Infusion set

• US 7,744,570 B2
• Filed: 07/22/2008
• Issued: 06/29/2010
• 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:
  US12/177,821
• Publication Number:
  US 20090112166A1
• Time in Patent Office: 707 Days
• Field of Search: 604/164.01, 604/164.04, 60416701-16704, 604/890.1, 604/201, 604/256, 604/288.01, 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. A medical apparatus for subcutaneous infusion of a liquid medication into a body for treating a physiological condition and for significantly reducing a number of times a skin of the body must be punctured in order to administer the medication, comprising:

a substantially disc-shaped base having upper and lower sides, an upwardly-extending port having a fluid pathway extending therethrough, a funnel-shaped portion positioned between the upper and lower sides, an outside of the port narrowing near the upper side of the base, the base comprising an annular region surrounding the fluid pathway adjacent the lower side of the base and inward of the periphery;

a funnel-shaped metal insert positioned within the port and overlaying at least a part of the funnel-shaped portion to protect at least a part of the funnel-shaped portion from being damaged by a needle;

a septum positioned near a top of the port and configured to substantially obstruct the fluid pathway, the septum being penetrable by a needle to access the fluid pathway;

an adhesive layer attached to the lower side of the base and a backing layer removably attached to the adhesive layer;

a soft cannula attached to the base in fluid communication with the fluid pathway extending through the port, the soft cannula extending downwardly from the port;

an introducer assembly configured to be removably engageable with the base, the introducer assembly having an introducer needle to be inserted through the fluid pathway and adapted to pierce the skin, and a base engaging portion configured to mechanically restrict rocking of the base relative to the introducer assembly, when the base and introducer assembly are coupled; and

a cap having an upper side, a lower side and a periphery, the cap being connected to the base at a location that is in close proximity to both the periphery of the cap and a periphery of the base, wherein a substantial portion of the lower side of the cap is spaced significantly farther from the upper side of the base than from the upper side of the cap such that the cap is generally dome-shaped with a generally hollow space between a generally dome-shaped portion of the lower side of the cap and a generally flat portion of the upper side of the base; and

a needle guard configured for removable insertion of at least a portion of the needle guard into an annular space surrounding the fluid pathway adjacent the lower side of the base and inward of a periphery of the base, the needle guard having sufficient length to prevent exposure of a sharpened needle tip of the introducer needle to prevent needle sticks by the introducer needle.

2. The medical apparatus of claim 1, wherein the base engaging portion provides a close fit between the introducer assembly and the base.

3. The medical apparatus of claim 2, wherein the lower side of the base engaging portion has a smaller diameter than a diameter of the upper side of the base.

4. A medical apparatus for infusion of a liquid substance into a body comprising:

a base having an upper side, a lower side, an upwardly extending port having a fluid pathway extending therethrough, and a funnel-shaped portion positioned between the upper and lower sides, an outside of the port narrowing near the upper side of the base;

a funnel-shaped metal insert positioned within the port and overlaying at least a part of the funnel-shaped portion to protect at least the part of the funnel-shaped portion from being damaged by a needle;

a septum positioned near a top of the port;

an adhesive layer attached to the lower side of the base with a backing removably attached to the adhesive layer;

a cannula attached to the base in fluid communication with the fluid pathway extending through the port, the cannula extending downwardly from the port;

a needle guard configured for removable insertion of a least a portion of the needle guard into an annular space surrounding the fluid pathway adjacent the lower side of the base and inward of a peripheral region of the base; and

an introducer assembly having an introducer needle removably extending through the fluid pathway and cannula, the introducer needle adapted to pierce the skin; and

a cap having an upper side, a lower side and a periphery, the cap being connected to the base at a location that is in close proximity to both the periphery of the cap and a periphery of the base, wherein a substantial portion of the lower side of the cap is spaced significantly farther from the upper side of the base than from the upper side of the cap such that the cap is generally dome-shaped with a generally hollow space between a generally dome-shaped portion of the lower side of the cap and a generally flat portion of the upper side of the base.

5. The medical apparatus of claim 4, wherein the needle guard is of sufficient length to prevent exposure of a sharpened needle tip of the introducer needle to prevent needle sticks by the introducer needle.

6. The medical apparatus of claim 4, wherein the base is substantially disc-shaped.

7. The medical apparatus of claim 4, wherein the cannula is soft.

8. The medical apparatus of claim 4, wherein the base engaging portion provides a close fit between the introducer assembly and the base.

9. The medical apparatus of claim 8, wherein the base engaging portion has a smaller diameter than the upper side of the base.