Universal Parenteral Fluid Administration Connector

Abstract

A connector for connecting parenteral fluid administration tubing to any one of a plurality of different parenteral fluid supply containers having different closure means. The connector includes threaded means for engagement with the threaded closure portion of one form of such parenteral fluid supply containers and piercing means for piercing a pierceable closure portion of a different form of such containers. The connector further includes an improved anti-siphoning valve providing for venting of the container during withdrawal of the fluid therefrom while preventing undesirable loss of the fluid through the venting means. The venting means includes means for filtering the venting fluid, such as ambient air.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to parenteral administration systems and, in particular, to connectors for connecting administration tubing to supply containers in such systems.

2. Description of the Prior Art

The containers for parenteral administration fluids as provided by different manufactures have different closure portions. In one form, the container defines a neck which is closed by a rubber plug having a pierceable portion. In another form, the container neck is provided with a molded thread means for attaching a cap means thereto which may selectively comprise a closure cap or a cap portion of a connector.

To provide venting of the container during the withdrawal of the fluid therefrom, valve devices have been developed permitting flow of venting air into the container as the fluid is withdrawn. Such valve devices include ball check valves and the like. Conventionally, sterile plugs are utilized in the venting line for preventing contamination of the fluid by the ambient air utilized as the venting fluid.

The known devices have the disadvantage of limited use in being specifically adapted for one or the other of the threaded closure and pierceable closure forms of such fluid supply containers and are relatively complicated and expensive of construction.

SUMMARY OF THE INVENTION

The present invention comprehends an improved form of parenteral fluid administration system connector eliminating the disadvantages of the above-discussed conventional connectors in a novel and simple manner.

More specifically, the invention comprehends the provision of such a connector for connecting parenteral fluid administration tubing to a parenteral fluid supply container comprising a connector body having means defining a tubular inlet upstanding therefrom and terminating in an upper sharp piercing tip, means defining an outlet adapted for connection of administration tubing thereto, a bore extending longitudinally through the inlet and the body to the outlet for delivering fluid from the inlet to the outlet, and threaded means on the body for threading the connector to a threaded delivery portion of a fluid supply container, the piercing tip being adapted to pierce a pierceable closure of a delivery portion of the fluid supply container.

Still further the invention comprehends the provision of such a connector further having means defining a second bore pg,3 extending longitudinally through the inlet means, and means defining a vent communicating with the second bore for passing air upwardly through the second bore for venting the supply container during withdrawal of fluid therefrom through the first bore.

The vent means herein includes an anti-siphoning valve comprising a first element having a through bore and an outwardly facing annular shoulder, a second element having a through bore and an inner end, and a diaphragm in the bore of the first element extending across the bore and having a periphery overlying the shoulder, the inner end of the second element clamping the diaphragm periphery sealingly against the shoulder, the diaphragm defining an openable portion defining a check valve permitting fluid flow only from the second element bore to the first element bore.

Thus, the present invention comprehends an improved lowcost connector structure eliminating the disadvantages of the avove-discussed conventional devices and providing an improved universal connector for use with the different forms of commercially available parenteral fluid supply containers and providing improved sterile venting thereof for facilitated fluid administration.

BRIEF DESCRIPTION OF THE DRAWING

Other features and advantages of the invention will be apparent from the following description taken in connection with the accompanying drawing wherein:

FIG. 1 is a side elevation of a connector structure embodying the invention;

FIG. 2 is an enlarged transverse section taken substantially along the line 2--2 of FIG. 1;

FIG. 3 is an enlarged transverse section taken substantially along the line 3--3 of FIG. 1;

FIG. 4 is an enlarged diametric section thereof with the elements thereof spaced apart for facilitating illustration of the construction thereof;

FIG. 5 is a fragmentary side elevation partially in section illustrating the use of the connector with a threaded closure fluid supply container; and

FIG. 6 is a fragmentary side elevation partially in section illustrating the use of the connector with a rubber stop closure fluid supply container .

DESCRIPTION OF THE PREFERRED EMBODIMENT

In the exemplary embodiment of the invention as disclosed in the drawing, a parenteral fluid administration system connector generally designated 10 is shown to comprise a connector adapted for use selectively with a parenteral fluid container 11 having a threaded closure portion 12 defined by the outlet neck 13 thereof, or a container 14 having a conventional pierceable plug 15 closing the tubular neck 16 thereof.

As best seen in FIG. 4, connector 10 includes a body portion 17, a cap portion 18, and a vent valve portion 19. The body portion defines a tubular inlet 20 upstanding therefrom and terminating at its upper end in a sharp tip 21 illustratively comprising a conical tip. The tubular element defines a longitudinal through bore 22 opening at 23 through the conical surface of tip 21 at the upper end of the tubular element, and through an opening 24 at the lower end of a depending outlet 25.

The connector cap portion 18 comprises a cup-shaped element 26 having a tubular side wall 27 defining an internal thread 28 preselected to be complementary to the thread 12 of delivery portion neck 13 of fluid container 11, herein illustratively comprising a 28.degree.-40.degree. finish thread. The base 29 of element 26 is secured to the upper surface 30 of connector body 17 with tubular element, or spike, 20 extending coaxially upwardly through element 26 to have tip 21 spaced upwardly thereof.

Tubular element 20 further defines a second through bore 31 having an opening 32 through conical tip 21 spaced from the axis of the element 20 diametrically opposite bore 22. The lower end of second bore 31 is defined by a laterally opening recess 33 having a frustoconical shape widening outwardly and communicating at its inner end with the lower end of the longitudinally extending portion of second bore 31. Second bore 31 defines a vent passage for admitting vent air into the container during the delivery of fluid therefrom.

Reverse flow of fluid downwardly through passage 31 is prevented by valve means 19 which includes a first tubular element 34 having a reduced diameter tubular connector portion 35 adapted to be sealingly wedged in bore recess 33. Tubular element 34 defines a stepped bore 36 including an outwardly facing annular shoulder 37 intermediate the ends thereof. A rubber diaphragm 38 extends across bore 36 and has a peripheral portion 39 overlying shoulder 37. A second tubular element 40 includes an inner end portion 41 received within the outer end of bore 36 to clamp diaphragm periphery 39 against shoulder 37 in sealed association with element 34. A plug of suitable material, such as sterile cotton, 42 is received in the through bore 43 of tubular element 40 for filtering air passed therethrough to connector bore 31. Air is permitted to flow past diaphragm 38 through a pierced check valve portion 44 provided at the center of the diaphragm. Illustratively, where the diaphragm is formed of pure gum rubber having a diameter of approximately 0.36 inches and a thickness of 0.014 inches, the check valve may comprise a pierced slit opening having a length of approximately 0.04 inches with no material being removed by the piercing operation.

To maintain the sterility of the connector prior to use, tip 21 of the spike, or tubular element, 20 may be covered by a cap 45 having a lower end 46 adapted to be removably secured to the upper portion of cap 18, and the vent means may be closed by a cap 47 having an inner end portion 48 adapted to be telescopically removably secured to the tubular element 40.

As indicated briefly above, connector 10 is adapted for universal use in connection with different forms of parenteral fluid containers, such as threaded container 11 and nonthreaded container 14. Thus, where connector 10 is to be used with the threaded container 11, the connector is attached by firstly effecting removal of the container threaded closure and simple threading of the connector onto the threaded portion 12 of the container neck with tubular element tip 21 being exposed to the fluid in the container for flow thereof to the transfer tubing 49 which may be connected to outlet 25 of the connector. When the bottle is inverted, as shown in FIG. 5, fluid may flow through opening 23 to tubing 49 through bore 22 and venting air may flow through valve means 19 upwardly through the tubular element passage 31 and outwardly through opening 32 into the container. The venting air is maintained sterile by the flow thereof through the plug 42 and parenteral fluid is prevented from flowing downwardly and outwardly through vent means 19 by the check valve action of slit 44 which permits only a unidirectional fluid flow upwardly through the passage 31. That is, since the valve diaphragm is held only at its edges, the elasticity of the material keeps the slit closed when the pressure on opposite sides of the diaphragm is equal. However, when liquid is withdrawn from the container, thereby reducing the pressure in the container, this pressure differential causes the diaphragm to bulge, thereby opening the slit and permitting air to flow into the container. The liquid in the container is prevented from flowing outwardly through the slit in the diaphragm because the pressure therein is insufficient to cause the diaphragm to bulge and open the slit. That is, there is a column of air trapped between the liquid and the diaphragm in the vent bore and this, together with the liquid pressure in the bottle, is insufficient to cause the diaphragm to bulge and open the slit.

Where a container 14 is to be utilized for administering the parenteral fluid, the user merely urges piercing tip 21 upwardly through the pierceable closure 15 to expose passage openings 23 and 32 to the fluid within the container. The connector functions in the same manner as with container 11 to permit the withdrawal of the parenteral fluid downwardly therethrough and providing venting air into the container through the valve portion 19.

Connector 10 is extremely simple of construction and, illustratively, may be formed primarily of molded plastic, such as polystyrene, with the several elements of the connector being secured together by suitable solvent-type cement. Herein, body 17, spike 20, and outlet 25 comprise a one-piece integral molding. Frustoconical surface 33 and valve means connector portion 35 may define a standard male luer taper. Outlet 25 may have a suitable outer diameter for connection thereto of the standard parenteral administration tubing, and illustratively, may have an outer diameter of approximately 0.125 inches for use with nominal 1/8 inch vinyl tubing 49.

Protective caps 45 and 47 may similarly be formed of molded plastic, such as polystyrene, and may be fitted to the connector in wedged sealed association while permitting ready removal therefrom at the time of use.

The foregoing disclosure of specific embodiments is illustrative of the broad inventive concepts comprehended by the invention.

Claims

I claim:

1. A connector for selectively connecting parenteral fluid administration tubing to parenteral fluid supply containers of first and second different types of constructions wherein the first type of construction has a threaded delivery portion and the second type of construction has a pierceable closure within the delivery portion thereof, comprising a body portion including an outlet for connection with said tubing, and a vent opening for connection to the atmosphere, a cap connected to said body portion and having a lower end wall, an upper open end, and axially extending side walls having threads thereon adapted to threadedly receive the threaded delivery portion of a container of said first type, a spike connected to said body portion and said cap and extending axially upwardly from said lower end wall of said cap, said spike having an upper end tip portion with first and second openings therein adapted to be disposed within a container of said first type, a first passageway extending through said body portion and said spike and connecting said first opening in said tip portion with said outlet for delivering fluid from a container to said tubing, a second passageway extending through said body portion and said spike and connecting said second opening in said tip portion with said vent opening, filter means connected to said vent opening for filtering air from the atmosphere to said vent opening to supply filtered air through said second passageways to said second opening in said tip portion and to a container during delivery of fluid therefrom to said tubing, and check valve means disposed between said filter means and said vent port for preventing fluid from flowing from said second passageway to said filter means, said spike extending axially upwardly a predetermined distance above said upper open end of said cap for receiving the pierceable closure of a supply container of said second type with said tip portion and said first and second openings disposed within the container.

2. The connector of claim 1 wherein said predetermined distance is greater than the axial distance between said lower wall and said open end of said cap.

3. The connector of claim 1 wherein said check valve means comprises a diaphragm having a piecred portion permitting fluid flow from the atmosphere to said container.

4. The connector of claim 3 further including a first tubular element disposed in said vent opening and having a stepped bore therein defining an annular shoulder, said diaphragm engaging said shoudler, and a second tubular element received in said first tubular element to hold the periphery of said diaphragm against said shoulder and secure said diaphragm in said first tubular element, and wherein said filter means are disposed in said second tubular element.

5. The connector according to claim 3 further including a first cover secured over said open end of said cap to enclose said tip portion of said spike prior to use of the connector with a supply container, and a second cover closing said second tubular element when said connector is not in use, said tubular element extending generally normal to the axis of said spike.