Needleless IV medical delivery system

Details Needleless IV medical delivery system Needleless IV medical delivery system

1996-02-10

1998-11-10

Stright, Jr., Ronald

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

604905, 604 86, 604244, 604256, A61M 2500

Patent

active

058336745

DESCRIPTION:

BRIEF SUMMARY
I. FIELD OF THE INVENTION

The present invention relates generally to medical systems for administering fluids to a patient, and more particularly to a plurality of components incorporating an injection site, including a preformed elastomeric, self-sealing septum, for receiving a syringe needle or a relatively blunt drug delivery spike.


II. BACKGROUND OF THE INVENTION

The administration of fluids to a patient is typically accomplished by inserting a catheter into a patient's vein, and then coupling a source of fluid thereto using an administration set including flexible tubing and one or more couplings or fittings. Occasionally, medication is prescribed by a physician and administered by injecting a dosage of the medication from a syringe into the catheter. This can be accomplished by temporarily disconnecting the catheter from the source of fluid and then coupling the syringe to the catheter.
Alternatively, Y-connectors are customarily incorporated in the administration set to merge fluids from two or more sources to a common tube and to the patient. A typical Y-connector has a self-sealable inlet at one branch, known as an injection site, through which the tip of a piercing member can penetrate for injecting medication. The source of fluid is coupled to a second branch of the Y-connector and remains connected while administering the medication via the first branch. These injection sites usually include an elastomeric plug, sometimes referred to as a "septum" to form a liquid seal.
To avoid accidental sticking while administrating a dosage to the Y-connector, a drug transfer spike, comprised of a cannula is typically attached to the syringe in place of a conventional hypodermic needle. The drug transfer spike has a blunt tip which is adapted to pierce and penetrate the sealable inlet or septum at the injection site. By implementing pre-slit septums in combination with drug transfer spikes having blunt tips, accidental punctures which might other wise result from the use of a standard syringe having a sharp-tipped hypodermic needle are avoided.
In U.S. Pat. No. 5,199,948 to McPhee, a needleless valve is disclosed having a pre-slit septum. The septum is held in place in a housing inlet by a cap affixed thereabout. The septum disclosed has a concave upper surface which bulges and flattens when disposed in the housing inlet and retained by the cap. A drug transfer spike is disclosed having a ball-shaped tip, pointed enough to penetrate the diaphragm of a drug vial, but which is not sharp enough to puncture human skin. The McPhee injection set comprises a total of three pieces. It does not include a locking mechanism for restricting accidental withdrawal of the drug transfer spike from the septum of the injection site.
U.S. Pat. No. 5,167,648 to Jepson et al. also teaches a pre-slit injection site and an associated cannula. A resealable septum is disposed in a cylindrical housing having tapering interior walls and the outer surface of the septum is forced into a dome-like shape due to axial forces applied to the septum's perimeter by the housing's swaged end members. The septum disclosed includes an elastomeric disc with a zero-clearance slit defined axially therethrough.


OBJECTS

It is accordingly a principle object of the present invention to provide an improved injection site for components used in administration sets, which will reliably seal about a blunt tipped drug delivery pin or cannula when pierced.
Another object of the invention is to provide in combination an elastomeric injection site septum and a blunt tipped drug delivery pin or cannula where the pin or cannula includes a means for locking itself to the injection site.
It is a further object of the present invention to provide an injection site comprised of a minimal number of parts, and of parts which can be easily and inexpensively manufactured.
Still another object of the present invention to provide an injection site which can be incorporated into a variety of devices including extension tubes, Y-connectors, vial adaptors, PRN adaptors

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