Plastic and nonmetallic article shaping or treating: processes – Direct application of fluid pressure differential to... – Including use of vacuum
Reexamination Certificate
1998-08-21
2001-04-03
Silbaugh, Jan H. (Department: 1732)
Plastic and nonmetallic article shaping or treating: processes
Direct application of fluid pressure differential to...
Including use of vacuum
C264S318000, C264S328100, C264S334000, C264S335000, C425S577000, C425SDIG005
Reexamination Certificate
active
06210624
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the medical arts, and more particularly to a method of forming a reseal element for use in a needleless injection site having particular utility in relation to 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 inadvertent 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.
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. In the parent application immediately preceding the present application, Applicant's needleless injection site is provided with design features which are adapted to prevent the inadvertent 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. These design features are largely embodied in the reseal member of the needleless injection site. The present invention provides a unique methodology for forming the reseal member, and in particular the body element thereof.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a novel and unique method for forming a reseal element of a reseal member used in a needleless injection site. Further in accordance with the present invention, there is provided a mold assembly for carrying out such method. The mold assembly comprises a movable first or bottom plate which defines a generally planar top surface and includes a core opening extending therethrough. In addition to the first plate, the mold assembly comprises a shell core which extends through the core opening of the first plate and protrudes from the top surface of the first plate. The shell core itself defines a flow passage which extends therethrough.
Extending through the flow passage of the shell core and protruding therefrom is a center pin of the mold assembly. The center pin is operable to selectively block the flow passage defined by the shell core. More particularly, the center pin is movable relative to the shell core between a pin molding position whereat the flow passage is blocked by the abutment of the centering pin against the shell core and an air blow position whereat the flow passage is unblocked by the extension of the center pin from the shell core in an amount sufficient to create a gap therebetween. The first plate is selectively movable upwardly and downwardly along those portions of the shell core and the center pin protruding from the top surface thereof.
The mold assembly of the present invention further comprises a center core which also extends within
Critical Device Corporation
Eashoo Mark
Silbaugh Jan H.
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