Infusion set

• US 8,657,788 B2
• Filed: 05/03/2006
• Issued: 02/25/2014
• 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): Mehta, Bhisma
• Assistant Examiner(s): Osinski, Bradley
• Application Number:
  US11/417,503
• Publication Number:
  US 20070185454A1
• Time in Patent Office: 2,855 Days
• Field of Search: 604/288.1, 60416401-16404, 604/164.07, 604/164.09, 604/164.1, 60416701-16704, 604/174
• US Class Current: 604/164.04
• 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 rigid base cannula permanently attached to and extending downwardly from a portion of the lower side, below a port extending upwardly from the upper side, the port being in fluid communication with the rigid base cannula, and the port comprising a septum adapted to substantially seal said port from fluid communication therethrough;

a needleless introducer cap adapted to be pressed against the upper side of the base and removably coupled to the base, the introducer cap comprising upper and lower sides and at least one generally flat surface for grasping the introducer cap and base assembly, whereby the coupled base and introducer cap assembly is adapted to be pressed against a patient'"'"'s skin such that the rigid base cannula pierces the skin and an adhesive layer on the lower side of the base contacts the skin;

a infusion cap comprising;

an upper side and a lower side, the infusion cap being adapted to be pressed against the upper side of the base and removably attached to the base after disengagement of the introducer cap from the base and being adapted to rotate with respect to the base about an axis that is generally perpendicular to the lower side of the base while the infusion cap and the base are engaged;

an infusion cannula extending downwardly from the lower side of the infusion cap;

at least one retention member configured to engage the base, thereby removably coupling the infusion cap to the base;

releasing members configured to release the at least one retention member from the base and

an elongate flexible lumen in fluid communication with the infusion cannula, the infusion cannula being adapted to extend through the septum on the upper side of the base upon engagement of the infusion cap and the base to place the flexible lumen and the infusion cap in fluid communication with the rigid base cannula;

wherein the needleless introducer cap is configured to be removed from the base prior to attachment of the infusion cap to the base.

2. The infusion set of claim 1, wherein the base is generally circular.

3. The infusion set of claim 1, wherein the surface for grasping the introducer cap is generally flat.

4. The infusion set of claim 1, wherein the introducer cap further comprises a flange extending generally upwardly from the upper side of the introducer cap, the flange comprising the at least one flat surface for grasping the introducer cap.

5. The infusion set of claim 1, wherein the infusion cap further comprises at least a second retention member, the at least a second retention member being configured to inhibit movement of the infusion cap toward the base.

6. The infusion set of claim 1, wherein the infusion cap further comprises an alignment structure extending generally downwardly from the lower side of the infusion cap, the alignment structure configured to align the infusion cannula with the port.

7. The infusion set of claim 6, wherein the alignment structure comprises a plurality of segments, the segments being spaced apart from one another.

8. The infusion set of claim 6, wherein the alignment structure is generally cylindrical.

9. The infusion set of claim 1, wherein the base further comprises an outer rim, and the at least one retention member is configured to engage the rim.

10. The infusion set of claim 9, wherein the outer rim is notched.

11. The infusion set of claim 9, wherein the at least one retention member is a foot configured to engage the rim of the base to releasably connect the infusion cap to the base.

12. The infusion set of claim 1, wherein the base further comprises at least one notched portion that extends generally along a perimeter of the base, and the at least one retention member is configured to engage the at least one notched portion.

13. The infusion set of claim 1, wherein the infusion cap is adapted to rotate in a complete circle with respect to the base while engaged.

14. The infusion set of claim 1, wherein the infusion cap is adapted to freely rotate with respect to the base while the infusion cannula and the rigid base cannula are in fluid communication.

15. The infusion set of claim 1, wherein infusion cap is adapted to rotate with respect to the base about the infusion cannula while the infusion cap and the base are engaged.

16. The infusion set of claim 15, further comprising at least a second foot configured to engage the rim of the base to releasably connect the infusion cap to the base.

17. The infusion set of claim 16, wherein the cap is configured such that each of the feet moves substantially the same distance when the releasing members are compressed.

18. The infusion set of claim 1, wherein the releasing members comprise a pair of grips.

19. The infusion set of claim 1, wherein the rigid cannula is a needle.

20. The infusion set of claim 1, wherein the infusion cap further comprises a reinforcing member configured to equalize the bending of the infusion cap when a force is applied to the releasing members.