Needleless injection site

Details Needleless injection site Needleless injection site

1997-11-07

2001-02-06

Kennedy, Sharon (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

C604S167020

Reexamination Certificate

active

06183448

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to the medical arts, and more particularly to a needleless injection site for use in intravenous infusion applications.
BACKGROUND OF THE INVENTION
It is common medical practice to intravenously infuse various fluids or medicaments into a blood vessel of a patient (e.g., a vein or artery). Such infusion is typically accomplished by the insertion of a hollow introducer needle into a target blood vessel. The introducer needle is fluidly connected to one end of an elongate, flexible tube or fluid line, the opposite end of which is fluidly connected to a solution bag. The solution bag itself is typically suspended above the patient so as to allow gravity to facilitate the flow of fluid downwardly through the fluid line and into the patient's blood vessel via the introducer needle which remains operatively positioned therewithin. The fluid tube and solution bag are connected to each other via a metering apparatus which controls the infusion rate of fluid from the bag into the tube.
In many intravenous infusion assemblies, an injection site is fluidly coupled within the tubing intermediate the introducer needle and the solution bag. The injection site typically has a Y-shaped configuration and comprises a tubular main body portion having a tubular side arm portion in fluid communication therewith. The distal end of the side arm portion is fluidly connected to the solution bag via an upper segment of the tubing, with the bottom end of the main body portion being fluidly connected to the introducer needle via a lower segment of the tubing. The top end of the main body portion is itself covered by a diaphragm which is typically fabricated from rubber or a similar resilient material.
The inclusion of the injection site within the tubing allows various medications to be selectively infused into the blood vessel of the patient by the addition thereof to the solution flowing from the solution bag into the blood vessel via the upper tubing segment, injection site, lower tubing segment and introducer needle. This supplemental infusion is typically accomplished through the utilization of a conventional syringe, the needle of which pierces and is extended through the diaphragm disposed on the top end of the main body portion of the injection site. Subsequent to the expulsion of the medication from within the syringe and into the flowing solution, the needle is retracted out of the main body portion of the injection site, with the aperture created in the diaphragm due to the passage of the needle therethrough being substantially closed upon such retraction due to the resiliency of the diaphragm. As will be recognized, the incorporation of the injection site within the tubing allows various medications to be intravenously administered to the patient through the existing infusion site within the blood vessel, thus eliminating the need to subject the patient to additional needle sticks.
Though providing certain benefits to the patient, the injection sites constructed in accordance with the prior art possess certain deficiencies which detract from their overall utility. As previously explained, the use of such injection sites typically requires that the needle of the conventional syringe be extended through (i.e., puncture) the diaphragm attached to the top end of the main body portion of the injection site. However, the necessity of having to utilize a syringe with a needle to facilitate the introduction of the medication into the solution flow is undesirable due to the risk of inadvertent needle sticks.
In recognition of this deficiency, there has also been developed in the prior art needleless injection sites which incorporate a diaphragm adapted to assume open and closed configurations without having a needle inserted thereinto. Though these needleless injection sites eliminate the necessity of having to puncture the diaphragm with a needle, they also possess certain deficiencies which detract from their overall utility. Foremost of these deficiencies is the difficulty associated with disinfecting the injection site, and in particular the diaphragm thereof, subsequent to medication being infused thereinto. In this respect, after each use of the injection site the diaphragm must be cleaned, with such cleaning typically being accomplished through the application of alcohol or a similar disinfecting agent thereto. However, due to the configuration of the diaphragm, complete and effective disinfection thereof is often difficult to achieve, thus increasing the risk of the inadvertent introduction of contaminates into the solution stream upon subsequent uses of the injection site.
In an effort to overcome the deficiencies associated with the prior art injection sites, Applicant developed the needleless injection sites disclosed in the previously identified issued patents and co-pending applications which are the parent cases of the present application. The present needleless injection site constitutes an improvement over those disclosed in the parent cases. In this respect, the present injection site is provided with design features which are adapted to prevent the inadvertant obstruction of the fluid flow path, and to increase the level of positive flow within the fluid flow path such that the withdrawal of a needled or non-needled introducer from within the injection site does not cause a vacuum to be pulled within a tubular fluid line connected thereto.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a needleless injection site which comprises a housing. The housing itself comprises an interior chamber, a central opening which communicates with the interior chamber, and an elongate, proximally extending dilator projection portion which defines a fluid passage and extends toward the central opening in coaxial alignment therewith.
In addition to the housing, the present needleless injection site comprises a reseal member which is disposed within the central opening and the interior chamber of the housing. The reseal member includes an elastically openable and closable aperture, and an expandable and collapsible reservoir which, when expanded, is adapted to retain a volume of fluid. The reseal member normally resides in a first position within the housing wherein the aperture is closed and the reservoir is collapsed. The reseal member is selectively deformable such that the application of distally directed compressive pressure thereto will cause the same to distally advance within the housing to a second position wherein the reservoir is expanded and the aperture is opened and placed into communication with the fluid passage and the reservoir. The removal of the distally directed compressive pressure from the reseal member facilitates the resilient return thereof to the first position wherein the aperture is closed and the reservoir is collapsed. The collapse of the reservoir which occurs when the reseal member resiliently returns to its first position forces the fluid within the reservoir into the fluid passage which effectively prevents the creation of a vacuum therewithin.
In accordance with the present invention, the reseal member comprises a resilient body having a distal end and a proximal end which defines inner and outer surfaces. Extending through the proximal end between the inner and outer surfaces thereof is the elastically openable and closable aperture. The proximal end of the body is defined by a generally cylindrical proximal portion thereof, with the distal end being defined by a generally cylindrical distal portion of the body. The proximal and distal portions are separated by a beveled shoulder formed therebetween, and are sized such that the diameter of the distal portion exceeds the diameter of the proximal portion.
In the present injection site, the inner surface of the proximal end of the body has a generally semi-spherical configuration to prevent any inadvertant tearing of the proximal end when the reseal member is moved between its first and second positions. Additionall

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