Infusion set

• US 7,931,615 B2
• Filed: 05/03/2006
• Issued: 04/26/2011
• Est. Priority Date: 02/07/2006
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F. Jr.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/417,660
• Publication Number:
  US 20070185441A1
• Time in Patent Office: 1,819 Days
• Field of Search: 60416401-16409, 604/93.01, 604/180
• US Class Current: 604/93.01
• 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 in a substantially fixed orientation, below a port extending upwardly from the upper side, the port being in fluid communication with the base cannula, and the port comprising a septum adapted to substantially seal said port from fluid communication therethrough;

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

wherein the infusion cap is adapted to rotate with respect to the base cannula about an axis that is generally perpendicular to the lower side of the base while the base and the infusion cap are engaged and the infusion cannula and the rigid base cannula are in fluid communication.

2. The infusion set of claim 1, wherein the infusion cap further comprises an alignment structure extending downwardly from the lower side of the infusion cap beyond the infusion cannula and at least one retaining member, the alignment structure being configured to align the infusion cannula with the port, wherein a lowest surface of the alignment structure is upwardly spaced from a lowest surface of the at least one retaining member.

3. The infusion set of claim 2, wherein the alignment structure comprises a plurality of segments, the segments being spaced apart from one another.

4. The infusion set of claim 2, wherein the alignment structure is generally cylindrical.

5. The infusion set of claim 1, wherein the base has a generally circular portion.

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

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

8. The infusion set of claim 7, wherein the outer rim is notched.

9. The infusion set of claim 7, wherein the at least one retaining member is a foot configured to engage the rim of the base to releasably connect the infusion cap to the base.

10. The infusion set of claim 9, further comprising at least a second foot configured to engage the rim of the base to releasably connect the infusion cap to the base.

11. 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 retaining member is configured to engage the at least one notched portion.

12. 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.

13. 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.

14. 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.

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

16. The infusion set of claim 1, wherein the septum is pre-slit.

17. The infusion set of claim 1, wherein the infusion cap covers substantially all of the upper surface of the base when the infusion cap and the base are engaged.

18. The infusion set of claim 1, further comprising an adhesive layer mounted to the lower side of the base.

19. The infusion set of claim 1, further comprising an introducer cap adapted to be pressed against the upper side of the base and removably coupled to the base, the coupled base and introducer cap being adapted to be pressed toward a patient'"'"'s skin such that the rigid base cannula pierces the skin.

20. The infusion set of claim 19, wherein the introducer cap has at least two retaining members configured to couple to an outer rim of the base by inhibiting movement of the introducer cap towards the base and away from the base.

21. The infusion set of claim 20, wherein the introducer cap further comprises two tabs extending upwardly from an upper side of the introducer cap which are configured to decouple the at least two retaining members from the outer rim when a force is applied to at least one of the tabs, and two regions of void space between the two tabs adapted to facilitate decoupling of the at least two retaining members by reducing the stiffness of the introducer cap.