Infusion set

• US 7,311,694 B2
• Filed: 05/03/2006
• Issued: 12/25/2007
• Est. Priority Date: 11/18/2003
• Status: Active Grant

• Current Assignee: Ypsomed AG (Ypsomed Holding AG)
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F. Jr.
• Primary Examiner(s): Sirmons, Kevin C.
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US11/417,488
• Publication Number:
  US 20060270990A1
• Time in Patent Office: 601 Days
• Field of Search: 604/164.01, 604/164.04, 60416701-16702, 604/180, 604/890.1, 604/533, 604/288.02
• US Class Current: 604/167.02
• 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 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• 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 from the upper side, the port being in fluid communication with the base cannula, and the port comprising a wall with a top portion and a sidewall portion, the port wall being shaped to receive a septum adapted to substantially seal said port from fluid communication therethrough, the septum being substantially flush with the top portion of the port, and the surface area of the top portion of the port being smaller than an exposed surface area of the septum;

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

an 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 a needle extending downwardly from the lower side, the needle being adapted to extend through the septum on the upper side of the base and through the base cannula on the lower side of the base, whereby the attached base and introducer cap are adapted to be pressed against a patient'"'"'s skin such that the needle pierces the skin, thereby permitting the base cannula to penetrate the skin with the needle and the adhesive layer on the lower side of the base to contact the skin such that base remains adhered to the patient'"'"'s skin when the needle is removed from the base cannula without disengaging the base cannula from the patient;

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 after disengagement of the introducer cap from the base, the infusion cap being adapted to rotate with respect to the base while engaged, 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.

2. The infusion set of claim 1, wherein the base is substantially round.

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

4. The infusion set of claim 1, wherein the introducer cap further comprises at least one generally flat surface to facilitate grasping the introducer cap.

5. The infusion set of claim 1, wherein the base further comprises a rim, and the infusion cap further comprises at least one retaining member configured to couple to the rim of the base.

6. The infusion set of claim 5, wherein the at least one retaining member comprises a foot.

7. The infusion set of claim 5, wherein the infusion cap further comprises at least a second retaining member configured to couple to the rim of the base.

8. The infusion set of claim 7, wherein retaining members are diametrically opposed.

9. The infusion set of claim 1, wherein the septum is flush with the top portion of the port.

10. The infusion set of claim 1, wherein the surface area of the top portion of the port wall is substantially smaller than the surface area of the exposed portion of the septum.

11. The infusion set of claim 1, wherein the introducer cap or the infusion cap includes a wall structure extending downwardly from the lower side thereof for assisting in directing the cap onto the base.

12. An infusion set comprising:

a base having upper and lower sides, a base cannula extending downwardly from the lower side, an adhesive layer mounted to the lower side, and 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 inhibit fluid communication through the port, the septum being substantially flush with a top portion of the port, and the surface area of the top portion of the port is smaller than the exposed surface area of the septum;

an 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 a needle extending downwardly from the lower side, the needle being adapted to extend through the septum on the upper side of the base and through the base cannula on the lower side of the base;

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, 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 infusion cannula in fluid communication with the base cannula.

13. The infusion set of claim 12, wherein the adhesive layer has a central opening and wherein the top portion of the port is the uppermost portion of the base.

14. The infusion set of claim 12, wherein the infusion cap is adapted to be removably attached to the base after disengagement of the introducer cap from the base.

15. The infusion set of claim 12, wherein the infusion cap is adapted to rotate with respect to the base while the infusion cap and the base are removably attached.

16. The infusion set of claim 12, wherein the infusion cap further comprises an elongate flexible lumen in fluid communication with the infusion cannula.

17. The infusion set of claim 12, wherein the base is substantially circular.

18. The infusion set of claim 12, wherein the septum is pre-slit.

19. The infusion set of claim 12, wherein the introducer cap further comprises at least one generally flat surface to facilitate grasping the introducer cap.

20. The infusion set of claim 12, wherein the base further comprises a rim, and the infusion cap further comprises at least one retaining member configured to couple to the rim of the base.

21. The infusion set of claim 20, wherein the at least one retaining member comprises a foot.

22. The infusion set of claim 20, wherein the infusion cap further comprises at least a second retaining member configured to couple to the rim of the base.

23. The infusion set of claim 22, wherein retaining members are diametrically opposed.

24. The infusion set of claim 12, wherein the septum is flush with the top portion of the port.

25. The infusion set of claim 24, wherein the surface area of the top portion of the port wall is substantially smaller than the surface area of the exposed portion of the septum.

26. The infusion set of claim 25, wherein the introducer cap or the infusion cap includes a wall structure extending downwardly from the lower side thereof for assisting in directing the cap onto the base.