# US 7,744,570 B2 · Infusion set

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- Number: US 7,744,570 B2
- Document ID: US7744570B2
- Status: Granted
- Kind: B2
- Application number: 12/177,821
- Filed: 2008-07-22
- Published: 2009-04-30
- Granted: 2010-06-29
- Earliest claimed: 2003-11-18
- Assignees: ICU Medical, Inc.
- Inventors: Thomas F. Fangrow, Jr.
- Web page: https://patentgrep.com/patent/US7744570B2

## CPC

- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61M 39/1011: {Locking means for securing connection; Additional tamper safeties (A61M39/16 takes precedence)}
- A61M 2005/1581: {Right-angle needle-type devices}
- A61M 2005/1587: {suitable for being connected to an infusion line after insertion into a patient}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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.

### Claim 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.

### Claim 5 (depends on 4)

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.

### Claim 6 (depends on 4)

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

### Claim 7 (depends on 4)

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

### Claim 8 (depends on 4)

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

### Claim 9 (depends on 8)

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