Infusion set

• US 7,309,326 B2
• Filed: 11/18/2003
• Issued: 12/18/2007
• 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:
  US10/715,985
• Publication Number:
  US 20050107743A1
• Time in Patent Office: 1,491 Days
• Field of Search: 604/164.01, 604/164.04, 604/167.01, 604/167.02, 604/180, 604/890.1, 604/533, 604/288.02, 604/164.08
• 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, an introducer cap, and an infusion cap. The base member preferably comprises a soft cannula extending from a lower side of the base member, and a port on an upper side thereof. The port is configured to be in fluid communication with the cannula. The port also comprises a septum adapted to seal the port against unwanted fluid flow. The introducer cap is adapted to be mounted to the base member and has a needle adapted to extend through the septum and said soft cannula in an assembled position. The infusion cap comprises a lumen adapted to receive an elongate flexible tube. The infusion cap also comprises a hard cannula adapted to be inserted through the septum and to place said soft cannula in fluid communication with said lumen.

Claims

1. An infusion set comprising:

a generally round base having upper and lower sides, an outer edge, a base cannula extending downwardly from the lower side, a retaining rim disposed at the outer edge, 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 of a different material from the port, positioned above the retaining rim, and adapted to seal said port from fluid communication therethrough;

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

an introducer cap adapted to be pressed against and cover substantially all of the upper side of the base and to be removably coupled to the base at the outer radial periphery of the retaining rim, 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 introducer needle pierces the skin and the adhesive layer on the lower side of the base contacts the skin; and

an infusion cap comprising an upper side and a lower side, the infusion cap being adapted to be pressed against and generally cover the upper side of the base and to be removably attached to the base at the retaining rim after disengagement of the introducer cap from the base such that a foot disposed on the infusion cap extends radially inwardly farther than the outer radial periphery of the retaining rim, 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 introducer cap includes at least one generally flat surface to facilitate grasping the cap.

3. The infusion set of claim 2, wherein the introducer cap includes at least two generally flat surfaces to facilitate pinching the cap to change its shape to allow the cap to be removably engaged with the base.

4. The infusion set of claim 3, wherein the base includes a funnel-shaped portion located between the port and the cannula.

5. The infusion set of claim 4, wherein the funnel-shaped portion is located between the septum and the cannula.

6. The infusion set of claim 1, wherein the introducer cap and the infusion cap both include a substantially cylindrical portion adapted to surround the port on the base when engaged therewith to help secure the caps to the base.

7. The infusion set of claim 1, wherein the infusion cap has a low-profile substantially dome-shaped upper side.

14. The infusion set of claim 1, wherein the septum comprises a slit.

15. The infusion set of claim 1, wherein the adhesive layer extends beyond the outer edge of the base.

16. The infusion set of claim 1, wherein substantially cylindrical portion of the infusion cap extends downwardly from the lower side beyond the infusion cannula.

21. The infusion set of claim 1, wherein the infusion cap covers substantially all of the upper surface of the base when coupled to the base.

8. An infusion set comprising:

a generally circular base having upper and lower sides, an outer edge, a base cannula extending downwardly from the lower side, a port extending upwardly from the upper side, and the port being in fluid communication with the base cannula, and the port comprising a septum at or near an upper side thereof, the septum of a different material from the port and adapted to seal the port from fluid communication therethrough;

a generally dome-shaped introducer cap adapted to cover substantially all of and to removably couple with the upper side of 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 engaged base and introducer cap are adapted to be pressed against a patient'"'"'s skin such that the introducer needle pierces the skin and the base is in close proximity to the skin; and

a low-profile, dome-shaped infusion cap comprising an upper side and a lower side, the infusion cap being adapted to generally cover and to removably engage with the upper side of the base after disengagement of the introducer cap from the base, the infusion cap being configured to freely 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.

9. The infusion set of claim 8, wherein the introducer cap includes at least one generally flat surface to facilitate grasping the cap.

10. The infusion set of claim 9, wherein the introducer cap includes at least two generally flat surfaces to facilitate pinching the cap to change its shape to allow the cap to be removably engaged with the base.

11. The infusion set of claim 10, wherein the base includes a funnel-shaped portion located between the port and the cannula.

12. The infusion set of claim 11, wherein the funnel-shaped portion is located between the septum and the cannula.

13. The infusion set of claim 8, wherein the introducer cap and the infusion cap both include a substantially cylindrical portion adapted to surround the port on the base when engaged therewith to help secure the caps to the base.

17. The infusion set of claim 8, wherein the septum comprises a slit.

18. The infusion set of claim 8, further comprising an adhesive layer mounted to the lower side of the base.

19. The infusion set of claim 18, wherein the adhesive layer extends beyond the outer edge of the base.

20. The infusion set of claim 8, wherein substantially cylindrical portion of the infusion cap extends downwardly from the lower side beyond the infusion cannula.

22. The infusion set of claim 8, wherein the infusion cap covers substantially all of the upper surface of the base when coupled to the base.