusion set of claim 7, wherein the second cap further comprises a flange extending upwardly on the upper side of the second cap.

9. An infusion set, comprising:

a base having upper and lower sides;

a base cannula configured to extend downwardly from the lower side of the base and the upper side of the base being configured to be in selective fluid communication with the base cannula;

a septum;

an adhesive layer on the lower side of the base;

a first cap comprising;

a housing defining a tube-receiving lumen that extends through the housing;

a tubing positioned within the tube-receiving lumen and extending therefrom to an end configured for connection to a pump or other fluid source; and

a cap cannula in fluid communication with the tubing and extending outwardly from the tube-receiving the tube receiving lumen, the cap cannula configured to extend into the septum when the first cap is attached to the base so as to place the tubing in fluid communication with the base cannula to thereby infuse fluid from the tubing into the cap cannula and from the cap cannula into the base cannula; and

a second cap comprising an upper side, a lower side, a guide wall inwardly spaced from a periphery of the second cap and extending downwardly on the lower side of the second cap to facilitate location of the second cap on the base, first and second engagement members configured to engage the base to retain the second cap on the base, and grooves to facilitate flexure of the engagement members for release of the engagement members from the base to permit removal of the second cap from the base, the septum of the base being unpenetrated when the second cap is attached to the base as the second cap prevents access to the septum from the upper side of the base;

wherein the infusion set is configured such that attachment of the first cap to the base prevents the second cap from attaching to the base and attachment of the second cap to the base prevents the first cap from attaching to the base.

10. The infusion set of claim 9, wherein the base further comprises a rim that surrounds the base.

11. The infusion set of claim 9, wherein the base cannula is rigid.

12. The infusion set of claim 9, wherein the first cap further comprises a guide wall inwardly spaced from a periphery of the first cap and extending downwardly on a lower side of the first cap and sized to closely surround the port when the first cap is attached to the base such that the guide wall facilitates location of the first cap on the base as the first cap is being attached to the base, and first and second engagement members configured to engage the base to retain the first cap on the base.

13. The infusion set of claim 9, wherein the first and second engagement members of the second cap comprise feet.

14. The infusion set of claim 13, wherein the feet comprise inwardly extending barbs.

15. The infusion set of claim 9, wherein the second cap further comprises upwardly extending portions to facilitate release of the engagement members from the base.

16. The infusion set of claim 15, wherein the second cap further comprises a flange extending upwardly on the upper side of the second cap.

17. The infusion set of claim 9, wherein the tubing further comprises a luer lock connector.

18. An infusion set, comprising:

a base having upper and lower sides and comprising;

a base cannula extending between a first open and a second open end;

a port on the upper side and being in fluid communication with the first open end of the base cannula;

a septum positioned on the port over the first open end of the base cannula; and

a base engagement member;

an adhesive layer mounted to the lower side of the base;

a first cap for infusing a medication through the infusion set to a user, the first cap having an upper side and a lower side and comprising;

a tube extending from the upper side;

a cap cannula extending from the lower side; and

a first cap engagement member, wherein when the first cap is attached to the upper side of the base, the first cap engagement member is connected to the base engagement member to retain the first cap on the base and the cap cannula extends into the septum of the base placing the tubing in fluid communication with the base cannula; and

a second cap having an upper side and a lower side and comprising;

a guide wall inwardly spaced from a periphery of the second cap and extending downwardly on the lower side of the second cap; and

a second cap engagement member, wherein when the second cap is attached to the upper side of the base, the second cap engagement member is connected to the base engagement member to retain the second cap on the base and the guide wall surrounds the septum and port of the base, the second cap having no needle configured to pass through the septum of the base when the second cap is attached to the base;

wherein attachment of the first cap engagement member to the base engagement member prevents the second cap engagement member from attaching to the base engagement member, thereby preventing the second cap from connecting to the base and attachment of the second cap engagement member to the base engagement member prevents the first cap engagement member from attaching to the base engagement member, thereby preventing the first cap from connecting to the base.

19. The infusion set of claim 18, wherein the base engagement member comprises a rim.

20. The infusion set of claim 19, wherein both the first cap engagement member and the second cap engagement member comprise feet configured to engage the rim of the base.